The effect of acupuncture on people with hepatitis C virus : a randomised controlled pilot study

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Background: The use of Complementary and Alternative Medicine (CAM) in Australia has been steadily increasing. This has resulted in many people infected with Hepatitis C Virus (HCV) consulting CAM practitioners in the hope of alleviating some of the debilitating symptoms associated with this viral infection. Chronic symptoms often lead to a reduction in everyday functional health producing a lower quality of life compared with healthy population norms or patients with other forms of liver disease. Current recommended pharmaceutical treatment has a sustained virological response in approximately 50-60% of patients. Also large numbers of people are either not suitable candidates or intolerant to treatment or do not choose this option. In the mid 1990s, HCV residents in a Sydney alcohol and drug rehabilitation centre who were also receiving auricular (ear) acupuncture as part of their rehabilitation program, verbally reported decrease in their alanine aminotransferase (ALT) blood levels after approximately 16 acupuncture treatments administered over a three month period (Berle 1997). Objective: To investigate whether 24 acupuncture treatments over a twelve week period has an effect on the health outcomes of people with HCV. Design: A randomised single blind controlled pilot study with two parallel arms. Participants: Sixteen applicants who met the eligibility criteria and agreed to participate in the study were randomised into either treatment or control group. Outcome measures: The primary outcome measure was ALT blood levels at the completion of treatment (week 12), weeks 16 and 20. The secondary outcomes were HCV PCR quantitative (viral load test) and hepatitis quality of life (QoL) questionnaire. In addition a HCV Traditional Chinese Medicine (TCM) pattern questionnaire, acupuncture treatment credibility questionnaire and acupuncture needling sensation questionnaire were administered. Setting: Participants were offered treatment at two clinic locations; a private clinic at Guildford and at the University of Technology, Sydney (UTS) city campus. Blinded serum pathology/testing was conducted through independent Douglass Hanly Moir Pathology clinics. Treatment: Sixteen HCV participants were randomly allocated to two groups; one group receiving verum acupuncture treatment and the other receiving invasive sham acupuncture treatment. The treatment methodology involved the development of a TCM pattern differentiation diagnostic/outcome measure which identified 17 TCM/HCV patterns. One participant (treatment group) left the study after eight treatments due to work commitments. Results: No significant change was found between the two groups for ALTs, viral load or any domains of the QoL measure. The TCM pattern questionnaire identified the primary, secondary and tertiary TCM pattern expressions for HCV within the study group. On completion of the treatment phase there was a significant reduction in the secondary and tertiary TCM pattern expression for the treatment group (p=0.045 and 0.037 respectively). No significant change was found for the control group. The acupuncture credibility questionnaire identified that neither the treatment nor control group identified the type of treatment they had received; however the treatment group did perceive their treatment as more credible than the control group at week 12. There was no significant difference found between or within the two groups for the acupuncture needling sensation questionnaire. Conclusions: Despite the small number of participants and no significant changes for ALTs, viral load or any domains of the QoL there was a significant difference in the secondary and tertiary TCM patterns.
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