Feasibility and Acceptability of Group Acupuncture in Veterans with Hepatitis C: A Pilot Study

Abstract

Background:

The Veterans Health Administration (VHA) system is the largest single provider for patients with hepatitis C (HCV) in the United States. Many individuals with HCV experience physical and psychologic symptoms, such as pain, fatigue, and depression. In addition, current antiviral therapy for HCV is long (24–48 weeks) and has many potential side-effects.

Objectives:

The purpose of this pilot study was to determine the acceptability, adherence, and feasibility of group acupuncture in order to inform the development of a larger randomized trial (RCT). The primary aim was to describe the experience of two groups of Veterans undergoing acupuncture for symptom management: (1) Veterans who have HCV and (2) Veterans who have HCV and were currently receiving antiviral therapy.

Materials and Methods:

This study used a prospective descriptive design that involved both quantitative and qualitative methods A total of 39 Veterans—23 in the HCV-only group and 16 in the HCV/antiviral group—were enrolled. Participants received a maximum of 16 acupuncture sessions over 8 weeks. The main outcome measures were semistructured qualitative interviews, attendance, and recruitment records.

Results

: Quantitative results. Adherence proportion for the HCV-only group was 74.5% and 69.9% for the HCV/antiviral therapy group. Qualitative results: Five themes emerged: (1) study participation; (2) barriers to attending acupuncture sessions; (3) timing of acupuncture sessions; (4) receiving acupuncture in a group setting; and (5) engagement and attitude regarding the VHA system.

Conclusions:

This study suggests that a larger RCT, using group acupuncture would be feasible and acceptable to veterans. This article proposes several design modifications for an RCT.

Introduction

Approximately 3.2 million persons in the United States have chronic hepatitis C virus (HCV) infection.¹ The Veterans Health Administration (VHA) is the largest single provider of HCV care in the United States. More than 165,000 Veterans with HCV are currently receiving VHA care. Many individuals with HCV experience significant physical and psychologic symptoms, including depression, anxiety, chronic pain, and fatigue.^2,3 Individuals with HCV frequently report eroding of social support and isolation from family members.⁴ In addition, management of pain is inherently more complex in persons with HCV, particularly in those with substance-use disorders and/or cirrhosis. Effective symptom management in this large population of Veterans with HCV is an important goal for the VHA.

Persons with HCV experience additional serious and debilitating adverse effects caused by antiviral therapy, including irritability and anxiety (33%), fatigue (56%), insomnia (30%), myalgia (37%), and arthralgia (28%).⁵ In addition, major depression occurs in ∼30% of individuals undergoing antiviral therapy.^6–8 As a result, quality of life (QoL) in persons with HCV can be affected adversely not only by their underlying physical and psychologic symptoms, but also by new or exacerbated symptoms resulting from antiviral therapy.

Acupuncture has been used in a variety of populations for managing physical and psychologic symptoms. Studies have shown that acupuncture may reduce pain in several chronic illnesses, including fibromyalgia,⁹ osteoarthritis,¹⁰ chronic shoulder pain,¹¹ and headaches.¹² Acupuncture may diminish symptoms of depression and anxiety in individuals with post-traumatic stress disorder (PTSD),¹³ and lessen symptoms of nausea and fatigue in patients who are receiving chemotherapy.¹⁴ In addition, two studies on acupuncture showed an improvement in QoL in patients with fibromyalgia,⁹ and osteoarthritis.¹⁰

While it is unclear what personal factors might motivate Veterans with HCV to begin acupuncture for symptom management, it is known that substantial interest in acupuncture exists among VHA patients.¹⁵ In a study of 401 Veterans with chronic non–cancer-related pain, 21.2% had used acupuncture in the past and 88.8% were willing to consider acupuncture. To the current authors' knowledge, only two small studies have specifically explored the use of acupuncture for symptom management in individuals with HCV. In a study of 28 individuals with hepatitis B and HCV, Turfan et al. reported in 2010 that acupuncture treatment resulted in a reduction of depressive symptoms and myalgia. These researchers did not, however, report whether the acupuncture was administered in an individual or in a group setting.¹⁶ Another study showed that acupuncture, administered in a group setting, reduced fatigue, muscle aches, irritability, and nausea experienced by 14 Veterans during antiviral therapy.¹⁷

Group acupuncture, if acceptable and feasible, could potentially provide a safe therapy alone or as an adjunct with pharmacologic therapy for treating symptoms experienced by individuals with HCV. As such, acupuncture may have the potential to improve QoL in the large Veteran population with HCV. Larger randomized control trials (RCTs) are needed to evaluate group acupuncture in the Veteran population, but it is unknown if such studies are feasible.

The purpose of this mixed-methods pilot study was to determine the acceptability of, adherence to, and feasibility of group acupuncture therapy in order to inform the development of a larger RCT. The primary aim of this feasibility study was to describe the experience of 2 groups of Veterans undergoing group acupuncture: (1) Veterans who had HCV and (2) Veterans who had HCV and were currently receiving antiviral therapy.

Materials and Methods

Design and Setting

This pilot study used a prospective descriptive design. The qualitative components utilized in this study are especially amenable to obtaining answers to questions related to feasibility and acceptability. This article includes a discussion on the qualitative feasibility data and includes the quantitative data related to adherence and recruitment.

Participants were recruited from outpatient clinics at the Portland Veterans Affairs Medical Center (PVAMC). Institutional review board approval was obtained, and written informed consent was obtained from all participants.

Participants

The study was open to Veterans with HCV who received care at the PVAMC. Potential participants were recruited through study flyers posted in the Medical Center and through referrals from Liver Clinic providers when participants were seen for routine care. Each patient's informed written consent was obtained by the research assistant prior to that patient's first acupuncture session. Eligibility criteria included positive HCV viral load, compensated liver disease, and at least one of the following: personal report of chronic pain; baseline Brief Fatigue Inventory score ≥4; or depression, as measured by the Center for Epidemiologic Studies Depression Scale (CESD), score ≥15. Participants were excluded if they were currently receiving acupuncture elsewhere or had decompensated liver disease (Childs Pugh B or C), cognitive impairment, or unstable psychiatric illness.

Methods

All participants were asked to attend 16 sessions of acupuncture, which involved two sessions per week for 8 weeks. Acupuncture was offered four times each week in a 2-hour drop-in group setting.

In addition, to the research informed consent, participants signed an acupuncture procedure consent form before receiving their first treatment. The acupuncturist assessed each participant by conducting a brief interview and pulse and/or tongue examination, and adapted an acupuncture treatment comprised of a combination of preselected scalp, ear, and body points (see Table 1). The predetermined acupuncture points were National Acupuncture Detoxification Association (NADA) protocol auricular points, scalp acupuncture points, or selected upper-extremity points. All point locations allowed easy acupuncturist access to the points in fully clothed patients in a group setting. Acupuncture treatments using these same points had shown efficacy in symptom management in 2 of the current authors' earlier study of patients with HCV receiving interferon.¹⁷

Table 1.

Preselected Acupuncture Points and General Indications for Use

Acupuncture system	Acupuncture points	Indication
NADA auricular points	Sympathetic, Shen Men, Thalamus, Liver, Kidney & Lung	Anxiety, detoxification & pain
Scalp acupuncture	Foot-motor-sensory	Pain & foot/leg symptoms
	GV 20	Stress
Body acupuncture	LI 4	Immune dysfunction
	LI 11	Low energy, arm/shoulder complaints & allergies
	LU 7	Lung symptoms
	HT 3	Sadness
	HT 5	Anxiety & irritability
	TH 4	Wind symptoms & wrist/hand complaints

NADA, National Acupuncture Detoxification Association

Three physician–acupuncturists provided the treatments and each practitioner used separate styles of acupuncture. Two acupuncturists had had their initial training in energetic acupuncture (i.e., Helm's Medical Institute training) and had been practicing for 9 and 7 years, respectively, and 1 had Traditional Chinese Medicine–style acupuncture training and had been practicing for 8 years. It was felt that standardizing the treatments would make the experience more consistent for the patients.

For each acupuncture treatment, the participant sat fully clothed in a chair. After the acupuncturist developed a treatment plan, the practitioner placed ear and body point needles with a provided guide tube and performed minimal needle manipulation. The needle depth was approximately 1 mm for ear points, 3 mm for body points, and 10 mm for scalp points. Scalp points were placed manually and were left unmanipulated. The acupuncture treatments utilized ∼10 needles in total. For example, a typical treatment could consist of unilateral ear points for Shen Men, Sympathetic, Liver, and Lung, as well as GV 20, and a bilateral LI 4, and TH4. The side of the ear acupuncture generally was alternated between treatments. All needles were sterile, single-use 1-inch stainless steel (Spring-Ten 0.18×25mm). Needles were left in place for 30–40 minutes. The acupuncturist remained with the participants for the entire session.

Sample Size

Thirty-nine Veterans in the study included 23 individuals with HCV not planning to start antiviral therapy who were enrolled in the HCV only group, and 16 individuals with HCV who were currently on antiviral therapy who wereenrolled in the HCV/antiviral therapy group. A subset of 15 individuals (8 from the HCV-only and 7 from the HCV/antiviral therapy group) were invited to participate in the qualitative interviews. All individuals in the study who were approached agreed to participate in the interviews.

To capture the experience of receiving acupuncture in a group setting, the interview took place during the final 2 weeks of acupuncture therapy. The sample allowed the researcher to explore the common and unique manifestations of the target phenomena, and the feasibility and acceptability of group acupuncture.

Data Collection and Analysis

Data collection

Qualitative data were collected by semistructured individual interviews. The interviews lasted 30–60 minutes and were conducted by the principal investigator in a private space. To explore the data for feasibility and acceptability of group acupuncture, the responses from the HCV-only and HCV/antiviral therapy interviews were combined for the qualitative analysis.

The interviews were audio-recorded and transcribed verbatim. The text was analyzed using content analysis to identify patterns in the data. Some codes (e.g., group setting) were developed from the literature; other codes were inductively derived from the interview data. As a measure of consistence in coding, the first 10 interviews were coded by 2 members of the research team. They first coded individually then met as a team to discuss coding and come to a consensus on discrepancies. Codes were grouped and placed into categories based on content. Eleven categories emerged: (1) transportation issues; (2) personal barriers to attending; (3) pro–group setting; (4) con–group setting; (5) time of day; (6) length of sessions; (7) attitude toward the VHA; (8) engagement with VHA services; (9) concerns about participating; (10) motivation for participating; and (11) adherence (attendance). The eleven categories were collapsed into five themes based on similarities of content: (1) study participation; (2) barriers to attending acupuncture sessions; (3) timing of acupuncture sessions; (4) receiving acupuncture in a group setting; and (5) engagement and attitude towards the VHA health care system.

Results

Quantitative Results

Baseline group characteristics are presented in Table 2. A majority of the participants were male (n=35; 84.6%). The mean age was 58 years and only 17.9% (n=7) of the participants were married.

Table 2.

Demographic Data (N=39)

Characteristic	All study participants (N=39)	HCV only (n=23)	HCV/antiviral therapy (n=16)	Interview participants (n=15)
Age (years) mean (SD)	58 (5.8)	56 (6.6)	60 (3.4)	58 (3.0%)
Male N (%)	35 (84.6%)	20 (87.0%)	15 (93.8%)	13 (86.7%)
Education N (%) high	5 (12.8%)	5 (21.7%)	0	0 (0%)
School or less	2 participants did not answer	1 participant did not answer	1 participant did not answer
Married N (%)	7 (17.9%)	2 (8.7%)	5 (31.3%)	3 (20.0%)

HCV, hepatitis C virus; SD, standard deviation.

A total of 39 individuals, 23 in the HCV-only group and 16 in the HCV/antiviral therapy group were recruited over 8 months. In the HCV-only group 13 participants were enrolled in the first 3 months of the study. In the HCV/antiviral therapy group all 16 participants were enrolled in the first 7 months.

The benchmark adherence proportion was set at attendance of 80% for all sessions. The adherence proportion for the HCV-only group (n=23) 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%. The many adverse effects of antiviral therapy made it challenging for Veterans to come twice per week for the acupuncture.

Of the 15 interviewed individuals, 7 had prior experience with receiving acupuncture but none had previously received acupuncture in a group setting.

Qualitative Themes

Study participation

For a majority of Veterans, this was their first time participating in a research study. All of the interviewees found participating in the study to be a positive experience.

Several Veterans reported that one of the reasons they had volunteered to participate in this research study was the potential to help other Veterans. Responses included: “Knowing that it was for a study that could help other Vets, that put my mental issues in line” and “I enjoy being part of something that could be helpful to others.”

Other responses included: “I made a commitment so I gotta show up,” “If I can do this and possible [sic] get a little released and possibly help other vets then I am in,” and “I was given an opportunity.”

Barriers to attending acupuncture sessions. Barriers related to attending the acupuncture sessions were both physical and personal. Physical barriers included the process of getting to the PVAMC. Transportation was a major concern for most of the Veterans. Many of the Veterans used public transportation or the VHA's shuttle buses. The VHA provides shuttle buses to bring Veterans from outlying communities to the PVAMC. The buses run on a regular daily schedule. Because of the transportation schedules, some Veterans had significant wait times either before or after the acupuncture sessions. In addition, the PVAMC has very limited parking. Veterans who drove reported that it was always challenging and frustrating to find a place to park.

Personal barriers included coming to the PVAMC. Veterans with PTSD sometimes found it difficult to be in crowded areas, such as the hospital lobby or waiting rooms. A few Veterans stated that just being in the hospital environment was stressful for them. Veterans were sometimes uncomfortable receiving acupuncture if the room was crowded.

Timing of sessions

Acupuncture was offered in 1–2-hour blocks, 4 days per week. The times were in the morning or early afternoon. Veterans were given a schedule of the sessions at the beginning of each month. Times and dates were usually consistent from month to month. Overall, Veterans preferred the 2-hour sessions over the 1-hour session. Several Veterans found it stressful to have only 1 hour available. Veterans were concerned that, if they had any delays—such as in traffic or late busses—that the sessions would be missed. Morning sessions were overwhelmingly preferred over afternoon sessions. However, Veterans acknowledged that, if working people were to be included, then evening sessions would be needed to accommodate these people's schedules. Parking would also be more available for evening sessions.

We had 3 practitioners providing acupuncture. Study participants reported various levels of comfort with the different providers.

Group setting for acupuncture

Veterans reported mixed feelings regarding the group sessions. A majority of the Veterans found the group setting to be a positive experience. However, a few had additional recommendations they felt would improve the group acupuncture experience.

Overall, veterans found the group setting to be a supportive experience. Responses included the following: “It's nice to be around my kind” and “I liked it because we commiserated, we shared hell … it's beneficial to have people in a group.” The Veterans enjoyed the opportunity to communicate with others Veterans who had similar military experiences. One Veteran stated: “I am used to doing things in a group setting in the military, sleep [sic] together in the barracks, or you wait in line and stuff like that.”

Some Veterans found that telling stories and learning how others had coped with their chronic symptoms to be beneficial. These Veterans found it helpful to learn that others had been through similar circumstances and found ways to cope. The conversations made the time seem to pass quickly. One Veteran said: “It's entertaining, education[al]. Hell … You learn stuff.” Another Veteran reported that it was positive experience and that everyone in the group believed that the acupuncture was beneficial as it “put the group in a positive frame of mind.”

Some Veterans, however, reported that the group setting sometimes diminished their acupuncture experiences. They felt self-conscious about receiving acupuncture in a room with other people. These Veterans would have preferred to have a quieter space to meditate and reflect during the session. A few individuals liked to read during the session and found the sometimes “boisterous” group conversation distracting.

A majority of the Veterans interviewed would have preferred a more-relaxing atmosphere, such as dimmed lights, candles, and background music. These Veterans believed that these additions would have enhanced their acupuncture experiences. However, all of these Veterans agreed that it would depend on the type of music provided.

Likewise, Veterans with PTSD also occasionally found it stressful to be in the small crowded room that was used for the acupuncture sessions. Sitting close to other people made it difficult for these Veterans to relax and meditate while receiving the acupuncture.

Several female Veterans suggested that a separate room or session for women only would be very helpful. They believed that some women might find it stressful to be the only woman in a roomful of men. One Veteran reported that it was helpful that all of the acupuncturists were female.

A couple of Veterans wanted the option to be in the group some days and the ability to sit apart from the group and have quiet time other days. One Veteran recommended “a quiet room and a conversations room.” Another Veteran remarked: “You know there's times where you just don't want to engage.”

Many of the Veterans volunteered that they had engaged in other VHA services when they came for acupuncture. For example, they had blood draws or scheduled other appointments. One Veteran reported that coming for the acupuncture brought him to the hospital and, while he was here, he accessed other services, so that “not only am I going to get pain relief [from the acupuncture] but I will be able to deal with my obligations to my primary care provider…get a chest X-ray, go to the pharmacy—things I normally would not have followed up on.” Another Veteran stated that coming to the acupuncture sessions motivated him to schedule other appointments on the days he came to acupuncture. “They [Veterans] might be coming to their appointments more [and] make other appointments coincide with the acupuncture session,” he said.

Discussion

To the current authors' knowledge, this is the first prospective study to determine the feasibility and acceptability of offering group acupuncture to Veterans with HCV. The qualitative component of the feasibility and acceptability presented has increased the current authors' understanding of the challenges associated with designing a larger RCT.

A primary aim of this study was to describe the acceptability and feasibility of offering acupuncture in a group setting. The group sessions were acceptable to a majority of the Veterans. In accordance to findings from other studies, many individuals enjoyed the camaraderie they experienced in the group setting.^18–20 The shared experience of HCV-only and HCV/antiviral therapy 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.

Despite overall positive assessment of the group acupuncture experience, several comments point to modifications in study design that would increase the success of an RCT. Women constitute a minority of the Veterans cared for by most VA Medical Centers and represented only 10% of the participants in this study. Although the women interviewed in the current study were comfortable in the mixed-gender groups, some of these women believed that some women would find a woman-only session more acceptable. Asprey et al. reported in 2012 that many women preferred a gender-specific acupuncture group.¹⁸ None of the men expressed a preference regarding gender membership of their groups.

The acupuncture sessions took place in a small patient examination room. This room was frequently crowded during the first 3 months of the study because of the rapid enrollment of participants. Many Veterans found that this crowding diminished the acupuncture experience. The crowding was not mentioned by Veterans who participated later in the study when group sizes were much smaller.

While most veterans enjoyed the group dynamics, other Veterans found the conversations to be distracting. A few Veterans wanted to meditate or read books while they received the acupuncture. Many Veterans suggested that a quiet room or a quiet section in a larger room be made available. Altering environmental factors were also suggested, such as softer lighting, candles, and background music, as several Veterans complained that the lighting in the room was bright and harsh. The current authors found nothing in the literature that addressed specific environmental aspects, such as lighting or room size when offering acupuncture in a group setting. The request for background music is potentially problematic, as it would likely be difficult to find a genre of music that would be enjoyed by everyone. Subjects in the study by Chang and coinvestigators, in 2007, used headphones to listen to tapes that contained instructions promote the relaxation response and a control group who listened to tapes with soft music.²¹ Using headphones would allow individuals who desired to hear music an option to listen to it or have quiet time and not engage in conversation.

The current study had 3 acupuncturists. Other studies have also reported using more providers; for instance studies by Asprey et al. and Otte et al. each used 4 providers and a study by Weidong et al. had 5 providers.^18,22,23 All providers in the current study followed the study protocol and used only prescribed acupuncture sites. However, participants reported various levels of comfort with the different providers. In 2010, Suarez-Almazor et al. found that the communication style of an acupuncturist could affect a participant's satisfaction and response to acupuncture therapy for pain.²⁴

In the current study, the benchmark for adherence was set at 80% attendance. However, adherence in the HCV/antiviral therapy group was 69.9%. In the months before recruitment began, antiviral therapy became more complex and debilitating. Antiviral therapy is a combination of weekly interferon injections, oral ribavirin, and an oral protease inhibitor (triple therapy). Individuals receiving triple therapy experienced many debilitating side-effects. While this made acupuncture therapy for symptom management appealing to many Veterans it also made it challenging for the Veterans to commit to twice-per-week acupuncture sessions. This also affected the ability to recruit participants for the HCV/antiviral therapy arm of the study. Individuals in the HCV-only group were not as debilitated, but were similarly motivated and attended a similar proportion of sessions.

The theme of attitudes and engagement with VHA services was unexpected and interesting. In the interviews, many Veterans volunteered that, because they were coming for the acupuncture, they engaged in other VHA services such as blood draws, scheduling appointments, attending other appointments, pharmacy-related issues, and other testing. A few 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 a sufficient motivator to engage Veterans who do not routinely participate in VHA services. Nothing was found in the literature that examined the relationship between offering acupuncture or any complementary and alternative medicine therapy and increased engagement in health care. The current authors plan to explore this further in future research.

Overall, participating in the research study and receiving acupuncture was a positive experience for a majority of Veterans. Several expressed gratitude to the VHA for being offered the opportunity to receive acupuncture.

Limitations

The sample size of this pilot feasibility study was small by design. The 15 interviews did provide rich descriptions of the experience of receiving acupuncture in a group setting.

It was not possible to recruit as many HCV/antiviral therapy participants as had been anticipated. The multiple debilitating side-effects that these individuals experienced while receiving antiviral triple therapy and the limited number of individuals who were treated during the time of recruitment was a significant barrier to recruitment.

Adherence in the HCV-only group was also less than the 80% benchmark. As a result of major life events not related to the study, 2 Veterans in the HCV-only group dropped out of the study in the first week. This affected the adherence rates. These results are similar to what Painvich et al. found in their study of 60 postmenopausal women in which 33 individuals completed the study. In the group that completed the study, adherence rates were 80% in the traditional acupuncture arm and 83% in the sham acupuncture arm.²⁵ Other studies have reported higher adherence rates. For example, Simcock et al. reported 100% adherence in men with radiation-induced xerostomia (n=12).¹⁹ Similarly, Turfan et al. also reported 100% adherence in 28 individuals with hepatitis who received acupuncture twice weekly for 6 weeks.¹⁶

Conclusions

This pilot study suggests that an RCT using group acupuncture would be feasible and acceptable to Veterans and that ∼70% of study participants would have satisfactory adherence (attending 80% of treatment sessions). Study design modifications in a larger RCT might 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. In future studies the current authors will explore the use of headphones for Veterans who would like to block out the group conversation or to listen to meditation music. Finally this study's data suggest that a conceptual model of positive treatment effects of group acupuncture might include the group experience, which may provide social support and enhance engagement in health care.

Disclosure Statement

No competing financial interest exists.

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