BMC Complement Altern Med. 2013 May 14;13:104. doi: 10.1186/1472-6882-13-104.
Diabetes remains a major health problem worldwide. Low-risk low-cost alternatives to pharmaceutical interventions are needed where lifestyle modifications have failed. We conducted a double-blind randomised placebo controlled trial to investigate the efficacy of a Chinese herbal formula, Jiangtang Xiaozhi, in treating impaired glucose control and insulin resistance in persons with prediabetes and controlled diabetes.
Seventy-one patients with prediabetes or 'controlled' diabetes were randomised to receive 3 capsules of Jiangtang Xiaozhi (n = 39) or placebo (n = 32) three times daily for 16 weeks with a follow up eight weeks later (week 24). The primary outcome was change in glycaemic control as evidenced by fasting blood glucose (FBG), post-prandial plasma glucose and glycosylated haemoglobin (HbA1c). Other measures included change in fasting insulin, insulin resistance and sensitivity, lipids, C-reactive protein (CRP), body mass index (BMI), waist girth, blood pressure (BP), health related quality of life (HRQoL) and safety. Analysis of covariance (ANCOVA) was used to model outcomes at 16 weeks, by treatment group corrected for baseline level of the outcome variable.
In patients receiving Jiangtang Xiaozhi, FBG was not significantly different (p = 0.73) compared to placebo after 16 weeks of treatment (6.3 ± 1.1 mmol/L vs 6.7 ± 1.3 mmol/L). There was a significant difference (p = 0.04) in the mean levels of fasting insulin between the treatment group (11.6 ± 5.5 mmol/L) and the placebo group (22.1 ± 25.9 mmol/L). Insulin resistance slightly decreased in the treatment group (1.58 ± 0.74) compared to that of the placebo group (2.43 ± 1.59) but this change did not reach statistical significance (p = 0.06). Patients taking Jiangtang Xiaozhi had a significant improvement in high-density lipoprotein (HDL) level compared to the placebo group at week 16 (p = 0.03). Mean levels of cholesterol, triglycerides, BMI, waist-girth, HRQoL, BP, CRP and insulin sensitivity were not significantly different between the two groups. The herbal medicine was well tolerated.
In the current study, the 16 week Jiangtang Xiaozhi treatment did not lower fasting blood glucose, but it improved serum insulin and HDL cholesterol in a Western population with prediabetes or controlled diabetes. Our trial may have been underpowered. Dosage needs to be considered before commencing a longer adequately powered trial.
Australian New Zealand Clinical Trials Registry ACTRN12612000128897; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362005.
糖尿病仍然是全球的一个主要健康问题。在生活方式改变失败的情况下，需要有低风险、低成本的药物干预替代方案。我们进行了一项双盲随机安慰剂对照试验，以研究一种中药配方降糖消脂胶囊在治疗糖尿病前期和控制糖尿病患者的葡萄糖控制受损和胰岛素抵抗方面的疗效。
71 名糖尿病前期或“控制”糖尿病患者被随机分为 3 组，分别接受降糖消脂胶囊（n = 39）或安慰剂（n = 32），每日 3 次，共 16 周，随后进行 8 周的随访（第 24 周）。主要结局是空腹血糖（FBG）、餐后血浆葡萄糖和糖化血红蛋白（HbA1c）的血糖控制变化。其他措施包括空腹胰岛素、胰岛素抵抗和敏感性、血脂、C 反应蛋白（CRP）、体重指数（BMI）、腰围、血压（BP）、健康相关生活质量（HRQoL）和安全性的变化。采用协方差分析（ANCOVA）对 16 周时的结局进行建模，根据结局变量的基线水平对治疗组进行校正。
在接受降糖消脂胶囊治疗的患者中，治疗 16 周后，FBG 与安慰剂相比无显著差异（p = 0.73）（6.3 ± 1.1 mmol/L 与 6.7 ± 1.3 mmol/L）。治疗组（11.6 ± 5.5 mmol/L）和安慰剂组（22.1 ± 25.9 mmol/L）之间的空腹胰岛素水平存在显著差异（p = 0.04）。与安慰剂组相比，治疗组的胰岛素抵抗略有下降（1.58 ± 0.74 与 2.43 ± 1.59），但差异无统计学意义（p = 0.06）。与安慰剂组相比，服用降糖消脂胶囊的患者在第 16 周时高密度脂蛋白（HDL）水平显著升高（p = 0.03）。两组之间的胆固醇、甘油三酯、BMI、腰围、HRQoL、BP、CRP 和胰岛素敏感性的平均水平无显著差异。该草药耐受性良好。
在目前的研究中，降糖消脂胶囊治疗 16 周并未降低空腹血糖，但在患有糖尿病前期或控制糖尿病的西方人群中，改善了血清胰岛素和高密度脂蛋白胆固醇。我们的试验可能没有足够的效力。在开始进行更长时间、足够有力的试验之前，需要考虑剂量。
澳大利亚和新西兰临床试验注册中心 ACTRN12612000128897；https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362005。
