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Effects of Chinese Herbal Formula Erxian Decoction for Treating Osteoporosis: a Systematic Review

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Effects of Chinese Herbal Formula Erxian Decoction for Treating Osteoporosis: a Systematic Review Journal name: Clinical Interventions in Aging Article Designation: Original Research Year: 2017 Volume: 12 Clinical Interventions in Aging Dovepress Running head verso: Li et al Running head recto: Erxian decoction for treating osteoporosis open access to scientific and medical research DOI: http://dx.doi.org/10.2147/CIA.S117597 Open Access Full Text Article ORIGINAL RESEARCH Effects of Chinese herbal formula Erxian decoction for treating osteoporosis: a systematic review Jin-Yu Li1,* Purpose: The aim is to systematically assess the effectiveness and safety of Chinese herbal Yu-Song Jia1,* formula Erxian decoction (EXD) for treating osteoporosis. Li-Min Chai1 Materials and methods: Six databases were searched from inception through September 17, Xiao-Hong Mu1 2016, without language restriction. All randomized controlled trials of EXD for osteoporosis were Sheng Ma1 included. One or more outcome measures including fracture, change in bone mineral density Lin Xu1 (BMD), pain symptom improvement, bone biochemical markers, quality of life, adverse event or adverse drug reaction were evaluated. Study selection, data extraction, quality assessment, Xu Wei2 and data analyses were conducted according to Cochrane standards. 1 Department of Orthopaedics, Results: Eight trials including 644 patients investigated the effects of EXD in the treat- Dongzhimen Hospital, Beijing University of Chinese Medicine, ment of osteoporosis. The methodological quality of the included trials was generally low. Beijing, People’s Republic of China; The meta-analysis from two trials showed favorable effects of EXD in improving BMD 2 Department of Scientific Research, of lumbar spine (mean difference [MD]: 0.05 [0.03, 0.06]; I2=0%; P,0.00001) and BMD Wangjing Hospital, China Academy 2 of Chinese Medical Sciences, Beijing, of femoral great trochanter (MD: 0.06 [0.02, 0.10]; I =59%; P=0.005) compared with People’s Republic of China caltrate tablets. The other meta-analysis from two trials showed beneficial effects of EXD *These authors contributed equally plus caltrate tablets and calcitriol in improving BMD of femoral neck (MD: 0.04 [0.00, to this work 0.09]; I2=56%; P=0.04), the level of calcium (MD: 0.20 [0.15, 0.24]; I2=0%; P,0.00001), and phosphorus (MD: -0.28 [-0.39, -0.17]; I2=68%; P,0.00001) compared with caltrate tablets and calcitriol alone. The adverse drug reactions of EXD were mainly slight gastro- intestinal symptoms. Conclusion: The study provides suggestive evidence of the superiority of EXD monotherapy or combination therapy over basic supplements for treating osteoporosis. However, the evidence remains weak. More rigorously designed and measured, randomized double-blind, placebo- controlled trials with larger sample size are needed to verify the current conclusions. Keywords: Chinese herbal formula, Erxian decoction, osteoporosis, systematic review, meta- analysis Correspondence: Lin Xu Department of Orthopaedics, Introduction Dongzhimen Hospital, Beijing University of Chinese Medicine, No 5 Haiyuncang Osteoporosis is a pathological condition that can lead to the reduction of bone mass Street, Dongcheng District, Beijing and the impairment of the bone architecture, which increases the risk of falling and 100700, People’s Republic of China 1,2 Tel +86 10 8401 5571 fracture. The disease affects a large amount of the population, especially the elderly Email [email protected] and postmenopausal women, being considered a very important problem as a growing 3 Xu Wei concern of aging. In the last two decades, significant progress has been made in Department of Scientific Research, epidemiology studies and in understanding its complex pathogenesis. However, the Wangjing Hospital, China Academy pathogenesis of osteoporosis is still complex and multifactorial, which makes us put of Chinese Medical Sciences, Huajiadi Street, Chaoyang District, Beijing 100102, more emphasis on preventing and treating this “silent disease”.4,5 Furthermore, a grow- People’s Republic of China ing body of research evidence has fostered the development of clinical practice guide- Tel +86 13 4887 16557 Email [email protected] lines to monitor and provide appropriate choices for osteoporosis intervention. submit your manuscript | www.dovepress.com Clinical Interventions in Aging 2017:12 45–53 45 Dovepress © 2017 Li et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you http://dx.doi.org/10.2147/CIA.S117597 hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Li et al Dovepress Reducing loss of bone mass, adequately treating clinical Materials and methods symptoms, and preventing osteoporotic fractures are the Search strategy major therapeutic targets. Therefore, osteoporosis manage- Two authors (Mu XH and Ma S) independently performed ment usually includes pharmacological approaches, physio- the literature search using predetermined inclusion/exclusion therapy interventions, health education measures, and in rare criteria. A computer-based online search was conducted in cases, surgical treatment.6 Among the treatment strategies, the PubMed, Embase, Cochrane Library, Chinese National the application of drugs in the management of osteoporosis Knowledge Infrastructure (CNKI), Chinese Scientific remains a clinical challenge as a result of patient selection, Journal Database (VIP), and Wanfang databases. In addi- potential adverse effects or patient adherence.7 Calcium (Ca), tion, the reference lists of all obtained articles were exam- vitamin D, bisphosphonates, and calcitonin are the com- ined for additional studies. All the articles were considered monly used medications. However, an increasing number of without language limitation. All of the searches ended on studies demonstrated that using these conventional medicines September 17, 2016. Search terms were Erxian decoction increased the risk of cardiovascular events.8,9 A recent study (Er-xian decoction) combined with osteoporosis. The strat- revealed that 8.5% reported low adherence to osteoporosis egy for searching PubMed was listed: ((osteoporosis [MeSH medications and 21.6% of patients stopped their medication Terms]) AND Erxian decoction) OR Er-xian decoction. completely over the 2-year follow-up period.10 Therefore, there is a need to seek alternative and effective treatment Study selection alternatives for osteoporosis. Clinical practice has shown a Randomized controlled trials (RCTs) were included, but bright future for Chinese herbal medicine and Chinese herbal crossover randomized trials and quasi-randomized trials formulas in treating osteoporosis.11,12 were excluded. Diagnosis of osteoporosis was established Erxian decoction (EXD), a traditional Chinese herbal by bone mineral density (BMD) examination. The following formula, has been widely used for treating many chronic interventions were considered for inclusion: EXD versus no diseases, such as osteoporosis, menopausal syndrome, and treatment or placebo, EXD versus routine anti-osteoporosis delayed puberty in the past 60 years.13,14 EXD is made up medications, EXD plus anti-osteoporosis medications versus of six herbs, containing Epimedii Folium (Yinyanghuo), anti-osteoporosis medications, EXD plus anti-osteoporosis Curculiginis Rhizoma (Xianmao), Morindae Officinalis Radix medications versus placebo plus anti-osteoporosis medica- (Bajitian), Anemarrhenae Rhizoma (Zhimu), Phellodendri tions. Modified EXD changes based on traditional Chinese Chinensis Cortex (Huangbai), and Angelicae Sinensis Radix medicine syndrome differentiations were acceptable. The (Danggui).13 Twelve anti-osteoporotic constituents, such outcome measures included fracture, change in BMD, pain as icariin, anemarsaponin BII, and berberine were isolated symptom improvement, bone biochemical markers, quality through bioactivity-guided fractionation.15 More and more of life, adverse event, or adverse drug reaction (ADR). Any fundamental researches revealed that EXD had a definite differences in opinion regarding inclusion in the review were anti-osteoporotic effect similar to estrogen.16–18 EXD displayed resolved by discussion or consulting a third party. inhibitory effects on osteoclastic bone resorption, including decreasing the formation of bone resorption pits, the number Data extraction and analysis of multinucleated osteoclasts, and so on.19 A recent experi- Two investigators (Jia YS and Chai LM) independently mental study further confirmed that EXD could increase bone extracted details of each included study: the principal authors, mass, elevate osteocalcin protein levels in vivo, and promote year of publication, sample sizes, patients’ characteristics, the self-renewal and osteoblastic differentiation of bone mes- details of intervention, details of control interventions, inter- enchymal stem cells ex vivo in ovariectomized mice.20 vention durations, and outcomes for each study. When impor- A previous systematic review and randomized double- tant data were not available, authors of the relevant study blind controlled trial has shown that EXD is effective in were
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