OBJECTIVE To evaluate the clinical efficacy and safety of Bushen Migu Tablet in treating oligoasthenospermia with spleen-kidney deficiency syndrome.

METHODS A total of 200 patients were randomly divided into an observation group (n=100) and a control group (n=100). The control group received levocarnitine oral solution combined with lifestyle interventions, while the observation group received additional Bushen Migu Tablet. The treatment lasted for 12 weeks. Traditional Chinese medicine (TCM) syndrome scores were recorded before treatment, at 4 weeks, and at 12 weeks of treatment. Changes in semen parameters semen volume, sperm density, percentage of progressively motile sperm (PR), sperm viability, linear motility rate, and percentage of normal-morphological sperm were detected using a computer-assisted semen analysis system. The clinical efficacy of the two groups was evaluated after treatment, and adverse drug reactions were monitored during the treatment period.

RESULTS After 4 and 12 weeks of treatment, both groups showed significant increases in semen volume, sperm density, PR, sperm viability, linear motility rate, and the proportion of normal-morphological sperm (P<0.05). At 4 weeks of treatment, the observation group had higher sperm viability, linear motility rate, and the proportion of normal-morphological sperm than the control group (P<0.05). At 12 weeks of treatment, the observation group showed significantly higher semen volume, sperm density, PR, sperm viability, linear motility rate, and proportion of normal-morphological sperm compared to the control group (P<0.05); the efficacy of the observation group was significantly better than that of the control group (P<0.01). At 4 and 12 weeks of treatment, the observation group showed significant reductions in spontaneous sweating and loose stools, soreness and weakness of the waist and knees, low semen volume, decreased sexual desire, frequent nocturnal urination, and total score (P<0.05), with the observation group outperforming the control group (P<0.05). At 12 weeks of treatment, the observation group had lower scores in spontaneous sweating, loose stools, soreness and weakness of the waist and knees, low semen volume, frequent nocturnal urination, and total score compared to 4 weeks of treatment (P<0.05). No significant adverse reactions were observed in either group during the treatment period.

CONCLUSION Bushen Migu Tablet combined with levocarnitine significantly improves semen quality and TCM symptoms in patients with oligoasthenospermia and spleen-kidney deficiency syndrome, demonstrating good safety.