Objective:To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi(HHRY)pills for endometriosis-associated dysmenorrhea.Methods:This study constitutes a multicenter,randomized,double-...Objective:To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi(HHRY)pills for endometriosis-associated dysmenorrhea.Methods:This study constitutes a multicenter,randomized,double-blind,placebo-controlled trial encompassing a three-menstrual cycle intervention followed by a three-menstrual cycle follow-up period.A total of 164 eligible females with endometriosis-associated dysmenorrhea were randomly divided into HHRY pills and placebo groups in a 1:1 ratio.The primary outcome included dysmenorrhea symptoms assessed using Visual Analog Scale(VAS)scores and quality of life,whereas the secondary outcome measures included the maximum VAS for non-menstrual pelvic pain,duration of pain episodes(in days),frequency and quantity of the consumption of ibuprofen sustained-release capsules(or other non-steroidal anti-inflammatory drugs),and days off work/study for staff/student due to dysmenorrhea,ovarian cyst,and/or pelvic nodule size.The safety was monitored throughout the treatment period.All the analyses were based on the intention-to-treat principle.For continuous outcomes,simple or multiple linear regressions were used to estimate the differences between the HHRY pills and placebo groups,with categorical data expressed as the number and percentage of occurrences.Differences were compared using the chi-square test or Fisher's exact test.The predefined analysis was adjusted for concomitant treatment,a variable considered to be associated with outcomes but unaffected by treatment allocation.Estimates of treatment effects were reported with 95%confidence intervals.Two-tailed P values≤.05 were considered statistically significant.Conclusion:Positive results from this trial,upon completion would provide robust evidence for the efficacy and safety of HHRY pills in treating dysmenorrhea in patients with endometriosis.展开更多
Objective:To explore the effect and mechanism of action of the Wenjing Zhitong recipe(WZR)in primary dysmenorrhea(PD)treatment.Methods:Uterine contractions were induced by estradiol benzoate and oxytocin in a PD model...Objective:To explore the effect and mechanism of action of the Wenjing Zhitong recipe(WZR)in primary dysmenorrhea(PD)treatment.Methods:Uterine contractions were induced by estradiol benzoate and oxytocin in a PD model and WZR was administrated.The rate of change in uterine contractility and the writhing test were used to evaluate the effects of WZR.The serum levels of prostaglandin F_(2a)(PGF_(2a))and prostaglandin E_2(PGE_2),and the activity of cyclooxygenase-2(COX2)were detected by enzyme-linked immunosorbent assay(ELISA).The changes in phosphor-phospholipase C(pPLC/PLC),phosphor-protein kinase C(pPKC/PKC),and connexin 43(CX43)expression were detected using immunohistochemistry and western blot.Results:WZR significantly reduced the rate of change in uterine contractility and writhing times in the PD model.WZR treatment inhibited the enzymatic activity of COX2 and reduced the levels of PGF_(2a),PGF_(2a)/PGE2and COX2 in the PD model.WZR also significantly reduced the expression of pPLC/PLC,pPKC/PKC and CX43.Targeting the inhibition of COX2 activity,caffeic acid and 1-acetyl-β-carboline were validated as the active ingredients in WZR responsible for reducing uterine contractions.Conclusion:WZR attenuated PD by inhibiting COX2 activity,downregulating PGF_(2a)/PGE_2 expression,and inhibiting the PKC signaling pathway.展开更多
Objective:The aim of this study is to compare the effect of Vitamin D and Vitamin E supplementations,alone,and in combination,on reducing the intensity and duration of dysmenorrhea in women who were referred to the Ko...Objective:The aim of this study is to compare the effect of Vitamin D and Vitamin E supplementations,alone,and in combination,on reducing the intensity and duration of dysmenorrhea in women who were referred to the Kowsar gynecological clinics of Shahid Motahari Hospital of Urmia University of Medical Sciences.Materials and Methods:A double-blinded clinical trial was conducted on 112 women with dysmenorrhea who were randomly allocated into the four study groups.Finally,100 women complete the study and received capsules containing a placebo(n=25),1000 IU of Vitamin D(n=25),400 mg of Vitamin E(n=25),and 1000 IU of Vitamin D+400 mg of Vitamin E(n=25)every 24 h for 2 consecutive months at the beginning of the menstrual period.The pain intensity and duration among groups were compared before and after the intervention.Results:The mean menstrual pain duration in all three experimental groups(Vitamin E,Vitamin D,and the combination of them)was lower than the placebo group(all P<0.05),and the mean pain intensity scores in all three experimental groups were significantly lower than the placebo group(all P<0.05).The results(means)for all of the drugs administered at the end of the 2nd month were better than the 1st month(all P<0.01).Conclusions:Vitamin E and Vitamin D,as well as their combination,are recommended as an effective and safe treatment for the management of the complications of dysmenorrhea.展开更多
基金supported by the National Natural Science Foundation of China(81830115).
文摘Objective:To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi(HHRY)pills for endometriosis-associated dysmenorrhea.Methods:This study constitutes a multicenter,randomized,double-blind,placebo-controlled trial encompassing a three-menstrual cycle intervention followed by a three-menstrual cycle follow-up period.A total of 164 eligible females with endometriosis-associated dysmenorrhea were randomly divided into HHRY pills and placebo groups in a 1:1 ratio.The primary outcome included dysmenorrhea symptoms assessed using Visual Analog Scale(VAS)scores and quality of life,whereas the secondary outcome measures included the maximum VAS for non-menstrual pelvic pain,duration of pain episodes(in days),frequency and quantity of the consumption of ibuprofen sustained-release capsules(or other non-steroidal anti-inflammatory drugs),and days off work/study for staff/student due to dysmenorrhea,ovarian cyst,and/or pelvic nodule size.The safety was monitored throughout the treatment period.All the analyses were based on the intention-to-treat principle.For continuous outcomes,simple or multiple linear regressions were used to estimate the differences between the HHRY pills and placebo groups,with categorical data expressed as the number and percentage of occurrences.Differences were compared using the chi-square test or Fisher's exact test.The predefined analysis was adjusted for concomitant treatment,a variable considered to be associated with outcomes but unaffected by treatment allocation.Estimates of treatment effects were reported with 95%confidence intervals.Two-tailed P values≤.05 were considered statistically significant.Conclusion:Positive results from this trial,upon completion would provide robust evidence for the efficacy and safety of HHRY pills in treating dysmenorrhea in patients with endometriosis.
基金supported by Beijing University of Chinese Medicine(1000061224003)National Natural Science Foundation of China(81903766,81900603,82104440)。
文摘Objective:To explore the effect and mechanism of action of the Wenjing Zhitong recipe(WZR)in primary dysmenorrhea(PD)treatment.Methods:Uterine contractions were induced by estradiol benzoate and oxytocin in a PD model and WZR was administrated.The rate of change in uterine contractility and the writhing test were used to evaluate the effects of WZR.The serum levels of prostaglandin F_(2a)(PGF_(2a))and prostaglandin E_2(PGE_2),and the activity of cyclooxygenase-2(COX2)were detected by enzyme-linked immunosorbent assay(ELISA).The changes in phosphor-phospholipase C(pPLC/PLC),phosphor-protein kinase C(pPKC/PKC),and connexin 43(CX43)expression were detected using immunohistochemistry and western blot.Results:WZR significantly reduced the rate of change in uterine contractility and writhing times in the PD model.WZR treatment inhibited the enzymatic activity of COX2 and reduced the levels of PGF_(2a),PGF_(2a)/PGE2and COX2 in the PD model.WZR also significantly reduced the expression of pPLC/PLC,pPKC/PKC and CX43.Targeting the inhibition of COX2 activity,caffeic acid and 1-acetyl-β-carboline were validated as the active ingredients in WZR responsible for reducing uterine contractions.Conclusion:WZR attenuated PD by inhibiting COX2 activity,downregulating PGF_(2a)/PGE_2 expression,and inhibiting the PKC signaling pathway.
文摘Objective:The aim of this study is to compare the effect of Vitamin D and Vitamin E supplementations,alone,and in combination,on reducing the intensity and duration of dysmenorrhea in women who were referred to the Kowsar gynecological clinics of Shahid Motahari Hospital of Urmia University of Medical Sciences.Materials and Methods:A double-blinded clinical trial was conducted on 112 women with dysmenorrhea who were randomly allocated into the four study groups.Finally,100 women complete the study and received capsules containing a placebo(n=25),1000 IU of Vitamin D(n=25),400 mg of Vitamin E(n=25),and 1000 IU of Vitamin D+400 mg of Vitamin E(n=25)every 24 h for 2 consecutive months at the beginning of the menstrual period.The pain intensity and duration among groups were compared before and after the intervention.Results:The mean menstrual pain duration in all three experimental groups(Vitamin E,Vitamin D,and the combination of them)was lower than the placebo group(all P<0.05),and the mean pain intensity scores in all three experimental groups were significantly lower than the placebo group(all P<0.05).The results(means)for all of the drugs administered at the end of the 2nd month were better than the 1st month(all P<0.01).Conclusions:Vitamin E and Vitamin D,as well as their combination,are recommended as an effective and safe treatment for the management of the complications of dysmenorrhea.