The effect of 1% pilocarpine mouthwash on salivation in patients undergoing head and neck radiotherapy: a double-blind randomized clinical trial

Abstract

Introduction: Hyposalivation in patients with head and neck cancers undergoing radiotherapy is a very common complication that severely affects their quality of life. The only drug that has been approved for hyposalivation so far is pilocarpine tablets. Side effects of taking pilocarpine tablets Along with the scarcity of this drug in Iran, the use of pilocarpine in the form of mouthwash has become a suitable alternative. However, so far no study has investigated the effect of pilocarpine mouthwash on improving salivation reduction in patients undergoing radiotherapy. The aim of this study was to evaluate the effect of 1% pilocarpine mouthwash on salivation rate in patients undergoing head and neck radiotherapy. Methods and Materials: This double-blind randomized clinical trial study was performed on 62 patients undergoing cervical radiotherapy referred to the radiotherapy ward of Shahid Madani Hospital in Tabriz. These patients were randomly divided into two groups. In the experimental group, pilocarpine hydrochloride 1% mouthwash and in the control group, normal saline mouthwash were used. Patients were asked to use these mouthwashes 4 times a day, 30 drops each time, for 2 minutes. Unstimulated salivation rate of patients was measured in four stages (two weeks before the first session of radiotherapy; one day, two weeks and four weeks after the first session of radiotherapy) using Spitting method and compared between the two groups. Results: In this study, the rate of salivation in patients in both pilocarpine and control groups was significantly reduced over time (except between baseline and one day after radiotherapy) (P <0.001). Comparison of salivation rate between pilocarpine mouthwash group and control group during different periods after radiotherapy showed that salivation rate in the control group decreased significantly more than pilocarpine mouthwash group (P <0.001). Conclusion: The use of 1% pilocarpine mouthwash can be effective to prevent hyposalivation during radiotherapy for head and neck cance.