Acupuncture as an Adjunctive Treatment for Hepatitis C Patients
Acupuncture as an Adjunctive Treatment for Hepatitis C Patients
Objective: to study the effect of Acupuncture on liver cirrhosis, SVR and health related
 quality of life in HCV patients receiving standard treatment (Peg Interferon+ Ribavirin).

 Methods: 60 HCV patients receiving standard treatment (Peg Interferon+ Ribavirin) will
 undergo Serologic screening for hepatitis C virus (Anti-HCV EIAs and/or recombinant
 immunoblot assay) plus Transient Ultrasound Elastography (FibroScan) to achieve baseline
 characteristics(17,18,19). Patients will be randomized into intervention and control groups,
 30 patients each.In the Intervention group each patient will receive an acupuncture treatment
 once a week for 12 consecutive weeks(Max 12, Min 8 treatments). Treatment protocol will be
 individualized for each patient according to TCM diagnosis. This treatment protocol is
 acceptable and has been published(20,21,22).In the control group patients will receive
 standard treatment alone, with no other intervention.

 Data collection: after 12 weeks patients will again undergo Serologic screening for hepatitis
 C virus (Anti-HCV EIAs and/or recombinant immunoblot assay) plus Transient Ultrasound
 Elastography (FibroScan) in order to detect changes from baseline and group differences.

 Inclusion criteria: adult patients with a confirmed HCV infection

 Exclusion criteria:

 Under 18 years Can not receive standard Peg interferon+ ribavirin treatment for any reason
 Psychiatric diagnosis Anaemia of hematologic origin Diabetic patient with uncontrolled
 diabetes Congestive heart failure, arrhythmia Hepatocellular carcinoma HIV infection
 Hepatitis B infection Auto immune liver disease or alcoholic liver disease Study duration: 1
 year Study Location: "Ziv" medical center, division of liver disease, Israel
Background:

 Hepatitis C is an infectious disease affecting primarily the liver, caused by the hepatitis C
 virus (HCV). HCV is a worldwide problem, An estimated 130-170 million people worldwide are
 infected with HCV, in Israel there are an estimated 80,000 patients. Most patients infected
 with HCV have chronic liver disease, which can progress to cirrhosis and Hepatocellular
 carcinoma (HCC). Chronic infection with HCV is one of the most important causes of chronic
 liver disease and the most common indication for orthotropic liver transplantation (OLT) in
 the United States. Medical care costs associated with the treatment of HCV infection in the
 United States are estimated to be more than $600 million a year.

 Chronic hepatitis C infection and chronic active hepatitis are slowly progressive diseases
 and result in severe morbidity in 20-30% of infected persons. Although acute HCV infection is
 usually mild, chronic hepatitis results in at least 75% of patients. Cirrhosis develops in
 20-50% of patients with chronic hepatitis C infection. Liver failure and Hepatocellular
 carcinoma can eventually result. Hepatocellular carcinoma occurs in 11-19% of patients . The
 diagnosis of acute or chronic HCV infection generally requires testing of serum for both
 antibody to HCV (anti-HCV) and for HCV RNA. The recombinant immunoblot assay is used to
 confirm HCV infection. A sensitive quantitative HCV RNA assay is recommended for diagnosis
 because it also provides information on the level of virus which is helpful in management of
 the disease.

 Combination therapy with pegylated interferon Alfa (PEG-IFN Alfa) and the nucleoside analogue
 ribavirin is the current standard of care in patients infected with HCV. Treatment of chronic
 HCV infection has 2 goals. The first is to achieve sustained eradication of HCV (ie,
 sustained virologic response [SVR]), which is defined as the persistent absence of HCV RNA in
 serum 6 months or more after completing antiviral treatment. The second goal is to prevent
 progression to cirrhosis, Hepatocellular carcinoma (HCC), and decompensated liver disease
 requiring liver transplantation.

 Adverse effects are common with IFN and ribavirin combination therapy. Approximately 75% of
 patients experience one or more of adverse effects. Common adverse effects are :

 1. Flulike symptoms

 2. Hematologic complications (ie, neutropenia, thrombocytopenia)

 3. Depression

 4. Low grade fever,

 5. Nausea, loss of weight

 6. Neuropsychiatric complications (ie, memory and concentration disturbances, visual
 disturbances, headaches, irritability)

 7. Metabolic complications (gout). Adverse events are a major reason that patients decline
 or stop therapy altogether. Currently there are limited options of managing these side
 effects, while being especially problematic are the flu like symptoms and depression .
 Traditional Chinese medicine(TCM) has been found as an effective treatment for improving
 quality of life in various medical conditions including hepatitis. TCM also positively
 affects chronic inflammation and improves inflammation markers in chronic inflammatory
 diseases such as asthma, crohn's disease, sinusitis and chronic pelvic inflammation .

 Acupuncture's effect on liver cirrhosis, SVR(sustained Viral Response) and health related
 quality of life in chronic HCV patients has yet to be studied.

 Study Aim: to study the effect of acupuncture as an adjunctive treatment for chronic HCV
 patients receiving standard treatment (Peg Interferon+ Ribavirin).
Inclusion Criteria:

 -  Adult patients with a confirmed HCV infection

 Exclusion Criteria:

 -  Under 18 years

 -  Can not receive standard Peg interferon+ ribavirin treatment for any reason

 -  Psychiatric diagnosis

 -  Anaemia of hematologic origin

 -  Diabetic patient with uncontrolled diabetes

 -  Congestive heart failure, arrhythmia

 -  Hepatocellular carcinoma

 -  HIV infection

 -  Hepatitis B infection

 -  Auto immune liver disease or alcoholic liver disease