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古古勒用于治疗高脂血症:自然标准研究协作组织的一项综述

Guggul for hyperlipidemia: a review by the Natural Standard Research Collaboration.

作者信息

Ulbricht Catherine, Basch Ethan, Szapary Philippe, Hammerness Paul, Axentsev Serguei, Boon Heather, Kroll David, Garraway Levi, Vora Mamta, Woods Jen

机构信息

Massachusetts General Hospital, USA.

出版信息

Complement Ther Med. 2005 Dec;13(4):279-90. doi: 10.1016/j.ctim.2005.08.003. Epub 2005 Sep 23.

DOI:10.1016/j.ctim.2005.08.003
PMID:16338199
Abstract

OBJECTIVE

To evaluate the scientific evidence on guggul for hyperlipidemia including expert opinion, folkloric precedent, history, pharmacology, kinetics/dynamics, interactions, adverse effects, toxicology, and dosing.

METHODS

Electronic searches were conducted in nine databases, 20 additional journals (not indexed in common databases), and bibliographies from 50 selected secondary references. No restrictions were placed on language or quality of publications. All literature collected pertained to efficacy in humans, dosing, precautions, adverse effects, use in pregnancy/lactation, interactions, alteration of laboratory assays, and mechanism of action. Standardized inclusion/exclusion criteria were utilized for selection.

RESULTS

Before 2003, most scientific evidence suggested that guggulipid elicits significant reductions in serum total cholesterol, low-density lipoprotein (LDL), and triglycerides, as well as elevations in high-density lipoprotein (HDL) [Kotiyal JP, Bisht DB, Singh DS. Double blind cross-over trial of gum guggulu (Commiphora mukul) Fraction A in hypercholesterolemia. J Res Indian Med Yoga Hom 1979;14(2):11-6; Kotiyal JP, Singh DS, Bisht DB. Gum guggulu (Commiphora mukul) fraction 'A' in obesity-a double-blind clinical trial. J Res Ayur Siddha 1985;6(1, 3, 4):20-35; Gaur SP, Garg RK, Kar AM, et al. Gugulipid, a new hypolipidaemic agent, in patients of acute ischaemic stroke: effect on clinical outcome, platelet function and serum lipids. Asia Pacif J Pharm 1997;12:65-9; Urizar NL, Liverman AB, Dodds DT, et al. A natural product that lowers cholesterol as an antagonist ligand for the FXR. Science 3 May 2002 [Science Express Reports]; Nityanand S, Srivastava JS, Asthana OP. Clinical trials with gugulipid. A new hypolipidaemic agent. J Assoc Physicians India 1989;37(5):323-8; Kuppurajan K, Rajagopalan SS, Rao TK, et al. Effect of guggulu (Commiphora mukul-Engl.) on serum lipids in obese, hypercholesterolemic and hyperlipemic cases. J Assoc Physicians India 1978;26(5):367-73; Gopal K, Saran RK, Nityanand S, et al. Clinical trial of ethyl acetate extract of gum gugulu (gugulipid) in primary hyperlipidemia. J Assoc Physicians India 1986;34(4):249-51; Agarwal RC, Singh SP, Saran RK, et al. Clinical trial of gugulipid-a new hypolipidemic agent of plant origin in primary hyperlipidemia. Indian J Med Res 1986;84:626-34; Verma SK, Bordia A. Effect of Commiphora mukul (gum guggulu) in patients of hyperlipidemia with special reference to HDL-cholesterol. Indian J Med Res 1988;87:356-60; Singh RB, Niaz MA, Ghosh S. Hypolipidemic and antioxidant effects of Commiphora mukul as an adjunct to dietary therapy in patients with hypercholesterolemia. Cardiovasc Drugs Ther 1994;8(4):659-64; Ghorai M, Mandal SC, Pal M, et al. A comparative study on hypocholesterolaemic effect of allicin, whole germinated seeds of bengal gram and guggulipid of gum gugglu. Phytother Res 2000;14(3):200-02]. However, most published studies were small and methodologically flawed. In August 2003, a well-designed trial reported small significant increases in serum LDL levels associated with the use of guggul compared to placebo [Szapary PO, Wolfe ML, Bloedon LT, et al. Guggulipid for the treatment of hypercholesterolemia: a randomized controlled trial. JAMA 2003;290(6):765-72]. No significant changes in total cholesterol, high-density lipoprotein (HDL), or triglycerides were measured. These results are consistent with two prior published case reports [Das Gupta R. Gugulipid: pro-lipaemic effect. J Assoc Physicians India 1990;38(12):346].

CONCLUSION

The effects of guggulipid in patients with high cholesterol are not clear, with some studies finding cholesterol-lowering effects, and other research suggesting no benefits. At this time, there is not enough scientific evidence to support the use of guggul for any medical condition. Guggul may cause stomach discomfort or allergic rash as well as other serious side effects and interactions. It should be avoided in pregnant or breast-feeding women and in children. Safety of use beyond 4 months has not been well studied.

摘要

目的

评估古古勒用于治疗高脂血症的科学证据,包括专家意见、民间先例、历史、药理学、动力学/动态学、相互作用、不良反应、毒理学及剂量。

方法

在九个数据库、另外20种期刊(常见数据库未收录)以及50篇选定的二次参考文献的参考文献中进行电子检索。对出版物的语言或质量未设限制。收集的所有文献均涉及对人类的疗效、剂量、注意事项、不良反应、妊娠/哺乳期使用、相互作用、实验室检测结果的改变及作用机制。采用标准化的纳入/排除标准进行筛选。

结果

2003年之前,多数科学证据表明,古古勒脂可显著降低血清总胆固醇、低密度脂蛋白(LDL)和甘油三酯水平,并升高高密度脂蛋白(HDL)[Kotiyal JP, Bisht DB, Singh DS. 古古勒(Commiphora mukul)A组分治疗高胆固醇血症的双盲交叉试验。《印度医学瑜伽顺势疗法研究》1979年;14(2):11 - 6;Kotiyal JP, Singh DS, Bisht DB. 古古勒(Commiphora mukul)“A”组分治疗肥胖症的双盲临床试验。《阿育吠陀 Siddha研究》1985年;6(1, 3, 4):20 - 35;Gaur SP, Garg RK, Kar AM等。古古勒脂,一种新型降血脂药物,用于急性缺血性中风患者:对临床结局、血小板功能和血脂的影响。《亚太药学杂志》1997年;12:65 - 9;Urizar NL, Liverman AB, Dodds DT等。一种作为FXR拮抗剂配体降低胆固醇的天然产物。《科学》2002年5月3日[科学快讯报道];Nityanand S, Srivastava JS, Asthana OP. 古古勒脂的临床试验。一种新型降血脂药物。《印度医师协会杂志》1989年;37(5):323 - 8;Kuppurajan K, Rajagopalan SS, Rao TK等。古古勒(Commiphora mukul - Engl.)对肥胖、高胆固醇血症和高脂血症患者血脂的影响。《印度医师协会杂志》1978年;26(5):367 - 73;Gopal K, Saran RK, Nityanand S等。古古勒(古古勒脂)乙酸乙酯提取物治疗原发性高脂血症的临床试验。《印度医师协会杂志》1986年;34(4):249 - 51;Agarwal RC, Singh SP, Saran RK等。古古勒脂——一种新型植物源降血脂药物治疗原发性高脂血症的临床试验。《印度医学研究杂志》1986年;84:626 - 34;Verma SK, Bordia A. 古古勒(Commiphora mukul)对高脂血症患者的影响,特别提及高密度脂蛋白胆固醇。《印度医学研究杂志》1988年;87:356 - 60;Singh RB, Niaz MA, Ghosh S. 古古勒(Commiphora mukul)作为饮食疗法辅助手段对高胆固醇血症患者的降血脂和抗氧化作用。《心血管药物治疗》1994年;8(4):659 - 64;Ghorai M, Mandal SC, Pal M等。大蒜素、孟加拉鹰嘴豆全发芽种子和古古勒脂降胆固醇作用的比较研究。《植物疗法研究》2000年;14(3):200 - 02]。然而,多数已发表的研究规模较小且方法存在缺陷。2003年8月,一项设计良好的试验报告称,与安慰剂相比,使用古古勒后血清LDL水平有小幅显著升高[Szapary PO, Wolfe ML, Bloedon LT等。古古勒脂治疗高胆固醇血症:一项随机对照试验。《美国医学会杂志》2003年;290(6):765 - 72]。未检测到总胆固醇、高密度脂蛋白(HDL)或甘油三酯有显著变化。这些结果与之前发表的两篇病例报告一致[Das Gupta R. 古古勒脂:促脂血症作用。《印度医师协会杂志》1990年;38(12):346]。

结论

古古勒脂对高胆固醇患者的影响尚不明确,一些研究发现有降胆固醇作用,而其他研究则表明无益处。目前,没有足够的科学证据支持将古古勒用于任何医学状况。古古勒可能会引起胃部不适或过敏性皮疹以及其他严重的副作用和相互作用。孕妇、哺乳期妇女及儿童应避免使用。超过4个月使用的安全性尚未得到充分研究。

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