PMID- 22336767
OWN - NLM
STAT- MEDLINE
DCOM- 20120830
LR  - 20220408
IS  - 1536-5409 (Electronic)
IS  - 0749-8047 (Linking)
VI  - 28
IP  - 5
DP  - 2012 Jun
TI  - Adverse events attributable to nocebo in randomized controlled drug trials in 
      fibromyalgia syndrome and painful diabetic peripheral neuropathy: systematic 
      review.
PG  - 437-51
LID - 10.1097/AJP.0b013e3182321ad8 [doi]
AB  - OBJECTIVE: The objectives of the study were to determine the impact of nocebo 
      effects on adverse events (AEs) in drug trials in fibromyalgia syndrome (FMS) and 
      painful diabetic peripheral neuropathy (DPN). METHODS: MEDLINE, CENTRAL, SCOPUS, 
      and the databases of the U.S. National Institutes of Health and the 
      Pharmaceutical Research and Manufacturers of America were searched until December 
      31, 2010. Randomized controlled trials with a parallel design of any drug therapy 
      compared with pharmacological placebo in patients with FMS and DPN were included. 
      Pooled estimates of nocebo effects (number of patients with at least 1 AE and 
      dropping out due AEs) were calculated for placebo and true drug groups by a 
      random effects model. RESULTS: Fifty-eight FMS (62 DPN) trials included a total 
      of 5065 (5095) patients in placebo groups. The quality of reporting the 
      assessment strategy of AEs was poor in most trials. The pooled estimate of the 
      event rate drop out rate due to AEs in placebo groups was 9.6 [95% confidence 
      control (CI): 8.6-10.7] in placebo and 16.3 (95% CI: 14.1-31.2) in true drug 
      groups of FMS trials and was 5.8 (95% CI: 5.1-6.6) in placebo and 13.2 (95% CI: 
      10.7-16.2) in true drug groups of DPN trials. Nocebo effects accounted for 72.0% 
      (44.9) of the drop outs in true drug groups in FMS (DPN). DISCUSSION: Nocebo 
      effects substantially accounted for AEs in drug trials of FMS and DPN. Standards 
      to assess and report AEs should be defined by regulatory agencies. Strategies to 
      minimize nocebo effects in both clinical trials and clinical practice should be 
      developed.
FAU - Hauser, Winfried
AU  - Hauser W
AD  - Department of Internal Medicine I, Klinikum Saarbrucken, Winterberg 1, 
      Saarbrucken, Germany. whaeuser@klinikum-saarbruecken.de
FAU - Bartram, Claas
AU  - Bartram C
FAU - Bartram-Wunn, Eva
AU  - Bartram-Wunn E
FAU - Tolle, Thomas
AU  - Tolle T
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
PL  - United States
TA  - Clin J Pain
JT  - The Clinical journal of pain
JID - 8507389
RN  - 0 (Analgesics)
SB  - IM
MH  - Adult
MH  - Analgesics/*adverse effects/therapeutic use
MH  - Diabetic Neuropathies/*drug therapy
MH  - Double-Blind Method
MH  - Drug Approval
MH  - Drug Industry
MH  - Female
MH  - Fibromyalgia/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain Management/*methods
MH  - Pain Measurement
MH  - *Placebo Effect
MH  - Publication Bias
MH  - Randomized Controlled Trials as Topic
MH  - Regression Analysis
MH  - Reproducibility of Results
MH  - Research Design
MH  - Research Support as Topic
MH  - Treatment Outcome
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2012/02/18 06:00
MHDA- 2012/08/31 06:00
CRDT- 2012/02/17 06:00
PHST- 2012/02/17 06:00 [entrez]
PHST- 2012/02/18 06:00 [pubmed]
PHST- 2012/08/31 06:00 [medline]
AID - 10.1097/AJP.0b013e3182321ad8 [doi]
PST - ppublish
SO  - Clin J Pain. 2012 Jun;28(5):437-51. doi: 10.1097/AJP.0b013e3182321ad8.