针刺配合药物治疗抑郁症的临床研究
摘要
抑郁症(depression)是情感性精神障碍的主要类型(mood disorder),是一种以显著而持久的心境低落为特征的综合征。抑郁症作为一个全球性的主要精神问题,严重危害人类的身心健康,因不对身体造成直接危害而常常被忽视。WHO估计全球约有抑郁患者3.4亿。美国每年有1100万人患临床抑郁症,患者的自杀率为10%～15%,受此症的影响,每年大约损失200亿美元。国内调查资料显示,抑郁症的自杀率比一般人群约高20倍。预测到2020年,抑郁症将成为仅次于癌症患者为第二大致残因素。精神病学新近研究表明,抑郁症的患病率已超过心脑血管疾病和肿瘤,跃居发达国家的第一位。在天人相应、整体观念指导下的中医治疗优势越来越得到体现。抑郁症是一种典型由生物、心理、社会等多种因素作用而致的疾病。而靶点明确、作用单一的西药不可避免的存在一些缺点:相对而言,具有多层次、多靶点、重视个体的中医针刺疗法更有一定的优势。因此,整理发掘古代文献,应用现代研究方法进行论证,探讨抑郁的病因病机、治则治法、以及中医作用机理,对提高本病认识水平以及治疗效果有所裨益。
目的:本文研究从降低抗抑药物的副作用角度出发,首先寻找能够减少临床症状,使抑郁症患者的疗效能保持在一个较高的水平。针刺疗法是一种既安全,无副作用又廉价的方法。本文对中西治疗方法进行临床研究对比,探讨醒脑安神取穴法在抑郁症治疗中发挥作用,以期凸显针刺疗法在临床实践中的价值。
方法:患者随机编码入组,入组前两周停服用抗抑郁药(西药组除外)。三组患者在研究过程中均不做任何形式的心理治疗。分组:
A.西药组(SSRIs)
药物:选择性5～HT再摄取抑制剂(SSRIs)类:氟西汀(FluoxetineHCL)或舍曲林(Sertraline)第一周剂量每日25mg,以后两周复查一次,根据病情及副作用大小增减剂量,用药量在25-75mg/日之间,共服6周。
B.西药加针刺组(SSRIs & Acupuncture)
在A组治疗基础上配合针刺六个与“醒脑安神”有关的穴位,分别为百会、印堂、神门(双侧)、三阴交(双侧)、四神聪、太冲(双侧),每周6次,翌日休息一天,共针刺6周。证型/随证加穴:肝气郁结証可加膻中、内关;气郁化火证可加行间、期门、风池;忧郁伤神可加水沟、大椎;心脾两虚可加心俞、脾俞:阴虚火旺可加太溪、肝俞、肾俞;
C.针刺组(Acupuncture)
针刺六个与“醒脑安神”有关的穴位,分别为百会、印堂、神门(双侧)、三阴交(双侧)、四神聪、太冲(双侧),每周6次,翌日休息一天,共针刺6周。
证型/随证加穴:肝气郁结証可加膻中、内关;气郁化火证可加行间、期门、风池:忧郁伤神可加水沟、大椎;心脾两虚可加心俞、脾俞:阴虚火旺可加太溪、肝俞、肾俞。疗效标准:结合目前各种中西医疗效评定标准而综合制订。于治疗第二、四、六周末分别采用Hamilton抑郁量表(HAMD),抑郁自评量表(SDS),中医症候改善量表,临床疗效总评量表(CGI-SI),药物TESS副反应量表进行统计分析。
结果:
1.文献研究结果
目前,大部份患者都以西药抗抑郁药为主要药物治疗,不可否认它能改善患者的症状,但却不能预防其复发,而且还会令患者有较大的不良反应和依赖性,主要包括眩晕、头痛、失眠、紧张、激动、焦虑、恶心、呕吐、口干、消化不良和腹泻,也可有厌食、体重减轻、倦怠、失眠、颤抖、惊厥和性欲减退及性功能障碍、甚至死亡,长期服用对肠胃、肝脏、肾脏会有严重的损害,而令患者难以坚持服药.
2.临床研究结果
(1)结果显示三组的显效率有显着性差异,P＜0.05。虽然三组的痊愈率差别不明显,从HAMD量表的减分率来看,针刺组的显效率比针药组高20%,而比西药组高达33%。
(2)治疗两周后,三组7个因子分和治疗前比较,均无明显的变化(P＞0.05),但针刺组对睡眠质量和日与夜的变化较为明显,分别降幅为10.5%和21.2%,总分与治疗前比较,三组均降低5%至8.2%。
(3)治疗四周后,三组7个因子分,除西药组的认知障碍和迟缓不明显外,各因子均较治疗前有20%至58%不同程度的降低。而7因子中,在改善焦虑/躯体化方面,针刺组较针药组降分率高6.1%而比西药组高15.9%;在睡眠质量和日与夜的变化,针刺组的降分率较针药组分别高16%和22.6%,而比西药组分别高17%和24%;针刺组较西药组的总分改善有着极明显的差异(P＜0.01),针药组也较西药组有明显的差异(P＜0.05)。
(4)治疗六周后,三组7个因子分的分数和总分均较治疗前有显著降低,针刺组在改善焦虑/躯体化,睡眠质量,日与夜的变化,认知障碍,迟缓和绝望感方面均降分率高达50.4%至86%,针药组则为50%至82.7%,而西药组为47.2%至78.5%。针刺组的总分的平均降分率为58.3%,针药组则为50%,西药组为47.2%。
(5)SDS抑郁自评量表评定结果显示,治疗两周后三组均较治疗前有显着差异(P＜0.01,P＜0.05),在治疗六周后针刺组较西药组有显着性差异(P＜0.01)。
(6)GI-SI临床疗效总体印象量表评定结果显示,三组疾病严重程度(SI)、疾病改善情况(GI)均无明显差异,说明三组临床疗效总体印象相当。针刺组的疗效指数(EI)明显高于西药组和针药组,说明针刺组的副作用明显小于西药组和针药组。
(7)TESS副反应量表评定结果显示,氟西汀和舍曲林在治疗中第二、四、六周后其副反应没有明显差异(P＞0.05)。
结论:
针刺治疗抑郁症的疗效较针药和西药显著,使抑郁症患者的治疗疗效质量能保持在一个较高的水平,针刺方法是一种既无副作用又廉价的理想方法。
Depression is the main type of mood disorder which characterizesa significant and long-lasting state of low morbid syndrome.Depression is a major global mental health problem,that causes serious physical and mental health of crimes against humanity,because they can not cause direct harm to the body and often be ignored.WHO has estimated that about 340 million patients are suffering from depression.In the United States,each year 11 million people are suffering from clinical depression,the suicide rate of patients is 10%~ 15%, subject to the impact of this disease,the annual loss is about 20 billion U.S.dollars.National survey data show that the rate of depression is 20 times higher than the general population.Forecast by 2020,depression will become the second largest disability factor beyond the Cancer patients.Recently, Psychiatry studies have shown that the prevalence rate of depression is higher than cardiovascular,cerebrovascular diseases and cancer,stayingat the first rank of developed countries.
In addition,since the beginning of the global financial problem,economic recession,debt problem,small and medium-sized faces closure,the increasing unemployment rate,the further reduction of GDP,GNP,personal income and the decline in the quality of life,all those pressures may direct burden on people's physical and mental health,causing drastically increase the number of depression patient outside of more than expected.Thus,we must face it seriously.
Nowadays,under the guidance of the concept of the traditional Chinese medicine,there are more and more advantages in treatment.The cause of disease involves in biological,psychological,social and other factors.The advantages of acupuncture can treat multi-level,multi-target of illness and provide individual needs by its methods & tools.That could be better than western medicine by using one drug for one symptom.
Objective:In order to cut drugs side-effect and the degree of intensity of symptoms,the study is to help the depression victims to find an inexpensive cure of up-to-standard,high performance without side effect.
By the comparison between Chinese and Western clinical healing,this is to study the Chinese way of healing,acupuncture points of mind refreshing,in order to show evidence of the theory of acupuncture clinically.
Method:90 depression victims in 3 groups:
A.Western medicine only
Medicine:SSRIs(Fluoxetine HCL,Sertraline)
Dosages 25mg/day in first week,inspect every 2 weeks,In accordance with the side-effects and symptoms to vary the dosage,the dose between 25-75mg/day,6 weeks taken.
B.Western medicine and acupuncture
Base on group A,in addition of six specific chosen acupuncture points, those are BaiHui,Yintang,Shenmen(both-side),Sanyinjiao(both-side), Sishencong and Taichong(both-side),six times per week,taken 6 weeks.
C.Acupuncture
Six specific chosen acupuncture points,those are BaiHui,Yintang, Shenmen(both-side),Sanyinjiao(both-side),Sishencong and Taichong(both-side),six times per week,taken 6 weeks.
In conformance of Chinese and Western treatment code of practice,take Hamilton(HAMD),Self-Rating Depression Scale(SDS),Clinical global impression(CGI)global improvement(GI)efficacy index(EI) and Treatment Emergent Symptom Scale(TESS)side effect check list to go statistics after 2,4 and 6 treatment weeks respectively.
Results:
1.The results of literature review
In the meantime,a large extent of victims receives western anti-depression medicines healing with no doubt it can release some of those symptoms yet, it cannot prevent the depression from repetition,but it can lead to victims of in-effects and drugs reliability,e.g.dizziness,headache,insomnia, tense,anxiety,vomit,nausea,dry mouth,indigestion and diarrhea, anorexia,weight loss,fatigue,tumor,convulsions and loss of libido and decline sexual desire and even death.Stomach,liver and kidney damage present after long-term drug treatment,so the patients feel hard to adhere to follow treatments.
2.The results of clinical study
(1) Results obviously shown in 3 groups of different performance,P＜0.05. Although the healing rate in these 3 groups are not obvious,Group C (Acupuncture group) is better than Group B(SRRIS &Acupuncture group) by 20%,Group A(SRRIs group) by 33%,by reference to HAMD.
(2) No obvious difference can be seen in 7 elements of these 3 groups after two treatment weeks,especially seen on Group C in sleeping quality,in decline of 10.5%and 21.2%respectively.Compare with the pre-therapy,the total score of them is decrease by 5%-8.2%.
(3) After four weeks treatment,the result of the 7 elements of these 3 groups, in regard of Group A in a cognition not obvious,every element shows declines between 20%-58%respectively.And 7 elements in improvement of anxiety/ somatization;Group C shows declines of 6.1%better than group B and 15.9% better than group A.In comparison of the change of day and night or sleep disorder,Group C shows declines 16%and 22.6%respectively better than Group B,and 17%and 24%respectively better than Group A.
Group C shows obvious difference than Group A in total of P＜0.01,further more Group D shows difference than Group A of P＜0.05.
(4)After six weeks treatment,the 3 group 7 elements results and total score shows a great declines.Group C shows declines in anxiety,sleep disorder, change in day and night,cognitive handicap,hysteresis and despair of 50.4%-86%.Group B are decline of 50%-82.7%,where Group A is decline 47.2%-78.5%.The average total score of group C is decline 58.3%,Group B is 50%where Group A is 47.2%.
In essence,Group C and B can be specified as Excellence level,but Group A is effective level.
(5)SDS depression self-teat shows that,after two weeks treatments,3 groups shows obvious difference of P＜0.01,P＜0.05,Group A and group C also have a great difference after 6 weeks treatment.
(6)GI-SI table shows 3 groups in SI,GI no obvious difference,telling that 3 groups are nearly the same in total impress.Group C in EI is better than group A and B,telling that the side-effect is the least.
(7)TESS shows that Fluoxetine and Sertraline of no obvious results(P＜0.05) in side effects after 2,4 and 6 weeks treatments.
Conclusion:Acupuncture healing depression shows better performance than SSRIs with acupuncture and SSRIs only.It is really inexpensive,without side-effect and high standard depression healing treatments.
目的:本文研究从降低抗抑药物的副作用角度出发,首先寻找能够减少临床症状,使抑郁症患者的疗效能保持在一个较高的水平。针刺疗法是一种既安全,无副作用又廉价的方法。本文对中西治疗方法进行临床研究对比,探讨醒脑安神取穴法在抑郁症治疗中发挥作用,以期凸显针刺疗法在临床实践中的价值。
方法:患者随机编码入组,入组前两周停服用抗抑郁药(西药组除外)。三组患者在研究过程中均不做任何形式的心理治疗。分组:
A.西药组(SSRIs)
药物:选择性5～HT再摄取抑制剂(SSRIs)类:氟西汀(FluoxetineHCL)或舍曲林(Sertraline)第一周剂量每日25mg,以后两周复查一次,根据病情及副作用大小增减剂量,用药量在25-75mg/日之间,共服6周。
B.西药加针刺组(SSRIs & Acupuncture)
在A组治疗基础上配合针刺六个与“醒脑安神”有关的穴位,分别为百会、印堂、神门(双侧)、三阴交(双侧)、四神聪、太冲(双侧),每周6次,翌日休息一天,共针刺6周。证型/随证加穴:肝气郁结証可加膻中、内关;气郁化火证可加行间、期门、风池;忧郁伤神可加水沟、大椎;心脾两虚可加心俞、脾俞:阴虚火旺可加太溪、肝俞、肾俞;
C.针刺组(Acupuncture)
针刺六个与“醒脑安神”有关的穴位,分别为百会、印堂、神门(双侧)、三阴交(双侧)、四神聪、太冲(双侧),每周6次,翌日休息一天,共针刺6周。
证型/随证加穴:肝气郁结証可加膻中、内关;气郁化火证可加行间、期门、风池:忧郁伤神可加水沟、大椎;心脾两虚可加心俞、脾俞:阴虚火旺可加太溪、肝俞、肾俞。疗效标准:结合目前各种中西医疗效评定标准而综合制订。于治疗第二、四、六周末分别采用Hamilton抑郁量表(HAMD),抑郁自评量表(SDS),中医症候改善量表,临床疗效总评量表(CGI-SI),药物TESS副反应量表进行统计分析。
结果:
1.文献研究结果
目前,大部份患者都以西药抗抑郁药为主要药物治疗,不可否认它能改善患者的症状,但却不能预防其复发,而且还会令患者有较大的不良反应和依赖性,主要包括眩晕、头痛、失眠、紧张、激动、焦虑、恶心、呕吐、口干、消化不良和腹泻,也可有厌食、体重减轻、倦怠、失眠、颤抖、惊厥和性欲减退及性功能障碍、甚至死亡,长期服用对肠胃、肝脏、肾脏会有严重的损害,而令患者难以坚持服药.
2.临床研究结果
(1)结果显示三组的显效率有显着性差异,P＜0.05。虽然三组的痊愈率差别不明显,从HAMD量表的减分率来看,针刺组的显效率比针药组高20%,而比西药组高达33%。
(2)治疗两周后,三组7个因子分和治疗前比较,均无明显的变化(P＞0.05),但针刺组对睡眠质量和日与夜的变化较为明显,分别降幅为10.5%和21.2%,总分与治疗前比较,三组均降低5%至8.2%。
(3)治疗四周后,三组7个因子分,除西药组的认知障碍和迟缓不明显外,各因子均较治疗前有20%至58%不同程度的降低。而7因子中,在改善焦虑/躯体化方面,针刺组较针药组降分率高6.1%而比西药组高15.9%;在睡眠质量和日与夜的变化,针刺组的降分率较针药组分别高16%和22.6%,而比西药组分别高17%和24%;针刺组较西药组的总分改善有着极明显的差异(P＜0.01),针药组也较西药组有明显的差异(P＜0.05)。
(4)治疗六周后,三组7个因子分的分数和总分均较治疗前有显著降低,针刺组在改善焦虑/躯体化,睡眠质量,日与夜的变化,认知障碍,迟缓和绝望感方面均降分率高达50.4%至86%,针药组则为50%至82.7%,而西药组为47.2%至78.5%。针刺组的总分的平均降分率为58.3%,针药组则为50%,西药组为47.2%。
(5)SDS抑郁自评量表评定结果显示,治疗两周后三组均较治疗前有显着差异(P＜0.01,P＜0.05),在治疗六周后针刺组较西药组有显着性差异(P＜0.01)。
(6)GI-SI临床疗效总体印象量表评定结果显示,三组疾病严重程度(SI)、疾病改善情况(GI)均无明显差异,说明三组临床疗效总体印象相当。针刺组的疗效指数(EI)明显高于西药组和针药组,说明针刺组的副作用明显小于西药组和针药组。
(7)TESS副反应量表评定结果显示,氟西汀和舍曲林在治疗中第二、四、六周后其副反应没有明显差异(P＞0.05)。
结论:
针刺治疗抑郁症的疗效较针药和西药显著,使抑郁症患者的治疗疗效质量能保持在一个较高的水平,针刺方法是一种既无副作用又廉价的理想方法。
Depression is the main type of mood disorder which characterizesa significant and long-lasting state of low morbid syndrome.Depression is a major global mental health problem,that causes serious physical and mental health of crimes against humanity,because they can not cause direct harm to the body and often be ignored.WHO has estimated that about 340 million patients are suffering from depression.In the United States,each year 11 million people are suffering from clinical depression,the suicide rate of patients is 10%~ 15%, subject to the impact of this disease,the annual loss is about 20 billion U.S.dollars.National survey data show that the rate of depression is 20 times higher than the general population.Forecast by 2020,depression will become the second largest disability factor beyond the Cancer patients.Recently, Psychiatry studies have shown that the prevalence rate of depression is higher than cardiovascular,cerebrovascular diseases and cancer,stayingat the first rank of developed countries.
In addition,since the beginning of the global financial problem,economic recession,debt problem,small and medium-sized faces closure,the increasing unemployment rate,the further reduction of GDP,GNP,personal income and the decline in the quality of life,all those pressures may direct burden on people's physical and mental health,causing drastically increase the number of depression patient outside of more than expected.Thus,we must face it seriously.
Nowadays,under the guidance of the concept of the traditional Chinese medicine,there are more and more advantages in treatment.The cause of disease involves in biological,psychological,social and other factors.The advantages of acupuncture can treat multi-level,multi-target of illness and provide individual needs by its methods & tools.That could be better than western medicine by using one drug for one symptom.
Objective:In order to cut drugs side-effect and the degree of intensity of symptoms,the study is to help the depression victims to find an inexpensive cure of up-to-standard,high performance without side effect.
By the comparison between Chinese and Western clinical healing,this is to study the Chinese way of healing,acupuncture points of mind refreshing,in order to show evidence of the theory of acupuncture clinically.
Method:90 depression victims in 3 groups:
A.Western medicine only
Medicine:SSRIs(Fluoxetine HCL,Sertraline)
Dosages 25mg/day in first week,inspect every 2 weeks,In accordance with the side-effects and symptoms to vary the dosage,the dose between 25-75mg/day,6 weeks taken.
B.Western medicine and acupuncture
Base on group A,in addition of six specific chosen acupuncture points, those are BaiHui,Yintang,Shenmen(both-side),Sanyinjiao(both-side), Sishencong and Taichong(both-side),six times per week,taken 6 weeks.
C.Acupuncture
Six specific chosen acupuncture points,those are BaiHui,Yintang, Shenmen(both-side),Sanyinjiao(both-side),Sishencong and Taichong(both-side),six times per week,taken 6 weeks.
In conformance of Chinese and Western treatment code of practice,take Hamilton(HAMD),Self-Rating Depression Scale(SDS),Clinical global impression(CGI)global improvement(GI)efficacy index(EI) and Treatment Emergent Symptom Scale(TESS)side effect check list to go statistics after 2,4 and 6 treatment weeks respectively.
Results:
1.The results of literature review
In the meantime,a large extent of victims receives western anti-depression medicines healing with no doubt it can release some of those symptoms yet, it cannot prevent the depression from repetition,but it can lead to victims of in-effects and drugs reliability,e.g.dizziness,headache,insomnia, tense,anxiety,vomit,nausea,dry mouth,indigestion and diarrhea, anorexia,weight loss,fatigue,tumor,convulsions and loss of libido and decline sexual desire and even death.Stomach,liver and kidney damage present after long-term drug treatment,so the patients feel hard to adhere to follow treatments.
2.The results of clinical study
(1) Results obviously shown in 3 groups of different performance,P＜0.05. Although the healing rate in these 3 groups are not obvious,Group C (Acupuncture group) is better than Group B(SRRIS &Acupuncture group) by 20%,Group A(SRRIs group) by 33%,by reference to HAMD.
(2) No obvious difference can be seen in 7 elements of these 3 groups after two treatment weeks,especially seen on Group C in sleeping quality,in decline of 10.5%and 21.2%respectively.Compare with the pre-therapy,the total score of them is decrease by 5%-8.2%.
(3) After four weeks treatment,the result of the 7 elements of these 3 groups, in regard of Group A in a cognition not obvious,every element shows declines between 20%-58%respectively.And 7 elements in improvement of anxiety/ somatization;Group C shows declines of 6.1%better than group B and 15.9% better than group A.In comparison of the change of day and night or sleep disorder,Group C shows declines 16%and 22.6%respectively better than Group B,and 17%and 24%respectively better than Group A.
Group C shows obvious difference than Group A in total of P＜0.01,further more Group D shows difference than Group A of P＜0.05.
(4)After six weeks treatment,the 3 group 7 elements results and total score shows a great declines.Group C shows declines in anxiety,sleep disorder, change in day and night,cognitive handicap,hysteresis and despair of 50.4%-86%.Group B are decline of 50%-82.7%,where Group A is decline 47.2%-78.5%.The average total score of group C is decline 58.3%,Group B is 50%where Group A is 47.2%.
In essence,Group C and B can be specified as Excellence level,but Group A is effective level.
(5)SDS depression self-teat shows that,after two weeks treatments,3 groups shows obvious difference of P＜0.01,P＜0.05,Group A and group C also have a great difference after 6 weeks treatment.
(6)GI-SI table shows 3 groups in SI,GI no obvious difference,telling that 3 groups are nearly the same in total impress.Group C in EI is better than group A and B,telling that the side-effect is the least.
(7)TESS shows that Fluoxetine and Sertraline of no obvious results(P＜0.05) in side effects after 2,4 and 6 weeks treatments.
Conclusion:Acupuncture healing depression shows better performance than SSRIs with acupuncture and SSRIs only.It is really inexpensive,without side-effect and high standard depression healing treatments.
引文
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