MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

Indian homeopaths recently published a clinical trial aimed at evaluating homeopathic treatment in the management of diabetic polyneuropathy. The condition affects many diabetic patients; its symptoms include tingling, numbness, burning sensation in the feet and pain, particularly at night. The best treatment consists of adequate metabolic control of the underlying diabetes. The pain can be severe often does not respond adequately to conventional pain-killers. It is therefore obvious that any new, effective treatment would be more than welcome.

The new trial  is a prospective observational study which was carried out from October 2005 to September 2009 by the Indian Central Council for Research in Homeopathy at its five Institutes. Patients suffering diabetic polyneuropathy (DPN) were screened and enrolled in the study, if they fulfilled the inclusion and exclusion criteria. The Diabetic Distal Symmetric Polyneuropathy Symptom Score (DDSPSS), developed by the Council, served as the primary outcome measure.

A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in the 30, 200 and 1 M potencies on an individualized basis. Patients were followed up for 12 months.

Of 336 diabetics enrolled in the study, 247 patients who attended at least three follow-up appointments and baseline nerve conduction studies were included in the analysis. A statistically significant improvement in DDSPSS total score was found at 12 months. Most objective measures did not show significant improvements. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the most frequently prescribed homeopathic remedies.

From these results, the authors concluded that: “homeopathic medicines may be effective in managing the symptoms of DPN patients.”

Does this study tell us anything worth knowing? The short answer to this question, I am afraid, is NO.

Its weaknesses are all too obvious:

1) There was no control group.

2) Patients who did not come back to the follow-up appointments – presumably because they were not satisfied – were excluded from the analyses. The average benefit reported is thus likely to be a cherry-picked false positive result.

3) The primary outcome measure was not validated.

4) The observed positive effect on subjective symptoms could be due to several factors which are entirely unrelated to the homeopathic treatments’ e.g. better metabolic control, regression towards the mean, or social desirability.

Anyone who had seen the protocol of this study would have predicted the result; I see no way that such a study does not generate an apparently positive outcome. In other words, conducting the investigation was superfluous, which means that the patients’ participation was in vain; and this, in turn, means that the trial was arguably unethical.

This might sound a bit harsh, but I am entirely serious: deeply flawed research should not happen. It is a waste of scarce resources and patients’ tolerance; crucially, it has a powerful potential to mislead us and to set back our efforts to improve health care. All of this is unethical.

The problem of research which is so poor that it crosses the line into being unethical is, of course, not confined to homeopathy. In my view, it is an important issue in much of alternative medicine and quite possibly in conventional medicine as well. Over the years, several mechanisms have been put in place to prevent or at least minimize the problem, for instance, ethic committees and peer-review. The present study shows, I think, that these mechanisms are fragile and that, sometimes, they fail altogether.

In their article, the authors of the new homeopathic study suggest that more investigations of homeopathy for diabetic polyneuropathy should be done. However, I suggest almost precisely the opposite: unethical research of this nature should be prevented, and the existing mechanisms to achieve this aim must be strengthened.

6 Responses to Where is the line between poor and unethical research?

  • I think that it is important to start recognising the moral aspects to problems with poorly done research or, just as importantly, spun results. Too many people can see research as being detached from real world consequences. Misleading claims in the research literature can cause real harm, and there should be a greater desire to hold those responsible for this accountable.

  • It is difficult to know when research becomes so bad that some sort of action should be taken though. I’d be interested to hear you expand your thoughts on this, if you could, as well as describing what interventions you think should be taken for unethical research. When I’ve tried to think this through, I’ve become stuck on the details.

    There’s been a recent trend for poorly done mainstream medical research to detail it’s limitations in the discussion section, but that doesn’t help make the results any more useful, and conclusions will still often be full of undue positivity. Such work can also go on to be cited uncritically in other papers, presentations, etc.

    There will always be misleading research founded upon error in science, and we cannot expect otherwise, but the current environment does too much to reward publishing papers (especially if ‘positive’ ones), and not enough to penalise publishing poor papers. I think that the often implausible nature of CAM interventions simply serves to highlight many of the same problems which are occurring within more respectable areas of medicine. I think that it’s important try to learn from this, and tighten up the requirements for mainstream medicine, rather than treat CAM as a separate category to be more readily criticised.

    • I wish I had an easy solution!
      most likely, there need to be not one but several. for instance, medline-listed journals should have critical thinkers on board and each submission should be reviewed by 1 or 2 of them. alt med journals are very poor in this respect. in a recent post, I published the fact that “HOMEOPATHY”, the journal where the article was published, fired me; and I had been their only critic of homeopathy. this sort of thing is counterproductive, I think.
      what I am trying to say is that there need to be many seemingly small measures to tighten up the system.

      • Different groups will have different ideas about what level of scepticism of reasonable though. Should global warming sceptics be required to review papers on climate change? How sceptical is it reasonable to be the the value of psychotherapy? Psychotherapists might have different views on that to others, and they tend to be the ones running journals on psychotherapy.

        I think that we need to be more honest about how deeply flawed peer review is. Currently I think that it could do more harm than good, by encouraging people to believe that the claims made in peer-reviewed papers are trustworthy and reasonable. I think that we should make pre-publication history public, and encourage more post-publication criticism. There should also be more recognition of the value of criticising poor or misleading work, and the work that this takes. This is probably just tinkering though, and I’m not sure that it will bring us much closer to an appreciation of the moral wrongs of poor and spun research. Thanks for your thoughts.

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