Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

HIV Infections Clinical Trial

Official title:

Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545623
• Other study ID #: R21AT003377-01
• Secondary ID: R21AT003377-01
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2007
• Last updated: August 31, 2014
• Start date: April 2007
• Est. completion date: September 2010

Study information

• Verified date: August 2014
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

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

Locations

Country	Name	City	State
United States	Pathways to Wellness	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chang BH, Sommers E. Acupuncture and the relaxation response for treating gastrointestinal symptoms in HIV patients on highly active antiretroviral therapy. Acupunct Med. 2011 Sep;29(3):180-7. doi: 10.1136/acupmed-2011-010026. Epub 2011 Jun 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	8 weeks	No