Efficacy of transcutaneous electrical acupoint stimulation for immunological non-responder in HIV/AIDS combined with amphetamine abuse: study protocol for a randomized controlled trial
Abstract Background Amphetamine-type stimulant (ATS) abuse is strongly associated with an elevated risk of HIV infection and transmission. Antiretroviral therapy (ART) serves as the primary approach for managing HIV infection and AIDS progression. However, ATS abuse diminishes the efficacy of ART in...
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BMC
2024-12-01
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| Series: | BMC Complementary Medicine and Therapies |
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| Online Access: | https://doi.org/10.1186/s12906-024-04724-7 |
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| author | Tao Li Jun Liu Zuoliang Li Shoujun Wang Su Zhang Xin Zhou Yulan Ren |
| author_facet | Tao Li Jun Liu Zuoliang Li Shoujun Wang Su Zhang Xin Zhou Yulan Ren |
| author_sort | Tao Li |
| collection | DOAJ |
| description | Abstract Background Amphetamine-type stimulant (ATS) abuse is strongly associated with an elevated risk of HIV infection and transmission. Antiretroviral therapy (ART) serves as the primary approach for managing HIV infection and AIDS progression. However, ATS abuse diminishes the efficacy of ART in HIV/AIDS patients, amplifying the vulnerability to immunological non-response (INR) and ultimately increasing the incidence rate and mortality of opportunistic infections. Currently, no effective interventions targeting INR exist. Acupuncture has demonstrated promise in bidirectionally modulating the body’s immune response and may be beneficial for INR in HIV/AIDS combined with ATS abuse. Nevertheless, further research and comprehensive evaluation are imperative to substantiate these findings. Methods This study is a two-center, randomized, non-acupoint controlled, single-blind clinical trial. It will be conducted in two large drug rehabilitation centers in western China, involving 114 INR patients receiving ART. The participants will be randomly assigned to either the Transcutaneous Electrical Acupoint Stimulation (TEAS) + ART group or the sham-TEAS + ART group, in a 1:1 ratio. Both groups will receive a 48-week treatment. The primary outcome measure assessed after treatment is the CD4 + T cell count. Secondary outcome measures include the immune reconstitution efficiency of HIV patients, CD4/CD8 ratio, CD4 + CD45RA + and CD4 + CD45RO + counts, CD4 + CD28 + counts, CD4 + CD38 + and CD8 + CD38 + counts, CD4 + ki67 + and CD8 + ki67 + counts, JC mitochondrial membrane potential testing, the incidence of opportunistic infections, and the HIV/AIDS PRO scale. Adverse events occurring during the study observation period will be documented. Discussion This study will investigate the effect of TEAS on immune reconstitution in patients with amphetamine abuse and HIV infection. Trial registration Chinese Clinical Trial Registry, ChiCTR 2300076363. Registered on October 7, 2023, https://www.chictr.org.cn/ . |
| format | Article |
| id | doaj-art-5f0eaa760ac44229ad9c2fd12e4e7af9 |
| institution | Kabale University |
| issn | 2662-7671 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Complementary Medicine and Therapies |
| spelling | doaj-art-5f0eaa760ac44229ad9c2fd12e4e7af92024-12-29T12:10:16ZengBMCBMC Complementary Medicine and Therapies2662-76712024-12-0124111010.1186/s12906-024-04724-7Efficacy of transcutaneous electrical acupoint stimulation for immunological non-responder in HIV/AIDS combined with amphetamine abuse: study protocol for a randomized controlled trialTao Li0Jun Liu1Zuoliang Li2Shoujun Wang3Su Zhang4Xin Zhou5Yulan Ren6School of Acupuncture and Tuina, Chengdu University of Traditional Chinese MedicineDrug Rehabilitation Administration of Sichuan Province, Medical Rehabilitation DepartmentCoercive Rehabilitation Center for Addicts Affiliated to the Public Security Bureau of ZiyangCoercive Rehabilitation Center for Addicts Affiliated to the Public Security Bureau of ZiyangSchool of Acupuncture and Tuina, Chengdu University of Traditional Chinese MedicineSchool of Acupuncture and Tuina, Chengdu University of Traditional Chinese MedicineSchool of Acupuncture and Tuina, Chengdu University of Traditional Chinese MedicineAbstract Background Amphetamine-type stimulant (ATS) abuse is strongly associated with an elevated risk of HIV infection and transmission. Antiretroviral therapy (ART) serves as the primary approach for managing HIV infection and AIDS progression. However, ATS abuse diminishes the efficacy of ART in HIV/AIDS patients, amplifying the vulnerability to immunological non-response (INR) and ultimately increasing the incidence rate and mortality of opportunistic infections. Currently, no effective interventions targeting INR exist. Acupuncture has demonstrated promise in bidirectionally modulating the body’s immune response and may be beneficial for INR in HIV/AIDS combined with ATS abuse. Nevertheless, further research and comprehensive evaluation are imperative to substantiate these findings. Methods This study is a two-center, randomized, non-acupoint controlled, single-blind clinical trial. It will be conducted in two large drug rehabilitation centers in western China, involving 114 INR patients receiving ART. The participants will be randomly assigned to either the Transcutaneous Electrical Acupoint Stimulation (TEAS) + ART group or the sham-TEAS + ART group, in a 1:1 ratio. Both groups will receive a 48-week treatment. The primary outcome measure assessed after treatment is the CD4 + T cell count. Secondary outcome measures include the immune reconstitution efficiency of HIV patients, CD4/CD8 ratio, CD4 + CD45RA + and CD4 + CD45RO + counts, CD4 + CD28 + counts, CD4 + CD38 + and CD8 + CD38 + counts, CD4 + ki67 + and CD8 + ki67 + counts, JC mitochondrial membrane potential testing, the incidence of opportunistic infections, and the HIV/AIDS PRO scale. Adverse events occurring during the study observation period will be documented. Discussion This study will investigate the effect of TEAS on immune reconstitution in patients with amphetamine abuse and HIV infection. Trial registration Chinese Clinical Trial Registry, ChiCTR 2300076363. Registered on October 7, 2023, https://www.chictr.org.cn/ .https://doi.org/10.1186/s12906-024-04724-7Complementary medicineAmphetamine abuseHIV/AIDSimmunological non-responderprotocol |
| spellingShingle | Tao Li Jun Liu Zuoliang Li Shoujun Wang Su Zhang Xin Zhou Yulan Ren Efficacy of transcutaneous electrical acupoint stimulation for immunological non-responder in HIV/AIDS combined with amphetamine abuse: study protocol for a randomized controlled trial BMC Complementary Medicine and Therapies Complementary medicine Amphetamine abuse HIV/AIDS immunological non-responder protocol |
| title | Efficacy of transcutaneous electrical acupoint stimulation for immunological non-responder in HIV/AIDS combined with amphetamine abuse: study protocol for a randomized controlled trial |
| title_full | Efficacy of transcutaneous electrical acupoint stimulation for immunological non-responder in HIV/AIDS combined with amphetamine abuse: study protocol for a randomized controlled trial |
| title_fullStr | Efficacy of transcutaneous electrical acupoint stimulation for immunological non-responder in HIV/AIDS combined with amphetamine abuse: study protocol for a randomized controlled trial |
| title_full_unstemmed | Efficacy of transcutaneous electrical acupoint stimulation for immunological non-responder in HIV/AIDS combined with amphetamine abuse: study protocol for a randomized controlled trial |
| title_short | Efficacy of transcutaneous electrical acupoint stimulation for immunological non-responder in HIV/AIDS combined with amphetamine abuse: study protocol for a randomized controlled trial |
| title_sort | efficacy of transcutaneous electrical acupoint stimulation for immunological non responder in hiv aids combined with amphetamine abuse study protocol for a randomized controlled trial |
| topic | Complementary medicine Amphetamine abuse HIV/AIDS immunological non-responder protocol |
| url | https://doi.org/10.1186/s12906-024-04724-7 |
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