Objective:This study aimed to explore the clinical effect of acupuncture therapy for menstruation regu-lation and pregnancy promotion on thin endometrium in the real world.Design:This study is a single-center pragmati...Objective:This study aimed to explore the clinical effect of acupuncture therapy for menstruation regu-lation and pregnancy promotion on thin endometrium in the real world.Design:This study is a single-center pragmatic randomized controlled trial blinded to the statisticians.Using the“blockrand”software package,based on the age(≥35,<35),37 patients were randomized into an intervention group(19 cases)and a control group(18 cases).After reassignment regarding patient preference,21 patients were included in the intervention group and 16 in the control group.Setting:The trial was executed in the Specialty Outpatient Clinic,Acupuncture-Moxibustion Hospital of China Academy of Chinese Medical Sciences,from March 1,2019,to September 30,2020.Participants:The study included 37 patients with thin endometrium and without previous acupuncture treatment.Intervention:The intervention group was administered acupuncture for menstruation regulation and pregnancy promotion and a small-dose of progynova(2 mg daily),while the control group was adminis-tered a large-dose of progynova(4 mg daily).Interventions started from Day 5 of menstruation until the end of ovulation under B-ultrasound monitoring.The intervention lasted for three menstrual cycles.Measurements:Primary outcomes were changes in endometrial thickness between baseline and after intervention completion and the difference between the two groups after intervention.The secondary outcomes were endometrial and subendometrial blood flow,serum estradiol levels,menstrual conditions,and adverse reactions.Results:(1)Comparison of each indicator before and after intervention completion in the two groups:in the intervention group,the differences were significant in endometrial thickness,menstrual score,estra-diol(E2)level in ovulatory period,the pulsatility index(PI)and resistance index(RI)of uterine artery,the ratio of peak systolic velocity to end-diastolic velocity(S/D),the endometrial vascular index(VI),flow index(FI),and vascular flow index(VFI)and volume(P<0.01).In the control group,significant changes were observed in endometrial thickness,menstrual score,and E2 before and after the interven-tion(P<0.05),and no differences were observed in uterine artery PI,RI,S/D and endometrial VI,FI,VFI,and volume(P>0.05).Compared with the control group,the intervention group showed significant differences in endometrial thickness,menstrual score,E2,uterine artery PI,RI,S/D,and endometrial VI,FI,VFI,and volume after intervention(P<0.01).No adverse reactions were reported in the intervention group.In contrast,the control group had two cases of nausea and gastrointestinal discomfort after med-ication,eight cases of breast distention during medication,and one case of breast nodules enlarged by 1 cm after trial completion.展开更多
基金Supported by Special Funds for Basic Scientific Research of Central Public Welfare Research Institutes:201814006。
文摘Objective:This study aimed to explore the clinical effect of acupuncture therapy for menstruation regu-lation and pregnancy promotion on thin endometrium in the real world.Design:This study is a single-center pragmatic randomized controlled trial blinded to the statisticians.Using the“blockrand”software package,based on the age(≥35,<35),37 patients were randomized into an intervention group(19 cases)and a control group(18 cases).After reassignment regarding patient preference,21 patients were included in the intervention group and 16 in the control group.Setting:The trial was executed in the Specialty Outpatient Clinic,Acupuncture-Moxibustion Hospital of China Academy of Chinese Medical Sciences,from March 1,2019,to September 30,2020.Participants:The study included 37 patients with thin endometrium and without previous acupuncture treatment.Intervention:The intervention group was administered acupuncture for menstruation regulation and pregnancy promotion and a small-dose of progynova(2 mg daily),while the control group was adminis-tered a large-dose of progynova(4 mg daily).Interventions started from Day 5 of menstruation until the end of ovulation under B-ultrasound monitoring.The intervention lasted for three menstrual cycles.Measurements:Primary outcomes were changes in endometrial thickness between baseline and after intervention completion and the difference between the two groups after intervention.The secondary outcomes were endometrial and subendometrial blood flow,serum estradiol levels,menstrual conditions,and adverse reactions.Results:(1)Comparison of each indicator before and after intervention completion in the two groups:in the intervention group,the differences were significant in endometrial thickness,menstrual score,estra-diol(E2)level in ovulatory period,the pulsatility index(PI)and resistance index(RI)of uterine artery,the ratio of peak systolic velocity to end-diastolic velocity(S/D),the endometrial vascular index(VI),flow index(FI),and vascular flow index(VFI)and volume(P<0.01).In the control group,significant changes were observed in endometrial thickness,menstrual score,and E2 before and after the interven-tion(P<0.05),and no differences were observed in uterine artery PI,RI,S/D and endometrial VI,FI,VFI,and volume(P>0.05).Compared with the control group,the intervention group showed significant differences in endometrial thickness,menstrual score,E2,uterine artery PI,RI,S/D,and endometrial VI,FI,VFI,and volume after intervention(P<0.01).No adverse reactions were reported in the intervention group.In contrast,the control group had two cases of nausea and gastrointestinal discomfort after med-ication,eight cases of breast distention during medication,and one case of breast nodules enlarged by 1 cm after trial completion.
