HIV/AIDS has become a chronic and manageable condition due to the use of combination therapy introduced in the mid-1990's. Despite this pharmacological advancement, people living with HIV/AIDS (PLWA) continue to experience a wide range of symptoms associated with clinical manifestations of HIV disease, related opportunistic conditions, and side effects from medications. Gastrointestinal symptoms are particularly prevalent and are often the side effect of the combination therapies. Due to the high prevalence of digestive side effects, adherence to the combination therapy is a great concern. The efficacy of acupuncture and the relaxation response (RR) in managing various prevalent symptoms among PLWA has been demonstrated in other studies and yet their use either alone or in combination on improving medication adherence through symptom reduction remain unexplored. We propose to recruit 80 PLWA for a 4-arm, single blinded, parallel randomized controlled trial to evaluate the individual and combined effects of acupuncture and the RR on reducing digestive symptoms, increasing medication adherence, and improving quality of life for PLWA. We will also explore the mechanism of acupuncture and the RR through oxygen consumption reduction. Enrolled patients will listen to tapes while receiving acupuncture treatment. We will use a 2x2 study design with 2 types of acupuncture points (symptom specific vs. sham) and 2 types of audiotapes (RR vs. control). Treatment will be provided twice weekly for 4 weeks and once weekly for another 4 weeks on an out-patient basis. The study outcomes are digestive symptom severity rating, medication adherence, and quality of life measures. Participants will use daily diaries to record symptom severity, as well as the number of combination-therapy pills taken each day at baseline and during the study period. Adherence will also be assessed from pharmacy refill records. Quality of Life questionnaires will be administered at baseline and upon the completion of the study. Oxygen consumption will be measured during the last treatment. Study outcome measures will be administrated again at the 6-month follow-up. We will use both the generalized estimating equation approach and random effects model to analyze the diary data. Our proposed study can contribute to the improvement of the well-being of PLWA and help to understand the mechanism of the therapeutic effects of these two remedies. ? ?
| Chang, Bei-Hung; Sommers, Elizabeth (2011) Acupuncture and the relaxation response for treating gastrointestinal symptoms in HIV patients on highly active antiretroviral therapy. Acupunct Med 29:180-7 |
