Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

NCT00545623 | Completed Phase 2 Results

• 1 other identifier: R21AT003377-01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

HIV/AIDS; Alternative Medicine; Complementary Medicine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

ACU+RR

ACTIVE COMPARATOR

acupuncture + relaxation response CD

Procedure: Acupuncture; Behavioral: Relaxation Response

SHAM+RR

ACTIVE COMPARATOR

sham acupuncture + relaxation response CD

Behavioral: Relaxation Response

ACU+EDU

ACTIVE COMPARATOR

acupuncture+control CD

Procedure: Acupuncture

SHAM+EDU

SHAM COMPARATOR

sham acupuncture+control CD

Other: sham acupuncture

Interventions

Acupuncture PROCEDURE

acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks

ACU+EDU; ACU+RR

Relaxation Response BEHAVIORAL

listening to CDs with verbal instructions of techniques to elicit relaxation response

ACU+RR; SHAM+RR

sham acupuncture OTHER

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

SHAM+EDU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Pathways to Wellness

Boston, Massachusetts, 02118, United States

Location

Related 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.

  PMID: 21705396 RESULT

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Bei-Hung Chang
• Organization: Boston University

bhchang@bu.edu

508-856-8959

Study Officials

• Bei-Hung Chang, Sc.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 17, 2007
• Study Start: April 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 3, 2014
• Results First Posted: September 3, 2014

Record last verified: 2014-08

Locations

US (1)