Clinical Study Of Photodynamics And Traditional Chinese Medicine And Western Medicine In The Treatment Of Primary Dysmenorrhea

Objectives The high incidence and periodic recurrence of primary dysmenorrhea make it a public problem which affects female health,has a negative impact on family and social development,and needs high attention.How to treat primary dysmenorrhea effectively and safely has become an important issue for clinicians.Although there are a large number of methods for primary dysmenorrhea,searching for a more safe and effective method is still a hot issue of primary dysmenorrhea.The aim of this study was to explore the safety and effectiveness of the low power visible photodynamic therapy device,and explore the mechanism of it.Materials and Methods A multi-center,open-label,randomized controlled clinical trial was conducted,the subjects included in this study were randomly assigned to four groups:Group A(Ding kun Dan),Group B(Placebo),Group C(Marvelon),and Group D(low power visible photodynamic therapy device),given corresponding treatment for three consecutive menstrual cycles.Collect the general baseline data of the subjects,observe the change of clinical symptoms and the fluctuation of the pain factors before and after treatment.Results In total,134 participants completed the intervention over three menstrual cycles,there is no significant difference between groups in the baseline data.1.VAS and pain-treating After treatment,there was a significant reduction of the VAS scores in four groups(P<0.05).Compared with the group B(31.3%),the total effective rate of group D(63.9%),group A(68.6%)and group C(83.9%)were all lower than the group B(P<0.05).No difference was detected between the three groups:A,B and C(P>0.05).During the first month of follow-up,both group D and group A showed a downward trend in the VAS scores,the group C and B tended to increase reversely.Four groups' VAS scores all increased in the second month,but the changes between follow-up and treatment were not significantly(P>0.05).2.CMSS and clinical symptoms effect A significant difference was observed in two domains of CMSS after three menstrual cycles in four groups,including the severity and duration(P<0.05).In terms of total effective rate of clinical symptoms,group A(57.1%),group C(77.4%)and group D(58.3%)were significantly lower than group B(25.0%)(P<0.05).Apart from group B,there was no dramatical difference among other three groups.During the follow-up,the total scores of CMSS in four groups went up,but the difference was not significant(P>0.05).3.SF-MPQ-2 The SF-MPQ-2 scores were declined notably in all 4 groups(P<0.05).The score of the group B were significantly higher than the group D after treatment(P<0.05).Considering the group A,group C and group D,no statistical difference was found among them(P>0.05).4.The level of pain factors The concentration of PGE2,PGF2?,ET,OT,and AVP in the group C and D decreased significantly after treatment(both P<0.05),?-EP and NO both increased,whereas ?-EP changed notably(P<0.05).Under the intervention of Ding KunDan,PGE2,PGF2?,ET,OT,and AVP concentration dropped dramatically(P<0.05),on the contrary,?-EP and NO rose(P<0.05).Only PGF2? and ET had significant changes in group B during the treatment(P<0.05).5.Safety results In group D,two patients terminated treatment due to pregnancy,whereas no application site reaction or other discomforts were reported.Some subjects in the group C reported mild nausea,diarrhea and other adverse effects,and two participants dropped because of adverse reactions intolerantly.One patient couldn't tolerate stomach pain so that dropped in group A,and two of them were excluded due to pregnancy.No serious adverse events were found in our research.All groups did not show any statistical changes in the chemical examinations(P>0.05).Conclusion The research illustrates the low-power visible photodynamic therapy device is safe and effective,and has a certain long-term effect and does not disturb the plan of pregnancy.The device may exert its therapeutic effect by regulating the concentration of PGE2,PGF2?,ET,?-EP,OT,AVP,and ?-EP,these factors could also be used to explore the mechanism and evaluate the effect of treatments.It is more comprehensively that evaluate the severity of dysmenorrhea by the combination of VAS,CMSS and SF-MPQ-2.