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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT003377-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACU+RR | Active Comparator | acupuncture + relaxation response CD |
|
| SHAM+RR | Active Comparator | sham acupuncture + relaxation response CD |
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| ACU+EDU | Active Comparator | acupuncture+control CD |
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| SHAM+EDU | Sham Comparator | sham acupuncture+control CD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bei-Hung Chang, Sc.D. | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pathways to Wellness | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21705396 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | SHAM+RR | sham acupuncture + relaxation response CD Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response |
| FG002 | ACUP+EDU | acupuncture+education CD Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks |
| FG003 | SHAM+EDU | sham acupuncture+education CD sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | SHAM+RR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Error | units on a scale | 8 weeks |
|
8 week study intervention period and 6 month follow up period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bei-Hung Chang | Boston University | 508-856-8959 | bhchang@bu.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Relaxation Response | Behavioral | listening to CDs with verbal instructions of techniques to elicit relaxation response |
|
| sham acupuncture | Other | sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks |
|
sham acupuncture + relaxation response CD Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response |
| BG002 | ACUP+EDU | acupuncture+education CD Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks |
| BG003 | SHAM+EDU | sham acupuncture+education CD sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | SHAM+RR | sham acupuncture + relaxation response CD Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response |
| OG002 | ACUP+EDU | acupuncture+education CD Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks |
| OG003 | SHAM+EDU | sham acupuncture+education CD sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks |
|
|
| 0 |
| 32 |
| 5 |
| 32 |
| EG001 | SHAM+RR | sham acupuncture + relaxation response CD Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response | 0 | 31 | 5 | 31 |
| EG002 | ACUP+EDU | acupuncture+education CD Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks | 0 | 33 | 5 | 33 |
| EG003 | SHAM+EDU | sham acupuncture+education CD sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks | 0 | 34 | 2 | 34 |
| broken hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| thrush | Infections and infestations | Non-systematic Assessment |
|
| car accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| abnormal but benign tissue in descending colon | Gastrointestinal disorders | Non-systematic Assessment |
|
| cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| cellulitis | Infections and infestations | Non-systematic Assessment |
|
| sever esophagitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| kidney problem | Renal and urinary disorders | Non-systematic Assessment |
|
| basal cell CA surgery | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| stomach virus | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |