Objective: To compare patient characteristics and outcomes between a randomized controlled trial (RCT) and an observational study (OS) of acupuncture treatment in patients with migraine.
Study design and setting: Within the framework of a research program for acupuncture for chronic pain, both an RCT and an OS of routine care were performed in patients with migraine. One hundred forty-five patients received acupuncture in the RCT and 732 in the OS. All patients completed a pain questionnaire, including instruments evaluating disability, quality of life, and depression, at baseline and at 6-month follow-up.
Results: At baseline, patients participating in the RCT had a significantly longer history of complaints and more headache days but better quality of life and fewer depressive symptoms than patients participating in the OS. In unadjusted analyses, improvements after 6 months were more pronounced in the OS than in the RCT. After adjustment for potential confounders, the differences decreased but were still significant for several outcomes.
Conclusion: Participants of the RCT were probably not representative of migraine patients undergoing acupuncture treatment in routine care under current regulations in Germany. However, changes after treatment were similar in the RCT and the OS of routine care.