Abstract
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.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.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.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.This feasibility study has provided important information that
can be used to guide the design and methodology of a full-randomised
controlled trial.
Users
Please
log in to take part in the discussion (add own reviews or comments).