OBJECTIVES: To establish the feasibility of conducting a randomised controlled trial to evaluate the efficacy of acupuncture in the treatment of mild-to-moderate depression. Control group intervention, blinding of treatment, outcome measures and the acceptability of such a trial amongst participants were key factors to be addressed. The findings from this study will be used to determine the design of a phase III randomised controlled trial. DESIGN:Nineteen participants were recruited through general practices in London, UK. Participants were randomly assigned on a 2:1 basis to either 12 sessions of verum acupuncture or 12 sessions of sham acupuncture (control). Sham acupuncture involved actual needling but at sites considered to be unrelated to depression. MAIN OUTCOME MEASURES: The Beck's Depression Inventory (BDI) and the RAND 36 Item Health Survey 1.0 (RAND) were completed at baseline and at the end of treatment or at treatment dropout. All participants also attended a brief qualitative interview at the end of the study. RESULTS: Treatment dropout was low and there were high levels of patient enthusiasm for a study of acupuncture. Referrals from General Practitioners (GPs) were lower than expected. The sham control method successfully maintained participant blinding to treatment and enabled the specific (or active) component of an acupuncture intervention to be isolated and its efficacy assessed. The outcome measures were sensitive enough to record changes in depressive symptoms and quality of life and are appropriate for use in a larger trial. CONCLUSIONS: This feasibility study has provided important information that can be used to guide the design and methodology of a full-randomised controlled trial.
RCT Entities:
OBJECTIVES: To establish the feasibility of conducting a randomised controlled trial to evaluate the efficacy of acupuncture in the treatment of mild-to-moderate depression. Control group intervention, blinding of treatment, outcome measures and the acceptability of such a trial amongst participants were key factors to be addressed. The findings from this study will be used to determine the design of a phase III randomised controlled trial. DESIGN: Nineteen participants were recruited through general practices in London, UK. Participants were randomly assigned on a 2:1 basis to either 12 sessions of verum acupuncture or 12 sessions of sham acupuncture (control). Sham acupuncture involved actual needling but at sites considered to be unrelated to depression. MAIN OUTCOME MEASURES: The Beck's Depression Inventory (BDI) and the RAND 36 Item Health Survey 1.0 (RAND) were completed at baseline and at the end of treatment or at treatment dropout. All participants also attended a brief qualitative interview at the end of the study. RESULTS: Treatment dropout was low and there were high levels of patient enthusiasm for a study of acupuncture. Referrals from General Practitioners (GPs) were lower than expected. The sham control method successfully maintained participant blinding to treatment and enabled the specific (or active) component of an acupuncture intervention to be isolated and its efficacy assessed. The outcome measures were sensitive enough to record changes in depressive symptoms and quality of life and are appropriate for use in a larger trial. CONCLUSIONS: This feasibility study has provided important information that can be used to guide the design and methodology of a full-randomised controlled trial.
Authors: Eldon Spackman; Stewart Richmond; Mark Sculpher; Martin Bland; Stephen Brealey; Rhian Gabe; Ann Hopton; Ada Keding; Harriet Lansdown; Sara Perren; David Torgerson; Ian Watt; Hugh MacPherson Journal: PLoS One Date: 2014-11-26 Impact factor: 3.240