Current Sho-saiko-to Clinical Trial Information

Medical studies are now being conducted in North America based on the acceptance and usage of Sho-saiko-to for serious liver concerns by the medical establishment in Japan. You can click on the links below to get more information about these studies:

Progressive Alternative Medicine Solution Undergoes Clinical Trials and Holds Promise of Benefiting Millions of Americans with Hepatitis C

Tuesday May 23, 12:00 pm ET

PHOENIX--(BUSINESS WIRE)--May 23, 2006--An estimated five million Americans have been infected with hepatitis C virus (HCV) according to a study published at the Liver Meeting by the American Association for the Study of Liver Diseases (AASLD) in November 2005. Chronic hepatitis C is associated with significant morbidity (liver cirrhosis and hepatocellular carcinoma) and mortality. Current treatment is based on interferon and ribavirin. However, treatment options are limited for patients who are not candidates for interferon-based therapy, particularly for those who suffer from HCV genotype 1 infection.

Sho-saiko-to, a standardized herbal formula, is under a clinical phase II trial by a leading New York Cancer Research Institute to determine its effect on hepatitis C patients. The research group has reported the preliminary results of 15 patients at the 2nd Society of Integrative Oncology Conference in San Diego on November 10, 2005. This study is titled "Sho-saiko-to for Patients with Chronic Hepatitis C Who Are Intolerant to or Have Contraindication to Interferon-Based Therapy: A Phase II Study." Sho-saiko-to is known to have anti-fibrotic effect by inhibition of lipid peroxidation in hepatocytes and stellate cells in animal studies. It has also been shown to reduce aminotransferase levels and the incidence of hepatocellular carcinoma in hepatitis and liver cirrhosis patients.

According to the design of the clinical trial, 31 patients will receive Sho-saiko-to daily for 52 weeks. Fifteen patients have completed the treatment and the preliminary results have been reported. No serious adverse events have been attributed to Sho-saiko-to among any patients who enrolled in the trial. Among the 15 patients who completed the study, reductions in alanine aminotransferase (ALT) were observed in 11 patients and aspartate aminotransferase (AST) in 10 patients. In 10 patients, the liver biopsy showed 20% improvement on histological assessment of the liver. This is consistent with the findings by the Japanese researchers for its anti-inflammatory effect. More interestingly, the majority of the patients whom participated in the clinical trial were genotype 1 infection.

In Japan, over 75% of physicians use at least some of the traditional herbal formulas. Over 1.5 million Japanese patients with hepatitis have been treated with Sho-saiko-to.

Phase II Study of Sho-saiko-to in Patients with Chronic Hepatitis C Who Cannot Use Interferon

Here is the press release information regarding this study:

Initial Results Reported in Clinical Study of Honso® Sho-saiko-to (H09) for Hepatitis C; Data Presented at the First Annual Society of Integrative Oncology Conference New York

November 28th 2004. Phoenix Arizona. A Japanese herbal product, Sho-saiko-to (H09), is under a clinical phase II trial by Memorial Sloan-Kettering Cancer Center to determine its effect on hepatitis C patients. The preliminary results of the trial have been reported at the 1st Annual Society of Integrative Oncology Conference in New York on November 18th, 2004. The testing herbal product, Honso® Sho-saiko-to (H09), is manufactured and supplied by Honso Pharmaceutical Co., Ltd. headquartered in Nagoya Japan and branched in Phoenix, Arizona.

Chronic hepatitis C is associated with significant morbidity (liver cirrhosis and hepatocellular carcinoma) and mortality. Current treatment is based on interferon and ribavirin. However, treatment options are limited for patients who are not candidates for interferon-based therapy. This study is entitled “Sho-saiko-to for Patients with Chronic Hepatitis C Who Are Intolerant to Or Have Contraindication to Interferon-Based Therapy: A Phase II Study”. Sho-saiko-to has been demonstrated in anti-fibrotic effect by inhibition of lipid peroxidation in hepatocytes and stellate cells in animal studies. It has also been shown to reduce aminotransferase levels and the incidence of hepatocellular carcinoma in hepatitis and liver cirrhosis patients.

According to the design of the clinical trial, 31 patients will receive Sho-saiko-to (H09) granules at 2.5 grams three times daily for 52 weeks. Ten patients have completed the treatment and the preliminary results have been reported. No serious adverse events have been attributed to Sho-saiko-to (H09) among all patients who enrolled in the trial.

Among the 10 patients who completed the study, reductions in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were observed in 8 patients, and reduction of viral load was observed in 4 out of 7 detectable patients. . This suggests anti-inflammatory and anti-viral activity. Liver biopsy response is defined as decrease in Knodell score of 2 points or more after the treatment in a blind fashion by an expert pathologist. The histologic responses were observed in 2 of the 10 patients who completed the study. This suggests anti-fibrotic effect in chronic hepatitis C patients.

Safety and Tolerability of Sho-saiko-to (SST) in Patients with Compensated Cirrhosis Due to Chronic HCV Infection, A Double blinded Phase II Trial

Here is the press release information regarding this study:

The Second Clinical Trial of Honso® Sho-saiko-to (H09) on Patients with Liver Cirrhosis Caused by Hepatitis C Begins at USCD Liver Center

Oct. 1. 2004. Phoenix, Arizona. The stability and tolerability of the Japanese herbal formula Honso® Sho-saiko-to (H09) will be tested in patients with cirrhosis of the liver due to chronic hepatits C virus (HCV) infections. This will be a Phase II trial led by Tarek Hassanein, M.D., Chief of Hepatology and Liver Transplant at UCSD Medical Center. The researchers at UCSD plan to determine the effects of Sho-saiko-to (H09) on patients with compensated cirrhosis. The main focus of this study will be evaluating the anti-fibrotic effect and tolerability of Sho-saiko-to (H09) in the patients.

The UCSD trial is a double blinded and placebo controlled phase II study with an IND from the Food and Drug Administration (FDA). There will be 40 patients taking part in this trial, 20 will receive Sho-saiko-to (H09) and the other 20 will receive placebo. A medical history exam, lab data, lung function test, and chest x-ray will be evaluated during the screening visit. Patients will return for evaluation at weeks 1, 2, 4, 8, 12, 18, 24 after initial dosage is given and then every 8 weeks until week 48.

Quality of Life and other parameters will be evaluated throughout the trial. Tarek Hassanein, MD., at UCSD sums up his thoughts on the trial by stating: “We’re excited about starting the study using Honso Sho-saiko-to in patients with liver cirrhosis, secondary to hepatitis C infection. It is important to investigate complimentary medicine in a scientific base. We look forward to evaluating Sho-saiko-to for its previously reported anti-fibrotic and chemopreventive effects in cirrhotic patients.”

Dan Wen, MD., the President of Honso USA, Inc. stated his opinions: “I am very excited about working together with Dr. Tarek Hassanein and the talented team of researchers at the UCSD Medical Center. This is an important next step after our first trial at Sloan-Kettering Cancer Center, which is studying the effects of Sho-saiko-to (H09) on Hepatitis C patients.

We are now furthering our knowledge on the Sho-saiko-to (H09) formula by researching its effects on cirrhosis of the liver. Most importantly, we will be able to assess the safety issue of the herbal formula as the side effect of pneumonitis has been reported in Japan in the mid-90’s. So far, the patients that are on or finished the treatment at the Sloan-Kettering trial have not reported any side effects. This UCSD trial will address the safety issue among the cirrhosis patients, which will greatly help us to understand the herbal formula”.