BACKGROUND/RATIONALE:
The Veterans Health Administration (VHA) is the largest single provider of hepatitis C (HCV) care in the United States. In 2008, there were 147,352 Veterans with chronic HCV who received care at the VHA. Many of these individuals experience physical and psychological symptoms such as pain, fatigue and depression that adversely affect their quality of life (QOL). This is an enormous public health issue for the VA. Effective symptom management in this large population of Veterans with HCV is a very important goal for VA clinicians. Acupuncture, if effective could provide a safe therapy either alone or as an adjunct with pharmacological therapy for the treatment of these symptoms. As such, acupuncture may have the potential to improve the QOL for the large Veteran population with HCV.

OBJECTIVE(S):
(1) Determine the acceptability, adherence and feasibility of group acupuncture therapy for symptom management (fatigue, depression and pain). (2) Explore and describe symptom (depression, pain, and fatigue) changes over time, particularly week to week variability, in order to inform power and statistical methods for a larger randomized trial (RCT). (3) Test the range and variability of symptom measures in this patient group, and effect of inclusion and exclusion criteria on sample size, in order to inform a RCT. (4) Describe, using qualitative methods, the experience of undergoing group acupuncture therapy for symptom management in order to refine procedures for a RCT.

METHODS:
DESIGN
Prospective descriptive, longitudinal, mixed method design using quantitative and qualitative methods.

SETTING
Veterans with HCV who received outpatient care at the Portland VA Medical Center.

PARTICIPANTS
Sample size of 46 Veterans - 30 with HCV only and 16 with HCV on antiviral therapy.

INCLUSION CRITERIA:
1. Male or female age 18 or older.
2. Detectable HCV viral load.
3. Currently on antiviral therapy.
4. Documented minimum level of one of the primary symptoms:
a. Personal report of chronic pain.
b. Personal report of fatigue - baseline Brief Fatigue inventory (BFI) score of 4.
c. Report of symptoms of depression or anxiety - Center for Epidemiological Studies Depression Scale (CES-D) 15.

EXCLUSION CRITERIA:
1. Currently receiving acupuncture treatments.
2. De-compensated liver disease - Childs B or C.
3. Cognitive impairment - Score of 24/30 or less on the Folstein McHugh Mini-Mental Status Examination.
4. History of non-compliance with appointments - missed > 50% of liver clinic appointments/ past one year.
5. Unstable psychiatric illness (e.g., unstable schizophrenia, suicidal ideation).

INTERVENTION
Participants received a maximum of 16 acupuncture sessions over eight weeks. Acupuncture was offered four times each week in a two hour drop-in group setting. Acupuncture treatment consisted of primarily auricular acupuncture points, in the style of the National Acupuncture Detoxification Association protocol.

MEASUREMENTS/OUTCOME MEASURES
We utilized quantitative and qualitative methods to determine the acceptability, feasibility and adherence of acupuncture therapy for symptom management. Quantitative outcome variables were depression (CES-D), pain (Visual Analogue Pain Scale), fatigue (BFI), number of symptoms (Memorial Symptom Assessment Scale Short form), and quality of life (Veterans Rand 36 Item Health Survey). Data were collected at baseline, weeks 2, 4, 6, 8 and at week 1 and 2 post intervention. A subset of 15 individuals participated in two semi-structured qualitative interviews, focusing on the group acupuncture experience.

ANALYSIS
Content analysis was used for the qualitative interviews. Analysis of the quantitative data obtained from the questionnaires is ongoing.

FINDINGS/RESULTS:
Enrollment: We had anticipated enrolling 20 Veterans with HCV and 20 Veterans with HCV on antiviral therapy. However, before enrollment began, the antiviral therapy regimen changed. Telaprevir was added to the 48 week treatment regime. Telaprevir added significant debilitating side effects. Many individuals on antiviral therapy were too debilitated to participate in the research study. We were only able to recruit 16 individuals. We expanded the sample of HCV-only Veterans to 30 individuals and were successful in quickly recruiting this number. Forty-one men and five women were enrolled, mean age was 58 years,

Recruitment: Our goal had been to complete recruitment in 18 months; 46 individuals were recruited in a 12 month period. In the HCV/antiviral therapy group all 16 were enrolled in the first 7 months.

Adherence: The benchmark adherence proportion was set at attendance of 80% of all sessions. The adherence proportion for the HCV only group (n=30) was 74.5%. Two participants dropped out during their first week because of serious personal events not related to the study. Adherence for the HCV/antiviral therapy group (n=16) was 69.9%.

QUALITATIVE RESULTS
A primary aim of this study was to describe the acceptability and feasibility of offering acupuncture in a group setting. We found that group sessions were acceptable for a majority of the Veterans. Individuals enjoyed the camaraderie they experienced in the group. The shared experience promoted a supportive and empathetic environment for a majority of the Veterans. The social support aspect of the group may have also contributed to the treatment effect. While most Veterans enjoyed the group dynamics, others found it to be a distraction. Many suggested that a quiet room or quiet section in a larger room be available. Several of the women suggested that a "woman only session" be offered in future studies. In the interviews, many Veterans volunteered that because they were coming for the acupuncture they engaged in other VA services such as blood draws, scheduling appointments, attending other appointments, pharmacy and other testing. Veterans stated that they might not have engaged in these services if they had not been coming for acupuncture. What is not known is if offering acupuncture would be sufficient motivator to engage Veterans who do not routinely participate in VA services.

IMPACT:
This pilot study suggests that a RCT using group acupuncture would be feasible and acceptable to Veterans. Study design modifications in a RCT will include offering gender specific sessions, attention to the size of groups and environment in which acupuncture is delivered, and having both a quiet space and a conversation space. Finally, our data suggests that a conceptual model of positive treatment effects of group acupuncture might include the group experience which may provide social support and enhance attitudes towards and engagement with VA health care.

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External Links for this Project

NIH Reporter

Grant Number: I01HX000418-01A1
Link: https://reporter.nih.gov/project-details/8202883

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PUBLICATIONS:

Journal Articles

1. Taylor-Young P, Miller D, Ganzini LK, Golden S, Hansen L. Feasibility and Acceptability of Group Acupuncture in Veterans with Hepatitis C: A Pilot Study. Medical acupuncture. 2014 Aug 22; 26(4):208-214. [view]

Conference Presentations

1. Taylor-Young P. Feasibility and Acceptability of Group Acupuncture in Veterans with Hepatitis C: A Pilot Study. Poster session presented at: Western Institute of Nursing Annual Meeting; 2014 Apr 10; Seattle, WA. [view]

DRA: Other Conditions
DRE: Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: none
MeSH Terms: none