[Randomized Controlled Clinical Trial for Analyzing Effect of "Spleen-Stomach Regulation Nee- dling" on Oxidative Stress Level in Patients with Diabetic Nephropathy].

OBJECTIVE: To observe the effect of "spleen-stomach needling" on changes of plasma malondialdehyde. (MDA), protein carbonyl (PCO, an oxidative stress damage biomaker), 8-hydroxyguanine (8-OHdG, an indicator of oxidative DNA damage) and the activity of superoxide dismutase (SOD) levels in patients with diabetic nephropathy, so as to explore its mechanisms underlying improving diabetic nephropathy.

METHODS: Diabetic nephropathy patients were randomized into routine acupuncture (control) group (n = 72) and spleen-stomach needling (observation) group (n = 70) according to a random digits table and by using multi-centers, randomized and blind methods in the present study. All the patients were received routine medication. In addition, patients of the control group were treated by acupuncture stimulation of Shenshu (BL 23), Taixi (KI 3), Sanyinjiao (SP 6), Yanglingquan (GB 34), Xuanzhong (GB 39), Guanyuan (CV 4), Shousanli (LI 10), Waiguan (TE 5), Yangxi (LI 5), Liangqiu (ST 34), Shangjuxu (ST 37), Neiting (ST.44), Huaroumen (ST 24), and Dachangshu (BL 25), and those of the observation group treated by acupuncture stimulation of Zhongwan (CV 12), Quchi (LI 11), HQgu (LI 4), Xuehai (SP 10), Zusanli (ST 36), Yinlingquan (SP 9), Fenglong (ST 40), Diji (SP 8), Sanyinjiao (SP 6),Taichong (LR 3), Gaohuang (BL 43), Shenshu (BL 23), Baihuanshu (BL 30) and Zhongji (CV 3) with spleen-stomach needling method. The treatment of both groups was conducted twice a day for six weeks except Sundays. Plasma MDA, PCO and 8-OHdG contents were detected by using ELISA, and SOD detected using xanthine oxidase method.

RESULTS: After 3 weeks' treatment, plasma MDA, PCO and 8-OHdG contents were significantly increased in both control and observation groups, and plasma SOD was obviously reduced in both groups (P < 0.05). No significant differences were found between the two groups in the plasma MDA, PCO and 8-OHdG contents (P > 0.05). While after 6 weeks' treatment, plasma MDA, PO and 8-OHdG contents were significantly decreased (turning to the normal levels) and plasma SOD level in the observation group was significantly up-regulated (P < 0.01). Following 3 weeks' treatment, of the 72 and 70 patients in the control and observation groups, 10 and 20 cases experienced marked improvement, 22 and 15 were improved, and 40 and 35 invalid, respectively. After 6 weeks' treatment, of the 72 and 70 patients in the control and observation groups, 12 and 39 experienced marked improvement, 28 and 20 cases were improved, 32 and 11 invalid, respectively. The therapeutic effect of the observation group was obviously superior to that of the control group (P < 0.01).

CONCLUSION: Acupuncture treatment with spleen-stomach regulation needling can down-regulate plasma MDA, PCO, 8-OHdG contents and up-regulate SOD activity in diabetic nephropathy patients, which may contribute to its effect in improving the patients' symptoms probably by resisting the oxidative stress damage.