Efficacy of pilocarpine lozenge for post‐radiation xerostomia in patients with head and neck cancer

Abstract

Background: Patients with radiation-induced xerostomia produce little or no saliva. Several studies have demonstrated the efficacy of systemic administration of pilocarpine hydrochloride in individuals with post-radiation xerostomia. However, analysis of pilocarpine lozenges for treatment of post-radiation xerostomia in patients with head and neck cancer has not been reported. Methods:The aim of this study was to quantify improvement in clinical symptoms and salivary function after treatment of post-radiation xerostomia with pilocarpine lozenges. In a double-blinded, placebo-controlled trial, 33 head and neck cancer patients were assigned randomly to receive Salagen® tablet, pilocarpine hydrochloride lozenge (3 or 5mg) or placebo lozenge every 10 days. At each visit, a subjective evaluation was undertaken through the use of visual analog scales before and at 180 minutes after treatment. Whole resting saliva was collected before and at 0, 30, 60, 90, 120, 150 and 180 minutes after treatment. Results:The percentage of patients with decreased feeling of oral dryness, sore mouth or speaking difficulties after taking 5-mg pilocarpine lozenge was greater than Salagen® or placebo. There were statistically significant increases in salivary production in pilocarpine treatment groups vs. placebo (P<0.05). Conclusion:The 5-mg pilocarpine lozenge produced the best clinical results, but further investigation with a larger group of patients is required.

Interventions for the management of radiotherapy-induced xerostomia and hyposalivation: A systematic review and meta-analysis

“…At endpoint, salivary function was assessed shortly after the intervention in four studies [28,29,35], after 60 minutes in two studies [17,18], and after 180 minutes in one study [19].…”

“…Taweechaisupapong et al reported a cross-over trial, which they claim was double blinded, where patients received every ten days one single pilocarpine tablet to be swallowed, or one pilocarpine lozenge (3 mg or 5 mg dose) or one placebo lozenge both to be dissolved in the mouth [19]. The study reported that the use of one 5mg lozenge was associated with a short-term (measured at 180 minutes) reduction in xerostomia and increase in salivary flow in significantly more patients than the 3mg lozenge, 5mg pilocarpine tablet and placebo.…”

“…Seventeen studies used changes in xerostomia symptoms as an outcome; outcome measures included the visual analogue scale (nine studies) [17][18][19][20][21][22][23][24][25], the xerostomia inventory (one study) [26], the Walizer Mouth Dryness questionnaire (one study) [27], the global rating of change scale (two studies in one paper) [28], general xerostomia questionnaires (two studies) [29,30], and the xerostomia items of the European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC-H&N35) instrument (two studies) [31,32]. At endpoint, symptoms were assessed shortly after administration of the intervention in three studies [28,29], and after 180 minutes in one trial [19], and therefore refer to symptoms perceived by participants during enhancement of salivary gland function. Two studies collected xerostomia symptom measurements one or more weeks after completion of the experimental treatment [31,33], therefore referring to symptoms perceived by patients during resting salivary condition.…”

Dose- and Time-Related Effects of Pilocarpine Mouthwash on Salivation

“…Though the rationale for topical administration of pilocarpine is to minimize adverse side effects of systemic pilocarpine, topical use is expected to offer some other benefits: there is mechanical salivary stimulation. [8][9][10][11][12] There exist a few studies concerning about topical use of pilocarpine. In 1980, topical use of pilocarpine was mentioned in a United States patent document, reporting that the 0.025% to 1% pilocarpine mouthwash was effective for dry mouth relief.…”

Pronóstico y tratamiento de la boca seca. Revisión sistemática

“…El segundo trabajo es un ensayo clínico en paralelo, tambié n en pacientes irradiados, que compara comprimidos de Salagen 1 (5 mg de pilocarpina en comprimidos que se ingieren con un vaso de agua) y de 3 y 5 mg de pilocarpina (comprimidos para disolver en boca) con placebo. Los mejores resultados se obtienen con los comprimidos de 5 mg de pilocarpina y no se presentan efectos adversos destacables ni modificaciones significativas de la presió n arterial entre los diferentes grupos 23 .…”