PMID- 37936549
OWN - NLM
STAT- MEDLINE
DCOM- 20240125
LR  - 20240202
IS  - 1365-2982 (Electronic)
IS  - 1350-1925 (Linking)
VI  - 36
IP  - 2
DP  - 2024 Feb
TI  - Nocebo effects and influencing factors in the randomized clinical trials of 
      chronic constipation: A systematic review and meta-analysis.
PG  - e14708
LID - 10.1111/nmo.14708 [doi]
AB  - BACKGROUND: Nocebo effects are unavoidable in randomized clinical trials. We 
      aimed to assess the magnitude of nocebo effects and explore the influencing 
      factors in chronic constipation. METHODS: We searched the PubMed, Embase, and 
      Cochrane Library databases up to July 2022. Randomized, placebo-controlled trials 
      investigating interventions in chronic constipation were included. We conducted a 
      random effects meta-analysis of the proportion of adverse events (AEs) in 
      placebo-treated participants and evaluated the effect of trial characteristics on 
      nocebo effects. KEY RESULTS: We identified 20,204 studies from the databases, of 
      which 61 were included in the final analysis. The pooled placebo AE rate was 
      30.41%, and AE-related withdrawal rate was 1.53%. The most commonly reported AEs 
      were headache (5.67%), diarrhea (4.45%), abdominal pain (3.98%), nasopharyngitis 
      (3.39%), nausea (3.36%), and flatulence (2.95%). The placebo AE rate was lower in 
      trials conducted in Asia compared to those in Europe, North America, and 
      international trials. It was also lower in trials diagnosed by Rome III compared 
      to clinician's opinion and Rome II. Additionally, the placebo AE rate was lower 
      in single-center trials compared to multicenter trials, lower in 5-8 weeks 
      therapy compared to 9-12 weeks therapy, lower in participants with FC compared to 
      those with IBS-C and CC, lower in trials with 2 arms compared to 3 arms, and 
      higher in trials with prokinetic drugs compared to secretagogues and laxatives. 
      CONCLUSIONS & INFERENCES: The placebo AE rate was 30.41% in patients with chronic 
      constipation. Based on our findings, we recommend that researchers take the 
      nocebo effects into consideration when designing and conducting clinical trials 
      and adopt specific measures to mitigate the negative influence of nocebo effects.
CI  - (c) 2023 John Wiley & Sons Ltd.
FAU - Yang, Jingze
AU  - Yang J
AD  - Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Guo, Jinlu
AU  - Guo J
AD  - Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Yang, Xin
AU  - Yang X
AD  - Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Chen, Jie
AU  - Chen J
AUID- ORCID: 0000-0002-4018-2502
AD  - Department of Pathology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Bai, Tao
AU  - Bai T
AUID- ORCID: 0000-0001-9697-8510
AD  - Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Liu, Shi
AU  - Liu S
AD  - Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
LA  - eng
GR  - National Natural Science Foundation of China/
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20231107
PL  - England
TA  - Neurogastroenterol Motil
JT  - Neurogastroenterology and motility
JID - 9432572
RN  - 0 (Laxatives)
SB  - IM
MH  - Humans
MH  - *Nocebo Effect
MH  - Randomized Controlled Trials as Topic
MH  - *Constipation/drug therapy
MH  - Laxatives/therapeutic use
MH  - Diarrhea/drug therapy
OTO - NOTNLM
OT  - adverse events
OT  - chronic constipation
OT  - meta-analysis
OT  - nocebo effects
EDAT- 2023/11/08 06:42
MHDA- 2024/01/25 06:43
CRDT- 2023/11/08 03:47
PHST- 2023/09/22 00:00 [revised]
PHST- 2022/10/04 00:00 [received]
PHST- 2023/10/26 00:00 [accepted]
PHST- 2024/01/25 06:43 [medline]
PHST- 2023/11/08 06:42 [pubmed]
PHST- 2023/11/08 03:47 [entrez]
AID - 10.1111/nmo.14708 [doi]
PST - ppublish
SO  - Neurogastroenterol Motil. 2024 Feb;36(2):e14708. doi: 10.1111/nmo.14708. Epub 
      2023 Nov 7.