Researchers from the National Institute of Homoeopathy (an autonomous organisation under the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy, Government of India) tested a Dysentery Compound (DC), a ‘bowel nosode’, against individualized homeopathy (IH) in the treatment of irritable bowel syndrome (IBS). For this purpose, they used an open, randomized (1:1), parallel arms, pragmatic, non-inferiority, pilot trial with 60 IBS patients. IBS Quality of Life (IBS-QOL) questionnaire was used as the primary outcome measure; assessed at baseline and after 3 months.
Six subjects dropped out. Groups were comparable at baseline (all p>0.01). Though intra-group changes were higher favouring IH over DC, group differences were statistically non-significant (all p>0.01). Non-inferiority was not demonstrated by DC against IH over 3 months (mean difference= −3.3, SE=5.2, lower 95% confidence limit −11.9, t= −0.453, p=0.674). No adverse events were reported from either group.
The authors concluded that non-inferiority of DC against IH in treatment of IBS was not demonstrated though it appeared as safe; still, being a pilot trial, no definite conclusion could be drawn. Further exploration of both efficacy and effectiveness of either of the therapies is necessary by adequately powered trials and independent replications.
This trial is a treasure trove of methodological flaws. Here I want to focus on merely one of them: The idea of conducting a non-inferiority study of two treatments, none of which have previously been shown to be effective.
Most clinical trials are ‘superiority studies’ designed to test whether one treatment is more effective than another one. This is fundamentally different in non-inferiority or equivalence studies. They aim to test whether one treatment is as effective as another therapy that has already been fully researched and is generally accepted to be effective for the condition in question. This approach avoids the ethical problems that can arise in superiority studies from giving placebos to patients who require an effective treatment for their condition. Equivalence studies can have many of the features of superiority studies but require a different statistical approach and usually need much larger sample sizes.
This means that the new study never had the slightest chance to generate a result that was in any way meaningful. Such a waste of resources is hardly surprising in the realm of homeopathy; over the years, we have become used to it. But, coming from the National Institute of Homeopathy, it is significant. On their website, the Institute claims this:
The mission of National Institute of Homoeopathy is to foster excellence in Homoeopathic Medical Education and Research, to educate and train undergraduate, post graduate students and research scholars of homoeopathy in accordance with highest professional standards and ethical values unfettered by the barriers of nationality, language, culture, plurality, religion and to meet the healthcare needs of the community through dissemination of knowledge and service.
Excellence in homeopathic research?
Well, you could have fooled me!