Linggui Yangyuan Paste for Male Infertility with Shen (Kidney) Deficiency and Blood Stasis Syndrome: A Multicenter, Double-Blind, Double-Dummy, Randomized Controlled Trial.
Sheng-Jing Liu, Qiu-Jian Feng, Yang Zhao et al.
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In 30 seconds
This multicenter, double-blind, double-dummy randomized trial compared Linggui Yangyuan Paste (LG) with Wuzi Yanzong Oral Solution in 162 men with infertility associated with asthenozoospermia or oligoasthenozoospermia and a Shen deficiency and blood stasis pattern. After 12 weeks of treatment, the per-protocol analysis found a greater increase in total progressive motile sperm count with LG, with an adjusted between-group difference of 8.81 × 10 6 sperm (P<0.05, 95% confidence interval 2.75-14.87). Cumulative pregnancy at week 24 was also higher with LG: 24.0% (18/75) vs. 10.0% (7/70).
Key findings
- At week 12, the adjusted between-group difference in total progressive motile sperm count favored LG by 8.81 × 10 6 sperm (P<0.05, 95% confidence interval 2.75-14.87).
- Cumulative pregnancy at week 24 was 24.0% (18/75) with LG and 10.0% (7/70) with Wuzi Yanzong Oral Solution (P<0.05).
- CM symptom scores decreased in both groups, with a greater reduction in the LG group (P<0.05).
- No adverse events or adverse drug reactions were reported in either group.
Why it matters
The trial reports improvements in a semen-based primary outcome and pregnancy rates with LG compared with an active treatment in men meeting the study’s specific infertility and traditional Chinese medicine pattern criteria. These findings add comparative clinical evidence for this population, while the trial’s duration and analysis population should inform interpretation of the results.
What to keep in mind
The per-protocol analysis included 145 of 162 randomized participants, and follow-up extended only 12 weeks beyond treatment. Findings apply to the specified infertility diagnoses and Shen deficiency and blood stasis pattern.