Trial Outcomes & Findings for Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence (NCT NCT00545623)
NCT ID: NCT00545623
Last Updated: 2014-09-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
8 weeks
Results posted on
2014-09-03
Participant Flow
Participant milestones
| Measure |
ACUP+RR
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+RR
sham acupuncture + relaxation response CD
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response
|
ACUP+EDU
acupuncture+education CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
SHAM+EDU
sham acupuncture+education CD
sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
33
|
34
|
|
Overall Study
COMPLETED
|
25
|
21
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
13
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
Baseline characteristics by cohort
| Measure |
ACUP+RR
n=31 Participants
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+RR
n=27 Participants
sham acupuncture + relaxation response CD
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response
|
ACUP+EDU
n=27 Participants
acupuncture+education CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
SHAM+EDU
n=30 Participants
sham acupuncture+education CD
sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
45.0 years
STANDARD_DEVIATION 7.1 • n=107 Participants
|
47.1 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
47.0 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
46.6 years
STANDARD_DEVIATION 8.5 • n=31 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
81 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=99 Participants
|
27 participants
n=107 Participants
|
27 participants
n=206 Participants
|
30 participants
n=7 Participants
|
115 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 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.
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.
Outcome measures
| Measure |
ACUP+RR
n=27 Participants
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+RR
n=25 Participants
sham acupuncture + relaxation response CD
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response
|
ACUP+EDU
n=25 Participants
acupuncture+education CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
SHAM+EDU
n=27 Participants
sham acupuncture+education CD
sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
|---|---|---|---|---|
|
Changes in GI Symptom Per Intervention Session
|
-0.24 units on a scale
Standard Error 0.04
|
-0.08 units on a scale
Standard Error 0.04
|
-0.09 units on a scale
Standard Error 0.04
|
-0.09 units on a scale
Standard Error 0.04
|
Adverse Events
ACUP+RR
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SHAM+RR
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
ACUP+EDU
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SHAM+EDU
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACUP+RR
n=32 participants at risk
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+RR
n=31 participants at risk
sham acupuncture + relaxation response CD
Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response
|
ACUP+EDU
n=33 participants at risk
acupuncture+education CD
Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
SHAM+EDU
n=34 participants at risk
sham acupuncture+education CD
sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
|---|---|---|---|---|
|
Infections and infestations
pneumonia
|
3.1%
1/32 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
3.2%
1/31 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
6.1%
2/33 • Number of events 2 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/34 • 8 week study intervention period and 6 month follow up period
|
|
Musculoskeletal and connective tissue disorders
broken hip
|
0.00%
0/32 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/31 • 8 week study intervention period and 6 month follow up period
|
3.0%
1/33 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/34 • 8 week study intervention period and 6 month follow up period
|
|
Infections and infestations
thrush
|
3.1%
1/32 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
3.2%
1/31 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
3.0%
1/33 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/34 • 8 week study intervention period and 6 month follow up period
|
|
Injury, poisoning and procedural complications
car accident
|
0.00%
0/32 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/31 • 8 week study intervention period and 6 month follow up period
|
3.0%
1/33 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/34 • 8 week study intervention period and 6 month follow up period
|
|
Gastrointestinal disorders
abnormal but benign tissue in descending colon
|
3.1%
1/32 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/31 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/33 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/34 • 8 week study intervention period and 6 month follow up period
|
|
Respiratory, thoracic and mediastinal disorders
cold
|
3.1%
1/32 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/31 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/33 • 8 week study intervention period and 6 month follow up period
|
2.9%
1/34 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
|
Infections and infestations
cellulitis
|
3.1%
1/32 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/31 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/33 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/34 • 8 week study intervention period and 6 month follow up period
|
|
Gastrointestinal disorders
sever esophagitis
|
0.00%
0/32 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/31 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/33 • 8 week study intervention period and 6 month follow up period
|
2.9%
1/34 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
|
Renal and urinary disorders
kidney problem
|
0.00%
0/32 • 8 week study intervention period and 6 month follow up period
|
3.2%
1/31 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/33 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/34 • 8 week study intervention period and 6 month follow up period
|
|
Skin and subcutaneous tissue disorders
basal cell CA surgery
|
0.00%
0/32 • 8 week study intervention period and 6 month follow up period
|
3.2%
1/31 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/33 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/34 • 8 week study intervention period and 6 month follow up period
|
|
Gastrointestinal disorders
stomach virus
|
0.00%
0/32 • 8 week study intervention period and 6 month follow up period
|
3.2%
1/31 • Number of events 1 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/33 • 8 week study intervention period and 6 month follow up period
|
0.00%
0/34 • 8 week study intervention period and 6 month follow up period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place