Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ACU+RR

acupuncture + relaxation response CD

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks

Relaxation Response

Intervention Type BEHAVIORAL

listening to CDs with verbal instructions of techniques to elicit relaxation response

SHAM+RR

sham acupuncture + relaxation response CD

Group Type ACTIVE_COMPARATOR

Relaxation Response

Intervention Type BEHAVIORAL

listening to CDs with verbal instructions of techniques to elicit relaxation response

ACU+EDU

acupuncture+control CD

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks

SHAM+EDU

sham acupuncture+control CD

Group Type SHAM_COMPARATOR

sham acupuncture

Intervention Type OTHER

sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks

Interventions

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Acupuncture

acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks

Intervention Type PROCEDURE

Relaxation Response

listening to CDs with verbal instructions of techniques to elicit relaxation response

Intervention Type BEHAVIORAL

sham acupuncture

sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No