Depressed patients treated by homeopaths: a randomised controlled trial using the "cohort multiple randomised controlled trial" (cmRCT) design

Trials. 2017 Jun 30;18(1):299. doi: 10.1186/s13063-017-2040-2.

Abstract

Background: Despite controversy regarding homeopathy, some patients consult homeopaths for depression. Evidence is required to determine whether this is an effective, acceptable and safe intervention for these patients.

Methods: A pragmatic trial using the "cohort multiple randomised controlled trial" design was used to test the effectiveness of adjunctive treatment by homeopaths compared to usual care alone, over a period of 12 months in patients with self-reported depression. One third of patients were randomly selected for an offer of treatment provided by a homeopath. The primary outcome measure was the Patient Health Questionnaire (PHQ-9) at 6 months. Secondary outcomes included depression scores at 12 months; and the Generalised Anxiety Disorder (GAD-7) outcome at 6 and 12 months.

Results: The trial over-recruited by 17% with a total of 566 patients. Forty percent took up the offer and received treatment. An intention-to-treat analysis of the offer group at 6 months reported a 1.4-point lower mean depression score than the no offer group (95% CI 0.2, 2.5, p = 0.019), with a small standardized treatment effect size (d = 0.30). Using instrumental variables analysis, a moderate treatment effect size in favour of those treated was found (d = 0.57) with a between group difference of 2.6 points (95% CI 0.5, 4.7, p = 0.018). Results were maintained at 12 months. Secondary analyses showed similar results. Similar results were found for anxiety (GAD-7). No evidence suggested any important risk involved with the intervention.

Conclusion: This trial provides preliminary support for both the acceptability and the effectiveness of treatment by a homeopath for patients with self-reported depression. Our results provide support for further pragmatic research to provide more precise estimates of treatment effect.

Trial registration: ISRCTN registry, ISRCTN02484593 . Registered on 7 January 2013.

Keywords: Anxiety; Depression; Homeopathy; Randomised controlled trial; Treatment by homeopaths.

Publication types

  • Pragmatic Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Clinical Protocols
  • Depression / diagnosis
  • Depression / psychology
  • Depression / therapy*
  • England
  • Female
  • Homeopathy / adverse effects
  • Homeopathy / methods*
  • Humans
  • Male
  • Middle Aged
  • Patient Health Questionnaire
  • Preliminary Data
  • Psychiatric Status Rating Scales
  • Research Design
  • Time Factors
  • Treatment Outcome
  • Young Adult

Associated data

  • ISRCTN/ISRCTN02484593