| ObjectivesPremenstrual syndrome with a series of physical and mental disorder has the extremely negative impact on the life quality of Premenstrual women. Currently effect of treatment methods used for premenstrual syndrome is not ideal, and with much adverse reactions, so their clinical application is estricted to a certain extent.Thus, exploring and investigations of the close-to-ideal alternative strategy are of the significant importance. It has been indicated that Traditional Chinese Medicine (TCM), including the TCM herbs and alternative therapies, has the potential of the treatment of climacteric symptoms. However, the efficacy and safety issues of TCM therapy for the treatment of Premenstrual syndrome need further investigations. Thus, the objective of this multi center, prospective, randomized, comparable clinical study is to investigate the efficacy and safety of TCM strategy (Chinese herbal medicines formula in combination with psychotherapy) and the Placebo therapy (placebo in combination with psychological support therapy) for the treatment of Premenstrual syndrome.MethodsIn this randomized, placebo-controlled clinical study, we screened the outpatients in five three first class hospitals, Guangdong Provincial Hospital of TCM, The Affiliated Hospital of Chengdu University of TCM, The Affiliated Hospital of Wenzhou Medical College, The Affiliated Baokang Hospital of Tianjin University of TCM, The Affiliated Longhua Hospital of Shanghai University of TCMduring the period between October2009and November2010. The pathogenesis is Liver Stagnancy. All the eligible subjects were recruited and randomly assigned to receive either TCM therapy (Chinese herbal medicines Xieding Chufang formula, and TCM psychotherapy) or Placebo therapy (Placebo and psychological support therapy). All the patients are treated for8weeks and followed up for4weeks. The Calendar of premenstrual experiences (COPE) and luteal phase of the sex hormones (E2, PRL, P) level were used to evaluate the treatment effect. And the safety parameters were heart rate, blood pressure, blood routine, urin-routine, sed-routine, liver function test, renal function test, and EKG. The time points of the research were baseline,4th week,8th week, and12th week (time point of follow-up). At each time point, The COPE scale were completed. Before and after the treatment, the sex hormones and safety parameters were measured. At the same time, adverse events and adverse effect were observed and recorded. The data were analyzed by SPSS17.0. The data were primarily analyzed by intent-to-treat (ITT) analysis and further confirmed by per-protocol (PP) analysis.Results1.The treatment period analysis of score of COPE:comprehensive analysis display that before and after treatment scale total score difference as well as two factors (somatization and emotional) difference between the independent sample t test, rank sum test and analysis of covariance difference has statistics significance(P＜0.05). After treatment compared with before treatment the TCM psychosomatic therapy group and the placebo group Scale total score mean respectively reduce17.64points and12.32points (two groups of difference between the mean difference is5.32points), The scale total score mean of the somatization factors respectively reduce6.70points and4.21points (two groups of difference between the mean difference is2.49points). The scale total score mean of the emotional factors respectively reduce10.94points and8.11points (two groups of difference between the mean difference is2..83points).The difference of mean between before and after treatment is large, Prompting that the TCM psychosomatic therapy group is more effective in relieving the symptoms than the placebo group, the effect of the TCM psychosomatic therapy group is better than he placebo group.2. The follow-up period analysis of score of COPE:comprehensive analysis display that before and after treatment scale total score difference as well as somatization factors difference between the independent sample t test and analysis of covariance difference has statistics significance (P＜0.05). After follow-up compared with before, the scale total score mean of the TCM psychosomatic therapy group continus to decline1.22points, and The scale total score mean of the placebo group rises0.21points. The total score of emotional factors of the TCM psychosomatic therapy group continus to decline, and the placebo group rises linghtly. It is shows that the placebo group symptom rebound, and the TCM psychosomatic therapy group continus to decline, it is shows that effect of the TCM psychosomatic therapy group is better than the placebo group. The independent samples t test of diffence of the somatization factors total score showes no statistically significant difference (P>0.05)3. Hormone levels:There was no statistically significant difference of two groups in The serum estradiol, progesterone and prolactin level after treatment with rank sum test and analysis of covariance(P＞0.05).4. During the treatment and follow-up period,2adverse events occurred, including neck, upper limb skin pruritus and Bosom frowsty, flustered. All events occurred in TCM psychosomatic therapy group. However, dverse reactions and clinical medication unrelated after analysis. Therefore, There was no statistically significant difference of two groups in safety evaluation.Conclusions1. The TCM psychosomatic therapy strategy (Chinese herbal medicines formula in combination with psychotherapy) and the placebo therapy (placebo in combination with psychological support therapy) both can improve PMS symptoms. The comparison of the total score, somatization and emotional factores score showed that effect of the TCM psychosomatic therapy was better than the placebo therapy in treatment period. The total score and somatization score showed hat effect of he TCM psychosomatic therapy was better than the placebo therapy in follow-up period.The TCM psychosomatic therapy can be effective to alleviate premenstrual syndrome, and to alleviate somatization and emotional symptomsat the same time, and the efficacy was lasting and stability, Especially efficacy for emotional factores was more stability than somatization factores.2. The serum estradiol, progesterone and prolactin level in luteal phase could not be improved effectly by Both the TCM psychosomatic therapy strategy (Chinese herbal medicines formula in combination with psychotherapy) and the placebo therapy (placebo in combination with psychological support therapy), and there was no statistically significant difference of two groups. 3. There was no adverse drug reaction associated with drugs in Both the TCM psychosomatic therapy strategy or the placebo therapy, and also shows the Safety of psychosomatic therapy is good.4. The TCM psychosomatic therapy strategy adapted in present study is an effective and relatively safe, and more Stable strategy for the treatment of Premenstrual syndrome. |
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