Safety and effect of a new artificial saliva containing Zingiber officinale and Cuminum cyminum on stimulating saliva secretion: In vitro, in vivo and preliminary clinical study

Abstract

Introduction

Xerostomia is a symptom that affects quality of life and may lead to malnutrition. While artificial saliva is used as a lubricant for the oral cavity, it rarely stimulates saliva secretion. The objective of this study was to develop a herbal artificial saliva (HAS) that could stimulate saliva secretion and be safe for human consumption.

Methods

Three HAS formulations were prepared with 0.3 % Cuminum cyminum extract and 0.05 %, 0.10 %, and 0.15 % Zingiber officinale extract (HAS0.05, HAS 0.10, and HAS0.15, respectively). In vivo skin and oral mucosal irritation tests were used to evaluate the safety of HAS0.15. Additionally, the preliminary efficacy and safety of the three HAS formulations were investigated in 21 healthy volunteers. The sample was sprayed into the oral cavity under the left and right sides of the tongue. Thirty minutes after spraying, the amount of saliva was assessed using a visual analogue scale and a Schirmer strip. In addition, dry mouth symptoms, the saliva pH, and adverse reactions were assessed before and after testing.

Results

HAS0.15 caused minimal skin irritation and did not alter the epithelium or other structures of the oral mucosa. The saliva quantity after using HAS0.10 and HAS0.15 was significantly higher than prior to testing (p < 0.05). None of the formulations induced mucositis or adverse reactions.

Conclusion

This study was successful in the development of a new HAS that stimulated saliva secretion and was safe for humans. However, this study is preliminary: Further clinical investigation in patients with hyposalivation will confirm the efficacy of this novel HAS. This novel HAS may be an alternative treatment for the elderly and patients with hyposalivation.