| Objective To observe the efficacy and safety of Shen Ling Gujing Decoction in the treatment of lifelong premature ejaculation with Syndrome of Heart and Gallbladder Qi deficiencyMethods From July 2018 to January 2019,66 patients with lifelong premature ejaculation with Syndrome of Heart and Gallbladder Qi deficiency who were admitted to the Andrology Department of Xiyuan Hospital of China Academy of Chinese Medicine Sciences were randomly divided into experimental group and control group.Patients in the experimental group were treated with Shen Ling Gujing Decoction, and 200 ml was taken orally in the morning and evening.Patients in the control group were treated with dapoxetine hydrochloride tablets,30 mg each time,and 1-3 hours before sexual intercourse.Both groups were treated for eight weeks and followed up for four weeks after discontinuation of the drug.The patients were visited every four weeks to record the intravaginal ejaculatory latency time(IELT),Premature Ejaculation Profile(PEP,including four measures:perceived control over ejaculation, satisfaction with sexual intercourse,personal distress related to ejaculation,and interpersonal difficulty related to ejaculation,respectively referred to as PEP1,PEP2,PEP3,PEP4),traditional Chinese medicine(TCM)syndrome score.Clinical global impression of change(CGIC)and adverse event.Finally,all observations are summarized and statistically analyzedResults1 Comparison of the baseline There was no significant difference in age,height, weight,body mass index,course of disease,educational level,IELT.PEP score and TCM syndrome score between the experimental group and the control group(P> 0.05).2 Comparison of curative effects(1)Comparison of the IELT:The median IELT of the patients in the experimental group were 40.0(30.0.55.0)seconds,80.0(60.0,120.0)seconds.180.0(70.0,240.0) Seconds and 65.0(50.0,150.0)seconds at baseline,week 4.week 8,and follow-up period,respectively.Median IELT increased at the week 4,week 8,and follow-up period compared with baseline,the difference was statistically significant(P<0.05);Median IELT also increased at the week 8 compared with week 4,the difference was statistically significant(P<0.05).There was no significant difference in Median IELT between the follow-up period and the week 4(P>0.05).The Median IELT decreased at the follow-up period compared with the week 8.The difference was statistically significant(P><0.05).The Median IELT of the control group were 42.5(30.0,55.0)seconds,120.0(60.0,150.0)seconds,197.5(65.0,300.0)seconds and 57.5(38.8,61.3)seconds at baseline,week 4,week 8,and follow-up period,respectively.Median IELT increased at the week 4 and the week 8 compared with baseline,the difference was statistically significant(P<0.05).IELT also increased at the week 8 compared with the week 4,the difference was statistically significant(P<0.05).IELT decreased at the follow-up period compared with the week 4 and the week 8,the difference was statistically significant(P<0.05).There were no significant differences in IELT between the follow-up period with baseline(P>0.05).At the week 4,the difference in Median IELT between the two groups was statistically significant(P<0.05),and the control group was higher than the experimental group.At the week 8,there was no significant difference in Median IELT between the two groups(P>0.05);During the follow-up period,the difference in Median IELT between the two groups was statistically significant(P<0.05),and the experimental group was higher than the control group.(2)Comparison of the PEP scores:In the experimental group,the PEP1 score and PEP2 score were increased and the PEP3 score and PEP4 score were decreased at the week 4,week 8,and follow-up period compared with baseline,the differences were statistically significant(P<0.05).The PEP1 score and the PEP2 score were increased and the PEP3 score and PEP4 score were decreased at the week 8 compared with the week 4,the differences were statistically significant(P<0.05).The PEP1 score and PEP2 score were decreased and PEP3 score and PEP4 score were increased at the follow-up period compared with week 8,the differences were statistically significant(P<0.05).There were no significant differences in the scores between the follow-up period with the week 4(P>0.05).In the control group,the PEP1 score and PEP2 score were increased and the PEP3 score and PEP4 score were decreased at the week 4 and week 8 compared with baseline,the differences were statistically significant(P<0.05).There were no significant differences in the scores between the week 4 with the week 8(P>0.05).The PEP1 score and PEP2 score were decreased and the PEP3 score and PEP4 score were increased at the follow-up period compared with the week 4 and week 8,the differences were statistically significant(P<0.05).There were no significant differences in the scores at the follow-up period compared with baseline(P>0.05).There was no significant difference in PEP1 score and PEP2 score between the two groups at the week 4(p>0.05).There were significant differences in PEP3 score and PEP4 score between the two groups at the week 4(p<0.05).and the experimental Group were higher than the control group.At the week 8,there were no significant differences in PEP1 score.PEP2 score,PEP3 score and PEP4 score between the two groups(P>0.05).During the follow-up period,the PEP1 score and PEP2 score of the experimental group were higher than the control group,the differences were statistically significant(P<0.05).and the PEP3 score and PEP4 score of the control group were higher than the experimental group,the differences were statistically significant(P<0.05).(3)Comparison of the TCM syndrome scores:The TCM syndrome scores of the patients in the experimental group were decreased at the week 4,week 8,and follow-up period compared with baseline,and the differences were statistically significant(P<0.05).During the week 8 and follow-up period compared with the week 4,the scores of TCM syndromes were decreased,and the differences were statistically significant(P<0.05).The TCM syndrome scores were increased during the follow-up period compared with the week 8.and the difference was statistically significant(P<0.05).In the control group,the scores of TCM syndromes were decreased at the week 4 and week 8 compared with baseline,and the differences were statistically significant(P<0.05).There was no significant difference in the scores between the week 4 with the week 8(P>0.05).TCM syndrome scores were increased at the follow-up period compared with the week 8 and week 4,and the differences were statistically significant(P<0.05).There was no significant in the scores at the follow-up period compared with baseline(P>0.05).At the week 4,the week 8 and the follow-up period,there were significant differences in TCM syndrome scores between the two groups(P<0.05).The TCM syndrome scores in the experimental group were lower than those in the control group.(4)Comparison of the CGIC scores:The CGIC scores of the two groups were increased at the week 8 compared with the week 4,and the differences were statistically significant(P<0.05).In the experimental group,the score was decreased during the follow-up period compared with the week 8,and the difference was statistically significant(P<0.05).There was no significantly difference in the score between the follow-up period with the week 4(P>0.05).The CGIC scores of the control group were decreased at the week 4,week 8 and follow-up period,and the differences were statistically significant(P<0.05).At the week 4,the week 8 and the follow-up period,the proportion of patients in the experimental group who felt that the condition improved was 71%,80.6%,and 54.8%,respectively.The proportion of patients in the control group was 66.7%,73.3%,and 16.7%,respectively.There was no significant difference in CGIC score between the two groups at the week 8 compared with the week 4(P>0.05).During the follow-up period,the score of the experimental group was higher than that of the control group,and the difference was statistically significant(P<0.05).3 Comparison of safety In the experimental group,2 patients had nausea and acid reflux symptoms after taking medicine on an empty stomach(the incidence rate was 6.45%)and the symptoms disappeared after taking medicine after meals.In the first dose of the control group,4 patients had nausea(the incidence rate was 13.3%),2 patients had dizziness(the incidence rate was 6.7%)and 1 patient had diarrhea(the incidence rate was 3.3%).The symptoms of the patients were alleviated when taking medicine again,and no discomfort occurred afterwards.Conclusions1 Shen Ling Gujing Decoction can significantly increase IELT,enhance the ability of control over ejaculation,enhance sexual satisfaction,alleviate personal distress related to ejaculation,improve the relationship with sexual partner and decrease TCM syndrome scores of patients with lifelong premature ejaculation with Syndrome of Heart and Gallbladder Qi deficiency.2 Shen Ling Gujing Decoction is effective in treating lifelong premature ejaculation with Syndrome of Heart and Gallbladder Qi deficiency,and Shen Ling Gujing Decoction has better long-term effect in prolonging IELT.which is obviously superior to Dapoxetine.Shen Ling Gujing Decoction is superior to Dapoxetine in improving the patient’s related clinical symptoms.3 Shen Ling Gujing Decoction has few side effects and is safe,which is worthy of further research and clinical application. |
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