Effects of Shugan Huoxue Yishen decoction on homocysteine, inflammatory factors and endothelial function in patients with metabolic syndrome-related erectile dysfunction

Corresponding author: Zhu Hong Qing, hongqingzhu@126.com

DOI: 10.12201/bmr.202508.00012

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  Abstract: Objective To observe the effect of Shugan Huoxue Yishen decoction on serum homocysteine(Hcy),inflammatory factors and endothelial homocysteine function in patients with metabolic syndrome (MS) related erectile dysfunction dysfunction (ED) . Methods A total of 91 patients with metabolic syndrome related erectile dysfunction from September 2023 to December 2024 in Nanjing University of Chinese Medicine in Taizhou affiliated hospital were collected, the patients were randomly divided into control group (N = 45) and observation group (N = 46) . The patients in the control group were treated with oral administration of tadanafil as needed, while those in the observation group were treated with the combination of Shugan Huoxue Yishen decoction and tadanafil as needed for 12 weeks. The clinical efficacy, TCM syndrome score, International Index of Erectile Function 5(IIEF-5) score, serum homocysteine, high sensitivity C-reactive protein (hs-CRP) , tumor necrosis factor-α (TNF-α) , interleukin-6(IL-6) , nitric oxide (No) and endothelin-1(ET-1) levels were observed before and after treatment in the two groups. Adverse reactions were observed in both groups. Results After 12 weeks of treatment, the clinical effect of the observation group was better than that of the control group (p < 0.05) , the score of TCM syndrome in the observation group was lower than that of the control group (p < 0.05) , and the score of IIEF-5 was higher than that of the control group (p < 0.05) The levels of Hcy, hs-CPR, TNF-α and IL-6 in the observation group were lower than those in the control group (p < 0.05) . The levels of NO in the observation group were higher than those in the control group, while the levels of ET-1 were lower than those in the control group (p < 0.05). There was no significant difference in adverse reactions between the two groups (P > 0.05).Conclusion Shugan Huoxue Yishen decoction can decrease the levels of serum homocysteine and inflammatory factors, improve endothelial function, improve erectile function and clinical efficacy in patients with MS-associated ED, it has clinical application value

  Key words: Erectile dysfunction；Metabolic syndrome；Shugan Huoxue Yishen decoction；Homocysteine； Inflammatory factors；Endothelial cells

  Submit time: 6 August 2025

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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