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Randomized, double-blind, crossover study

Jellema AP et al., (2001) evaluated in a randomized, double blind, placebo controlled, crossover study the efficacy of Xialine® (xanthan gum) saliva substitute spray in 30 patients (aged 46-79 years) with radiation-induced xerostomia for 1 week per phase, overall 3 week. Changes in subjective sensations due to xerostomia before and after administration of Xialine® were evaluated.

Twenty-nine patients completed the study. In general, no differences were noted with regard to the baseline values of the analyzed scales on visit 1 and visit 3. Therefore, a 1 week washout period was considered to be sufficient. Xialine® was used with a mean frequency of 14 times a day, which was comparable to the frequency observed when the placebo was used (13 times per day). The order in which Xialine® and placebo were used did not affect the results.

Xerostomia in general decreased with both Xialine® and placebo to almost the same degree. A trend towards higher response rates after Xialine® was observed for problems with speech and decreased senses compared to placebo. The response rate for both scales was 45% after using Xialine®compared to 21 and 24%, respectively, after using placebo.

Authors concluded that xerostomia decreased with both Xialinew and placebo to almost the same degree. A trend was noted towards a higher degree of improvement of problems with speech and senses when Xialine® was used. However, the results do not support an additional value of xanthan gum-based saliva substitutes over other saliva substitutes among patients with radiation-induced xerostomia.

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