PMID- 32932856
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201028
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 9
IP  - 9
DP  - 2020 Sep 11
TI  - Shortcomings of Trials Assessing Antidepressants in the Management of Irritable 
      Bowel Syndrome: A Critical Review.
LID - 10.3390/jcm9092933 [doi]
LID - 2933
AB  - Irritable bowel syndrome (IBS) is a common disorder requiring complex, 
      multidisciplinary management. Antidepressants are commonly used and recommended 
      in guidelines for the treatment of patients with IBS. We assessed randomized 
      controlled trials (RCTs) on antidepressants in patients with IBS, with specific 
      attention to study design and data quality/reporting characteristics. Following a 
      comprehensive search, data and RCT characteristics were systematically 
      summarized. Fragility index, representing the number of positive "events" that 
      the study relies on for its significance, was calculated. Eighteen RCTs were 
      included. Overall, tricyclic antidepressants (TCAs), but not selective serotonin 
      reuptake inhibitors (SSRIs), appeared to be efficacious in IBS. Eight studies 
      reported on adverse events (AEs), which were significantly greater in patients 
      receiving antidepressants versus placebo. The median (mean) fragility index of 
      TCA trials was 0 (1.5). RCTs with positive results had significantly lower 
      placebo rates (20.8%) versus negative studies (45.7%; p < 0.0001). RCTs exhibited 
      limitations related to study design (sample size and blinding), data analysis 
      (outcomes and placebo response), and data reporting (selective reporting of AEs 
      and publication bias). Careful consideration of limitations of RCTs on 
      antidepressants in IBS is warranted to formulate a safe and beneficial treatment 
      regimen for patients with IBS.
FAU - Oh, Sun Jung
AU  - Oh SJ
AD  - Johns Hopkins Hospital, Baltimore, MD 21287, USA.
FAU - Takakura, Will
AU  - Takakura W
AD  - Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
FAU - Rezaie, Ali
AU  - Rezaie A
AD  - Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA.
LA  - eng
GR  - Funding for technical editorial assistance that was provided under the direction 
      of the authors/Salix Pharmaceuticals/
PT  - Journal Article
PT  - Review
DEP - 20200911
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC7564007
OTO - NOTNLM
OT  - antidepressive agents
OT  - healthcare quality assessment
OT  - irritable bowel syndrome
OT  - publication bias
OT  - serotonin reuptake inhibitors
OT  - tricyclic antidepressants
COIS- Sun Jung Oh and Will Takakura declare no conflict of interest. Ali Rezaie reports 
      serving as a consultant for and receiving research grants from Salix 
      Pharmaceuticals. The sponsor had no role in the design, execution, 
      interpretation, or writing of the study, or in the decision to publish the 
      results.
EDAT- 2020/09/17 06:00
MHDA- 2020/09/17 06:01
PMCR- 2020/09/11
CRDT- 2020/09/16 01:01
PHST- 2020/07/16 00:00 [received]
PHST- 2020/09/02 00:00 [revised]
PHST- 2020/09/09 00:00 [accepted]
PHST- 2020/09/16 01:01 [entrez]
PHST- 2020/09/17 06:00 [pubmed]
PHST- 2020/09/17 06:01 [medline]
PHST- 2020/09/11 00:00 [pmc-release]
AID - jcm9092933 [pii]
AID - jcm-09-02933 [pii]
AID - 10.3390/jcm9092933 [doi]
PST - epublish
SO  - J Clin Med. 2020 Sep 11;9(9):2933. doi: 10.3390/jcm9092933.