Radio 4’s You and Yours programme has been running a series on Chronic Fatigue Syndrome/ME. Today saw the last in the series and concentrated on ‘alternative treatments’ for patients who do not get ‘satisfaction’ from their GP.
ME is a quack’s dream. It does not have a specific set of diagnostic criteria – it is what left when all other possibilities have been ruled out – follows a cyclical pattern of symptoms, and tends to get better on its own. Kerching. As such, the Radio 4 programme explored the full zoology of quack therapies for ME, including reflexology, nutritional therapy, mickel therapy and, of course, homeopathy.
The first homeopath to be interviewed was Dr Susie Rockwell, who is an NHS GP, but also runs her own private homeopathy clinic. She points out on her website the rather confusing contradiction,
I advise on management and treatment according to NICE guidance. This guidance does not support the use of complementary therapies in CFS/ME as there is currently insufficient evidence for their use. However a wide range of complementary therapies have been tried in CFS/ME and I can advise about which may be useful and how to access them.
Now as most ME sufferers will seek alternative help like this at one of their lower points in their illness, ‘subtle effects’ towards improvement may well take place over a few weeks. It’s called regression to the mean. Dr Rockwell’s assertion that she sees her patients getting better is no evidence that it is anything to do with homeopathy.
One person who has made an honest attempt to improve the evidence base for homeopathic treatment for ME is Shefield University psychologist Dr Elaine Weatherley-Jones.
Dr Weatherley-Jones obviously had high expectations of the trial as she ‘aimed to find a strong clinically significant effect’. Unfortunately, the trial did not yield a strong significant effect. On most measures, there was no significant difference between the placebo group and the homeopathicly treated group. Overall though, “there is weak but equivocal evidence that the effects of homeopathic medicine are superior to placebo. ” Hardly, the ringing endorsement the researchers were looking for. And as DR W-J admits, “further studies are needed to determine whether these differences hold in larger samples. ” It is highly likely that this is just a statistical anomaly.
But, given the very disappointing nature of the trial, does Dr Weatherley-Jones admit that homeopathy may not be the wonder treatment for ME? Of course not, its the trial that was the problem. I think her words speak for themselves, (it is worth quoting at length)
Since completing and reporting on this study, I have reflected on and researched the relevance and appropriateness of the design of this study for investigating homeopathic treatment. (…) At the time of designing this trial, I believed the triple/double-blind placebo randomized controlled trial fit these criteria.
In retrospect, however, it is clear that the presence of a placebo arm in a study of homeopathic treatment can compromise the practice of homeopathy. In a further paper, colleagues and I conclude that “It is not reasonable to assume that the specific effects of homeopathic medicine and the non-specific effects of consultations are independent of each other—specific effects of the medicine (as manifested by patients’ reactions) may influence the nature of subsequent consultations and the non-specific effects of the consultation may enhance or diminish the effects of the medicine.” and that “For clinical trials of homeopathy to be accurate representations of practice, we need modified designs that take into account the complexity of the homeopathic intervention.”.
It is probably the case that the results of the CFS/ME homeopathic treatment trial were influenced by the existence of a placebo arm in the study. (…) They are also a possible explanation why only small effects are seen in placebo-controlled trials of homeopathy.
Whilst placebo-controlled trials of specific homeopathic remedies are valid, it is time to halt the misguided task of conducting placebo-controlled RCTs to test efficacy of individualized treatments; to redirect our energies to analyses of whole-systems health care and to design more relevant and meaningful pragmatic studies of comparative effectiveness, where untested treatments are compared to those where there is evidence of effectiveness.”