BHA Response Part 2: Expectations of the evidence base


In the second of a linked series, the BHA provides detailed comments on the recommendations of the Science & Technology Committee’s “Evidence Check 2: Homeopathy” issued on 22 February 2010. 

Part 2:  Expectations of the evidence base (Recommendations 2-6)

2. We consider that conclusions about the evidence on the efficacy of homeopathy should be derived from well designed and rigorous randomised controlled trials (RCTs). (Paragraph 20)

Response:
We agree there is a need for high-quality placebo-controlled RCTs that examine the efficacy of given homeopathic medicines in the treatment of given medical diagnoses.  As was made clear in BHA statements to the Science and Technology Committee, there have been 87 RCTs that studied the efficacy of a given homeopathic medicine: 37 of them reported positive findings (see also the BHA’s supplementary memorandum, Ev 53–59 of printed report).  Of 50 other RCTs of this nature, 2 were negative and 48 were inconclusive.  It seems to have escaped the Committee’s consideration that these particular RCTs were designed in essentially the same way as pharmaceutical drug trials, which eliminates the impact of any homeopathic consultation effect.  Their quality is generally superior to equivalent studies in conventional medicine.

It is not clear what the report means by “efficacy of homeopathy”.  Given the use of the word “efficacy”, we assume it is referring to findings from placebo-controlled trials of individualised homeopathy, which is a sub-set of RCTs that was not specifically addressed in the parliamentary hearing or in written submissions.  There are in fact 33 such RCTs: 15 were positive, one was negative, and the remainder were inconclusive.  In each of those RCTs, the “drug” being examined was not a single medicine.  The “drug” intervention was any and all of the individually and carefully prescribed homeopathic medicines taken by the test group of particular patients, compared with a placebo group whose individualised prescriptions per patient were potentially very different from those of the test group.

Homeopathy is a whole system of medicine tailored to each individual patient, not a particular pharmaceutical “drug” and, as such, its clinical effectiveness (as distinct from efficacy) needs to be studied “in the real world”, where comparison can be made with patients randomised to something other than placebo.  As tabulated in the BHA’s submission to the enquiry (Ev 37–43 of printed report), 22 RCTs on clinical effectiveness have been published: 11 of them positive; 8 negative; 3 inconclusive.  It is inexplicable that the report fails to mention such studies, instead commenting on issues of “patient satisfaction” in non-controlled outcome studies.

Given the above, it is clear that the RCT evidence is neither definitively for nor against homeopathic medicine as a therapeutic modality in the diagnostic areas in which it has been researched to date.  It is obvious that more research is required.

3. We expect the conclusions on the evidence for the efficacy of homeopathy to give particular weight to properly conducted meta-analyses and systematic reviews of RCTs. (Paragraph 25)

Response:
We agree the value of well-conducted reviews and meta-analyses.  However, conclusions from comprehensive systematic reviews are severely limited by the heterogeneous range of medical conditions and of homeopathic modalities that have been the collective subject of scrutiny.  It is more appropriate to focus on the findings of systematic reviews that are condition-specific and where the particular homeopathic intervention is precisely defined.  These were summarised and highlighted in our written submission and inoral evidence.

4. We have set out the issue of efficacy and effectiveness at some length to illustrate that a non-efficacious medicine might, in some situations, be effective (patients feel better) because of the placebo effect. That is why we put more weight on evidence of efficacy than of effectiveness. (Paragraph 39)

Response:
As stated above (recommendation 2), the committee did not adequately take into account the meaning of “efficacy of homeopathy”, nor did it enquire about the findings of the specific RCTs that may be associated with the concept.

5. We would expect the Government to have a proper understanding of the power and complexities of the placebo effect and the ethical issues surrounding its use in a clinical setting; otherwise it cannot hope to make good decisions relating to patients and public health. (Paragraph 40)

Response:
The committee has taken the rigid and incorrect view that homeopathy has been proven to be the same as placebo, without reflecting the balance of research evidence and without appreciating the fact that all homeopathically-trained doctors in the NHS prescribe homeopathic medicines based on considered judgment that such prescription will benefit the individual patient.

One important strand of evidence, which strongly suggests that homeopathy is not a placebo effect, but has real physiological effects, is that arising from in-vitro biological models.  Systematic reviews of this evidence have been published and were referenced and summarised in Dr Peter Fisher’s written submission, and mentioned in his oral evidence.

6. Our expectations of the evidence base relevant to government policies on the provision of homeopathy are straightforward. We would expect the Government to have a view on the efficacy of homeopathy so as to inform its policy on the NHS funding and provision of homeopathy. Such a view should be based on the best available evidence, that is, rigorous randomised controlled trials and meta-analyses and systematic reviews of RCTs. If the effects of homeopathy can be primarily attributed to the placebo effect, we would expect the Government to have a view on the ethics of prescribing placebos. (Paragraph 47)

Response:
We refute the committee’s premise that the research evidence clearly indicates that the effects of homeopathy can be primarily attributed to the placebo effect.  Evidence from RCTs, biological research models, and systematic reviews and meta-analyses of such research do not support such a view.

Dr Sara Eames, President, Faculty of Homeopathy
Dr Peter Fisher, Director, Royal London Homeopathic Hospital
Dr Robert T Mathie, Research Development Adviser, British Homeopathic Association
Ms Cristal Sumner, Chief Executive, British Homeopathic Association