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01.12.2017 | Research | Ausgabe 1/2017 Open Access

Trials 1/2017

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

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Petter Viksveen, Clare Relton, Jon Nicholl
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-2040-2) contains supplementary material, which is available to authorized users.

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.
Zusatzmaterial
Additional file 1: CONSORT 2010 checklist of information to include when reporting a randomised trial. (DOC 219 kb)
13063_2017_2040_MOESM1_ESM.doc
Additional file 2: Table S1. Depression outcomes at 6 and 12 months. Intention-to-treat analysis of the offer of treatment. (DOCX 15 kb)
13063_2017_2040_MOESM2_ESM.docx
Additional file 3: Table S2. Anxiety outcomes at 6 and 12 months. Intention-to-treat analysis of the offer of treatment. (DOCX 15 kb)
13063_2017_2040_MOESM3_ESM.docx
Additional file 4: Table S3. Depression outcomes at 6 and 12 months. Instrumental variables analysis of treatment received. (DOCX 14 kb)
13063_2017_2040_MOESM4_ESM.docx
Additional file 5: Table S4. Anxiety outcomes at 6 and 12 months. Instrumental variables analysis of treatment received. (DOCX 14 kb)
13063_2017_2040_MOESM5_ESM.docx
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