Wilairat Sarideechaigul1,2, Aroonsri Priprem3,4, Sucharat Limsitthichaikoon5, Pensri Phothipakdee1, Rajda Chaijit6, Teekayu P Jorns1,2, Nopphakhun Lungruammit7, Krittiporn Chaiya7. 1. Department of Oral Biomedical Science, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand. 2. Neuroscience Research and Development Group, Khon Kaen University, Khon Kaen 40002, Thailand. 3. Faculty of Pharmacy, Mahasarakham University, Mahasarakham 44150, Thailand. 4. Melatonin Research Group, Khon Kaen University, Khon Kaen 40002, Thailand. 5. Department of Pharmaceutical Technology, College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand. 6. Department of Preventive Dentistry, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand. 7. Dental Student, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand.
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. Copyright:
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. Copyright:
Authors: R Bernardi; C Perin; F L Becker; G Z Ramos; G Z Gheno; L R Lopes; M Pires; H M T Barros Journal: Braz J Med Biol Res Date: 2002-01 Impact factor: 2.590