Investigation of therapeutic effect of Longchai Formula Granule on chronic hepatitis B patients: A double-blind, controlled and randomized clinical trial

¹ Affiliated Hospital of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing 210028, China
² Jiangsu Province Institute of Traditional Chinese Medicine, Nanjing 210028, China
³ Taizhou Integrated Hospital of Traditional Chinese and Western Medicine, Taizhou 225300, China
⁴ Changzhou Third People’s Hospital, Changzhou 213001, China
⁵ Wuxi Infectious Diseases Hospital, Wuxi 214005, China
⁶ Nantong Third People’s Hospital, Nantong 226000, China

^a Corresponding to: Fangshi Zhu, E-mail: zhufangshi@126.com Tel: +86-25-52632761, Address: No.100, Shizi Street, Hongshan Road, Nanjing City, Jiangsu Province, China.

Abstract

Objective: To objectively evaluate the clinical efficacy of Longchai Formula Granule (LCFG) on chronic hepatitis B (CHB). Methods: According to GCP, 100 CHB patients who meet enter criterion were encoded and divided randomly into the test group (50 cases) and the control group (50 cases). The patients in test group were treated with LCFG and matrine capsule simulation agent, the patients in control group was treated with matrine capsule and LCFG simulation agent. Both groups have 12-week treatment period. The changes of Chinese medicine symptoms, ALT, AST, graduation of liver function, HBeAg, HBsAg, HBVDNA in CHB patients were observed and compared. Results: After unblinding, statistical data showed that there were 82 effective actual CHB cases composed of 40 CHB patients in test group (10 cases dropout) and 42 CHB patients in control group (8 cases dropout). The total efficient of Chinese symptoms improvement and ALT in test group is better than the control group (P<0.05). The contents of AST, the graduation of liver function, HBeAg, HBsAg, and HBV-DNA in two groups were totally improved than before treatment, but there was no significant differences between groups (P>0.05). As a whole, it shows a tendency that the change of these values in test group induced by LCFG is better than these values in control group induced by matrine capsule. Conclusions: In summary, LCFG is effective for CHB patients and has no significant difference with matrine cpasules. However, LCFG is better than matrine capsule in the improvement of symptomatology and liver function.