中医“心身同治”方案治疗经前期综合征的随机对照临床研究
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摘要
目的：
经前期综合征一系列躯体及精神症状严重影响了妇女的生活质量。目前用于经前期综合征的治疗方案效果欠理想,且不良反应多,在一定程度上限制了其临床应用。因此,探索可替代的安全有效的针对经前期综合征的治疗方案具有非常重要的临床意义。虽然一些临床报道提示中医药治疗经前期综合征具有一定的优势,但其确切疗效及安全性尚待进一步研究证实。鉴于以上研究现状,进行设计科学严谨的临床试验,对于系统评价中医药治疗方案对于经前期综合征的有效性和安全性具有非常重要的意义。本多中心、前瞻、随机对照临床试验目的在于评价和比较中医“心身同治”方案(中药协定处方免煎颗粒联合中医情志治疗)与安慰剂对照方案(中药免煎颗粒安慰剂联合支持性心理疗法)对于经前期综合征的有效性和安全性。
方法：
采用全国多中心、随机、对照研究设计,纳入自2009年10月至2010年11月在广东省中医院、成都中医药大学附属医院、温州医学院附属医院、天津中医药大学附属保康医院、上海中医药大学附属龙华医院五家三级甲等医院的妇科门诊就诊的经前期综合征患者144例。纳入病例辨证主证为肝郁证,将纳入病例随机分为试验组及对照组两组,试验组给予中药协定处方免煎颗粒,同时给予中医情志治疗方案。对照组给予中药免煎颗粒安慰剂,同时给予支持性心理治疗方案。上述两组治疗方案疗程均为8周,随访4周。疗效指标包括主要疗效指标月经前期体验每日记录(COPE)和次要疗效指标黄体期的性激素(E2、P、PRL)水平。安全性指标主要包括血常规、尿常规、大便常规、肝功(ALT)、肾功(BUN、Cr)、心电图。观察时点为初诊、治疗第4周、第8周及第12周(随访时点)。每个时点均测量主要疗效指标,治疗前后进行次要疗效指标及安全性指标检测。同时,研究期间严密观察并记录不良事件及药物不良反应。所得数据应用SPSS17.0软件包进行统计分析,组内及组间疗效分析均采用“意向性治疗分析”(intent-to-treat analysis,ITT分析)和“符合方案分析”(per-protocol analysis,PP分析),将ITT分析和PP分析两者的结果互相参照及比较,以期更客观、全面地对试验及对照方案的有效性做出评价。
结果：
1.COPE评分治疗期分析：综合分析结果,组内比较显示中医“心身同治”治疗方案和安慰剂对照方案均能有效降低COPE评分。组间比较显示治疗前后量表总分差值以及两个因素(躯体及精神因素)差值的秩和检验及其协方差分析差异有统计学意义(P<0.05)。中医“心身同治”治疗组与安慰剂组治疗后较治疗前量表总分均数下降分别为17.64分和12.32分(两组间差值的均数相差5.32分),躯体总分均数下降分别为6.70分和4.21分(两组间差值的均数相差2.49分),精神总分均数下降分别10.94分和8.11分(两组间差值的均数相差2.83分),两组间治疗前后均数的差值较大,提示中医“心身同治”治疗组比安慰剂能更有效的缓解症状,中医“心身同治”治疗组效果优于安慰剂组。
2. COPE评分随访期分析：综合分析结果,组内比较显示,中医“心身同治”治疗组COPE评分继续降低,安慰剂对照组COPE评分升高。组间比较显示,随访期量表总分差值以及精神因素差值的独立样本秩和检验及协方差分析结果差异有统计学意义(P<0.05),中医“心身同治”治疗组随访后较治疗后量表总分均数持续下降1.22分,安慰剂组随访后较治疗后均数升高0.21分。中医“心身同治”治疗组随访后较治疗后精神因素总分均数持续下降,安慰剂组随访后较治疗后均数轻度升高,这说明安慰剂组症状有所反弹,中医“心身同治”治疗组症状持续下降,提示中医“心身同治”治疗组比安慰剂疗效更持久,中医心身同治随访期效果优于安慰剂组。躯体因素差值的秩和检验及协方差分析结果,显示差异无统计学意义(P>0.05)。
3.激素水平：分析结果均显示治疗后三种激素(E2、P、PRL)水平的秩和检验、协方差分析两组差异均无统计学意义。
4.本研究中,试验期间共发生不良事件2件·人,分别为颈部、上肢皮肤瘙痒；胸闷、心慌,均为中医“心身同治”方案治疗组,经分析两例不良反应均与临床用药无关,故两组用药是安全的。
结论：
1.中医“心身同治”方案(协定处方联合中医情志治疗)与安慰剂对照治疗方案(安慰剂联合支持性心理治疗)均能改善经前期综合征患者症状,两者比较,治疗期COPE评分总分及躯体、精神因素得分均显示中医“心身同治”治疗组疗效优于安慰剂,随访期量表总分及精神因素显示治疗组疗效优于安慰剂。中医“心身同治”方案治疗能有效缓解经前期综合征,且能同时缓解躯体及精神症状,而且疗效持久稳定,尤其对治疗精神症状的疗效比躯体症状更持久。
2.中医“心身同治”方案(协定处方联合中医情志治疗)及安慰剂对照治疗方案(安慰剂联合支持性心理治疗)均不能有效改善黄体期激素(E2、P、PRL)水平,且两者比较差异无统计学意义。
3.中医“心身同治”方案与安慰剂组均未发现药物不良反应,提示中医“心身同治”方案安全性好。
4.本研究中所采用的中医“心身同治”方案是一种安全有效、较稳定的治疗经前期综合征方案,值得进一步临床推广。
Objectives
Premenstrual 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.
Methods
In 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.
Results
1.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.
Conclusions
1. 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.
经前期综合征一系列躯体及精神症状严重影响了妇女的生活质量。目前用于经前期综合征的治疗方案效果欠理想,且不良反应多,在一定程度上限制了其临床应用。因此,探索可替代的安全有效的针对经前期综合征的治疗方案具有非常重要的临床意义。虽然一些临床报道提示中医药治疗经前期综合征具有一定的优势,但其确切疗效及安全性尚待进一步研究证实。鉴于以上研究现状,进行设计科学严谨的临床试验,对于系统评价中医药治疗方案对于经前期综合征的有效性和安全性具有非常重要的意义。本多中心、前瞻、随机对照临床试验目的在于评价和比较中医“心身同治”方案(中药协定处方免煎颗粒联合中医情志治疗)与安慰剂对照方案(中药免煎颗粒安慰剂联合支持性心理疗法)对于经前期综合征的有效性和安全性。
方法：
采用全国多中心、随机、对照研究设计,纳入自2009年10月至2010年11月在广东省中医院、成都中医药大学附属医院、温州医学院附属医院、天津中医药大学附属保康医院、上海中医药大学附属龙华医院五家三级甲等医院的妇科门诊就诊的经前期综合征患者144例。纳入病例辨证主证为肝郁证,将纳入病例随机分为试验组及对照组两组,试验组给予中药协定处方免煎颗粒,同时给予中医情志治疗方案。对照组给予中药免煎颗粒安慰剂,同时给予支持性心理治疗方案。上述两组治疗方案疗程均为8周,随访4周。疗效指标包括主要疗效指标月经前期体验每日记录(COPE)和次要疗效指标黄体期的性激素(E2、P、PRL)水平。安全性指标主要包括血常规、尿常规、大便常规、肝功(ALT)、肾功(BUN、Cr)、心电图。观察时点为初诊、治疗第4周、第8周及第12周(随访时点)。每个时点均测量主要疗效指标,治疗前后进行次要疗效指标及安全性指标检测。同时,研究期间严密观察并记录不良事件及药物不良反应。所得数据应用SPSS17.0软件包进行统计分析,组内及组间疗效分析均采用“意向性治疗分析”(intent-to-treat analysis,ITT分析)和“符合方案分析”(per-protocol analysis,PP分析),将ITT分析和PP分析两者的结果互相参照及比较,以期更客观、全面地对试验及对照方案的有效性做出评价。
结果：
1.COPE评分治疗期分析：综合分析结果,组内比较显示中医“心身同治”治疗方案和安慰剂对照方案均能有效降低COPE评分。组间比较显示治疗前后量表总分差值以及两个因素(躯体及精神因素)差值的秩和检验及其协方差分析差异有统计学意义(P<0.05)。中医“心身同治”治疗组与安慰剂组治疗后较治疗前量表总分均数下降分别为17.64分和12.32分(两组间差值的均数相差5.32分),躯体总分均数下降分别为6.70分和4.21分(两组间差值的均数相差2.49分),精神总分均数下降分别10.94分和8.11分(两组间差值的均数相差2.83分),两组间治疗前后均数的差值较大,提示中医“心身同治”治疗组比安慰剂能更有效的缓解症状,中医“心身同治”治疗组效果优于安慰剂组。
2. COPE评分随访期分析：综合分析结果,组内比较显示,中医“心身同治”治疗组COPE评分继续降低,安慰剂对照组COPE评分升高。组间比较显示,随访期量表总分差值以及精神因素差值的独立样本秩和检验及协方差分析结果差异有统计学意义(P<0.05),中医“心身同治”治疗组随访后较治疗后量表总分均数持续下降1.22分,安慰剂组随访后较治疗后均数升高0.21分。中医“心身同治”治疗组随访后较治疗后精神因素总分均数持续下降,安慰剂组随访后较治疗后均数轻度升高,这说明安慰剂组症状有所反弹,中医“心身同治”治疗组症状持续下降,提示中医“心身同治”治疗组比安慰剂疗效更持久,中医心身同治随访期效果优于安慰剂组。躯体因素差值的秩和检验及协方差分析结果,显示差异无统计学意义(P>0.05)。
3.激素水平：分析结果均显示治疗后三种激素(E2、P、PRL)水平的秩和检验、协方差分析两组差异均无统计学意义。
4.本研究中,试验期间共发生不良事件2件·人,分别为颈部、上肢皮肤瘙痒；胸闷、心慌,均为中医“心身同治”方案治疗组,经分析两例不良反应均与临床用药无关,故两组用药是安全的。
结论：
1.中医“心身同治”方案(协定处方联合中医情志治疗)与安慰剂对照治疗方案(安慰剂联合支持性心理治疗)均能改善经前期综合征患者症状,两者比较,治疗期COPE评分总分及躯体、精神因素得分均显示中医“心身同治”治疗组疗效优于安慰剂,随访期量表总分及精神因素显示治疗组疗效优于安慰剂。中医“心身同治”方案治疗能有效缓解经前期综合征,且能同时缓解躯体及精神症状,而且疗效持久稳定,尤其对治疗精神症状的疗效比躯体症状更持久。
2.中医“心身同治”方案(协定处方联合中医情志治疗)及安慰剂对照治疗方案(安慰剂联合支持性心理治疗)均不能有效改善黄体期激素(E2、P、PRL)水平,且两者比较差异无统计学意义。
3.中医“心身同治”方案与安慰剂组均未发现药物不良反应,提示中医“心身同治”方案安全性好。
4.本研究中所采用的中医“心身同治”方案是一种安全有效、较稳定的治疗经前期综合征方案,值得进一步临床推广。
Objectives
Premenstrual 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.
Methods
In 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.
Results
1.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.
Conclusions
1. 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.
引文
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