Effectiveness of a spray containing 1% malic acid in patients with xerostomia induced by graft-versus-host disease

Background: To evaluate the clinical effectiveness of a topical sialogogue spray (malic acid, 1%) in the treatment of xerostomia in patients with chronic Graft versus Host Disease (cGVHD). Material and methods: This study was designed as a randomized double-blind clinical study. Twenty-eight patients with cGVHD suffering from xerostomia were divided into 2 groups: the first group (14 patients) received a topical sialagogue spray containing malic acid 1% (SalivAktive®) whereas the second group (14 patients) received a placebo. Both groups received treatment for 2 weeks. Dry Mouth Questionnaire (DMQ) scores and unstimulated salivary flows rate were collected before and after treatment. Results: DMQ scores increased significantly from 1.3 ± 0.4 to 3.5 ± 0.4 points (p<0.05) after two weeks of treatment with malic acid, whereas in the control group DMQ scores increased from 1.2 ± 0.7 points to 1.4 ± 0.6 (p>0.05). The unstimulated salivary flow rate in patients treated with malic acid increased significantly from 0.15 ± 0.06 mL/min to 0.24± 0.08 mL/min, while that of the patients treated with placebo went from 0.16 ± 0.07 mL/min to 0.17 ± 0.09 mL/min (p>0.05). Conclusions: Malic acid 1% spray can be considered effective in the treatment of GVHD induced xerostomia.