The effectiveness of topical pilocarpine in carboxymethylecllulose saliva substitute for post irradiation xerostomia in patients with head and neck carcinoma compared with carboxymethylcellulose solution alone : a randomized-controlled trial

Abstract

Objective: To compare the effectiveness of topical pilocarpine in carboxymethylcellulose saliva substitute with carboxymethylcellulose solution alone in post irradiation xerostomia patients Study design: Double- blind randomized, controlled study Setting : Department of Otolaryngology, Phramongkutklao Hospital and Otolaryngology Unit, Cancer Institute of Thailand Research Methodology: 80 xerostomia- post irradiation patients were randomly assigned into 2 groups: pilocarpine dissolved in carboxymethylcellulose solution group (N=40) or carboxymethylcellulose alone group (N=40). Xerostomia were evaluated 3 weeks after starting the treatment by subjective xerostomia visual analog scale (VAS) and frequency of fluid intake. The physical examination score was evaluated by LENT SOMA scale, recorded by 2 independent professional observers. Results: No significant difference in xerostomia VAS, frequency of fluid intake and LENT SOMA score were found between the PCMC and CMC groups (P= 0.988, P=0.897, P=0.880). Pre and post treatment VAS and LENT SOMA score were improved in all variables in both groups. The subjective VAS had non correlation with LENT SOMA scale in this trial (P =0.37). No significant adverse effects were found in both groups. Conclusion: No difference in effectiveness between pilocarpine dissolved in carboxymethylcellulose solution and carboxymethylcelullose solution alone was found by both subjective and LENT SOMA scale measurements.