Post-radiation severe xerostomia relieved by pilocarpine:: a prospective French cooperative study

Background and purpose: The aim of the study was: (1) to confirm the action of pilocarpine hydrochloride (Salagen) against xerostomia; (2) to correlate the response to dose/volume radiotherapy parameters. Materials and methods: From June 1995 to February 1996, 156 patients with severe radiation induced xerostomia received pilocarpine hydrochloride orally, 15 mg per day with a 5 mg optional increase at 5 weeks up to a daily dose of 25 mg beyond 9 weeks. Results: One hundred and forty five patients ale fully evaluable. Treatment compliance was 75%. Thirty eight patients (26%) stopped treatment before week 12 for acute intolerance (sweating, nausea, vomiting) or no response. No severe complication occurred. Ninety seven patients (67%) reported a significant relief of symptoms of xerostomia at 12 weeks. Within 12 weeks, the size of the subgroup with normal food intake almost doubled (13-24 patients) while the size of the subgroup with (nearly) impossible solid food ingestion decreased by 38% (47 vs. 29 patients). The impact on quality of life was considered important or very important by 77% of the responders. Conclusions: No difference was found according to dose/volume radiotherapy parameters suggesting that oral pilocarpine hydrochloride: (1) acts primarily by stimulating minor salivary glands; (2) can be of benefit to patients suffering of severe xerostomia regardless of radiotherapy dose/volume parameters: (3) all responders are identified at 12 weeks. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.