Acupuncture as an Adjunctive Treatment for Hepatitis C Patients

December 12, 2012 updated by: Assy Nimer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Safed, Israel, 13100
        • Ziv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group - acupuncture treatment
Device: Acupuncture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assy Nimer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 12, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0094-12-ZIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acupuncture

Clinical Trials on Acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe