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Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence

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ClinicalTrials.gov Identifier: NCT00545623
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Bei-Hung Chang, Boston University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Procedure: Acupuncture
Behavioral: Relaxation Response
Other: sham acupuncture
Enrollment 130
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACUP+RR SHAM+RR ACUP+EDU SHAM+EDU
Hide Arm/Group Description

acupuncture + relaxation response CD

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

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

sham acupuncture + relaxation response CD

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

acupuncture+education CD

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

sham acupuncture+education CD

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

Period Title: Overall Study
Started 32 31 33 34
Completed 25 21 20 23
Not Completed 7 10 13 11
Arm/Group Title ACUP+RR SHAM+RR ACUP+EDU SHAM+EDU Total
Hide Arm/Group Description

acupuncture + relaxation response CD

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

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

sham acupuncture + relaxation response CD

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

acupuncture+education CD

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

sham acupuncture+education CD

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

Total of all reporting groups
Overall Number of Baseline Participants 31 27 27 30 115
Hide Baseline Analysis Population Description
A total of 15 patients did not start the intervention after enrollment, 1, 4, 6, and 4 patients in ACUP+RR, SHAM+RR, ACUP+EDU, and SHAM+EDU arms respectively. As such there are a total of 115 patients with baseline data.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 27 participants 27 participants 30 participants 115 participants
47.2  (8.8) 45.0  (7.1) 47.1  (9.9) 47.0  (8.2) 46.6  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 27 participants 27 participants 30 participants 115 participants
Female
9
  29.0%
9
  33.3%
7
  25.9%
9
  30.0%
34
  29.6%
Male
22
  71.0%
18
  66.7%
20
  74.1%
21
  70.0%
81
  70.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 27 participants 27 participants 30 participants 115 participants
31 27 27 30 115
1.Primary Outcome
Title Changes in GI Symptom Per Intervention Session
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
An intent-to-treat approach was used for analysis. That is all patients who had at least one data points were included in the analysis.
Arm/Group Title ACUP+RR SHAM+RR ACUP+EDU SHAM+EDU
Hide Arm/Group Description:

acupuncture + relaxation response CD

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

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

sham acupuncture + relaxation response CD

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

acupuncture+education CD

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

sham acupuncture+education CD

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

Overall Number of Participants Analyzed 27 25 25 27
Mean (Standard Error)
Unit of Measure: units on a scale
-0.24  (0.04) -0.08  (0.04) -0.09  (0.04) -0.09  (0.04)
Time Frame 8 week study intervention period and 6 month follow up period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACUP+RR SHAM+RR ACUP+EDU SHAM+EDU
Hide Arm/Group Description

acupuncture + relaxation response CD

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

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

sham acupuncture + relaxation response CD

Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response

acupuncture+education CD

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

sham acupuncture+education CD

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

All-Cause Mortality
ACUP+RR SHAM+RR ACUP+EDU SHAM+EDU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ACUP+RR SHAM+RR ACUP+EDU SHAM+EDU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      0/31 (0.00%)      0/33 (0.00%)      0/34 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ACUP+RR SHAM+RR ACUP+EDU SHAM+EDU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/32 (15.63%)      5/31 (16.13%)      5/33 (15.15%)      2/34 (5.88%)    
Gastrointestinal disorders         
abnormal but benign tissue in descending colon *  1/32 (3.13%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0 0/34 (0.00%)  0
sever esophagitis *  0/32 (0.00%)  0 0/31 (0.00%)  0 0/33 (0.00%)  0 1/34 (2.94%)  1
stomach virus *  0/32 (0.00%)  0 1/31 (3.23%)  1 0/33 (0.00%)  0 0/34 (0.00%)  0
Infections and infestations         
pneumonia *  1/32 (3.13%)  1 1/31 (3.23%)  1 2/33 (6.06%)  2 0/34 (0.00%)  0
thrush *  1/32 (3.13%)  1 1/31 (3.23%)  1 1/33 (3.03%)  1 0/34 (0.00%)  0
cellulitis *  1/32 (3.13%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0 0/34 (0.00%)  0
Injury, poisoning and procedural complications         
car accident *  0/32 (0.00%)  0 0/31 (0.00%)  0 1/33 (3.03%)  1 0/34 (0.00%)  0
Musculoskeletal and connective tissue disorders         
broken hip *  0/32 (0.00%)  0 0/31 (0.00%)  0 1/33 (3.03%)  1 0/34 (0.00%)  0
Renal and urinary disorders         
kidney problem *  0/32 (0.00%)  0 1/31 (3.23%)  1 0/33 (0.00%)  0 0/34 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
cold *  1/32 (3.13%)  1 0/31 (0.00%)  0 0/33 (0.00%)  0 1/34 (2.94%)  1
Skin and subcutaneous tissue disorders         
basal cell CA surgery *  0/32 (0.00%)  0 1/31 (3.23%)  1 0/33 (0.00%)  0 0/34 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Bei-Hung Chang
Organization: Boston University
Phone: 508-856-8959
Responsible Party: Bei-Hung Chang, Boston University
ClinicalTrials.gov Identifier: NCT00545623     History of Changes
Other Study ID Numbers: R21AT003377-01 ( U.S. NIH Grant/Contract )
R21AT003377-01 ( U.S. NIH Grant/Contract )
First Submitted: October 15, 2007
First Posted: October 17, 2007
Results First Submitted: July 25, 2014
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014