| Objective:This research aimed to evaluate the clinical efficacy and safety of traditional Chinese medicine(TCM)Qixiongzhongzi Decoction in the treatment of patients with idiopathic asthenozoospermia.Methods:1.Study designThis was a prospective,randomized,and controlled clinical trial.2.ObjectiveA total of 66 patients with idiopathic asthenozoospermia according to the inclusion creria were included from January 2015 to August 2016 at Department of Andrology in Xiyuan Hospital.Patients were randomly divided into experimental and control groups by using SAS generated code at the raio of 1:1,with 33 patients in each group.3.Therapeutic methodThe patients in the experimental group were administrated orally with Qixiongzhongzi Decoction composed of Astragalus monholicus(20g),Herba epimedii(10g),Rehmannia glutinosa(15g),common yam rhizome(10g),Fructus corni(10g),Ligusticum wallichii(10g),Semen cuscutae(10g),medlar(15g),Caulis spatholobi(10g),Radix achyranthis bidentatae(10g),Fructus amomi(6g)and goldthread(3g),twice daily,150 mL per time.And the patients in the control group took levocamitine oral liquid,twice daily,1g per time.The two groups received medication for 12 weeks and were followed up for 4 weeks.4.Observation index and time pointPatients' general demographic data were obtained as well as therapeutic index:?sperm parameters(including sperm density,sperm motility,semen volume);secondary therapeutic index:?pregnancy probability;?TCM syndrome standard score(record the symptom score before and after treatment).Safety index included blood routine test,urine routine test,liver function(ALT,AST),renal function(BUN,Cr).All indices were checked before and after treatment.Results:1.Drop-off and withdrawWe included 66 patients with asthenozoospermia.After treatment,5 'cases(7.58%)were lost,2 cases from the experimental group and 3 from the control group.The 5 cases were documented with the first visit,data after treatment were unavailabe.Therefore,they were removed from the full analysis set(FAS)and per protocl set(PPS).The rest 61 cases finished the trial and were included into the FAS and PPS,with 31 in the experiment group and 30 in the control group.2.Baseline data2.1 AgeAmong the 31 patients in the experimental group,age ranged from 25 to 40 years old,with the average of 31.19±4.36 years.Of the 30 patients in the control group,age ranged from 24 to 39 years old,with the average of 32.03±3.10 years.Patients' age were comparable between groups without statistical significant(t=-0.86,P=0.39>0.05 by independent-samples t test).2.2 Course of diseaseOf all patients in the experimental group,disease course ranged from 12 to 36 months,with the average of 18.32±12.05 months.Of all patients in the control group,disease course ranged from 12 to 42 months,with the average of 14.63±3.26 months.Patients' disease course were comparable between the two groups without statistical significant(t=1.62,P=0.11>0.05by independent-samples t test).2.3 Educational backgroundOf all patients in the experimental group,there were 1 patient with primary school education,3 with junior high school,9 with senior high school,and 18 with college education or above;while in the control group,there were 0,1,10 and 19 respectivly.Patients' education levers were comparable between the two groups without statistical significant(P>0.05).2.4 Sperm volumeThe sperm volumes of the experimental and control groups before treatment were 2.60±0.30 and 5.56±0.33 mL,respectively.The sperm volume levers were comparable between the two groups without statistical significant(t=-0.45,P=0.65>0.05).2.5 Sperm densityThe sperm density(Ś106/L)of the experimental and control groups before treatment were 36.35±18.14 and 34.68±14.71,respectively.There were no statistical significant difference between the two groups(t=0.40,P=0.69>0.05).2.6 PR grade spermThe PR grade sperms(%)of the experimental group and the control group before treatment were 9.47±6.23 and 9.25±5.21,respectively.There were no statistical significant difference between the two groups(t=0.40,P=0.69>0.05).2.7 PR+NP grade spermThe baseline values for PR+NP grade sperm of the experimental and control groups were 18.42±8.72 and 21.05±8.45,respectively.There were no statistical significant difference between the two groups(t=1.19,P=0.24>0.05).2.8 TCM syndrome standard scoreTCM syndrome standard scores of the experimental and control groups before treatment were 16.77±4.18 and 14.80±4.54,respectively.There was no statistical difference between the two groups(t=-1.77,P=0.08>0.05).3.Clinical curative effect3.1 Semen volumeThere was no significant statistical difference in the semen volume between the two groups after 4-,8-and 12-week treatment(P>0.05).3.2 Sperm densityThere was no significant statistical difference in the semen density between the two groups after 4-,8-and 12-week treatment(P>0.05)3.3 PR grade spermIn the 4th week,the PR grade sperm was 12.17±6.13%for the experimental group and there was no statistical difference as compared with 9.47±6.23%before treatment(P>0.05);and in the 8th and the 12th week,the PR grade sperms were 15.98%±8.01%and 22.71±9.00%respectively,and there was statistical difference compared with before treatment(P<0.05).As to the control group,the PR grade sperms of the 4th,8th and 12th week were 9.95%±7.37%,12.15%±6.64%and 14.13%±8.83%,respectively.After 8-and 12-week treatment,there was statistical difference compared with baseline value(P<0.05)showing improvement in PR grade sperm.As compared with the control group,the experimental group showed no statistical differencein PR grade sperm at 4th and 8th week(P>0.05),but after 12-week treatment,it showed greater improvement than the control group(P<0.05).3.4 PR+NP grade spermThe PR+NP grade sperm at baseline,4-,8-and 12-week were18.42%±8.72%,23.83%±10.65%,29.29%±12.20%and 38.71%±14.06%of the experiment group,and 21.05%±8.45%,21.22%±11.98%,27.13%±11.55%and 26.17%15.40%of the control group,respectively.As compared with the baseline,the improvement of PR+NP grade sperm at both groups showed no statistical difference at 4th week(P>0.05),but noticeable statistical difference were observed at 8th and 12th week(P<0.05).There was no statistical difference of PR+NP grade sperm between groups at 4-and 8-week treatment(P>0.05).However,after 12-week treatment,the experiment group showed remarkable improvement compared with the control group(P<0.05).3.5 Pregnancy probabilityThere was no statistical difference in pregnancy probability of patietns' wives between the two groups during 12-week treatment at each time point(P>0.05).3.6 TCM syndrome scoreTCM syndrome score of the experimental group were 12.3±3.30,9.63±2.72 and 7.1±2.28 at the 4-,8-?and 12-week treatment,respectively.Compared with baseline level(16.77±4.18)before treatment,TCM syndrome score declined with statistical significance at a time-dependent manner(P<0.05).As for the control group,the score were 14.80±4.54,13.86±3.50,12.99±2.71 and 3.40±2.27 at baseline,4-,8-and 12-week treatment,respectively.There was no statistical difference among each time point in the control group(P>0.05).4.SafetyThere were 3 cases of adverse events,2 cases of experimental group and 1 case in control group;but discomfort to ease without intervention;There were without adverse reactions.Patients in the two groups had no obvious abnormality in blood routine,urine routine,liver and kidney function tests during the treatment period.The two methods were all safe and feasible except for the drop-off and withdrew cases.Conclusion:1.Qixiongzhongzi Decoction can improve the PR grade sperm and the PR+NP grade sperm in the treatment of asthenozoospermia after 8-and 12-week treatment.2.After 12-week treatment,Qixiongzhongzi Decoction shows better efficacy than levocarnitine oral liquid in improving the PR grade sperm and the PR+NP grade sperm.3.After 4-week treatment with Qixiongzhongzi Decoction,TCM syndrome score declines.As the treatment time elapses,the decline becomes more remarkable.4.Qixiongzhongzi Decoction is safe with no obvious side effects. |
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