一项随机对照试验：辣木与二甲双胍在改善2型糖尿病患者血糖控制中的协同作用

IF 2.2 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Journal of Herbal Medicine Pub Date : 2025-05-16 DOI:10.1016/j.hermed.2025.101029

Asma Irfan , Saleeha Fatima Said , Soma Siddique , Muhammad Hassaan Farooq , Noor ul Ain Irfan , Sadia Mubarak , Saima Latif , Rubab Rameez , Saira Safdar , Irfan A. Mughal , Areej Niazi , Yasir Khan Niazi , Syed Haider Raza Rizvi , Aleena Naveed Butt , Khawaja Muhammad Usman , Muhammad Azadar Abbas , Muhammad Ibrahim Khan , Shaheer Zaman

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引用次数: 0

摘要

辣木叶对糖尿病患者有降糖作用。然而，有限的临床证据支持它们作为标准抗糖尿病治疗的辅助治疗。本研究评价油松叶甲醇提取物联合二甲双胍对2型糖尿病（T2DM）患者血糖控制的协同作用。方法于2023年2月至11月在伊斯兰堡Akbar Niazi教学医院（ANTH）进行随机对照试验。使用世界卫生组织样本量计算器共招募了50名参与者（25名对照，25名病例）。被诊断为T2DM的患者，每天两次服用二甲双胍500 mg，并愿意参与研究。获得知情同意，并保持三重盲法。病例组服用二甲双胍加含有1 g辣木粉的辣木叶胶囊，对照组服用二甲双胍加安慰剂。监测空腹血糖、HbA1c、肝功能检查（LFTs）、肾功能检查（RFTs）和血脂。该研究已在http://clinicaltrials.gov （NCT06125873）上注册，并得到伊斯兰堡医学和牙科学院机构审查委员会的批准。采用SPSS version 26进行统计分析。连续变量用均值±SD或中位数（min, max）表示，分类变量用频率和百分比表示。采用配对t检验和双向方差分析来评估治疗前后的效果，显著性设置为P <；0.05.结果：与安慰剂组相比，接受油酸支原体治疗的患者在HbA1c水平、空腹血糖和血压方面均有显著改善。然而，在体重指数（BMI）、LFTs、RFTs或脂质谱方面没有观察到显著变化。一些人报告轻微的胃部不适，在第一周调整剂量后缓解。结论本研究提示，油葵作为二甲双胍的辅助用药，可显著改善T2DM患者的血糖控制。BMI、LFTs、RFTs和脂质谱无显著变化，表明其对人类使用是安全的。

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Synergistic effects of Moringa oleifera with metformin in improving glycemic control in type 2 diabetics through a randomised controlled trial

Introduction

Moringa oleifera leaves have demonstrated hypoglycemic effects in diabetic patients. However, there is limited clinical evidence supporting their use as an adjunct therapy alongside standard antidiabetic treatment. This study evaluates the synergistic effects of M. oleifera leaf methanolic extracts in combination with Metformin on glycemic control in type 2 diabetes mellitus (T2DM) patients.

Methods

A randomised controlled trial was conducted at Akbar Niazi Teaching Hospital (ANTH), Islamabad, from February 2023 to November 2023. A total of 50 participants (25 control, 25 case) were recruited using the World Health Organization sample size calculator. Patients diagnosed with T2DM, on Metformin 500 mg twice daily, and willing to participate were included. Informed consent was obtained, and triple blinding was maintained. The case group received Metformin plus Moringa leaf capsules containing 1 g of Moringa powder, while the control group received Metformin and a placebo. Fasting blood glucose, HbA1c, liver function tests (LFTs), renal function tests (RFTs), and lipid profiles were monitored. The study was registered at http://clinicaltrials.gov (NCT06125873) and approved by the Institutional Review Board of Islamabad Medical and Dental College.

SPSS version 26 was used for statistical analysis. Continuous variables were expressed as mean ± SD or median (min, max), while categorical variables were presented as frequencies and percentages. Paired t-tests and two-way Analysis of Variance were performed to assess pre- and post-treatment effects, with significance set at P < 0.05.

Results

Participants receiving M. oleifera demonstrated significant improvements in HbA1c levels, fasting blood glucose, and blood pressure compared to the placebo group. However, no significant changes were observed in body mass index (BMI), LFTs, RFTs, or lipid profiles. Some individuals reported mild gastric discomfort, which resolved with dosage adjustment in the 1st week.

Conclusion

This study suggests that M. oleifera, when used as an adjunct to Metformin, significantly improves glycemic control in T2DM patients. The absence of significant changes in BMI, LFTs, RFTs, and lipid profiles indicates its safety for human use.

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来源期刊

Journal of Herbal Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

3.90

自引率

0.00%

发文量

期刊介绍： The Journal of Herbal Medicine, the official journal of the National Institute of Medical Herbalists, is a peer reviewed journal which aims to serve its readers as an authoritative resource on the profession and practice of herbal medicine. The content areas of the journal reflect the interests of Medical Herbalists and other health professionals interested in the clinical and professional application of botanical medicines. The objective is to strengthen the research and educational base of herbal medicine with research papers in the form of case studies, original research articles and reviews, monographs, clinical trials and relevant in vitro studies. It also publishes policy statements, opinion pieces, book reviews, conference proceedings and profession related information such as pharmacovigilance reports providing an information source for not only the Herbal Practitioner but any Health professional with an interest in phytotherapy.