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

October 15, 2007
August 31, 2014
April 2007
September 2010   (final data collection date for primary outcome measure)
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.
GI symptoms and HIV medication adherence [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00545623 on ClinicalTrials.gov Archive Site
Not Provided
Quality of Life [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • 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
  • Active Comparator: ACU+RR
    acupuncture + relaxation response CD
    Interventions:
    • Procedure: Acupuncture
    • Behavioral: Relaxation Response
  • Active Comparator: SHAM+RR
    sham acupuncture + relaxation response CD
    Intervention: Behavioral: Relaxation Response
  • Active Comparator: ACU+EDU
    acupuncture+control CD
    Intervention: Procedure: Acupuncture
  • Sham Comparator: SHAM+EDU
    sham acupuncture+control CD
    Intervention: Other: sham acupuncture
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. Epub 2011 Jun 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00545623
R21 AT003377-01, R21AT003377-01
No
Bei-Hung Chang, Boston University
Boston University
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Bei-Hung Chang, Sc.D. Boston University
Boston University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP