Acupuncture Clinical Trial
Official title:
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).
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