Possible modulating action of plant infusion of Ocimum sanctum L. on chromosomal aberrations and sister chromatid exchanges induced by chlormadinone acetate in human lymphocytes in vitro.

Chlormadinone acetate (CMA) is a synthetic progesterone analogue. It has its usage in oral contraceptives formulations and also for estrous synchronization of animals. The aim of the present study is to study the anti- genotoxic activity of the plant infusion against the CMA induced genotoxic damage on cultured human lymphocytes, using chromosomal aberrations and sister chromatid exchanges (SCFs) as parameters. For chromosomal aberration analysis, the treatment of 40 microM of CMA was associated with 4.33% abnormal metaphases. The treatment of 40 microM of CMA, separately with 1.075 x 10(-4), 2.125 x 10(-4) and 3.15 x 10(-4) gm l(-1) of plant infusion results in the reduction of the number of abnormal metaphases i.e. 2.67%, 2.00% and 1.67% respectively. For sister chromatid exchange analysis, the frequency of sister chromatid exchange per cell (SCE(S)/Cell) for the treatment of 40 microM of CMA was 6.43. The treatment of 40 microM of CMA, separately with 1.075 x 10(-4), 2.125 x 10(-4) and 3.15 x 10(-4) gm l(-1) of plant infusion results in the significant reduction of the frequency of SCE(S)/Cell i.e. 3.76, 3.01 and 2.94, respectively, as compared to the CMA (40 microM) treatment alone (6.43). The used dosages of plant infusion did not increase chromosomal aberrations and sister chromatid exchanges at significant level as compared to the untreated. The results of the present study suggest that the plant infusion per se does not have genotoxic potential, but can modulate the genotoxicity of chlormadinone acetate in human lymphocytes in vitro.

Experiencia chilena con el uso de un anticonceptivo oral combinado de acetato de clormadinona/etinilestradiol: estudio no intervencional / Efficacy, tolerability and safety of an oral contraceptive containing ethinylestradiol/chlormadinone acetate: the Chilean experience

Objetivos: Evaluar en mujeres chilenas, la eficacia, tolerabilidad y seguridad del anticonceptivo Belara® (Acetato de Clormadinona 2 mg y Etinilestradiol 0,03 mg) (ACM/EE). Métodos: Estudio no intervencional, multicéntrico, prospectivo, de 6 ciclos de seguimiento, evaluando efectividad anticonceptiva, estabilidad de ciclo, tolerabilidad, seguridad y acción sobre peso, piel y cabello. Resultados: ACM/EE fue tomado por 593 mujeres durante 3426 ciclos. Hubo 2 embarazos durante el seguimiento, uno voluntario y otro involuntario; en ninguno de los casos se consideró como falla del método. Durante el tratamiento se observó mejoría progresiva en la estabilidad del ciclo menstrual, sangrado intermenstrual, amenorrea y dismenorrea, con frecuencia de 4,5%, 1,4%, 2,5% y 11,6% al sexto ciclo, respectivamente. El porcentaje de mujeres con piel normal incrementó de 25,5% antes del tratamiento a 63,6% después de seis meses de administración continua de ACM/EE. El peso promedio se mantuvo estable durante el tratamiento. Los eventos adversos mas frecuentes fueron: cefalea (10,4%), aumento de peso (8,3%), mastalgia (6,1%) y trastornos del ánimo (2%). El 11% de las usuarias (n=63) suspendió ACM/EE antes de terminar los 6 meses de observación. El 97,2% de los médicos y 96,1% de las usuarias calificaron los resultados con ACM/EE como “buenos o muy buenos”. Conclusiones: Similar a los resultados reportados en la literatura europea, este estudio realizado en población chilena, confirma la eficacia, seguridad y tolerabilidad de ACM/EE así como los beneficios antiandrogénicos adicionales sobre piel y cabello, y su efecto neutral sobre el peso corporal.

Objectives: To evaluate the efficacy, tolerability and safety of the contraceptive Belara® (chlormadinone 2 mg/ethinylestradiol 0.03 mg; ACM/EE) in chilean women. Methods: Non interventional, multicentric, prospective, 6 cycles follow up trial, evaluating contraceptive efficacy, cycle stability, tolerability, safety, and effect on hair and skin. Results: AMC/EE was taken by 593 women for a total of 3426 cycles. Two pregnancies were reported during follow-up, one voluntary and the other involuntary; they were not considered failure of the method. Progressive improvement in cycle stability, intermenstrual bleeding, amenorrhea and dysmenorrhea occurred during the treatment period reaching 4.5%, 1.4%, 2.5% y 11.6% at the 6th cycle respectively. The percentage of women with normal skin increased from 25.5% prior to treatment, to 63.6%, after taking ACM/EE during six months. The average body weight was maintained throughout treatment. The most frequent adverse events were: headache (10.4%), weight increase (8.3%), breast tenderness (6.1%) and mood changes (2%). An 11% of users (n=63) discontinued the use of ACM/EE before completing the observational period of six months. A 97.2% of physicians and 96.1% of users qualified the results with ACM/EE as “good or very good”. Conclusions: Similar to the results reported in the European literature, this study in the Chilean population confirmed the efficacy, safety and tolerability of ACM/EE, together with its antiandrogenic benefits on skin and hair, and its neutral effect on body weight.

Protective role of allicin and L-ascorbic acid against the genotoxic damage induced by chlormadinone acetate in cultured human lymphocytes.

In our present study, different doses of allicin and L-ascorbic acid were tested against the genotoxic damage induced by chlormadinone acetate (CMA; 40 microM) using chromosomal aberrations (CAs) and sister chromatid exchanges (SCEs) as the parameters. Treatment with allicin and L-ascorbic acid resulted in reduction of CAs and SCEs. The results suggested a protective role of allicin and L-ascorbic acid against CMA induced genotoxic damage.