Large study (283 women) on the effectiveness of Manosar®: 2 g of d-mannose + 140 mg of proanthocyanidins (PAC), of prolonged release. / Amplio estudio (283 mujeres) sobre la eficacia de Manosar®: 2 g de d-manosa + 140 mg de proantocianidinas (PAC), de liberación prolongada frente a 240 mg de PAC de liberación prolongada en la prevención a 6 meses por vía oral de las infecciones urinarias recurrentes.

OBJECTIVE: To compare the efficacy and safety in the prophylasis of urinary tract infections (UTIs) with a food supplement that contains D-mannose like active ingredient (Manosar®), in comparison to another preparation in which the active ingredient are the proanthocyanidins (PAC), both of them, in prolonged released, after, they was administered for 24 weeks. METHODS: A multicenter, randomized and double blind experimental study was carried out. 283 women with a history of recurrent UTIs without evidence of complication were included. They were randomized 1: 1 in two groups. In one group, 1 oral sachet of Manosar® a day was administered, and in the other group 1 oral sachet of a compound of 240 mg of continuous-release PAC. Prior to inclusion in the study, the episode of UTI was confirmed at least by the clinical symptoms and positivity of the Combur test. RESULTS: Valid data were obtained from 184 patients with an average age of 49.5 years: 90 received Manosar® and 94 isolated PAC. A total of 72 patients suffered an UTI due to E.coli: 25 patients in the arm with Manosar® versus 47 patients in the isolated PAC group, this difference being statistically significant (p=0.002). The free time of new UTI recurrences was 98.6 days in the group treated with Manosar® and 84.6 days in the group with isolated PAC. CONCLUSION: The oral taking of a daily sachet of Manosar® is effective and safe in preventing recurrent UTIs in women, being superior to the oral taking of isolated PAC.

OBJETIVO: Comparar la eficacia y seguridad de la profilaxis de las infecciones del tracto urinario (ITUs) con un complemento alimenticio que contiene D-manosa como principio activo principal (Manosar®), en comparación con otro preparado cuyo principio activo único son las proantocianidinas (PAC), ambos de liberación continuada, tras su administración durante24 semanas.MÉTODOS: Estudio experimental multicéntrico, aleatorizado y doble ciego. Se incluyeron 283 mujeres con historia de ITUs recurrentes sin evidencias de complicación. Se randomizaron 1:1 en dos grupos. En un grupo se administró 1 sobre diario oral de Manosar®, y en el otro 1 sobre diario oral de un compuesto de 240 mg de PAC de liberación continuada. Previo a la inclusión en el estudio se confirmó el episodio de ITU al menos por la sintomatología clínica y positividad del test de Combur. RESULTADOS: Se obtuvieron datos válidos de 184 pacientes con edad media de 49,5 años: 90 recibieron Manosar® y 94 PAC aislado. Un total de 72 pacientes padecieron una ITU por E.coli: 25 pacientes en el brazo con Manosar® frente a 47 pacientes en el grupo de PAC aislado, siendo esta diferencia estadísticamente significativa (p=0,002). El tiempo libre de nuevas recurrencias de ITU fue de 98,6 días en el grupo tratado con Manosar® y de 84,6 días en el grupo con PAC aislado.CONCLUSIÓN: La toma oral de un sobre al día de Manosar® es eficaz y segura en la prevención de las ITUs recurrentes en la mujer, siendo superior a la toma oral de PAC aislado.

Eficacia y tolerancia terapéutica de la D-manosa (2 g) de liberación prolongada 24 horas (asociada a proantocianidinas), frente a proantocianidinas aisladas en el manejo de una serie de mujeres con infecciones urinarias recurrentes / Efficacy and safety of D-mannose (2 g), 24h prolonged release, associated with Proanthocyanidin (PAC), versus isolate PAC, in the management of a series of women with recurrent urinary infections

Objetivo: Comparar la eficacia y seguridad de un complemento alimenticio (Manosar®) (2 gramos de D-manosa, 140 mg de PAC y 7,98 mg de ácido ursólico junto con las vitaminas A, C y E, y el oligoelemento Zinc) en la recurrencia de la ITU y su comparación con un compuesto basado con 240 mg proantocianidinas (PAC aislado), con una duración de administración esperada de 24 semanas. Métodos: Estudio experimental multicéntrico, aleatorizado y doble ciego. Aprobado por el Comité Ético de Investigación clínica del "Complejo Hospitalario de Toledo". Todos los pacientes firmaron el consentimiento. Se incluyeron 150 mujeres con historia de ITU recurrentes sin evidencias de complicación. Se obtuvieron datos válidos de 93 pacientes con edad media de 47,62 años. 42 recibieron Manosar y 51 PAC aislado. Controles cada 30 días durante 6 meses. La confirmación del episodio clínico previo de ITU fue definido al menos por la sintomatología clínica y tira de orina Combur (positiva a leucocito-esterasa y/o nitritos). La confirmación del nuevo episodio incidente durante el estudio fue confirmado por la sintomatología clínica, tira de orina y urinocultivo. Resultados: 33 pacientes (35,48%) padecieron una ITU durante el periodo de 6 meses de seguimiento. En el grupo tratado con Manosar® se observó ITU a los seis meses en un 23,8%, mientras que en el grupo control (PAC aislado) fue de 45,1% (p<0,05). El tiempo libre de enfermedad fue de 78,81 días en el grupo control (PAC aislado) y de 94,7 días en el grupo tratado con Manosar®. Se observó una baja incidencia de acontecimientos adversos, siendo la diarrea el más frecuente en ambos grupos. Conclusión: La toma oral de Manosar®, un sobre al día, es más eficaz que la toma oral de 240 mg de PAC aislado, un sobre al día, en la prevención de las infecciones urinarias de repetición en la mujer (AU)

Objetive: To compare the efficacy and safety of dietary supplement "Manosar®" composed of D-mannose (2 g), 24 h prolonged release, associated with Proanthocyanidin (PAC) (140 mg), ursolic acid (7.98 mg), A, C, and D vitamins and the oligoelement zinc, versus 240 mg of PAC in recurrent urinary tract infections (UTI), for a designed follow-up of 24 weeks, in women. Methods: A multicenter randomized experimental double-blind study was carried out. The study was approved by review board of "Complejo Hospitalario de Toledo" (Spain), and all patients gave informed consent. A total of 150 women with non complicated UTI were screened for participation. Valid data was obtained from 93, with mean age of 48 years. Fortyfour patients were assigned to the Manosar® group and 51 patients to the PAC group. Patients were followed during six months. A previous UTI was defined based on a combination of symptoms and a positive reactive urine trip. Confirmation of a new UTI was based on symptoms, reactive urine strip and urine culture. Results: Thirty-three patients (35%) had an UTI during the six months follow-up. The percentage of UTI of the Manosar® group during this period was 24%, while the percentage of the PAC group was 45% (p<0.05). The disease-free time for the Manosar® group was 95 days, while this time was 79 days for the PAC group. The incidence of side effects was low. Diarrhea was the most frequent side-effect in both groups. Conclusion: Manosar® (oral once a day) is more effective than single dose PAC (240 mg daily orally) to prevent recurrent UTI in women (AU)

[Efficacy and safety of D-mannose (2 g), 24h prolonged release, associated with Proanthocyanidin (PAC), versus isolate PAC, in the management of a series of women with recurrent urinary infections.] / Eficacia y tolerancia terapéutica de la D­manosa (2 g) de liberación prolongada 24 horas (asociada a proantocianidinas), frente a proantocianidinas aisladas en el manejo de una serie de mujeres con infecciones urinarias recurrentes.

OBJECTIVE: To compare the efficacy and safety of dietary supplement "Manosar®" composed of D-mannose (2 g), 24 h prolonged release, associated with Proanthocyanidin (PAC) (140 mg), ursolic acid (7.98 mg), A, C, and D vitamins and the oligoelement zinc, versus 240 mg of PAC in recurrent urinary tract infections (UTI), for a designed follow-up of 24 weeks, in women. METHODS: A multicenter randomized experimental double-blind study was carried out. The study was approved by review board of "Complejo Hospitalario de Toledo" (Spain), and all patients gave informed consent. A total of 150 women with non complicated UTI were screened for participation. Valid data was obtained from 93, with mean age of 48 years. Fortyfour patients were assigned to the Manosar® group and 51 patients to the PAC group. Patients were followed during six months. A previous UTI was defined based on a combination of symptoms and a positive reactive urine trip. Confirmation of a new UTI was based on symptoms, reactive urine strip and urine culture. RESULTS: Thirty-three patients (35%) had an UTI during the six months follow-up. The percentage of UTI of the Manosar® group during this period was 24%, while the percentage of the PAC group was 45% (p〈0.05). The disease-free time for the Manosar® group was 95 days, while this time was 79 days for the PAC group. The incidence of side effects was low. Diarrhea was the most frequent side-effect in both groups. CONCLUSION: Manosar® (oral once a day) is more effective than single dose PAC (240 mg daily orally) to prevent recurrent UTI in women.