阴阳调理灸治疗寒凝血瘀型原发性痛经的临床疗效评价及经济学分析:随机对照试验OA

Objective To observe the clinical therapeutic effect and effect mechanism of regulating-yinyang moxibustion therapy for primary dysmenorrhea(PD)of cold induced blood stasis,and conduct cost-effectiveness analysis.Methods Sixty-six patients with PD of cold induced blood stasis were randomly divided into an observation group(33 cases,1 case dropped out)and a control group(33 cases,3 cases dropped out).The patients in the observation group received regulating-yinyang moxibustion therapy.Centered at Mingmen(GV4)and Guanyuan(CV4),moxibustion therapy for warming yang and benefiting kidney and for warming kidney and uterus was operated within an 8 cm to 10 cm radius separately.Moxibustion therapy for warming yang and benefiting kidney was delivered 10 days before menstruation(60 min),and that for warming kidney and uterus was performed 2 days before menstruation(40 min).One course of regulating-yinyang moxibustion therapy consisted of 1 operation for warming yang and benefiting kidney and 1 for warming kidney and uterus,and the treatment for 3 menstrual cycles was required.In the control group,gentle moxibustion therapy was operated at Guanyuan(CV4),Shenque(CV8),and bilateral Sanyinjiao(SP6),for 20 min at each acupoint.The intervention began 10 days before menstruation,once every other day;1 course of treatment consisted of 5 interventions,and the treatment for 3 menstrual cycles was required.Before and after treatment,as well as in follow-up for 3 menstrual cycles after treatment,the scores of visual analogue scale(VAS)for pain,Cox menstrual symptom scale(CMSS),and traditional Chinese medicine(TCM)clinical syndromes were observed in the two groups.Before and after treatment,the contents of nerve growth factor(NGF)and prostaglandin F2α(PGF2α)in serum were detected.After treatment,the clinical therapeutic effect was compared,the cost-effectiveness analysis performed,and the sensitivity analysis conducted to verify the reliability of the results in the two groups.Results After treatment and in follow-up,the VAS scores for pain were reduced in comparison with those before treatment in each group(P＜0.05),and the scores in the observation group were lower than those of the control group(P＜0.05).The scores for the severity and duration in CMSS were lower than those before treatment in the observation group(P＜0.05),and lower when compared with those in the control group(P＜0.05).When compared with the score before treatment,the TCM syndrome scores in the observation group were reduced after treatment and in follow-up(P＜0.05),and the score in the control group was lower after treatment(P＜0.05).In follow-up,the TCM syndrome score in the observation group was lower than that in the control group(P＜0.05).After treatment,the serum contents of NGF and PGF2α decreased in comparison with those before treatment(P＜0.05),and the contents in the observation group were lower than those in the control group(P＜0.05).After treatment,the total effective rate was 81.3%(26/32)in the observation group and was 73.3%(22/30)in the control group,without statistical significance(P＞0.05).The cost-effectiveness analysis showed that the cost-effectiveness ratio(CER)in the observation group was lower than that in the control group.The sensitivity analysis found that there was no significant fluctuation of CER in either group.Conclusion Regulating-yinyang moxibustion therapy effectively alleviates pain and TCM syndromes in patients with PD of cold induced blood stasis,which may be related to the decrease of the contents of NGF and PGF2α in serum.This therapy shows its advantages in terms of health economics compared with the conventional gentle moxibustion therapy.