[Efficacy and safety of misoprostol in obstetrics]. / Eficacia y seguridad de misoprostol en obstetricia.

OBJECTIVE: To review the efficacy and safety of misoprostol for indications not included in the prescription information given for the product, including abortion, labor induction, treatment and prevention of postpartum bleeding, and hysteroscopy preparation. METHOD: Pubmed was searched for controlled, randomized, blinded clinical trials of misoprostol in obstetrics from 1999 through 2004. RESULTS: Nineteen clinical trials were found. The efficacy for abortion in association with mifepristone at a dosage of 400 microg/6 h is superior versus both placebo and gemeprost, but misoprostol is more painful and less effective than dilation and subsequent evacuation. Regarding the administration route, trials show similar efficacy for the vaginal and oral approaches. In the prevention and treatment of postpartum hemorrhage, misoprostol was not any better than oxytocin. When used as a labor inducing agent, results are best with doses of 50 microg/3-8 h, but no controlled clinical trials were found. Although its use for hysteroscopy facilitates the procedure versus placebo, it entails a higher frequency of adverse events. No controlled clinical trials were found for other options. CONCLUSIONS: The efficacy of misoprostol for indications reviewed in this paper is controversial, and studies found are heterogeneous. Designing and conducting further clinical trials to investigate appropriate dosage and administration routes, as well as the drug s adverse effect profile under such circumstances is essential, and would potentially allow an application for approval to be filed with health authorities regarding its use in obstetric practice.

Eficacia y seguridad de misoprostol en obstetricia / Efficacy and safety of misoprostol in obstetrics

Objetivo: Revisar la eficacia y seguridad de misoprostol en las indicaciones no aprobadas en ficha técnica, tales como aborto, inducción al parto, tratamiento y prevención de hemorragia posparto y previo a la realización de una hisperoscopia. Método: Se realizó una búsqueda bibliográfica en Pubmed, de los ensayos clínicos realizados con misoprostol en obstetricia, controlados, randomizados y enmascarados desde 1999 hasta 2004. Resultados: Se encontraron 19 ensayos clínicos. La eficacia en el aborto asociado a mifepristona a dosis de 400 µg/6 h es superior, tanto frente a placebo como frente a gemeprost, aunque es más doloroso y menos eficaz que el aborto por dilatación y posterior evacuación. En cuanto a la vía de administración, los ensayos muestran una eficacia similar tanto por vía vaginal como por vía oral. En la prevención y tratamiento de la hemorragia posparto, misoprostol no presentó mejores resultados que la oxitocina. Utilizado como inductor del parto muestra los mejores resultados a dosis de 50 µg/3-8 h, pero no se encontraron ensayos clínicos controlados. Aunque su uso en histeroscopia facilita el proceso comparado con placebo, presenta una mayor frecuencia de efectos adversos. No se encontraron ensayos clínicos controlados con otras alternativas. Conclusiones: La eficacia del misoprostol en los usos revisados en este trabajo es controvertida y los estudios encontrados son muy heterogéneos. Es necesario diseñar y realizar más ensayos clínicos que permitan conocer la dosis y vía de administración idóneas, así como su perfil de efectos adversos en estas circunstancias, lo que permitiría la posibilidad de solicitar a las autoridades sanitarias la aprobación de su uso en indicaciones obstétricas

Objective: To review the efficacy and safety of misoprostol for indications not included in the prescription information given for the product, including abortion, labor induction, treatment and prevention of postpartum bleeding, and hysteroscopy preparation. Method: Pubmed was searched for controlled, randomized, blinded clinical trials of misoprostol in obstetrics from 1999 through 2004. Results: Nineteen clinical trials were found. The efficacy for abortion in association with mifepristone at a dosage of 400 µg/6 his superior versus both placebo and gemeprost, but misoprostol is more painful and less effective than dilation and subsequent evacuation. Regarding the administration route, trials show similar efficacy for the vaginal and oral approaches. In the prevention and treatment of postpartum hemorrhage, misoprostol was not any better than oxytocin. When used as a labor inducing agent, results are best with doses of 50 µg/3-8 h, but no controlled clinical trials were found. Although its use for hysteroscopy facilitates the procedure versus placebo, it entails a higher frequency of adverse events. No controlled clinical trials were found for other options. Conclusions: The efficacy of misoprostol for indications reviewed in this paper is controversial, and studies found are heterogeneous. Designing and conducting further clinical trials to investigate appropriate dosage and administration routes, as well as the drug’s adverse effect profile under such circumstances is essential, and would potentially allow an application for approval to be filedwith health authorities regarding its use in obstetric practice