RESUMEN
OBJECTIVE: To evaluate the reduction of pain by misoprostol compared with placebo prior to hysteroscopy in postmenopausal and premenopausal nulliparous women. DESIGN: Randomised multicentre double-blind placebo controlled trial. SETTING: Two Dutch teaching hospitals and one Dutch university medical centre. POPULATION: Postmenopausal and premenopausal nulliparous women undergoing office hysteroscopy. METHODS: Patients were randomised to receive either 400 microgram misoprostol or placebo 12 and 24 hours before hysteroscopy. Pain was quantified by the use of real time pain measurement using the continuous pain score meter (CPSM) and VAS scores. MAIN OUTCOME MEASURES: Primary outcome was pain measured by the CPSM during passage of the hysteroscope through the cervical canal, quantified by the area under the curve (AUC). Secondary outcomes included VAS scores, other CPSM parameters, failures and side effects. RESULTS: In all, 149 patients were randomly assigned to either misoprostol (n = 74) or placebo (n = 75). The AUC during introduction did not significantly differ between the intervention and the placebo group. The VAS score during introduction, however, demonstrated a significant difference in premenopausal nulliparous women favouring misoprostol: 2.9 (95% CI 1.3-4.4) versus placebo 5.5 (95% CI 3.9-7.1), P = 0.02, as well as the AUC during the entire procedure: 618 (95% CI 410-827) versus 1126 (95% CI 671-1580), P = 0.04. Failures were equally distributed between the misoprostol (16%) and placebo group (13%). Intestinal side effects occurred significantly more frequently in the misoprostol group (67%) than in the placebo group (32%) [OR 4.2 (95% CI 2.1-8.3), P < 0.01]. CONCLUSION: Misoprostol prior to hysteroscopy reduces pain in premenopausal nulliparous women but not in postmenopausal women. It does cause side effects. TWEETABLE ABSTRACT: RCT: misoprostol versus placebo prior to hysteroscopy in 149 women significantly reduces some pain parameters.