ABSTRACT
Background: Acupuncture use is increasing worldwide for many conditions, including movement disorders. Clinical research in acupuncture has also increased to test anecdotal reports of clinical benefits empirically and investigate potential mechanisms. Method: This article describes considerations for designing a double-blinded, randomized, placebo-controlled clinical trial of acupuncture for fatigue in Parkinson's disease (PD) and describes the current authors' experience in the implementation and early conduct of this trial. Relevant literature is also reviewed to provide guidance for other researchers seeking to perform clinical research relevant to PD and related disorders. Results: Trial design should be driven by a well-defined research question and sufficient detail to meet Standards for Reporting Interventions in Clinical Trials of Acupuncture criteria when a trial is complete. Important items for review include: randomization and blinding; recruitment and participant selection; sham methodology choice; staff training; and practical implementation of study procedures. Sample forms used for the current authors' trial are shared. Conclusions: High-quality clinical trials of acupuncture can provide valuable information for clinicians, patients, and policymakers. Acupuncture trials differ in critical ways from pharmaceutical trials and might require additional considerations regarding design and implementation. Adequate preparation for the unique challenges of acupuncture studies can improve trial implementation, design, efficiency, and impact.
ABSTRACT
BACKGROUND: Fatigue is a common and debilitating nonmotor symptom of PD. Because preliminary evidence suggests that acupuncture improves fatigue in other conditions, we sought to test its efficacy in PD. METHODS: Ninety-four PD patients with moderate-to-high fatigue were randomized to receive 6 weeks of biweekly real or sham acupuncture. The primary outcome was change on the Modified Fatigue Impact Scale at 6 weeks. Secondary outcomes included sleep, mood, quality of life, and maintenance of benefits at 12 weeks. RESULTS: Both groups showed significant improvements in fatigue at 6 and 12 weeks, but with no significant between-group differences. Improvements from baseline in mood, sleep, and quality of life were noted without between-group differences. Overall, 63% of patients reported noticeable improvements in their fatigue. No serious adverse events were observed. CONCLUSIONS: Acupuncture may improve PD-related fatigue, but real acupuncture offers no greater benefit than sham treatments. PD-related fatigue should be added to the growing list of conditions that acupuncture helps primarily through nonspecific or placebo effects. © 2016 International Parkinson and Movement Disorder Society.
