OBJECTIVES: The study of complementary and alternative medicine (CAM) using a randomized, controlled trial (RCT) design poses challenges, such as treatment standardization and blinding. We designed an RCT, which avoided these two common challenges, to evaluate the effect of adding the relaxation response (RR) to usual acupuncture treatment. In this paper, we report on the feasibility and patients' experience from the study participation. DESIGN, SETTING, AND SUBJECTS: Our study was a two-arm, double-blind RCT conducted in an acupunctureclinic in Boston. Study subjects were patients with human immunodeficiency virus/autoimmunodeficiency syndrome (HIV/AIDS), who reported having at least one of the highly prevalent HIV-related symptoms, and were receiving acupuncture treatment. INTERVENTION: The intervention group wore earphones to listen to tapes with instructions to elicit the RR and also soft music while receiving acupuncture treatment, while the control group only listened to soft music. The intervention group was also required to listen to the RR tapes at home daily. OUTCOME MEASURES: A study evaluation was completed upon termination of the 12-week study (36 intervention and 44 control patients). RESULTS: A majority of participants in both groups reported: no discomfort wearing earphones (82.9%, 81.8%); the study met their expectations (87.1%, 85.4%); and they would recommend the study to others (91.1%, 90.5%). Intervention participants reported better experiences with the tapes than the control group (p = 0.056) (72.4% versus 52.8% felt better with tapes; 3.5% versus 16.7% felt better without tapes; and 24.1% versus 30.6% felt no difference). Intervention participants were also more likely than the control group (p = 0.02) to report positive emotional/physical/spiritual changes (45.5% vs. 20.9%) and relaxed/peaceful/calm feelings (30.3% vs. 25.6%) from the study participation. CONCLUSIONS: We demonstrated the feasibility of conducting a unique trial that examined the synergistic effects of two types of CAM practices. The intervention group reported more positive study-related experiences than the control group.
RCT Entities:
OBJECTIVES: The study of complementary and alternative medicine (CAM) using a randomized, controlled trial (RCT) design poses challenges, such as treatment standardization and blinding. We designed an RCT, which avoided these two common challenges, to evaluate the effect of adding the relaxation response (RR) to usual acupuncture treatment. In this paper, we report on the feasibility and patients' experience from the study participation. DESIGN, SETTING, AND SUBJECTS: Our study was a two-arm, double-blind RCT conducted in an acupuncture clinic in Boston. Study subjects were patients with human immunodeficiency virus/autoimmunodeficiency syndrome (HIV/AIDS), who reported having at least one of the highly prevalent HIV-related symptoms, and were receiving acupuncture treatment. INTERVENTION: The intervention group wore earphones to listen to tapes with instructions to elicit the RR and also soft music while receiving acupuncture treatment, while the control group only listened to soft music. The intervention group was also required to listen to the RR tapes at home daily. OUTCOME MEASURES: A study evaluation was completed upon termination of the 12-week study (36 intervention and 44 control patients). RESULTS: A majority of participants in both groups reported: no discomfort wearing earphones (82.9%, 81.8%); the study met their expectations (87.1%, 85.4%); and they would recommend the study to others (91.1%, 90.5%). Intervention participants reported better experiences with the tapes than the control group (p = 0.056) (72.4% versus 52.8% felt better with tapes; 3.5% versus 16.7% felt better without tapes; and 24.1% versus 30.6% felt no difference). Intervention participants were also more likely than the control group (p = 0.02) to report positive emotional/physical/spiritual changes (45.5% vs. 20.9%) and relaxed/peaceful/calm feelings (30.3% vs. 25.6%) from the study participation. CONCLUSIONS: We demonstrated the feasibility of conducting a unique trial that examined the synergistic effects of two types of CAM practices. The intervention group reported more positive study-related experiences than the control group.
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