PMID- 37577771
OWN - NLM
STAT- MEDLINE
DCOM- 20231102
LR  - 20231102
IS  - 1751-2980 (Electronic)
IS  - 1751-2972 (Linking)
VI  - 24
IP  - 8-9
DP  - 2023 Aug-Sep
TI  - Nocebo response intensity and influencing factors in the randomized clinical 
      trials of functional dyspepsia: A systematic review and meta-analysis.
PG  - 440-451
LID - 10.1111/1751-2980.13216 [doi]
AB  - OBJECTIVES: In this study we aimed to evaluate the nocebo response rate in 
      patients with functional dyspepsia (FD) and to explore its influencing factors. 
      METHODS: A literature search of the EMBASE, PubMed, and Cochrane Library 
      databases was conducted for all articles published up to March 2021. Randomized, 
      parallel-designed, placebo-controlled trials on pharmacological interventions for 
      patients with FD were included. A meta-analysis that utilized random effects to 
      analyze the incidence of adverse events (AEs) among participants who were given 
      placebo was conducted, and the correlation between trial characteristics and the 
      magnitude of the nocebo response rate was analyzed. RESULTS: Altogether, 27 
      studies including 1866 paitents were deemed eligible and included in the 
      analysis. The total nocebo response rate was 26% (95% confidence interval [CI] 
      18%-33%). The most frequently reported AEs included nasopharyngitis (9%), 
      constipation (6%), headache (5%), and diarrhea (3%). There were significant 
      differences in nocebo response rates among studies conducted in different country 
      or region, treatment duration, types of medication, sponsorship and different 
      versions of the Rome criteria used for FD diagnosis. While number of centers 
      engaged in the study, types of FD diagnosis and dosing frequency were not 
      significantly associated with the nocebo response rate. CONCLUSIONS: Patients 
      with FD exhibit notable nocebo response strength in clinical trials. The 
      researchers should adopt a more careful approach when analyzing the relationships 
      between AEs and interventions in such trials.
CI  - (c) 2023 Chinese Medical Association Shanghai Branch, Chinese Society of 
      Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University 
      School of Medicine and John Wiley & Sons Australia, Ltd.
FAU - Li, Rui Jie
AU  - Li RJ
AD  - Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
FAU - Zhang, Qing Qing
AU  - Zhang QQ
AD  - Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
FAU - Feng, Yu Qing
AU  - Feng YQ
AD  - Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
FAU - Pei, Qiao Qiao
AU  - Pei QQ
AD  - Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
FAU - He, Xuan Xuan
AU  - He XX
AD  - Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
FAU - Chen, Fu Ping
AU  - Chen FP
AD  - Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
FAU - Wang, Dong Ke
AU  - Wang DK
AD  - Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
FAU - Liu, Xing Huang
AU  - Liu XH
AD  - Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
FAU - Liu, Jin Song
AU  - Liu JS
AD  - Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
FAU - Hou, Xiao Hua
AU  - Hou XH
AD  - Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
FAU - Bai, Tao
AU  - Bai T
AUID- ORCID: 0000-0001-9697-8510
AD  - Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei Province, China.
LA  - eng
GR  - 8190034466/National Natural Science Foundation of China/
GR  - 8187031677/National Natural Science Foundation of China/
GR  - Undergraduate Innovation and Entrepreneurship Project of the First Clinical 
      College of Huazhong University of Science and Technology/
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20230920
PL  - Australia
TA  - J Dig Dis
JT  - Journal of digestive diseases
JID - 101302699
SB  - IM
MH  - Humans
MH  - *Nocebo Effect
MH  - *Dyspepsia/drug therapy
MH  - Randomized Controlled Trials as Topic
OTO - NOTNLM
OT  - drug-related side effects and adverse reactions
OT  - functional dyspepsia
OT  - meta-analysis
OT  - nocebo effect
OT  - systematic review
EDAT- 2023/08/14 06:43
MHDA- 2023/08/14 06:44
CRDT- 2023/08/14 05:05
PHST- 2023/05/28 00:00 [revised]
PHST- 2023/02/01 00:00 [received]
PHST- 2023/08/07 00:00 [accepted]
PHST- 2023/08/14 06:44 [medline]
PHST- 2023/08/14 06:43 [pubmed]
PHST- 2023/08/14 05:05 [entrez]
AID - 10.1111/1751-2980.13216 [doi]
PST - ppublish
SO  - J Dig Dis. 2023 Aug-Sep;24(8-9):440-451. doi: 10.1111/1751-2980.13216. Epub 2023 
      Sep 20.