Outcome related to impact on daily living: preliminary validation of the ORIDL instrument

BMC Health Services ResearchBioMed Central Research article Open Access Outcome related to impact on daily living: preliminary validation of the ORIDL instrument David Reilly*1, Stewart W Mercer2, Annemieke P Bikker1 and Tansy Harrison1 Address: 1AdHom Academic Departments, Centre for Integrative Care, Glasgow Homœopathic Hospital, 1053 Great Western Road, Glasgow G12 OXQ, Scotland, UK and 2General Practice and Primary Care, Division of Community-based Sciences University of Glasgow, Glasgow G12 9LX, Scotland, UK Email: David Reilly* - davidreilly1@compuserve.com; Stewart W Mercer - sm83z@clinmed.gla.ac.uk; Annemieke P Bikker - A.Bikker@btinternet.com; Tansy Harrison - tansyharrison@hotmail.com * Corresponding author Published: 2 September 2007 Received: 7 December 2006 BMC Health Services Research 2007, 7:139 doi:10.1186/1472-6963-7-139 This article is available from: http://www.biomedcentral.com/1472-6963/7/139 Accepted: 2 September 2007 © 2007 Reilly et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Background: The challenge of finding practical, patient-rated outcome measures is a key issue in the evaluation of health care systems and interventions. The ORIDL (Outcome in Relation to Impact on Daily Living) instrument (formerly referred to as the Glasgow Homoeopathic Hospital Outcomes Scale or GHHOS) has been developed to measure patient's views of the outcome of their care by asking about change, and relating this to impact on daily life. The aim of the present paper is to describe the background and potential uses of the ORIDL, and to report on its preliminary validation in a series of three studies in secondary and primary care. Methods: In the first study, 105 patients attending the Glasgow Homoeopathic Hospital (GHH) were followed-up at 12 months and changes in health status were measured by the EuroQol (EQOL) and the ORIDL. In the second study, 187 new patients at the GHH were followed-up at 3, 12, and 33 months, using the ORIDL, the Short Form 12 (SF-12), and the Measure Yourself Medical Outcome Profile (MYMOP). In study three, 323 patients in primary care were followed for 1 month post-consultation using the ORIDL and MYMOP. In all 3 studies the Patient Enablement Instrument (PEI) was also used as an outcome measure. Results: Study 1 showed substantial improvements in main complaint and well-being over 12 months using the ORIDL, with two-thirds of patients reporting improvements in daily living. These improvements were not significantly correlated with changes in serial measures of the EQOL between baseline and 12 months, but were correlated with the EQOL transitions measure. Study 2 showed step-wise improvements in ORIDL scores between 3 and 33 months, which were only weakly associated with similar changes in SF-12 scores. However, MYMOP change scores correlated well with ORIDL scores at all time points. Study 3 showed similar high correlations between ORIDL scores and MYMOP scores. In all 3 studies, ORIDL scores were also significantly correlated with PEI-outcome scores. Conclusion: There is significant agreement between patient outcomes assessed by the ORIDL and the EQOL transition scale, the MYMOP, and the PEI-outcome instrument, suggesting that the ORIDL may be a valid and sensitive tool for measuring change in relation to impact on life. (page number not for citation purposes) Page 1 of 10 BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 Background The challenge of finding practical, patient-focussed, clini- cally-relevant outcome measures is a key issue in the increasing call for patient-centred care and clinical govern- ance in health systems around the world [1,2]. However, there are relatively few patient-rated outcome measures that seek to measure change from the patients' perspec- tive, using simple concepts such as change in main prob- lems or symptoms and well-being [3,4]. Furthermore, it is difficult to know from these measures how meaningful any reported changes are in terms of impact on the indi- viduals' daily life. The ORIDL (Outcome in Relation to Impact on Daily Liv- ing) instrument measures patients' views of the outcome of care [5]. Created initially for evaluating experimental clinics [6], its increasing adoption under its former name, the Glasgow Homoepathic Hospital Outcome Scale (GHHOS), in a number of centres [7-11] and studies [12- 17] has created a need to study its validity which has not previously been explored. It differs from many other scales by asking about change directly, and by relating outcome to the effect of the intervention on impact on daily life. In the present paper we report on a series of studies in which we have had the opportunity to compare the ORIDL with three validated measures in secondary (integrative care) and primary (conventional care) set- tings. Methods The rationale behind the development of the ORIDL was to base the instrument on the type of dialogue that the doctor (or other health care professional) and patient would have to evaluate outcome in the clinical encounter. For example, a dialogue may be as follows: Doctor: Well, was there any effect from what we did? Patient: Yes, I think it helped... Doctor: Yes, but was it a useful effect? Can you give me an example? Patient: Yes, it was really useful, I was able to get about more and go to the shops. Doctor: Really? And is that a major change, a really marked benefit, or is it less than that? Patient: No, this is really marked, it's the best thing I've had for the problem. I'm not saying It has cured it or any- thing, I mean I still have the problem, but I could live with it now. The aim was to embed the essence of these dialogues in the design of the instrument, but allow it to be standard- ised in a way that would allow a questionnaire based ver- sion of the scale to measure the participants' opinions on the effects of the intervention (not their view on the natu- ral progression of the health problems being considered). The validation studies took place in the outpatient unit of GHH, an NHS-funded Centre for Integrative care, and in primary conventional care in an area of high deprivation in Glasgow. Ethical approval was obtained for all 3 studies from the West of Glasgow University NHS Trust. Written consent was obtained from all patients. In the GHH study 1, four senior doctors took part and the participants were adult out-patients attending the GHH for various periods of time (see ref 12 for details). In GHH Study 2, nine doc- tors took part (not including 2 of the 4 senior doctors who took part in study 1) and the participants were all new outpatients above 12 years of age whom the doctors saw in the 3 months from September to December 2002, as reported previously [14]. In study 3, five GP Principals took part working in the same Practice, and the partici- pants were adult patients registered with the practice. The ORIDL offers nine options for the participant to choose. In study 1, the format used to elicit patients' views was as shown in Figure 1. In study 2, a different format was used to elicit patients' views on these 9 options, as shown in Figure 2. This ques- tion was then repeated for 'your overall well-being'. In study 3, the format used in study 1 was adopted (Figure 1), but modified to 'the overall effect of your treatment by your GP' as it was a primary care study of general practi- tioners. A score of 2 or above was used as a 'ORIDL threshold' score as the wording at this level records an effect on qual- ity of daily living as perceived by the patient. Choosing timings and targets The target and timing of use of the ORIDL is chosen by the participants and the context, and so reporting needs to make clear what choices were used. We have used ORIDL in the current studies for patients' views. It is less explored for recording practitioners own views. Presenting results Individual results can be recorded in the medical casenotes as need be, perhaps beside the intervention they refer to, or as overall results. This has been useful in clinical prac- tice at the GHH as a 'shorthand' code allowing the care team to share a sense of the value or otherwise of interven- tions. Group results can be presented graphically to show Page 2 of 10 (page number not for citation purposes) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 The following questions ask you, compared to how you were when you first attended GHH, what has been the overall effect of your treatment at Glasgow Homoeopathic Hospital on your main complaint, and general feeling of well-being with the problem up to the present time?” Please complete the 2 boxes using the scale shown above: 1.The main complaint for which you came for treatment 2. Your overall well-being +4 Cured /Back to normal +3 Major Improvement +2 Moderate improvement, affecting daily living +1 Slight improvement, no effect on daily living 0 No change/Unsure -1 Slight deterioration, no effect on daily living -2 Moderate deterioration, affecting daily living -3 Major deterioration -4 Disastrous deterioration FOiRguIDrLe f1ormat in study 1 ORIDL format in study 1. the range of results for a group or cohort of patients, as reported in the present paper. Procedure Immediately before their consultation, the patients were asked to complete the EQOL [18] (Study 1, GHH) or the SF-12 [18] (Study 2; GHH) and during the consultation (with the practitioner) they did the initial MYMOP [3] (Study 2; GHH, Study 3; Primary Care). After the consul- tation they completed demographic questions and put the forms in a sealed collection box. In Study 1, the patients were posted a follow up questionnaire containing the EuroQOL and ORIDL (main complaint and well-being) at 12 months after baseline assessment. In Study 2, the patients were posted follow up questionnaires at 3 months, 12 months and 33 months after initial consulta- tion (baseline assessment) containing the SF-12, MYMOP, and ORIDL. In Study 3, patients were posted a follow up questionnaire at 3–4 weeks after contact consul- tation (baseline assessment). In studies 1 and 2, non- responders received two postal reminders, in study 3, 1 postal reminder followed by a telephone call. Validated measures used to compare with ORIDL The Measure Yourself Medical Outcome Profile (MYMOP) has four items which are completed during the consultation [3]. The patients choose (with regard to their main problem) up to two main symptoms and one activ- ity of daily living, which are scored for severity over the past week on a seven-point scale (from 0 = "As good as it could be", to 6 = "As bad as it could be"). In a similar way a general well being question is completed. By adding up the scores to all the items and dividing the total by the number of answered items an overall profile score is cal- culated. On the follow up questionnaire the wording of the chosen symptoms and activity are copied and scored again by the patients [3]. The EuroQOL-5D (EQOL) and the Short Form 12 (SF-12) are both widely used self-completed instruments to meas- ure health status [18,19]. In the EQOL, five domains make up the descriptive system of the instrument; mobil- ity, self-care, usual activities, pain/discomfort, and anxi- ety/depression. There are three possible responses for each domain. Results can be presented descriptively, or scores added to give an un-weighted total score or an index (weighted) score can be calculated from published tables togiveaco-efficientbetweenzeroandone.Inaddition the EQOL has a VAS component which asks the patient to rate their current health status on a visual analogue scale from 0 (worst imaginable health state) to 100 (best imag- inable health status). Finally, the EQOL also includes a transition measure, asking patients to rate their current health state against the previous 12 months (Better, Same Worse). In the SF-12, twelve questions comprise several concepts, such as physical functioning, social functioning, and bodily pain. The responses are weighted and com- bined to derive two summary scales: (1) the physical com- ponent score (PCS), which is an indicator of physical health (2) the mental component score (MCS), which is an indicator of mental health. The two scores range Page 3 of 10 (page number not for citation purposes) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 The following questions ask you what the overall effect your treatment has had on your main complaints, general feeling of well-being, and your coping with the problem up to present time. The questions are asked in such a way that they reflect the dialogue you may have during the consultation with your doctor or practitioner. Please, answer the questions by ticking the boxes and then follow either the arrows to the next question or the instructions next to boxes. 1. Your main complaint(s)... (please tick boxes) 1. “Has the treatment caused any improvement or deterioration in your main complaint(s)?” +1 Yes, it improved 0 No, no change (Please go to Q.2) -1 Yes, it got worse 2................ “Is/was this change enough to affect the quality of your daily living?” +2 Yes, it improved No, no change (Please go to Q.2) -2 Yes, it got worse 3............................... “Is/was this change very marked, a major effect?” +3 Yes, a major improvement No, no change (Please go to Q.2) -3 Yes, a major deterioration 4. “Is/was this change a complete resolution or disastrous deterioration of the problem?” +4 Yes, a complete resolution No, neither -4 Yes, a disastrous deterioration FOiRguIDrLe f2ormat in study 2 ORIDL format in study 2. between 0 and 100 and higher scores imply better overall health. The Patient Enablement Instrument (PEI) is a six-item measure that was developed and validated to measure the immediate outcome of consultations in primary care [20]. However, we have recently used the PEI to measure patients views on enablement over time [14] and qualita- tive work suggests it may be a useful outcome for patients in terms of changes in self-concept [21]. Therefore we have reported on the PEI as a longer-term outcome meas- ure (PEI-Outcome) in the present paper. Participants Study 1 (GHH) – patients completed the follow-up study at 12 months, patient details have been reported else- where [12,22]. Study 2 (GHH) – patients completed the follow up ques- tionnaire at three months, at twelve months, and 33 months. Details of the patients characteristics have been previously reported [14]. An additional time points at 20 months was included using the ORIDL only. Study 3 (Primary Care) – patients completed the follow up questionnaire at 1 month. Analysis The data were analysed through the statistical package SPSS. Comparisons between the ORIDL scores with the change scores (i.e. the difference between the scores from the first and follow up questionnaires) of the EQOL, MYMOP and SF-12 was assessed by using Spearman's rank correlation coefficient. Through independent sam- ples t-tests it was checked whether people who had scores below the ORIDL threshold (< +2) had significantly lower change scores on the MYMOP and SF-12 than the people who had scores above the ORIDL threshold (+2 and above). Results Study 1: ORIDL and EQOL scores over 12 month 105 patients consented to follow-up, and 74 returned the questionnaire at 12 months (75% response rate). Of these 74, there were 5 missing values (6.8%) for ORIDL (both main complaint and well-being). Missing values for EQOL ranged from 6.8–10.9%, (mean 9.0%). Page 4 of 10 (page number not for citation purposes) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 Figure 3 shows the distribution of ORIDL scores at 12 months post contact consultation in patients attending the GHH. The majority of patients reported overall improvements in their main complaint and well-being, with some 68% and 77% reporting improvements in quality of daily living (ORIDL scores of 2+ or better) in main complaint and well-being, respectively. However, the lack of a 'ceiling effect' should also be noted, with no patient recording a score of plus 4 ('cured'). With the EQOL, small but statistically significant improvements (p < 0.001, chi-squred) between baseline and follow-up scores were observed for usual activities (13% of patients showing improvement), pain/discom- fort (22% showing improvement) and anxiety/depression (13% showing improvement). No significant changes were found in mobility or self-care (results not shown). A significant but small difference in EQOL VAS score was found between baseline and follow-up (baseline; mean Health State Today 62.5, follow-up: mean Health State Today 68.6, p = 0.001) signifying a small improvement in perceived overall health status. The EQOL transition score (Health state today compared with 12 months ago) showed much larger perceived changes, with 66% of patients reporting 'better', 21 % 'same' and 13% 'worse' health state. Table 1 shows the correlations between ORIDL and EQOL scores. No significant correlations were found between the ORIDL and the EQOL total score for the change in the 5 domains between baseline and follow-up (calculated as either a weighted or un-weighted total scores). Changes in the individual domains of the EQOL were also not signif- icantly correlated with the ORIDL, except for a weak cor- relation (rho 0.25, p = 0.04) between EQOL-Mobility and ORIDL-Well-Being (results not shown). EQOL-VAS change showed a weak but significant correlation with ORIDL-wellbeing score but not with ORIDL-main com- plaint (Table 1). However, EQOL-transitions score (per- ceived change over the last 12 months) were highly correlated with both components of the ORIDL (Table 1). Similarly PEI-Outcome scores (change in enablement over 12 months) were also significantly related to ORIDL scores (Table 1). The correlation between ORIDL-main complaint and ORIDL-well being was 0.724, p < 0.001. gFOoiRgwuIDHrLeosm3coreeospoatvheirc 1H2omspoitnatlh(sSitnudpyat1ie)nts attending the Glas- ORIDL scores over 12 months in patients attending the Glas- gow Homoeopathic Hospital (Study 1). Study 2: ORIDL and MYMOP and SF-12 scores at 3 months, 12 months, and 33 months in new patients 187 new patients consented to follow-up, and question- naire response rates were 117 (63%), 76 (41%) and 75 (40%) at 3, 12, and 33 months respectively. Missing val- ues for ORIDL items at the different time points ranged from 0.9 – 6.4% (mean 3.4%). Missing values for MYMOP symptom 1 and well-being items ranged from 40 30 20 10 0 -2.00 -1.00 .00 ORIDL-MC 1.00 2.00 3.00 17 33 35 6 4 4 50 40 30 20 10 0 3 41 36 9 6 6 -2.00 -1.00 .00 ORIDL-WB 1.00 2.00 3.00 Table 1: Spearman's correlations between ORIDL and EQOL at GHH (study 1) ORIDL-main complaint ORIDL-well being 0.083 (63) 0.029 (63) 0.261 (64) * 0.546 (67)*** 0.487 (67)*** Change in EQOL Score (un-weighted) Change in EQOL Score (Weighted) Change in EQOL – VAS EQOL – transition scale PEI Outcome * p < 0.05, ** p < 0.01, *** p < 0.001 0.201 (63) 0.115 (63) 0.152 (64) 0.643 *** (66) 0.418 ***(67) (page number not for citation purposes) Page 5 of 10 Percent Percent BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 5.3–15.8% (mean 11.0%) and for SF-12 items from 4.0– 22.4% (mean 13.6%). Figure 4 shows the ORIDL scores (expressed as % scoring 2+ or above) of new patients attending the GHH followed prospectively up to 33 months. As can be seen there was a slow but steady improvement in main complaint and well-being in terms of effect on daily life over the 33 month period. The baseline and follow-up scores at 3 months and 12 months for the SF-12 and the MYMOP have been pub- lished previously (Bikker et al 2005) and showed no changes in SF-12 scores but significant improvement in MYMOP scores. Similarly, SF-12 scores showed no signif- icant changes between baseline and 33 months for either the physical or mental health components (results not shown). MYMOP scores did however show significant improvements (paired t-test) in scores for symptoms (baseline 4.24, 33 months 3.16, p < 0.001), well-being (baseline 3.50, 33 months 2.84, p < 0.01), and profile score (baseline 4.02, 33 months 3.18, p < 0.001). Table 2 shows the correlations between ORIDL and MYMOP, SF-12 and PEI-outcome at 3,12, and 33 months. As can be seen, ORIDL scores were only weakly related to SF-12 change scores at all 3 time points, with few signifi- cant correlations. However, ORIDL and MYMOP change scores were much more highly correlated, showing signif- icant relationships to each other at all time points and for all components reported (MYMOP symptom change, MYMOP well-being change, and MYMOP profile change all significantly related to both ORIDL main complaint and ORIDL well-being). There was no indication that the strength of the correlation between ORIDL and MYMOP weakened with time (i.e., correlations at 33 months were as strong, if not stronger, than at 3 months). The strongest correlations with ORIDL was generally with the change in MYMOP profile score. IFmiogpnurtorhevse4amteGnHtsHin(dStauildyyliv2i)ng reported by the ORIDL over 33 Improvements in daily living reported by the ORIDL over 33 months at GHH (Study 2). Table 2 also shows that the PEI-outcome measure also correlated significantly with the ORIDL at 3 months and 12 months (PEI-outcome was not measured at 33 months). 50 40 30 20 10 44 24 37 20 3 months Time (months) 12 months 20 months 33 months 50 40 30 20 10 0 40 15 35 13 3 months Time (months) 12 months 20 months 33 months Table 2: Spearman's correlation between ORIDL and SF-12, MYMOP, and PEI at GHH (study 2) ORIDL – main complaint ORIDL – well being 12 months 0.152 (57) 0.040 (57) 0.487** *(62) 0.485*** (69) 0.439** *(63) 0.640*** (63) SF-12 PCS Change SF-12 MCS Change MYMOP Change inProfile MYMOP Change in Symptoms MYMOP Change in Well-Being PEI Overall Outcome 3 months 0.214* (90) 0.245* (90) 0.444*** (90) 0.433*** (109) 0.334** (102) 0.451** (105) 12 months 0.186 (56) 0.015 (56) 33 months 0.224 (63) 0.334** (63) 3 months 0.211* (90) 0.235* (90) 0.400** (99) 0.435** *(109) 0.333** (101) 0.528*** (104) 33 months 0.336** (63) 0.388** (63) 0.541*** (68) 0.446***(70) 0.383** (64) - Page 6 of 10 0.474*** (61) 0.444** *(68) 0.314* (62) 0.586***(62) - 0.499** *(68) 0.440 ** *(70) 0.390** (64) * p < 0.05, ** p < 0.01, *** p < 0.001 (page number not for citation purposes) ORIDL-WB Score +2 or above (%) ORIDL-MC Score +2 or above (%) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 Table 3: Spearman's correlation of ORIDL with MYMOP and PEI in primary care (study 3) 40 30 20 10 0 29 22 6 17 18 3 3 -2.00 -1.00 .00 ORIDL-main complaint 1.00 2.00 3.00 4.00 50 40 30 20 10 0 40 17 15 15 4 3 4 -3.00 -2.00 ORIDL-well being -1.00 .00 1.00 2.00 3.00 4.00 MYMOP Profile Score MYMOP Symptom 1 Score MYMOP Well-Being Score PEI Outcome *** p < 0.001 ORIDL- main complaint 0.510*** 0.553*** 0.358*** 0.572*** ORIDL- well being 0.437*** 0.409*** 0.385*** 0.584*** FOiRguIDrLe o5utcomes in primary care at 1 month ORIDL outcomes in primary care at 1 month. Study 3 (Primary Care): ORIDL and MYMOP at 1 month post-baseline 323 patients consented to follow-up, and 159 returned the questionnaire at 1 month (49% response rate). Of these 159, missing values (6.8%) for ORIDL main com- plaint and well-being items were 10% and 11%, respec- tively. Missing values for MYMOP symptom 1 and well- being items ranged from 2.0–7.0% (mean 4.7%). Missing values for PEI ranged from 2.6–5.0% (mean 4.0). Figure 5 shows the distribution of ORIDL scores 1 month after contact consultation in primary care. The percent reporting a significant impact of daily living for main complaint is 43% and for well-being is 34%. The percent- age reporting no change (a score of zero) was 29% for main complaint and 40% for well-being. This was similar to the percentage showing no change (a change score of zero) for the MYMOP (32% for symptom 1, 41% for well- being). For MYMOP scores at baseline and 1 month significant improvements were found in symptom (baseline 4.50, 1 month 3.58, p < 0.001) and profile score (baseline 4.07,1 month 3.64, p < 0.001) but not in well-being (baseline 3.53, 1 month 3.53). Table 3 shows the relationship between ORIDL and MYMOP and PEI in primary care. ORIDL components were highly and significantly correlated with all MYMOP change scores, with the highest correlations found between ORIDL -main complaint and MYMOP symptom change and profile change. A significant relationship between MYMOP well-being change and the ORIDL items was also found. PEI-outcome was highly correlated with the ORIDL items. The ORIDL threshold score (+2) Scores of ≥ +2 on the ORIDL denotes a meaningful change in the outcome to the patient (i.e. sufficient to improve daily living), so it was hypothesised that patients with scores of +2 and above would have significantly higher results on the change scores of the MYMOP compare with patients with ORIDL scores below +2. As Table 4 shows, this was the case in all instances in all three studies and at all time points measured. Discussion The development of the ORIDL instrument arose from directly asking patients questions of clinical relevance: 'Did the treatment work?', 'Was it any good?', 'Is this serv- ice helping reduce suffering?' Determining outcome is always challenging, 'proof' changes as it emerges from a complex of scientific, cultural and personal factors – an 'Evidence Mosaic' – determined as much by who is asking the question, why and when, as by any abstract notion of pure science [23]. The ORIDL scale contributes by being rooted in the patient's experience of how the outcome of care has affected their daily life. As the scale (under its former name of GHHOS) has come into use in clinical and research contexts in recent years by virtue of its high face validity and practical ease of use, this paper's aim was to formalise its introduction, comment on its practical use, and take forward issues of validity. Page 7 of 10 (page number not for citation purposes) Percent Percent BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 Table 4: Mean change in MYMOP profile scores in ORIDL categories 2+ or better versus less than 2+ n 73 GHH 12 mths Mean (SD, n) GHH 33 mths Mean (SD, n) GP 1 mth Mean (SD, n) 0.027 (1.47) 47 ORIDL-main complaint MYMOP Change (Profile) GHH (3 mths) Mean (SD) < 2+ 0.00 (1.38) 2+ or better 1.49 (1.17) 26 1.61 (0.98) 14 ORIDL-well being < 2+ 2+ or better 0.14 1.09 (1.48) (1.24) 73 26 0.38 1.58 (1.51) (0.536) 53 9 p-value <0.01 <0.05 <0.01 <0.001 P-value <0.001 <0.01 0.15 (1.49) 3236 4028 0.25 1.31 (1.26) (1.42) 106 37 <0.001 0.31 0.99 (1.36) (1.32) 114 28 1.40 (1.27) <0.001 0.32 1.48 (1.46) (1.29) In the present series of studies, the ORIDL instrument showed significant and moderate-high correlations with the MYMOP at all time-points examined and in both the secondary (integrative) care setting of the GHH (Study 2) and in the primary (conventional) care setting (Study 3). This is an important finding, given that the MYMOP is now a well established instrument used to chart changes in patients symptoms and well-being, and is known to be to be more responsive to change than other widely-used tools such as the SF-36 [3] and the EuroQOL [23]. Fur- thermore, the consistency of the relationship between the ORIDL and the MYMOP, even up to 33 months after ini- tial baseline measurement, suggest a stability to the changes captured by the ORIDL. This is again of consider- able importance, given that academic opinion is divided on the use of transition measures versus serial measures when measuring health outcome. Whereas some argue that measuring change retrospectively (as in ORIDL) is highly fallible because it depends on accurate memory of the past [24,25], others take the opposite view, with evi- dence to show that patients' retrospective assessments are more sensitive, and correlate better with patient satisfac- tion and physical and biological indicators of change in disease state [26,27]. These two opposing academic views of psychometrics and 'clinimetrics' have not been recon- ciled as yet, and it has been argued that both may be valid and important depending on the context [20,26]. The ORIDL scale was created by a clinician (DR) and thus reflects this direct approach of asking patients about change, as carried out by clinicians in practice. However, by anchoring the scale in the concept of improvement in daily living, it may be that the ORIDL has a meaning not found in other transition scales. There was, as we expected, less correlation between the ORIDL and the EQOL, and the SF12, similar to the weak relationship shown between the EQOL and the MYMOP [28] and the SF-36 and the MYMOP [2], reflecting the pre- viously reported poor sensitivity to change by these two widely used tools. The significant correlations found between the EQOL transition scale and the ORIDL, and the PEI-outcome instrument and the ORIDL are new find- ings, not reported previously in the literature, though the use of the PEI as an outcome measure has been reported previously [14,21]. The response rate in the present series of studies varied, with a high response rate in study one (75%), but a diminishing response rate in study two (from 60–40%) and a 49% response rate in study three. However, we have no evidence to suggest the lower response rates were related to the ORIDL. It may well relate to the length of questionnaire and the context of the study. For example, study 3 was set in a primary care centre in an area of high socio-economic deprivation, where low response rates to postal follow-up is common (S Mercer, unpublished data). The fact that the number of missing items for ORIDL was low in all three studies, and around the same or less than the other instruments (MYMOP, EQOL, SF- 12), would support the face validity of the tool. However, qualitative work with patients is required to confirm this. Qualitative work is also required to allow us to establish the best way of presenting the ORIDL choices to patients. In the present work study 2 used a different format from the other two studies (as shown in the methods) but we have no information at present as to which format patients find easiest to understand. Page 8 of 10 (page number not for citation purposes) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 The current data should only be seen as part of a wider pic- ture of validation. Previous studies have found clinically coherent correlations between indicators of consultation quality and outcomes measured by ORIDL [10-12,20]. In terms of its clinical potential, any measurement scale can only give a simplified version of what goes on and cannot hope to capture and represent the richness and complexity of daily clinical care. However, as a contribution to patient-centred outcome measures, ORIDL has two key characteristics. Firstly, it is modelled on how patients and doctors already assess care in daily practice (i.e., by asking about change directly), and secondly, it anchors the out- come to the patient's assessment of significant deteriora- tion or improvement in terms of daily living. Further work is required to establish how many patients are needed per doctor in order to establish a reliable ORIDL score for individual doctors [25], if a comparison between doctors is desired. Further qualitative research is also required to assess patients' views on the ORIDL and this will be of major importance in trying to validate the instrument further. Strengths and weaknesses of the ORIDL Overall, we feel the scale has the following strengths: 1. It is quick and simple to use and its results are easy to communicate. 2. It is generic and so flexibly adaptive to different contexts and targets. 3. It aims to link outcome to the experience of daily living. 1. It is a broad-brush measure (and so lacks detail and pre- cision) and would often need supplemented by other measures if more detailed results are needed. 2. It is subjective, even though anchored in experience of daily living. 3. It is only as good as the participants' views, and shares all the strengths and weaknesses of ordinary clinical prac- tice. 4. It focuses only on the participants' views of the impact of the care – other issues like 'How?', or 'Duration?, or 'Why – e.g: placebo?', or, objective verification – need to be addressed through other approaches. 5. It can be used without a measured baseline, so is subject to the bias of recall, and the shift in perception as health status changes. Conclusion Given the current search for appropriate outcome meas- ures of routine care [29,30] we think it is worthwhile to try to relate measures of outcome to the patients' view of its impact on their daily lives. Clearly further work is required to validate the accuracy of the ORIDL in assess- ing such change. However, our experience and data to date suggest that the ORIDL scale may prove of value in tracking routine care in clinical practice and in evaluating healthcare interventions. Competing interests The author(s) declare that they have no competing inter- ests. 4. It models how patients and practitioners already asses care in daily busy practice. 5. It can be used in routine clinical practice without dis- rupting the care process. 6. It may allow comparison across different contexts of healthcare in the degree of useful impact achieved by the intervention. 7. It establishes a useful shared language, for example, whatever the context if you say a patient experienced '+2' then others know that this was change was at least suffi- cient to impact on the quality of daily living. 8. It can be used without measuring a previous baseline, capturing the participants' views of any change over time. Some of its weaknesses are: Authors' contributions DR devised the ORIDL and co-supervised the research in studies 1 and 2. He wrote the initial version of the manu- script and contributed to modifications. He contributed in addition intellectual input at all stages. SWM carried out the data collection and analysis in Studies 1 and 3, and re-analysed part of the data in Study 2. He re-shaped the initial version of the manuscript, and led the re-writ- ing of subsequent versions. He also contributed intellec- tual input at all stages. APB carried out part of the data collection in Study 2, and analysed part of the data, and contributed to writing and modifying drafts of the manu- script. She contributed intellectually, especially to the interpretation of the data. TH carried out part of the data collection in Study 2, and contributed to the final version of the manuscript. All authors read and approved the final manuscript. Page 9 of 10 (page number not for citation purposes) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 Acknowledgements Stewart Mercer is supported by a Primary Care Research Career Award from the Chief Scientist Office of the Scottish Executive. The AdHom Aca- demic Departments are supported by the AdHominem Charity. References 1. Swage T: Clinical governance in health care practice. Butter- worth Heinemann 2004. ISBN0750644532 2. Gill TM, Feinstein AR: A critical appraisal of the quality of qual- ity-of-life measurements. JAMA 1994, 272:619-626. 3. Paterson C: Measuring outcomes in primary care: a patient generated measure, MYMOP, compared with the SF-36 health survey. BMJ 1996, 312:1016-1020. 4. Paterson C: In pursuit of patient-centred outcomes: a qualita- tive evaluation of the 'Measure Yourself Medical Outcome Profile'. J Health Service Res Pol 2002, 5:27-36. 5. The Academic Departments of the Centre forIntegrative Care [http://www.adhom.com] 6. Reilly D, Taylor MA: Experimental integrated clinics. Comp Ther Med 1993, 1(Supplement 1):16-17. 7. Sevar R: Audit of outcome in 455 consecutive patients treated with homeopathic medicines. Homeopathy 2005, 94:215-21. 8. Neville-Smith R: Community hospital clinic: Audit of the first 12 months activity. Brit Hom J 1999, 88:20-23. 9. Sevar R: Audit of outcome in 829 consecutive patients treated with homeopathic medicine. Brit Hom J 2000, 89:178-187. 10. Richardson WR: Patient benefit survey: Liverpool regional department of homoeopathic medicine. Brit Hom J 2001, 90:158-162. 11. Riley D, et al.: Homeopathy and conventional medicine: An outcomes study comparing effectiveness in a primary care setting. J Alt Comp Med 2001, 7:149-159. 12. Mercer S, Reilly D, Watt G: The importance of empathy in the enablement of patients attending the Glasgow Homoeo- pathic Hospital. BJGP 2002, 52:901-905. 13. MacPherson H, Mercer SW, Scullion T, Thomas KJ: Empathy, ena- blement, and outcome: an exploratory study on acupunc- ture patients' perceptions. J Alt Comp Med 2003, 9:869-76. 14. Bikker AP, Mercer SW, Reilly D: A pilot prospective study on the consultation and relational empathy, patient enablement, and health changes over 12 months in patients going to the Glasgow Homoeopathic Hospital. J Alt Comp Med 2005, 11:591-600. 15. Greenwood JE: The challenge to find a safe and effective cure for verruca pedis. Podiatry Now 2004, 8:20-24. 16. Thompson EA, Montgomery A, Douglas D, Reilly D: A pilot, rand- omized, double-blinded, placebo-controlled trial of individu- alized homeopathy for symptoms of estrogen withdrawal in breast-cancer survivors. J Alt Comp Med 2005, 11(1):13-20. 17. Ricciotti F, Bernardini C, D'Aco L, Giannuzzi AL, Passali GC, Passali D: Pilot study on chronic rhinosinusitis in order to evaluate efficacy and tolerability of a standard antibiotic treatment (Amoxicillin and Clavulanic Acid) associated to an homeo- pathic complex (Dr. Reckeweg R1). Rivista Italiana di Otorinolarin- gologia Audiologia e Foniatria 2005, 25:109-117. 18. The EuroQol Group: EuroQol – a new facility for the measure- ment of health related quality of life. Health Policy 1990, 16:199-208. 19. Ware J, Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of relia- bility and validity. Medical Care 1996, 34:220-233. 20. Howie J, Heaney DJ, Maxwell M, Walker JJ: A Comparison of a Patient Enablement Instrument (PEI) against two estab- lished satisfaction scales as an outcome measure of primary care consultations. Fam Pract 1997, 15:165-171. 21. Paterson C: Measuring change in self-concept: a qualitative evaluation of outcome questionnaires in people having acu- puncture for their chronic health problems. BMC Comp Alt Med 2006, 6:7. doi: 10.1186/1472-6682-6-7 22. Mercer SW: Practitioner empathy, patient enablement, and health outcomes of patients attending the Glasgow Homoe- opathic Hospital : a retrospective and prospective compari- son. Wien Med Wochenschr 2005, 155:498-501. 23. Reilly D, Taylor M: The Evidence Profile. Developing Inte- grated Medicine. Comp Ther Med 1993, 1:11-12. 24. Paterson C, Langan CE, McKaig GA, Anderson PM, Maclaine GDH, Rose LB, et al.: Assessing patient outcomes in acute exacerba- tions of chronic bronchitis: The measure your medical out- come profile (MYMOP), medical outcomes study 6-item general health survey (MOS-6A) and EuroQol (EQ-5D). Qual Life Res 2000, 9:521-527. 25. Guyatt GH, Norman GR, Jumiper EF, Griffith LE: A critical look at transition ratings. J Clin Epidemiol 2002, 55:900-908. 26. Steiner DL, Norman GR: Health measurement scales 3rd edition. Oxford: Oxford University Press; 2003. 27. Fischer D, Stewart AL, Bloch DA, Lorig K, Laurent D, Holman H: Capturing the patient's view of change as a clinical outcome measure. JAMA 1999, 282:1157-1162. 28. Ziebland S, Fitzpatrick R, Jenkinson C, Mowat A, Mowat A: Compar- ison of two approaches to measuring change in health status in rheumatoid arthritis: the Health Assessment Question- naire (HAQ) and modified HAQ. Ann Rheum Dis 1992, 51:1202-1205. 29. Paterson C: Seeking the patient's perspective: a qualitative assessment of EuroQol, COOP-WONCA Charts and MYMOP. QualLife Res 2004, 13:871-881. 30. Verhoef MJ, Vanderheyden LC, Dryden T, Mallory D, Ware M: Eval- uating complementary and alternative medicine interven- tions: in search of appropriate patient-centred outcome measures. BMC Comp Alt Med 2006, 6:38. doi:10.1186/1472-6882- 6-38 Pre-publication history The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1472-6963/7/139/pre pub Publish with Bio Med Central and ever y scientist can read your work free of charge "BioMed Central will be the most significant development for disseminating the results of biomedical researc h in our lifetime." Sir Paul Nurse, Cancer Research UK Your research papers will be: available free of charge to the entire biomedical community peer reviewed and published immediately upon acceptance cited in PubMed and archived on PubMed Central yours — you keep the copyright Submit your manuscript here: BioMedcentral http://www.biomedcentral.com/info/publishing_adv.asp (page number not for citation purposes) Page 10 of 10 

Principles of Epidemiology (for CBC Marketplace)

http://www.cdc.gov/ophss/csels/dsepd/ss1978/ss1978.pdf

Why extreme dilutions reach non-zero asymptotes: a nanoparticulate hypothesis based on froth flotation.

http://www.ncbi.nlm.nih.gov/pubmed/23083226 Langmuir. 2012 Nov 13;28(45):15864-75. doi: 10.1021/la303477s. Epub 2012 Nov 1. Why extreme dilutions reach non-zero asymptotes: a nanoparticulate hypothesis based on froth flotation. Chikramane PS1, Kalita D, Suresh AK, Kane SG, Bellare JR. Author information Abstract

Extreme dilutions, especially homeopathic remedies of 30c, 200c, and higher potencies, are prepared by a process of serial dilution of 1:100 per step. As a result, dilution factors of 10(60), 10(400), or even greater are achieved. Therefore, both the presence of any active ingredient and the therapeutic efficacy of these medicines have been contentious because the existence of even traces of the starting raw materials in them is inconceivable. However, physicochemical studies of these solutions have unequivocally established the presence of the starting raw materials in nanoparticulate form even in these extreme (super-Avogadro, >10(23)) dilutions. In this article, we propose and validate a hypothesis to explain how nanoparticles are retained even at such enormous dilution levels. We show that once the bulk concentration is below a threshold level of a few nanograms/milliliter (ng/mL), at the end of each dilution step, all of the nanoparticles levitate to the surface and are accommodated as a monolayer at the top. This dominant population at the air-liquid interface is preserved and carried to the subsequent step, thereby forming an asymptotic concentration. Thus, all dilutions are only apparent and not real in terms of the concentrations of the starting raw materials.

Homeopathic treatment of multimorbid patients: a prospective outcome study with polarity analysis

Homeopathic treatment of multimorbid patients: a prospective outcome study with polarity analysisHeiner Freiemail University of Berne, Kreuzplatz 6, CH-3177 Laupen, Switzerland Received: March 13, 2014; Received in revised form: August 27, 2014; Accepted: September 2, 2014; Published Online: October 10, 2014 DOI: http://dx.doi.org/10.1016/j.homp.2014.09.001 Publication stage: In Press Corrected Proof

Abstract Full Text Images References

Highlights

•We examined the treatment outcome with polarity analysis in 50 multimorbid patients. •43 patients were successfully treated and reached an average improvement of 91%. •The cost of homeopathic treatment is estimated to be 41% of a conventional therapy. •Thus, homeopathy can play a substantial role in treating multimorbid patients.

Background

The treatment of multimorbid patients who have a combination of three or more concurrent complaints is one of the core competencies of homeopathy. In this article we introduce the application of polarity analysis (PA) in multimorbidity. PA came to prominence through the Swiss homeopathic ADHD double-blind study, which successfully demonstrated a significant difference between highly dilute homeopathic remedies and placebo. PA enables homeopaths to calculate a relative healing probability, based on Boenninghausen's grading of polar symptoms. After its evaluation in the treatment of a variety of acute and chronic disease, which showed improved results compared to a conventional homeopathic approach, it was a challenge to test PA with multimorbid patients. Since such patients almost invariably have a multiple symptoms, the question was whether we can nevertheless successfully use Polarity Analysis or whether the method is rendered ineffective by the multitude of symptoms. Methods

We treated 50 multimorbid patients with PA and prospectively followed them over one year. Results

43 patients (86%) completed the observation period, achieving an average improvement of 91% in their initial symptoms. Six patients dropped out, and one did not achieve an improvement of 80%, and was therefore also counted as a treatment failure. The cost of homeopathic treatment was 41% of projected equivalent conventional treatment. Conclusions

Polarity Analysis is an effective method for treating multimorbidity. The multitude of symptoms does not prevent the method from achieving good results. Homeopathy may be capable of taking over a considerable proportion of the treatment of multimorbid patients, at lower costs than conventional medicine. http://www.homeopathyjournal.net/article/S1475-4916%2814%2900084-8/abstract

Will CBC bring more attention to Homeoprophylaxis (what they’ll describe as an alternative to vaccines) than homeopaths can?!?

http://www.newagora.ca/will-cbc-bring-more-attention-to-homeoprophylaxis/ Will CBC bring more attention to Homeoprophylaxis (what they’ll describe as an alternative to vaccines) than homeopaths can?!?

A few years ago, a journalist requested information on homeopathy for a show on CBC. I am a typical Canadian and so therefore I have a strong affinity for CBC.

I asked the organizers of the show whether this would be a fair and true representation of homeopathy. I know that it is easy to target aspects of homeopathy because of its complex and unique principles of healing. However, the producers of CBC’s Marketplace expressed specifically and clearly that this would not be the way they would use the information they gather. I met with them and they interviewed me at my clinic. I also faithfully gave them a number for one of my clients that had agreed she wouldn’t mind being interviewed. I printed out for them a thick pile of many research reports that presented sound science backing up many of the principles of healing used in the science of homeopathy. That show which has repeated more times than any other episode of CBC’s Marketplace ended up being truly blatantly biased and absolutely NOT scientific. There was no mention of the scientific reports that I and others had given to them.

When that episode was shown, there were many people who posted words of support and commitment to the option of homeopathy in the healing choices. The Marketplace website seemed to edit and only release a certain number of the responses. People writing in support of homeopathy reported that their posts had not been published. People wrote in to CBC’s producers, CBC’s Ombudsman, and the homeopathic community bonded over the outrage of this slander. This fall, CBC plans to release another show about an aspect of homeopathic practice known as homeoprophylaxis. Homeoprophylaxis is the use of homeopathic remedies in anticipation for prevention of a specific health concern. The founder of homeopathy, Samuel Hahnemann writes about using the principles of homeoprophylaxis back in 1798 in his publication on Scarlet Fever called “The Cure and Prevention of Scarlet Fever”, in ‘Lesser Writings’ (B.Jain Publishing. New Delhi. P.369ff). http://www.feg.unesp.br/~ojs/index.php/ijhdr/article/viewFile/360/407 using the homoeopathic remedy called Belladonna. He also refers to the ways to conduct homeoprophylaxis in the Aphorisms number 100, 101, 102 and 241 of his written guide to homeopathy known as ‘The Organon’ first published in 1810 (Hahnemann S. Organon of medicine. 6th Edn. (Translated by William Boericke). New Delhi: B Jain Publishers, 1991). The most contemporary uses of homeoprophylaxis are based on the science conducted mostly by Dr. Isaac Golden http://www.homstudy.net/Research/

and Dr. G. Bracho. http://www.ncbi.nlm.nih.gov/pubmed/20674839

Despite that currently there exists (and will continually be more of) quality research to demonstrate the effective use of homeopathy to address specific health concerns, CBC will attempt to convince you that there is none. Let me guide you to the BOX WIDGET on my blog https://homeopathiccures.wordpress.com

That is where you’ll be able to access homeopathic expert’s advice or writings by homeopathic experts. In the words of Merriam-Webster Dictionary (http://www.merriam-webster.com/dictionary/expert), an expert is defined as “having or showing special skill or knowledge because of what you have been taught or what you have experienced”. With this in mind, please QUESTION who CBC will refer to as ‘experts’ on topics of homeopathy.

Instead of truthfully facing the experts on homeopathy (myself and a known few of my colleagues) CBC Marketplace’s approach to get information from us was to plant a fake client into our private practice. A few months later, an email was sent to me stating that they had done this and would I do an interview them?

Instead they chose a mysterious random bunch of people https://homeopathiccures.files.wordpress.com/2014/09/centre-for-inquiry.pdf…random people who don’t know that you can NOT overdose on homeopathic remedies – and that this is a GOOD thing BUT that it is IRRESPONSIBLE to try to do your own ‘experiments’ on a form of medicine that you don’t have a clue about.

Needless to say, I am NOT doing any kind of happy dance http://animalfactoftheday.blogspot.ca/2012/04/manakin-bird-can-moonwalk.html in anticipation of a new episode focusing on Homeoprophylaxis.

The tragic irony is that I have a feeling that CBC Marketplace’s blatant show of ignorance will be apparent to most critical thinkers that are their audience and those people will either look for more information to satisfy their curiosity OR they will stand stronger in their commitment to choices for health care options for Canadians. In case this is the place you’ve come to for more information, let me assure you that maintaining the homeopathy as a choice made available to us is more important than our regular freedoms of choice as it has to do with the most important aspect of our existence because as they say, ‘if we don’t have our health, what do we have?’ That is the essence of what drives most people to homeopathy. In ONE country alone there are over 100 million people using homeopathy (http://drnancymalik.wordpress.com/article/status-of-homeopathy/)(India). Also keep in mind that the top two most debated topics on Wikipedia are Jesus and homeopathy If you’ve seen the CBC Marketplace’s representation of homeopathy and would like to take part in some discussions about it, please keep in touch at https://www.facebook.com/AccessNaturalHealing/photos/a.119846306893.123640.10145471893/10152470442151894/?type=1&theater

Sincerely Yours in Homeopathy Elena Cecchetto (EL) info@accessnaturalhealing.com 604-568-4663 http://www.accessnaturalhealing.com © 2014 Elena Cecchetto

Effectiveness of homoeopathic therapeutics in the management of childhood autism disorder

http://www.ijrh.org Indian Journal of Research in Homoeopathy / Vol. 8 / Issue 3 / Jul-Sep 2014 147 ORIGINAL ARTICLE Effectiveness of homoeopathic therapeutics in the management of childhood autism disorder Praful M. Barvalia, Piyush M. Oza, Amit H. Daftary, Vijaya S. Patil, Vinita S. Agarwal 1 , Ashish R. Mehta 2 ABSTRACT Background and Objectives: Childhood autism is severe and a serious disorder. A study was conducted by Spandan holistic institute of applied Homoeopathy, Mumbai, with the objective of demonstrating the usefulness of homeopathic management in autism. Materials and Methods: Sixty autistic children of both sexes, ≤12 years were selected for this study. It was nonrandomized, self‑controlled, pre and post‑intervention study, wherein the initial 6 months of observation period was used as the control period and the same patients were thereafter treated for 1 year and compared with post‑intervention findings. Results: The study demonstrated significant improvement of autistic features with mean change in ATEC score (ATEC 1 ‑pre‑treatment with ATEC 5 ‑post‑treatment) was 15.12 and ATEC mean percent change was 19.03. Statistically significant changes in ATEC scores were observed in all the quarters analyzed through repeated measures ANOVA, with F‑ value 135.952, P = 0.0001. An impact was observed on all core autistic features, which included communication, 12.61%, socialization, 17%, sensory awareness, 18.82%, and health and behavior, 29% ( P = 0.0001). Significant improvement was observed in behavior by Autistic Hyperactivity Scale, AHS 1 36 to AHS 5 14.30 with F‑value 210.599 ( P = 0.0001). Outcome assessment was carried out using MANOVA, which showed statistically significant changes in post‑treatment scores, P < 0.005. Total 88.34% cases showed improvement, 8.33% showed status quo, and 3.33% cases worsened. Nine out of 60 cases showed a reversal of CARS putting them into non‑autistic zone, P = 0.0001. A sharp decrease (34%) in ATEC scores, in the first quarter implied positive effect of homoeopathic medicines, prescribed, as per the homoeopathic principles. Conclusion: The study has demonstrated usefulness of homoeopathic treatment in management of neuropsychological dysfunction in childhood autism disorder, which is reflected in significant reduction of hyperactivity, behavioral dysfunction, sensory impairment as well as communication difficulty. This was demonstrated well in psychosocial adaptation of autistic children

A model for homeopathic remedy effects: low dose nanoparticles, allostatic cross-adaptation, and time-dependent sensitization in a complex adaptive system.

BellKoithan2012BMCCAMNanoparticleModelHomeopathyFINAL1472-6882-12-191.pdf http://www.ncbi.nlm.nih.gov/pubmed/?term=2012+BMCCAM+Nanoparticle+Model+Homeopathy+FINAL+1472-6882-12-191.pdf A model for homeopathic remedy effects: low dose nanoparticles, allostatic cross-adaptation, and time-dependent sensitization in a complex adaptive system. Bell IR1, Koithan M. Author information Abstract BACKGROUND:

This paper proposes a novel model for homeopathic remedy action on living systems. Research indicates that homeopathic remedies (a) contain measurable source and silica nanoparticles heterogeneously dispersed in colloidal solution; (b) act by modulating biological function of the allostatic stress response network (c) evoke biphasic actions on living systems via organism-dependent adaptive and endogenously amplified effects; (d) improve systemic resilience. DISCUSSION:

The proposed active components of homeopathic remedies are nanoparticles of source substance in water-based colloidal solution, not bulk-form drugs. Nanoparticles have unique biological and physico-chemical properties, including increased catalytic reactivity, protein and DNA adsorption, bioavailability, dose-sparing, electromagnetic, and quantum effects different from bulk-form materials. Trituration and/or liquid succussions during classical remedy preparation create "top-down" nanostructures. Plants can biosynthesize remedy-templated silica nanostructures. Nanoparticles stimulate hormesis, a beneficial low-dose adaptive response. Homeopathic remedies prescribed in low doses spaced intermittently over time act as biological signals that stimulate the organism's allostatic biological stress response network, evoking nonlinear modulatory, self-organizing change. Potential mechanisms include time-dependent sensitization (TDS), a type of adaptive plasticity/metaplasticity involving progressive amplification of host responses, which reverse direction and oscillate at physiological limits. To mobilize hormesis and TDS, the remedy must be appraised as a salient, but low level, novel threat, stressor, or homeostatic disruption for the whole organism. Silica nanoparticles adsorb remedy source and amplify effects. Properly-timed remedy dosing elicits disease-primed compensatory reversal in direction of maladaptive dynamics of the allostatic network, thus promoting resilience and recovery from disease. SUMMARY:

Homeopathic remedies are proposed as source nanoparticles that mobilize hormesis and time-dependent sensitization via non-pharmacological effects on specific biological adaptive and amplification mechanisms. The nanoparticle nature of remedies would distinguish them from conventional bulk drugs in structure, morphology, and functional properties. Outcomes would depend upon the ability of the organism to respond to the remedy as a novel stressor or heterotypic biological threat, initiating reversals of cumulative, cross-adapted biological maladaptations underlying disease in the allostatic stress response network. Systemic resilience would improve. This model provides a foundation for theory-driven research on the role of nanomaterials in living systems, mechanisms of homeopathic remedy actions and translational uses in nanomedicine.

Homeoprophylaxis aka "Alternative to Vaccines or Homeopathic Vaccines" as CBC Marketplace would describe it as!

Dearest Clients,
Sometime this year I received a call from a young mother expressing concerns about
the safety of vaccines for her baby and asking if she and another woman (I forget
what she said their relation was) could come in and talk to me about homeopathic
alternatives (CBC's fake client). This is a common request from (especially
educated) parents, aware of media stories of vaccine damage as well as the myopic
perspective of mainstream medicine for whom there are no alternatives, no
accommodations, no individualizing of vaccination schedules. For this, I offer a
"Free Information Session" until they decide to come in for the First Consultation
appointment so that they know I will not be offering any therapeutic advice during
this information session.
People who come to talk to me about vaccination concerns and seeking information
about alternatives are presented with a nuanced discussion. I cannot ignore the
plethora of requests for information and I believe it is against my code of ethics
as a health practitioner (See ethics on Beneficence vs. NonMaleficence) to not offer
the information which I am an expert on (homeopathy). I end these discussions with
the advice that the parents go home, think, read, research, talk, and then let me
know the ways that I can best support their child’s health and wellbeing, no matter
what decision they make in the end: full vaccination, no vaccination, partial
vaccination.
This was exactly the sort of conversation I had with CBC's fake client. The fake was
not actually a concerned mother, but a reporter for CBC Marketplace who came into my
clinic (with maybe a fake baby and friend) under false pretenses, and then proceeded
to clandestinely tape and film our meeting for the purpose of “undercover”
journalism in preparation for an upcoming episode on CBC Marketplace on vaccination
alternatives. The ethical issues involved in this approach are extraordinary, and I
think it important that all Canadians know the sordid activities of their public
broadcaster. The extraordinary thing is that the CBC’s own regulations on
clandestine reporting suggest that it is allowed only in situations in which there
is “antisocial” behavior, “abuse of trust”, or there is no other way to get the
information needed. I am not sure which of these descriptors cover the visit to my
office, but certainly, the homeopathic community has been fully forthcoming in
offering Marketplace information on homeoprophylaxis without any secret high jinx
involved.
For some of my clients, the bully tactics of my patient-in-disguise did not end
there. Upon leaving, “the fake” asked for a nosode remedy to protect her baby
against measles while she and her husband were making their decision about
vaccination; she told them they would be travelling to an area where there had
recently been a measles outbreak and they were concerned about exposure. Of course
they helped her – this is what homeopaths do. It turns out that Marketplace then
made a formal complaint to Health Canada about the labeling of the remedy(ies) that
had dispensed (the ONLY complaints made to Health Canada regarding homeopathic
treatments ever made as far as I know). Unfortunately, “the fake” and their team
didn’t do their research and were unaware of the regulations that cover homeopathic
practitioners. Needless to say, Health Canada found the complaints spurious and
dismissed them, assuring the homeopaths that they were practicing well within
regulatory norms. I might add, that Health Canada has conferred a DIN-HM number on
many nosodes plus over 6000 different remedies, giving them a “seal of approval” as
it were. There is no salacious story here, no matter how Marketplace frames it.
So it turns out that the Marketplace episode on vaccines will be aired tonight on
CBC. If you watch the program, please know the producers have a strong bias against
homeopathy -- and are likely to present homeopaths as luring parents away from
vaccination. The illicitly filmed segments of myself and the other homeopaths
similarly witch-hunted are most assuredly small excerpts of much more complex
conversations, taken out of context and presented without any of the other
information offered.
Perhaps this offers a good opportunity for people to speak up for homeopathy and to
speak up for free choice in making decisions about the health decisions we make. If
you are invested in the vaccine issue you can go online to CBC Marketplace's site
(www.cbc.ca/marketplace ) for the episode entitled "Vaccines: Shot of Confusion" and
post about your experiences, and share your decision making process around this
issue. It is important that homeopaths do not allow themselves to be pushed into the
closet because of the bully pulpit of media shows such as CBC Marketplace. Speak up
– let them know what you think.
If you would like any other resources to refer to, please feel free to refer to
http://www.homeopathiccures.wordpress.com
for research and other publications on homoepathy and homeoprophylaxis from around
the world.

Nonlinear Response Amplification Mechanisms for Low Doses of Natural Product Nanomedicines: Dynamical Interactions with the Recipient Complex Adaptive System

Belletal2013NonlinearAmplificationMechanismsforHomeopathicNanomedicines.pdfwww.omicsonline.org

Nonlinear Response Amplification Mechanisms for Low Doses of Natural Product Nanomedicines: Dynamical Interactions with the Recipient Complex Adaptive System Iris R Bell1,2, Barbara Sarter3, Mary Koithan2, Leanna J Standish4, Prasanta Banerji5 and Pratip Banerji5

1Department of Family and Community Medicine, The University of Arizona College of Medicine, USA 2College of Nursing, The University of Arizona, Tucson, AZ, USA 3Hahn School of Nursing and Health Sciences, University of San Diego, San Diego, California, USA 4Bastyr University, Kenmore, WA, USA 5PBH Research Foundation, Kolkata, India Abstract The purpose of the present paper is (a) to outline the self-organized, complex adaptive network nature of the organism as recipient of nanomedicines; (b) to propose several nonlinear endogenous amplification processes by which pulsed low doses of traditional, homeopathically-manufactured natural product nanomedicines may stimulate a return toward healthier function; and (c) to discuss their potential relevance to novel, but safer than conventional dosing strategies for contemporary nanomedicines. Homeopathy is an over 200-year-old system of complementary and alternative medicine (CAM) that uses low doses of natural plant-, mineral-, and animal-sourced nanomedicines. Homeopathic manufacturing is “green”, with mechanical grinding in lactose and agitation in ethanol-water as primary reagents. Agitation within glass containers at room temperature may also contribute nanosilica and nanosilicon as drug delivery vehicles and biological amplifiers. The medicine selection is matched to the recipient organism’s systemic patterns of dysfunction and pulsed in the timing of the discrete doses. Endogenous amplification processes within the recipient organism may involve hormesis, time-dependent sensitization, and/or stochastic resonance. Effects are adaptive and systemically diffuse, i.e., causally indirect, rather than pharmacological and local, i.e., direct. All of these nonlinear response processes require interaction of the nanoparticle (NP) dose with the organism as a complex adaptive system. The pulsed NP dose serves as a low intensity salient danger signal for the organism to make network-wide adaptive changes that can lead to healing. The historically safe therapeutic approach of homeopathic nanomedicine dosing avoids risks of high, continuous doses and cumulative toxicity that contemporary nanomedicine researchers are now trying to solve while using NPs as if they were conventional bulk drugs. Integrating the insights, technical procedures, and clinical dosing approaches from modern and homeopathic nanomedicine could lead to major advances in the field for more effective and safer translational applications. Keywords: Nanomedicine; Homeopathy; Nanoparticles; Hormesis; Stochastic resonance; Nonlinear dynamical systems; Complex adaptive systems.

Extreme homeopathic dilutions retain starting materials- A nanoparticulate perspective

Extreme homeopathic dilutions retain starting materials- A nanoparticulate perspective Extreme homeopathic dilutions retain starting materials: A nanoparticulate perspective Prashant Satish Chikramane1, Akkihebbal K Suresh1,2, Jayesh Ramesh Bellare1,2,* and Shantaram Govind Kane1,* 1Department of Chemical Engineering, Indian Institute of Technology (IIT), Bombay, Adi Shankaracharya Marg, Powai, Mumbai 400 076, Maharashtra, India 2Department of Biosciences and Bioengineering, Indian Institute of Technology (IIT), Bombay, Adi Shankaracharya Marg, Powai, Mumbai 400 076, Maharashtra, India Homeopathy is controversial because medicines in high potencies such as 30c and 200c involve huge dilution factors (1060 and 10400 respectively) which are many orders of magnitude greater than Avogadro’s number, so that theoretically there should be no measurable remnants of the starting materials. No hypothesis which predicts the retention of properties of starting materials has been proposed nor has any physical entity been shown to exist in these high potency medicines. Using market samples of metal- derived medicines from reputable manufacturers, we have demonstrated for the first time by Transmission Electron Microscopy (TEM), electron diffraction and chemical analysis by Inductively Coupled Plasma-Atomic Emission Spectroscopy (ICP-AES), the presence of physical entities in these extreme dilutions, in the form of nanoparticles of the starting metals and their aggregates. Homeopathy (2010) 99, 231e242. Keywords: Homeopathy; Nanoparticles; Nanocrystalline materials; Transmission Electron Microscopy Introduction Homeopathy, a mode of therapy, was established in the late 18th century by German physician, Samuel Hahne- mann. Hahnemann, during his experiments, prepared medi- cines from a wide variety of natural products. He discerned that the infinite dilutions of these substances carried out in steps and accompanied by vigorous shaking ‘succussion’ (together known as potentization) at each dilution step, elicited some kind of a potent activity to these solutions.1,2 In spite of the various controversies and frequent challenges by the scientific community regarding its efficacy, this mode of treatment has stood the test of time, and is still being used in many countries for treatment of various chronic conditions, with medicines being prepared from a variety of herbal, animal, metal and other mineral sources. *Correspondence: Jayesh Ramesh Bellare and Shantaram Go- vind Kane, Department of Chemical Engineering, Indian Institute of Technology (IIT), Bombay, Adi Shankaracharya Marg, Powai, Mumbai 400 076, Maharashtra, India. E-mail: jb@iitb.ac.in, sgkane@gmail.com Received 6 November 2009; revised 22 April 2010; accepted 22 May 2010 However, a major lacuna has been the lack of evidence of physical existence of the starting material. The main dif- ficulty in arriving at a rational explanation stems from the fact that homeopathic medicines are used in extreme dilu- tions, including dilution factors exceeding Avogadro’s number by several orders of magnitude, in which one would not expect any measurable remnant of the starting material to be present. In clinical practice, homeopathic potencies of 30c and 200c having dilution factors of 1060 and 10400 respectively, far beyond Avogadro’s number of 6.023 1023 molecules in one mole, are routinely used. Many hypotheses have been postulated to justify and elu- cidate their mechanisms of action. While some hypotheses such as the theory of water memory,3e5 formation of clathrates,6 and epitaxy7 are conjectural in nature, others such as those based on the quantum physical aspects of the solutions8,9 have not been sufficiently tested, either due to complexity in validating the hypothesis or due to non-reproducible results. The ‘silica hypothesis’10 is the only model that proposes the presence of physical entities such as siloxanes or silicates resulting from leaching from the glass containers. Following a dearth of credible and test- able hypotheses to identify any physical entity responsible for medicinal activity, most modern scientists continue to believe that homeopathy at best provides a placebo effect. Homeopathy (2010) 99, 231e242 ! 2010 The Faculty of Homeopathy doi:10.1016/j.homp.2010.05.006, available online at http://www.sciencedirect.com ORIGINAL PAPER  232 Nanoparticles of starting materials in homeopathic medicines PS Chikramane et al Despite the extreme dilutions in 30c and 200c potencies, our approach has been to test for the presence of the starting materials in the form of nanoparticles.. Medicines selected were metal-based, and were so chosen that the metals would not arise either as impurities or as contaminants. The six metals and their respective homeopathic medicines were gold (Aurum metallicum or Aurum met), copper (Cuprum metallicum or Cuprum met), tin (Stannum metallicum or Stannum met), zinc (Zincum metallicum or Zincum met), silver (Argentum metallicum or Argentum met) and platinum (Platinum metallicum or Platinum met). Three potencies: 6c, 30c, and 200c were selected. The dilution factor for 6c is 1012 which is less than Avogadro’s number, whereas the dilution factors for 30c and 200c are well above. Market samples of these medicines in 90%v/v ethanol were obtained from two reputable manufacturers: SBL, India, and Dr. Willmar Schwabe India (WSI) Private Limited. We examined the following physico-chemical aspects: a. The presence of the physical entities in nanoparticle form and their size by Transmission Electron Microscopy (TEM) by bright-field and dark-field imaging. b.Their identification by matching the Selected Area Electron Diffraction (SAED) patterns against literature standards for the corresponding known crystals. c. Estimation of the levels of starting metals by a 500-fold concentration of medicines, followed by chemical analysis using Inductively Coupled Plasma-Atomic Emission Spectroscopy (ICP-AES). Materials and methods Materials The homeopathic medications used for the purpose of re- search were obtained commercially from authorized distrib- utors of a leading homeopathic drug manufacturer in India (SBL) and an Indian subsidiary of a multi-national homeo- pathic company viz. Dr. Willmar Schwabe India Pvt. Ltd. Random batch number samples were purchased from the market and no special effort was made to get samples from the company. Since we purchased these medicines from the market, only in certain cases were we able to obtain them from a single manufacturing batch. Also no special ef- forts were made to obtain the drugs from a batch. The High- performance liquid chromatography (HPLC) grade ethanol used for the purpose of ICP-AES analyses was procured from Commercial Alcohols Inc., Canada. The TEM grids obtained from Pacific Grid-Tech (USA) were 200 mesh cop- per grids coated with carboneformvar. Methods then allowed to dry completely after which another drop was added. The usual drying time for each drop was ap- proximately 30e60 min in air at room temperature. This procedure was repeated 5 times. After air-drying the sam- ple for further 30e60 min, the grid was kept under an IR lamp for approximately 20 min to ensure complete drying of the sample and thereby preventing the possibility of solvent molecules from adhering to the particles on the grid. The SAED patterns of the particles were taken and the d-spacings were calculated using the camera length (calibrated daily using a standard gold colloid). The dark-field images were also taken by selecting three spots from two inner rings on the SAED pattern. The d-spacing values from SAED patterns and the crystallite sizes from the dark-field images were calculated using the Image-J software. Elemental composition by ICP-AES: The determination of the starting elements in ultra-trace concentrations was performed on Ultima 2, (Jobin Yvon Horiba, Japan). The operating parameters for the ICP-AES instrument were as follows: plasma gas flow rate (Argon gas): 12 l/min; auxil- iary gas flow rate: 0.2 l/min; sample uptake: 2.5 ml/min; integration time: 5.0 s, Spray Chamber: cyclonic chamber. The limit of detection of the instrument was 10 ppb. For the purpose of ICP-AES analyses, the samples were pre- pared by pre-concentrating the solutions (6c, 30c, and 200c potencies) 500-fold in a vacuum rotary evaporator, Roteva Model #8706R (Equitron, India) at 45C and 100 rpm speed. The homeopathic medicines that we purchased were in ei- ther 100 ml or 500 ml capacity bottles. Most of the SBL homeopathic medicine bottles were of 500 ml capacity with a few of 100 ml capacity, while those obtained from Willmar Schwabe India (WSI) Pvt. Ltd. were all 100 ml bot- tles. In the case of medicines obtained as 500 ml bottles, so- lutions from 4 bottles of the same medicine and potency were pooled together for concentration, whereas for medi- cines which were marketed as 100 ml bottles, solutions from 20 bottles of each medicine at the same potency were pooled. The concentration was carried out in a 50 ml clean round bottom flask on a rotary vacuum evaporator. The flask was filled with the solution (approximately 30e35 ml at a time) and the solvent was evaporated. Upon complete evaporation of the solvent, the flask was re- filled with fresh homeopathic solution and the process was repeated till the entire volume of 2000 ml was evaporated. Only one bottle was opened at a time to maintain the integ- rity of the purchased medicines. To prevent contamination, under no circumstances was the solution in the bottle kept exposed. The residues of Cuprum met, Stannum met, and Zincum met were acidified to solubilize the particles of their respective starting metals by addition of concentrated nitric acid. Similarly, aqua regia (concentrated nitric acid and con- centrated hydrochloric acid in the ratio 1:3) was added to residues of Aurum met, Argentum met, and Platinum met. A 1:1 ratio of water: acid was maintained for all the concen- trated samples. The amount of acid and water was adjusted so that the final volume was 4 ml, thus, amounting to a con- centration by a factor of 500. The samples were filtered Nanoparticle characterization by TEM/SAED: analyses were performed on Tecnai G2 120 kV Cryo-TEM (FEI, Hillsboro, USA). All samples were viewed at 120 kV. The TEM analyses were performed for the medicines by placing a drop of the original solution (without pre-concen- tration) on the carboneformvar coated copper TEM grids in a clean environment. The drop of the solution was The TEM Homeopathy through Whatman 40 filter paper to remove the residual mat- ter prior to analysis. The SBL samples were analyzed in trip- licate and samples from WSI were analyzed in duplicate. As a negative control, 90%v/v ethanol samples were also pre- pared using HPLC grade ethanol and Milli-Q water. These ethanolic solutions were also concentrated in the manner similar to that employed for the medicines. The emission lines selected for measuring the concentra- tion of the metals are as follows: Gold: 242.795 nm, Copper: 324.754 nm, Tin: 283.999 nm, Zinc: 213.856 nm, Silver: 328.068 nm, Platinum: 265.945 nm. The instrument re- sponse was calibrated using standards prior to analyses of the samples. Results and discussion Determination of size and morphology by TEM Zincum met, Aurum met, Stannum met and Cuprum met 30c and 200c were analyzed by TEM. The results are given as photomicrographs (Figure 1(a)e(p)), which clearly dem- onstrate the presence of nanoparticles and their aggregates. Due to extreme dilution often only a single nanoparticle or a large aggregate is seen. Hereafter, the term ‘particles’ col- lectively refers to the nanoparticles and their aggregates. We noted a high polydispersity of the particles in the so- lutions with respect to their shapes and sizes for various medicines and potencies. A scrupulous examination of the entire manufacturing process of these medicines sug- gested that two key processes played a vital role in impart- ing the high polydispersity. They are: 1. The dilution steps in the solid phase (till 6 potency) in- volved trituration of the raw materials with lactose. Such a comminution process is expected to generate particles of varied shapes and sizes. The physical characteristics of these particles are dependent on the type of raw mate- rial and the shearing force applied. 2. During liquid dilutions, the succussion process at each potentization step played a vital role. The succussions given to the liquid mass are expected to produce particles of varied shapes and sizes due to three factors including shearing forces generated during the pounding of the liq- uid container against an elastic stop, the properties of the raw materials involved, and variations during pounding of the container, between individuals. The permutations and combinations of the above-men- tioned factors and the possible subtle differences in the manufacturing processes employed by various manufac- turers can explain the findings regarding polydispersity between different medicines and manufacturers. We also made another prominent observation regarding the presence of surface asperities on the particles which were clearly evident from the differences in contrast on sur- faces of these particles along with a substantial difference in their size between different starting metals. Thus, larger aggregates were found in Zincum met (Figure 1(a)e(d)) and Stannum met (Figure 1(i)e(l)) as compared to those Nanoparticles of starting materials in homeopathic medicines PS Chikramane et al observed in Aurum met (Figure 1(e)e(h)) and Cuprum met (Figure 1(m)e(p)) at the same potencies. The mechanism of cavitation or generation of vapor bub- bles caused by ultra-sound irradiation (acoustic cavitation) in the entire liquid mass during manufacturing may explain the observations noted above. We suggest that the process of succussion is the cause of cavitation. As set out in a later section, the extant theories of cavitation11e14 can, in principle, provide an explanation of our findings. The aggregation behavior of the particles seems to be de- pendent on the physical property of the starting metal, spe- cifically its melting point. We observed that the aggregates of zinc in Zincum met and tin in Stannum met were rela- tively larger as compared to the smaller aggregates of gold and copper found in Aurum met and Cuprum met re- spectively. The bulk melting points of tin and zinc are w505 K and w692 K respectively as compared to the higher melting points of gold and copper (w1337 K and w1357 K respectively). A decrease in melting points of metallic and semiconductor particles with decreasing size has also been well characterized.15 A combination of ex- tremely high surface temperatures along with a decrease in the melting point of these particles could facilitate the formation of aggregates that we found. It is probable that during the succussion process, the col- lisions of the particles induce surface temperatures well above the melting points of tin and zinc, thereby facilitat- ing their aggregation. However, the melting points of gold and copper being much higher, the occurrence of melting and fusion of these particles would be relatively less frequent than for tin and zinc. Overall, our data for bright-field TEM do not indicate a major difference in the size or nature of the particles in a particular medicine as we increase potency from 30c to 200c. Therefore, the individual crystallite sizes were deter- mined by dark-field TEM (as shown for Zincum met for both manufacturers in Figure 2(a)e(d)). We observed that the aggregates of all the metals tested had maximum crystal- lites (w40e50%) in the size range of 5e10 nm, and that 70e95% of all the crystallites were below 15 nm (Figure S1 e Supplementary information). Thus, in the case of dark-field TEM also, there was no major potency- dependent difference in size distribution of crystallites. Confirmation of elemental composition of particles by SAED The nanoparticles and aggregates identified in TEM were analyzed by SAED for confirmation of the elemental compo- sition. We took multiple SAED patterns of the same particle at varying intensities so as to focus on the inner and outer rings for calculation of the d-spacings of the respective ele- ments. The SAED patterns of the nanoparticles and their ag- gregates found in the metal-based homeopathic medicines are represented in Figure 3(a)e(p). SAED analyses of all samples showed patterns consis- tent with the starting materials. In particular, Aurum met and Cuprum met from both suppliers (SBL and WSI) in- dexed to gold and copper respectively. Table 1 shows the values of the d-spacings calculated from the diameters of 233 Homeopathy 234 Nanoparticles of starting materials in homeopathic medicines PS Chikramane et al Figure 1 Bright-field TEM images of nanoparticles and aggregates. Zincum met: (a) 30c (SBL), (b) 200c (SBL), (c) 30c (WSI), (d) 200c (WSI). Aurum met: (e) 30c (SBL), (f) 200c (SBL), (g) 30c (WSI), (h) 200c (WSI). Stannum met: (i) 30c (SBL), (j) 200c (SBL), (k) 30c (WSI), (l) 200c (WSI). Cuprum met: (m) 30c (SBL), (n) 200c (SBL), (o) 30c (WSI), (p) 200c (WSI). the ring patterns of particles observed in Aurum met sam- ples. Similarly, in the case of Stannum met from SBL, the observed pattern indexed to a-Sn whereas that from WSI to b-Sn. In the case of Zincum met samples from both sup- pliers, we did not observe pure metallic zinc, but the SAED patterns indexed to zinc hydroxide which is an expected compound derived from zinc (d-spacing data for zinc, tin and copper have been given as Supplementary information e Tables S2eS5). The confirmed presence of these crystalline species of starting materials or those derived from them (as evident from the SAED patterns) despite the ultra-high dilutions Homeopathy such as 30c and 200c was astounding, proving that the starting materials were retained even with extremely high dilutions. The d-spacing values for the particular elements con- formed well to the Joint Committee on Powder Diffraction Standards (JCPDS) data in literature in the range of `2%. However, for some d-spacings corresponding to a few planes in the crystal, the values differed by approximately `4%. The differences in some of the d-spacing values for each metal can be explained on the basis of induction of mi- nor plastic deformations in the crystals. The initial tritura- tion process involving high shearing forces, together with the succussion process involving high-velocity collisions of nanoparticles resulting in the generation of shock waves caused by the imploding cavitations, may have induced minor plastic deformations in the metal crystals. In a few of the SAED patterns for the metals analyzed, the particles also showed presence of diffused ring Figure 1 (continued). Nanoparticles of starting materials in homeopathic medicines PS Chikramane et al 235 Homeopathy 236 Nanoparticles of starting materials in homeopathic medicines PS Chikramane et al Figure 2 Bright-field and corresponding dark-field TEM images of nanoparticles and aggregates observed in Zincum met: (a) 30c (SBL), (b) 200c (SBL), (c) 30c (WSI), (d) 200c (WSI). Inset e SAED patterns of the corresponding nanoparticle/aggregate. patterns similar to that of an amorphous material. The probable reason for presence of amorphous phases on the surface of the nanoparticles and aggregates is de- scribed later in this paper. On the whole, the SAED data indicated that the particles of the starting materials were present in the homeopathic medicines even in po- tencies such as 30c and 200c. In order to quantify the ex- act amounts of these starting metals in ultra-high potencies, we conducted the ICP-AES analyses of these medicines. Estimation of concentration of the starting materials by ICP-AES ICP-AES is an established technique for the estimation of metals and other elements. Our equipment had a mini- mum detectable limit of 10 ppb, thereby necessitating Homeopathy Nanoparticles of starting materials in homeopathic medicines PS Chikramane et al Figure 3 SAED patterns of corresponding nanoparticles and aggregates (shown in Figure 1(a)e(p)). Zincum met: (a) 30c (SBL), (b) 200c (SBL), (c) 30c (WSI), (d) 200c (WSI). Aurum met: (e) 30c (SBL), (f) 200c (SBL), (g) 30c (WSI), (h) 200c (WSI). Stannum met: (i) 30c (SBL), (j) 200c (SBL), (k) 30c (WSI), (l) 200c (WSI). Cuprum met: (m) 30c (SBL), (n) 200c (SBL), (o) 30c (WSI), (p) 200c (WSI). 237 Homeopathy Nanoparticles of starting materials in homeopathic medicines PS Chikramane et al 238 Figure 3 (continued). Homeopathy PS Chikramane et al Table 1 Electron diffraction pattern e comparison of d-spacing for Aurum met 30c and 200c potencies 239 Nanoparticles of starting materials in homeopathic medicines hkl values Relative intensity 111 100 200 52 220 32 311 36 222 12 400 6 331 23 420 22 422 23 333 e 440 e 531 e 442 e 620 e 533 e 622 e 444 e d-spacing Gold [#A] 2.3550 2.0390 1.4420 1.2300 1.1774 1.0196 0.9358 0.9120 0.8325 0.7850 0.7210 0.6890 0.6800 0.6450 0.6220 0.6150 0.5890 Aurum met 30C SBL e Figure 3(e) 2.0300 1.2000 1.0700 0.7600 0.6600 Aurum met 200C SBL e Figure 3(f) 2.0393 1.4389 1.2598 1.1809 1.0072 0.9120 0.7843 0.7179 0.6939 Aurum met 30C WSI e Figure 3(g) 2.3515 2.0213 1.4454 1.1732 1.0152 0.9079 0.8286 0.7196 Aurum met 200C WSI e Figure 3(h) 2.3312 2.0224 1.4418 1.2514 1.1695 1.0211 0.9530 All d-spacing values are in #A units. d-spacing data in ‘bold’ e from JCPDS#04-0784, remaining d-spacing data from Edington.16 concentration of the homeopathic solutions using a tech- nique in which there is absolutely no possibility of adding inadvertently the metal to be detected. The analyses of the metal-based medicines, performed after the concentration of the solutions gave startling re- sults. The starting metals were detected for all potencies (6c, 30c, and 200c) at concentrations of the order of picogram/ml (pg/ml). The measured concentrations are presented in Table 2. The data presented in the table are back-calculated concentrations of the metals in the origi- nal homeopathic medicines. The analyses of the negative control of 90%v/v ethanol did not indicate the presence of either the noble metals or tin, and for metals such as cop- per and zinc, indicated far lower concentrations than those in the medicines. We analyzed several samples of Aurum met, Argentum met, and Platinum met for the presence of their respective starting metals. In the case of Aurum met (SBL), some of the samples tested, including higher potencies such as 30c and 200c indi- cated presence of approximately 60e100 pg/ml of gold; the levels being much higher than the sensitivity of the instrument whereas in the ethanolewater negative controls there was no signal for the presence of gold. However, a few Aurum met (SBL) samples did not show presence of gold. Our results point towards a considerable batch-to-batch variation in the concentrations of the starting material. This is certainly not surprising, considering that the method of preparation in- volved manual processes along with an absence of any at- tempt to estimate the concentrations of the starting materials at the end of the manufacturing process of a partic- ular batch. The Aurum met (WSI) samples did not show gold in detectable quantities. Analogous results were obtained for the Argentum met (SBL) samples wherein silver was detected in one 30c and one 200c sample (30.6 pg/ml and 116 pg/ml respec- tively). The concentrations in the other samples were below the detection limit. Likewise, we discerned detect- able concentration of platinum (w40e220 pg/ml) in the Platinum met (SBL) samples for all potencies. The concentrations of non-noble metals such as copper, tin and zinc in their respective homeopathic medicines viz. Cuprum met, Stannum met, and Zincum met were higher (2e30 times that of noble metals) and easily detectable. In the Cuprum met samples (SBL), we detected w500e2500 pg/ml of copper in the solutions. Similarly, 6c potency of WSI indicated high concentration of copper (w370 and w900 pg/ml respectively in the two samples). However, the concentrations of copper in the higher poten- cies viz. 30c and 200c were very low (w10e40 pg/ml) in some and below detectable limits in the others. Likewise for Stannum met samples (SBL) we detected tin; albeit with very high variations from w70 to 1000 pg/ml. In the WSI homeopathic solutions of Stannum met however, lower concentrations of tin were detected in the range of w20e180 pg/ml. As compared to the other samples of non-noble metals noted above, the concentration of zinc in the Zincum met samples was much higher. In the Zincum met samples we detected presence of zinc with a very high variation in the concentrations between manufacturers from w200 to 2700 pg/ml and w1400 to 4000 pg/ml for SBL and WSI respectively. It was reassuring that there was good reproducibility in terms of the estimated concentrations of the starting mate- rials in the pair of samples of the same medicine, potency, and the manufacturing batch. We observed a variation up to 40% in the samples prepared from the same manufacturing batch as compared to a variation up to 1550% in samples from different batches. These results clearly highlighted the following: 1. Validation of the accuracy of our method involving pre- concentration of the medicines prior to analyses as exemplified by the moderate variation in intra-batch samples (refer data sets for Cuprum met, Stannum met, and Zincum met marked in bold in Table 2). 2. High inter-batch variation in the concentration of the starting materials for a given manufacturer and potency, and between manufacturers. Homeopathy 240 PS Chikramane et al Table 2 Estimated concentration of starting metals in various potencies by ICP-AES (pg/ml) Homeopathic dilution SBL (pg/ml) WSI (pg/ml) 12312 Nanoparticles of starting materials in homeopathic medicines 90%v/v Ethanol ND Aurum met 6c 81.4 Aurum met 30c 64.8* Aurum met 200c ND 90%v/v Ethanol 153.4 Cuprum met 6c 1199.0 Cuprum met 30c 730.2 Cuprum met 200c 485.4 90%v/v Ethanol ND Stannum met 6c 569.4 Stannum met 30c 901.6 Stannum met 200c 877.8 90%v/v Ethanol 208.2 Zincum met 6c 380.0 Zincum met 30c 655.2 Zincum met 200c 357.8 90%v/v Ethanol ND Argentum met 6c ND Argentum met 30c ND Argentum met 200c ND 90%v/v Ethanol ND Platinum met 6c 220.6* Platinum met 30c 41.0* Platinum met 200c 213.6 ND 76.4 ND 104.6 245.0 995.2 703.2 432.2 ND 409.2 889.6 1055.8 210.2 366.0 165.4 191.2* ND ND 116.0 ND ND ND 58.2 ND 149.0 1355.6* 1383.4* 2680.2* ND 195.8* 145.6 63.8* 199.0 1002.8 1224.0 2743.6 ND 30.6 ND ND Samples not obtained ND ND Samples not obtained ND ND ND ND 245.0 149.0 893.4 370.8 38.6* ND ND ND ND ND 180.8 153.0 93.8 76.4 20.8 73.0 208.2 210.2 1432.6* 3989.6 3068.6* 1377.6 2230.2* 2322.8 Samples not obtained Samples not obtained ‘Bold’ against a pair of samples in Limit of Detection (LOD) of the instrument was 10 ng/ml corresponding to 20 pg/ml in the original solutions. All concentrations below this value have been reported as ‘Not Detected’ or ‘ND’. * Data indicate that the bottles used to make up the required quantity (2000 ml) were from the same manufacturing batch. Thus, for each metal-based medicine of a particular po- tency, the estimated values appeared to be within a band of 2 orders of magnitude. These variations could be attributed to the processes employed for manufacturing. A visit to a reputed manufacturer revealed that the initial lactose trit- urations were performed on an automated machine using a mortar and pestle. Apart from the control of particle sizes of the metal powders at 1 potency (wherein 80% of the particles of the starting material should be below 10 mm and none above 50 mm),17 there are no further checks for the distribution of the metals in the triturated 6 mixture, which is the starting material for proceeding to the liquid based succussion steps. This is believed to be the cause of these large variations. The liquid dilutions and the potentization steps (includ- ing succussion) were done manually during manufactur- ing, wherein the entire mass of the liquid in the glass container was pounded against a rubber stop 10 times, with inevitable variation in the force of impact and the ex- tent of cavitation generated during these human powered succussions. Apart from the initial trituration with lactose, succussion per se could also be an important method of generation of nanoparticles of the starting materials, due to intense shearing of these nanoparticles against the walls of the glass containers, by the fluid shear and possibly by particle collision due to the implosion of the cavitations created by the ultra-sound waves generated. Therefore, a difference in the shearing force imparted during succus- sion could result in a large difference in the formation of the nanoparticle fraction of the starting materials, thereby reflecting as inter-batch variation. Once the succussion process was completed, the entire mass of liquid was allowed to settle, prior to transfer of 1% of this dilution to 99 parts fresh 90%v/v ethanol. How- ever, the settling time for the dilutions was not fixed. Also, the removal of one part of the previous dilution for the pur- pose of transferring into a fresh solvent was carried out ran- domly from the container and was a manual process. All the above-mentioned factors combined are expected to im- part a lot of disparity in the concentrations of the starting materials in the final medicines which we observed in our studies. During our analyses we also noted the plateauing effect of the concentrations of the starting metals per se in a partic- ular concentration range in potencies 6c, 30c and 200c, in spite of 30c and 200c potencies being 1048 and 10388 respec- tively more dilute than 6c. It is interesting to note that the plateau for non-noble metals showed a higher metal content than for noble metals. Our ICP-AES results suggested that the asymptote effect commences around 6c potency (Figure 4). Our findings appear to be an extension of the trends noted at lower potencies by Ro ̈der et al.,18 who analyzed the concentrations of a few metals in decimal dilutions from 6 to 8 (corresponding to centesimal potencies of 3c to 4c). Part ‘A’ in Figure 4 explicitly depicts de- crease in the concentrations of starting materials with di- lutions. Only in the case of Au3+ in AuCl3 solutions, the a row for given manufacturer and potency indicates their preparation from same manufacturing batch. The Homeopathy Nanoparticles of starting materials in homeopathic medicines PS Chikramane et al Figure 4 Estimated concentrations of starting elements in homeopathic potencies. Part ‘A’ e estimated by Ro ̈ der et al.18 e solid symbols: expected concentrations, open: estimated concentrations, circles: Au3+, star: Fe3+, left triangle: Hg2+, right triangle: Zn2+. Part ‘B’ e estimated by ICP-AES in our work e squares: zinc concentrations, open: Zincum met (SBL), solid: Zincum met (WSI), open triangles: gold concentrations in Aurum met (SBL) samples. The dotted line at 20 pg/ml indicates the LOD of the instrument. 241 actual concentrations determined were lesser than the expected concentrations (circles, solid: expected; open: estimated concentrations). On the contrary, the concentra- tions of Fe3+ though slightly lower than expected at the 6 potency, did not decrease as expected, and were in fact slightly higher at 7 and 8 potencies (stars, solid: expected; open: determined concentrations). Likewise, the concentrations of Hg2+ and Zn2+ were almost 200% higher than expected at 8 potency. A scrupulous, concurrent analysis of these results suggested the com- mencement of an asymptote formation in the vicinity of the 8 (i.e. 4c) potency. When the data from Part ‘A’ of the graph are compared with our data (Part ‘B’), there appears to be a plateauing effect, reached at 6c potency. While a plateau is reached for each metal, the concentra- tion range varied from one metal to another and between manufacturers. The plateau of Zincum met (WSI) (solid squares) was appreciably higher (between 1300 and 4000pg/ml) than that for Zincum met (SBL) (open squares), albeit with the inherent variation mentioned ear- lier. Similar trends were also observed for all the other metals that were analyzed. Possible key mechanisms at large dilutions Acoustic cavitation, a well studied phenomenon11e14 may explain our TEM findings regarding surface asperities and particle aggregation. Researchers have observed that the vapor bubbles generated due to the high-energy sound waves had temperatures exceeding a few thousand degrees (w5000 K) along with intense pressures (w1000 atm). The bubbles so formed had very short lives before imploding, creating intense shock waves which propel particles in the solution at extremely high velocities resulting in collisions which induced the following morphological changes on the particle surfaces: 1. When the particles collided head-on, localized melting occurred on their surfaces at the point of contact, with the temperatures being w3000 K. With the surrounding liquid at ambient temperature, the melted surfaces instantly cooled at extremely high rates (>1010 K/s), thereby solidifying the melted area instantaneously and fusing the particles at the point of contact to form aggregates. 2. The extremely high rate of cooling, while not allowing for re-crystallization at the point of contact, led to an amorphous phase on the particle surface as evident from the diffused rings obtained in the electron diffraction (ED) patterns. 3. Collision of particles at a glancing angle led to fragmen- tation of the particle surface which may have given rise to surface asperities. The above theories support our observations regarding the presence of the surface asperities we see in TEM, since the forceful pounding of the glass containers during the succus- sion process may have been instrumental in generating the ultra-sound waves, resulting in their formation. Homeopathy 242 Nanoparticles of starting materials in homeopathic medicines PS Chikramane et al Another question that arises from our observations is how in spite of such huge dilutions the particles of the start- ing materials are retained even at 200c potency? The an- swer to this question could lie in the manufacturing process itself. We perceive that during the succussion pro- cess, the pounding of solutions against a rubber stop gener- ates numerous nanobubbles19 as a result of entrapment of air and cavitation due to generation of ultra-sound waves. The particles of the starting material instantaneously get adsorbed on the surface of these bubbles and cavitations. This phenomenon could be similar to the mechanism of formation of Pickering emulsions,20e22 wherein the emulsified phase viz. air bubbles or liquid droplets are stabilized by a layer of particles. This nanoparticleenanobubble complex rises to the sur- face and can be within a monolayer once the total metal concentrations are well below 1ppm (Table S6 e Supplementary information). It is this 1% of the top layer of the solution which is collected and added to the next vessel, into 99 parts of fresh solvent and the succussion process is repeated. This transfer of the top 1% layer in each step will ensure that once we reach below a certain concentration i.e. well within a monolayer, the entire start- ing material continues to go from one dilution to the next, resulting in an asymptote beyond 6c. Conclusion Using state-of-the-art techniques (TEM, SAED, and ICP-AES) we have demonstrated the presence of nanopar- ticles of the starting materials and their aggregates even at extremely high dilutions. The confirmed presence of nano- particles challenges current thinking about the role of dilu- tion in homeopathic medicines. We have found that the concentrations reach a plateau at the 6c potency and be- yond. Further, we have shown that despite large differences in the degree of dilution from 6c to 200c (1012 to 10400), there were no major differences in the nature of the parti- cles (shape and size) of the starting material and their abso- lute concentrations (in pg/ml). How this translates into change in biological activity with increasing potency needs further study. Concrete evi- dence of the presence of particles as found by us could help take the research in homeopathy a step forward in under- standing these potentised medicines and also help to posi- tively change the perception of the scientific community towards this mode of treatment. Conflict of interest There are neither any financial nor any personal conflicts of interest with respect to the work carried out for this article. Acknowledgements We thank the Department of Earth Sciences and the Cryo-TEM central facility at IIT Bombay for ICP-AES and TEM analyses respectively. We also gratefully acknowledge funding by Shridhar Shukla, S G Kane and Industrial Research and Consultancy Center (IRCC), IIT Bombay. We also thank P N Varma for valuable insights. Supplementary data Supplementary data associated with this article can be found in the online version at doi:10.1016/j.homp.2010. 05.006. References 1 Khuda-Bukhsh AR. Laboratory research in homeopathy: Pro. Integr Cancer Ther 2006; 5: 320e332. 2 Khuda-Bukhsh AR. Towards understanding molecular mechanisms of action of homeopathic drugs: an overview. Mol Cell Biochem 2003; 253: 339e345. 3 Davenas E, Beauvais F, Amara J, et al. Human basophil degranula- tion triggered by very dilute antiserum against IgE. Nature 1988; 333: 816e818. 4 Chaplin MF. The memory of water: an overview. Homeopathy 2007; 96: 143e150. 5 Teixeira J. Can water possibly have a memory? A skeptical view. Homeopathy 2007; 96: 158e162. 6 Anagnostatos GS. Small water clusters (clathrates) in the homoeo- pathic preparation process. In: Endler PC, Schulte J (eds). Ultra High Dilution e Physiology and Physics. Dordrecht, the Nether- lands: Kluwer Academic Publishers, 1994, p. 121e128. 7 Rao ML, Roy R, Bell IR, Hoover R. The defining role of structure (including epitaxy) in the plausibility of homeopathy. Homeopathy 2007; 96: 175e182. 8 Walach H, Jonas WB, Ives J, van Wijk R, Weinga ̈rtner O. Research on homeopathy: state of the art. J Altern Complement Med 2005; 11: 813e829. 9 Davydov AS. Energy and electron transport in biological systems. In: Ho MW, Popp FA, Warnke U (eds). Bioelectrodynamics and Biocommunication. Singapore: World Scientific Publishing Co. Pte. Ltd., 1994. Chap 17, pp 411e430. 10 Anick DJ, Ives JA. The silica hypothesis for homeopathy: physical chemistry. Homeopathy 2007; 96: 189e195. 11 Doktycz SJ, Suslick KS. Interparticle collisions driven by ultra- sound. Science 1990; 247: 1067e1069. 12 Suslick KS, Doktycz SJ. The sonochemistry of Zn powder. J Am Chem Soc 1989; 111: 2342e2344. 13 Suslick KS, Price GJ. Applications of ultrasound to materials chemistry. Annu Rev Mater Sci 1999; 29: 295e326. 14 Suslick KS. The chemical effects of ultrasound. Sci Am 1989 (Feb);80e86. 15 Goldstein AN, Echer CM, Alivisatos AP. Melting in semiconductor nanocrystals. Science 1992; 256: 1425e1427. 16 Edington JW. Philips technical library e monographs in practical electron microscopy in materials science 2 e electron diffraction in the electron microscope. Eindhoven: N.V. Philips’, 1975, p 110. 17 Varma PN, Vaid I. Encyclopedia of homoeopathic pharmacopoeia & drug index. New Delhi: B. Jain Publishers, 2007, pp 2722e2745. 18 Ro ̈der E, Pu ̈tz W, Frisse R. Bestimmung von Au, Fe, Zn und Hg in homo ̈opathischen Dilutionen durch zersto ̈rungsfreie Neutronenak- tivierungsanalyse. Fresenius Z Anal Chem 1981; 307: 120e126. 19 Roy R, Tiller WA, Bell I, Hoover MR. The structure of liquid water: novel insights from materials research; potential relevance to home- opathy. Mater Res Innov 2005; 9: 577e608. 20 Pickering SU. Emulsions. J Chem Soc 1907; 91: 2001e2021. 21 Binks BP. Particles as surfactants e similarities and differences. Curr Opin Colloid Interface Sci 2002; 7: 21e41. 22 Binks BP, Lumsdon SO. Influence of particle wettability on the type and stability of surfactant-free emulsions. Langmuir 2000; 16: 8622e8631. Homeopathy

Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control.

http://www.ncbi.nlm.nih.gov/pubmed/20674839 Homeopathy. 2010 Jul;99(3):156-66. doi: 10.1016/j.homp.2010.05.009. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Bracho G1, Varela E, Fernández R, Ordaz B, Marzoa N, Menéndez J, García L, Gilling E, Leyva R, Rufín R, de la Torre R, Solis RL, Batista N, Borrero R, Campa C. Author information Abstract BACKGROUND:

Leptospirosis is a zoonotic disease of major importance in the tropics where the incidence peaks in rainy seasons. Natural disasters represent a big challenge to Leptospirosis prevention strategies especially in endemic regions. Vaccination is an effective option but of reduced effectiveness in emergency situations. Homeoprophylactic interventions might help to control epidemics by using highly-diluted pathogens to induce protection in a short time scale. We report the results of a very large-scale homeoprophylaxis (HP) intervention against Leptospirosis in a dangerous epidemic situation in three provinces of Cuba in 2007. METHODS:

Forecast models were used to estimate possible trends of disease incidence. A homeoprophylactic formulation was prepared from dilutions of four circulating strains of Leptospirosis. This formulation was administered orally to 2.3 million persons at high risk in an epidemic in a region affected by natural disasters. The data from surveillance were used to measure the impact of the intervention by comparing with historical trends and non-intervention regions. RESULTS:

After the homeoprophylactic intervention a significant decrease of the disease incidence was observed in the intervention regions. No such modifications were observed in non-intervention regions. In the intervention region the incidence of Leptospirosis fell below the historic median. This observation was independent of rainfall. CONCLUSIONS:

The homeoprophylactic approach was associated with a large reduction of disease incidence and control of the epidemic. The results suggest the use of HP as a feasible tool for epidemic control, further research is warranted.

2010 Elsevier Ltd. All rights reserved.

TITLE: Homeoprophylaxis – Can you believe it?

TITLE: Homeoprophylaxis; Can you believe it?AUTHOR: © Elena Cecchetto CCH, NSHom(NA), MSc(cand) AUDIENCE: Myself, my professors, other students, other homeopaths, other interested parties. PURPOSE: To critically challenge the epistemology of an element of Homeopathic Practice; specifically the idea that Homeopathy can be successful in preventing disease amongst a population for epidemic or pandemic disease outbreaks. ABSTRACT: I have written this essay to deconstruct an aspect of my clinical practice. There is controversy around the use of homeoprophylaxis in preventing disease during epidemics and pandemics. I wanted to see if there was research that could demonstrate the ability to use homeopathy in epidemics/pandemics. If so, what type of research and can it be recognized as valid. If it is not, why not? I explored and gathered information, interviews with practitioners, charts, essays, population studies and Random Controlled Trials. These helped to see the various levels of ability for homeopathic remedies to be used to prevent infectious diseases in a laboratory and in actual contemporary populations. However, these studies are in contrast within the prevailing paradigm to do with how homeopathic remedies work. Since there is an underlying disbelief in the idea that highly diluted substances could work, there is a difficulty in accepting the studies that demonstrate success for homeopathic remedies.

Introduction:

Can homeopathy help for prevention of disease in epidemics or pandemics? I have been using Dr. Isaac Golden’s (2007) homeoprophylaxis (HP) program for children in my homeopathic clinical practice for 8 years. However, when clients and others ask for the scientific evidence, my reference to historical accounts of the use of homeopathy during actual epidemics doesn’t always seem to satisfy them. As I am questioning what is science and what is knowledge, I am also unsure. The purpose of this essay is to identify and come to an understanding of the idea behind using homeopathy for the prevention of illness in epidemic or pandemic diseases and addressing whether there is valid demonstration of the successful use of homeopathy for epidemics/pandemic diseases. Ranging from historical references, Random Control Trials (RCTs) and population studies, and provings; are these sufficient to demonstrate the premise that homeopathic treatment can be used to have an impact on infectious diseases? Are there factors limiting the research or use of the information generated?

Important aspects of this essay defined:

According to Webster’s online dictionary (2013), Epidemics and pandemics refer to an outbreak of an infections disease where many people are affected in a wide geographic area. A pandemic is the same except it is affecting a larger geographic area that can occur beyond borders of one region or even country. The founder of homeopathy, Samuel Hahnemann explains in the Organon (1996), that homeopathy is most simply defined as a medical art relying on two main principles being the law of minimum dose and the law of similars. Homeoprophylaxis is the use of homeopathic remedies to prevent ahead of time a specific disease. A homeopathic remedy proving is a collection of observed and recorded signs and symptoms conducted according to the instructions outlined in Hahnemann’s (1996) Organon. The material medica is the resource where these provings and other useful sources are compiled for organized reference of each remedy’s therapeutic uses.

How did the use of homeopathy for epidemics start?

Dr. Samuel Hahnemann and homeopaths inspired by him and his writings in the Organon have seemed to make good use of homeopathic treatment to help people who have succumbed to infectious diseases or to help prevent them from succumbing to them. It was Hahnemann’s discriminating observation in 1789 that began the exploration of prevention of disease with homeopathic remedies. In his Lesser Writings (1852), he first described his experience preventing Scarlet Fever by giving them all doses of Belladonna in addition to the members of the family who had contracted it. Using the principles of homeopathic medicine combined with knowledge of homeopathic remedies from provings or other material medica resources has granted the use remedies homeoprophylactically.

Physician’s records:

Historical references of hospital reports are one way a direct comparison can be made between homeopathy and non-homeopathic treatment. In the chart below compiled by Navab (2012), numbers of patient deaths in hospitals are compared to allopathic numbers of deaths. In these reports the rate of success for homeopaths in specific hospitals is shown as a mortality rate of less than 10% for the treatment of scarlet fever, cholera, typhus fever, pneumonia, yellow fever and Spanish influenza. The mortality rates for the conventional doctors of the time (termed allopaths) are over 10% for each of these diseases. The treatments the allopaths had for the 1918 flu were limited to aspirin or acetylsalicylic acid according to Billings (1997) compared to what is available now. It is also very plausible that the results in charts are simply lower for allopaths because the allopathic medicines used between 1798 and 1918 were not as sophisticated as the ones in the present.

homeopathic immunizations historical success rates for homeopathy and homeoprophylaxis in the medical system

In the 1800’s and early 1900’s when homeopaths were working as physicians within the medical system of society of the day, they had access to a statistically significant number of patients. Because these reports were created centuries ago, the information is open to interpretation. Reading the information in the chart above, different people will have different perspectives on the information presented depending on a person’s prior knowledge, beliefs and filters that can affect the conclusions (Fuller, 2003). A person educated in homeopathy (presumable already believing that homeopathy works) might ask ‘what remedies did they use?’ while a person not knowing homeopathy might simply ask the question ‘how’.

The homeopathic physicians had the same or similar access to clinical surroundings and tools available to the allopathic physicians. During the 1918 Influenza in California, Elsa Engle was a nurse practitioner using homeopathic remedies under instruction from Dr. Engle. As Malthouse (2010) wrote from an interview that was conducted by Frances Kalfus in 1992, the then 97 year old Elsa Engle explains their success at Hahnemann Hospital; “They all had about the same symptoms. You didn't have to do anything else but give them a bottle of Gelsemium, followed with a bottle of Eupatorium perfoliatum... In five days practically all of them were well”. Gelsemium and Eupatorium perfoliatum are homeopathic remedies that are still commonly used for influenza. The CBC report (Puri, 2009) explained to viewers during the many homeopathic clients were turning to the remedy Gelsemium that was “used extensively during the Spanish flu epidemic of 1918” for the H1N1 flu. However, with information or data and its style of presentation, each person will come to a different conclusion depending on prior experiences and beliefs. In order for something like homeopathy, because it might be in contrast with a strong belief, even the highest quality of research won’t suffice to change that belief despite what a study shows. Rutten (2008) describes the problem that “Prior beliefs are updated in the Bayesian process, but the first prior belief has a special position. This first prior belief is very strong, we need to consider how strong and why. It is in fact paradigmatic and might not be susceptible to Bayes’ theorum”. Perhaps only a strong personal experience (seeing is believing) might be the only thing that can change a strong prior belief.

RCTs Japanese Encephalitis (JE):

Looking at two Random Control Trials (RCTs) in a clinical laboratory where studies were done with the infectious disease Japanese Encephalitis (JE) and doses of the homeopathic remedy, Belladonna. The authors Bandyopadhyay et al. (2010 and 2011) found statistically significant success showing that Belladonna is effective in preventing disease indicators. This is a chart from Bandyopadhyay et al. (2010) showing decreased viral infection found in the Choriallontoic Membrane (CAM) of unhatched chicks dosed with Belladonna in the four different potencies of 3, 6, 30 and 200;

For the RCT done on suckling mice by Bandyopadhyay et al. (2011), average survival rates of the infected suckling mice treated with Belladonna 200C daily for 14 days had almost double the survival rate than those not treated with Belladonna 200C. 47% survival rate for untreated mice versus 79.24% and 80.60% for the Belladonna treated mice for 7 and 14 days. In the discussion of this successful study, the authors Bandyopadhyay et al. (2011) state that homeopathic practitioners have historically been using the homeopathic remedy Belladonna for the prevention of JE without any RCT experimental proof of how it works and therefore there is further need to test how it is that the homeopathic remedy Belladonna has showed an ability to prevent JE. This study has successfully shown a specific outcome. However, the question of the properties of Belladonna that made it work is what the authors chose to recommend as required further study.

Population Studies: Swine Flu in India:

In India 2009 a Swine Flu patient study involving 23 Homeopaths and 1146 patients was conducted by Mathie et al. (2013) which took a set of previous agreed upon (by the Centre for Clinical Research of Homeopathy (CCRH)) group of symptoms defining Swine Flu by Homeopaths working in government approved health centres in India. The Homeopaths agreed to record their results in a formatted excel chart between October, 2009 and February, 2010. The most frequently prescribed remedy that helped the patients as the primary care for the Swine Flu was Arsenicum album; the very same remedy that the CCRH had identified as the as a prophylactic Genus Epidemicus for this pandemic. Results like this can tempt the enthusiast to proclaim at this as proof that homeopathy can be used in epidemics.

However, the overarching challenge in demonstrating the proof that homeopathy can be successful for epidemics and pandemics through research and information is that it contrasts the current prevailing paradigm. To express this idea Rutten (2008) quotes Vandenbroucke (2001) “Accepting that infinite dilutions work would subvert more than conventional medicine; it wrecks a whole edifice of chemistry and physics”. With this in mind, the work shown in this study could present to different conclusions to people with different prior beliefs. If accepting the validity of homeopathic remedies is not a possibility within the belief system than accepting this study as successfully demonstrating that homeopathy can help in epidemics is also not a possibility.

Leptospirosis in Cuba:

A study by Bracho et al. (2009) was conducted with 2.3 million people in Cuba. The population above 1 year of age was given two oral doses of the Leptospirosis Nosode in the 200C and 10M potencies with an interval of 7-9 days between doses. Then ten to twelve months later, they were given another two oral doses of the 10M potency 7-9 days apart. These homeopathic remedies were administered by approximately 5000 Cuban public health system personnel using five drops (250-300 µL) under the tongue (sublingually) 20 minutes away from eating or drinking or smoking. One year of comparison between the area that received doses (the Intervention Region, IR) and the Rest of the Country (RC) showed a significant decrease of cases of Leptospirosis in the IR. This study looked at the numbers generated by the same institutions that are responsible for managing epidemic disease diagnosis and prognosis in Cuba (the national weekly report based on provincial data generated by the Trend Analysis Unit from the Minister of Epidemiology of the Ministry of Public Health of Cuba). According to Bracho (2009) their prediction of number of cases of Leptrospirosis was 111-461 in the Intervention Region in the most precarious 3 week period (weeks 47-52 of 2007 because of number of days between the start of the increased rainfalls and infection rates) when only actually 38 confirmed cases showed up. This was a reduction of 91.8% to 65.8% in the IR. Despite that there were increased risks of Leptospirosis infection that year due to extreme rainfall in October-November in the IR, the annual number of cases decreased by 84% while in the RC there was an increase of 21.7%. The authors conclude that these findings lend to a high degree of confidence that using homeopathic remedies to prevent disease in populations is a useful tool for epidemics and pandemics.

This study shows successful implementation of homeopathy for a population during an actual epidemic and demonstrates that homeopathy is successful in preventing illness during epidemics or pandemics. Whether this study will model a way that homeopathy can show success in preventing disease amongst a population for epidemic or pandemic disease outbreaks is still in question (Roniger, 2010). The positive aspect of this study is that there were millions of Cubans who willingly experienced homeopathy by taking those remedies in compliance with their predominant health professionals. As Rutton (2008) points out, changing towards a belief in homeopathic medicine might require a turning point such as a personal experience. What that has been shown to do is “We may accept evidence that we did not accept before. We may abandon the first prior, rearrange and re-interpret the evidence and then the process of sequential updating can start”. That way a previous belief that contradicts the idea that homeopathic remedies will not continue to stand in the way of some possible data or information being presented in research of various types.

Conclusions:

In this essay I’ve brought to attention various types of demonstrations of the use of homeopathy for epidemics and pandemics, including some that are the accepted standard for medical science. Using these examples it seems to be possible to demonstrate the specific success with RCT studies, population studies plus historical records on the use of homeopathy during epidemics/pandemics. As Bracho says (2010) it is also possible to conduct further studies with a significant level of confidence that homeopathy will prove itself as a valid way to address the health of populations during epidemics/pandemics. However, the criteria required in order to conduct this type of research isn’t always easily available to homeopaths in various parts of the world. So far it seems that there is a facility in Cuba that has opportunity to do this plus certain homeopaths in certain clinics of India are also already established for these types of studies.

There are challenges to the understanding and acceptance of use of homeopathic remedies for epidemics and pandemics. Part of it lies within the current paradigm that predominates. The disbelief that highly diluted substances such as homeopathic remedies could have a therapeutic action is the paradigm that limits the acceptance of studies on homeopathy despite their success in showing specific outcomes. With a prior acceptance of biochemical medicine combined with an expectation that homeopathy would act in the same manner, there is not a certain type of research that would qualify to change that disbelief that homeopathic remedies work because the prior belief is too many steps away from the new belief. It is recommended from this overview that any further studies to address the ability to use homeopathy for epidemics and pandemics should acknowledge that whether the reader concludes the study acceptable or not has to do with the challenge of the paradigm surrounding how homeopathic remedies work. Do not use this publication or any part of this publication without permission from the author © Elena Cecchetto CCH, NSHom(NA), MSc(cand)

REFERENCES:

Bandyopadhyay, B. (2010) Decreased intensity of japanese encephalitis virus infection in chick chorioallantoic membrane under influence of ultradilutions of belladonna extract. American Journal of Infectious Diseases 6 (2): 24-28.

Bandyopadhyay, B. (2011) Suckling mice of “belladonna 200” fed mothers evade virulent nakayama strain japanese encephalitis virus infection. International Journal of Microbiological Research 2 (3): 252-257.

Billings, M. (1997) The Medical and Scientific Conceptions of Influenza. Last accessed December 16th, 2013 at http://virus.stanford.edu/uda/fluscimed.html

Bodman, F. (1975) The quest for specifics. British Homoeopathic Journal. 64 (1): 30-39.

Bracho, G., Varela, E., Ferna ́ndez, R., Ordaz, B., Marzoa, N., Mene ́ndez, J., Garc ́ıa, L., Gilling, E., … Campa, C. (2010) Large-scale application of highly-diluted bacteria for leptospirosis epidemic control. Homeopathy 99, 156-166. doi:10.1016/j.homp.2010.05.009

Fuller, S. (2003) Kuhn vs. Popper. Duxford, Cambridge, UK: Icon Books Ltd.

Golden, I. (2007) Vaccination & homeoprophylaxis? A review of risks and alternatives (6th edition), Canberra: National Library

Hahnemann, S. (1996). Organon of the medical art (6th Edition) edited and annotated by W.B. O’Rielly. Redmond, Washington: Birdcage Books.

Hahnemann, S. (1852) Lesser writings of Samuel Hahnemann last accessed Dec 2, 2013 at http://books.google.ca/books?id=YwTZzl_fk74C&dq=lesser%20writings%20by%20samuel%20hahnemann&pg=PR7#v=onepage&q=lesser%20writings%20by%20samuel%20hahnemann&f=false

Mathie, R., Baitson, E., Frye, J., Nayak, C., Manchanda, R, and Fisher, P. (2013) Homeopathic treatment of patients with influenza-like illness during the 2009 A/H1N1 influenza pandemic in india. Homeopathy 102, 187-192. http://dx.doi.org/10.1016/j.homp.2013.04.001

Malthouse, S., (2010) Homeopathy and Influenze; The Spanish Flu experience. The Immunity Challenge Conference Presentation. last accessed December 2, 2013 at http://www.cmcgc.com/media/handouts/061035/040_Malthouse.pdf

Navab, I. (2012) Lives saved by homeopathy in epidemics and pandemics. last accessed November 23, 2013 at http://drnancymalik.wordpress.com/2013/01/23/epidemics-and-pandemics/

Puri, B. (2009) Last accessed Dec 12-13 at http://www.cbc.ca/news/canada/british-columbia/some-seek-alternative-swine-flu-therapies-1.833973

Roniger, H & Jacobs. (2010) Prophylaxis against leptospirosis using a nosode: Can this cohort study serve as a model for future replications?. The Faculty of homeopathy 99, 152-155. doi.10.1016/j.homp.2010.06.004

Rutton, A. (2008) How can we change beliefs? A bayesian perspective. The Faculty of Homeopathy 97, 214-219. doi:10.1016/j.homp.2008.09.007

Vandenbroucke, JP & de Crean. (2001) Alternative medicine “a mirror image” for scientific reasoning in conventional medicine. Ann Intern Med 135, 507-513

Webster’s online dictionary. Last accessed November 23rd, 2013 at http://www.webster-dictionary.org/definition/epidemic

Webster’s online dictionary. Last accessed November 23rd, 2013 at http://www.webster-dictionary.org/definition/pandemic Do not use this publication or any part of this publication without permission from the author © Elena Cecchetto CCH, NSHom(NA), MSc(cand)

Homeoprophylaxis (What CBC's Marketplace is calling an alternative to vaccines)

Will CBC bring more attention to Homeoprophylaxis (what they’ll describe as an alternative to vaccines) than homeopaths can?!?
A few years ago, a journalist requested information on homeopathy for a show on CBC. I am a typical Canadian and so therefore I have a strong affinity for CBC. I asked clearly to the organizers of the show that this would be a fair and true representation of homeopathy. I know that it is easy to target aspects of homeopathy because of its complex and unique principles of healing. However, the producers of CBC’s Marketplace expressed specifically and clearly that this would not be the way they would use the information they gather. I met with them and they interviewed me at my clinic. I also faithfully gave them a number for one of my clients that had agreed she wouldn’t mind being interviewed. I printed out for them a thick pile of many research reports that presented sound science backing up many of the principles of healing used in the science of homeopathy. That show which has repeated more times than any other episode of CBC’s Marketplace ended up being truly blatantly biased and absolutely NOT scientific. There was no mention of the scientific reports that I and others had given to them.
When that episode was shown, there were many people who posted words of support and commitment to the option of homeopathy in the healing choices. The Marketplace website seemed to edit and only release a certain number of the responses. People writing in support of homeopathy reported that their posts had not been published. People wrote in to CBC’s producers, CBC’s Ombudsman, and the homeopathic community bonded over the outrage of this slander. This fall, CBC plans to release another show about an aspect of homeopathic practice known as homeoprophylaxis. Homeoprophylaxis is the use of homeopathic remedies in anticipation for prevention of a specific health concern. The founder of homeopathy, Samuel Hahnemann writes about using the principles of homeoprophylaxis back in 1798 in his publication on Scarlet Fever called “The Cure and Prevention of Scarlet Fever”, in ‘Lesser Writings’ (B.Jain Publishing. New Delhi. P.369ff). http://www.feg.unesp.br/~ojs/index.php/ijhdr/article/viewFile/360/407 using the homoeopathic remedy called Belladonna. He also refers to the ways to conduct homeoprophylaxis in the Aphorisms number 100, 101, 102 and 241 of his written guide to homeopathy known as ‘The Organon’ first published in 1810 (Hahnemann S. Organon of medicine. 6th Edn. (Translated by William Boericke). New Delhi: B Jain Publishers, 1991). The most contemporary uses of homeoprophylaxis are based on the science conducted mostly by Dr. Isaac Golden http://www.homstudy.net/Research/ and Dr. G. Bracho. http://www.ncbi.nlm.nih.gov/pubmed/20674839
Despite that currently there exists (and will continually be more of) quality research to demonstrate the effective use of homeopathy to address specific health concerns, CBC will attempt to convince you that there is none. Let me guide you to the BOX WIDGET on my blog https://homeopathiccures.wordpress.com
That is where you’ll be able to access homeopathic experts advice or writings by homeopathic experts. In the words of Merriam-Webster Dictionary (http://www.merriam-webster.com/dictionary/expert), an expert is defined as “having or showing special skill or knowledge because of what you have been taught or what you have experienced”. With this in mind, please QUESTION who CBC will refer to as ‘experts’ on topics of homeopathy.
Instead of truthfully facing the experts on homeopathy (myself and a known few of my colleagues) CBC Marketplace’s approach to get information from us was to plant a fake client into our private practice. A few months later, an email was sent to me stating that they had done this and would I do an interview them?

ARRGH!

Instead they chose a mysterious random bunch of people https://homeopathiccures.files.wordpress.com/2014/09/centre-for-inquiry.pdf…random people who don’t know that you can NOT overdose on homeopathic remedies – and that this is a GOOD thing BUT that it is IRRESPONSIBLE to try to do your own ‘experiments’ on a form of medicine that you don’t have a clue about.
Needless to say, I am NOT doing any kind of happy dance http://animalfactoftheday.blogspot.ca/2012/04/manakin-bird-can-moonwalk.html in anticipation of a new episode focussing on Homeoprophylaxis.
The tragic irony is that I have a feeling that CBC Marketplace’s blatant show of ignorance will be apparent to most critical thinkers that are their audience and those people will either look for more information to satisfy their curiosity OR they will stand stronger in their commitment to choices for health care options for Canadians. In case this is the place you’ve come to for more information, let me assure you that maintaining the homeopathy as a choice made available to us is more important than our regular freedoms of choice as it has to do with the most important aspect of our existence because as they say, ‘if we don’t have our health, what do we have?’ That is the essence of what drives most people to homeopathy. In ONE country alone there are over 100 million people using homeopathy (http://drnancymalik.wordpress.com/article/status-of-homeopathy/)(India). Also keep in mind that the top two most debated topics on Wikipedia are Jesus and homeopathy
If you’ve seen the CBC Marketplace’s representation of homeopathy and would like to take part in some discussions about it, please keep in touch at https://www.facebook.com/AccessNaturalHealing/photos/a.119846306893.123640.10145471893/10152470442151894/?type=1&theater
Sincerely Yours in Homeopathy
Elena Cecchetto (EL)
info@accessnaturalhealing.com
604-568-4663
http://www.accessnaturalhealing.com
© 2014 Elena Cecchetto

CBC and Homeopathy; The Real Truth

https://homeopathiccures.wordpress.com/2014/09/29/cbc-and-homeopathy-the-real-truth/ Will CBC bring more attention to Homeoprophylaxis (what they’ll describe as an alternative to vaccines) than homeopaths can?!?

A few years ago, a journalist requested information on homeopathy for a show on CBC. I am a typical Canadian and so therefore I have a strong affinity for CBC. cbc fan-not I asked clearly to the organizers of the show that this would be a fair and true representation of homeopathy. I know that it is easy to target aspects of homeopathy because of its complex and unique principles of healing. However, the producers of CBC’s Marketplace expressed specifically and clearly that this would not be the way they would use the information they gather. I met with them and they interviewed me at my clinic. I also faithfully gave them a number for one of my clients that had agreed she wouldn’t mind being interviewed. I printed out for them a thick pile of many research reports that presented sound science backing up many of the principles of healing used in the science of homeopathy. That show which has repeated more times than any other episode of CBC’s Marketplace ended up being truly blatantly biased and absolutely NOT scientific. There was no mention of the scientific reports that I and others had given to them.

When that episode was shown, there were many people who posted words of support and commitment to the option of homeopathy in the healing choices. The Marketplace website seemed to edit and only release a certain number of the responses. People writing in support of homeopathy reported that their posts had not been published. People wrote in to CBC’s producers, CBC’s Ombudsman, and the homeopathic community bonded over the outrage of this slander. This fall, CBC plans to release another show about an aspect of homeopathic practice known as homeoprophylaxis. Homeoprophylaxis is the use of homeopathic remedies in anticipation for prevention of a specific health concern. The founder of homeopathy, Samuel Hahnemann hahnemann tribute statuewrites about using the principles of homeoprophylaxis back in 1798 in his publication on Scarlet Fever called “The Cure and Prevention of Scarlet Fever”, in ‘Lesser Writings’ (B.Jain Publishing. New Delhi. P.369ff). http://www.feg.unesp.br/~ojs/index.php/ijhdr/article/viewFile/360/407 using the homoeopathic remedy called Belladonna. He also refers to the ways to conduct homeoprophylaxis in the Aphorisms number 100, 101, 102 and 241 of his written guide to homeopathy known as ‘The Organon’ first published in 1810 (Hahnemann S. Organon of medicine. 6th Edn. (Translated by William Boericke). New Delhi: B Jain Publishers, 1991). The most contemporary uses of homeoprophylaxis are based on the science conducted mostly by Dr. Isaac Golden http://www.homstudy.net/Research/ vaccineworked (1)and Dr. G. Bracho. http://www.ncbi.nlm.nih.gov/pubmed/20674839

Despite that currently there exists (and will continually be more of) quality research to demonstrate the effective use of homeopathy to address specific health concerns, CBC will attempt to convince you that there is none. Let me guide you to the BOX WIDGET on my blog https://homeopathiccures.wordpress.com

That is where you’ll be able to access homeopathic experts advice or writings by homeopathic experts. In the words of Merriam-Webster Dictionary (http://www.merriam-webster.com/dictionary/expert), an expert is defined as “having or showing special skill or knowledge because of what you have been taught or what you have experienced”. With this in mind, please QUESTION who CBC will refer to as ‘experts’ on topics of homeopathy.

Instead of truthfully facing the experts on homeopathy (myself and a known few of my colleagues) CBC Marketplace’s approach to get information from us was to plant a fake client into our private practice. A few months later, an email was sent to me stating that they had done this and would I do an interview them?

ARRGH!

Instead they chose a mysterious random bunch of people https://homeopathiccures.files.wordpress.com/2014/09/centre-for-inquiry.pdf…random people who don’t know that you can NOT overdose on homeopathic remedies – and that this is a GOOD thing BUT that it is IRRESPONSIBLE to try to do your own ‘experiments’ on a form of medicine that you don’t have a clue about.

Needless to say, I am NOT doing any kind of happy dance http://animalfactoftheday.blogspot.ca/2012/04/manakin-bird-can-moonwalk.html in anticipation of a new episode focussing on Homeoprophylaxis.

The tragic irony is that I have a feeling that CBC Marketplace’s blatant show of ignorance will be apparent to most critical thinkers that are their audience and those people will either look for more information to satisfy their curiosity OR they will stand stronger in their commitment to choices for health care options for Canadians. In case this is the place you’ve come to for more information, let me assure you that maintaining the homeopathy as a choice made available to us is more important than our regular freedoms of choice as it has to do with the most important aspect of our existence because as they say, ‘if we don’t have our health, what do we have?’ That is the essence of what drives most people to homeopathy. In ONE country alone there are over 100 million people using homeopathy (http://drnancymalik.wordpress.com/article/status-of-homeopathy/)(India). Also keep in mind that the top two most debated topics on Wikipedia are Jesus and homeopathy 10403113_10152470442151894_5729566789284618701_n If you’ve seen the CBC Marketplace’s representation of homeopathy and would like to take part in some discussions about it, please keep in touch at https://www.facebook.com/AccessNaturalHealing/photos/a.119846306893.123640.10145471893/10152470442151894/?type=1&theater

Sincerely Yours in Homeopathy Elena Cecchetto (EL) info@accessnaturalhealing.com 604-568-4663 http://www.accessnaturalhealing.com © 2014 Elena Cecchetto