Human Reproduction, Vol. 15, No. 6, 1425,
June 2000
© 2000 European Society of Human Reproduction and Embryology
Letters to the Editor |
Service de Gynecologie-Obstetrique, Hopital Antoine Beclere, 157 Rue de la Porte de Trivaux, 92140 Clamart Cedex, France
Dear Sir,
The study we have reported recently (Gervaise et al., 1999
), compared the clinical efficacy and safety of a thermal balloon system with the reference treatment of dysfunctional uterine bleeding, hysteroscopic endometrial resection.
This study was non-randomized, but the indications of both interventions were strictly similar, in terms of age, normality and depth of the uterine cavity and number of pads per cycle used. About the menopausal status, all post-menopausal women were taking substitutive hormone therapy which in our opinion has the same meaning in terms of functional excessive bleeding. Furthermore, the Cox proportional hazards model was applied in order to analyse the simultaneous relationships between event failure and possible co-variates, and to study the influence of prognostic factors on the appearance of failure. Menopausal status (and parity) were forced into the Cox model in order to ensure that their possible confounding effects were controlled, and the multivariate analyses have shown that the menopausal status was not a factor associated with failure.
The choice between the two procedures was surgeon-dependent. For both groups of patients, the procedure was done by the French referent surgeon for the technique: H.Fernandez for the thermal uterine balloon system, and J.Hamou for the hysteroscopic endometrial resection.
With reference to the follow-up, the thermal uterine balloon system which is a new surgical technique, needed a frequent follow-up to evaluate efficacy and safety. This follow-up was done by phone-contact using a check-list, to record the date of failure. Since endometrial resection is a well-known surgical procedure, only one phone-contact in this group gave us enough information. Although two different frequencies of follow-up were used, the fact is that no patients were lost to follow-up.
Concerning the end-points, it appears that amenorrhoea and hypomenorrhoea were not significantly different between the two techniques. It is true that combination of these two end-points leads to a relative risk in favour of endometrial resection. However, we defined clinical failure as persistent menorrhagia. We consider that eumenorrhoea is a good result for these women suffering excessive uterine bleeding, and this endpoint was in favour of thermal balloon system (p < 0.001). These treatments are not supposed to create amenorrhoea, as did the Elitt laser system in 68% of cases (Donnez et al., 1999). About the disappearance of dysmenorrhea, our results are similar with those obtained by Meyer et al. (1998) with no statistical difference between thermal balloon system and endometrial resection.
In summary, with the criteria we defined, our comparative study is statistically valid, and allows us to conclude that thermal uterine balloon system appears to be as efficacious as endometrial resection for the treatment of dysfunctional uterine bleeding.
Notes
1 To whom correspondence should be addressed E-mail: herve.fernandez{at}abc.aphop-paris.fr 
References
Gervaise, A., Fernandez, H., Capella-Allouc, S. et al. (1999) Thermal balloon ablation versus endometrial resection for the treatment of abnormal uterine bleeding. Hum. Reprod., 14, 2743–2747.
Donnez, J., Polet, R., Squifflet, J. et al. (1999) Endometrial laser intrauterine thermo-therapy (ELITT): a revolutionary new approach to the elimination of menorrhagia. Curr. Opin. Obstet. Gynecol., 11, 363–370.[Medline]
Meyer, W., Walsch, B., Grainger, D.et al. (1998) Thermal Balloon and Roller-ball ablation to treat menorrhagia. A multicenter comparison. Obstet. Gynecol., 92, 98–103.[Web of Science][Medline]
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