Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 130

Inclusion Criteria

Confirmed HIV-positive status or AIDS diagnosis
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.
Being on a stable antiretroviral regimen containing Nucleoside/nucleotide reverse transcriptase inhibitors and/or protease inhibitors- for at least 8 weeks.

Exclusion Criteria

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.
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.
Onset of acute opportunistic infection.
Hemophilia or other bleeding disorder since that will make acupuncture treatment unsafe.
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.
Current users of acupuncture for treating GI symptoms.
Current practice of relaxation response.
Current enrollment in another clinical intervention study.
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.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ACU+RR	Acupuncture	acupuncture + relaxation response CD
ACU+EDU	Acupuncture	acupuncture+control CD
ACU+RR	Relaxation Response	acupuncture + relaxation response CD
SHAM+RR	Relaxation Response	sham acupuncture + relaxation response CD
SHAM+EDU	sham acupuncture	sham acupuncture+control CD

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures