Objective: To observe the c1inical effect, pharmacology and toxicology of Tangxiao capsule (TXC), a preparation of Chinese herbal medicine for treatment of diabetes mellitus.

Methods: l65 patients selected from inpatients of the authors' hospital adopting the diagnostic standard of WHO (l985) were divided into the TXC group (n=l55) and the control group (n=l0). Serial tests dealing with blood sugar renal and liver function, blood lipid was conducted in each patient at the time of hbspitaization. Dietotherapy and physical exercise were taken in both groups. To the TXC group, TXC (consists mainly of Radix Polygonum Multiflorum, Radix Astragalus, Radix Rehmannia etc. Made into capsule form, each containing 0.35g) was given 4 capsules, three times per day. And VBl, VB6, VBl2 were given in coordination by each l tablet three times per day. The control group took the vitamins same as in the TXC group, and the Ganlu Xiaoke capsule (another preparation for diabetes mellitus treatment) 4 capsules three times a day. The therapeutic course for both groups were same. Serial tests were repeated at ending the therapeutic course, then efficacy of therapy was assayed according to the Standard adopted domestically in general. Pharmacological and toxicological experiments were conducted in the same period.

Result: The total effective the in the TXC group was 94.l9% and that in the control group was 80%, P<0.05, showing statistical significance. No toxic or side effect was found both in clinical and experimental observation, suggesting that TXC was safe in use.

Conclusion: TXC has good effect in treating patients with diabetes mellitus and without any marked toxic and side effect.

(By Zhang Zequan, Ren Xiankai, Xu ShengWang, From Guangji Hospital Affiliated to Guangji TCM Institute of Prevention and Tretheent of Diabetes Mellitus, ShanXi 030032, China)