Singh Ajaypal, Kant Ravi, Raina Rohit, Dhingra Vandana, Nema Rajeev, Bairwa Mukesh Chand, Kanwar Varsha, Mukherjee Rifika L Sukhes, Mirza Anissa Atif, Agarwal Mayank
Department of Internal Medicines, All India Institute of Medical Sciences, Veerbhadra Road, Rishikesh, Uttarakhand, India.
Department of Nuclear Medicine, All India Institute of Medical Sciences, Veerbhadra Road, Rishikesh, Uttarakhand, India.
Indian J Endocrinol Metab. 2024 Jan-Feb;28(1):35-42. doi: 10.4103/ijem.ijem_84_23. Epub 2024 Feb 26.
Gastrointestinal neuropathies are frequently found in diabetic patients. The pathogenesis of diabetic gastroparesis (DG) is multifactorial. The usual treatment for DG includes dietary modifications, prokinetic and antiemetic agents. There is increasing demand for more effective medicines to treat DG. The current study was conducted on the stem extract to add to the armamentarium of DG treatment and to find the efficacy of plant extract (mastic gum) in comparison to levosulpiride in DG for improvement in gastroparesis symptoms and gastric emptying scintigraphy (GES) in a single centric double-blind non-inferiority randomised control trial.
Thirty-eight individuals were recruited and equally randomised into two study groups based on Gastroparesis Cardinal Symptom Index (GCSI) score and TC Radionuclide GES, mastic gum group and levosulpiride group. Both pre and post-intervention (8 weeks) GCSI scores were calculated, GES was performed to quantify the improvement in gastric emptying. Power analysis was performed using G*POWER software version 3.1.9.7 and data analysis using SPSS 23.0, variables measured in mean ± standard deviation (SD). Various statistical tests were used such as independent t-test, Chi-square test or Fisher's exact test, Wilcox Mann-Whitney test, analysis of variance (ANOVA) test, and posthoc pairwise tests.
The mastic gum is found effective in the improvement of 4 h gastric emptying percentage from the mean (SD) 76.60 (± 9.96) to mean (SD) 97.20 (2.17)% ( < 0.001). Mastic gum has the property of HbA1c reduction, which is more significant than that of levosulpiride ( = 0.044). Mastic gum also had significant Low density lipoprotein (LDL) (mg/dL) levels reduction, ( < 0.001), compared to levosupiride. An absolute increase was observed in haemoglobin (HB) level in mastic gum at a 2-month mean (SD) of 1.03 (0.77) (g/dL) (-value <0.001).
To our knowledge, this is the first study to compare the effect of levosulpiride with mastic gum concerning improvement in diabetic gastroparesis (DG) using GES. In the study, mastic gum was found to have great properties to improve DG with many important pleiotropic effects.
胃肠道神经病变在糖尿病患者中很常见。糖尿病胃轻瘫（DG）的发病机制是多因素的。DG的常规治疗包括饮食调整、促动力药和止吐药。对更有效治疗DG药物的需求日益增加。本研究对一种茎提取物进行了研究，以增加DG治疗的手段，并在一项单中心双盲非劣效性随机对照试验中，比较植物提取物（乳香）与左舒必利在改善DG患者胃轻瘫症状和胃排空闪烁扫描（GES）方面的疗效。
招募了38名个体，根据胃轻瘫主要症状指数（GCSI）评分和TC放射性核素GES，将其平均随机分为两个研究组，即乳香组和左舒必利组。计算干预前后（8周）的GCSI评分，进行GES以量化胃排空的改善情况。使用G*POWER软件3.1.9.7进行功效分析，使用SPSS 23.0进行数据分析，变量以均值±标准差（SD）表示。使用了各种统计检验，如独立t检验、卡方检验或Fisher精确检验、Wilcox Mann-Whitney检验、方差分析（ANOVA）检验和事后成对检验。
发现乳香可有效将4小时胃排空率从平均（SD）76.60（±9.96）%提高到平均（SD）97.20（2.17）%（P<0.001）。乳香具有降低糖化血红蛋白（HbA1c）的特性，且比左舒必利更显著（P = 0.044）。与左舒必利相比，乳香还能显著降低低密度脂蛋白（LDL）（mg/dL）水平（P<0.001）。在乳香组中，观察到血红蛋白（HB）水平在2个月时平均（SD）绝对增加了1.03（0.77）（g/dL）（P值<0.001）。
据我们所知，这是第一项使用GES比较左舒必利与乳香对改善糖尿病胃轻瘫（DG）效果的研究。在该研究中，发现乳香具有改善DG的良好特性，并具有许多重要的多效性作用。
