Preliminary report of a randomized, double-blind placebo- controlled trial of a Chinese herbal medicine preparation CH-100 in the treatment of chronic hepatitis C
The treatment of chronic hepatitis C is relatively unsatisfactory and many patients have turned to unproven alternative medicines to modify the course of their illness. We report a study of a Chinese herbal medicine preparation CH-100 in the management of chronic hepatitis C. Patients with documented chronic hepatitis C were randomly allocated to receive active herbal or placebo tablets (five tablets thrice daily). Patients were followed monthly and evaluated by a Western and a traditional Chinese medical practitioner. Therapy was monitored by measurement of liver function tests, creatinine and full blood count on a monthly basis. Twenty patients in each group were well matched for age, sex, duration of illness, previous interferon therapy and alcohol intake. Active Chinese herbal medication was associated with a significant reduction in alanine aminotransferase (ALT) levels over the 6 month study period (P < 0.03). No patient cleared the virus but four normalized their ALT on treatment. Appropriately prescribed Chinese herbal medicine may have a role in the management of chronic hepatitis C and further controlled studies are indicated.
[Show abstract] [Hide abstract] ABSTRACT: Traditional Chinese medicine (TCM) is an integral part of mainstream medicine in China. Due to its worldwide use, potential impact on healthcare and opportunities for new drug development, TCM is also of great international interest. Recently, a new era for modernisation of TCM was launched with the successful completion of the Good Practice in Traditional Chinese Medicine Research in the Post-genomic Era (GP-TCM) project, the European Union's Seventh Framework Programme (FP7) coordination action on TCM research. This 3.5-year project that involved inputs from over 200 scientists resulted in the production of 20 editorials and in-depth reviews on different aspects of TCM that were published in a special issue of Journal of Ethnopharmacology (2012; volume 140, issue 3). In this narrative review, we aim to summarise the findings of the FP7 GP-TCM project and highlight the relevance of TCM to modern medicine within a historical and international context. Advances in TCM research since the 1950s can be characterised into three phases: Phase I (1950s-1970s) was fundamental for developing TCM higher education, research and hospital networks in China; Phase II (1980s-2000s) was critical for developing legal, economic and scientific foundations and international networks for TCM; and Phase III (2011 onwards) is concentrating on consolidating the scientific basis and clinical practice of TCM through interdisciplinary, interregional and intersectoral collaborations. Taking into account the quality and safety requirements newly imposed by a globalised market, we especially highlight the scientific evidence behind TCM, update the most important milestones and pitfalls, and propose integrity, integration and innovation as key principles for further modernisation of TCM. These principles will serve as foundations for further research and development of TCM, and for its future integration into tomorrow's medicine.0Comments 17Citations
- "...products were shown to be efficacious in the treatment of irritable bowel syndrome and hepatitis C [58,59]. These clinical trials, among others, set important milestones for the overseas use of Chinese h..."In Japan, double-blind placebo-controlled trials showed two kampo drugs to be both safe and efficacious in the treatment of constipation and perennial nasal allergy . In Australia, two TCM products were shown to be efficacious in the treatment of irritable bowel syndrome and hepatitis C [58,59]. These clinical trials, among others, set important milestones for the overseas use of Chinese herbal medicine.
- "... with a significant reduction in ALT levels, although no treated person cleared the virus (Batey et al., 1998). The National Center for Complementary and Alternative Medicine (NCCAM) is currently supporting a ..."Transforming growth factor β and collagen type I, III, and IV gene transcripts were reduced while matrix metalloproteinase I was increased, suggesting a reversal of early stages of cirrhosis through the correction of imbalance in the dynamics of synthesis and degradation of the extracellular matrix (Jia et al., 1996a,b; Wang et al., 1998). In a double-blind, placebo-controlled trial involving patients with chronic hepatitis C, treatment with the CH-I00 (a formulation of 19 different herbs) was associated with a significant reduction in ALT levels, although no treated person cleared the virus (Batey et al., 1998). The National Center for Complementary and Alternative Medicine (NCCAM) is currently supporting a study of a 10-herb combination, referred to as 3AR.
[Show abstract] [Hide abstract] ABSTRACT: Spirulina platensis, a cynobacterium used frequently as a dietary supplement had been found to exhibit many immune-stimulating and antiviral activities. It had been found to activate macrophages, NK cells, T cells, B cells, and to stimulate the production of Interferon gamma (IFN-γ) and other cytokines. Natural substances isolated from Spirulina platensis had been found to be potent inhibitors against several enveloped viruses by blocking viral absorption/penetration and some replication stages of progeny viruses after penetration into cells. We aimed to study whether this dietary supplement possesses any therapeutically feasible activity worthy of further larger controlled clinical evaluation. Sixty six patients with chronic hepatitis C virus infection and eligible for inclusion had been randomized to either Spirulina or Silymarin treated groups for a period of six months treatment.The two groups were followed up and blindly compared for early (after 3 months) and end of 6 months treatment virological response. The effects of both treatments on each of alanine aminotransferase (ALT), Chronic Liver Disease Questionnaire scores (CLDQ), Arizona Sexual Experience Scale scores (ASEX) and the occurrence of any attributable adverse events were also compared. Among the 30 patients who had been treated with Spirulina and completed the 6 months protocol, 4 patients (13.3%) had a complete end of treatment virological response and 2 patients (6.7%) had a partial end of treatment response defined as significant decrease of virus load of at least 2-logs10. Though the proportion of responders in Spirulina group was greater than in the Silymarin group, the difference was not statistically significant at the end of both 6 months (p = 0.12) and 3 months treatment (p = 0.22) by Exact test. Alanine aminotransferase as well as CLDQ and ASEX scores were found to be more significantly improved in Spirulina than in Silymarin treated group. Our results could suggest a therapeutically feasible potential for Spirulina platensis in chronic HCV patients, worthy to conduct a larger sized and longer study to confirm these safety and efficacy encouraging results. WHO Clinical Trial Registration ID: ACTRN12610000958088http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12610000958088.0Comments 11Citations
- "... in the treatment of viral hepatitis, Glycyrrhizin, Silymarin, Curcumin, Schiszandra are examples1415161718. Spirulina is a blue-green alga (cyanobacterium) that has been consumed as food in many count..."An alternative treatment which is less costly, safer and more efficacious is being the search of many research authorities al-over the world. Many herbal products had been studied and proved to offer some hepatoprotective activity and showed some benefits in the treatment of viral hepatitis, Glycyrrhizin, Silymarin, Curcumin, Schiszandra are examples1415161718. Spirulina is a blue-green alga (cyanobacterium) that has been consumed as food in many countries since ancient times.
- [Show abstract] [Hide abstract] ABSTRACT: There has been a substantial increase in the use of so-called complementary and alternative therapies by patients with liver disease. Although many such modalities are available, herbal therapies are the most popular, and of these remedies, silymarin extracted from the milk thistle is most widely subscribed to as a remedy for liver diseases. Available evidence points to a potential, but unproven, benefit for this as well as other therapies based on free radical scavenger or antioxidant principles in treating patients with liver disease. These therapies deserve further investigation through experimental studies and well-controlled clinical trials. Benefits to patients from these therapies, especially to patients with established cirrhosis, are most likely to be modest and insignificant. Conversely, the hepatotoxic potential of some alternative treatments is well recognized. As practitioners educating and treating patients with liver disease, we are obliged to be informed about popular alternative therapies, understanding of our patients' need to be partners in their care, and open-minded to the possibility that some benefit may come from some therapies currently regarded as alternative. We need to be effective and tolerant in learning about which alternative treatments our patients are taking, so that we can monitor their effects if any and counsel appropriately against those that may cause harm.0Comments 19Citations
- [Show abstract] [Hide abstract] ABSTRACT: Hepatic fibrosis is a wound-healing process that occurs when the liver is injured chronically. Hepatic stellate cells (HSC) are responsible for the excess production of extracellular matrix (ECM) components. The activation of HSC, a key issue in the pathogenesis of hepatic fibrosis, is mediated by various cytokines and reactive oxygen species released from the damaged hepatocytes and activated Kupffer cells. Therefore, inhibition of HSC activation and its related subsequent events, such as increased production of ECM components and enhanced proliferation, are crucial goals for intervention in the hepatic fibrogenesis cascade. This is especially true when the etiology is unknown or there is no established therapy for the cause of the chronic injury. This review explores the rationale for choosing HSC as a target for the pharmacological, molecular, and other novel therapeutics for hepatic fibrosis. One focus of this review is the inhibition of two cytokines, transforming growth factor-beta and platelet-derived growth factor, which are important in hepatic fibrogenesis. A number of new agents, such as Chinese herbal recipes and herbal extracts, silymarin, S-adenosyl-L-methionine, polyenylphosphatidylcholine, and pentoxifylline are also discussed.0Comments 194Citations
- [Show abstract] [Hide abstract] ABSTRACT: Administration of concanavalin A (Con A) leads to acute hepatitis that involves T-cell activation and inflammatory mediator production in mice and rats. We examined the role of CH-100, a Chinese herbal medicine previously trialed in human hepatitis C, in the prevention of Con A-related, T-cell-mediated, acute liver injury in rats. Female Wistar rats were fed 40% ethanol, 2% sucrose, or isocaloric sucrose for 8 weeks. At the same time, these animals were fed either the Chinese herbal medicine CH-100 (4 tablets/kg body weight/ day) or placebo in chow daily. Blood from the tail vein was collected for endotoxin (lipopolysaccharide) assay at 0, 4, and 8 weeks of ethanol consumption. Twenty-four hours after injection of Con A (20 mg/kg body weight) or phosphate-buffered saline, blood from the tail vein was collected for alanine aminotransferase and tumor necrosis factor (TNF)-alpha assays. Liver-associated CD4+ T cells were isolated from liver perfusates and then cultured with Con A (5 microg/ml) at 37 degrees C for 24 hr. Supernatants were harvested for TNF-alpha assay. The proportion of CD4+ T cells in blood and liver perfusates was measured. Liver samples were collected for histopathological analysis. Lipopolysaccharide levels were significantly reduced in CH-100-treated ethanol-fed rats compared with placebo-treated rats. After Con A injection, alanine aminotransferase levels were lower at 12 and 24 hr in herb-treated rats compared with placebo-treated rats. Furthermore, serum TNF-alpha levels were lower in ethanol-fed rats on herbal treatment. A significant decrease in TNF-alpha production by liver-associated CD4+ T cells in culture was observed in CH-100-treated ethanol-fed rats. CH-100 treatment was associated with a decreased percentage of CD4+ cells in both blood and liver perfusate in all groups. Herb-treated rats displayed markedly less hepatic necrosis and a reduced CD4+ T-cell infiltrate in portal areas than did placebo-fed rats. The results demonstrate that CH-100 modified the T-cell response to Con A injection. The effect was more marked in ethanol-fed rats, which suggests a possible role for CH-100 in treating alcoholic liver disease.0Comments 12Citations