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Peer-reviewedCC BY-NC 4.0Diabetes, Metabolic Syndrome and Obesity

Efficacy of Hongjing Qiwei Formula Combined with Tadalafil in the Treatment of Erectile Dysfunction Associated with Type 2 Diabetes Mellitus: A Double-Blind, Single-Dummy, Randomized Controlled Trial

  • Hao Wang1,2
  • Yongqing Zhao2
  • Hongyuan Chang2
  • Dicheng Luo2
  • Jiwei Zhang2
  • Boda Guo3
  • Jun Guo2
  1. 1Department of Andrology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, People’s Republic of China
  2. 2Department of Andrology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, People’s Republic of China
  3. 3Department of Urology, Peking University Third Hospital, Beijing, People’s Republic of China
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Abstract

Background: Erectile dysfunction associated with diabetes mellitus (DMED) is common and may respond inadequately to phosphodiesterase type 5 inhibitor therapy. Evidence regarding traditional Chinese medicine combined with tadalafil for DMED remains limited. This study evaluated the efficacy and safety of Hongjing Qiwei Formula (HJQWF) plus tadalafil in patients with type 2 DMED.

Methods: In this double-blind, single-dummy, randomized controlled trial, 76 participants were randomly assigned in a 1:1 ratio to receive HJQWF plus tadalafil 5 mg (treatment group) once daily or matched HJQWF placebo plus tadalafil 5 mg (control group) once daily for 6 weeks, followed by a 4-week post-treatment follow-up. The primary outcome was the International Index of Erectile Function-5 (IIEF-5). Secondary outcomes included erection hardness score (EHS), Traditional Chinese Medicine syndrome score (TCMSS), Sexual Encounter Profile Questions 2 and 3 (SEP-2 and SEP-3), and safety outcomes.

Results: Seventy-one participants completed the intervention (treatment group, n = 36; control group, n = 35). At week 6, the mean change in IIEF-5 from baseline was greater in the treatment group than in the control group (5.53 ± 3.81 vs 3.26 ± 3.89; P < 0.05). The corresponding improvement in EHS was also greater with HJQWF (0.92 ± 0.84 vs 0.46 ± 0.70; P < 0.05). TCMSS decreased more markedly in the treatment group than in the control group (−16.14 ± 5.32 vs −2.77 ± 4.60; P < 0.05). At week 6, the proportion of participants reporting successful intercourse on SEP-3 was higher in the treatment group than in the control group (72.22% vs 45.71%; P < 0.05). No serious adverse events or clinically significant laboratory abnormalities were reported.

Conclusion: HJQWF added to tadalafil may provide additional short-term improvement in erectile-function outcomes in men with type 2 DMED, and can still continuously improve erectile function even four weeks after discontinuation with no major safety signal observed during the study period.

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Cite

BibTeXRIS
BibTeX
@article{wang2026efficacy,
  title = {{Efficacy of Hongjing Qiwei Formula Combined with Tadalafil in the Treatment of Erectile Dysfunction Associated with Type 2 Diabetes Mellitus: A Double-Blind, Single-Dummy, Randomized Controlled Trial}},
  author = {Hao Wang and Yongqing Zhao and Hongyuan Chang and Dicheng Luo and Jiwei Zhang and Boda Guo and Jun Guo},
  journal = {Diabetes, Metabolic Syndrome and Obesity},
  year = {2026},
  month = oct,
  doi = {10.2147/dmso.s644621},
  url = {https://doi.org/10.2147/dmso.s644621},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Efficacy of Hongjing Qiwei Formula Combined with Tadalafil in the Treatment of Erectile Dysfunction Associated with Type 2 Diabetes Mellitus: A Double-Blind, Single-Dummy, Randomized Controlled Trial
AU  - Hao Wang
AU  - Yongqing Zhao
AU  - Hongyuan Chang
AU  - Dicheng Luo
AU  - Jiwei Zhang
AU  - Boda Guo
AU  - Jun Guo
PY  - 2026
DA  - 2026/10/30
JO  - Diabetes, Metabolic Syndrome and Obesity
DO  - 10.2147/dmso.s644621
UR  - https://doi.org/10.2147/dmso.s644621
AB  - Background: Erectile dysfunction associated with diabetes mellitus (DMED) is common and may respond inadequately to phosphodiesterase type 5 inhibitor therapy. Evidence regarding traditional Chinese medicine combined with tadalafil for DMED remains limited. This study evaluated the efficacy and safety of Hongjing Qiwei Formula (HJQWF) plus tadalafil in patients with type 2 DMED.  Methods: In this double-blind, single-dummy, randomized controlled trial, 76 participants were randomly assigned in a 1:1 ratio to receive HJQWF plus tadalafil 5 mg (treatment group) once daily or matched HJQWF placebo plus tadalafil 5 mg (control group) once daily for 6 weeks, followed by a 4-week post-treatment follow-up. The primary outcome was the International Index of Erectile Function-5 (IIEF-5). Secondary outcomes included erection hardness score (EHS), Traditional Chinese Medicine syndrome score (TCMSS), Sexual Encounter Profile Questions 2 and 3 (SEP-2 and SEP-3), and safety outcomes.  Results: Seventy-one participants completed the intervention (treatment group, n = 36; control group, n = 35). At week 6, the mean change in IIEF-5 from baseline was greater in the treatment group than in the control group (5.53 ± 3.81 vs 3.26 ± 3.89; P < 0.05). The corresponding improvement in EHS was also greater with HJQWF (0.92 ± 0.84 vs 0.46 ± 0.70; P < 0.05). TCMSS decreased more markedly in the treatment group than in the control group (−16.14 ± 5.32 vs −2.77 ± 4.60; P < 0.05). At week 6, the proportion of participants reporting successful intercourse on SEP-3 was higher in the treatment group than in the control group (72.22% vs 45.71%; P < 0.05). No serious adverse events or clinically significant laboratory abnormalities were reported.  Conclusion: HJQWF added to tadalafil may provide additional short-term improvement in erectile-function outcomes in men with type 2 DMED, and can still continuously improve erectile function even four weeks after discontinuation with no major safety signal observed during the study period.
SN  - 1178-7007
ER  -