Atropine drops for drooling: a randomized controlled trial

• Published in: Palliative medicine Vol. 20; no. 7; pp. 665 - 671
• Main Authors: De Simone, Gustavo G, Eisenchlas, Jorge H, Junin, Marta, Pereyra, Facundo, Brizuela, Rafael
• Format: Journal Article
• Language: English
• Published: Thousand Oaks, CA Sage Publications 01.10.2006; Turpin; Sage Publications Ltd
• Subjects: Administration, Sublingual; Aged; Aged, 80 and over; Alzheimer's disease; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Atropine - therapeutic use; Biological and medical sciences; Cancer; Cancer therapies; Clinical death. Palliative care. Organ gift and preservation; Clinical trials; Cross-Over Studies; Digestive System Neoplasms - complications; Disease; Double-Blind Method; Drooling; Drug dosages; Drugs; Ethics; Female; Hospitals; Humans; Male; Medical research; Medical sciences; Middle Aged; Miscellaneous; Palliative care; Placebos - therapeutic use; Public health. Hygiene; Public health. Hygiene-occupational medicine; Quality of life; Sialorrhea - complications; Sialorrhea - drug therapy; Toxicity; Treatment Outcome; Variance analysis; Argentina; drooling; advanced cancer; palliative care; atropine; Stomatology; Malignant tumor; Sialorrhea; Cholinergic receptor; Randomization; Atropine; Palliative care; Clinical trial; Muscarinic receptor; Antagonist; Antidote; Parasympatholytic; Public health; Cancer
• ISSN: 0269-2163; 1477-030X
• DOI: 10.1177/0269216306071702

Introduction: 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. Population and methodology: 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.