Sublingual hyoscyamine for patient comfort during screening sigmoidoscopy : a randomized, double-blind, placebo-controlled clinical trial.
Screening sigmoidoscopy is an underutilized method for detecting early colorectal cancer, and patient discomfort is one reason for poor compliance in the general population.
The possible benefit of a welltolerated, low-cost antispasmodic medication, sublingual hyoscyamine, used before flexible sigmoidoscopy was assessed in a randomized, double-blinded, placebo-controlled trial.
One hundred fifty patients were enrolled and randomized to receive two sublingual hyoscyamine tablets (0.125 mg/tablet) or the placebo 10 minutes before sigmoidoscopy.
Patient comfort and the endoscopist's perception of the ease of insertion were measured using a 100 mm visual analog scale.
The depth of sigmoidoscope insertion was measured in centimeters, and complications were recorded.
The median age was 55 years (range 25 to 83 years).
There were 100 men (66.7%) and 50 women (33.3%). Approximately half (n=76,50.7%) had a prior sigmoidoscopy or colonoscopy.
No statistical differences were found between treatment group means for age, gender, pain score, ease of insertion, or depth of insertion.
The hyoscyamine group tended to have lower mean pain (32.4 vs. 37.7, p=0.18) and difficulty (29.9 vs. 33.7, p=0.31) scores and greater depth of sigmoidoscope insertion (51.3 vs. 47.7, p=0.07) ; however, the differences were not statistically significant.
The treatment groups differed with a higher percentage of the hyoscyamine group having a previous endoscopy (60.0% vs. (...)
Mots-clés Pascal : Carcinome, Côlon, Rectum, Sigmoïdoscopie, Dépistage, Prémédication, Chimiothérapie, Spasmolytique, Bien être, Hyoscyamine, Voie sublinguale, Essai clinique, Etude double insu, Randomisation, Homme, Tumeur maligne, Appareil digestif pathologie, Intestin pathologie, Côlon pathologie, Rectum pathologie, Endoscopie
Mots-clés Pascal anglais : Carcinoma, Colon, Rectum, Sigmoidoscopy, Medical screening, Premedication, Chemotherapy, Antispasmodic agent, Well being, Hyoscyamine, Sublingual administration, Clinical trial, Double blind study, Randomization, Human, Malignant tumor, Digestive diseases, Intestinal disease, Colonic disease, Rectal disease, Endoscopy
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0446610
Code Inist : 002B02C. Création : 25/01/1999.