Electroacupuncture Analgesia for Colonoscopy: A Prospective, Randomized, Placebo-Controlled Study Lorella Fanti, M.D., Marco Gemma, M.D., Sandro Passaretti, M.D., Mario Guslandi, M.D., Pier Alberto Testoni, M.D., Andrea Casati, M.D., and Giorgio Torri, M.D. Department of Gastroenterology, and Department of Anesthesiology, Vita-Salute University of Milan, IRCCS San Raffaele Hospital, Milan, Italy OBJECTIVE: A study was undertaken to compare the effec- tiveness of acupuncture in reducing patient’s discomfort and anxiety during colonoscopy with a standard sedation proto- col. METHODS: Thirty patients scheduled to undergo colonos- copy were randomly assigned to receive acupuncture, sham, or no acupuncture. A verbal rating scale was used to mea- sure patient’s pain when the endoscope reached four sched- uled positions. Midazolam was administered at baseline and again anytime patients complained of “severe” pain. The amount of midazolam administered was recorded. A verbal rating scale was used to assess patient’s satisfaction with the level of sedation achieved. RESULTS: Pain level was lower, although not significantly, in the acupuncture group. Midazolam boluses were required in three patients with acupuncture (30%), eight in the sham group (80%), and nine in the control group (90%) (p = 0.01). Six patients in the acupuncture group (60%) reported optimum acceptance of colonoscopy compared with only one in the sham group (10%) and none in the control group (0%) (p = 0.016). Satisfaction scores, assessed 24 –72 h after colonoscopy, were extremely high (median score 90 of 100) in the three groups. CONCLUSIONS: Acupuncture may decrease the demand for sedative drugs during colonoscopy by reducing discomfort and anxiety of the patient and the well-known adverse effects of pharmacologic sedation. (Am J Gastroenterol 2003;98:312–316. © 2003 by Am. Coll. of Gastroenterol- ogy) INTRODUCTION Colonoscopy is considered highly invasive and is generally assumed to be an uncomfortable and often painful proce- dure. Although it has been shown that colonoscopy can also be performed without sedation (1), in many countries it has become a standard practice to achieve a satisfactory level of relaxation, cooperation, and amnesia during the procedure using i.v. premedication (2– 4). Previous studies have re- ported that the use of sedative and analgesic drugs increases both cost and complication of colonoscopy; routine sedation frequently prolongs recovery room observation and brings about rare but well-known adverse events (5–7). A few studies have reported the use of acupuncture for patient sedation during endoscopic procedures. The aim of this prospective, randomized, placebo-controlled study is to compare the effectiveness of acupuncture in reducing pa- tient’s discomfort, pain, and anxiety during colonoscopy with a standard sedation protocol. MATERIALS AND METHODS After approval by our Hospital Ethical Committee and after obtaining written informed consent from the patients, we enrolled 30 consecutive patients scheduled to undergo colonoscopy. Associated medical illnesses were graded ac- cording to the American Society of Anesthesiologists’ Phys- ical Status Classification (8). Exclusion criteria were: refusal to sign the informed consent form, age younger than 18, previous colonic resection, known or suspected stenosis of the colon, pregnancy, physical status grade II, neuropsy- chiatric disorders, concomitant treatment with psychotropic drugs, drug abuse, or alcoholism. Patients who had any technical knowledge of acupuncture were also excluded to maintain blindness between acupuncture and sham acupunc- ture. As patients arrived to the Endoscopy Unit, they re- ceived an adequate training in the use of the visual analogue scale for the evaluation of anxiety before the procedure, rating preprocedure anxiety on a 100-mm visual analogue scale (0 = no anxiety, 100 = worst anxiety possible). Therefore, using a computer-generated sequence of num- bers, patients were randomly assigned to one of three groups: A) acupuncture, with electrical bilateral stimulation of active points (10 patients); B) sham acupuncture, with analogous stimulation of 10 inactive symmetrical points near the active points (10 patients); and C) no acupuncture (10 patients). All the patients received midazolam 0.02 mg/kg i.v. 15 min before the beginning of colonoscopy. Colonoscopy was always performed by the same experi- enced endoscopist, who did not have any technical knowl- edge of acupuncture and was blind to the enrollment of patients in group A or group B. Acupuncture was performed by a qualified staff anesthesiologist. Patients enrolled in THE AMERICAN JOURNAL OF GASTROENTEROLOGY Vol. 98, No. 2, 2003 © 2003 by Am. Coll. of Gastroenterology ISSN 0002-9270/03/$30.00 Published by Elsevier Science Inc. doi:10.1016/S0002-9270(02)05899-9