Hongjing Qiwei formula combined with tadalafil in the treatment of erectile dysfunction associated with type 2 diabetes mellitus: study protocol for a double-blind, single-dummy, randomized controlled trial

Fórmula Hongjing Qiwei combinada con tadalafilo en el tratamiento de la disfunción eréctil asociada a la diabetes mellitus de tipo 2: protocolo de estudio para un ensayo controlado aleatorizado, doble ciego y con un único inóculo

Background: Traditional Chinese Medicine (TCM) has been utilized for the treatment of sexual dysfunction in China for thousands of years, and in recent years, despite advancements in this field, the efficacy of phosphodiesterase-5 inhibitors (PDE5i) for managing diabetes mellitus erectile dysfunction (DMED) remains limited. Therefore, many patients with type 1 DMED or type 2 diabetes mellitus erectile dysfunction (T2DMED) are turning to combination therapy involving PDE5i and TCM. The Hongjing Qiwei (HJQW) formula, a traditional TCM formulation, has been used to address DMED based on TCM principles. Methods: This study presents a randomized, controlled, double-blind, single-dummy clinical trial protocol designed to evaluate the efficacy and safety of combining TCM with PDE5i in the treatment of T2DMED. The participants will be randomly assigned to one of two groups: the treatment group, receiving tadalafil 5 mg combined with the HJQW formula, and the control group, receiving tadalafil 5 mg combined with a placebo mimicking the HJQW formula. The intervention will be administered over 6 consecutive weeks, with an additional 4 weeks allocated for follow-up. Primary and secondary outcomes will be assessed at baseline and at weeks 2, 4, 6 and 10. Results: Although emerging evidence suggests that TCM therapies may enhance erectile function in patients with sexual dysfunction, their specific efficacy in T2DMED remains underexplored. Conclusions: This study aims to address this gap and provide empirical evidence supporting the use of combination therapy in treating male sexual dysfunction. Clinical Trial Registration: This study was registered with http://www.chictr.org.cn as: ChiCTR2400085314.

Resumen

Antecedentes: La medicina tradicional China (MTC) se ha utilizado para el tratamiento de la disfunción sexual en China durante miles de años, y en los últimos años, a pesar de los avances en este campo, la eficacia de los inhibidores de la fosfodiesterasa-5 (IPDE-5) para el manejo de la diabetes mellitus disfunción eréctil (DMDE) sigue siendo limitada. Por lo tanto, muchos pacientes con diabetes mellitus tipo 1 DMDE o diabetes mellitus tipo 2 con disfunción eréctil (T2DMDE) están recurriendo a la terapia de combinación que involucra IPDE-5 y MTC. La fórmula Hongjing Qiwei (HJQW), una formulación tradicional de MTC, se ha utilizado para tratar la DMDE sobre la base de principios de MTC. Métodos: Este estudio presenta un protocolo de ensayo clínico aleatorizado, controlado, doble ciego, diseñado para evaluar la eficacia y la seguridad de la combinación de MTC con IPDE-5 en el tratamiento de T2DMDE. Los participantes serán asignados al azar a uno de dos grupos: el grupo de tratamiento, que recibe 5 mg de tadalafilo combinado con la fórmula HJQW, y el grupo de control, que recibe 5 mg de tadalafilo combinado con un placebo que imita la fórmula HJQW. La intervención se administrará durante 6 semanas consecutivas, con 4 semanas adicionales asignadas para el seguimiento. Los resultados primarios y secundarios se evaluarán al inicio y a las semanas 2, 4, 6 y 10. Resultados: Aunque la evidencia emergente sugiere que los tratamientos con MTC pueden mejorar la función eréctil en pacientes con disfunción sexual, su eficacia específica en T2DMDE sigue siendo poco explorada. Conclusiones: Este estudio tiene como objetivo abordar esta brecha y proporcionar evidencia empírica que apoye el uso de la terapia combinada en el tratamiento de la disfunción sexual masculina. Registro del Ensayo Clínico: Este estudio fue registrado en http://www.chictr.org.cn con el número: ChiCTR2400085314.

Diabetes mellitus; Erectile dysfunction; Hongjing Qiwei formula; Protocol

Palabras Clave

Diabetes mellitus; Disfunción eréctil; Fórmula Hongjing Qiwei; Protocolo

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