PMID- 28802556
OWN - NLM
STAT- MEDLINE
DCOM- 20180727
LR  - 20181202
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Print)
IS  - 0016-5107 (Linking)
VI  - 86
IP  - 6
DP  - 2017 Dec
TI  - Randomized sham-controlled trials in endoscopy: a systematic review and 
      meta-analysis of adverse events.
PG  - 972-985.e3
LID - S0016-5107(17)32170-3 [pii]
LID - 10.1016/j.gie.2017.07.046 [doi]
AB  - BACKGROUND AND AIMS: Sham procedures in endoscopy are used with the intention of 
      controlling for placebo response, potentially allowing more precise evaluation of 
      treatment effect. Nevertheless, this type of study may impose significant risk 
      without potential benefit for those in the sham group. The aim of the current 
      study was to systematically review and analyze the endoscopic literature to 
      assess the safety of sham controls. METHODS: MEDLINE and Embase databases were 
      searched for endoscopic sham procedures for all dates to July 2017. Only 
      randomized controlled trials comparing an endoscopic therapy with a sham were 
      included. Primary outcome was adverse events (AEs) categorized as mild, moderate, 
      or severe. Results were combined using a random-effects model. Heterogeneity was 
      assessed with the I(2) statistic, and publication bias was assessed with the 
      Egger test and funnel plots. RESULTS: Data were extracted from 34 publications 
      (1987-2017; 100% full text), with a total of 2492 procedures (1355 treatment/1137 
      sham). Sham procedures involved upper endoscopy (31 studies) and ERCP (3 
      studies). Treatment arms included procedures with the following indications: 
      weight loss (38.2%), GI bleeding (26.5%), GERD (20.6%), sphincter of Oddi 
      dysfunction (8.8%), and dysphagia (6.2%). Overall percentage of severe adverse 
      events (SAEs) in the sham group was 1.7% (19/1137). Of these, the most common 
      SAEs in the sham groups were need for surgery/intensive care unit stay (35.3%), 
      post-ERCP pancreatitis (23.5%), and perforation (11.8%). There was no significant 
      difference in the odds of developing an SAE between the treatment group and the 
      sham group (odds ratio, 1.3; 95% confidence interval [CI], 0.7-2.3). The pooled 
      additional risk incurred from being initially randomized to the sham arm and then 
      receiving a cross-over intervention was significant (RR, 1.33; 95% CI, 1.14-1.56; 
      P < .001), compared with patients initially randomized to the study intervention. 
      CONCLUSION: The frequency of AEs in endoscopic sham procedures is substantial, 
      and patients are subjected to considerable morbidity. These results raise a 
      serious ethical dilemma regarding the use of sham-controlled trials.
CI  - Copyright (c) 2017 American Society for Gastrointestinal Endoscopy. Published by 
      Elsevier Inc. All rights reserved.
FAU - Schulman, Allison R
AU  - Schulman AR
AD  - Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's 
      Hospital, Boston, Massachusetts, USA; Harvard Medical School, Boston, 
      Massachusetts, USA.
FAU - Popov, Violeta
AU  - Popov V
AD  - New York University, New York, New York, USA.
FAU - Thompson, Christopher C
AU  - Thompson CC
AD  - Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's 
      Hospital, Boston, Massachusetts, USA; Harvard Medical School, Boston, 
      Massachusetts, USA.
LA  - eng
GR  - P30 DK034854/DK/NIDDK NIH HHS/United States
GR  - T32 DK007533/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20170809
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
RN  - 0 (Placebos)
SB  - IM
CIN - Gastrointest Endosc. 2018 Jul;88(1):203-204. PMID: 29935620
CIN - Gastrointest Endosc. 2018 Jul;88(1):204. PMID: 29935622
MH  - Cholangiopancreatography, Endoscopic Retrograde/*adverse effects
MH  - Critical Care
MH  - Endoscopy, Gastrointestinal/*adverse effects
MH  - Humans
MH  - Pancreatitis/etiology
MH  - Placebos/*adverse effects
MH  - Randomized Controlled Trials as Topic/ethics
PMC - PMC5693737
MID - NIHMS898764
EDAT- 2017/08/15 06:00
MHDA- 2018/07/28 06:00
PMCR- 2018/12/01
CRDT- 2017/08/14 06:00
PHST- 2017/03/23 00:00 [received]
PHST- 2017/07/30 00:00 [accepted]
PHST- 2017/08/15 06:00 [pubmed]
PHST- 2018/07/28 06:00 [medline]
PHST- 2017/08/14 06:00 [entrez]
PHST- 2018/12/01 00:00 [pmc-release]
AID - S0016-5107(17)32170-3 [pii]
AID - 10.1016/j.gie.2017.07.046 [doi]
PST - ppublish
SO  - Gastrointest Endosc. 2017 Dec;86(6):972-985.e3. doi: 10.1016/j.gie.2017.07.046. 
      Epub 2017 Aug 9.