针灸调肝固本法治疗脑卒中后抑郁症的临床研究
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摘要
目的：
客观评价针灸调肝固本法治疗脑卒中后抑郁症(Post stroke depression, PSD)的有效性、安全性,为针灸治疗脑卒中后抑郁症的治疗方案提供有价值的临床参考依据。
方法：
1.文献研究
采用电子检索结合手工检索方式,对近十年针灸治疗PSD文献检索,按照Cochrane Review Handbook5.0推荐使用的质量评价标准进行文献系统评价,采用RevMan5.0.22软件进行Meta分析,为临床试验研究提供前期循证支持依据。
2.临床研究
(1)遵循随机对照试验原则,结合针灸临床特点,纳入合格PSD受试者123例,随机分为针灸试验组42例、药物对照组40例、针药结合对照组41例,分别给予针灸调肝固本法、单纯药物帕罗西汀口服以及针药结合治疗,共治疗4周,随访3月。
(2)采用单盲法结合采用第三者评价法进行各时点临床疗效评价,采用SPSS18.0软件进行数据统计分析。选取Hamilton抑郁量表(HAMD)为主要疗效评价指标,以日常生活能力量表(Barthel指数)、世界卫生组织生存质量测定量表简表(WHOQOL-BREF)为次要疗效评价指标；选取中医脾胃证候量表进行中医证候疗效评定；选取副反应量表(TESS)进行安全性评价；采用改良Rankin量表(MRS)评价致残率,并结合病死率、复发率、不良事件发生率进行终点结局疗效评价。
成果：
1.文献研究结果
系统评价纳入23项随机对照试验,共有2435例患者,仅有1项多中心试验,大多为小样本试验,12项仅提及随机字样。所有试验均未描述是否实施分配隐藏,3项试验未描述基线情况。Meta分析显示针灸治疗脑卒中后抑郁症疗效与西药比较,疗效优势尚不能确定,但是不良反应少。
2.RCT研究结果
(1)基线比较
三组治疗前一般资料、HAMD, Barthel、 WHOQOL-BREF、中医脾胃证候评分比较均无统计学意义(P>0.05),提示三组基线均衡。
(2)三组治疗前后HAMD评分比较
各时点三组前后评分差异均有统计学意义(P<0.05)。治疗15天时,针灸组与针药组HAMD评分改善率比较无统计学意义(P>0.05),但均显著优于药物组(P<0.01)。治疗30天时,三组组内治疗前后HAMD评分比较均有统计学意义(P<0.05),但组间显愈率比较无统计学意义(P>0.05)。HAMD评分轮廓趋势图显示三组临床抗抑郁疗效：针药组>针灸组>药物组。
(3)三组治疗前后WHOQOL-BREF评分比较
在生理、心理、环境领域,各时点针灸组与针药组评分均较治疗前提高(P<0.05),但组间评分比较无统计学意义(P>0.05)；药物组在治疗第30天时评分较治疗前提高(P<0.05)。各时点针灸组、针药组评分与药物组比较均有统计学意义(P<0.05)。在社会领域评定,各组各时点评分组内前后与组间比较均无统计学意义(P>0.05)。
(4)三组治疗前后脾胃证候评分比较
各时点针灸组、针药组评分治疗前后比较均有统计学意义(P<0.05),但组间比较无统计学意义(P>0.05)；药物组评分治疗前后比较无统计学意义(P>0.05)。
(5)三组治疗前后Barthel指数比较
三组Barthel指数治疗前后比较均有统计学意义(P<0.05)。针灸组与针药组组间比较无统计学意义(P>0.05),但均优于药物组(P<0.05)。
(6)三组治疗前后TESS副反应评分比较
治疗结束时,针灸组与针药组副反应评分组间比较无统计学意义(P>0.05),但均低于药物组(P<0.01)。
(7)终点指标比较
①随访期末病死率及残疾率
3个月后电话随访,三组均未出现死亡病例；针灸组42例患者中有11例残疾(26%),药物组40例中有16例残疾(40%),针药组41例中有9例残疾(23%),经卡方检验无统计学意义(P>0.05)。
②复发率
3个月随访,针灸组41例患者中复发6人(14.3%),药物组42例患者复发9人(22.5%),针药组41例患者复发5人(12.2%),经卡方检验无统计学意义(P>0.05)。
③不良事件发生率
针灸组44例中有2人(4.5%)出现不可耐受的疼痛,药物组所有44例患者有3人(9.1%)出现并发症,针药组44例中有3人(6.8%)出现不可耐受的疼痛。
(8)依从性分析
针灸组中有2人、针药组有3人因为不可耐受的疼痛(不良事件)退出,药物组中有3人因为并发症停止治疗而退出试验,1人家属要求主动退出。脱落病例数已算在10%的脱落率中,三组最终样本含量符合设计要求。
结论：
1.Meta分析结果显示纳入试验多为小样本随机对照试验,针灸治疗脑卒中后抑郁症与西药比较可能等效,需要更多高质量的随机对照试验来进一步证实。
2.针灸调肝固本法抗抑郁疗效肯定,且不劣于药物治疗,安全性更高。
3.针灸调肝固本法取穴固定、操作规范,安全可靠,患者中医证候改善、日常生活能力及生存质量提高均优于药物对照组。
Objective
To objectively evaluate the safety and efficacy of the acupuncture treatment based on the liver regulation and original consolidate therapy for Post-Stroke-Depression (PSD), and provide a valuable clinical reference.
Methods
1. Literature
The searching method includes the electronic and manual retrieval, retrieve the PSD literature at home and abroad in recent10years of acupuncture treatment, and do literature evaluation of the quality criteria according to the Cochrane Review Handbook5.0. And a meta-analysis was used for providing theoretical evidences to the clinical research.
2. Clinical Researches
2.1According to the principle of RCT and the acupuncture clinical features,123patients were recruited and randomly allocated to the acupuncture group of42cases, drug group of40cases and the combined group of41cases. The acupuncture group were treated by the liver regulation and original consolidate therapy, the drug group were treated by paroxetine, while the combine group were treated with both the acupuncture and paroxetine, all three groups were treated for4weeks and have a3-month-long follow-up.
2.2Single-blind method and the third party evaluation are used of clinical efficacy evaluation. The Hamilton rating scale for depression(HAMD) was applied as the primary outcome of the study, and Activities of Daily Living(Barthel index), the World Health Organization Quality of Life-BREF(WHOQOL-BREF on) were applied as the secondary outcomes; the TCM syndrome scale of spleen and stomach scale were applied as TCM syndromes outcomes; the Treatment Emergent Symptom Scale(TESS) as the safety outcome; the modified Rankin scale as the mobility outcome, along with the mortality rate and the relapse rate, the efficacy of the study was out coming.
Results
1. Literature study results
Systematic reviews included23RCTs, with a total of2435patients, which are mostly small sample RCTs, when only one multicenter trial, and12trials only referred the word "random", all the tests were not mentioned the implementation of allocation concealment,3of the trials did not describe the baseline situations. Beside the adverse reactions, meta-analysis indicated that it was uncertain whether acupuncture treatment for PSD is better than drugs or not.
2. The results of the RCT
2.1Baseline
By analyzing the general information, HAMD, Barthel, WHOQOL-BREF, TCM syndrome scale of spleen and stomach scale, there was no statistically significant difference(P)0.05) among three groups, which indicates that the baseline among all three groups are equal.
2.2HAMD score
Differences in scores among the three groups at each observation point were statistically significant (P<0.05).15days after treatment, the HAMD score of the acupuncture group and the combined group improve-rate was similar (P>0.05), but the two groups were significantly better than the drug group (P<0.01).30days after treatment, the differences among HAMD scores of three groups were statistically significant (P<0.05), but the cure rate between every two groups was not significantly different (P>0.05). The figure of HAMD outline showed the efficacy of three groups:Combined Group> acupuncture group>drug group.
2.3WHOQOL-BREF scale
The scores of physical, psychological and environmental aspect of the acupuncture group and the combined group were increased (P<0.05), and their efficacy were equivalent (P>0.05). Both the two groups has better efficacy than the drug group during the trial (P<0.05). There were no difference inter-and intra-three groups in the social aspect (P>0.05).
2.4The TCM syndrome scale of spleen and stomach
During the treatment, the scores of acupuncture group and combined group indicated that the patients'taste were improved (P<0.05), but the intra-group effect was equivalent (P>0.05), when the drug group didn't show obvious improvement (P>0.05).
2.5Barthel index
After treatment, Barthel index scores of three groups increased (P<0.05). The Barthel improvement of the acupuncture group and the combined group was resembled (P>0.05), and were better than the drug group (P<0.05).
2.6TESS
After treatment, the results showed that there were less side effects on the acupuncture group and the combined group than the drug group(P<0.01).
2.7Comparison of end-point
(1) Follow-up end of mortality and disability rates
Telephone follow-up at three months after treatment, there were no deaths; the acupuncture group has11disability (26%), drug group has16cases disability (40%) and combined group has9cases (23%), with chi-analysis, there were no significant difference(P>0.05).
(2) The relapse rate
After the3-month-followup, relapse in the acupuncture group was6(14.3%), while the drug group was9(22.5%), and the combined group was5(12.2%), with chi-analysis, there showed no difference (P>0.05).
(3) The incidence of adverse events
2(4.5%) patients in the acupuncture group and3(6.8%) in the combined group had intolerable pain, while the drug group had3(9.1%) with complications.
(4) Compliance analysis
2people in the acupuncture group and3patients in the combined group quit because of the intolerable pain,3people in the drug group withdrew from the study because of the complications, and one was asked to take the initiative quit. All these cases have been counted in the10%drop-offs.
Conelusion
1. Meta-analysis results showed that the collected trials were mostly small randomized controlled trials, and the acupuncture treatment was probably equivalent, which more high quality needs randomize controlled trials to further confirm.
2. Acupuncture treatment based on the liver regulation and original consolidate therapy for PSD has a curative and no worse efficacy to the drug treatment.
3. The liver regulation and original consolidate therapy was clearly established the criteria and safety of acupuncture treatment for PSD, and the points and operation is fixed, which improve the patients'life quality.
客观评价针灸调肝固本法治疗脑卒中后抑郁症(Post stroke depression, PSD)的有效性、安全性,为针灸治疗脑卒中后抑郁症的治疗方案提供有价值的临床参考依据。
方法：
1.文献研究
采用电子检索结合手工检索方式,对近十年针灸治疗PSD文献检索,按照Cochrane Review Handbook5.0推荐使用的质量评价标准进行文献系统评价,采用RevMan5.0.22软件进行Meta分析,为临床试验研究提供前期循证支持依据。
2.临床研究
(1)遵循随机对照试验原则,结合针灸临床特点,纳入合格PSD受试者123例,随机分为针灸试验组42例、药物对照组40例、针药结合对照组41例,分别给予针灸调肝固本法、单纯药物帕罗西汀口服以及针药结合治疗,共治疗4周,随访3月。
(2)采用单盲法结合采用第三者评价法进行各时点临床疗效评价,采用SPSS18.0软件进行数据统计分析。选取Hamilton抑郁量表(HAMD)为主要疗效评价指标,以日常生活能力量表(Barthel指数)、世界卫生组织生存质量测定量表简表(WHOQOL-BREF)为次要疗效评价指标；选取中医脾胃证候量表进行中医证候疗效评定；选取副反应量表(TESS)进行安全性评价；采用改良Rankin量表(MRS)评价致残率,并结合病死率、复发率、不良事件发生率进行终点结局疗效评价。
成果：
1.文献研究结果
系统评价纳入23项随机对照试验,共有2435例患者,仅有1项多中心试验,大多为小样本试验,12项仅提及随机字样。所有试验均未描述是否实施分配隐藏,3项试验未描述基线情况。Meta分析显示针灸治疗脑卒中后抑郁症疗效与西药比较,疗效优势尚不能确定,但是不良反应少。
2.RCT研究结果
(1)基线比较
三组治疗前一般资料、HAMD, Barthel、 WHOQOL-BREF、中医脾胃证候评分比较均无统计学意义(P>0.05),提示三组基线均衡。
(2)三组治疗前后HAMD评分比较
各时点三组前后评分差异均有统计学意义(P<0.05)。治疗15天时,针灸组与针药组HAMD评分改善率比较无统计学意义(P>0.05),但均显著优于药物组(P<0.01)。治疗30天时,三组组内治疗前后HAMD评分比较均有统计学意义(P<0.05),但组间显愈率比较无统计学意义(P>0.05)。HAMD评分轮廓趋势图显示三组临床抗抑郁疗效：针药组>针灸组>药物组。
(3)三组治疗前后WHOQOL-BREF评分比较
在生理、心理、环境领域,各时点针灸组与针药组评分均较治疗前提高(P<0.05),但组间评分比较无统计学意义(P>0.05)；药物组在治疗第30天时评分较治疗前提高(P<0.05)。各时点针灸组、针药组评分与药物组比较均有统计学意义(P<0.05)。在社会领域评定,各组各时点评分组内前后与组间比较均无统计学意义(P>0.05)。
(4)三组治疗前后脾胃证候评分比较
各时点针灸组、针药组评分治疗前后比较均有统计学意义(P<0.05),但组间比较无统计学意义(P>0.05)；药物组评分治疗前后比较无统计学意义(P>0.05)。
(5)三组治疗前后Barthel指数比较
三组Barthel指数治疗前后比较均有统计学意义(P<0.05)。针灸组与针药组组间比较无统计学意义(P>0.05),但均优于药物组(P<0.05)。
(6)三组治疗前后TESS副反应评分比较
治疗结束时,针灸组与针药组副反应评分组间比较无统计学意义(P>0.05),但均低于药物组(P<0.01)。
(7)终点指标比较
①随访期末病死率及残疾率
3个月后电话随访,三组均未出现死亡病例；针灸组42例患者中有11例残疾(26%),药物组40例中有16例残疾(40%),针药组41例中有9例残疾(23%),经卡方检验无统计学意义(P>0.05)。
②复发率
3个月随访,针灸组41例患者中复发6人(14.3%),药物组42例患者复发9人(22.5%),针药组41例患者复发5人(12.2%),经卡方检验无统计学意义(P>0.05)。
③不良事件发生率
针灸组44例中有2人(4.5%)出现不可耐受的疼痛,药物组所有44例患者有3人(9.1%)出现并发症,针药组44例中有3人(6.8%)出现不可耐受的疼痛。
(8)依从性分析
针灸组中有2人、针药组有3人因为不可耐受的疼痛(不良事件)退出,药物组中有3人因为并发症停止治疗而退出试验,1人家属要求主动退出。脱落病例数已算在10%的脱落率中,三组最终样本含量符合设计要求。
结论：
1.Meta分析结果显示纳入试验多为小样本随机对照试验,针灸治疗脑卒中后抑郁症与西药比较可能等效,需要更多高质量的随机对照试验来进一步证实。
2.针灸调肝固本法抗抑郁疗效肯定,且不劣于药物治疗,安全性更高。
3.针灸调肝固本法取穴固定、操作规范,安全可靠,患者中医证候改善、日常生活能力及生存质量提高均优于药物对照组。
Objective
To objectively evaluate the safety and efficacy of the acupuncture treatment based on the liver regulation and original consolidate therapy for Post-Stroke-Depression (PSD), and provide a valuable clinical reference.
Methods
1. Literature
The searching method includes the electronic and manual retrieval, retrieve the PSD literature at home and abroad in recent10years of acupuncture treatment, and do literature evaluation of the quality criteria according to the Cochrane Review Handbook5.0. And a meta-analysis was used for providing theoretical evidences to the clinical research.
2. Clinical Researches
2.1According to the principle of RCT and the acupuncture clinical features,123patients were recruited and randomly allocated to the acupuncture group of42cases, drug group of40cases and the combined group of41cases. The acupuncture group were treated by the liver regulation and original consolidate therapy, the drug group were treated by paroxetine, while the combine group were treated with both the acupuncture and paroxetine, all three groups were treated for4weeks and have a3-month-long follow-up.
2.2Single-blind method and the third party evaluation are used of clinical efficacy evaluation. The Hamilton rating scale for depression(HAMD) was applied as the primary outcome of the study, and Activities of Daily Living(Barthel index), the World Health Organization Quality of Life-BREF(WHOQOL-BREF on) were applied as the secondary outcomes; the TCM syndrome scale of spleen and stomach scale were applied as TCM syndromes outcomes; the Treatment Emergent Symptom Scale(TESS) as the safety outcome; the modified Rankin scale as the mobility outcome, along with the mortality rate and the relapse rate, the efficacy of the study was out coming.
Results
1. Literature study results
Systematic reviews included23RCTs, with a total of2435patients, which are mostly small sample RCTs, when only one multicenter trial, and12trials only referred the word "random", all the tests were not mentioned the implementation of allocation concealment,3of the trials did not describe the baseline situations. Beside the adverse reactions, meta-analysis indicated that it was uncertain whether acupuncture treatment for PSD is better than drugs or not.
2. The results of the RCT
2.1Baseline
By analyzing the general information, HAMD, Barthel, WHOQOL-BREF, TCM syndrome scale of spleen and stomach scale, there was no statistically significant difference(P)0.05) among three groups, which indicates that the baseline among all three groups are equal.
2.2HAMD score
Differences in scores among the three groups at each observation point were statistically significant (P<0.05).15days after treatment, the HAMD score of the acupuncture group and the combined group improve-rate was similar (P>0.05), but the two groups were significantly better than the drug group (P<0.01).30days after treatment, the differences among HAMD scores of three groups were statistically significant (P<0.05), but the cure rate between every two groups was not significantly different (P>0.05). The figure of HAMD outline showed the efficacy of three groups:Combined Group> acupuncture group>drug group.
2.3WHOQOL-BREF scale
The scores of physical, psychological and environmental aspect of the acupuncture group and the combined group were increased (P<0.05), and their efficacy were equivalent (P>0.05). Both the two groups has better efficacy than the drug group during the trial (P<0.05). There were no difference inter-and intra-three groups in the social aspect (P>0.05).
2.4The TCM syndrome scale of spleen and stomach
During the treatment, the scores of acupuncture group and combined group indicated that the patients'taste were improved (P<0.05), but the intra-group effect was equivalent (P>0.05), when the drug group didn't show obvious improvement (P>0.05).
2.5Barthel index
After treatment, Barthel index scores of three groups increased (P<0.05). The Barthel improvement of the acupuncture group and the combined group was resembled (P>0.05), and were better than the drug group (P<0.05).
2.6TESS
After treatment, the results showed that there were less side effects on the acupuncture group and the combined group than the drug group(P<0.01).
2.7Comparison of end-point
(1) Follow-up end of mortality and disability rates
Telephone follow-up at three months after treatment, there were no deaths; the acupuncture group has11disability (26%), drug group has16cases disability (40%) and combined group has9cases (23%), with chi-analysis, there were no significant difference(P>0.05).
(2) The relapse rate
After the3-month-followup, relapse in the acupuncture group was6(14.3%), while the drug group was9(22.5%), and the combined group was5(12.2%), with chi-analysis, there showed no difference (P>0.05).
(3) The incidence of adverse events
2(4.5%) patients in the acupuncture group and3(6.8%) in the combined group had intolerable pain, while the drug group had3(9.1%) with complications.
(4) Compliance analysis
2people in the acupuncture group and3patients in the combined group quit because of the intolerable pain,3people in the drug group withdrew from the study because of the complications, and one was asked to take the initiative quit. All these cases have been counted in the10%drop-offs.
Conelusion
1. Meta-analysis results showed that the collected trials were mostly small randomized controlled trials, and the acupuncture treatment was probably equivalent, which more high quality needs randomize controlled trials to further confirm.
2. Acupuncture treatment based on the liver regulation and original consolidate therapy for PSD has a curative and no worse efficacy to the drug treatment.
3. The liver regulation and original consolidate therapy was clearly established the criteria and safety of acupuncture treatment for PSD, and the points and operation is fixed, which improve the patients'life quality.
引文
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