Abstract
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.
Keywords
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Article info
Publication history
Published online: October 04, 2006
Accepted:
June 6,
2006
Identification
Copyright
© 2007 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
