Homeopathy for Cancer-Related Fatigue: Protocol for a Series of N-of-1 Trials, with Meta-analysis of Individual Patient Data

This abstract caught my attention; it is unusual in that it reports not a trial but a protocol of a trial of homeopathy. I think it deserves a short comment:

Cancer-related fatigue (CRF) poses a significant challenge in cancer care and affects the quality of life of many patients. Despite the prevalence and impact of the condition, identifying effective therapies remains a challenge. Non-pharmacological remedies, such as complementary therapies including homeopathy, are under-researched. A clinical trial with n-of-1 design has therefore been planned to evaluate the potential of individualized homeopathic medicinal products (IHMPs) in the management of CRF.A series of double-blind, randomized, placebo-controlled, n-of-1 trials will be conducted. Each participant will undergo three rounds of two intervention phases in a randomly determined order. The study will be performed at the Oncology Outpatient Department of D. N. De Homoeopathic Medical College and Hospital. Participants with CRF who meet pre-defined eligibility requirements will be enrolled. The FACIT-F sub-scale is the primary outcome measure; Short Form-36 and the Wu Cancer Fatigue Scale are the secondary outcomes. All outcomes will be measured at baseline, on day 7 and then every 10 days for 2 months. The sample size will be the number of patients who can be recruited during the 18-month period of the trial. The Numerical Rating Scale (0-10) measuring fatigue severity will be used in screening and preliminary evaluation of the degree of fatigue. Comprehensive blood tests to evaluate various physiological factors related to CRF will also be performed. An assessment of the effect of the IHMPs will be obtained per individual and by aggregating the data of all participants via meta-analysis.The results of our study will clarify the possible therapeutic effects of IHMPs for patients with CRF, as well as improve our understanding of the n-of-1 study design as it is applied to homeopathy research.

‘N of one’ trials make sense for testing the hypothesis that a treatment reproducibly works not for all but only for some individuals. If that is the case, a conventional trial would produce a negative overall result by drowning the positive cases in the sea of negative findings.

Evidently, the Indian authors believe that this is true for homeopathy. Therefore the study design they probose seems reasonable.

Hold on!

Reasonable?

Skeptics would argue that there is nothing reasonable about the assumption that homeopathy can reduce cancer fatigue beyond placebo. They would thus predict that – provided the study is rigorously conducted and reported – the end result of this series of N=1 studies will be negative and that the whole excercise is a waste of resources.

I agree – but I still fear that the results will yield some positive findings and the authors will conclude that, indeed, some individuals do reproducibly benefit from homeopathy beyond placebo. I suspect this will happen because already the protocol was published in the journal ‘HOMEOPATHY’ rather than in a respected journal. What is even more concerning are the affiliations of the authors:

• ¹Department of Pathology and Microbiology, D. N. De Homoeopathic Medical College and Hospital, Government of West Bengal, Kolkata, West Bengal, India.
• ²Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Government of West Bengal, Kolkata, West Bengal, India.
• ³Department of Radiation Oncology, North Bengal Medical College and Hospital, Government of West Bengal, Kolkata, West Bengal, India.

This, I fear, suggests that the above mentioned precondition might not be met and the study might not be rigorously conducted and reported.

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