Short Term Effects of the Vaginal Administration of Gestrinone and Miodesi on Endometriosis Pain

Abstract

Hugo Maia, Wilson Saback and Elsimar M Coutinho

Introduction: Gestrinone a 19 nor testosterone derivative with androgenic, anti-estrogenic and anti-progesterone properties was used either alone or associated with plant derived anti-inflammatory drugs to treat pain in deep endometriosis patients.

Patient and Methods: In the present study Gestrinone was used alone or in combination with either a higher (500 mg) or a lower (170 mg) doses of Myodesin™ in order to treat pelvic pain in patients with deep endometriosis . In the higher dose group Miodesin™ was dispensed without Astaxanthin. Miodesin is the trade name for a herbal complex prepared by Fagron Brazil whose composition contains a mixture of plant extracts from an amazon tree Uncaria tomentosa together other plants. In the lower dose group (170 mg), on the other hand, a novel composition of Miodesin™ was tested that also contained H. pluviallis extract containing Astaxanthin. Forty patients with deep endometriosis and severe pain were enrolled for this study. Patients were divided into 3 groups according to treatment scheme. In Group A (n=11) they were treated with vaginal Gestrinone alone (2,5mg/g twice a week). In Group B (n=17) the patients received Gestrinone (2.5 mg/g twice a week) together with Miodesin™ (500 mg/3g daily)(Fagron Brazil). In Group C (n=12) the patients were treated with a daily dose of 1 mg/g of Gestrinone together with a lower dose of Miodesin™ 170 mg/g containing H pluvialis extract as described above . All medications were dispensed vaginally dissolved in Pentravan® (Fagron, Netherland). In group C only 1g of Pentravan® was necessary to dissolve 170 mg of the new composition of Miodesin™ containing H. pluvialis extract while in group B it was necessary to use 3g to solubilize the 500 mg of traditional Miodesin™.

Results: In all 3 groups total pain scores reduced significantly after one month of treatment. However the post treatment scores were always significantly lower in patients who had used either the higher dose of Miodesin™ (Group B) or the new composition of Miodesin™ (Groups C) when compared to Gestrinone alone (Group A )(p<0.02).

Conclusion: Although Miodesin™ was administered in a lower dose in group C the addiction of H.pluviallis extract standardized to contain Astaxanthin increased its efficacy to treat endometriosis pain when used together with Gestrinone. Miodesin™ is an inhibitor of NF-kappa-b activation while Astaxanthin is a carotenoid with potent antioxidant effects and their combined administration had a synergetic effect that allowed the reduction of the doses of Miodesin™ without compromising its efficacy.

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