Qianggu capsule for the treatment of primary osteoporosis: evidence from a Chinese patent medicine

Wei et al. BMC Complementary and Alternative Medicine (2017) 17:108 DOI 10.1186/s12906-017-1617-3 RESEARCH ARTICLE Open Access Qianggu capsule for the treatment of primary osteoporosis: evidence from a Chinese patent medicine Xu Wei1,2, Aili Xu3, Hao Shen4 and Yanming Xie4* Abstract Background: Qianggu Capsule, a Chinese patent medicine, has been widely applied in the clinical practice of primary osteoporosis (POP) in recent years. This study aims to summarize the effectiveness and safety of Qianggu Capsule in treating POP. Methods: We searched seven electronic databases, all searches ended in 30 September, 2015. All randomised controlled trials comparing the efficacy of Qianggu Capsule treatment with no treatment, placebo or conventional therapy for POP were included. Combined therapies of Qianggu Capsule were also included. Cochrane risk of bias tool was used to assess methodological quality of primary studies. Revman 5.2.0 software was used for data analysis. Results: Ten trials were enrolled. The combined effect showed that Qianggu Capsule plus Caltrate D was better than Caltrate D on lumbar spine bone mineral density (BMD) (MD = 0.05 g/cm2; 95% CI: 0.02–0.07; P = 0.0004), femoral neck BMD (MD = 0.03 g/cm2; 95% CI: 0.01–0.05; P = 0.001), femoral great trochanter BMD (MD = 0.04 g/cm2; 95% CI: 0.03–0. 06; P < 0.001). Meta-analysis exhibited a significant antiosteoporosis effect of Qianggu Capsule on femoral neck BMD (MD = 0.03 g/cm2; 95% CI: 0.01–0.05; P = 0.003) and femoral trochanteric BMD (MD = 0.07 g/cm2; 95% CI: 0.02–0.12; P = 0.006) compared with α-D3 capsule. However, the methodological quality of included studies was low. Constipation and dry mouth were the most common adverse drug reactions of Qianggu Capsule. Finally the evidence level was evaluated to be low or very low. Conclusions: The effect of Qianggu Capsule for POP was supported in improving BMD. Due to the methodological drawbacks of the included studies, the conclusions should be treated with caution for future research. Keywords: Qianggu Capsule, Primary osteoporosis, Chinese patent medicine, Systematic review Background Primary osteoporosis (POP) is one of the most common chronic conditions, and affects both old men and postmenopausal women [1, 2]. Osteoporosis is estimated to cause 1.5 million fractures every year in the United States [3]. In China, there have been about 202.43 million people aged 60 years and older at the end of 2013, which faces higher risk of osteoporosis-related fractures [4]. From 2002 to 2006, the rates of hip fracture over age 50 years have increased 58% in women and 49% in men based on a population-based study in * Correspondence: 4 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China Full list of author information is available at the end of the article Beijing [5]. Most important of all, the most serious consequences of osteoporotic fractures, especially hip fracture, are the increasing proportion of mortality and disability [6]. Therefore, interventions to treat POP or prevent osteoporotic fractures should be implemented. Although research efforts have been expanded for several decades, an urgent need exists for continued improvement so far, particularly in the treatment of POP. Many strategies are available to treat POP, but pharmacological treatments still plays the dominant role. Major antiosteoporosis agents including bisphosphonates, denosumab, hormone replacement therapy, selective estrogen receptor modulators, recombinant human parathyroid hormone and strontium ranelate are currently available on the market [7]. The common outcomes are © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Wei et al. BMC Complementary and Alternative Medicine (2017) 17:108 Page 2 of 11 osteoporotic fractures [8, 9], bone mineral density (BMD) value [10], bone turnover markers [11], pain assessment [12], quality of life [13], and adverse event or adverse drug reaction mainly from antiosteoporosis drugs [14]. In some cases, POP patients can benefit from drug therapy optimization and combination therapy. Despite the fact that several western medicines have demonstrated to be effective in the treatment of POP, however, poor medication adherence remains a major problem [15, 16]. Suboptimal adherence to therapy may partially be due to adverse effects of long-term conventional antiosteoporosis drugs, such as bisphosphonates [17, 18]. Hence, there is a requirement for long-term treatment to be associated with a positive benefit-risk balance [19]. Now more and more studies of complementary and alternative medicine have increased the awareness of the problem and have improved our understanding of the prevention and control of osteoporosis. In China, herbal fufang and single Chinese herb have been widely used for the treatment of POP [20–22]. Qianggu Capsule, the main effective components of which are the total flavonoids of Rhizoma Drynariae (Gusuibu) [23], has been approved by China Food and Drug Administration for treating POP (drug approval numbers: Z20030007). According to the theory of traditional Chinese medicine and results of population pharmacokinetics, Qianggu Capsule has the effect of replenishing the kidney and strengthening the bones which applies to shen-yang deficiency pattern [24, 25]. Modern research has also proven that Qianggu Capsule can increase lumbar and femoral BMD, raise serum calcium, improve analgesia action, control the levels of serum IL-6 and TNFa, and accelerate the secretion of IL-4 in rats. No abnormal changes are found in the toxicity test [26]. So Qianggu Capsule is reliable and safe in laboratory studies. In contrast to the wealth of data about the efficacy of chemical agents in the management of POP, information regarding their efficacy and safety in Chinese herbal medicine is relatively limited. In recent years, a large number of clinical studies reported the effect of Qianggu Capsule and Qianggu Capsule combined with antiosteoporosis drugs. Therefore, this systematic review provides an evidence of Qianggu Capsule for the management of POP from the randomised controlled trials. Infrastructure (CNKI), Wanfang database, Chinese Scientific Journals Database (VIP), Chinese Biomedical Literature Database (CBM). Additional published or unpublished literature was retrieved through manual searches of reference lists of included studies and (...truncated)