| Disease location is the premise and foundation of diagnosis and treatment. In acupuncture treatment, disease location is the basis of acupoint-selection. The disease location of primary dysmenorrhea (PD) is uterus. Gynecological Anatomy shows that uterine position including anteverted uterus, straight uterus and retroflexion uterus, and the uterine position may affect the incidence of primary dysmenorrhea. Acupuncture for primary dysmenorrhea has good results. Our previous studies confirmed that the effect of acupoint on regulating uterus has relative specificity. This effect of acupoints may relate with uterine position of the patient.Objective:(1) Questionnaire investigation:To discuss the relationship between uterine position and incidence through questionnaire investigation on patients and to provide basic data for clinical researches.(2) Clinical trial analysis I:To explore the relationship between uterine position and acupoint effect through data analysis from a multi-center, randomized, controlled trial for the treatment of PD patients with electroacupuncture.(3) Clinical trial analysis II:To explore the relationship between uterine position, menstrual pain degree and acupoint effect through data analysis from a multi-center, randomized, controlled trial for the treatment of PD patients with Cold and Dampness Stagnation pattern.(4) Clinical trial program:Based on the above survey and analysis, a multi-center, randomized, controlled trial program was proposed to explore the relationship between uterine position and acupoint effect, and to verify the data results of above secondary analysis.Methods:(1) Questionnaire investigation:This is a questionnaire investigation on368PD patients from4hospitals. On the first painful day in menstruation, every subject finished the patient part questionnaire and then the gynecologist gave uterine position diagnosis and filled doctor part questionnaire when the visual analogue scale (VAS) score of menstrual pain was equal or more than40mm. The baseline data, uterine position distribution, pain level and accompanying symptoms of these patients were surveyed.(2) Clinical trial analysis I:368PD participants, from4hospitals, were randomly and equally divided into three treatment groups with bilateral electroacupuncture at three acupoints respectively:SP6, GB39, and the non-acupoint. The uterine position of participants were diagnosed before the treatment. The intervention was carried out when the VAS score of menstrual pain was equal or more than40mm on the first day, and lasted for30minutes with alternating2/100Hz waves at the highest intensity each participant could tolerate. The improvement of pain was measured with a0～100mm VAS before the intervention, at5min,10min and30min during the intervention, and at30minutes after the completion of this intervention. The needle immediate effect (pre-treatment VAS value-30min VAS value) and after-effect (pre-treatment VAS value-40minVAS value),50%reductionin the VAS (before and after electro-acupuncture reduces VAS value of50%or more the proportion of patients) and RSS values of patients were compared. Data were analyzed to use one-way analysis of variance (ANOVA) or non-parametric test (Kruskal-Wallis H test) and repeated-measures analysis of variance.(3) Clinical trial analysis Ⅱ:96Cold and Dampness Stagnation pattern PD participants, from4hospitals, were randomly and equally divided into two treatment groups: deqi group and no deqi group. Participants were diagnosed with uterine position by Ultrasonography and Gynecological examination before the treatment. The intervention was carried out on bilateral Sanyinjiao (SP6) when the participant’s visual analog scale of pain (VAS-P) score was equal or more than40mm, deqi group with Φ0.3×40mm disposable tube needle piercing1to1.2cun, no deqi group with Φ0.18×13mm disposable tube needle into epidermis, both groups remain the needle30min and withdraw it gradually and slowly. The improvement of pain was measured with a0～100mm VAS-P before the intervention, at5min,30min and40min during the intervention. Data were analyzed to use repeated-measures analysis of variance, chi-square test analysis and one-way analysis of variance (ANOVA) or non-parametric test.(4) Clinical trial program:According to the central random program,144PD participants of different uterine position were equally divided into three treatment groups with bilateral electroacupuncture at three acupoints respectively:SP6, CV4, and BL33. The uterine position of participants were diagnosed before the treatment. The intervention was carried out when the VAS score of menstrual pain was equal or more than40mm on the first day, and lasted for30minutes with alternating2/100Hz waves at the highest intensity each participant could tolerate. Treatment only once per person. The improvement of pain was measured with a0～100mm VAS before the intervention, at5min,10min and30min during the intervention, and at30minutes after the completion of this intervention. The50%reductionin the VAS (before and after electro-acupuncture reduces VAS value of50%or more the proportion of patients), Overall efficiency (before and after electro-acupuncture reduces VAS value was equal or more than10mm the proportion of patients), needle immediate effect (pre-treatment VAS value-30min VAS value) and after-effect (pre-treatment VAS value-40minVAS value) and RSS values of patients were compared. Data were analyzed to use repeated-measures analysis of variance, chi-square test analysis, one-way analysis of variance (ANOVA) or non-parametric test (Kruskal-Wallis H test), paired sample T test or nonparametric tests (Wilcoxon test).Results:(1) Questionnaire investigation:Of all the368female college students with moderate and severe PD who finished this investigation,258subjects (70.11%) were anteverted uterus,20subjects (5.43%) were straight uterus and90subjects (24.46%) were retroflexion uterus. Moderate pain in patients mainly with anteverted uterus, severe pain in patients mainly with retroflexion uterus. Among them,317subjects (86.14%) accompanied with fatigue,267 subjects (68.75%) felt low back pain and154subjects (66.03%) felt leg pain,192subjects (52.17%) accompanied with loss of appetite and192subjects (52.17%) appeared depression. Patients with different uterine position are associated with systemic symptom (fatigue) and psychological symptom (depression), the former than the latter. In addition, anteverted uterus and straight uterus are also accompanied with isolated symptoms (low back pain, leg pain) and digestive symptoms (loss of appetite). But retroflexion uterus is not associated with these isolated symptoms and digestive symptom.(2) Clinical trial analysis I:Among the different uterine position patients, VAS values at each time point, needle immediate effect and after-effect and50%reduction in the VAS were no significant difference (P≥0.05). But RSS values before and after EA intervention in anteverted uterus and retroflexion uterus alleviated significantly, while straight uterus was not alleviated.(3) Clinical trial analysis II: VAS values in each group were observed within40min of having a downward trend change with time gone. Among the different uterine position patients, VAS-P values at each time point, pain constituent ratio,50%reduction in the VAS, overall efficiency, needle immediate effect and after-effect were no significant differences (P>0.05).(4) Clinical trial program:(expected results):We expect to observe the relationship between uterine position and acupoint effect and to verify the results of the secondary analysis by conducting a prospective study.Conclusion:(1) Questionnaire investigation:Uterine position may affect the menstrual pain degree and associated symptoms of primary dysmenorrhea. It shows that uterine position may have certain relationship with relevant organs and meridians.(2) Clinical trial analysis I:The results suggest that uterine position has no relation with acupoint(SP6) effect.(3) Clinical trial analysis Ⅱ:The results suggest that uterine position has no relation with acupoint effect.(4)In summary:Uterine position may related with menstrual pain degree and accompanying symptoms of primary dysmenorrhea, while uterine position has no relation with acupoint(SP6) effect. Prospective randomized controlled clinical trial is needed to evaluate those results. |
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