Can self-reported depression be helped by homeopaths? A pragmatic cohort randomised controlled trial with qualitative interviews with patients.

Introduction: Depression is a common health problem. Some patients seek help from homeopaths as a complement or an alternative to conventional treatment. This may be due to reluctance to using or insufficient effect of “talking therapies” or antidepressants, or side-effects of such drugs. Insufficient evidence exists to determine whether homeopathy is acceptable, effective and safe. Aims: To evaluate the effectiveness of offering adjunctive treatment by homeopaths to patients with self-reported moderate to severe depression, and assess acceptability and safety. Methods: A pragmatic cohort multiple randomised controlled trial design was used. One third who fulfilled inclusion criteria were randomly selected to be offered a course of treatment by a homeopath. The primary outcome was the Patient Health Questionnaire (PHQ-9), 6 months post-randomisation. An intention-to-treat analysis compared “Offer” and “No offer” groups. An instrumental-variables-analysis (IV) assessed effects of received treatment. Safety was assessed through patients’/practitioners’ reports. Qualitative interviews were used to learn about patients’ experiences. Results: The full sample (n=566) was recruited. One third (n= 185) were randomly selected to the “Offer group” were offered treatment by a homeopath, 40% (n=74/185) accepted the offer of treatment. Four-hundred-and-fifty-eight (81%) responded to the 6 month questionnaire. At 6 months, the “Offer” group (ITT-analysis) reported lower PHQ-9 scores (mean 1.4, 95% CI 0.2, 2.5) compared to the “No offer” group (p=0.019), with a small effect size (d=0.30). Secondary analyses showed similar results. IV-analysis showed 2.6 points (95% CI 0.5, 4.7, p=0.018) lower depression scores for those who received treatment by a homeopath (medium effect size, d=0.57). Although 14 adverse events were possibly linked to the intervention, most were mild, none were life-threatening and all were transient. Themes developed from 46 qualitative interviews with 33 patients regarding their experiences included feeling listened to, supported and accepted during consultations, and as a result, opening up and coming to realisations. Some patients described improvement in their mood, wellbeing, energy and physical symptoms, others experienced little or no change, or felt worse. Conclusion: These preliminary (6 month) results suggest that treatment provided by homeopaths for patients with self-reported depression is acceptable. The effect size (d=0.30) is comparable to “talking therapies”; however, wide confidence intervals preclude firm conclusions from being drawn. There was no evidence that treatment by a homeopath was unsafe. Analysis of 12-month results is now required.