The Efficacy and Safety of DLBS3233, A Combined Bioactive Fraction of Cinnamomum burmanii and Lagerstroemia speciosa Plants on The Endocrine-Metabolic Profile of Women with Polycystic Ovary Syndrome: A Randomized Clinical Trial.

IF 2.3 Q2 OBSTETRICS & GYNECOLOGY
Andon Hestiantoro, Wiryawan Permadi, Raymond R Tjandrawinata, Budi Wiweko, Mulyanusa Amarallah Ritonga, Ade Indra Ferrina, Kanadi Sumapraja, R Muharam, Tono Djuwantono
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引用次数: 0

Abstract

Background: A bioactive fraction of Cinnamomum burmanii and Lagerstroemia speciosa, DLBS3233, has recently been used for type-2-diabetes treatment due to its favorable effect on insulin sensitivity. The insulin resistance leading to metabolic syndrome is closely linked to hyperandrogenemia in polycystic ovary syndrome (PCOS). This study evaluated the metabolic and reproductive efficacy and safety of DLBS3233 in insulin-resistant PCOS women.

Materials and methods: This was a 2-arm, randomized, double-blind, controlled, noninferiority clinical study over a 6-month therapy with DLBS3233 100-mg daily in comparison to metformin-XR 750 mg twice daily, involving 124 PCOS women with insulin resistance. The primary efficacy endpoint was the improvement of Homeostasis Model Assessment-Insulin Resistance (HOMA-IR). Secondary endpoints were improvements in other metabolic and reproductive parameters. Safety endpoints were based on blood pressure, heart rate, electrocardiogram findings, liver and renal function, and adverse events.

Results: After 6 months, HOMA-IR improvement in DLBS3233-treated group (-1.03 ± 0.50) and metformin-XR (-1.19 ± 0.50) were comparable, with a between-group difference fell within the pre-set non-inferiority margin (0.16; 95% confidence interval (CI): -1.24, 1.56; P=0.3168). The HOMA-IR in both groups were significantly improved from baseline. On all secondary endpoints, both groups showed comparable effects. Markedly fewer adverse events occurred in the DLBS3233 treated group than in the Metformin-XR-treated group and most were mild clinically and had been resolved by the end of the study.

Conclusion: Treatment with DLBS3233 100-mg daily in PCOS women demonstrated comparable efficacy to metformin- XR 750-mg twice daily in improving insulin resistance. However, the non-inferiority of DLBS3233 to metformin- XR remains inconclusive. DLBS3233 was more tolerable than metformin-XR (registration number: NCT01733459).

多囊卵巢综合征妇女内分泌代谢谱的 DLBS3233(一种肉桂和野葛根的复合生物活性成分)的有效性和安全性:随机临床试验》。
背景:最近,肉桂(Cinnamomum burmanii)和麝香草(Lagerstroemia speciosa)的一种生物活性成分 DLBS3233 因其对胰岛素敏感性的有利影响而被用于治疗 2 型糖尿病。导致代谢综合征的胰岛素抵抗与多囊卵巢综合征(PCOS)中的高雄激素血症密切相关。本研究评估了 DLBS3233 对胰岛素抵抗性多囊卵巢综合征妇女的代谢和生殖疗效及安全性:这是一项为期 6 个月的双臂、随机、双盲、对照、非劣效性临床研究,DLBS3233 每日 100 毫克,与二甲双胍-XR 750 毫克每日两次相比,有 124 名胰岛素抵抗的多囊卵巢综合征女性参与。主要疗效终点是改善稳态模型评估-胰岛素抵抗(HOMA-IR)。次要终点是其他代谢和生殖参数的改善。安全性终点基于血压、心率、心电图结果、肝肾功能和不良事件:6个月后,DLBS3233治疗组(-1.03 ± 0.50)和二甲双胍-XR治疗组(-1.19 ± 0.50)的HOMA-IR改善程度相当,组间差异在预设的非劣效性范围内(0.16;95% 置信区间(CI):-1.24,1.56;P=0.3168)。两组患者的 HOMA-IR 与基线相比均有显著改善。在所有次要终点上,两组的效果相当。与二甲双胍-XR治疗组相比,DLBS3233治疗组发生的不良反应明显较少,而且大多数不良反应临床症状轻微,并在研究结束时得到缓解:结论:在改善胰岛素抵抗方面,每天服用100毫克DLBS3233治疗多囊卵巢综合征妇女的疗效与每天服用两次、每次750毫克二甲双胍-XR的疗效相当。然而,DLBS3233与二甲双胍- XR的非劣效性仍无定论。DLBS3233的耐受性优于二甲双胍-XR(注册号:NCT01733459)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.20
自引率
0.00%
发文量
68
审稿时长
>12 weeks
期刊介绍: International Journal of Fertility & Sterility is a quarterly English publication of Royan Institute . The aim of the journal is to disseminate information through publishing the most recent scientific research studies on Fertility and Sterility and other related topics. Int J Fertil Steril has been certified by Ministry of Culture and Islamic Guidance in 2007 and was accredited as a scientific and research journal by HBI (Health and Biomedical Information) Journal Accreditation Commission in 2008. Int J Fertil Steril is an Open Access journal.
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