Cho Yeeun, Lee Seunghoon, Kim Jihye, Kang Jung Won, Baek Yong-Hyeon, Seo Byung-Kwan, Lee Jae-Dong
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, South Korea.
Department of Acupuncture & Moxibustion Medicine, Kyung Hee University Hospital of Korean Medicine, Seoul, 02447, South Korea.
Trials. 2018 Sep 10;19(1):482. doi: 10.1186/s13063-018-2854-6.
Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have side effects, and the development of safer and more effective treatments is urgently needed. The aim of this study is to evaluate the efficacy and safety of BHH10, a traditional Korean herbal medicine, in the treatment of postmenopausal osteoporosis.
METHODS/DESIGN: This is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial and will include 168 postmenopausal women aged 55 years and older with osteoporosis. The participants will be recruited competitively from two sites of the Acupuncture and Moxibustion Department of Kyung Hee University Hospital of Korean Medicine, either Hoegidong or Gangdong in Seoul, Korea. Participants will be assigned randomly to one of two groups, the BHH10 group or the placebo group, in a 1:1 ratio, and will have five scheduled visits. Participants will take two tablets of BHH10 or placebo three times daily for 12 weeks. The primary efficacy outcome is the change in bone mineral density at the lumbar spine (L1-4) between baseline (visit 1) and 12 weeks after randomization (visit 5). Other outcome variables include changes in bone turnover markers, the Deficiency Syndrome of the Kidney Index, EuroQol five-dimension questionnaire score, and laboratory parameters, as well as adverse events.
To our knowledge, this will be the first clinical trial to assess the efficacy and safety of BHH10 in postmenopausal women with osteoporosis. It is anticipated that the results will contribute to the development of traditional herbal medicines that can be used to treat osteoporosis in postmenopausal women in Korea. If the superiority of BHH10 over placebo is demonstrated, this study could provide the foundation for a phase III clinical trial. The results of the study will be published in a peer-reviewed journal.
Clinical Research Information Service, KCT0001842 . Registered on 14 March 2016.
骨质疏松症在全球老龄化社会中日益普遍，骨质疏松性骨折所致的经济负担十分巨大。目前用于治疗骨质疏松症的药物有副作用，因此迫切需要开发更安全、更有效的治疗方法。本研究旨在评估韩国传统草药BHH10治疗绝经后骨质疏松症的疗效和安全性。
方法/设计：这是一项II期、多中心、随机、双盲、安慰剂对照的临床试验，将纳入168名55岁及以上患有骨质疏松症的绝经后女性。参与者将从韩国韩医庆熙大学医院针灸科的两个地点（韩国首尔鹤溪洞或江东）竞争性招募。参与者将以1:1的比例随机分配到两组之一，即BHH10组或安慰剂组，并将进行五次预定访视。参与者将每天服用两片BHH10或安慰剂，共三次，持续12周。主要疗效指标是腰椎（L1-4）骨密度在基线（第1次访视）和随机分组后12周（第5次访视）之间的变化。其他结果变量包括骨转换标志物的变化、肾虚证候指数、欧洲五维健康量表评分、实验室参数以及不良事件。
据我们所知，这将是第一项评估BHH10对绝经后骨质疏松症女性疗效和安全性的临床试验。预计结果将有助于开发可用于治疗韩国绝经后女性骨质疏松症的传统草药。如果证明BHH10优于安慰剂，本研究可为III期临床试验提供基础。研究结果将发表在同行评审期刊上。
临床研究信息服务中心，KCT0001842。于2016年3月14日注册。
