Effectiveness and Safety Evaluation of Qixiong Zhongzi Decoction () in Idiopathic Asthenozoospermia Treatment: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the clinical effectiveness and safety of the Chinese medicine (CM) Qixiong Zhongzi Decoction (, QZD) in the treatment of patients with idiopathic asthenozoospermia. METHODS: A total number of 66 patients with idiopathic asthenozoospermia were included and randomly divided into treatment and control groups by SAS-generated code from January 2015 to August 2016, 33 patients in each group. Patients in the treatment group were administered with 150 mL of QZD twice a day, whereas those in the control group were given 1 g of levocarnitine oral liquid twice a day. The two groups received the indicated medication for 12 weeks and were then followed up for 4 weeks. The primary outcome was sperm motility, and the secondary therapeutic indices were sperm volume, density, pregnancy probability, and CM syndrome score. The comparison between groups was carried out at 4, 8 and 12 weeks, respectively. The safety was determined before and after treatment. RESULTS: (1) Drop-off: 5 cases (7.58%) were lost after treatment (2 from the treatment group and 3 from the control group). (2) Primary outcomes: after 8- and 12-week treatment, the progressive sperms in the two groups were significantly higher than the baseline (all P<0.05); however, the treatment group showed greater improvement compared with the control group at 12-week treatment (22.7% ± 9.0% vs. 14.1% ±8.8%, P<0.05). The increasement of non-progressive grade sperms at both groups was observed at 8- and 12-week treatment with statistical difference (all P<0.05), however, the treatment group showed remarkable improvement compared with the control group at 12-week treatment (38.7% ±14.1% vs. 26.2% ±15.4%, P<0.05). (3) Secondary outcomes: no significant statistical differences were found in semen volume and density (4, 8, and 12-week treatment) and pregnancy probability of patients' wives (12-week treatment) between two groups (all P>0.05), however, the CM syndrome score of the treatment group significantly declined compared with baseline level at each time points (all P<0.05). (4) Safety: no obvious side reactions were found during the treatment in both groups. CONCLUSION: QZD could improve the progressive and non-progressive grade sperm in the treatment of idiopathic asthenozoospermia. It is safe with no obvious side effects.

[Treatment of Benign Prostatic Hyperplasia by Longbishu Capsule Combined Doxazosin Mesylate Tablet].

Objective To observe the efficacy and safety of Longbishu Capsule (LBS) com- bined Doxazosin Mesylate Tablet (DMT) in treating benign prostatic hyperplasia (BPH). Methods Total- ly 360 BPH with Shen deficiency blood stasis syndrome (SDBSS) were randomly assigned to group A, B, and C, 120 cases in each group. Patients in Group A took LBS placebos combined DMT. Those in Group B took LBS combined DMT. Those in Group C took LBS combined DMT placebos. The dose for LBS was 3 pills each time, 0. 3 g/pill, twice per day. The dose of DMT was 1 tablet each time, 2 mg/tablet, once per day. The therapeutic course for all was 12 months. A total of 113 cases in Group A were recruited in FAS analysis, 115 cases in Group B, and 116 cases in Group C. Main efficacy indicators [International Prostate Symptom Score (IPSS) , maximum urinary flow rate (Qmax) , Quality of Life (QOL) ] , and sec- ondary efficacy indicators [postvoid residual urine volume (PVR) and prostate volume (PV) , symptoms scores of Chinese medicine (CM) I were observed in each group. The efficacy was analyzed in the three groups by taking average age of subjects (66 years) as the hierarchy factor (50 ≤age ≤66 and <66 0. 05). There was no statistical difference in clinical efficacy among post-treatment groups (P >0. 05). The efficacy in subjects more than 66 years old of Group B was superior to that of Group A and C with statistical difference (P <0. 05). Conclusions LBS, DMT, or LBS combined DMT was safe and effective for treating BPH. LBS combined DMT was suit- able for patients complicated with abnormal PVR or aged over 66 years.

Effect of Longbishu capsule () plus doxazosin on benign prostatic hyperplasia: a randomized controlled trial.

OBJECTIVE: To investigate the effect of Longbishu Capsule (, LBS), doxazosin, and combination therapy on benign prostatic hyperplasia (BPH). METHODS: A randomized, double-blind, multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing (108 cases), Heilongjiang (90 cases), Sichuan (90 cases), Shanghai (72 cases), China. They were randomly assigned with central randomization method to group A (LBS placebo plus doxazosin), group B (LBS plus doxazosin) or group C (LBS plus doxazosin placebo), 120 cases for each group. The international prostate symptom score, maximum urinary flow rate, postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments. RESULTS: At baseline, there was no significant difference in the measured variables among the three groups. After 12-month treatment, the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline (P<0.01). Although postvoid residual urine volume was not significantly different from the baseline in group A (P>0.05), it significantly decreased in group B and C (P<0.05). The incidence of adverse events were similar among the three groups. CONCLUSIONS: The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH. The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well.

[Treatment of oligospermia/asthenozoospermia patients by three different Chinese medical principles: a randomized control clinical study].

OBJECTIVE: To assess the efficacy and safety of three different Chinese medical principles in treating patients with male infertility (oligospermia/asthenozoospermia). METHODS: Totally 128 patients with male infertility were classified into 3 groups, i.e., Shen-essence deficiency syndrome, Pi-Shen deficiency syndrome, Shen-deficiency blood-stasis syndrome. They were assigned to the Chinese medical treatment group (96 cases) and the Western medical treatment group (32 cases) by stratified randomization in the ratio of 3: 1. Those in the Chinese medical treatment group were treated with Chinese drugs for Shen invigorating and blood activating, Shen invigorating and Pi supplementing, Shen-qi benefiting. Those in the Western medical treatment group were treated with Clomifene (at the daily dose of 25 mg per day, once daily). Three months consisted of one therapeutic course. The parameters of semen, the pregnancy rate, and adverse reactions were observed. RESULTS: Totally 24 patients dropped out in the two group, 17 in the Chinese medical treatment group (9 patients of Shen deficiency blood stasis syndrome, 5 of Shen-Pi deficiency syndrome, and 3 of Shen-essence deficiency syndrome) and 7 in the Western medical treatment group. Compared with before treatment, there was no statistical difference in the improvement of semen amount at 3 months after treatment between the two groups (P > 0.05). There was statistical difference in the improvement of semen density, class A semen, class A +B semen, and 1-h activity ratio (P < 0.05). The improvement was most obvious in Shen deficiency blood stasis syndrome, followed by Shen-Pi deficiency syndrome and Shen-essence deficiency syndrome. The improvement was the weakest in the Western medical treatment group. There was no statistical difference in the improvement of semen amount, semen density, class A semen, or 1-h activity ratio at 3 months after treatment between the two groups (P > 0.05). Best effect was obtained in improving class A + B semen quality in patients of Shen deficiency blood stasis syndrome, showing statistical difference when compared with the other two syndrome types and the Western medical treatment group (P < 0.05, P < 0.01). No obvious adverse reaction occurred in the two groups during the treatment course. CONCLUSION: Shen invigorating and blood activating method could improve the semen density and semen activities, and it was superior to other therapeutic methods.