Aim: To evaluate the efficacy of scopolamine administered transdermally for the treatment of drooling in severely disabled patients.
Methods: A prospective, randomized, double-blind, crossover, placebo-controlled clinical trial was designed. The study group consisted of 30 handicapped patients with persistent drooling. The exclusion criteria were the specific contra-indications of scopolamine. Severity of drooling was quantified using a modified Thomas-Stonell and Greenberg visual scale simplified into three grades: 1 = dry; 2 = mild/moderate; 3 = severe/fulsome. The frequency of drooling was estimated using the number of bibs used each day. The baseline observational phase was followed by the application of a 1.5 mg scopolamine (Scopoderm TTS; Novartis Consumer Healthcare, UK) or placebo patch every 72 h for a fortnight. This was followed by a 1 week washout period and then crossover of assignments for 2 weeks.
Results: At baseline, 77% of patients showed grade 3 of drooling. The placebo administration showed no significant reduction in drooling. We found a significant drooling reduction (P < 0.005) in the scopolamine group in the 1 and 2 week controls (69% and 80% respectively <or= grade 3). The mean number of bibs/day decreased during the scopolamine phase from 6/day at baseline to 3/day at the 2 week control. Four patients (13.3%) dropped out because of scopolamine side effects and minor adverse reactions were observed in three other patients. No blood alterations were found during the study period.
Conclusion: Scopolamine can be useful to control drooling in severely disabled patients although it requires appropriate patient selection and is not free from adverse effects.