RESUMEN
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.
RESUMEN
BACKGROUND: Primary dysmenorrhea occurs 40%-50% in women of reproductive age. Acupuncture may assist treatment of menstrual pain. OBJECTIVE: This study compared the effects of the acupuncture program Chongmai, or Thoroughfare Vessel (TV), to sham acupuncture on primary dysmenorrhea. METHODS: The current authors selected 3 groups of 10 patients each with primary dysmenorrhea for this comparative, prospective longitudinal study. The first group was treated at the TV points, the second group underwent sham acupuncture, and the third group (control) did not receive any kind of acupuncture. All groups were allowed to use steroidal anti-inflammatory drugs (NSAIDs). Menstrual pain was measured using a visual analogue scale (VAS). The results were analyzed using a Student's-t test in GraphPad Prism 5.0. Acupuncture needles were applied at the following TV acupuncture points: (1) Gongsun (SP 4); (2) Qichong (ST30); (3) Neiguan (PC 6); and (4) Baihuanshu (BL 30), the metameric action point of the pelvic area. Electrical stimulation was applied through each needle at 120 Hz for 40 minutes. RESULTS: TV acupuncture, sham acupuncture, and/or NSAIDs substantially reduced pain in all 10 patients in each respective group (100%). TV acupuncture treatment reduced the symptoms of primary dysmenorrhea, and symptoms were reduced for at least 6 months. Application of needles at simulated points away from the TV acupuncture program did not reduce pain significantly. CONCLUSIONS: TV acupuncture treatment can reduce the symptoms of primary dysmenorrhea, and the effect can last for 6 months.