Aim of study: To explore issues that need to be addressed in the design of a clinical trial of acupuncture for people with depression.
Methods: In this study we conducted a focus group with 6 volunteer participants with experiences of depression, and a prospective case series of 10 patients who received acupuncture treatment for their depression. In the case series study, 10 patients were referred by their general practitioner, and received up to 10 individualized acupuncture treatments from one of two acupuncturists. Acupuncturists recorded traditional acupuncture diagnoses and details of the treatment provided. Measures of depression (Beck Depression Inventory and the Hospital Anxiety and Depression Scale) and health status (SF-36) were taken at baseline and 10 weeks later. Changes in mean before and after scores were analyzed using the Wilcoxon signed ranks test. Adverse events were also monitored.
Results: The focus group and the case series both identified considerable heterogeneity among people with depression. In the case series, only 6 patients both received treatment and completed 10-week questionnaires; however, significant improvements between before and after were found in their levels of depression (p < 0.05). Many factors, as well as the acupuncture, may have contributed to these improvements. No serious adverse events occurred. In the context of designing a clinical trial of acupuncture for depression, a series of methodological challenges is explored.
Conclusion: This study highlighted the complexities of evaluating acupuncture for patients with depression. Successfully addressing the identified methodological challenges in the design of a trial will increase its relevance and impact.