Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: A randomised feasibility study in the United Kingdom

Abstract

Purpose: Xerostomia is common symptoms in the elderly and this has been impaired quality of life continuously. Many conventional treatments for xerostomia have limitations for their side effects. Hence, interest in treatment using the traditional Korean medicine (TKM) has been rising. In TKM theory, the main pathology of xerostomia in the elderly is considered as Yin-Deficiency (YD) and Yukmijihwang-tang (YJT) has been used for treatment of YD. This study aimed to investigate the efficacy and safety of YJT for xerostomia in the elderly and evaluate the correlation the xerostomia and YD. Methods: The current study was randomized, placebocontrolled, double-blinded, two center trial conducted in Kyung Hee University Korean Medicine Hospital and Kyung HeeUniversityHospital at Gangdong. Ninety-six subjects aged 60-80 years with xerostomia for over 3 months were randomly allocated to YJT and placebo group. These subjects also presented with score >40 on VAS for xerostomia and unstimulated salivary flow rate under 0.3mL/min. The subjects and all researchers were blinded to the group assignment. YJT or placebo was administered to each group for 8 weeks. The primary outcome was change in the scores of the VAS for xerostomia from 0 to 8 weeks. Results: Both YJT and placebo group had xerostomiarelieving effect after 8 week administration by decreasing VAS for xerostomia and other xerostomia-related variables. In addition, 8 week-administration of YJT increased the level of oral moisture. The participants with BMI lower than 29.37kg/m2 showed improvement of VAS after 8 week treatment in YJT group only. Therewere not any significant adverse events related to YJT including SAE. In addition, xerostomiarelated variables had causal relationship with YDQ and Ig A. Conclusion: YJT could increase oral moisture status and improve subjective symptom of dry mouth in the elderly with lower BMI and more YD tendency. Besides, the correlation between xerostomia and YD was reconfirmed. Contact: Gajin Han, kmdhgj@naver.com