Atropine drops for drooling: a randomized controlled trial.
BACKGROUND
Drooling occasionally occurs in cancer patients, impairing their quality of life. Recommended treatment includes the use of anticholinergic drugs, but there is a lack of scientific evidence supporting it; some recent reports tested the use of sublingual atropine, and further controlled studies have been recommended.


OBJECTIVE
To evaluate the effectiveness of sublingual atropine for the relief of drooling when compared with a placebo, in a population of patients with upper digestive cancer at the Gastroenterology 'Bonorino Udaondo' Hospital.


METHODS
From March 2002 to March 2003, 22 consecutive patients were enrolled in a prospective, randomized, placebo-controlled, double-blind, cross-over trial (gender: M/F=14/8; median age=66, range: 4887 years). Patients were randomly allocated to receive atropine or placebo for 48 hours (phase 1), followed by a wash-out period of 48 hours, and final cross-over during the next 48 hours (phase 2). We evaluated the impact on sialorrhoea, choking, interference with daily and social activities, and global impact from drooling by visual analogue scales (VAS) at the beginning and end of each phase, as well as patients' choice at the end of the study.


RESULTS
Mean score for sialorrhoea was 59.6 (SD=28.5) at baseline and 34.9 (SD=27.7) after 48 hours of receiving atropine; 62.1 (SD=27.6) at baseline and 40.7 (SD=30.5) after 48 hours of placebo. Analysis of variance (ANOVA) for repeated measures and two factors was not significant for either the variable sialorrhoea (P=0.58) or any of the secondary outcomes measured. No severe toxicity was reported.


CONCLUSIONS
This study failed to demonstrate the effectiveness of atropine over placebo in this population; we provide further discussion of results.
De Simone
Gustavo G
GG
Palliative Care Service, Hospital Bonorino Udaondo and Pallium Latinoamerica, Buenos Aires.
Eisenchlas
Jorge H
JH
Junin
Marta
M
Pereyra
Facundo
F
Brizuela
Rafael
R
D000286:Administration, Sublingual; D000368:Aged; D000369:Aged, 80 and over; D001285:Atropine / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004067:Digestive System Neoplasms / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000627:therapeutic use; D012798:Sialorrhea / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
D010919:Placebos; D001285:Atropine