General Practice and Primary Care - Theses
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ItemPilot study of an approach to successfully undertake a methodologically rigorous trial of acupuncture( 2011)BACKGROUND: Randomised controlled trials (RCTs) are considered the “gold standard” when evaluating the effectiveness of therapeutic interventions, because of their ability to minimise bias. Bias refers to any process that leads to a conclusion that is systematically different from the truth, and four key features of RCTs that serve to minimise bias have been identified. These are discussed using the case of acupuncture, a popular and safe complementary therapy, for treating hot flushes or vasomotor symptoms (VMS), which are common and bothersome during menopause. The methodological shortcomings of existing RCTs on this topic are discussed. AIM: To determine the feasibility of a rigorous randomised-controlled study evaluating the efficacy of needle acupuncture compared to non-penetrating sham control for treatment of VMS, in Melbourne, Australia. METHOD: A randomised sham-controlled pilot study was conducted. Various recruitment strategies, including online strategies, were implemented to recruit 27 acupuncture-naïve women having more than seven hot flushes a day and who were diagnosed with Kidney Yin deficiency, a Traditional Chinese Medicine diagnosis. Women were randomised into intervention or control groups and received ten treatments over eight weeks. The intervention group received needling at four acupuncture points while the control group received needling with a non-penetrating (blunt) needle (“the Park Sham Device”) at four non-acupuncture points. The main outcome measures were recruitment, enrolment and dropout rates; adequacy of blinding; adverse events; and qualitative assessment of trial procedures by participants. Changes in hot flushes were measured by a seven-day hot flush diary administered at baseline, four weeks, six weeks, end of treatment and three month follow-up. Quality of life (QOL) using the Menopause-Specific Quality of Life Questionnaire (MENQOL) was administered at the same times. Between-group differences for hot flush and QOL measures were analysed using non-parametric measures of equality (Wilcoxon ranksum test). RESULTS: Out of 98 enquiries, 38 women were eligible. The enrolment fraction was 71% and dropout rate 26%. Online strategies were the most effective. None of the women in the control group guessed that they were receiving sham acupuncture. Adverse events were generally mild. 23 women began treatment and 20 completed all treatments and follow-up. 14 women were interviewed and all gave positive feedback on trial procedures. Hot flush score was higher in the intervention group at baseline. There were no statistically significant differences between treatment and control groups in terms of hot flush or QOL measures except for hot flush score at end-of-treatment, with the control group having a lower score. DISCUSSION: A RCT appears to be feasible, based on the success of recruitment, a relatively low dropout rate, the adequacy of the control method, and the acceptability of the trial procedures. Although this pilot study was not powered to detect a treatment effect, lessons learned from this pilot will directly inform the design of a RCT which will evaluate the efficacy of acupuncture for VMS and add significantly to the current body of evidence.