Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2013:2013:965723.
doi: 10.1155/2013/965723. Epub 2013 Dec 4.

The efficacy and safety of traditional chinese medicine (jiang zhi granule) for nonalcoholic Fatty liver: a multicenter, randomized, placebo-controlled study

Jielu Pan  1 , Miao Wang  1 , Haiyan Song  1 , Lin Wang  2 , Guang Ji  3
Affiliations

The efficacy and safety of traditional chinese medicine (jiang zhi granule) for nonalcoholic Fatty liver: a multicenter, randomized, placebo-controlled study

Jielu Pan et al. Evid Based Complement Alternat Med. 2013.

Abstract

Objective. To evaluate the efficacy and safety of Jiang Zhi Granule (JZG), a Chinese herbal formula, in patients with nonalcoholic fatty liver (NAFL). Methods. A multicenter, randomized, double-blind, placebo-controlled, parallel clinical trial was conducted for 24 weeks in 224 patients with NAFL at 6 university-affiliated hospitals. Patients were randomized 1 : 1 to receive JZG and placebo, respectively. Primary outcome was the change of liver to spleen ratio (L/S ratio) over computed tomography (CT). Secondary outcomes included body mass index (BMI), serum triglyceride (TG), and total cholesterol (TC) levels. Results. Of all the 224 eligible patients, 221 patients were analyzed in the full analysis set (FAS), 205 in the per protocol set (PPS), and 3 patients were withdrawn prematurely. For FAS, JZG significantly increased L/S ratio from 0.74 ± 0.21 to 0.99 ± 0.24 compared to that from 0.79 ± 0.18 to 0.85 ± 0.27 in placebo group (P = 0.0011). For PPS, it showed an increase of 0.26 ± 0.23 of L/S ratio in the patients on JZG versus 0.07 ± 0.22 in those on placebo (P = 0.0003). Superiority of JZG over placebo was also observed with greater reduction in BMI (P < 0.05) in both FAS and PPS. No observable difference in decrease of serum TC and TG was recorded (P > 0.05). There were no serious adverse events (AEs) in the study process and safety indices were normal in both groups. Conclusions. The Chinese herbal formula JZG was found to be superior to placebo in increasing L/S ratio and reducing BMI in NAFL patients. It was also well tolerated in patients and might be a safe and effective medicine for NAFL.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Patient flow diagram of the 2 trial groups.
Figure 2
Figure 2
Changes in secondary outcomes (FAS) of the treatment. (a) BMI: body mass index. *P < 0.05 versus baseline. **P < 0.05 versus baseline; (b) serum TG: triglyceride; (c) serum TC: total cholesterol.
See this image and copyright information in PMC

References

    1. Angulo P. Medical progress: nonalcoholic fatty liver disease. The New England Journal of Medicine. 2002;346(16):1221–1231. - PubMed
    1. Ruhl CE, Everhart JE. Epidemiology of nonalcoholic fatty liver. Clinics in Liver Disease. 2004;8(3):501–519. - PubMed
    1. Nugent C, Younossi ZM. Evaluation and management of obesity-related nonalcoholic fatty liver disease. Nature Clinical Practice Gastroenterology and Hepatology. 2007;4(8):432–441. - PubMed
    1. Marchesini G, Brizi M, Blanchi G, et al. Nonalcoholic fatty liver disease: a feature of the metabolic syndrome. Diabetes. 2001;50(8):1844–1850. - PubMed
    1. Malaguarnera M, Di Rosa M, Nicoletti F, Malaguarnera L. Molecular mechanisms involved in NAFLD progression. Journal of Molecular Medicine. 2009;87(7):679–695. - PubMed

LinkOut - more resources