HIV Infections
Conditions
Keywords
HIV/AIDS, Alternative Medicine, Complementary Medicine
Brief summary
The aims of the study are to investigate individual, combined and added effects of acupuncture and the relaxation response in reducing gastrointestinal symptoms, improving medication adherence and quality of life among people living with HIV/AIDS. The study will also explore the mechanism of these therapeutic effects of acupuncture and the relaxation response.
Interventions
PROCEDUREAcupuncture
acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
BEHAVIORALRelaxation Response
listening to CDs with verbal instructions of techniques to elicit relaxation response
OTHERsham acupuncture
sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Confirmed HIV-positive status or AIDS diagnosis 2. Self report of having at least one of the 6 GI symptoms: diarrhea, loose stools, gas/flatulence or bloating, abdominal pain, nausea, or vomiting that have persisted for at least 8 weeks. 3. Being on a stable antiretroviral regimen containing Nucleoside/nucleotide reverse transcriptase inhibitors and/or protease inhibitors- for at least 8 weeks.
Exclusion criteria
1. Incident diagnosis of any of the following conditions within the past month or during study period: Pneumocystis carinii pneumonia, Kaposi's sarcoma, Mycobacterium avian complex, Cytomegalovirus, Non-Hodgkins lymphoma, Lymphoma or other cancer, Pelvic inflammatory disease, AIDS-related dementia, Bacterial or other infection, Diabetes, Acute moderate or severe neutropenia, Cryptococcus, Progressive multifocal leukoencephalopathy, Idiopathic thrombocytopenic purpura. All of these conditions are major opportunistic infections or medical complications that may require hospitalization and additional pharmaceutical intervention. 2. GI diagnoses of irritable bowel syndrome, Crohn's Disease, parasites, any type of gastric ulcer or ulcerative colitis or cancer in any part of the gastrointestinal system. These are conditions not related to HIV diagnosis and could result in digestive problems similar to those we are investigating. 3. Onset of acute opportunistic infection. 4. Hemophilia or other bleeding disorder since that will make acupuncture treatment unsafe. 5. Pregnant women will be excluded since, although none of the acupuncture points or combinations are contraindicated in pregnancy, the presence of morning sickness could serve as a potential confounding factor. 6. Current users of acupuncture for treating GI symptoms. 7. Current practice of relaxation response. 8. Current enrollment in another clinical intervention study. 9. Cognitive impairment as measured by Mini Mental Status Examination (MMSE), a reliable and valid screening instrument for the detection of cognitive impairment, using a commonly used cut-off point of 24. 10. If use of Chinese herbs has been recently discontinued, a potential participant must have at least 2 weeks without herb use to be eligible for the study. Because use of herbs is occasionally accompanied by digestive disorders,a period of stabilizing is required before acupuncture treatment can be initiated. This washout period has been conservatively estimated by ACP staff herbalists to constitute a sufficient time for effects of herbs to cease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in GI Symptom Per Intervention Session | 8 weeks | We used the GI symptom subscale of the Revised HIV Sign and Symptom Checklist (SSC-HIV) to measure the intensity (0-10) of the six targeted GI symptoms: diarrhea, loose stools, gas/bloating, abdominal pain, nausea and vomiting, with 0 indicating no symptom and 10 indicating most sever symptom. Rating changes per intervention session were estimated using a mixed effects regression model controlling for baseline ratings. Data of loose stools are presented here. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACUP+RR acupuncture + relaxation response CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response | 31 |
| SHAM+RR sham acupuncture + relaxation response CD
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response | 27 |
| ACUP+EDU acupuncture+education CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks | 27 |
| SHAM+EDU sham acupuncture+education CD
sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks | 30 |
| Total | 115 |
Baseline characteristics
| Characteristic | ACUP+RR | SHAM+RR | ACUP+EDU | SHAM+EDU | Total |
|---|---|---|---|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 8.8 | 45.0 years STANDARD_DEVIATION 7.1 | 47.1 years STANDARD_DEVIATION 9.9 | 47.0 years STANDARD_DEVIATION 8.2 | 46.6 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United States | 31 participants | 27 participants | 27 participants | 30 participants | 115 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 7 Participants | 9 Participants | 34 Participants |
| Sex: Female, Male Male | 22 Participants | 18 Participants | 20 Participants | 21 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 32 | 5 / 31 | 5 / 33 | 2 / 34 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 | 0 / 33 | 0 / 34 |
Outcome results
Primary
Changes in GI Symptom Per Intervention Session
We used the GI symptom subscale of the Revised HIV Sign and Symptom Checklist (SSC-HIV) to measure the intensity (0-10) of the six targeted GI symptoms: diarrhea, loose stools, gas/bloating, abdominal pain, nausea and vomiting, with 0 indicating no symptom and 10 indicating most sever symptom. Rating changes per intervention session were estimated using a mixed effects regression model controlling for baseline ratings. Data of loose stools are presented here.
Time frame: 8 weeks
Population: An intent-to-treat approach was used for analysis. That is all patients who had at least one data points were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACUP+RR | Changes in GI Symptom Per Intervention Session | -0.24 units on a scale | Standard Error 0.04 |
| SHAM+RR | Changes in GI Symptom Per Intervention Session | -0.08 units on a scale | Standard Error 0.04 |
| ACUP+EDU | Changes in GI Symptom Per Intervention Session | -0.09 units on a scale | Standard Error 0.04 |
| SHAM+EDU | Changes in GI Symptom Per Intervention Session | -0.09 units on a scale | Standard Error 0.04 |