S. Nizamudeen , Muzafar Din Ahmad Bhat , Rabia Malik , Mehjabeen Fatima , Radhika K , Firdous Ahmad Najar , Altaf Hussain Shah
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Subjects took B. ligulata (4 gm) or placebo in capsule form, orally, for 8 weeks. Fasting blood sugar (FBS) and postprandial blood sugar (PPBS) were measured at baseline, fourth week, and end of the trial. Haemoglobin A1c (HbA1c) and quality of life (Asian Diabetes Quality of Life; ADQOL) scores were measured at baseline and the end of the trial. Data were statistically analyzed using analysis of variance (ANOVA), student's <em>t</em>-test, chi-square, and Fisher exact test to assess the effect of the intervention.</p></div><div><h3>Results</h3><p>After 8 weeks of treatment, the decrease in mean fasting blood sugar (FBS) level showed a significant difference between groups (Cohen's <em>d</em>= -0.457, 95 % confidence intervals (CIs) -0.174 to -1.082). PPBS level was significantly reduced in the test group compared to the control group (Cohen's <em>d</em>= -1.457, 95 % confidence interval (CIs) -0.749 to -2.150). There was a statistically significant reduction in HbA1c level in the test group compared to the control group (Cohen's <em>d</em>= -0.798, 95 % confidence interval (CIs) -0.148 to -1.438). B. <em>ligulata</em> was found to be more effective in improving ADQOL scores than placebo (Cohen's <em>d</em> = 0.762, 95 % confidence interval (CIs) 0.115 to 1.400). No B. <em>ligulata</em> related adverse events were observed.</p></div><div><h3>Conclusion</h3><p>B. <em>ligulata</em> appears to be an effective adjuvant treatment for type 2 diabetes mellitus. It reduced FBS, PPBS, and HbA1c and improved ADQOL scores significantly compared to the placebo. However, for more valid results, larger samples are needed.</p></div><div><h3>Clinical trial registration no</h3><p>CTRI /2019/05/019087.</p></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"67 ","pages":"Article 102359"},"PeriodicalIF":1.9000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of Bergenia ligulata (Wall.) in type 2 diabetes mellitus: A randomized placebo-controlled trial\",\"authors\":\"S. Nizamudeen , Muzafar Din Ahmad Bhat , Rabia Malik , Mehjabeen Fatima , Radhika K , Firdous Ahmad Najar , Altaf Hussain Shah\",\"doi\":\"10.1016/j.eujim.2024.102359\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Globally 8.8 % of people aged 20–79 years have diabetes. Diabetes mellitus (DM) is a group of metabolic disorders characterized by hyperglycemia. 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引用次数: 0
摘要
导言全球 20-79 岁人群中有 8.8% 患有糖尿病。糖尿病（DM）是一组以高血糖为特征的代谢紊乱疾病。本研究旨在评估 B. ligulata 根茎作为辅助剂降低 II 型糖尿病患者血糖水平的效果。方法：40 名患者被纳入单盲、随机、安慰剂对照研究；20 名患者被分配到试验组和对照组。只有那些目前正在使用两种或两种以下口服降糖药的患者才被纳入其中。受试者连续 8 周口服 4 克 B. ligulata 胶囊或安慰剂。分别在基线、第四周和试验结束时测量空腹血糖（FBS）和餐后血糖（PPBS）。在基线和试验结束时测量血红蛋白 A1c（HbA1c）和生活质量（亚洲糖尿病生活质量；ADQOL）评分。采用方差分析（ANOVA）、学生 t 检验、卡方检验和费舍尔精确检验对数据进行统计分析，以评估干预效果。与对照组相比，试验组的 PPBS 水平明显降低（Cohen's d= -1.457, 95 % 置信区间 (CIs) -0.749 to -2.150）。与对照组相比，试验组的 HbA1c 水平在统计学上有明显降低（Cohen's d= -0.798，95 % 置信区间（CIs）-0.148 至 -1.438）。与安慰剂相比，B. ligulata 能更有效地改善 ADQOL 评分（Cohen's d = 0.762，95 % 置信区间 (CIs) 0.115 至 1.400）。结论 B. ligulata 似乎是治疗 2 型糖尿病的有效辅助疗法。与安慰剂相比，它能降低 FBS、PPBS 和 HbA1c，并显著改善 ADQOL 评分。然而，要获得更有效的结果，还需要更多的样本。
Effect of Bergenia ligulata (Wall.) in type 2 diabetes mellitus: A randomized placebo-controlled trial
Introduction
Globally 8.8 % of people aged 20–79 years have diabetes. Diabetes mellitus (DM) is a group of metabolic disorders characterized by hyperglycemia. Bergenia ligulata (Wall.) is a small, perennial, rhizomatous flowering herb used medicinally in India.
The present study aimed to evaluate the effect of B. ligulata rhizome as an adjuvant in decreasing blood glucose levels in type-II diabetes mellitus.
Methods
Forty patients were enrolled in a single-blind, randomized, placebo-controlled study; twenty patients were assigned to each of the test and control groups. Only those currently using 2 or less oral hypoglycaemic agents were included. Subjects took B. ligulata (4 gm) or placebo in capsule form, orally, for 8 weeks. Fasting blood sugar (FBS) and postprandial blood sugar (PPBS) were measured at baseline, fourth week, and end of the trial. Haemoglobin A1c (HbA1c) and quality of life (Asian Diabetes Quality of Life; ADQOL) scores were measured at baseline and the end of the trial. Data were statistically analyzed using analysis of variance (ANOVA), student's t-test, chi-square, and Fisher exact test to assess the effect of the intervention.
Results
After 8 weeks of treatment, the decrease in mean fasting blood sugar (FBS) level showed a significant difference between groups (Cohen's d= -0.457, 95 % confidence intervals (CIs) -0.174 to -1.082). PPBS level was significantly reduced in the test group compared to the control group (Cohen's d= -1.457, 95 % confidence interval (CIs) -0.749 to -2.150). There was a statistically significant reduction in HbA1c level in the test group compared to the control group (Cohen's d= -0.798, 95 % confidence interval (CIs) -0.148 to -1.438). B. ligulata was found to be more effective in improving ADQOL scores than placebo (Cohen's d = 0.762, 95 % confidence interval (CIs) 0.115 to 1.400). No B. ligulata related adverse events were observed.
Conclusion
B. ligulata appears to be an effective adjuvant treatment for type 2 diabetes mellitus. It reduced FBS, PPBS, and HbA1c and improved ADQOL scores significantly compared to the placebo. However, for more valid results, larger samples are needed.
期刊介绍：
The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education.
EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians.
The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.
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