Document Detail


Is blinding the endoscopists to bowel preparations in randomized-controlled trials a reality?
MedLine Citation:
PMID:  17113722     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: A number of studies compared the quality, efficacy and tolerability of oral sodium phosphate (NaP) and polyethylene glycol (PEG)-based solutions in preparation for colonoscopy. The primary aim of this study was to explore whether endoscopists can be effectively blinded to the type of bowel preparation. METHODS: We recruited 3 experienced endoscopists and 57 outpatients (18-65 years old) undergoing colonoscopy. We randomized eligible patients to receive one of the two bowel preparations. Endoscopists who performed the tests were blinded to the type of preparation, and made their best judgment on the type and quality of the bowel preparation. RESULTS: Forty-five patients completed the study. The overall correct estimation of the type of bowel preparation was 60.0% (95% CI; 45.5%, 73.0%). The cleansing quality did not differ between the two preparations. Patients found oral NaP solution much easier to take (81.8% versus 36.4%; P = 0.005) and the PEG-based group tended to have more nausea or vomiting. 47.6% of patients in the PEG group indicated they would prefer to try another bowel preparation in the future compared to 4.5% in the oral NaP group (P = 0.002). We stopped the study after an interim analysis indicating that more than 600 patients would be required to detect statistically significant differences in the primary aim. CONCLUSION: Our findings suggest that blinding of endoscopists in clinical trials comparing oral NaP to PEG had a relatively low likelihood of bias. The study also suggests that oral NaP is easier to take and more tolerable than PEG without impairing cleansing quality.
Authors:
Samer El-Dika; Thomas Mahl; Shahid Mehboob; Jihad Miqdadi; Diane Heels-Ansdell; Barbara Handley; Michael Sitrin; Holger Schünemann
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial     Date:  2006-11-20
Journal Detail:
Title:  Cancer detection and prevention     Volume:  30     ISSN:  0361-090X     ISO Abbreviation:  Cancer Detect. Prev.     Publication Date:  2006  
Date Detail:
Created Date:  2006-12-05     Completed Date:  2007-03-14     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7704778     Medline TA:  Cancer Detect Prev     Country:  England    
Other Details:
Languages:  eng     Pagination:  552-9     Citation Subset:  IM    
Affiliation:
Department of Medicine, Veterans Affairs Medical Center, Salem, VA 24153, USA. samer.eldika@med.va.gov
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MeSH Terms
Descriptor/Qualifier:
Cathartics / administration & dosage*
Colonoscopy
Enema / methods*
Female
Humans
Male
Middle Aged
Phosphates / administration & dosage*
Polyethylene Glycols / administration & dosage*
Randomized Controlled Trials as Topic / methods*
Chemical
Reg. No./Substance:
0/Cathartics; 0/Phosphates; 0/Polyethylene Glycols; 7632-05-5/sodium phosphate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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