A Comparison of Two Therapies for Xerostomia
Name: Elaine Walizer
Rank: LTC, USA
Organization: Henry M. Jackson Foundation
Performance Site: Walter Reed Army Medical Center, Washington, DC
Year Published: 1994
Abstract Status: Final
This double-blind, crossover clinical trial compared canola oil to Xerolube as xerostomia therapy in adults with carcinoma of the head and neck who had undergone irradiation, were at least 4 weeks post-therapy, and could communicate in English and visit biweekly. Expecting a 30% dropout rate, 32 participants were recruited; 3 withdrew by week 3. The 29 remaining completed the protocol on schedule.The Oral Assessment Guide (OAG) has 8 items scaled from 1 to 3. The 25-item Mouth Dryness Questionnaire (MDQ) examines xerostomia's impact on daily life. The Demographic Data Sheet assesses age, gender, medications, tumor type, alcohol use and smoking, and radiation received. Groups were randomly stratified on OAG score to ensure equal numbers of severely impaired patients and were similar except in exposure to radiation, tobacco use, and moistening agents used, differences controlled by the crossover design and washout periods.For 2 weeks before treatment, participants were allowed only fluids to relieve dryness. Another 2-week washout period followed treatment before crossing over to the second phase. Participants returned every 2 weeks to change therapy, have the OAG, and complete the MDQ. Afterward, participants could continue preferred therapy.Products were in blinded 8-oz pump-style spray bottles, with instructions to use 3-4 sprays with meals and at bedtime, with normal oral hygiene. Neither was significantly more effective. Both groups experienced dryness during washout and significant relief during treatment. Mean dryness reduction on the MDQ was 3.9 points with Xerolube and 4.6 points with vegetable oil.Non-tobacco users improved significantly more with oil whereas tobacco users preferred Xerolube. Significantly less oil was used at much lower cost. Participants split equally on which product to continue, but disliked both. Oil relieved dryness longer. Our findings suggest vegetable oil should be included among treatment options for patients with radiation-induced xerostomia.
Final Report is available on NTRL: https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/PB2007107...