A Randomized Controlled Study On The Clinical Effect And Mechanism Of Premenstrual Syndrome With Treatment From Liver

ObjectivePremenstrual syndrome(PMS),especially the premenstrual dysphoric disorder(PMDD)impacts on women' s physical and mental health and daily life seriously,whose incidence is increasing day by day.A large number of clinical studies show that has good effect from the liver of PMS,but the specific mechanism is unknown.This research through clinical randomized single-blind study,explores the treatment mechanism of cilical effect of PMDD from liver.In order to clarify that,the changes of endocrine hormones and their metabolites and neurotransmitters(such as monoamine oxidase,dopamine,and brain neurotrophic factor)were compared before and after treatment.The study provides scientific evidence for the treatment of PMS from liver,which has a veryimprotant practical significance for the prevention and the treatment of the PMS.MethodsIn this clinical randomized single-blind study,66 PMS patients are included,whose pathogenesis is liver qi stagnation.They are divided into traditional Chinese medicine group and western medicine group.All the patients are treated for 3 menstrual cycles,by the first 10 days before menstrual period to take medicine.The scale of Syndrome Severity of PMDD,Symptom Severity Daily Report and the Hamilton Depression Scale were used to evaluate the treatment effect.In order to clarify the treatment mechanism,the changes of endocrine hormones,Adrenal hormones,thyroid hormones and neurotransmitters were compared before and after the treatment.The data were analyzed by SPSS 17.0.The data were primarily analyzed by T test,Rank sum test or Variance test.Results(1)Before treatment,the 2 groups had no statistical significance of differences in age,marriage,education level,occupation and related history,P>0.05,Also,the degree of the scale of Symptom Severity Daily Report,Syndrome Severity of PMDD,Hamilton Depression Scale and the endocrine hormones,Adrenal hormones,thyroid hormones,neurotransmitters and a total of 13 items were not statistically the difference,P>0.05.(2)The degree of DRSP in 2 groups were decreased gradually after trea-tment,there were statistical significance differences,P<0.01.After 3 m enstrual cycles,in the TCM group,29 cases were effective,9 cases werei neffective,the total effective rate was 76.5%;the western medicine gro-up 17 cases were effective,3 cases were invalid,the total effeczive rat e was 85%.The efficacy of the 2 groups is the same.(3)The degree of scale of Syndrome Severity of PMDD in 2 groupswere decreased,there were statistical significance differences,P<0.01.Before treatment,after the treatment and in the follow-up period the degree was decreased gradually.After 3 menstrual cycles,in the TCM group,19 cases were markedly effective,14 cases were effective,7 cases were ineffective,the total effective rate was 83%;in the western medicine group,9 cases were markedly effective,9 caseswere effective,2 cases were ineffective,the total effective rate was 90%.The efficacy of the 2 groups is the same.But after treatment the decreased degree of TCM group was slightly better than the western medicine group.(4)The degrees of HAMD in 2 groups were decreasedgradually,there were statistical significance differences,P<0.01.After 3 menstrual cycles,in the TCM group,12 cases were cured,9 cases were markedly effective,6 cases were effective,the total effective rate was 94.1%;in the western medicine group was 6 cases,markly effective 3 cases,effective2cases,invalid 1 cases,the total effective rate was 93.7%.The efficacy of the 2 groups is the same.(5)After treatment,the MAO in 2 groups was increased in luteal phase,decreased in menstrual period,but the difference was not statistically significant,P>0.01.The MAO in 2 groups decreased in ovulation phase,there was a statistical difference,P<0.01.Within the group of different menstrual cycle period in the 2 groups before treatment,MAO of ovulation period was highest,menstrual period was lower,the difference has statistical significance,P<0.01.In the TCM group,MAO can be adjusted in different menstrual cycle;and the western medicine group can only adjust the difference of MAO in the luteal phase and the menstrual period,menstrual period and ovulation period,can not in the luteal phase and ovulation period.Comparison between groups found that the two groups in the same menstrual cycle on the MAO adjustment effect is quite,the difference was not statistically significant,P>0.05.(6)After treatment,the DA in 2 groups was increased in luteal phase andovulation phase,but the difference was not statistically significant,P>0.05.The DA in 2 groups decreased in menstrual period,there was a statistical difference,P<0.01.Within the group of different menstrual cycle period in the 2 groups before treatment,DA of menstrual period was highest,luteal phase was lower,the difference has statistical significance,P<0.01.In the TCM group,DA can be adjusted between menstral period and ovulation phase;and the western medicine group can adjust the difference of DA in the luteal phase and the menstrual period,menstrual period and ovulation period.Comparison between groups found that the two groups in the same menstrual cycle on the DA adjustment effect is quite,the difference was not statistically significant,P>0.05.(7)After treatment,the BDNF in 2 groups was increased in luteal phase anddecreased in menstrual period,but the difference was not statistically significant,P>0.05.The BDNF in 2 groups increased in ovulation period,there was a statistical difference,P<0.01.In the TCM group,BDNF can be adjusted between menstrual period and letual phase,ovulation period and letual phase;and the western medicine group can not adjust the difference of BDNF in different menstrual cycle.Comparison between groups found that the two groups in the same menstrual cycle on theBDNF adjustment effect is quite,the difference was not statistically significant,P>0.05.(8)There were significant differences in the menstrual cycle of progesterone and prolactin,P<0.05.But comparison of the 2 groups before and after treatment of sex hormone,there was no significant difference P>0.05,(9)Before treatment,COR?ACTH had no change in the difference cycle P>0.05.Both ACTH and COR weredecreased after treatment,but only in the luteal phase and menstrual period,there were statistically significantin the TCM group,P<0.01,while there were not in western group.Compared between groups,the 2 groups' effect is equivalent,P>0.05Conclusion(1)The 2 groups can reduce the clinical symptoms of PMDD patients,two groups of curative effect is quite.Treatment from liver is an effective method to treat the patients with PMDD.(2)The variety of MAO?DA and BDNF in different menstrual cycle may be one of the pathogenesis of PMDD.Both of 2 group can decrease MAO in ovulation period,DA in menstrual period and increase BDNF in menstrual.Treatment from liver could regulate PMDD patients in different menstrual cycle of MAO,DA,BNDF change,compare with western medicine group.However,comparison between different menstrual cycles within the group found that the TCM group in the regulation of MAO and BDNF is superior to the western medicine group.(3)The changes of progesterone and PRL in the menstrual cycle of PMDD patients may be one of the pathogenesis of PMDD?There were no change in sex hormones of PMDD of the 2 groups.(4)The variety of CORin different menstrual cycle may be one of the pathogenesis of PMDD.TCM group can reduce COR in luteal phase and mentraul period,while not in the western group.So,TCM in the adjustment of patients with COR in different periods of change is better than western medicine group.There was no significant difference in ACTH between different menstrual cycles in patients with early stage syndrome.2 groups were unable to adjust the ACTH of the patients with PMDD.