Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bei-Hung Chang, Boston University
ClinicalTrials.gov Identifier:
NCT00545623
First received: October 15, 2007
Last updated: August 31, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
HIV Infections
Procedure: Acupuncture
Behavioral: Relaxation Response
Other: sham acupuncture
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Changes in GI Symptom Per Intervention Session [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 130
Study Start Date: April 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545623

Locations
United States, Massachusetts
Pathways to Wellness
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Bei-Hung Chang, Sc.D. Boston University
  More Information

Publications:
Responsible Party: Bei-Hung Chang, Associate Professor, Boston University
ClinicalTrials.gov Identifier: NCT00545623     History of Changes
Other Study ID Numbers: R21 AT003377-01, R21AT003377-01
Study First Received: October 15, 2007
Results First Received: July 25, 2014
Last Updated: August 31, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Boston University:
HIV/AIDS
Alternative Medicine
Complementary Medicine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014