Han Gajin, Ko Seok-Jae, Kim Juyeon, Oh Ja-Young, Park Jae-Woo, Kim Jinsung
Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, Kyung Hee University, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul Republic of Korea; Department of Korean Gastroenterology, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul 130-701, Republic of Korea.
Department of Korean Gastroenterology, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul 130-701, Republic of Korea.
J Ethnopharmacol. 2016 Apr 22;182:160-9. doi: 10.1016/j.jep.2016.02.014. Epub 2016 Feb 20.
Yukmijihwang-tang (YMJ) is a typical herbal formula to treat Yin-deficiency (YD) syndrome by enriching the fluid-humor of the body. YMJ has been used to treat dry mouth symptoms for hundreds of years in traditional East Asian medicine. Xerostomia, a subjective oral dryness, is common in the elderly and results in impaired quality of life. Many conventional treatments for xerostomia provide only temporary symptom relief, and have side effects. The aim of this study is to investigate the efficacy and safety of YMJ for the treatment of xerostomia in the elderly.
This study was designed as a randomized, placebo-controlled, double-blinded, two center trial. Ninety-six subjects aged 60-80 years who had experienced xerostomia for at least 3 months and presented with score>40 on the visual analog scale (VAS) for subjective oral dryness were recruited and randomly allocated to YMJ and placebo groups. YMJ or placebo was administered to each group for 8 weeks (3g of YMJ or placebo, three times per day). The primary outcome was change of VAS for xerostomia from 0 to 8 weeks.
VAS for xerostomia was decreased by 22.04±22.76 in the YMJ group and 23.58±23.04 in the placebo group. YMJ had no effect on xerostomia. However, participants with BMIs lower than 29.37kg/m(2) showed improvement of xerostomia after 8 weeks of treatment with YMJ compared to placebo. In addition, YMJ improved oral moisture, which is associated with subjective oral dryness in the YMJ group, and the relationship between VAS for xerostomia and YD was significant.
A trend was observed in which YMJ improved oral moisture status and subjective oral dryness in elderly subjects with lower BMI and greater tendency toward YD.
玉女煎（YMJ）是一种通过滋养人体阴液来治疗阴虚（YD）证的典型中药方剂。在传统东亚医学中，玉女煎已被用于治疗口干症状数百年。口干症是一种主观的口腔干燥感，在老年人中很常见，并会导致生活质量下降。许多传统的口干症治疗方法只能暂时缓解症状，且有副作用。本研究的目的是探讨玉女煎治疗老年人口干症的疗效和安全性。
本研究设计为一项随机、安慰剂对照、双盲、双中心试验。招募了96名年龄在60 - 80岁之间、经历口干症至少3个月且主观口腔干燥视觉模拟量表（VAS）评分>40的受试者，并将其随机分配到玉女煎组和安慰剂组。每组给予玉女煎或安慰剂8周（玉女煎或安慰剂3g，每日三次）。主要结局是0至8周口干症VAS的变化。
玉女煎组口干症的VAS下降了22.04±22.76，安慰剂组下降了23.58±23.04。玉女煎对口干症无影响。然而，体重指数（BMI）低于29.37kg/m²的参与者在接受玉女煎治疗8周后与安慰剂相比，口干症有所改善。此外，玉女煎改善了口腔湿度，这与玉女煎组的主观口腔干燥有关，且口干症VAS与阴虚之间的关系显著。
观察到一种趋势，即玉女煎改善了BMI较低且阴虚倾向较大的老年受试者的口腔湿度状况和主观口腔干燥感。
