TY - JOUR
T1 - Randomized trial vs. observational study of acupuncture for migraine found that patient characteristics differed but outcomes were similar
AU - Linde, Klaus
AU - Streng, Andrea
AU - Hoppe, Andrea
AU - Weidenhammer, Wolfgang
AU - Wagenpfeil, Stefan
AU - Melchart, Dieter
N1 - Funding Information:
Funding was provided by the following statutory sickness funds: Deutsche Angestellten-Krankenkasse, Hamburg; Barmer Ersatzkasse, Wuppertal; Kaufmännische Krankenkasse, Hannover; Hamburg-Münchener Krankenkasse, Hamburg; Hanseatische Krankenkasse, Hamburg; Gmünder Ersatzkasse, Schwäbisch Gmünd; HZK Krankenkasse für Bau- und Holzberufe, Hamburg; Brühler Ersatzkasse, Solingen; Krankenkasse Eintracht Heusenstamm, Heusenstamm; and Buchdrucker Krankenkasse, Hannover.
PY - 2007/3
Y1 - 2007/3
N2 - 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.
AB - 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.
KW - Acupuncture
KW - External validity
KW - Generalisability
KW - Migraine
KW - Observational study
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=33846821635&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2006.06.014
DO - 10.1016/j.jclinepi.2006.06.014
M3 - Article
C2 - 17292022
AN - SCOPUS:33846821635
SN - 0895-4356
VL - 60
SP - 280
EP - 287
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
IS - 3
ER -