Impact of Herbal Preparations on Outcomes of Highly Active Antiretroviral Therapy: A One-Year Prospective Cohort Study.

OBJECTIVE: To investigate the impacts of two herbal preparations for human immunodeficiency virus/aquired immune deficiency syndrome (HIV/AIDS) patients, Shenling Fuzheng Capsule (, SLFZC) and Qingdu Capsule (, QDC), on the efficacy of highly active antiretroviral therapy (HAART). METHODS: HIV/AIDS patients met the criteria were all enrolled in a 1-year cohort study, in which patients receiving HAART alone were designated as Group A, those receiving HAART in combination with SLFZC were designated as Group B, and those receiving HAART in combination with QDC were designated as Group C, 100 cases in each group. The dose of SLFZC was 1.48 g (4 capsules), 3 times daily, and QDC 1.56 g (4 capsules), 3 times daily. T cell subsets, HIV RNA and HIV-1 drug resistance were detected at enrollment and 1 year after treatment. Patients were followed up every 3 months, during which side-effects and other clinical data were recorded. RESULTS: After 1-year treatment, the median increment in CD4 counts was 165.0, 178.0 and 145.0 cells/µL for Group A, B and C, respectively. HIV RNA was undetectable in 94% of patients in Group A, 96% in Group B and 92% in Group C. There were no differences regarding the increment in CD4 counts, HIV RNA and frequency of HIV-1 drug resistance mutations. Two of the 14 suspected side-effect symptoms, i.e. fatigue and dizziness, were lower in Groups B and C than in Group A (P<0.05, respectively) CONCLUSIONS: SLFZC and QDC do not have a negative impact on immunological and virological response to HAART; however, these preparations are not as potent in reducing HAART-associated side-effects as anticipated.

Clinical application of fast-track surgery with Chinese medicine treatment in the devascularization operation for cirrhotic portal hypertension.

OBJECTIVE: To investigate the clinical effect of fast-track surgery combined with Chinese medicine treatment in devascularization operation for cirrhotic esophageal varices. METHODS: Seventy-two patients with cirrhotic esophageal varices were selected from January 2009 to June 2013, and randomly assigned to a conventional group and a fast-track group (fast-track surgery combined with Chinese medicine treatment) using a randomized digital table, 36 cases in each group. Operation and anesthesia recovery time, postoperative hospitalization and quality of life were recorded and compared between groups during the perioperative period. RESULTS: Compared with the conventional group, the fast-track group had longer operation time (253.6±46.4 min vs. 220.6±51.0 min) and anesthesia recovery time (50.5±15.9 min vs. 23.5±9.6 min; P<0.01); less bleeding (311.3±46.8 mL vs. 356.2±57.5 mL; P<0.01) and less transfusion (1932.3±106.9 mL vs. 2045.6±115.4 mL; P<0.01); as well as faster recovery of gastrointestinal function, shorter postoperative hospitalization and higher quality of life. There were no serious postoperative complications and no further bleeding occurred. CONCLUSION: Fast-track surgery combined with Chinese medicine treatment is a safe and feasible approach to accelerate the recovery of patients with cirrhotic portal hypertension in perioperative period of devascularization operation.

Treatment of posthepatitic cirrhosis by Fuzheng Huayu Tablet for reinforcing qi and resolving stasis.

OBJECTIVE: To investigate the efficacy and safety of the Fuzheng Huayu Tablet FZHYT), which is used to reinforce qi and resolve stasis in patients with posthepatitic cirrhosis (PHC). METHODS: A multicenter, randomized, controlled clinical trial was conducted in 180 patients with PHC. The patients were randomly assigned using random numbers to a treatment group treated with FZHYT and a placebo group; the treatment course was 6 months for both groups. Overall response, adverse events (AEs), and the 2-year survival rate were assessed after treatment. Evaluations were made on changes in liver function, liver fibrosis, coagulation, hemodynamics, degrees of esophagogastric varices, ascites, quality of life (QOL), and scores of main symptoms. RESULTS: The overall response was significantly higher in the treatment group than the placebo group (86.7% vs. 62.2%, P<0.01). Patients in both groups had significant improvements in liver function [total bilirubin (TBIL), albumin (ALB)], liver fibrosis [hyaluronic acid (HA), type IV collagen (CIV)], coagulation [prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), and thrombin time (TT)], hemodynamics portal venous flow (PVF), and splenic vein flow (SVF) after treatment. Between-group comparisons showed that compared with the placebo group patients in the treatment group achieved significantly greater improvements in TBIL, ALB, HA, C IV, PT, APTT, PVF, SVF, time to ascites resolution, 2-year survival, QOL, and symptom scores (P<0.05 or P<0.01). There were no significant AEs during the treatment. CONCLUSION: FZHYT is effective and safe for the treatment of hepatic cirrhosis as it is associated with improved liver function, liver fibrosis, coagulation, portal hypertension state, QOL, 2-year survival rate, and fewer AEs.

A clinical study of weining granules in the treatment of gastric precancerous lesions.

OBJECTIVE: To investigate the clinical effects of Weining granules on gastric precancerous lesions (GPLs). METHODS: 120 patients with GPLs were randomly assigned in a 1:1 ratio to receive Weining granules (trial group) or the comparator Weifuchun tablets (control group) for 6 months. Outcomes were compared between the two groups including: overall response; gastroscopically-determined response; pathologically-confirmed response; eradication of Helicobacter pylori (HP); microvessel density (MVD) in the gastric mucosa; expression of vascular endothelial growth factor (VEGF); interleukin 2 (IL-2); interleukin 6 (IL-6); T lymphocyte subsets; immunoglobulins; symptom scores; quality of life (QOL); and adverse reactions. RESULTS: Patients in the trial group had a significantly higher (P < 0.05) overall response rate (81.7%) as compared with those in the control group (63.3%). Relative to treatment with Weifuchun tablets treatment with Weining granules resulted in a significant improvement (P < 0.05) in the scores for gastric pain, distension and stuffiness in the hypochondrium, and anorexia. As compared with the tablets the granules were associated with a significantly higher overall gastroscopically-determined response rate (78.3%; P < 0.05). Pathological examination of tissue samples indicated that 61.7% of patients receiving the granules were cured with an overall response rate of 75.5%; these rates were significantly higher than in the control group (P < 0.05). In comparison with patients receiving the tablets, those given the granules were significantly more likely to have their HP eradicated (75.0% vs. 51.4%; P < 0.05). Improvements in MVD, VEGF, CD4+, CD4+/ CD8+, IL-2, IL-6 and IgG were significantly greater with the Weining Granules than with the Weifuchun tablets (P < 0.05 or P < 0.01). After follow-up of 1 year, 17.5% of patients in the trial group relapsed as compared with 39.5% in the control group (P < 0.05). Relative to the control group, the trial group showed significantly greater improvements in physical, psychological and social relationships, and in environmental domains (P < 0.05 or P < 0.01). No significant adverse reactions were observed during treatment. CONCLUSION: The Weining granules appear to be effective in improving the gastric precancerous state and the main symptoms, in inhibiting angiogenesis, enhancing immune function and QOL, and in reducing 1-year relapses. In addition, this preparation seems to be associated with a low risk of adverse events, making it a safe and efficacious option for the treatment of GPLs.

Influence of Fuzheng Huayu Tablet on mental state and social function of patients with post-hepatitis B liver cirrhosis.

OBJECTIVE: To observe the influence of Fuzheng Huayu Tablet on mental state and social activity of patients with post-hepatitis B liver cirrhosis (LC-HB). METHODS: Adopting grouped randomized double-blinded control method, 180 LC-HB patients in 3 research centers were distributed to 2 groups, the treated group and the control group, 90 in each group. Patients in the treated group were administered with FZHYT; while those in the control group treated with conventional therapy combined with placebo, the course for all patients were 6 months. Their mental state and social activity were evaluated before treatment, after 3 months' treatment and at terminal of the 6-month therapeutic course by estimating with Zung self-rating anxiety scale (SAS), self-rating depression scale (SDS) and social deficit screening scale (SDSS). Additionally, the basic demographic materials, liver function, cirrhosis index, hepatic and splenic images, blood coagulation function, etc. in the patients were tested and compared as well. RESULTS: As compared with before treatment, the normal rate of SAS and SDS scores increased and the social deficit rate decreased in the treated group significantly after treatment, showing statistical significance (P<0.05 or P<0.01); while in the control group, change was only shown in the social deficit (P<0.01), inter-group comparisons after treatment showed significant differences in all the three indexes (P<0.05 or P<0.01). Additionally, after treatment, levels of liver function, cirrhosis, blood coagulation function and splenomegaly in the treated group were all improved significantly P<0.05 or P<0.01), and the improvements were better than those in the control group (P<0.01) in levels of total bilirubin (TBIL), albumin (ALB), type IV collagen (IV-C), prothrombin time (PT), prothrombin activity (PTA). CONCLUSION: Most patients of LC-HB have mental disturbance and social activity deficit, which could definitely be improved by intervention with Chinese FZHYT.

Effects of the Ganning formula on liver fibrosis in patients with chronic hepatitis B.

OBJECTIVE: To investigate the clinical efficacy and safety of the Ganning formula for the treatment of liver fibrosis in patients with chronic hepatitis B. METHODS: In a multicenter, randomized, controlled clinical trial, 150 patients with liver fibrosis secondary to hepatitis B virus (HBV) infection were randomly assigned in equal numbers to receive either the Ganning formula (a Chinese herbal decoction; active treatment group) or oral entecavir (control group) for two 3-month courses. Patients were monitored for any treatment-induced changes in liver function test parameters (ALT, AST, and GGT), liver fibrosis markers (LN, HA, IV-C, and PCIII), HBV DNA level, hepatosplenic imaging, quality of life scores, or psychological and social functioning scores. Patients were also observed for any adverse effects. RESULTS: After treatment, patients in both groups experienced significant improvements in liver function, HBV DNA load, hepatosplenic B-mode ultrasonography, quality of life, and psychological and social functioning (P < 0.05 or P < 0.01). Patients receiving the Ganning formula achieved greater improvements in HA, IV-C, quality of life, and psychological and social functioning compared with those on entecavir (P < 0.05 or P < 0.01). There were no abnormal changes in blood tests, urine, feces, renal function, or electrocardiogram. Additionally, no adverse effects were observed in any patients in either group. CONCLUSIONS: The Ganning formula appears to have the potential to inhibit liver fibrosis and therefore improve liver function by inhibiting HBV replication in patients with chronic hepatitis B. Additionally, this formula is helpful in improving quality of life and psychological and social functioning.