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

Abstract

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. Key words: Xerostomia, malic acid, transplantation.

Efficacy of a 1% malic acid spray for xerostomia treatment: A systematic review and meta‐analysis

“…After joint screening by two reviewers, five RCTs were finally included for quantitative analysis, including Bardellini et al (2019), Gómez‐Moreno et al (2013), Gómez‐Moreno et al (2013), Gómez‐Moreno et al (2014) and Niklander et al (2018). As shown in Table 1, 244 patients were included in five studies (126 in the malic acid group and 118 in the placebo group), which included 79 men and 165 women.…”

“…In three of the studies (Bardellini et al, 2019; Gómez‐Moreno et al, 2013; Gómez‐Moreno et al, 2013), the DMQ was used to assess the degree of dry mouth, but in the other two studies, the severity of xerostomia was evaluated using the XI (Gómez‐Moreno et al, 2014) and the VAS (Niklander et al, 2018). In terms of the severity of xerostomia, the higher the DMQ scores, the milder the symptoms.…”

“…The main data extracted were as follows: the country where the research institute is located, the time the research was carried out, the number and gender of the research subjects, the age of the research subjects, and the sprays of each group every day, frequency of use, duration of spray effect, number of people with improved xerostomia, DMQ scores (Bardellini et al, 2019; Gómez‐Moreno et al, 2013; Gómez‐Moreno et al, 2013), VAS scores (Niklander et al, 2018), XI scores (Gómez‐Moreno et al, 2014; Thomson, 2007), stimulated and unstimulated saliva flow rate initially and 2 weeks after the intervention. To ensure the accuracy of the extracted data, the features of the included studies were independently extracted twice by two authors.…”

Therapeutic Recommendations for the Management of Older Adult Patients with Sjögren’s Syndrome

“…Xylitol does not stimulate saliva but it reduces erosion and cariogenic potential. Thus, a spray containing malic acid with xylitol seems to be a safe topical sialagogue [34].…”

Aging-Related Metabolic Dysfunction in the Salivary Gland: A Review of the Literature

“…A few metabolite-based therapies have also been developed to ameliorate xerostomia. A topical sialagogue spray containing 1% malic acid already showed significant effectiveness against xerostomia patients [ 121 , 122 ]. Malic acid is an important intermediate metabolite in various metabolic pathways, including the Krebs cycle.…”