acupuncture for nausea in hiv

Conditions: HIV Infections

Summary: the subjects in this research study will be 159 men and women with hiv infection who have a history of chronic nausea for three months or greater and show evidence of two or more episodes of nausea and/or report a duration of two hours or more (per day) in baseline symptom diaries. subjects will be randomized (by chance) to one of three conditions: condition 1, subjects receive standard acupuncture (active treatment); condition 2, subjects receive individualized acupuncture based on traditional chinese medical diagnosis (active treatment); condition 3, (control group), subjects receive sham acupuncture. subjects in conditions 1, 2, \& 3 will attend scheduled sessions over 24 weeks.

the subjects in the proposed experiment will be 159 men and women with hiv infection who have a history of chronic nausea for three months or greater and show evidence of two or more episodes of nausea and/or report a duration of 2 hours or greater (per day) in prospective baseline symptom diaries. subjects will be randomized to one of three experimental intervention conditions: condition 1, subjects receive standard acupuncture; condition 2, subjects receive individualized acupuncture based on traditional chinese medical diagnosis; condition 3, (control group), subjects receive sham acupuncture. subjects in conditions 1, 2, \& 3 will attend 16 scheduled sessions over 24 weeks. all subjects will: be assessed by a diagnostic acupuncturist (blinded to treatment assignments); be administered the same instruments; and submit their symptom diaries for data entry and analysis. after a screening/intake session, randomization and treatment sessions will follow. there will be four weeks of twice weekly treatment sessions, four weekly treatment sessions and three follow-up sessions. all conditions will be identical in duration and be administered by licensed acupuncturists trained in traditional chinese medicine. this study is a prospective, randomized, controlled, blinded (subject and evaluator), parallel groups clinical trial aimed at reducing chronic nausea and improving quality of life in persons with hiv/aids.

Eligibility criteria:
inclusion criteria: * men and women hiv positive or cdc aids diagnosed * history of chronic nausea for three months or greater * experience an average of two or more episodes of nausea and/or who experience an average duration of 2 hours or more (of nausea) per day * verification from primary provider of subject's: hiv status, knowledge of patient's nausea and their agreement that their patient is clinically suitable for the study. * individuals able to successfully complete a mini-mental status exam * individuals who understand and agree to complete daily symptom diaries for the duration of the study. * individuals taking antiretroviral combinations must have completed an initial 8 weeks of a stable regime (same drug(s), dose \& frequency) prior to entry into the study. * individuals taking anti-emetic medications must be on a stable regime (same drug, dose \& frequency) for at least fourteen days prior to entry into the study. * individuals on all other medications which may have nausea listed as a side effect must be on a stable regime (same drug(s), dose \& frequency) for at least fourteen (14) days prior to entry in the study exclusion criteria: * individuals with an acute medical condition, i.e. pneumocystis carinii pneumonia, tuberculosis and or other opportunistic infections or conditions that would require medical attention. * pregnant women * individuals receiving acupuncture currently and less than 6 months prior to enrollment. * individuals currently receiving other types of complementary therapies such as herbs, massage, acupressure wrist bands, reiki etc. * individuals with plans for travel, lifestyle change, or other activity that would preclude attending all of the planned study sessions and/or recording daily diary information.

Keywords: nausea vomiting retching hiv/aids symptom management complementary therapies