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espanolEstudio comparativo controlado con placebo realizado en tres grupos de 20 mujeres cada uno, posmenopausicas, de edades comprendidas entre los 50 y los 75 anos y con alopecia androgenica femenina (AAF) en estadio I-II de la escala de Ludwig. Los tratamientos asignados segun un esquema previo de aleatorizacion fueron: complemento alimenticio inhibidor de la enzima 5α-reductasa con la combinacion de los extractos vegetales Pygeum africanum/Serenoarepens en dosis de 100 mg cada uno + metilsulfonilmetano (MSM) en dosis de 500 mg; complemento alimenticio inhibidor de la enzima 5α-reductasa con la combinacion de los extractos vegetales Pygeum Africanum/Serenoa repens en dosis de 50 mg cada uno; y placebo. Se realizaron tres visitas a lo largo del estudio: visita T0basal a la inclusion en el estudio; visita T8 a las 8 semanasde tratamiento; y visita T16 a las 16 semanas de tratamiento. Se establecio una pauta de tratamiento de 2 capsulas aldia en dos tomas, manana y noche. Las variables principales de eficacia evaluadas fueron: fototricograma (cabello total y cabello en fase anagena), resistencia del cabello a la traccion (prueba de traccion o pull test) y evaluacion clinica (eritema y prurito). Comovariables secundarias, se valoraron: tolerabilidad y cuestionario de evaluacion subjetiva del estado del cabello. Todas las variables fueron evaluadas en el momento basal T0, enT8 a las 8 semanas y en T16 a las 16 semanas de tratamiento, excepto la evaluacion subjetiva, que unicamente se rea- lizo en la visita T16. En el analisis comparativo, se observa a las 16 semanas de tratamiento que, con la formulacion Pygeum africanum en dosis de 100 mg/Serenoa repens en dosis de 100 mg + MSM en dosis de 500 mg, se obtiene con respecto a la formulacion Pygeum africanum en dosis de 50 mg/Serenoa repens en dosis de 50 mg: un aumento significativo del numero de cabellos totales; un mayor aumento de la proporcion de cabellos en fase anagena patente desde la visita T8, siendo un 30% superior en la visita de las 16 semanas; y una mejora de la resistencia del cabello a la traccion tres veces superior. A la luz de los resultados obtenidos en el estudio comparativo, se podria concluir que, con las aportaciones de la nueva formulacion incrementando la dosis de sus extractos vegetales de 50 a 100 mg e incorporando la nueva molecula de MSM en dosis de 500 mg con propiedades antioxidantes y antiinflamatorias, se objetiva un efecto adicional, «efec- to PLUS», que mejora la efectividad del tratamiento y contribuye a un abordaje clinico mas integral de la AAF. EnglishComparative study controlled with placebo including three groups of 20 50-to-75-year- old postmenopausal women with female androgenetic alopecia (FAA) in stage I-II of the Ludwig scale. Treatments were assigned according to the previous randomization scheme: a 5α-reductase inhibitor food supplement with the combination of Pygeum africanum/Serenoa repens plant extracts at a dose of 100 mg each one + methylsulfonylmethane (MSM) at a dose of 500 mg; a 5α-reductase inhibitor food supplement with the combination of Pygeum africanum/Serenoa repens plant extracts at a dose of 50 mg each one; and placebo. Three visits were made throughout the study: baseline T0 visit at the inclusion in the study; visit T8 after 8 weeks of treatment; and visit T16 at 16 weeks of treatment. A treatment regi- men of 2 capsules per day was established in two doses, in the morning and at night. The main efficacy variables evaluated were: phototrichogram (total hair and hair in anagen phase), hair resistance to traction (pull test), clinical evaluation (erythema and pruritus). As secondary variables, the following ones were measured: tolerability and a subjective assessment of hair condition questionnaire. All the variables were evaluated at baseline (T0), and at 8 weeks (T8) and 16 weeks (T16) of treatment, except for the sub- jective evaluation that was only performed at visit T16. At 16 weeks of treatment, the comparative analysis shows that with the formulation Pygeum africanumat a dose of 100 mg/Serenoa repens at a dose of 100 mg + MSM at a dose of 500 mg several advantages are obtained over the formulation Pygeum africanum at a dose of 50 mg/Serenoa repens at a dose of 50 mg: a significant increase in the number oftotal hair; a greater increase in the proportion of hair in the patent anagen phase since the T8 visit, being 30% higher in the visit at 16 weeks; and a three times better improve- ment in the resistance of hair to traction. These findings show us that, in the comparative study, the contributions of the new for- mulation increasing the dose of its plant extracts from 50 mg to 100 mg and incorporat- ing the new MSM molecule at a dose of 500 mg, with antioxidant and anti-inflammatory properties, provides an additional beneficial effect, a «PLUS effect», which improves treat- ment effectiveness and contributes to a more integrated clinical approach to FAA.

Estudio comparativo de dos complementos alimenticios inhibidores de la 5a-reductasa en la alopecia androgénica femenina