INTERIM ANALYSIS OF ACUPUNCTURE PROVES BLINDING IN A RANDOMIZED CONTROLLED TRIAL IS FEASIBLE IN THE INTENSIVE CARE UNIT

Objective: The use of alternative therapies in the intensive care unit(ICU) is infrequent in the United States.Acupuncture has been proven to reduce pain, swelling, nausea, and sedative use for agitation.We hypothesized that acupuncture would reduce sedative and analgesic requirements during mechanical ventilation(MV) with fewer side effects, and decrease length of MV and length of ICU stay.Additionally, we hypothesized that acupuncture can be effectively blinded in the ICU.Methods: A randomized controlled trial was conducted randomly assigning patients in the ICU to verum or sham acupuncture.Medians were compared between the two groups using descriptive statistics.Univariate analysis using Mann-Whitney-U tests was used on all continuous data.Results: Fourteen enrolled patients were included in the interim analysis, 8 males(57%) and 6 females(43%).Verum and sham groups had similar vital signs when compared over all sessions: heart rate(97.2 vs.93.8; P=0.78), systolic blood pressure(110.2 vs.116.4; P=0.47), respiratory rate(16.8 vs.14.2; P=0.36) and RASS score(-1.3 vs.-2.7; P=0.52).No significance was found when assessing age(51 vs.50; P=0.79), APACHE score(15 vs.10.5; P=0.1), number of completed sessions(3 vs.2.5; P=0.37), or time to first acupuncture session(20 h vs.18.2 h; P=0.89).Although without statistically significant(P=0.69), large variation was demonstrated in time to extubation(65.3 h vs.138.3 h).Blinding proved successful as there was no significant difference between groups(P=0.77).Conclusion: Blinding in a randomized controlled trial of acupuncture in the ICU is feasible.