Tohru Tanigawa1,2, Jun-ichi Yamashita3, Takashi Sato4, Atsushi Shinohara5, Rei Shibata6, Hiromi Ueda1, Hirokazu Sasaki1,2. 1. Department of Otolaryngology, Aichi Medical University, Nagakute, Aichi, Japan. 2. Department of Otolaryngology, Tono Kosei Hospital, Mizunami, Gifu, Japan. 3. Public Health Center, Okazaki City Medical Association, Okazaki, Aichi, Japan. 4. Department of Otolaryngology, Aichi Gakuin University, Aichi, Japan. 5. Department of Oral and Maxillofacial University, Matsumoto Dental University, Shiojiri, Nagano, Japan. 6. Department of Cardiology, Nagoya University, Tsurumai, Nagoya, Japan.
Abstract
OBJECTIVE: Xerostomia is a common condition and can impair quality of life. Pilocarpine tablet ingestion can relieve dry mouth symptoms, but produces numerous adverse effects. We investigated the safety and efficacy of pilocarpine mouthwash. METHODS:Forty elderly patients were randomly divided into a pilocarpine mouthwash or water rinse (control) group. Outcomes were assessed by visual analog scale (VAS) scores and stimulated salivary flow rate before and 1 month after treatment. Patients recorded all adverse effects. RESULTS: In the pilocarpine group, we evaluated safety in 24 patients and efficacy in 19 patients. In the water rinse group, we evaluated safety and efficacy in 14 patients. VAS scores were significantly reduced after pilocarpine mouthwash treatment (70 ± 12.9 to 47.9 ± 13.1, p < 0.05). Overall improvement was observed in 47% of the pilocarpine group compared to 14% of the controls (p < 0.05). Stimulated salivary flow rate significantly increased (0.71 ± 0.14 to 0.83 ± 0.12 mL/minute, p < 0.05) after pilocarpine mouthwash treatment. Five of 24 patients reported side effects after pilocarpine mouthwash use, predominantly limited to oral discomfort. CONCLUSIONS:Pilocarpine mouthwash relieved dry mouth symptoms and improved saliva production with minor side effects.
RCT Entities:
OBJECTIVE:Xerostomia is a common condition and can impair quality of life. Pilocarpine tablet ingestion can relieve dry mouth symptoms, but produces numerous adverse effects. We investigated the safety and efficacy of pilocarpine mouthwash. METHODS: Forty elderly patients were randomly divided into a pilocarpine mouthwash or water rinse (control) group. Outcomes were assessed by visual analog scale (VAS) scores and stimulated salivary flow rate before and 1 month after treatment. Patients recorded all adverse effects. RESULTS: In the pilocarpine group, we evaluated safety in 24 patients and efficacy in 19 patients. In the water rinse group, we evaluated safety and efficacy in 14 patients. VAS scores were significantly reduced after pilocarpine mouthwash treatment (70 ± 12.9 to 47.9 ± 13.1, p < 0.05). Overall improvement was observed in 47% of the pilocarpine group compared to 14% of the controls (p < 0.05). Stimulated salivary flow rate significantly increased (0.71 ± 0.14 to 0.83 ± 0.12 mL/minute, p < 0.05) after pilocarpine mouthwash treatment. Five of 24 patients reported side effects after pilocarpine mouthwash use, predominantly limited to oral discomfort. CONCLUSIONS:Pilocarpine mouthwash relieved dry mouth symptoms and improved saliva production with minor side effects.