A randomized study to assess the effectiveness of orally administered pilocarpine during and after radiotherapy of head and neck cancer.

BACKGROUND: This prospective randomized study was undertaken to assess the effectiveness of oral pilocarpine chloratum (Salagen) during and after radiotherapy. PATIENTS AND METHODS: Between October 1999 and December 2003, 66 patients received 60 Gy of irradiation to their head and neck cancer. Half of the patients received 5 mg oral pilocarpine 3 times a day from the beginning of radiotherapy over a period of 12 weeks. The control group received similar doses of pilocarpine only in the second 6 weeks following irradiation. Patient saliva secretion was recorded, and a visual analog scale measuring overall and daily xerostomia, difficulty in sleeping, speaking, eating and wearing dentures was employed.
RESULTS: Pilocarpine, given concomitantly with radiotherapy, statistically improved the salivary flow and induced better patient comfort by the end of radiotherapy. Patient comfort and symptoms related to xerostomia greatly decreased compared to patients receiving pilocarpine after irradiation in the second 6-week period of therapy. The patients' quality of life, saliva production and symptoms related to xerostomia showed significant progress by the end of the 12 weeks.
CONCLUSION: The results suggest that stimulated salivary glands suffer less decrease in saliva production during radiotherapy. The stimulated saliva flow reduced the side-effects of irradiation.

RCT Entities:   Population Interventions Outcomes