Efficacy and safety of two artificial saliva-based polymers containing 0.1% pilocarpine for treatment of xerostomia: A randomized clinical pilot trial

Abstract

Background Topical agents are the mainstay in the treatment of xerostomia, a common complaint most frequently associated with salivary dysfunction. This study aimed to compared the efficacy and safety for xerostomia treatment of 2 artificial saliva preparations containing 0.1% pilocarpine, and, either sodium carboxymethylcellulose (SCMC), or, sodium polyacrylate (SPA). Material and Methods Thirty-one xerostomia patients were randomly allocated into either a SCMC-treated group (15 patients), or, a SPA-treated group (16 patients). The formulations were taken 0.5 ml, 4 times daily for 6 weeks and double-blinded assessed before and after treatments using Xerostomia Inventory (XI) and Clinical Oral Dryness Score (CODs). Unstimulated and stimulated whole salivary flow rates were measured. Results After treatment, the SCMC-treated group had significantly lower CODs and higher unstimulated and stimulated whole salivary flow rates ( p <0.001, p =0.035, and p =0.013, respectively), while the SPA-treated group showed significantly lower CODs only ( p =0.004). In contrast, SCMC-treated and SPA-treated groups at the 6th week after treatments showed non-significant differences in all assessments ( p >0.05, all). Some adverse events (AEs) were reported, e.g., burning tongue, dizziness and watery eyes, but no severe AEs. Conclusions This randomized controlled pilot trial demonstrated superior efficacy of SCMC-formula over a SPA-formula after 6 weeks of xerostomia treatment. These formulations with topical pilocarpine proved safe in clinical use with minimal reported AE. Key words: Xerostomia, artificial saliva, sodium carboxymethylcellulose, sodium polyacrylate, pilocarpine.

Artificial saliva plus beta-glucan for treatment of xerostomia in older adults: The clinical study of effectiveness and salivary total antioxidant capacity levels

“…In earlier research, artificial saliva based on sodium carboxymethylcellulose (SCMC) was frequently used to treat the symptoms of xerostomia, owing to its moderate efficacy in relieving dry mouth symptoms. 18,19 Oh et al discovered that a saliva substitute made of carboxymethylcellulose may reduce the suffering of patients from dry mouth both during the day and at night, with significantly greater efficacy shown for patients with functional residual secretory capacity. 7 In this study, we mainly recruited people whose secretory glands were still functional.…”

Comparison of the 1 and 2% pilocarpine mouthwash in a xerostomic population: a randomized clinical trial

“…Previous studies have examined the effects of pilocarpine mouthwash at concentrations ranging from 0.01 to 4% and have indicated that the effect increases with concentration [ 1 , 17 , 23 , 25 , 34 ]. Bernardi’s study examined the effects of 0.5, 1, and 2% pilocarpine mouthwashes in healthy volunteers and showed a dose-dependent increase in whole unstimulated saliva [ 20 ].…”

“…Generally, the sufferers have symptoms that impact their health and the social and emotional elements of their lives. It can also cause many short-term and long-term complications such as tooth caries, burning mouth sensation, periodontal diseases, dysgeusia, difficulty using dentures, and fungal infections resulting in reduced quality of life [ 1 – 5 ]. In addition, hyposalivation is when the unstimulated total salivary flow rate is less than 0.01 mL/min during awake hours [ 6 ].…”

Recent advances in prevention and treatment of post-radiotherapy xerostomia in patients with head and neck cancer

“…Their main purpose is to lubricate the mucous membrane and facilitate chewing, swallowing and speaking. Some preparations may be combined with pilocarpine which stimulates the salivary glands to produce more natural saliva [7,8]. Artificial saliva was in the past only rarely a subject of a clinical controlled trial as such.…”

“…Recently, several clinical trials with different formulations of artificial saliva with or without pilocarpine were published which suggests developments of new and improved preparations [8][9][10]. A study by Sarideechaigul et al [8] aimed to compare the efficacy and safety of xerostomia treatment of two artificial saliva formulations containing 0.1% pilocarpine, and, either sodium carboxymethylcellulose or, sodium polyacrylate. Thirty-one xerostomia patients with xerostomia were randomly allocated into either a carboxymethylcellulose-treated group (15 patients) or, a polyacrylate-treated group (16 patients).…”