Systematic review: Placebo response in drug trials of fibromyalgia syndrome and painful peripheral diabetic neuropathy-magnitude and patient-related predictors

被引:99
作者
Haeuser, Winfried [1 ,2 ]
Bartram-Wunn, Eva [1 ,2 ]
Bartram, Claas [1 ,2 ]
Reinecke, Henriette [3 ]
Toelle, Thomas [4 ]
机构
[1] Klinikum Saarbrucken, Dept Internal Med 1, D-66119 Saarbrucken, Germany
[2] Tech Univ Munich, Dept Psychosomat Med, D-81675 Munich, Germany
[3] Tech Univ Darmstadt, Dept Clin Psychol & Psychotherapy, D-64293 Darmstadt, Germany
[4] Tech Univ Munich, Dept Neurol, D-81675 Munich, Germany
关键词
Fibromyalgia syndrome; Painful peripheral diabetic neuropathy; Placebo; Systematic review; Meta-analysis; CLINICAL-TRIALS; METAANALYSIS; EFFICACY; MIGRAINE;
D O I
10.1016/j.pain.2011.01.050
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
The magnitude of placebo response and its predictors in fibromyalgia syndrome (FMS) and painful peripheral diabetic neuropathy (DPN) had not been studied. We performed a systematic review by searching MEDLINE, CENTRAL, SCOPUS, and the databases of the U. S. National Institutes of Health and the Pharmaceutical Research and Manufacturers of America until July 2010. We included randomised controlled trials of any pharmacological therapy compared with pharmacological placebo in patients with FMS and painful DPN. Pain values were converted to a 0 to 100 scale. We computed the pooled weighted mean difference (WMD) between pain baseline and end of treatment scores in placebo and active drug groups using a random effects model. A total of 72 studies (9827 patients) in FMS and of 70 studies in DPN (10,297 patients) were included. The pooled WMD in the FMS-placebo group was 7.69 (95% confidence interval [CI] 6.10 to 9.29) and 17.11 (95% CI 16.41 to 17.90) in painful DPN. The pooled WMD in the FMS-active drug group was 13.96 (95% CI 11.93 to 15.99) and in painful DPN was 22.54 (95% CI 20.49 to 24.58). The correlation between WMD in the placebo and active drug group in FMS was r = 0.69 and painful DPN r = 0.47. Placebo accounted for 45% of the response in the drug groups in FMS and for 62% in painful DPN. The placebo response was higher in painful DPN than in FMS (P < .001). The placebo response was not associated with age, sex, and race, but with year of study initiation, pain baseline, and effect size in active drug groups in both diseases. (C) 2011 International Association for the Study of Pain. Published by Elsevier B. V. All rights reserved.
引用
收藏
页码:1709 / 1717
页数:9
相关论文
共 45 条
[1]   Statistics Notes - Interaction revisited: the difference between two estimates [J].
Altman, DG ;
Bland, JM .
BMJ-BRITISH MEDICAL JOURNAL, 2003, 326 (7382) :219-219
[2]  
[Anonymous], REV MAN REVMAN COMP
[3]  
[Anonymous], 2010, SURGERY, DOI DOI 10.1016/J.SURG.2009.06.030
[4]  
[Anonymous], COMPR MET SOFTW VERS
[5]  
[Anonymous], 1983, Journal of Educational Statistics, DOI [DOI 10.2307/1164923, DOI 10.3102/1076998600800215]
[6]  
[Anonymous], EFFECTIVENESS EFFICI
[7]  
[Anonymous], 2010, EFFECT VOLUNATARY EX
[8]   OPERATING CHARACTERISTICS OF A BANK CORRELATION TEST FOR PUBLICATION BIAS [J].
BEGG, CB ;
MAZUMDAR, M .
BIOMETRICS, 1994, 50 (04) :1088-1101
[9]   A meta-analysis of the placebo response in complementary and alternative medicine trials of irritable bowel syndrome [J].
Dorn, S. D. ;
Kaptchuk, T. J. ;
Park, J. B. ;
Nguyen, L. T. ;
Canenguez, K. ;
Nam, B. H. ;
Woods, K. B. ;
Conboy, L. A. ;
Stason, W. B. ;
Lembo, A. J. .
NEUROGASTROENTEROLOGY AND MOTILITY, 2007, 19 (08) :630-637
[10]   Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations [J].
Dworkin, Robert H. ;
Turk, Dennis C. ;
Wyrwich, Kathleen W. ;
Beaton, Dorcas ;
Cleeland, Charles S. ;
Farrar, John T. ;
Haythornthwaite, Jennifer A. ;
Jensen, Mark P. ;
Kerns, Robert D. ;
Ader, Deborah N. ;
Brandenburg, Nancy ;
Burke, Laurie B. ;
Cella, David ;
Chandler, Julie ;
Cowan, Penny ;
Dimitrova, Rozalina ;
Dionne, Raymond ;
Hertz, Sharon ;
Jadad, Alejandro R. ;
Katz, Nathaniel P. ;
Kehlet, Henrik ;
Kramer, Lynn D. ;
Manning, Donald C. ;
McCormick, Cynthia ;
McDermott, Michael P. ;
McQuay, Henry J. ;
Patel, Sanjay ;
Porter, Linda ;
Quessy, Steve ;
Rappaport, Bob A. ;
Rauschkolb, Christine ;
Revickl, Dennis A. ;
Rothman, Margaret ;
Schmader, Kenneth E. ;
Stacey, Brett R. ;
Stauffer, Joseph W. ;
Von Stein, Thorsten ;
White, Richard E. ;
Witter, James ;
Zavislc, Stojan .
JOURNAL OF PAIN, 2008, 9 (02) :105-121