effect of jytk on antioxidant status and inflammation in patients with type 2 diabetes: a randomized double-blind clinical trial

Background: diabetes is a metabolic disorder caused by oxidative stress and inflammation. jianyutangkang (jytk), as a potential chinese integrative medicine, is an antioxidant used in chinese medicine with potential anti-inflammatory properties. objectives: the present randomized clinical trial was carried out to evaluate the effects of jytk on oxidative stress and inflammation in patients with type 2 diabetes mellitus (t2dm). patients and methods: the parallel, randomized, double-blinded, placebo-controlled clinical trial included 150 newly diagnosed t2dm patients receiving metformin treatment (1.5 g/day), some of whom also received jytk (4.5 g/day) in tablet form. the control group received 4.5 g/day placebo plus 1.5 g/day metformin. body mass index (bmi), fasting plasma glucose, urinary albumin-to-creatinine ratio, and complete blood count as well as antioxidant and inflammation indices such as tumor necrosis factor (tnf)-α, interleukin (il)-6, superoxide dismutase (sod), malonaldehyde (mda), glutathione peroxidase (gpx), and high sensitivity c-reactive protein (hs-crp) levels were assessed at baseline and at different time points during the treatment. results: all 112 patients, including 59 in the treatment group (jytk + metformin) and 52 controls (metformin only) completed the 26-week clinical trial. jykt plus metformin treatment increased il-6 (36.4 ± 11.5 ng/l; p < 0.05), tnf-α (17.5 ± 11.3 vs. 22.5 ± 12.9 ng/l; p < 0.05), and mda (1.9 ± 0.9; p < 0.05) levels compared to the control (2.2 ± 0.6 mm/ml), whereas total sod level decreased (98.1 ± 30.4 vs. 78.5 ± 29.3 u/ml; p < 0.05). there were no changes in gpx and hs-crp levels. there were no adverse effects associated with jytk treatment. conclusions: jytk combined with metformin improves some antioxidant indices (sod and mda), and decreases inflammation in patients with t2dm, suggesting that it can reduce the risk of diabetic complications.