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A Placebo-Controlled Trial

Lixing Lao, PhD, LAc; Stewart Bergman, DDS; Gayle R. Hamilton, PhD; Patricia Langenberg, PhD; Brian Berman, MD

Arch Otolaryngol Head Neck Surg. 1999;125:567-572.

Background  Acupuncture is increasingly being used by the general population and investigated by conventional medicine; however, studies of its effects on pain still lack adequate control procedures.

Objectives  To evaluate the (1) efficacy of Chinese acupuncture in treating postoperative oral surgery pain, (2) validity of a placebo-controlled procedure, and (3) effects of psychological factors on outcomes.

Design  Randomized, double-blind, placebo-controlled trial.

Setting  Dental School Outpatient Clinic, University of Maryland at Baltimore.

Participants  Thirty-nine healthy subjects, aged 18 to 40 years, assigned to treatment (n=19) and control (n=20) groups.

Main Outcome Measures  Patients' self-reports of time until moderate pain, time until medication use, total pain relief, pain half gone, and total pain medication consumption.

Results  Mean pain-free postoperative time was significantly longer in the acupuncture group (172.9 minutes) than in the placebo group (93.8 minutes) (P=.01), as was time until moderate pain (P=.008). Mean number of minutes before requesting pain rescue medication was significantly longer in the treatment group (242.1 minutes) than in the placebo group (166.2 minutes) (P=.01), as was time until medication use (P=.01). Average pain medication consumption was significantly less in the treatment group (1.1 tablets) than in the placebo group (1.65 tablets) (P=.05). There were no significant between-groups differences on total-pain-relief scores or pain-half-gone scores (P>.05). Nearly half or more of all patients were uncertain of or incorrect about their group assignment. Outcomes were not associated with psychological factors in multivariate models.

Conclusions  Acupuncture is superior to the placebo in preventing postoperative dental pain; noninsertion placebo procedure is valid as a control.

From the Complementary Medicine Program, Department of Family Medicine, School of Medicine (Drs Lao and Berman), Department of Oral and Maxillofacial Surgery, Dental School (Dr Bergman), and Department of Epidemiology and Preventive Medicine, School of Medicine (Dr Langenberg), University of Maryland at Baltimore; and Center for the Advancement of Public Health, George Mason University, Fairfax, Va (Dr Hamilton).

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