Continuous low-level topical heat in the treatment of dysmenorrhea

Objective: To compare the efficacy of topically applied heat far menstrual pain with oral ibuprofen and placebo treatment. Methods: We conducted a randomized placebo and active controlled (double du mmy), parallel study using an abdominal patch (heated or unheated) for appr oximately 12 consecutive hours per day and oral medication (placebo or ibup rofen 400 mg) three times daily, approximately 6 hours apart for 2 consecut ive days. Pain relief and pain intensity were recorded at 17 time points. T here was at least 85% power to detect a true one-unit difference in the 2-d ay pain relief treatment means for comparisons with the unheated patch plus oral placebo group using a one-tailed test at the .05 level of significanc e, based on an observed within-group standard deviation of 1.147. Results: Eighty-four patients were enrolled and 81 completed the study prot ocol. Over the 2 days of treatment, the heated patch plus placebo tablet gr oup (mean 3.27, P < .001), the unheated patch plus ibuprofen group (mean 3. 07, P = .001), and the combination heated patch plus ibuprofen group (mean 3.55, P < .001) had significantly greater pain relief than the unheated pat ch plus placebo group (mean 1.95). Greater pain relief was not observed for the combination heated patch plus ibuprofen group compared with the unheat ed patch plus ibuprofen group (P = .096); however, the time to noticeable p ain relief was statistically significantly shorter for the heated patch plu s ibuprofen group (median 1.5 hours) compared with the unheated patch plus ibuprofen group (median 2.79 hours, P = .01). Conclusion: Continuous low-level topical heat therapy was as effective as i buprofen for the treatment of dysmenorrhea. (C) 2001 by The American Colleg e of Obstetricians and Gynecologists.