Objective: This study aims to observe the clinical efficacy of herbal-cake-partitioned moxibustion(HCPM)of acupoints on Du and Ren meridians for primary dysmenorrhea(PD)and the relationship between dose and efficacy,explore its possible therapeutic mechanism for PD,and provide clinical theoretical support for the diagnosis and treatment of PD by traditional Chinese medicine(TCM).Methods: A total of 120 cases with PD that were in conformity with the inclusion criteria were randomly divided into Observation Group 1,Observation Group 2,Observation Group 3 and Control Group by random number table,with 30 cases in each group.Observation Group 1 was treated by HCPM with five moxa-cones,Observation Group 2 was treated by HCPM with seven moxa-cones,and Observation Group 3 was treated by HCPM with nine moxa-cones.Moxa-cones were all big ones,and Mingmen and Yaoyangguan points on Du meridian and Shenque and Guanyuan points on Ren meridian were selected for moxibustion.The cases in the Control Group were treated by oral administration of Ibuprofen Sustained Release Capsules,twice a day after meals and 0.4g for each time.The treatment of all the four groups was started from three days before menstruation and ended on the second day of menstruation,and the treatment lasted for three consecutive menstrual cycles.The VAS scores and dysmenorrhea symptom scores of the four groups of patients before and after treatment and after 3 months of follow-up were recorded,and the levels of serum estradiol(E2)and progesterone before and after treatment were measured.Results:(1)Before treatment,there was no significant difference in age,course of disease,VAS scores,dysmenorrhea symptom scores,and levels of serum E2 and progesterone among the four groups of patients(P>0.05).(2)After treatment:(1)Comparison of VAS scores and dysmenorrhea symptom scores of the four groups of patients: both of them decreased when compared with that before treatment(P < 0.05),and the difference between the four groups was statistically significant(P<0.05)and the degree of decrease in the Control Group was greater than that of the observation groups,indicating that all the four groups could lower pain severity,relieved the symptoms of dysmenorrhea and had a good therapeutic efficacy,but the short-term efficacy of the Control Group was better than that of the observation groups while that of Observation Group 3 was better than Observation Group 2 and Observation Group 1.(2)Comparison of levels of serum E2 and progesterone of the four groups: the level of serum E2 of observation groups decreased and the level of progesterone increased(P<0.05),while that of the Control Group did not change significantly(P>0.05).There were differences in the levels of serum E2 and progesterone between the observation groups(P<0.05),indicating that the observation groups had different degrees of regulation on the levels of serum E2 and progesterone,and the degree of regulation of Observation Group 3 was better than Observation Group 2 and Observation Group 1.(3)Follow-up of three months after the end of treatment:(1)Comparison of VAS scores and dysmenorrhea symptom scores of the four groups of patients: both of them decreased when compared with that before treatment(P < 0.05),indicating that there was still efficacy after three months of follow-up,but there was no significant difference in the efficacy in Observation Groups 1,2and 3 when compared with that after treatment(P>0.05);while the VAS scores and dysmenorrhea symptom scores of Control Group showed an upward trend,and the difference was significant compared with that after treatment(P<0.05),indicating that the persistence of the efficacy of the observation groups was better than that of Control Group.There were differences when compared among the four groups(P < 0.05).The VAS scores and dysmenorrhea symptom scores of the observation groups were lower than those of the control group,indicating that there were still differences in the efficacy of the four groups three months after the end of treatment,and the efficacy of observation groups was better than that of Control Group and that of Observation Group 3 was better than Observation Group 2 and Observation Group 1.(2)Follow-up of three months after the end of treatment showed that the total effective rates of Observation Group 1,Observation Group 2,Observation Group 3,and Control Group were 73.33%,80.00%,93.33% and 36.67% respectively.According to the rank sum test,the differences in efficacy between the four groups had statistical significance of(P<0.05).The long-term efficacy of observation groups was better than that of the Control Group,and the efficacy of Observation Group 3 was the best,and then followed by Observation Group 2 and Observation Group 1.Conclusion:(1)Both HCPM and oral administration of Ibuprofen Sustained Release Capsules can relief the pain and concomitant symptoms in patients with PD.The short-term efficacy of oral administration of Ibuprofen Sustained Release Capsules is better than that of HCPM,while the persistence of the efficacy of HCPM is more stable,and HCPM has good long-term efficacy.The choosing of acupoints on Du and Ren meridians to treat dysmenorrhea for treatment of dysmenorrhea,which can regulate the balance of yin and yang,make the circulation of qi and blood unobstructed,and achieve the purpose of searching for the primary cause of disease in treatment,is an effective way of treating dysmenorrhea.(2)All HCPM with five,seven and nine moxa-cones have efficacy and there is a difference in efficacy,and the efficacy improves with the increasing the dose of HCPM,suggesting that the dose of HCPM has an impact on the efficacy,and increasing the dose can increase the thermal energy.The efficacy of HCPM with nine moxa-cones is the best in this study.(3)HCPM can lower the level of serum E2 and increase the level of serum progesterone in patients with PD,inferring that the therapeutic mechanism of HCPM in the treatment of PD is related to the regulation of levels of serum E2 and progesterone and indirectly relieving of the hypercontractility of uterine smooth muscle. |