Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

Boston University

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Procedure: Acupuncture; Behavioral: Relaxation Response; Other: sham acupuncture

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00545623

R21AT003377-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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130 participants in 4 patient groups

ACU+RR

Active Comparator group

Description:

acupuncture + relaxation response CD

Treatment:

Procedure: Acupuncture

Behavioral: Relaxation Response

SHAM+RR

Active Comparator group

Description:

sham acupuncture + relaxation response CD

Treatment:

Behavioral: Relaxation Response

ACU+EDU

Active Comparator group

Description:

acupuncture+control CD

Treatment:

Procedure: Acupuncture

SHAM+EDU

Sham Comparator group

Description:

sham acupuncture+control CD

Treatment:

Other: sham acupuncture