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Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Relaxation Response
sham acupuncture
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV/AIDS, Alternative Medicine, Complementary Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pathways to Wellness

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

ACU+RR

SHAM+RR

ACU+EDU

SHAM+EDU

Arm Description

acupuncture + relaxation response CD

sham acupuncture + relaxation response CD

acupuncture+control CD

sham acupuncture+control CD

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2007
Last Updated
August 31, 2014
Sponsor
Boston University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00545623
Brief Title
Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
Official Title
Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV/AIDS, Alternative Medicine, Complementary Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACU+RR
Arm Type
Active Comparator
Arm Description
acupuncture + relaxation response CD
Arm Title
SHAM+RR
Arm Type
Active Comparator
Arm Description
sham acupuncture + relaxation response CD
Arm Title
ACU+EDU
Arm Type
Active Comparator
Arm Description
acupuncture+control CD
Arm Title
SHAM+EDU
Arm Type
Sham Comparator
Arm Description
sham acupuncture+control CD
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Response
Intervention Description
listening to CDs with verbal instructions of techniques to elicit relaxation response
Intervention Type
Other
Intervention Name(s)
sham acupuncture
Intervention Description
sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Primary Outcome Measure Information:
Title
Changes in GI Symptom Per Intervention Session
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bei-Hung Chang, Sc.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pathways to Wellness
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21705396
Citation
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.
Results Reference
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Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

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