Evaluation of the efficacy of a topical sialogogue spray containing malic acid 1% in elderly people with xerostomia: a double-blind, randomized clinical trial.

OBJECTIVE: The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid for elderly people affected by xerostomia. MATERIAL AND METHODS: This research took the form of a double-blind, randomized clinical trial. Forty-one individuals (mean age: 78.7 years) with xerostomia were divided into two groups: for the first 'intervention group' (21 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second 'control group' (20 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The Xerostomia Inventory (XI) was used to evaluate xerostomia levels before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after spray application, were measured. RESULTS: XI scores decreased significantly (clinically meaningful) from 36.4 ± 7.3 points to 29.1 ± 7.1 (p < 0.05) with an XI difference of 7.2 ± 6.1, after the combination among 1% malic acid with xylitol and fluoride application. After 2 weeks of 1% malic acid application, unstimulated and stimulated salivary flows rates increased significantly (p < 0.05). CONCLUSION: A topical sialogogue spray containing 1% malic acid improved xerostomia in an elderly population and increased unstimulated and stimulated salivary flows rates.

Effectiveness of malic acid 1% in patients with xerostomia induced by antihypertensive drugs.

OBJECTIVES: Assessing the clinical effectiveness of a topical sialogogue on spray (malic acid, 1%) in the treatment of xerostomia induced by antihypertensive drugs. STUDY DESIGN: This research has been carried out through a randomized double-blind clinical trial. 45 patients suffering from hypertensive drugs-induced xerostomia were divided into 2 groups: the first group (25 patients) received a topical sialogogue on spray (malic acid, 1%) whereas the second group (20 patients) received a placebo. Both of them were administered on demand for 2 weeks. Dry Mouth Questionnaire (DMQ) was used in order to evaluate xerostomia levels before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after application, were measured. All the statistical analyses were performed by using SPSS software v17.0. Different DMQ scores at the earliest and final stage of the trial were analysed by using Mann-Whitney U test, whereas Student's T-test was used to analyse salivary flows. Critical p-value was established at p<0.05. RESULTS: DMQ scores increased significantly (clinical recovery) from 1.21 to 3.36 points (p<0.05) after malic acid (1%) application whereas DMQ scores increased from 1.18 to 1.34 points (p>0.05) after placebo application. After two weeks of treatment with malic acid, unstimulated salivary flow increased from 0.17 to 0.242 mL/min whereas the stimulated one increased from 0.66 to 0.92 mL/min (p<0.05). After placebo application unstimulated flow ranged from 0.152 to 0.146 mL/min and stimulated flow increased from 0.67 to 0.70 mL/min (p>0.05). CONCLUSIONS: Malic acid 1% spray improved antihypertensive-induced xerostomia and stimulated the production of saliva.

The efficacy of a topical sialogogue spray containing 1% malic acid in patients with antidepressant-induced dry mouth: a double-blind, randomized clinical trial.

BACKGROUND: One of the most important antidepressants side effects is dry mouth. The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid on patients affected by dry mouth caused by antidepressants drug. MATERIALS AND METHODS: This research took the form of a double-blind, randomized clinical trial at Faculty of Dentistry of University of Granada (Spain). Seventy participants with antidepressant-induced dry mouth were divided into two groups: for the first "intervention group" (35 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second "control group" (35 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The dry mouth questionnaire (DMQ) was used to evaluate dry mouth symptoms before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after application, were measured. RESULTS: Dry mouth symptoms improved after 1% malic acid topical spray application (p < .05). After 2 weeks of 1% malic acid application, unstimulated and stimulated salivary flows rates increased significantly (p < .05). CONCLUSIONS: A sialogogue spray containing 1% malic acid improved dry mouth feeling of the patients suffering antidepressant-induced dry mouth and increased unstimulated and stimulated salivary flows rates.