Evaluation of the clinical efficacy of Biotène Oral Balance in patients with secondary Sjögren's syndrome: a pilot study.

The objective of the present study was to evaluate the efficacy of Oral Balance saliva substitute in alleviating dry mouth symptoms in a sample of patients with secondary Sjögren's syndrome. Twenty-one consecutive secondary Sjögren's syndrome patients with dry mouth complaints and hyposalivation were included in this study. Patients used a lactoperoxidase-system-containing gel (Biotène Oral Balance) for 4 weeks. The effects on subjective oral symptoms were recorded by means of a 7-items questionnaire which contained questions regarding dry mouth sensation and its effect on chewing, swallowing, taste, speech, burning sensation and denture retention. The severity of symptoms was assessed using a visual analogical scale. Oral symptom scores and unstimulated whole salivary flow were recorded at baseline and after 4 weeks' use of the product. Two patients withdrew from the study, because of nausea and unpleasant taste caused by the product. Nineteen patients (all women, mean age 52.7 years) participated throughout the entire study. Wilcoxon signed-ranked tests indicated significant improvements in visual analogical scale scores posttreatment for 5 of the 7 items on the oral dryness questionnaire, although no increase in salivary flow was found. However, the improvement in certain variables did not take a positive course in all cases. Patients with lower salivary flow at baseline tended to have greater improvement in oral symptoms. The study suggests that the use of Oral Balance gel is effective in alleviating the dry mouth symptoms in secondary Sjögren's syndrome patients, but a randomized controlled trial is needed to assess the placebo effect.

RCT Entities:   Population Interventions Outcomes