Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
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ClinicalTrials.gov Identifier: NCT00545623 |
Recruitment Status
:
Completed
First Posted
: October 17, 2007
Results First Posted
: September 3, 2014
Last Update Posted
: September 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Procedure: Acupuncture Behavioral: Relaxation Response Other: sham acupuncture | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |
Arm | Intervention/treatment |
---|---|
Active Comparator: ACU+RR
acupuncture + relaxation response CD
|
Procedure: Acupuncture
acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Behavioral: Relaxation Response
listening to CDs with verbal instructions of techniques to elicit relaxation response
|
Active Comparator: SHAM+RR
sham acupuncture + relaxation response CD
|
Behavioral: Relaxation Response
listening to CDs with verbal instructions of techniques to elicit relaxation response
|
Active Comparator: ACU+EDU
acupuncture+control CD
|
Procedure: Acupuncture
acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
Sham Comparator: SHAM+EDU
sham acupuncture+control CD
|
Other: sham acupuncture
sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
- Changes in GI Symptom Per Intervention Session [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545623
United States, Massachusetts | |
Pathways to Wellness | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Bei-Hung Chang, Sc.D. | Boston University |
Publications of Results:
Responsible Party: | Bei-Hung Chang, Associate Professor, Boston University |
ClinicalTrials.gov Identifier: | NCT00545623 History of Changes |
Other Study ID Numbers: |
R21AT003377-01 ( U.S. NIH Grant/Contract ) |
First Posted: | October 17, 2007 Key Record Dates |
Results First Posted: | September 3, 2014 |
Last Update Posted: | September 3, 2014 |
Last Verified: | August 2014 |
Keywords provided by Bei-Hung Chang, Boston University:
HIV/AIDS Alternative Medicine Complementary Medicine |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |