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http://drinkanddrugsnews.com/tag/tracy-woodward-gagetta/ Studying homeopathy led Tracy Woodward Gagetta to explore an innovative titration system for drug detoxification, as she explains
After training and working in the fields of mental health and addictions, I developed a dilution titration system to reduce the withdrawal symptoms of and cravings for heroin, while studying for a degree in homeopathy. This was originally a research proposal for my graduating year, but soon developed into a titration for different drug detoxes, called the Tauto-Mod titration system.
The first pilot project was funded by the Homeopathy Action Trust and was a one-day-a-week project in a rehabilitation centre in Luton and a homeless day programme in Slough. After results proved positive for the programme, the detox was then taken on by South Westminster Drug and Alcohol Service (SWDAS) to be used in conjunction with a range of other interventions at the service. Detoxification from opioids and alcohol in this service is carried out under medical supervision, and employs a range of NICE approved drug (allopathic) therapies, with adjuvant evidence based psychosocial interventions. The homeopathic treatment outlined in this article was additional to this.
Since the pilot started at SWDAS in April 2013, 45 clients have taken part in the detox and study. Out of these clients, 60 per cent had self-referred after attending a guest speaker group and hearing about the detox from other clients. Seventy per cent were male and 30 per cent female, with a dropout rate (attending less than three appointments) of six clients in total. Alcohol clients had the highest overall attendance, at 55 per cent. Among all the clients, there was an overall retention rate of 80 per cent for weekly appointments and a successful completion rate of 61 per cent (including those detoxing from the programme, remaining abstinent and/or no longer using the primary drug.) Of those on the programme, nine clients were also on a drug replacement therapy prescription, including detoxing from methadone.
The drugs we detox, and which were included in the SWDAS study, are alcohol, cocaine/crack, heroin, cannabis, methadone, benzodiazepines, amphetamines, methamphetamine, GBL and ketamine.
The Tauto-Mod system adopts a tautopathic approach, which involves the drug or substance that has caused the illness and/or toxicity in the client being prescribed at a high dilution. This system is believed to work in accordance with the ‘hormesis concept’.
Hormesis in toxicity involves providing a low-dose stimulation (the drug in high dilution) to cells in order to trigger a restorative process – that is, the compensatory response to damage. It is proposed that these low doses of toxins or other stressors might activate the repair mechanisms of the body. In layman’s terms, the Tauto-Mod system works primarily at the cellular level to flush toxins from the body, thus reducing cravings, withdrawal symptoms and long-term toxicity.
The recording of results and the prescribing of the appropriate dilution occurs weekly and is based on whether the symptoms for each drug present as nil, mild, moderate or severe for each titration chart. For example, a client presenting with mostly moderate to severe withdrawal and toxicity symptoms will be prescribed the appropriate tautopathic medication at low dilution. The more amelioration of symptoms recorded in subsequent weeks, the more the dilution of the tautopathic medicine is increased. Clients are recommended in most cases to take a couple of doses daily. This is to ensure they are receiving the full effects of the medication, particularly as most are still using the drug on top of their tautopathic prescription and maybe taking conventional medications alongside this system.
Tauto-Mod involves weekly titration charts that record symptom levels for each drug misused per person. Depending on the level of severity of symptoms, the client is then prescribed the drug at a specified dilution level. The higher the level of symptoms and toxicity, the lower the dilution of the drug. The system titrates upwards only, which differs from conventional methods of prescribing methadone. The premise is that the higher the dilution, the more this method is believed to work on the mental/emotional level once most of the physical symptoms have been alleviated by the lower dilution preparations.
The expectation of the Tauto-Mod detox is that the patient attends weekly appointments to observe and record shifts in symptoms and prescription. This also allows the practitioner to liaise directly with the project workers and medical staff to ensure the best treatment is provided and to flag any risks and concerns, as well as positive progress. Substance misusers often live chaotic lifestyles, so it is not always possible to see the patient on a weekly basis for a minimum of 12 weeks; however, so far at SWDAS, the attendance rate has been high and surpassed expectations.
This programme also has a second system running parallel to the tautopathic prescriptions. Since the addictions sector is now acknowledging that we must focus on the client’s underlying reasons for becoming a substance misuser in the first place, the project also prescribes dilution medications for any associated mental and physical health symptoms, ensuring that the client receives holistic support in their recovery. Mental health issues, such as depression, anxiety, delusions and paranoia, are prescribed for with relevant homeopathic medications. The same follows for any physical health symptoms such as restless leg syndrome, chronic coughs, headaches and constipation. This holistic approach allows the client to develop a sense of overall wellness and attempts to pre-emptively address any reasons why the service user may relapse in the future, such as past trauma and life changing events.
With the aim of rolling this out to other services in south east England and eventually nationwide, I realised I needed help from someone else in the industry and partnered with Mark Dempster, practising psychotherapist, drugs counsellor and author of Nothing to Declare. He was very enthusiastic about an ‘innovative detoxification system that has limitless potential in the future’ and said that ‘a titration system fit for purpose which can accommodate the needs of developing drug trends and markets has to be a good thing.’
As the system is not only a clinical treatment programme but also a study, progressive services and boroughs throughout the country now have the opportunity to benefit from our results, helping to obtain more positive outcomes as well as being part of this exciting study. This service has worked well in an integrated health care system and can be accessed at most levels of treatment.
The aim is to ensure that the service user can access a holistic treatment system that is tailor-made to their needs, expectations and long-term health goals. The substance misuse field is finally addressing the issue of long-term methadone maintenance. However, there is still great scope for investigation into complementary and unconventional therapies, their worth to the sector, and the holistic side of treatment.
Tracy Woodward Gagetta is CEO and founder of Restorative Recovery Prescribing Ltd. For more information on the Tauto-Mod system, visit www.recoveryprescribing.com http://drinkanddrugsnews.com/tag/tracy-woodward-gagetta/
Homeopathy an effective alternative Published on Mon Mar 16 2015 Re: Scientists skeptical of study on ADHD care, March 6 Scientists skeptical of study on ADHD care, March 6
As a medical doctor, I use homeopathy on a daily basis to fill in gaps or improve on the conventional therapies I also use in family practice. There is no doubt that homeopathy works – even in children and in skeptical patients that are willing to give it a try (particularly if they have tried everything else without benefit); sometime even in patients’ pets. Sure, good interaction and placebo play a role, just as in any therapeutic encounter, but that does not explain the results I observe. When a group of “top” scientists declare that there is no evidence to support homeopathy, you cannot but wonder at their agenda. In fact, there have been several meta-analyses and governmental assessments that show homeopathy is effective (BMJ 1991, Lancet 1997, Eur J. Clin Pharmacology 2000, Swiss Federal Office for Public Health 2006). There are numerous positive trials, many of fair to high quality. Medical doctors around the world have accepted homeopathy based on sound evidence and the personal experience that confirms it. In Belgium, for example, 4000 doctors prescribe homeopathic medicines routinely. Homeopathy is inexpensive, convenient, integrates well with conventional medicine, and patient satisfaction and safety are excellent. It is included in the national health schemes of Great Britain, France, Switzerland, Brazil, Mexico, India and many other countries. The recent discovery of nanoparticles in homeopathic ultra-dilutions has undermined the “implausibility argument” or “I can’t understand how it works, therefore it can’t work.” This type of flat-earth thinking is not helpful in promoting better healthcare and has no place in medical practice or research. The main reason pseudo-scientists become quack-busters and criticize therapies such as homeopathy is fear. Perceived as a threat to their world-view, they use the labels “unscientific” or “implausible” to defend themselves against the barbarians at the gate. It is not really an issue of evidence or science. It’s a subconscious defense mechanism that cannot be overcome, even if the research is piled up to the ceiling. It may be disguised as defending the public, but as Shakespeare says: “The lady doth protest too much.” The potential benefits of homeopathy demand research such as Dr. Heather Boon’s ADHD study at University of Toronto, and we should not let fixed thinkers get in the way of progress in medicine. In fact, the criticism here should be levelled at McGill University for permitting its Office for Science and Society to exist and Dr. Joe Schwarcz to continue to “interpret science for the public.” Dr. Stephen Malthouse, past president, Canadian Complementary Medical Association, Denman Island, B.C.
http://www.washingtonpost.com/blogs/wonkblog/wp/2013/01/24/surprise-we-dont-know-if-half-our-medical-treatments-work/?utm_content=bufferda437&utm_medium=social&utm_source=facebook.com&utm_campaign=buffer
Open Access Highly Accessed Research article The impact of NHS based primary care complementary therapy services on health outcomes and NHS costs: a review of service audits and evaluations
Lesley Wye*, Deborah Sharp and Alison Shaw
* Corresponding author: Lesley Wye lesley.wye@bristol.ac.uk
Author Affiliations
Academic Unit of Primary Health Care, University of Bristol, 25 Belgrave Road, Bristol, BS8 2AA, UK
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BMC Complementary and Alternative Medicine 2009, 9:5 doi:10.1186/1472-6882-9-5
The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1472-6882/9/5
Received: 28 October 2008 Accepted: 6 March 2009 Published: 6 March 2009
© 2009 Wye 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 aim of this study was to review evaluations and audits of primary care complementary therapy services to determine the impact of these services on improving health outcomes and reducing NHS costs. Our intention is to help service users, service providers, clinicians and NHS commissioners make informed decisions about the potential of NHS based complementary therapy services. Methods
We searched for published and unpublished studies of NHS based primary care complementary therapy services located in England and Wales from November 2003 to April 2008. We identified the type of information included in each document and extracted comparable data on health outcomes and NHS costs (e.g. prescriptions and GP consultations). Results
Twenty-one documents for 14 services met our inclusion criteria. Overall, the quality of the studies was poor, so few conclusions can be made. One controlled and eleven uncontrolled studies using SF36 or MYMOP indicated that primary care complementary therapy services had moderate to strong impact on health status scores. Data on the impact of primary care complementary therapy services on NHS costs were scarcer and inconclusive. One controlled study of a medical osteopathy service found that service users did not decrease their use of NHS resources. Conclusion
To improve the quality of evaluations, we urge those evaluating complementary therapy services to use standardised health outcome tools, calculate confidence intervals and collect NHS cost data from GP medical records. Further discussion is needed on ways to standardise the collection and reporting of NHS cost data in primary care complementary therapy services evaluations. Background
To make informed decisions about the usefulness of complementary therapies, service users, clinicians and NHS commissioners need good quality information on the contribution complementary therapies can make to improving health outcomes and reducing NHS costs. Although there has been extensive debate on the best way to assess the impact of complementary therapy treatments on health outcomes [1-3], randomised controlled trials tend to dominate. Randomised controlled trials are conducted in tightly controlled experimental environments in which a particular intervention is targeted to a medically defined symptom (e.g. acupuncture for migraine headaches). When treatments are removed from this experimental context and integrated into the real world of healthcare service delivery, these tight controls disappear and local contextual factors may alter the impact of the treatments. Hence, in investigating the potential usefulness of complementary therapies as part of mainstream healthcare provision, research into the effectiveness of treatments and the impact of services is necessary.
To date, however, the majority of research has been into the therapeutic effectiveness of complementary therapy treatments, with approximately 1500 trial based papers published annually [4]. More recently, the cost effectiveness of complementary therapy treatments has become a focus. A review of 14 studies of complementary therapy treatments meeting quality criteria found that seven treatments were cost effective, including guided imagery, relaxation and potassium diets for cardiac patients and osteopathy and chiropractic for neck pain [5]. Another economic review of five complementary therapy treatments concluded that four treatments resulted in additional costs to the NHS compared to usual care, largely to cover the costs of the practitioner. They also found that the estimates of cost of the complementary therapy treatments compared favourably with other interventions approved for use in the NHS [6]. Nonetheless, although research evidence on the clinical and cost effectiveness of complementary therapy treatments is growing, we have less information on the impact of complementary therapy services on health outcomes or NHS costs.
One attempt to address this was a report by Christopher Smallwood and colleagues published in 2005 [7]. Drawing on three case sites where complementary therapy services were provided in NHS settings, the authors came to the conclusion that [In the] majority of cases, specific conditions have improved, as have patients' general health and sense of well-being... [and] there seems to be good reason to believe that a number of CAM (complementary and alternative) treatments offer the possibility of significant savings in cost [7].
Perhaps unsurprisingly, given the controversy surrounding NHS provision of complementary therapies, the credibility of this report was challenged [8]. Notwithstanding, these were possibly overly bold assertions, in light of the limited quantity and questionable quality of some of the case study data. Aim of this study
In a previous exercise, we collected evaluations of 25 complementary therapy services to identify the methodologies used to assess services [9]. In addition, we explored the relationship between evaluation content and methodology and NHS funding and found that a favourable report did not necessarily result in NHS funding. Subsequently, we interviewed NHS funders and found that although health outcome information was useful, information on the impact of complementary therapy services on NHS resource utilisation (e.g. GP consultations, prescription and hospital services) was necessary to inform commissioning decisions [10].
We have since continued to collect service evaluations and the purpose of this paper is to report on the data contained within this larger collection of documents. Specifically, our aim is to identify the potential impact of primary care complementary therapy services on health outcomes and NHS costs, as reported in complementary therapy service evaluations. The target audiences for this paper are NHS commissioners, who may be considering provision of complementary therapy services, and current and future providers of NHS based complementary therapy services, who can build on the experiences of colleagues conducting earlier evaluations. Methods Search strategy
Because the majority of complementary therapy services are located within primary care, we limited our review to this sector. We collected published and unpublished evaluations from November 2003 to April 2008. A rigorous, comprehensive searching strategy was devised including:
Contacting colleagues at the Foundation for Integrated Health, mid-Devon Primary Care Research Group and the Universities of Bristol, Sheffield, Thames Valley and Westminster, who had conducted evaluations and/or were networked to identify others who had.
Telephoning professional complementary therapy organisations e.g. Society of Homeopaths, British Council of Acupuncture, General Chiropractic Council, General Osteopathic Council.
Identifying potential studies from bibliographies of reports previously collected.
Searching the database of registered users for the SF36 and MYMOP questionnaires.
Searching PubCAM, AMED (Allied and Complementary Medicine) and Google Scholar.
Hand searching the archives of several journals including Complementary Therapies in Medicine, Homeopathy and Acupuncture in Medicine.
Search terms were: audit, general practice, primary care, complementary, alternative, homeopathy, acupuncture, evaluation and service. A full list of all evaluations located is available on request. Inclusion and exclusion criteria
We included documents if the service was located within England or Wales, was delivered by NHS clinicians or professional therapists and was situated in a NHS primary care setting. An exception was the inclusion of the Lewisham service [11]. Although outpatient hospital based, this evaluation was included because it was one of only two which employed a randomised controlled trial methodology and was similar to other primary care based services. We excluded evaluations if:
they reported throughput alone (e.g. numbers of patient seen)
they described solely the setting up of the service
the service setting was private, a charity or outside England or Wales
the service was part of an acute hospital department e.g. physiotherapists using acupuncture for pain
Because of the lack of high quality evaluations, no studies were excluded on methodological grounds. Data extraction and analysis
We devised a proforma to identify the type of information contained in the reports including health outcome tools (e.g. SF36, SF12, MYMOP, Glasgow Homeopathic Hospital Outcome Score, etc.) and NHS cost data (i.e. hospital, GP consultation or prescription costs). We then selected evaluations which collected health status data, using SF36 or MYMOP. These outcome tools were chosen because they were the most commonly used standardised health status questionnaires and so comparison across different services was easier.
The SF36 is a questionnaire which asks the service user to assess their health status in eight domains, including physical functioning, role physical, social functioning, pain, vitality, mental health, role emotional and general health [12]. For example, for 'physical functioning' respondents are asked to score a number of statements about their specific abilities to climb stairs or walk a mile while for 'role physical', respondents score statements about the extent of their ability to perform physical tasks generally. Although there is considerable debate about interpretation of SF36 scores, it is generally held that an improvement of 10 points or more indicates a strong effect (see http://www.sf36.org webcite 'norm based scoring and interpretation').
MYMOP asks the service user to identify and then rate the first and second priority symptoms that "bother" them the most, an activity affected by those symptoms and overall wellbeing on a scale of 0 to 6 [13]. In some cases, a profile score, which amalgamates the scores from symptoms 1 and 2, wellbeing and activity, is calculated. An improvement of 1 point or more is considered clinically significant (see http://www.pms.ac.uk/mymop webcite).
In addition to selecting evaluations with SF36 and MYMOP health status data, we also selected evaluations with extractable NHS cost data obtained from medical records. Once all relevant documents were identified, we then extracted details including:
number of service users
data collection time points
baseline and follow up health status scores
baseline and follow up rates and costs of prescriptions, GP consultations and hospital consultations
confidence intervals
p values.
If confidence intervals were missing and it was possible, we calculated the confidence intervals ourselves.
We gathered the results from individual service evaluations into outcome specific tables (i.e. SF36, MYMOP, prescriptions and GP consultations) and compared results across the services. For costs relating to use of hospital services, the data could not be combined into one table and so the data from the two relevant complementary therapy services are presented separately. We considered synthesizing the data for each table, but decided against this as the therapies offered, service models and ways of collecting the data differed considerably between sites. Results
In total, we collected 49 documents for 40 services. Further details about the methodology and content of the reports have been published previously [9]. Of the documents collected, we found 21 documents for 14 services contained extractable data on NHS costs and/or health status. Details of the services and evaluation documents are summarised in Additional file 1.
Additional file 1. Supplementary table one. Evaluations of NHS based primary care complementary therapy services with standardised health outcome and NHS cost data
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This file can be viewed with: Microsoft Word ViewerOpen Data Health status – SF36
Of the 14 services meeting our criteria, six administered and reported SF36 data that could be extracted (Additional file 2) [11,14-17]. Confidence intervals were available for four of the six service evaluations. Across the evaluations, four of the eight SF36 domains consistently have confidence intervals which do not cross zero for the average difference between baseline and follow up scores (role physical, social functioning, pain and vitality). This suggests that the complementary therapy services in this review have had a positive effect on the scores for the health status domains for these samples of service users. The pain scores showed the largest change. The fewest changes across these four services appear to have been made in role emotional, mental health and general health.
Additional file 2. Supplementary table two. SF36 scores from six complementary therapy service evaluations without control groups
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Of those using the SF36, only the Lewisham service also administered this questionnaire to a waiting list control group. The Lewisham service provided homeopathy, acupuncture and osteopathy delivered by professional therapists for over 20 different conditions. The baseline SF36 was administered before the first treatment and follow up occurred at the last session or three months after baseline (whichever came first). One hundred and seventy nine people in the treatment group and 151 in the control group completed baseline and follow up SF36 questionnaires. Results suggest a moderate to strong improvement for seven of the eight SF36 areas; only physical functioning showed no change [11]. Health status – MYMOP
Of the 14 services included in the review, nine reported MYMOP data, but only seven provided extractable data (Additional file 3). In comparing the scores for the five services with confidence intervals, overall the first symptom identified by service users showed the greatest change followed by the second symptom. The average change in score was consistently greater than one, and in some cases it was closer to a two and half point difference. This suggests that these complementary therapy services had a substantial effect on health status scores, as measured by MYMOP, for these service users. Only the confidence intervals for the activity domain for the Sheffield service crossed zero (average difference 1.9, 95% CI -0.4 to 4.2), which suggests that the Sheffield complementary therapy service did not have a positive impact on the activity scores for this sample of service users. This may be understandable as service users were suffering from the menopause and symptoms do not tend to impact on activity levels.
Additional file 3. Supplementary table three. MYMOP scores for seven service evaluations without control groups
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The quality and quantity of data on NHS costs was less robust or available than data for health status. Seven evaluations reported cost data extracted from GP medical records, one of which used randomised controlled trial methodology. Although all of the reports had methodological flaws, two were of especially poor quality (Newcastle [18] and St. Margaret's [19]). In these evaluations, a sub-sample of patients was identified (unclear as to how selected), relevant medical records were extracted and then the findings for the sub-samples were extrapolated across the entire service populations, resulting in guesstimates of potential savings. Nonetheless, as both of these evaluations justified further funding of these services by the NHS, and in the absence of better cost data, they are reported here.
A recurring methodological problem is that NHS cost data are less easily standardised than health status data. We found that the different evaluations used different ways to calculate costs. For example, prescription data was collected and analysed as average costs of prescriptions per month per patient, average number of prescriptions per month per patient, proportion of patients who reduced their number of prescriptions overall, total number of prescriptions and total cost savings of reduction in prescriptions by the entire sample. GP consultation data were more homogeneous in that all data were reported as consultation rates, but the time period varied between average consultation rates per patient per month, per six months or per year.
In looking at prescription costs, three out of six uncontrolled evaluations reported that service users reduced their prescriptions substantially by 57% (Coventry [20]), 45% (Glastonbury [21]) and 39% (Newcastle [18]). St. Margaret's reported potential savings of £8944. Results from the Impact evaluation suggested that there was no change in the number of prescriptions (change of 0.04, 95% CI -0.99 to 0.87) [16]. The prescription costs for service users of Get Well UK increased after using the service (average baseline cost per patient per month £3.24, 95% CI £1.80 to £4.80 and average follow up cost per patient per month £3.75, 95% CI £1.74 to £6.49) [22]. (Additional file 4)
Additional file 4. Supplementary table four. Changes in prescriptions identified in six service evaluations without control groups
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In looking at GP consultation rates, three of the six uncontrolled evaluations reported that their sample of service users consulted their GPs about a third less often (Glastonbury [21] Newcastle [18] and Coventry [20]), while the St. Margaret's evaluation [19] found that service users consulted their GPs over two thirds less often. The results for the Impact service evaluation found that there was almost no change (change of 0.14, 95% CI -0.97, 1.83) [22]. Data from Get Well UK indicated that GP consultation rates amongst their sample of service users increased from an average of 0.5 per patient per month (95% CI 0.4, 0.7) at baseline to an average of 0.8 (95% CI 0.6 to 1.1) at follow up. Moreover, the Get Well UK evaluation suggested an increase in GP consultation costs per patient per month with an average baseline cost of £11.27 (95% CI £8.60, £13.90) and an average follow up cost of £17.53 (95% CI £11.40, £24.00) [22]. To put consultation rate data into context, the average practice consultation rate per listed patient per month in England was 0.44 in 2006 [23]. (Additional file 5)
Additional file 5. Supplementary table five. Changes in GP consultation rates identified in service evaluations without control groups
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The Get Well UK and Glastonbury reports provided data on secondary care consultations. The Get Well UK evaluation found that the rates of secondary care referrals and diagnostic tests combined per month were reduced (average combined of 1.38 at baseline to average combined of 0.70 at follow up), as were their corresponding costs (mean £112.64 at baseline to mean £64.72 at follow up) [22]. The Glastonbury evaluation found that usage of physiotherapy, x-rays, blood and urine, tests and consultant referrals were all reduced for a sub-sample of 41 patients with a total saving of over £2500 [21].
Only the Randomised Osteopathic Manipulation Study (ROMANS) collected NHS cost data for a control group. This was a pragmatic randomised controlled trial to evaluate a medical osteopathy service [24]. Two hundred and one patients with neck and back pain were randomised into two groups: usual GP care or medical osteopathy from a single GP practitioner. Service users in the active group received three to four medical osteopathy consultations. Medical record data on healthcare utilisation for 101 people in the usual care group and 86 in the medical osteopathy group were collected. Data for over twenty different NHS healthcare activities were collected, including rates for prescriptions, GP consultations and secondary care activities such as consultant and physiotherapy consultations. When calculating costs for all conditions suffered by the osteopathy service users and non-users, there was no difference between the medical osteopathy group and the control group (average total costs £22, 95% CI -£159, £142). Costs related to spinal pain were higher in the group using medical osteopathy than those who did not (average cost difference of £65, 95% CI £32, £155). This might be partly explained by the inclusion of the costs of the medical osteopathy consultations themselves [25]. (Table 1)
Table 1. NHS healthcare utilisation rates for ROMANS medical osteopathy service users and non-users for six months (during and after) Discussion Summary of key points
Few services collected data on health status using standardised health outcome tools and even fewer collected data on NHS costs. Of those that did, the quality of the evaluations was variable.
In comparing research into the effectiveness of complementary therapy treatments and the impact of complementary therapy services on health outcomes, we found that service evaluations were largely positive. All service evaluations collecting data on health status (SF36 or MYMOP) without a control group showed a substantial improvement in scores. When data were also collected for a control group (Lewisham), health status scores continued to demonstrate positive changes. With regard to the SF36, across evaluations both with and without a control group, the greatest changes were consistently found in role physical, social functioning, pain and vitality. Although more studies are needed, this suggests that NHS complementary therapy services may have an impact on health outcomes.
Data from complementary therapy service evaluations on NHS costs were much scarcer and less robust. Uncontrolled service evaluations found increases, decreases and no change in prescriptions and GP consultations. Both uncontrolled evaluations found decreases in secondary care usage. The only controlled study investigating the impact of a complementary therapy service on NHS costs (ROMANS) found that the medical osteopathy service made no impact on healthcare utilisation costs for all conditions. Costs associated only with spinal pain, which included the costs of the medical osteopathy consultations, were increased. Strengths and limitations
A strength of this study is that this is the first comprehensive attempt to collect and review the growing number of evaluations of NHS complementary therapy services in primary care. However, because of the scarcity of good quality data, we can draw few conclusions about the impact of these services on health status and NHS costs.
One limitation of this study is that very few evaluations met our selection criteria of reporting standardised health status or NHS cost data. A second limitation is that amongst those who did, there were gaps in the reporting of the data collection processes and inconsistencies across the evaluations that made comparison difficult e.g. varying data collection time points, different health outcome tools, prescriptions calculated as rates, costs and total savings etc. A third limitation is that only two service evaluations collected data for control groups. Control groups are used to demonstrate that any changes that have occurred can be attributed to the intervention (in this case a complementary therapy service) and would not have occurred anyway. This is necessary to assure some (scientifically minded) clinicians and Primary Care Trust managers of the potential impact of complementary therapies on health outcomes and NHS costs [26]. Implications
Because NHS based complementary therapy services are often marginalised, face constant battles to secure funding [27] and have limited access to research expertise, those services that do carry out service evaluations deserve congratulations. Nonetheless, evaluations of NHS primary care complementary therapy services need greater rigour to provide better understanding of the impact these services can make on health outcomes and NHS costs. An earlier attempt to address this was the BESTCAM Delphi exercise which aimed to improve the content of complementary therapy service evaluations by identifying useful data collection items [28]. Our intention is to focus on improvements in the process of data collection and reporting.
The following figure illustrates a suggested scale of quality markers for evaluations of complementary therapy services. (Figure 1) At a basic level, those evaluating complementary therapy services could collect data on health outcomes with standardised outcome tools such as MYMOP and SF36, rather than designing their own questionnaires. Although there are many such tools available, we found that MYMOP and SF36 were most commonly used in complementary therapy service evaluations. In comparing SF36 to MYMOP, the SF36 allows for better identification of the domains where complementary therapy services may score the largest improvement, but MYMOP is more patient oriented. Both of these are available without charge on the Internet (see http://www.sf-36.org webcite and http://www.pms.ac.uk/mymop webcite).
thumbnailFigure 1. Quality markers for evaluations of NHS primary care complementary therapy services.
A further step in improving the quality of evaluations of NHS complementary therapy services would be the inclusion of confidence intervals around estimates. Confidence intervals provide valuable information on the range of values that might occur and give an indication of the strength of the impact of an intervention (in this case, a complementary therapy service). So, for example, for the first symptom for the CHIPs service [29] there was an average improvement of 1.9 for service users between baseline and follow up MYMOP scores on a six point scale. Using confidence intervals, we can say that we are 95% confident that the value of that difference within this population will fall somewhere between 1.5 and 2.3, which suggests a moderately strong impact. If a confidence interval crosses zero, this suggests that the service does not have an impact on improving the score for that domain. Although potentially daunting, confidence intervals are not difficult to calculate and instructions can be found in Additional file 6.
Additional file 6. How to calculate confidence intervals
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A further improvement in the quality of evaluations would be the collection of NHS cost data from GP medical records. This is a significant undertaking, as it requires obtaining permission to access medical records from GP surgeries (and possibly ethics approval see http://www.nres.npsa.nhs.uk webcite), an understanding of medical terminology and extensive time. Furthermore, there is great variety in the way NHS cost data are collected as, unlike health status data, there are not standardised tools. However, the evaluations in this review showed a trend towards the calculation of GP consultation rates as average rates per patient over six or twelve months. Further research is needed into the optimum way of collecting and calculating prescription and secondary care data.
Once NHS cost data are collected, a further rung on the quality marker scale would be to calculate confidence intervals for cost data in addition to health status data.
Each of the first four stages on the quality marker triangle would require increasing confidence with research language and skills, although all of them could conceivably be undertaken with little or no academic involvement. However, the final step on the quality marker scale, to collect standardised health status and NHS cost data with confidence intervals for treatment and control groups, i.e. complementary therapy service users and non-users, would require significant engagement with academic researchers, possibly from a registered clinical trial unit (see http://www.ukcrn.org.uk webcite). But such an endeavour would also necessitate substantial outside funding. This could help explain why so few randomised controlled trials of complementary therapy services have taken place. Moreover, even if conducting randomised controlled trials were less challenging, we do not know the extent to which randomised controlled trials actually influence clinicians and NHS commissioners' decisions around complementary therapy service provision [10]. Conclusion
In reviewing complementary therapy service evaluations, we found that uncontrolled health status data suggest that such services improve health outcome scores, but the data on the impact of these services on NHS costs are scarcer and inconclusive. Moreover, the overall quality of these evaluations was poor. To improve the quality of evaluations and increase understanding of the impact these services may have, we urge those evaluating complementary therapy services to use standardised health outcome tools, calculate confidence intervals and consider the collection of NHS cost data from GP medical records. Furthermore, discussion with the wider NHS healthcare community is needed on the optimum ways to standardise the collection and reporting of NHS cost data in evaluations of complementary therapy services. Competing interests
The authors declare that they have no competing interests. Authors' contributions
Funding for the study was obtained by AS and DS. The study was conceived by LW. The majority of the data were collected and analysed by LW, with assistance from AS and DS especially at the interpretative stages. LW drafted the manuscript and DS made substantive revisions. Acknowledgements
Thanks to Alan Montgomery for statistical advice and to Boo Armstrong and Clare Emmett for commenting on earlier drafts.
Funding for LW and AS was provided by the National Co-ordinating Centre for Research Capacity Development. References
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Pre-publication history
http://www.biomedcentral.com/1472-6882/9/5
http://www.gofundme.com/HomeopathyResearch
Current research points towards the likely existence of water structures which, although being largely unexplored, in principle have the necessary characteristics to explain the mechanism of action of homeopathic medicines.
The Water Research Laboratory aims to investigate these new water structures using a multidisciplinary approach involving theoretical physics, mathematical modelling and experimental exploration.
In the field of the physics of high dilutions, which has immediate relevance to homeopathy, many research groups have reported interesting findings. In particular, Prof Luc Montagnier (who won the Nobel Prize for discovering the HIV/AIDS virus), has shown homeopathic dilutions to have electromagnetic properties which differ from those of normal water1,2.
Benveniste was a eminent French immunologist, adviser to the French government on scientific issue, he was the director of INSERM unit 200, directed at immunology, allergy and inflammation.
In a seminal paper published in the prestigious journal Nature in 1988, Dr Benveniste’s team of reported their results investigating the effects of high-dilutions on human basophils (a type of white blood cell). They diluted a solution of human anti-IgE antibodies in water to such a degree that there was virtually no possibility that a single molecule of the antibody remained in the water solution. They reported, human basophils responded to the solutions just as though they had encountered the original antibody (part of the allergic reaction). The effect was reported only when the solution was shaken violently during dilution.
This publication led to a large controversy around ‘the memory of water‘. Since then 28 scientific papers have been published in this area, 23 of which reported positive results. Of the 11 publications judged to be of high quality, 8 (72%) reported positive results.4
The initial efforts of the HRI/WRL collaboration are centered around repeating the famous basophil degranulation experiments of the late Dr Jacques Benveniste (1935-2004)3, with the aim of making the experiment more easily reproducible in standard laboratory setting and of studying important physical parameters crucial to the phenomenon. In particular we aim to study the influence of electromagnetic fields on the system, in line with Prof Luc Montagnier’s recent results.
Alexander Tournier BSc DIC MASt Cantab PhD
Dr Tournier studied physics at Imperial College, London, and theoretical physics at the University of Cambridge. He wrote his PhD on the biophysics of water-protein interactions at the University of Heidelberg, Germany. For the last 10 years he has been conducting interdisciplinary research at the boundaries between mathematics, physics and biology, as an independent researcher for Cancer Research UK (5th institute worldwide for molecular biology).
Confirming the existence of structured phase of water would have considerable ramifications not only for homeopathy, but could also lead to completely novel therapeutic and diagnostic techniques.
Dr Alexander Tournier PhD
https://www.hri-research.org/hri-research/how-do-homeopathic-medicines-work/water-research-laboratory/
With swine flu claiming lives at an alarming rate, death toll reaching a shocking 1300 across the country, it becomes clear that prevention is better than cure. But the sad part is many fall prey to rumours and quacks while looking for preventive measures to be safe and healthy. However, if one resents the conventional form of treatment, homeopathy stands to be a safe and wise option to follow. Moreover, it stands to be the second largest system of medicine in India. Here are 10 tips every parent should follow to keep children safe from swine flu. ‘It is a safe method of treatment with almost no side effects. The advantage of homeopathy drug is such that apart from taking care of the main symptoms, it also helps in dealing with other problems in a subtle way. So if one patient is given doses for say gastric problem, the same drug could also help in treating other minor issues of the body and build immunity. Going the homeopathy way is a safe and secure method for anyone who is looking for prevention from swine flu,’ informs Dr Bhavi Mody, Vrudhi Homeopathy and Wellness Centre, Mumbai. Here is how you can build immunity to save yourself from a bout of swine flu.
Can homeopathy be as effective in treating swine flu as the conventional form of medication?
A study conducted by the Central Council for Research in Homeopathy from September 2009 to February 2010 pointed out that homeopathy drugs, when used to treat patients suffering from symptoms of swine flu, showed effective results in treating them. ‘In the discipline of homeopathy, when there is an outbreak of an epidemic, the few main symptoms are taken into consideration along with the major drugs that could treat the same. With swine flu, it was observed that the drug ARS. alb. 30 stood effective in both, treating and preventing a bout of swine flu,’ informs Dr Bhavi. The study also indicated that the drug could treat 80 percent of the symptoms of the flu effectively. Here are 10 facts about swine flu you need to know.
Moreover, the Indian Department of AYUSH (alternative systems) suggests use of the homeopathic medicine ARS. alb. 30, also known as Arsenic alba 30; one dose for three consecutive days as prevention for Swine flu. Here are the symptoms of swine flu that you need to be aware off.
So is homeopathy a better approach for preventing swine flu?
‘Homeopathy drugs don’t just treat the symptoms of the ailment but act on the psycho-neuron-axis of the brain, helping in building immunity and improving overall well-being. So if a patient has been following a homeopathy treatment for some other illness, his immunity is already been taken care of and would not need the said drug to fight swine flu,’ says Bhavi. Here is the answer to an important question — Is swine flu curable?
However, for others who wish to take adequate prevention to ward off a viral attack, taking homeopathy pills, prescribed by a practitioner, can help. Remember, it is advised not to take homeopathy pills without proper consultation. As with homeopathy, all drugs are not suitable for everyone. ‘Homeopathy is a line of medicine where drugs are prescribed after taking into account the patient’s history, other signs and symptoms, apart from the existing symptoms or illness. It is a long painstaking process, so it is better to see a doctor rather than self-treat,’ says Dr Bhavi. Here is what you should know how life treats one after recovering from swine flu.
When should one turn to homeopathy?
One can take help of homeopathy treatment or use it for preventive measures at any point in time. However, keeping in mind the swine flu epidemic, it is better to reach to your practitioner soon after you see the symptoms – persistent cold, cough, high fever, etc. ‘When taken on time or soon after the symptoms of flu are noticed, homeopathy drugs can help fight swine flu and put one on the road to recovery effectively,’ says Dr Bhavi.
Image source: Getty Images
http://www.thehealthsite.com/news/homeopathy-for-swine-flu-is-homeopathy-the-answer-da0315/
China has fined the British pharmaceuticals giant GlaxoSmithKline (GSK) $488.8 million (3 billion Yuan) for a "massive bribery network" to get doctors and hospitals to use its products. Five former employees were sentenced to two to four years in jail, but ordered deported instead of imprisoned, according to state news agency Xinhua today.
The guilty verdict was delivered after a one day closed door trail in Changsha, the capital city of Hunan province. The fine was the biggest ever imposed by a Chinese court.
The court gave Mark Reilly, former head of GSK Chinese operations, a three-year prison sentence with a four-year reprieve, which meant he is set to be deported instead of serving his time in a Chinese jail. His co-defendants received two to four years prison sentences with reprieves.
Reilly was accused of operating a "massive bribery network" in May. The police said it is believed Reilly authorized his salespeople to pay doctors, hospital officials and health institutions to use GSK's products since 2009.
Chinese authorities first announced the investigation on GSK in July 2013. The police said the company had funneled up to 3 billion Yuan to travel agencies to facilitate bribes to doctors and officials. The money was the exact amount of the fine.
Throughout 2012 a stream of anonymous emails alleging bribery authorized by senior staff at GSK were sent to Chinese regulators, according to media reports. Atthe beginning of 2013, the anonymous emails began to arrive at GSK headquarter in London, along with a sex tape of Mark Reilly and his Chinese girlfriend, according to media reports.
The charges claim that GSK hired Shanghai-based investigator Peter Humphrey and his American wife, Yu Yingzeng, to locate the whistleblower. The Humphreys were detained and charged with illegally obtaining phone logs, travel records and other data which then they put in a report to GSK.
GSK released a statement of apologies to the Chinese government and people on its website.
"GSK Plc has reflected deeply and learned from its mistakes, has taken steps to comprehensively rectify the issues identified at the operations of GSKCI, and must work hard to regain the trust of the Chinese people," the statement said.
The statement also said future commitments include investment in Chinese science, improved access of its products in both city and rural areas across the country through greater expansion of production and flexible pricing.
Taking bribery from drug companies and over prescribing medicine to patients is a common hidden rule among doctors in China. It is not uncommon for patients give doctors red envelopes with cash as a blunt plea for them to do a good job on surgeries.
http://abc7chicago.com/316390/
Americans are less likely to say vaccination is “extremely important” than they were in 2001, according to a poll released Friday. They are also much more likely to have heard about disadvantages of vaccines — 30 percent said they’d heard “a great deal” about such disadvantages, up from 15 percent in 2001.
A slight majority of Americans, 54%, say it is extremely important that parents get their children vaccinated, down from the 64% who held this belief 14 years ago. Another 30% call it ‘very important’ — unchanged from 2001. The rest, 15%, consider it ‘somewhat,’ ‘not very’ or ‘not at all important,’ up from 2001.
…
These results, based on interviews conducted Feb. 28-March 1 on Gallup Daily tracking, follow a relatively large measles outbreak in the U.S. stemming from pockets of unvaccinated children. This outbreak called attention to the continuing controversy over the possibly serious side effects of vaccines, a hypothesis advanced by some anti-vaccine activists, but vigorously denied by most doctors and scientists.
http://takingnote.blogs.nytimes.com/2015/03/06/facts-figures-vaccines-under-fire/?ref=opinion&_r=0
by Brian ShilhavyHealth Impact News Editor
The Depart of Justice issues a report on vaccine injuries and deaths every quarter to the Advisory Commission on Childhood Vaccines [1]. This March 5, 2015 report states that there were 117 cases for vaccine injuries and deaths compensated from 11/16/2014 to 2/15/2015.
92 of the settlements were listed in the report, giving the name of the vaccines, the injury, and the amount of time the case was pending before settlement. Five of those settlements were for deaths linked to vaccines, with three deaths related to the flu shot. 73 of the 92 settlements were for injuries and deaths due to the flu shot, and the majority of flu shot injuries were for Guillain-Barré Syndrome.
These quarterly reports on vaccine injuries and death settlements from the U.S. vaccine court are seldom, if ever, reported in the mainstream media. We report them here at Health Impact News [2]. Here is the March 5, 2015 report:
[3]
[4]
[5]
[6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
In November of 2014 the Government Accounting Office (GAO) issued the first report [14] on America’s “Vaccine Court,” known as the National Vaccine Injury Compensation Program (NVICP), in almost 15 years. Most citizens of the United States are not even aware that there is something called the National Vaccine Injury Compensation Program, and that if you suffer harm or death due to a vaccine, that you cannot sue the manufacturer of the vaccine, but you must sue the Federal Government and try to obtain compensation from the Vaccine Injury Compensation Trust Fund, which is funded by taxes paid on vaccines.
The November 2014 GAO report criticized the government for not making the public more aware that this program exists, and that there are funds available for vaccine injuries. Therefore, the settlements represented by vaccine injuries and deaths included in the DOJ report probably represent a small fraction of the actual vaccine injuries and deaths occurring in America today.
But even for those families and individuals who are aware of the NVICP, fighting a legal battle that can take years to get access to the funds ensures that many who do file claims never get any of the funds reserved for vaccine injuries. That fund, the Vaccine Injury Compensation Trust Fund, is currently over $3.5 billion, largely because the U.S. Government refuses to even hear cases related to autism which would quickly deplete the fund. (See: How the Government has Earned $3.5 BILLION from the Claim that Vaccines Don’t Cause Autism [15].)
Wayne Rohde, author of the book The Vaccine Court: The Dark Truth of America’s Vaccine Injury Compensation Program [13], explains how the NVICP is no longer a viable justice venue for the vaccine injured as Congress intended it to be. (See: GAO Report on Vaccine Court Reveals Vaccine Injured Victims Not Being Helped [16].)
The unified message presented by the U.S. mainstream media and certain government agencies is that vaccines are safe.
This is a lie. Vaccines are dangerous. People are injured and killed by vaccines, and the quarterly reports from the DOJ, which probably reflects a very small percentage of the actual cases, clearly reflect that inherent danger.
So many people were being injured and killed by vaccines in the 1980s, that the pharmaceutical companies petitioned Congress to pass legislation giving them legal immunity from cases in civil court. They basically blackmailed Congress by threatening to get out of the vaccine business if such legislation was not passed.
Congress obliged in 1986, and today we have the NVICP, while new vaccines entering this “protected” and “guaranteed” market have soared. The largest purchaser of vaccines is the CDC, purchasing over $4 billion worth of vaccines a year [17].
In addition, the U.S. Government holds patents on some vaccines, and earns royalties on them [18], such as the Gardasil vaccine. Julie Gerberding was in charge of the CDC from 2002 to 2009, which includes the years the FDA approved Gardasil as a vaccine. Soon after she took over the CDC, she ties to the vaccine industry [19].
Gerberding resigned from the CDC on January 20, 2009, and is now the president of Merck’s Vaccine division, a 5 billion dollar a year operation, and the supplier of the largest number of vaccines the CDC recommends (article here [20]).
In 2014 Dr. William Thompson, a senior epidemiologist at the CDC who co-authored and published research on the MMR vaccine for the CDC back in 2004, made the decision to become a whistleblower and reveal data that was concealed by the CDC linking the MMR vaccine to autism among African American boys. In addition, Merck has been involved in a long federal lawsuit with allegations of fraud over the mumps portion of the MMR vaccine, in a case filed back in 2010 by two whistleblowers, virologists who worked for Merck. Merck has apparently tried hard to get this case thrown out of court, and keep this news out of the media, but late in 2014 a federal judge finally ruled that the case is to move forward. (See: Why is the Mainstream Media Ignoring Measles Vaccine Fraud Cases [21]?)
The U.S. government has massive conflicts of interest where it concerns policies related to the vaccine industry. Before you make a potential life-changing decision for you or your children by agreeing to be vaccinated, do your own research. The government cannot be trusted on vaccine matters, and the mainstream media and many doctors are also not doing their own research related to the vaccine industry. Be informed and educated regarding vaccines, before you become a statistic among the vaccine injured and dead.
Previous DOJ reports on vaccine injuries and deaths [2].
Saying NO To Vaccines By Dr. Sherri Tenpenny You have legal options!
[22]
http://vaccineimpact.com/2015/march-2015-settlements-in-vaccine-court-117-vaccine-injuries-and-deaths/print/
http://thepromisefilm.net/
Since the implementation of the mass vaccination campaign against hepatitis B in France, the appearance of multiple sclerosis, sometimes occurring in the aftermath of vaccinations, led to the publication of epidemiological international studies. This was also justified by the sharp increase in the annual incidence of multiple sclerosis reported to the French health insurance in the mid-1990s. Almost 20 years later, a retrospective reflection can be sketched from these official data and also from the national pharmacovigilance agency. Statistical data from these latter sources seem to show a significant correlation between the number of hepatitis B vaccinations performed and the declaration to the pharmacovigilance of multiple sclerosis occurring between 1 and 2 years later. The application of the Hill’s criteria to these data indicates that the correlation between hepatitis B vaccine and multiple sclerosis may be causal.
The first doubts regarding vaccines as a possible cause or exacerbation of multiple sclerosis (MS) were formulated by Miller more than half century ago [1]. Hepatitis B (HB) vaccine has been the subject of greatest concern, especially in France where mass HB vaccine administration was performed in a short time. In 1992, the World Health Organization (WHO) recommended undertaking a universal HB vaccination of all young infants in order to eradicate the HB virus. WHO explained that the teenagers’ vaccination could also be used in addition to or instead of the vaccination of young children in low-endemic countries. In 1994, the French health authorities launched a national vaccination campaign of all pupils in the first year of secondary school. The following year, HB vaccine was added to the national immunization program for all young babies and preteenagers. This intensive campaign had quickly exceeded its expected targets by also encouraging the adult population to be mass-vaccinated, whereas the vaccination of the infants remained less significant. This resulted in an unprecedented “wave” of immunization in adults, with 20 million French individuals vaccinated against HB, concentrated in 4 years, from 1994 to 1997.
MS cases in some vaccinated adults were rapidly notified to the French national pharmacovigilance system (ANSM), triggering investigation by this agency. This inquiry, started in 1994, was therefore already underway when French media revealed possible occurrence of post-immunization MS in 1998. This year, French health authorities abruptly terminated routine school-based vaccination of preteens, and adult HB vaccination began to be less widespread.
Several epidemiological studies have been evaluating the correlation between HB vaccination and MS in adults for a decade. Most of these publications found the absence of a link [2–6] or a slightly increased risk, but not sufficiently significant on the statistical level [7–9]. However, different opinions have also been formulated. A study aiming at quantifying underreporting in Fourrier’s article [8] was conducted by D. Costagliola on request of the French pharmacovigilance. This unpublished study showed by the “capture–recapture” method that the real number of MS cases linked to HB vaccine was 2–2.5 higher than the officially registered number [10]. This additional calculation makes Fourrier’s publication [8] clearly significant. Another case–control epidemiological study was conducted to evaluate serious post-vaccination adverse events registered in the United States through a spontaneous reporting system in the VAERS database. Adults receiving HB immunization had significantly increased odds ratios (OR) for MS (OR 5.2; CI 1.9–20) in comparison with an age-, sex-, and vaccine year-matched unexposed tetanus-containing vaccine group [11]. A Hernan’s paper, based on a case–control study in the United Kingdom within the General Practice Research Database (GPRD), found an increased risk (OR 3.1; CI 1.5–6.3) of MS within the 3 years following HB immunization [12]. In the same way, a French study on demyelination in childhood [13] showed that Engérix B® vaccine administration was associated with an increased trend of confirmed MS after 3 years (OR 2.77; CI 1.23–6.24).
On these grounds, we compared temporal HB vaccine dose distribution and MS occurrence in the French population, using the official data collected by the French pharmacovigilance system (ANSM) and the national health insurance (CNAM). The results confirmed, at the global population level, a significant correlation between the number of immunizations and both the number of MS cases declared to the pharmacovigilance system 1–2 years later and an overall increase in identified MS cases in the country.
We compared data from two independent national databases: the National Health Service database (CNAM) [14] and the French pharmacovigilance system (ANSM) [15].
The French general insurance provides each year the number of new cases of MS in which care is fully supported. These data are available online on the Web site of the CNAM [14]. The concerned population represents a very large majority of people covered by the healthcare system (83 % of the French population in 1996).
This organization identifies spontaneous adverse event reports emerged in the aftermath of vaccinations since the beginning of the establishment of HB immunization (1981). The most common diseases reported were neurological damages of myelin, known under the generic term of demyelinating diseases. This condition is clinically called MS when at least two attacks of demyelination repeat themselves. When the neurological disorder remains single, without temporal or spatial diffusion, we speak of central nervous system demyelination.
The French pharmacovigilance is based on “spontaneous reporting” of adverse drug reactions. This allows the establishment of a possible relationship as well as the imputability to generate alerts. However, this system underestimates the real frequency of adverse reactions (1–10 % of severe side effects are reported) [16].
On the other hand, from 1997, the notification by REVAHB, the association of victims of HB vaccine, allowed the completion of these spontaneous reports of potential side effects. Since its inception, this association has been able to transmit more than 2,000 files of individuals who have experienced a neurological problem of post-vaccine demyelination. However, about a third of these files are not used by the French pharmacovigilance (classified as “not documented”) when the physician does not answer to the questionnaire which ANSM sends him for confirming the diagnosis. Of course, this rate of not documented files is an obvious factor of underreporting.
We used the R statistical software to compute correlations and perform linear regressions.
The number of MS was very stable, about 2,500 new cases each year until 1993. The following years, and especially since 1996, a progressive increase in the number of new MS reported to the Health Insurance occurred. This figure increased to about 4,500 cases in 2003 and remains steady since.
The annual incidence was 5.3/105 in 1993 and increased to 8.7/105 insured people a decade later (Fig. 1), which translates into a 65 % increase in incidence over the 10-year period. These figures are consistent with epidemiological data published in this country. Indeed, the incidence of MS in France was estimated at around 4.3/105 inhabitants in the years 1993–1997 from a representative sample of the Burgundy region [17]. It was reassessed by the same team at a rate between 7.6 and 8.8/105 inhabitants for the period 2001–2007, from French CNAM data [18].
Epidemiological studies measuring prevalence of this disease provide an increase in the same magnitude. This figure was 40/105 insured people in 1994, at the beginning of the mass vaccination campaign [19]. It increases rapidly until 95/105 12 years later [20].
Since the beginning of practicing HB vaccination in France until December 31, 2010, ANSM has registered 1,650 demyelinating diseases including 1,418 MS. These data are available online on the Web site of ANSM in the French national commission for pharmacovigilance of September 27, 2011 [15]. When you draw a distribution curve of MS reported each year to ANSM in the aftermath of a vaccine injection, we see that this distribution is neither linear nor regular, far from it (Fig. 2). There is a huge peak of reported MS culminating in the years 1995 (229 reports) and 1996 (246 reports). This peak of post-vaccine neurological disorders during the period 1994–1998 corresponds, with an interval of one year, to the beginning of the campaign and intense promotion of the HB vaccination in France (culminating in the year 1995 with about 23 million vaccine doses sold).
We studied the correlation between MS data (Y) and vaccinations data (X). This correlation is high and maximum (0.9365863) between the number of vaccines sold at t time (called Xt) and the number of MS occurring the following year, t + 1 (called Yt + 1). There is also a high correlation (0.7350417) between vaccines sold at t time (Xt) and the number of reported MS 2 years later (called Yt + 2).
If we model this relationship in a linear fashion without constant (since in the absence of vaccination there are no MS cases registered by pharmacovigilance), the best model is one where the coefficient of determination adjusted R2 is the highest (i.e., = 0.9497).
This model is defined by the relation: Yt + 2 = ß1Xt + ß2Xt + 1 + ß3Xt + 2
The series of sold vaccines at t time (Xt) and 1 year later (Xt + 1) have a significant influence (p = 0.00106 for Xt and 0.02491 for Xt + 1) on the number of reported MS at t + 2 years (Yt + 2), i.e., 2 years later. But we cannot say whether the number of vaccines sold in year t + 2 (Xt + 2) has a significant influence (p = 0.07014). Graphically, this relation is also the model that best fits the peak of reported MS to ANSM.
It is difficult to adjust the MS data after year 2002. There is then a notable difference between the theoretical series (models) and the actual series. This can be explained by the fact that the number of vaccinations mentioned by ANSM became less precise figures, rounded and approximate. In addition, since 1999, the immunization target has been focused on young children. Adult vaccination has become uncommon, reserved only for high-risk groups. Finally, the number of MS reported to pharmacovigilance has arguably become more and more underestimated over the years. The problem of the emergence of post-vaccine MS had been widely publicized in the years 1996–1999. Thereafter, over the years, this problem has been trivialized or forgotten. Since this period, underreporting became more important. People who have been victims of adverse events have not necessarily reminded the physician of the injection of a HB vaccine some weeks or months before.
Are we able to establish a relation between these results and the Hill’s criteria [21]? Is there a causal relationship between the HB vaccination and the incidence of MS in France? The Hill’s criteria for causation include nine items detailed in Table 1. We will detail now the most important criteria in the text, the other being a simple bibliographic reference mentioned in this table.
The current study satisfies the first criterion. The association is highly statistically significant between reported MS (Yt + 2) to pharmacovigilance and the series of HB vaccines that were sold 1 and 2 years before (p < 0.01 for sold vaccines 2 years before (Xt) and p < 0.05 for sold vaccines 1 year before (Xt + 1); adjusted R2 = 0.9497). Although it is possible to demonstrate here a statistical relationship between the number of sold vaccines and MS reported to the pharmacovigilance, it is not enough to affirm an absolute causality. This is a strong signal that requires further epidemiological studies.
The positive and statistically significant correlation between HB vaccine exposure and reported MS incidence is consistently observed in different places, circumstances, and times (criterion 2).
First, this result is consistent with the Hernan’s case–control study [12] that found in the British population an increased risk of MS (OR 3.1; CI 1.5–6.3) in the 3 years following HB vaccination. Moreover, in this same study, the risk was greater when the last immunization took place within the second or third years before first symptoms of MS (OR 4.1; CI 1.3–13.6).
The results of the case–control study by Geier [11] in USA are also consistent with the French pharmacovigilance data. There is a very significant change in the risk of developing MS after HB vaccine in adults in the VAERS database (OR 5.2, p < 0.0003; CI 1.9–20).
The Costagiola’s study [10] found underreporting of post-vaccine reported MS during the observation period (1994–1996) of an epidemiological study requested by French pharmacovigilance [9]. The combination of these two studies suggests a real number of cases significantly higher (RR = 1.66) than the expected number of MS during the 3 years of the collection.
Most publications where there is no link between HB vaccination and the onset of MS [2–5] received grants from pharmaceutical industry. Other criticism that can be raised for some of these negative case–control studies is the limited period (2–24 months) of their survey [4, 7–9]. Moreover, the Hernan’s publication [12] shows also a negative result (OR 1.8; CI 0.5–6.3) for a period of 1 year and becomes significant between 2 and 3 years of follow-up after HB immunization.
The case–control study nested in the Nurses’ Health by Asherio [4] presents several biases. The vaccination status was obtained retrospectively like the date of first symptoms of the disease assessed by questionnaires. This process may cause selection bias leading to a downwardly biased OR as the specific (nurses) selected population [26].
At last, a meta-analysis [27], based on six epidemiological case–control studies [4–7, 11, 12], did not find significant change in the risk of developing MS after HB vaccine in adults (OR 0.92; CI 0.84–1.004). This paper can also be criticized. Strangely, the statistical computing of this meta-analysis attributes a non-significant value to the Hernan’ study [12], with an OR 1 (CI 0.5–2.1) by using the cases’ date of diagnosis as the index date instead of the date of first symptoms as the author does. But as Hernan wrote [12], “the use of dates that are posterior to the true date of first symptoms may cause a downward bias of the OR for acute exposures such as vaccinations”. In addition, the most significant study by Geier [11] is removed, being regarded as a “source of heterogeneity”. So, withdrawal of a positive study and changing the result of another one more easily allows a negative outcome.
Generally speaking, we know that a low risk of adverse post-vaccination cannot be demonstrated by studies of low statistical power with small numbers of exposed people. Therefore, results in a population of over 20 million vaccinated people should attract attention and require further epidemiologic studies. Moreover, studies with a short period of post-vaccination monitoring are inadequate because they do not take into account the long biopersistence of immunostimulatory vaccine compounds (such as aluminum hydroxide) in the body. In this, vaccines derogate from the rule generally used for side effects of drugs.
The temporal relationship (criterion 4) clearly exists here. The annual incidence of MS recorded by the French insurance was stable about 5.5/105 until 1995. It rose sharply in 1996 to stabilize around 8/105 from 1998. But this sharp increase (65 %) closely follows a major peak in the number of vaccines sold between 1995 and 1997 in France (Fig. 1). The number of MS occurring in the aftermath of a HB vaccination reported to the French pharmacovigilance almost draws the same peak with a delay between 1 and 2 years (Fig. 2). Moreover, some papers report observations of MS relapses triggered by repeated injections of HB vaccine [28, 29].
The official explanations of the increase in this incidence are twofold, first a better screening of MS whose diagnosis has been made easier and faster by using radiological data provided by MRI. This is a dubious explanation. This new radiological technique has begun to develop gradually in French hospitals in 1990 and thus before the obvious increase in the recruitment of MS by French national insurance (1996). Otherwise, if this earlier diagnosis was really so important in the increased incidence of MS, we should have observed in France a decrease in the average age of newly diagnosed cases. And this rejuvenation was not observed [30].
The second factor involves the change in treatment protocol of this period with the introduction of treatment with interferon-beta in 1995, an innovative and very expensive drug that prompted physicians to quickly seek a total care by French health insurance. In 2004, the emergence of a new drug (glatiramer), indicated for the most common form of MS (relapsing–remitting), has not been followed by an increase in cases registered by CNAM that year and the following. The incidence remained the same. This explanation cannot alone explain a so rapid and significant increase (65 % over 4 years) in the incidence of a disease like MS.
A third factor must be considered in such a sudden increase in MS incidence. So the changing of an environmental etiological factor must be taken into account seriously. This therefore appears to be the case for the question of the potential role of HB vaccination carried out in France for a short time and in a massive way, about 20 million people concentrated in 4 years. It is interesting to compare these figures with those countries where routine vaccination has not been recommended. In Norway, the incidence of MS is higher than in France in the early 1990 s (8.7/105 between 1990 and 1995). Then, it decreases slightly in subsequent years (7.2/105 from 1996 to 2000) [31]. In the county of Värmland (Sweden), the incidence of MS has remained similar (6.4/105) during the periods 1991–1995 and 1996–2000 [32].
Specificity (criterion 3) is likely for a very specific population at a specific site and disease. This is not applicable to diseases such as MS. Genetic risk (HLA-DR2) and environmental factors (vitamin D insufficiency) or infectious factors (Epstein–Barr virus, endogenous retroviruses) are clearly involved in the occurrence of MS although its etiology and pathophysiology are not completely understood. These other environmental and genetic factors may have contributed to the raise in MS incidence and should be mentioned.
Biological plausibility (criterion 6): A plausible mechanism between cause and effect is helpful. Are there explanations regarding plausible mechanisms by which vaccines and particularly this vaccine may induce harm? This issue has been extensively studied in recent years. Various aspects of the causal and temporal interactions between vaccines and autoimmune phenomena are known, as well as the possible mechanisms by which different components of vaccines might induce autoimmunity [33]. A first hypothesis could be the similarity between the protein S (used in the vaccine against HB) and some myelin proteins such as PLP (proteolipid proteins) [34]. Another interesting track would be contamination by minor HB virus polymerase proteins. And we know that HB virus polymerase shares significant amino acid similarities with the human MBP (myelin basic protein) [35]. This process is called molecular mimicry: a foreign antigen that shares sequence or structural similarities with self-antigens.
Another runway about biological plausibility is to take into account the metabolism of vaccine adjuvants in the human body. The long-term persistence of aluminum adjuvant at the site of vaccine injection is now well established [36]. Furthermore, transferring of aluminum particles from muscle to brain is demonstrated in animals [37]. A new syndrome entitled ASIA, “Autoimmune (Auto-inflammatory) Syndrome Induced by Adjuvants”, was recently described, grouping four similar illnesses [38]. These diseases (siliconosis, the Gulf war syndrome, the macrophagic myofasciitis syndrome and post-vaccination phenomena) were linked with previous exposure to an immune adjuvant (silicone, aluminum salts). In another publication, the same authors found common clinical characteristics of the ASIA criteria among 93 patients diagnosed with immune-mediated conditions post-HB vaccination, suggesting a common denominator in these diseases [39].
The figures available in France thus show a definite statistical signal in favor of a causal link between the HB vaccine event and the apparition of MS with a maximum correlation in the 2 years following immunization. The impact of other factors (new use of MRI, beginning of interferon-beta) is probably associated. The weakness of this study is its retrospective nature and therefore subject to bias of notoriety. Its strength is that it is based on indisputable official data on large numbers and during about 12 years. The appearance of a spectacular “vaccine wave” in France has remained the only one in its kind. The intensive lobbying carried out in the years 1994–1997 led to concentrate as many vaccinated people as possible in the shortest period of time. This particularity is perhaps the explanation of the emergence of the problem of post-vaccine MS, especially recorded in this country. The low overall frequency of this adverse effect, not measurable in most epidemiological studies, here becomes more obvious because of a kind of involuntary very large scale experiment carried out on a third of the French population. All this is expected to require further epidemiological studies, particularly from the French health insurance data. Indeed, CNAM has information on millions of insured persons for many years that would be usable if we could more easily access it.
The author thanks Mr. A. Sesboüe (Department of Statistics, Caen University, France) a lot for his statistical interpretation. He also gratefully acknowledges Pr. C. Exley (Bioinorganic Chemistry Laboratory, Keele University, Staffordshire, UK) and Pr. R. K. Gherardi (Department of Pathology, Creteil University Hospital, France) for their judicious rewriting.
The author declares that he has no conflict of interest.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4266455/
Elia V, Napoli E, Niccoli M, Nonatelli L, Ramaglia A, Ventimiglia E. New physico-chemical properties of extremely diluted aqueous solutions. Journal Of Thermal Analysis & Calorimetry [serial online]. October 2004;78(1):331-342. Available from: Academic Search Complete, Ipswich, MA. Accessed February 25, 2015.
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