Methods
kidney yang deficiency syndrome, sore, asthenospermia
ADVERSE EVENTS, BLIND, MALE INFERTILITY, ASTHENOSPERMIA
The related studies on the subject was found through a search in PubMed, Embase, the Cochrane Library, and CKNI. Google was used to search the grey literature.This randomized, positive drug-controlled, single-blind pilot study enrolled outpatients from the Third Department of Traditional Chinese Medicine Surgery, Shanghai University of Traditional Chinese Medicine, Shanghai, China, between April and September 2020. The study was approved by the Ethics Committee of the Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China (approval number: 2018SHL-KYYS-16). All patients provided written informed consent before any study procedure. The work was carried out in accordance with the Institutional Review Board and carried out with the ethical standards set forth in the 1975 Helsinki Declaration.The inclusion criteria were: i) 23-40 (inclusive) year-old male patient; ii) diagnosed with male infertility according to the diagnostic criteria of Western medicine;Asthenospermia due to kidney yang deficiency syndrome was defined as a loss of libido, low sperm count, low survival rate, weak motility, or poor ejaculation. The waist and knees are sore, tired, and weak, and the urine is long and clear. The tongue is pale, the coating is thin and white, and the pulse is heavy and thin.The dropout criteria were: i) participants with poor compliance (those who failed to follow the treatment as prescribed or use other treatment methods for male asthenospermia during the study) and ii) participants with serious adverse events (SAEs) during the study treatment.The randomization sequence was prepared by a third-party statistician using a random number table and in the form of sealed sequential envelopes. The patient received the indicated treatment according to the opened envelopes. Only the patients were blind to grouping.Peng’s Shengjing recipe was prepared using 18 grams (g) of Mantis egg case, 18 g of honeycomb, 18 g of rigid silkworm, 9 g of roasted astragalus, 9 g of codonopsis, 15 g of atractylodes, 15 g of rehmannia, 15 g of cornus, and 9 g of Yizhiren. The participants had to take 200 ml orally twice a day. A course of treatment was 12 weeks.The control group received the compound Xuanju capsule (Z20060462, Zhejiang Shiqiang Pharmaceutical Co., Ltd., 0.42 g/capsule) 3 times a day, 3 capsules each time, orally. Previous studies showed that Xuanju capsules could increase sperm density, sperm motility, and sperm activity and reduce the rate of sperm deformity without obvious adverse events.The percentage of sperms rated grade A, A+B, and A+B+C, semen volume, and efficacy were recorded by routine semen examinations. Each semen collection was carried out by masturbation after 3-5 days of abstinence. Semen quality was evaluated using computer-aided, fully automatic semen analysis (CASA) technology. The items included sperm motility and other parameters according to international standards.Treatment efficacy was rated as 1-markedly effective (sperm motility was normal after treatment), 2-effective (improvement of sperm motility to >30% for grade A+B and clinical symptoms improved), or 3-invalid (sperm motility <30% for grade A or A+B or no change after treatment. The clinical effective rate was calculated as (significantly effective number + effective number) / total number of people treated × 100%. The levels of gonadotropins (FSH, luteinizing hormone [LH], and testosterone) in the 2 groups were recorded before and after treatment.According to the World Health Organization (WHO) criteria, asthenospermia was defined as sperm motility rated <25% for class A or rated <50% for class A+B.According to preliminary data, the clinical effective rate of Peng’s Shengjing recipe was approximately 60%, while the clinical effective rate of Fufang Xuanju capsule was approximately 40%. Therefore, the number of cases in each observation group was set as 30 cases/60%=50 cases.