| ObjectiveA prospective randomized controlled study was used to compare the differences in the improvement of symptoms,recurrence and safety of patients with mastalgia treated by XiaoPi Tincture combined with health education and pure health education.Methods1.All cases in this study originated from mastalgia patients in the outpatient department of breast department of Guangdong Traditional Chinese Medicine Hospital.2.After the qualified subjects were determined according to the criteria for exclusion,the design method of a randomized controlled study was used to include all 106 patients randomly into a test group and a control group at a 1:1 ratio.3.The control group was given pure health education,and the test group was treated with external health treatment on the basis of health education.4.The visual analogue scale(VAS)and Cardiff mastalgia scale were used before and after treatment,during treatment,and during follow-up evaluation.The curative effect was determined by calculating the rate of improvement of the score before and after treatment.Results1.A total of 106 patients were enrolled,12 of whom were shed,and 49 of the experimental group and 45 of the control group were actually included.After 3 months of menstrual cycle treatment,the cured,markedly effective,effective,and ineffective cases in the test group were 6,15,21,and 7,respectively,and the total effective rate in the test group was 85.71%.The cured,markedly effective,effective,and ineffective cases in the control group were 2,8,18,and 17,respectively,and the total effective rate in the control group was 62.22%.There was a significant difference in efficacy between the two groups(P=0.008).2.The VAS score of the control group before treatment(5.04±1.31)was not significantly different from the VAS score of the test group(5.2±1.34);the VAS score of the control group after treatment(2.96±1.35)and the VAS score of the test group(2.08±1.41)confirmed the test group relieve breast pain more significantly than the control group(P<0.05);after 3 months of follow-up,the VAS score of the control group(3.2±1.22)and the VAS score of the test group(2.31±1.40)were still significantly different(P<0.05).The difference in VAS scores at different time points within the two groups was also statistically significant(P<0.05).Both groups showed a linear downward trend,and the interaction between time and groups was significant,indicating that the effect of time factors varies from group to group.The downward trend of the test group is more significant.There was no significant difference in the VAS score between the two groups after treatment and follow-up(P>0.05),suggesting that the treatment effect was stable and there was no significant recurrence of breast pain.3.The Cardiff breast pain index(8.26±2.2)in the control group and the Cardiff breast pain index(8.45±2.15)in the test group were not significantly different before treatment.In the first month of treatment,there was no significant difference in Cardiff breast pain index between the control group(8.5±1.8)and the test group(8.82±2.26)(P>0.05);the second month of treatment in the test group(6.67±1.9)Cardiff breast pain The index was significantly lower than that of the control group(7.75±2.19)(P<0.05).At the third month,the Cardiff breast pain index of the control group(7.13±2.37)and the test group(6.1±1.99)were also significantly different(P<0.05).The difference in Cardiff breast pain index at different time points within the two groups was also statistically significant(P<0.05).Both groups showed a linear downward trend,and the interaction between time and groups was significant,indicating that the effect of time factors varies from group to group.The downward trend of the test group is more significant.4.During the follow-up period(3 months after the end of treatment),both groups showed 7 cases of recurrent symptoms,and the recurrence rates of the experimental group and the control group were 16.67%and 25.0%,respectively.The recurrence rates of the control group were higher than that of the test group,but the difference was statistically insignificant(P>0.05).5.During the treatment period,no local or systemic adverse reactions were observed in the test group,suggesting the safety of XiaoPi Tincture in the treatment of mastalgia.ConclusionXiaoPi Tincture combined with health education in the treatment of mastalgia due to Stagnation of the Liver-Qi,in the improvement of breast pain,the effect is obviously better than simple health education,and easy to operate,high safety,low recurrence rate,has a certain clinical application and promotion value. |
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