The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis

Zhu, Huanfeng; Qin, Ling; Garnero, Patrick; Genant, H K; Zhang, G.; Dai, Kerong; Yao, Xin‐Sheng; G, Gu; Hao, Yongqiang; Li, Zheyi; Zhao, Yongfang; Li, W.; Yang, Jun; Zhao, Xiao-Feng; Shi, Dong; Fuerst, Thomas; Lu, Yu-Ren; Li, H.; Zhang, Xinquan; Li, C.; Zhao, Jiahui; Wu, Qianju; Zhao, Shanshan

doi:10.1007/s00198-011-1577-2

Cited by 87 publications

(85 citation statements)

References 23 publications

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“…Based on over ten years of clinical practice, the guideline that TCM with qi-tonifying and meridian-warming effects have the potential effects on treating osteoporosis is summarized from experience [8]. QiangGuYin is based on the combination therapy of Chinese medicine for tonifying qi and warming meridians.…”

Section: Introductionmentioning

confidence: 99%

Effect of Traditional Chinese Medicine Product, QiangGuYin, on Bone Mineral Density and Bone Turnover in Chinese Postmenopausal Osteoporosis

Shi

Zhang²,

et al. 2017

Evidence-Based Complementary and Alternative Medicine

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Introduction. The aim of this study was to investigate the efficacy of herbal formula QiangGuYin (QGY) in postmenopausal women. Materials and Methods. A total of 240 participants from six clinical centers were randomly to receive alendronate 70 mg/week, QGY granules 20 g/day, and placebo. Primary end points were BMD changes over 6 and 12 months; secondary end points were bone turnover markers changes at 3, 6, 9, and 12 months. Safety was monitored by clinical adverse events reported during the follow-up. Results. Of 240 women recruited, 218 completed the study. Significant BMD increases from baseline were observed over 6 and 12 months at each observed part both in QGY and alendronate compared with placebo (p < 0.01). Alendronate-treated subjects had significant decreases in β-CTX compared to QGY-treated subjects at each time point assessed (p < 0.01). Reduction in t-P1NP was only observed in the QGY group at 3 and 6 months (−23.81% and −3.07%, resp.). No significant difference was observed in the overall incidence of clinical adverse events among the alendronate group and the QGY group (5.0% versus 7.5%, p = 0.513). Conclusion. 1-Year treatment with QGY demonstrated a safe statistical increase in BMD and new balance may be rebuilt after 9 months. This trail is registered with ChiCTR-POC-16008026.

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Section: Introductionmentioning

confidence: 99%

Effect of Traditional Chinese Medicine Product, QiangGuYin, on Bone Mineral Density and Bone Turnover in Chinese Postmenopausal Osteoporosis

Shi

Zhang²,

et al. 2017

Evidence-Based Complementary and Alternative Medicine

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“…A multicenter and randomized clinical trial of XLGB shows a statistically significant increase in bone mineral density at lumbar spine at 6 months in postmenopausal women (Zhu et al, 2012). Moreover, XLGB can prevent ovariectomyinduced deterioration of musculoskeletal tissues at the hip in old rats, and that the possible pharmacodynamic mechanism is that it acts similar to a phyto-estrogen (Qin et al, 2005).…”

Section: Discussionmentioning

confidence: 98%

A 26-week repeated dose toxicity study of Xian-ling-gu-bao in Sprague-Dawley rats

Cheng

Liu

Wang

et al. 2013

Journal of Ethnopharmacology

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“…Xian‐Ling‐Gu‐Bao (XLGB), the only traditional Chinese medicine prescription recorded in the China National Basic Drugs Catalogue, is widely used for the treatment of aseptic osteonecrosis, fracture, osteoporosis and osteoarthritis (Gui & Shen, ; Li, ; Qin et al, ; Zhu et al, ). The recipe of XLGB comprises six herbal medicines, Epimedii Herba (1167 g), Dipsaci Asperoidis Radix (167 g), Psoraleae Fructus (83 g), Anemarrhenae Rhizoma (83 g), Salviae Miltiorrhizae Radix (83 g) and Rehmanniae Radix (83 g) for every 1000 capsules (State Food and Drug Administration of China, ).…”

Section: Introductionmentioning

confidence: 99%

Biotransformation and metabolic profile of Xian‐Ling‐Gu‐Bao capsule, a traditional Chinese medicine prescription, with rat intestinal microflora by ultra‐performance liquid chromatography coupled with quadrupole time‐of‐flight tandem mass spectrometry analysis

Gao

Tang

Zhang

et al. 2018

Biomedical Chromatography

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Xian-Ling-Gu-Bao capsule (XLGB), a well-known traditional Chinese medicine prescription, has been used for the prevention and treatment of osteoporosis. The safety and efficacy of XLGB have been confirmed based on the principle of evidence-based medicine. XLGB is usually administered orally, after which its multiple components are brought into contact with intestinal microflora in the alimentary tract and biotransformed. However, investigations on the comprehensive metabolic profile of XLGB are absent. In this study, 12 representative compounds bearing different typical structures (including iridoid glycosides, prenylated flavonol glycosides, prenylated flavonoids, triterpenoid saponins, steroidal saponins, coumarins and monoterpene phenols) were selected and then investigated for their biotransformation in rat intestinal microflora. In addition, the metabolic profile of XLGB in rat intestinal microflora was investigated by ultra-performance liquid chromatography coupled with quadrupole time-of-flight tandem mass spectrometry. As a result, a total of 87 biotransformation components were identified from incubated solutions of 12 representative compounds and XLGB, which underwent 16 metabolic reactions (including deglycosylation, glycosylation, dehydrogenation, hydrogenation, oxidation, epoxidation, hydroxylation, dehydration, hydration, hydrolysis, methylation, isomerization, cyclization, pyrolysis reaction, amino acid conjugation and nucleophilic addition reaction with NH ). This demonstrated that the deglycosylation reaction by cleavage of the sugar moieties is the main metabolic pathway of a variety of glycosides, including prenylated flavonol glycosides, coumarin glycosides, iridoid glycosides and saponins. In addition, compared with the biotransformation of 12 representative compounds, a different biotransformed fate was observed in the XLGB incubated samples of rat intestinal microflora. It is worth noting that the amino acid conjugation was first discovered in the metabolism of prenylated flavonol glycosides in rat intestinal microflora.

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The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis

Abstract: XLGB over 1-year treatment at the conventional dose demonstrated safe and only a statistically significant increase in BMD at lumbar spine at 6 months in postmenopausal women.

Cited by 87 publications

References 23 publications

Effect of Traditional Chinese Medicine Product, QiangGuYin, on Bone Mineral Density and Bone Turnover in Chinese Postmenopausal Osteoporosis

Effect of Traditional Chinese Medicine Product, QiangGuYin, on Bone Mineral Density and Bone Turnover in Chinese Postmenopausal Osteoporosis

A 26-week repeated dose toxicity study of Xian-ling-gu-bao in Sprague-Dawley rats

Biotransformation and metabolic profile of Xian‐Ling‐Gu‐Bao capsule, a traditional Chinese medicine prescription, with rat intestinal microflora by ultra‐performance liquid chromatography coupled with quadrupole time‐of‐flight tandem mass spectrometry analysis

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