针灸治疗抑郁症的文献评价和临床研究
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摘要
抑郁症是一种因多种原因导致的以持续情绪低落为主要症状的精神疾病。临床表现为心情抑郁、思维迟钝、兴趣减退、意志活动减少,并伴有焦虑不安、食欲减退、性功能减退、睡眠障碍等症状。2001年世界卫生组织发表的《世界卫生报告》指出,全球抑郁症的发病率约为11%,目前已成为世界第四大疾患,预计到2020年将仅次于缺血性心脏病,位居第二；2005年亚太精神科学高峰会议提到,越来越多的亚洲人正遭受抑郁症的折磨,估计抑郁症在这一地区造成的直接和间接经济损失超过1000亿美元；WHO对我国疾病负担的研究报告指出,抑郁症在15-44岁疾病负担中排行第二,占8.6%,已成为我国疾病负担的主要原因之一位列心血管疾病及恶性肿瘤之前。本病严重地影响了患者的生命健康,给社会、家庭带来了巨大负担。
现代医学主要采用抗抑郁药物进行长期治疗,但这些药物存在不同程度的副作用。此外,有些患者不能耐受药物,或者药物治疗的效果不明显。因此,研究一种有效、安全、无毒副作用,并且能改善抑郁症患者生存质量的治疗方法是目前的研究热点。针灸治疗该病可能具有上述优势,值得进一步研究。
1.通过对既往文献进行系统评价,寻找针灸治疗抑郁症的循证医学证据。
2.通过临床随机单盲安慰对照研究,评价针灸疏肝调神法治疗抑郁症的临床疗效,以及在改善患者生存质量方面的作用。
1.文献评价：
(1)针灸治疗抑郁症文献发表量的趋势分析
以“针灸”or“针刺”and“抑郁”为检索词,在中国生物医学文献数据库(CBM)、中国学术文献网络出版总库(CAJD)、中国期刊全文数据库(中国知网CNKI)中国生物医药数据库(维普VIP)、万方中华医学会期刊数据库上检索从1989年1月至2010年12月在正式学术期刊中发表的治疗抑郁症的相关文献,采用文献计量分析方法对针灸治疗抑郁症文献发表量进行趋势分析。
(2)文献系统评价
对1999年1月至2010年12月针灸治疗抑郁症的国内外临床随机对照试验文献进行质量评价及meta分析,客观评价临床疗效、研究存在的问题及改进的方向。中文检索词是“针灸”or“针刺”and“抑郁”,中文数据库是中国生物医学文献数据库(CBM)、中国学术文献网络出版总库(CAJD)、中国期刊全文数据库(中国知网CNKI)、中国生物医药数据库(维普VIP)、万方中华医学会期刊数据库进行检索；英文检索词是"Depression" or "Depressive Disorder" and "Acupuncture",英文数据库是PubMed数据库、Embase医药数据库、Cochrane协作网中心注册数据库、JSTOR西文过刊全文库、LISTA with Full Text图书馆信息与科学技术数据库、Ovid平台医学电子期刊。阅读标题、摘要、全文后经Jadad量表评分,筛选出分值≥3分的高质量临床随机对照文献,对其质量进行系统评价及meta分析。
2.临床研究：
将符合纳入标准的163例抑郁症受试者随机分为针灸疏肝调神组、穴位浅刺组与非穴位浅刺组。
疏肝调神组：先针刺四关穴,进针深度是10-12mm,采取均匀提插捻转手法,以得气为度,并配合导气法。再针百会、印堂穴,进针深度4-5mmm,采取均匀捻转手法,得气即止。留针时间为30分钟。接着取四花穴进行艾炷直接灸,艾炷燃烧接近2/3,且病人有温热或轻微灼痛感时,即用棉签将未燃尽的艾炷移去,每个穴位各灸5壮。最后取双侧心俞和肝俞埋皮内针,由外侧向脊柱方向,沿皮下横向平刺,将皮内针5mm针身全部刺入,针柄留于皮外。然后用医用胶布粘贴固定,留置2天后撕下胶布,取出皮内针。
穴位浅刺组：针刺、艾灸、埋皮内针的选穴和疏肝调神组一致,但四关穴和百会、印堂穴针刺深度均为2-3mm,且不要求有针感；直接灸时,艾炷燃烧接近1/3,且病人还无热感时就移去艾炷；皮内针横刺深度为1-2mm。
非穴位浅刺组：针刺、艾灸、埋皮内针的操作方法和穴位浅刺组一致,但针刺选穴为合谷穴桡侧lOmm处(双)、太冲穴外侧10mm处(双)、百会左侧10mm处、印堂左侧10mm处；艾灸选穴为膈俞外侧lOmm(双)、胆俞外侧10mm(双)；埋皮内针选穴为心俞外侧10mm(双)、肝俞外侧10mm(双)。
三组治疗每周2次,每次治疗间隔时间>48h,共治疗12周。评价疏肝调神法对抑郁症的干预效果以及对患者生存质量的影响,在治疗前、疗程结束时、治疗结束后一个月、治疗结束后三个月的四个不同时点对相关疗效指标进行测量,以评价疏肝调神针灸方案对治疗抑郁症的近期效应及中、远期疗效,运用描述性分析、x2、秩和检验等统计方法,与穴位浅刺组和非穴位浅刺组进行对照,探讨各组治疗抑郁症的效果差异。
1.文献评价
(1)针灸治疗抑郁症文献发表量的趋势分析
在1989-2010年的22年间,发表治疗抑郁相关文献共2920篇,其中针灸治疗抑郁的文献篇数为249篇,占8.53%,针灸治疗抑郁的随机对照文献篇数为86篇,占针灸治疗抑郁文献篇数的34.54%,大多数(163篇,占65.46%)为非随机对照文献。临床针灸治疗抑郁的文献发表量在1989-1999年间不多,2002年以后,对抑郁的相关研究呈上升趋势,但高质量的研究较少。
(2)文献系统评价
按检索策略、文献筛选方法,共检索到正式学术期刊发表的随机对照文献283篇,其中中文文献248篇,英文文献35篇。阅读标题、摘要、全文后经Jadad量表评分,筛选出分值≥3分的高质量临床随机对照文献26篇,其中中文文献20篇,英文文献6篇。
26篇高质量文献中共纳入15个试验,合计2269例患者,均采用HAMD减分率计算有效率,其中HAMD减分率≥50%且<75%视为有效。采用固定效应模型,合并0R=2.25,95%CI为(1.66,3.05),合并效应值检验统计量Z=5.25,治疗组与对照组有效率差异有显著性意义(P＜0.01),可以认为治疗组疗效优于对照组。
HAMD评分共纳入16个研究,异质性检验(P<0.01)两组不同质,采用随机效应模型。WMD=-1.92,95%CI为(-3.27,-0.58),治疗组与对照组评分结果差异有统计学意义(P<0.01),且治疗组效果优于对照组。同时进行固定效应模型分析,分析结果同随机效应模型,认为结果稳定性相对较高。
SDS评分共纳入7个研究。采用随机效应模型,WMD=-8.20,95%CI为(-11.24,-5.16),两组SDS评分差异有显著性意义(P＜0.01),认为治疗组疗效优于对照组。
BDI评分共纳入4个研究。采用随机效应模型,WMD=-1.15,95%CI为(-7.05,4.74),两组SDS评分差异无显著性意义(P>0.05),认为治疗组疗效与对照组相当。
2.临床研究
(1)基线资料
三组患者在年龄、身高、体重、病程、性别、文化程度、职业、、生活习惯是否规律、曾服用中西药治疗、曾接受针灸治疗方面比较差异均无统计学意义(P>0.05)；在医疗保障、家族病史、曾接受心理治疗方面,因理论数小于5,使用fisher精确概率法后,差异无统计学意义(P>0.05)。治疗前,HAMD量表、SF-36生存质量量表、SCL-90症状自评量表及抑郁症中医证候量表评分组间比较,差异均无统计学意义(P>0.05),可认为三组基线水平一致,具有可比性。
(2)总有效率
治疗后各时点的总有效率,疏肝调神组、穴位浅刺组分别与非穴位浅刺组比较,差异均有统计学意义(P<0.0167)。在治疗后,疏肝调神组(93.62%)与非穴位浅刺组(62.50%)比较,差异均有统计学意义(P<0.0167)；治疗后1个月,疏肝调神组(89.36%)与非穴位浅刺组(47.92%)比较,差异均有统计学意义(P＜0.0167)；治疗后3个月,疏肝调神组(87.23%)与穴位浅刺组(79.17%)非穴位浅刺组(35.42%)比较,差异均有统计学意义(P＜0.0167)
认为在以总有效率为主要疗效指标的评价中,疏肝调神组、穴位浅刺组在治疗后各时点疗效均优于非穴位浅刺组；其中,疏肝调神组疗效最佳,穴位浅刺组次之。
(3) HAMD抑郁量表
三组治疗后各时点的HAMD评分均较治疗前降低,差异均有统计学意义(P＜0.05),提示三组治疗后均有改善。但疏肝调神组与穴位浅刺组比较,差异无统计学意义(P>0.05)；疏肝调神组、穴位浅刺组分别与非穴位浅刺组比较,差异均有统计学意义(P<0.05)
认为在以HAMD量表评分为主要疗效指标的评价中,疏肝调神组、穴位浅刺组在治疗后各时点疗效均优于非穴位浅刺组；其中,疏肝调神组的疗效最佳,穴位浅刺组次之。
(4)SF-36生存质量量表
治疗后各时点与治疗前自身前后比较,疏肝调神组、穴位浅刺组与非穴位浅刺组在SF-36生存质量量表8个维度评分均较治疗前上升,差异均有统计学意义(P＜0.05)。治疗后各时点,对于SF-36生存质量量表8个维度评分,疏肝调神组与穴位浅剌组、非穴位浅刺组比较,差异均有统计学意义(P<0.0125)；治疗后,穴位浅刺组与非穴位浅刺组8个维度评分比较,差异均有统计学意义(P<0.0125)；治疗后1个月、治疗后3个月穴位浅刺组与非穴位浅刺组除社会功能评分差异无统计学意义外(Z=1.51,P=0.13),其他各维度评分差异均有统计学意义(P＜0.0125)。
认为在以SF-36生存质量量表评分为主要疗效指标的评价中,疏肝调神组治疗后各时点在生理机能、生理职能、躯体疼痛、一般身体状况、精力、社会功能、情感职能和精神健康8个维度的生存质量改善情况均优于均优于穴位浅刺组、非穴位浅刺组。
(5)SCL-90症状自评量表
认为在以SCL-90症状自评量表评分为测量指标的评价中,疏肝调神组治疗后各时点在躯体化、强迫、抑郁、焦虑、敌对、偏执、精神病性及其他8个维度改善情况优于非穴位浅刺组,且在抑郁、焦虑、敌对3个维度改善情况优于穴位浅刺组。
(6)抑郁症中医证候量表
认为在以抑郁症中医证候量表评分为测量指标的评价中,疏肝调神组、穴位浅刺组在治疗后各时点疗效均优于非穴位浅刺组；其中,疏肝调神组疗效最佳,穴位浅刺组次之。
1.本文献研究发现,临床针灸治疗抑郁的文献发表量在1989-1999年间不多,2002年以后,对抑郁症的相关研究呈上升趋势,但缺乏高质量、大样本的研究。因此,需要加强大样本的临床RCT进行规范研究。此外,提倡采用国际公认的CONSORT声明和STRICTA标准对针灸疗法的RCT研究进行规范报告。26篇高质量文献经过系统评价,认为针灸治疗抑郁症的疗效可能优于或相当于有效的药物,且不良反应较少。
2.本临床试验研究表明,疏肝调神针灸方案能改善抑郁症患者HAMD抑郁量表评分和SF-36生存质量量表8个维度评分,有效提高患者的生存质量,通过与穴位浅刺组和非穴位浅刺组比较,提示在近期效应和中、远期疗效上均优于对照组,具有良好的应用前景和推广价值。
Depression is a mental illness mainly featured with symptom of continue depressive mood resulted from a variety of reasons. Clinical manifestations are depression, mental retardation, decreased interest, decreased mental activity, which are accompanied by anxiety, loss of appetite, sexual dysfunction, sleep disorders and other symptoms. In 2001, the "World Health Report" published by the World Health Organization (WHO) pointed out that the global incidence of depression is about 11%, which has become the world's fourth largest disease and is expected to be second only ischemic heart disease in 2020; 2005 Psychiatry Asia Pacific Summit pointed out that there were more and more Asians were suffering from depression, the direct and indirect economic loss resulted from depression in the region is estimated as over 100 billion U.S. dollars; In 1998, a study on disease burden in China from WHO reported that depression ranked second in the disease burden of 15-44 year-olds, accounting for 8.6%, which has become one of the main burdens of disease in our country, ranking before cardiovascular disease and cancer. The disease has seriously affected the life and health of patients and brought a huge burden to the society and the family. Thus, actively looking for effective interventions is of great clinical and social significance.
Modern medicine mainly use antidepressant for long-term treatment of depression, there are many problems. We should fully use the advantages of effectiveness, safety, simplicity, and non-toxic side effects of acupuncture treatment of depression, in particular, for those who can not tolerate the western medicine or to those the effect of western medicine treatment is not obvious, acupuncture has good prospects and value of promotion
Purpose:
1. Through systematic review of previous literature, we can find evidence based medicine of acupuncture treatment for depression.
2. From the clinical aspects, we explore the effectiveness of acupuncture group of soothing the liver qi and regulating the spirit in the treatment of depression, and the role of improving patients'quality of life
Contents and methods:
1. Literature Evaluation:
(1) Trend analysis of the publication amount of the literature of acupuncture treatment for depression
To make "acupuncture and moxibustion" or "acupuncture" and "depression" as the search words, searched the relevant literature on the treatment of depression published in the official academic journals from January 1989 to December 2010 in the Chinese Biomedical Literature Database (CBM), Chinese web publishing academic literature pool (CAJD), China Academic Journal (CNKI), China Biomedical database (VIP), Articles on the Chinese Medical Association, use the method of bibliometric analysis to do the trend analysis of acupuncture treatment for depression
(2) systematic review of literature
To do the quality assessment and meta analysis of domestic and international RCT literature on acupuncture treatment of depression published from January 1999 to December 2010, and to objectively assess the clinical efficacy, research problems and directions for improvement. To make "acupuncture and moxibustion" or "acupuncture" and "depression" as the Chinese search words, searched the relevant literature on the treatment of depression published in the official academic journals from January 1989 to December 2010 in the Chinese Biomedical Literature Database (CBM), Chinese web publishing academic literature pool (CAJD), China Academic Journal (CNKI), China Biomedical database (VIP), Articles on the Chinese Medical Association. English key words are "Depression" or "Depressive Disorder" and "Acupuncture", English databases are PubMed database, Embase medicine database, Cochrane Central Register Database Collaboration, JSTOR Archive Library of Western, LISTA with Full Text Library Information and scientific and technical databases, Ovid platform medical electronic journals. Finally choose the literature which score is more than 3 by the standard of Jadad to do the further research.
2. Clinical Research:
The 163 patients who met the inclusion criteria were randomly divided into acupuncture group of soothing the liver qi and regulating the spirit, superficial acupuncture group and non-acupoint superficial acupuncture group.
For acupuncture group of soothing the liver qi and regulating the spirit,we used LR3 (bilateral), LI14 (bilateral), DU20, EX-HN3. For LR3 and LI14, the needle should be inserted with the depth of 10-12mm, four points needed to be inserted up and down and the manipulation of twist and turn until the qi was attained with the method of regulating qi. Then DU20 and EX-HN3 were inserted with the depth of 4-5mm, both taking even twisting, the total needle retention time was 30 minutes. Then do the direct moxa cone moxibustion on BL15 (bilateral) and BL18 (bilateral). When the cone burned closeto its 2/3 part and the patients had a sense of warm or mild burning pain, remove the remaining moxa cone, each point done the moxibustion of 5 mins. Last, buried intradermal needle on BL15 (bilateral), BL18(bilateral). Pierce the needle within the skin with the depth of 5mm horizontally with with the direcition from the lateral, leaving the needle handle outside the skin. Then paste the handle with medical tape, after a retention of 2 days, remove the intradermal needle.
For superficial acupuncture group, the points of acupuncture, moxibustion and buried intradermal needle were the same with the previous group, but LR3, LI14, DU20 and EX-HN3 would be inserted with depth of 2-3mm, and the sensation of qi was not required. When the cone burned closeto its 1/3, remove the remaining moxa cone. Intradermal needle would be buried with the depth of 1-2mm.
For Superficial acupuncture group of non-acupoint acupuncture, the operation of aucuncture, moxibustion, buried intradermal needle are the same with that of superficial acupuncture group, but the acupoints would be 10mm from the radial side of LI14(bilateral),10mm from the lateral side of LR3 (bilateral),10mm from the left side of DU20,10mm from the left side of EX-HN3, for moxibustion the acupoints would be 10mm from the lateral side of BL17(bilateral),10mm from the lateral side of BL19(bilateral), for intradermal needle, the acupoints would be 10mm from the lateral side of BL15(bilateral) and BL18(bilateral), for the lateral (double), gall Yu lateral 10mm (double); buried intradermal needle selection of points outside the Xinshu 10mm (double), liver Yu lateral 10mm (double).
Three groups' treatments are arranged as 2 times per week, and the time between every two treatments must be more than 48 hours, totally 12 weeks. To evaluate at 4 different time points:before the treatment, at the end of treatment, one month after the treatment, three months after the treatment with the Hamilton Depression Rating Scale (HAMD), SF-36 Quality of Life Scale, Symptom rating scale (SCL-90) and syndromes of depression. To use descriptive analysis,rank sum test and other statistical methods to compare clinical efficacy and quality of life improvements among the acupuncture group of soothing the liver qi and regulating the spirit, superficial acupuncture group and superficial acupuncture group of non-acupoint acupuncture.
Results:
1. Literature Evaluation
(1) Trend analysis of the amount of the literature of acupuncture treatment for depression
There are 2920 related literature of treating depression, among which there are 249 articles about acupuncture treatment during 22 years which are from 1989 to 2010, accounting for 8.53%, there are 86 RCT literature of acupuncture treating depression, which account for 34.54%, most of which (163, accounting for 65.46%) are non-randomized controlled literature.There are relatively fewer literature of clinical treatment published between 1989-1999, after 2002, research on depression is rising, but there are relatively few randomized, controlled documents, research quality is not high. (2) systematic review of literature
By using search strategy and literature screening methods, we can retrieve 283 randomized controlled documents published in official academic journals, including 248 Chinese literature and 35 English literature. To grade with the Jadad scale score after reading the title, abstract, full text and screen out 26 high-quality randomized controlled clinical literature with score of≥3 points, in which there are 20 Chinese literature and 6 English literature.
26 high-quality literature which contain 2269 patients were included into 15 trials, all using HAMD points rate reduction to calculate the efficacy rate, in which HAMD reduction rate is regarded as effective when it≥50% and <75%. Use fixed effect model, combined OR=2.25,95% CI of (1.66, 3.05), the value of combined effects of the test statistic Z=5.25, the efficacy rate difference between treatment group and control group was significant (P<0.01), we can consider that the efficacy of treatment group is better than that of control group.
16 studies were included for HAMD score, heterogeneity test (P<0.01) suggested that two groups are heterogeneous, therefore a random effects model would be used. WMD=-1.92,95% CI of (-3.27,-0.58), the difference between treatment group and control group was significant (P<0.01), the efficacy of treatment group is better than that of control group.
We also do the fixed effect model analysis and the results is the same with the random effects model, we can consider that the results have relatively high stability.
7 were included for SDS score. Use random effect model, WMD=-8.20,95% CI is (-11.24, -5.16), the difference of SDS scores between the two groups is statistically significant (P<0.01), therefore the efficacy of the treatment group is better than the control group.
4 were included for BDI score. Use random effect model, WMD=-1.15,95% CI is (-7.05,4.74), the difference of SDS score between the two groups is no significant (P>0.05), therefore the efficacy of the two groups are the same.
2. Clinical Research
(1) baseline information
The difference in terms of age, height, weight, disease duration, sex, educational level, occupation, whether living habits are regular, whether western medicine was taken and whether acupuncture treatment has been among 3 groups is no significant (P>0.05), so there is comparability; in the aspects of health care, family history and whether psychological treatment was received, because theoretical number is less than 5, after using fisher precise probability method, the difference was not statistically significant (P>0.05). And, the difference of scores of HAMD scale, SF-36 Quality of Life Scale, SCL-90 symptom scale and TCM syndrome rating scale among the three groups of depressed patients before treatment was not statistically significant (P>0.05), baseline level can be considered the same among the three groups.
(2) Total effective rate
Compare the total effective rate of the treatment group and superficial acupuncture group with that of non-acupoint superficial acupuncture group at 3 time points:after treatment,1 month after treatment,3 months after treatment, the difference was significant (P<0.01). At the time points of after treatment and 1 month after treatment, compare the efficacy rate of treatment group (93.62%) with that of the superficial acupuncture group (89.58%), the difference was not statistically significant (P> 0.05), prompting the effect of two groups are the same after treatment and 1 month after treatment; 3 months after treatment, compare the efficacy rate of treatment group (87.23%) with that of superficial acupuncture group (79.17%), the difference was statistically significant (P<0.01).
(3) HAMD scale
Compare the HAMD scores at each time point of the 3 groups with that of before the treatment, we found that the previous ones were higher than that of before treatment, the differences were statistically significant (P<0.05), prompted the three groups had improvement after treatment. We can see from the analysis of the HAMD score at each time point that the difference between the treatment group and superficial acupuncture group was not significant (P>0.05); The differences between treatment group and superficial non-acupoint acupuncture group were statistically significant, the differences between superficial acupuncture group and superficial non-acupoint acupuncture group were statistically significant (P<0.05).
In the evaluation of the the HAMD scale, the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit and the superficial acupuncture group are better than the superficial acupuncture group of non-acupoint, and the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit is the best.
(4) SF-36 scale
Compare the scores of the treatment group and superficial acupuncture group with that of non-acupoint superficial acupuncture group at 3 time points:after treatment,1 month after treatment,3 months after treatment, eight dimensions of quality of life in the SF-36 scale scores are all higher that that of before the treatment, the difference was significant (P<0.05). Compare the scores of the treatment group with that of superficial acupuncture group and non-acupoint superficial acupuncture group at 3 different time points, which are after the treatment, after 1 month after the treatment,3 months after treatment, the difference was significant (P<0.0125); compare the 8 dimension scores of superficial acupuncture group with that of non-acupoint superficial acupuncture group after the treatment, the differences were statistically significant (P<0.0125); Compare the SF-36 scores of superficial acupuncture group with that of non-acupoint superficial acupuncture group 1 month after treatment and 3 months after treatment, difference was not statistically significance, (Z=1.51, P=0.13), the differences other dimension scores were statistically significant (P<0.0125).
In the evaluation of the the SF-36 scale, the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit are better than the superficial acupuncture group and the superficial acupuncture group of non-acupoint in 8 aspects of the SF-36 scale.
(5) SCL-90 scale
In the evaluation of the the SCL-90 scale, the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit are better than the superficial acupuncture group of non-acupoint in 8 aspects of the SCL-90 scale, and they are better than the superficial acupuncture group in 3 aspects of the SCL-90 scale.
(6) Syndrome Rating Scale
In the evaluation of the Syndrome Rating Scale, the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit and the superficial acupuncture group are better than the superficial acupuncture group of non-acupoint, and the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit is the best.
Conclusions:
1.The literature review found that the majority of literature report of acupuncture treatment of depression had low quality. Therefore we advocate the adoption of internationally recognized standards of CONSORT statement and STRICTA to do the standardized report of RCT research of acupuncture. After doing the systematic reviews of the 26 high-quality literature, we consider that the efficacy of acupuncture treatment for depression may be better than or equal to drugs and with fewer adverse reactions.
2. The acupuncture method of soothing liver qi and regulating the spirit is an academic idea with "treat with the liver qi, regulating qi first"as a core, combine the acupuncture, direct moxibustion with moxa cone and buried intradermal needle, this study shows that the treatment group can effectively improve the score of HAMD scale and SF-36 scale. In terms of short and long term efficacy and extent of the role, the treatment group is better than superficial acupuncture group and non-acupoint superficial acupuncture group, it is effective and safe in improving depression and quality of life of patients which has a good application and promotion prospects.
现代医学主要采用抗抑郁药物进行长期治疗,但这些药物存在不同程度的副作用。此外,有些患者不能耐受药物,或者药物治疗的效果不明显。因此,研究一种有效、安全、无毒副作用,并且能改善抑郁症患者生存质量的治疗方法是目前的研究热点。针灸治疗该病可能具有上述优势,值得进一步研究。
1.通过对既往文献进行系统评价,寻找针灸治疗抑郁症的循证医学证据。
2.通过临床随机单盲安慰对照研究,评价针灸疏肝调神法治疗抑郁症的临床疗效,以及在改善患者生存质量方面的作用。
1.文献评价：
(1)针灸治疗抑郁症文献发表量的趋势分析
以“针灸”or“针刺”and“抑郁”为检索词,在中国生物医学文献数据库(CBM)、中国学术文献网络出版总库(CAJD)、中国期刊全文数据库(中国知网CNKI)中国生物医药数据库(维普VIP)、万方中华医学会期刊数据库上检索从1989年1月至2010年12月在正式学术期刊中发表的治疗抑郁症的相关文献,采用文献计量分析方法对针灸治疗抑郁症文献发表量进行趋势分析。
(2)文献系统评价
对1999年1月至2010年12月针灸治疗抑郁症的国内外临床随机对照试验文献进行质量评价及meta分析,客观评价临床疗效、研究存在的问题及改进的方向。中文检索词是“针灸”or“针刺”and“抑郁”,中文数据库是中国生物医学文献数据库(CBM)、中国学术文献网络出版总库(CAJD)、中国期刊全文数据库(中国知网CNKI)、中国生物医药数据库(维普VIP)、万方中华医学会期刊数据库进行检索；英文检索词是"Depression" or "Depressive Disorder" and "Acupuncture",英文数据库是PubMed数据库、Embase医药数据库、Cochrane协作网中心注册数据库、JSTOR西文过刊全文库、LISTA with Full Text图书馆信息与科学技术数据库、Ovid平台医学电子期刊。阅读标题、摘要、全文后经Jadad量表评分,筛选出分值≥3分的高质量临床随机对照文献,对其质量进行系统评价及meta分析。
2.临床研究：
将符合纳入标准的163例抑郁症受试者随机分为针灸疏肝调神组、穴位浅刺组与非穴位浅刺组。
疏肝调神组：先针刺四关穴,进针深度是10-12mm,采取均匀提插捻转手法,以得气为度,并配合导气法。再针百会、印堂穴,进针深度4-5mmm,采取均匀捻转手法,得气即止。留针时间为30分钟。接着取四花穴进行艾炷直接灸,艾炷燃烧接近2/3,且病人有温热或轻微灼痛感时,即用棉签将未燃尽的艾炷移去,每个穴位各灸5壮。最后取双侧心俞和肝俞埋皮内针,由外侧向脊柱方向,沿皮下横向平刺,将皮内针5mm针身全部刺入,针柄留于皮外。然后用医用胶布粘贴固定,留置2天后撕下胶布,取出皮内针。
穴位浅刺组：针刺、艾灸、埋皮内针的选穴和疏肝调神组一致,但四关穴和百会、印堂穴针刺深度均为2-3mm,且不要求有针感；直接灸时,艾炷燃烧接近1/3,且病人还无热感时就移去艾炷；皮内针横刺深度为1-2mm。
非穴位浅刺组：针刺、艾灸、埋皮内针的操作方法和穴位浅刺组一致,但针刺选穴为合谷穴桡侧lOmm处(双)、太冲穴外侧10mm处(双)、百会左侧10mm处、印堂左侧10mm处；艾灸选穴为膈俞外侧lOmm(双)、胆俞外侧10mm(双)；埋皮内针选穴为心俞外侧10mm(双)、肝俞外侧10mm(双)。
三组治疗每周2次,每次治疗间隔时间>48h,共治疗12周。评价疏肝调神法对抑郁症的干预效果以及对患者生存质量的影响,在治疗前、疗程结束时、治疗结束后一个月、治疗结束后三个月的四个不同时点对相关疗效指标进行测量,以评价疏肝调神针灸方案对治疗抑郁症的近期效应及中、远期疗效,运用描述性分析、x2、秩和检验等统计方法,与穴位浅刺组和非穴位浅刺组进行对照,探讨各组治疗抑郁症的效果差异。
1.文献评价
(1)针灸治疗抑郁症文献发表量的趋势分析
在1989-2010年的22年间,发表治疗抑郁相关文献共2920篇,其中针灸治疗抑郁的文献篇数为249篇,占8.53%,针灸治疗抑郁的随机对照文献篇数为86篇,占针灸治疗抑郁文献篇数的34.54%,大多数(163篇,占65.46%)为非随机对照文献。临床针灸治疗抑郁的文献发表量在1989-1999年间不多,2002年以后,对抑郁的相关研究呈上升趋势,但高质量的研究较少。
(2)文献系统评价
按检索策略、文献筛选方法,共检索到正式学术期刊发表的随机对照文献283篇,其中中文文献248篇,英文文献35篇。阅读标题、摘要、全文后经Jadad量表评分,筛选出分值≥3分的高质量临床随机对照文献26篇,其中中文文献20篇,英文文献6篇。
26篇高质量文献中共纳入15个试验,合计2269例患者,均采用HAMD减分率计算有效率,其中HAMD减分率≥50%且<75%视为有效。采用固定效应模型,合并0R=2.25,95%CI为(1.66,3.05),合并效应值检验统计量Z=5.25,治疗组与对照组有效率差异有显著性意义(P＜0.01),可以认为治疗组疗效优于对照组。
HAMD评分共纳入16个研究,异质性检验(P<0.01)两组不同质,采用随机效应模型。WMD=-1.92,95%CI为(-3.27,-0.58),治疗组与对照组评分结果差异有统计学意义(P<0.01),且治疗组效果优于对照组。同时进行固定效应模型分析,分析结果同随机效应模型,认为结果稳定性相对较高。
SDS评分共纳入7个研究。采用随机效应模型,WMD=-8.20,95%CI为(-11.24,-5.16),两组SDS评分差异有显著性意义(P＜0.01),认为治疗组疗效优于对照组。
BDI评分共纳入4个研究。采用随机效应模型,WMD=-1.15,95%CI为(-7.05,4.74),两组SDS评分差异无显著性意义(P>0.05),认为治疗组疗效与对照组相当。
2.临床研究
(1)基线资料
三组患者在年龄、身高、体重、病程、性别、文化程度、职业、、生活习惯是否规律、曾服用中西药治疗、曾接受针灸治疗方面比较差异均无统计学意义(P>0.05)；在医疗保障、家族病史、曾接受心理治疗方面,因理论数小于5,使用fisher精确概率法后,差异无统计学意义(P>0.05)。治疗前,HAMD量表、SF-36生存质量量表、SCL-90症状自评量表及抑郁症中医证候量表评分组间比较,差异均无统计学意义(P>0.05),可认为三组基线水平一致,具有可比性。
(2)总有效率
治疗后各时点的总有效率,疏肝调神组、穴位浅刺组分别与非穴位浅刺组比较,差异均有统计学意义(P<0.0167)。在治疗后,疏肝调神组(93.62%)与非穴位浅刺组(62.50%)比较,差异均有统计学意义(P<0.0167)；治疗后1个月,疏肝调神组(89.36%)与非穴位浅刺组(47.92%)比较,差异均有统计学意义(P＜0.0167)；治疗后3个月,疏肝调神组(87.23%)与穴位浅刺组(79.17%)非穴位浅刺组(35.42%)比较,差异均有统计学意义(P＜0.0167)
认为在以总有效率为主要疗效指标的评价中,疏肝调神组、穴位浅刺组在治疗后各时点疗效均优于非穴位浅刺组；其中,疏肝调神组疗效最佳,穴位浅刺组次之。
(3) HAMD抑郁量表
三组治疗后各时点的HAMD评分均较治疗前降低,差异均有统计学意义(P＜0.05),提示三组治疗后均有改善。但疏肝调神组与穴位浅刺组比较,差异无统计学意义(P>0.05)；疏肝调神组、穴位浅刺组分别与非穴位浅刺组比较,差异均有统计学意义(P<0.05)
认为在以HAMD量表评分为主要疗效指标的评价中,疏肝调神组、穴位浅刺组在治疗后各时点疗效均优于非穴位浅刺组；其中,疏肝调神组的疗效最佳,穴位浅刺组次之。
(4)SF-36生存质量量表
治疗后各时点与治疗前自身前后比较,疏肝调神组、穴位浅刺组与非穴位浅刺组在SF-36生存质量量表8个维度评分均较治疗前上升,差异均有统计学意义(P＜0.05)。治疗后各时点,对于SF-36生存质量量表8个维度评分,疏肝调神组与穴位浅剌组、非穴位浅刺组比较,差异均有统计学意义(P<0.0125)；治疗后,穴位浅刺组与非穴位浅刺组8个维度评分比较,差异均有统计学意义(P<0.0125)；治疗后1个月、治疗后3个月穴位浅刺组与非穴位浅刺组除社会功能评分差异无统计学意义外(Z=1.51,P=0.13),其他各维度评分差异均有统计学意义(P＜0.0125)。
认为在以SF-36生存质量量表评分为主要疗效指标的评价中,疏肝调神组治疗后各时点在生理机能、生理职能、躯体疼痛、一般身体状况、精力、社会功能、情感职能和精神健康8个维度的生存质量改善情况均优于均优于穴位浅刺组、非穴位浅刺组。
(5)SCL-90症状自评量表
认为在以SCL-90症状自评量表评分为测量指标的评价中,疏肝调神组治疗后各时点在躯体化、强迫、抑郁、焦虑、敌对、偏执、精神病性及其他8个维度改善情况优于非穴位浅刺组,且在抑郁、焦虑、敌对3个维度改善情况优于穴位浅刺组。
(6)抑郁症中医证候量表
认为在以抑郁症中医证候量表评分为测量指标的评价中,疏肝调神组、穴位浅刺组在治疗后各时点疗效均优于非穴位浅刺组；其中,疏肝调神组疗效最佳,穴位浅刺组次之。
1.本文献研究发现,临床针灸治疗抑郁的文献发表量在1989-1999年间不多,2002年以后,对抑郁症的相关研究呈上升趋势,但缺乏高质量、大样本的研究。因此,需要加强大样本的临床RCT进行规范研究。此外,提倡采用国际公认的CONSORT声明和STRICTA标准对针灸疗法的RCT研究进行规范报告。26篇高质量文献经过系统评价,认为针灸治疗抑郁症的疗效可能优于或相当于有效的药物,且不良反应较少。
2.本临床试验研究表明,疏肝调神针灸方案能改善抑郁症患者HAMD抑郁量表评分和SF-36生存质量量表8个维度评分,有效提高患者的生存质量,通过与穴位浅刺组和非穴位浅刺组比较,提示在近期效应和中、远期疗效上均优于对照组,具有良好的应用前景和推广价值。
Depression is a mental illness mainly featured with symptom of continue depressive mood resulted from a variety of reasons. Clinical manifestations are depression, mental retardation, decreased interest, decreased mental activity, which are accompanied by anxiety, loss of appetite, sexual dysfunction, sleep disorders and other symptoms. In 2001, the "World Health Report" published by the World Health Organization (WHO) pointed out that the global incidence of depression is about 11%, which has become the world's fourth largest disease and is expected to be second only ischemic heart disease in 2020; 2005 Psychiatry Asia Pacific Summit pointed out that there were more and more Asians were suffering from depression, the direct and indirect economic loss resulted from depression in the region is estimated as over 100 billion U.S. dollars; In 1998, a study on disease burden in China from WHO reported that depression ranked second in the disease burden of 15-44 year-olds, accounting for 8.6%, which has become one of the main burdens of disease in our country, ranking before cardiovascular disease and cancer. The disease has seriously affected the life and health of patients and brought a huge burden to the society and the family. Thus, actively looking for effective interventions is of great clinical and social significance.
Modern medicine mainly use antidepressant for long-term treatment of depression, there are many problems. We should fully use the advantages of effectiveness, safety, simplicity, and non-toxic side effects of acupuncture treatment of depression, in particular, for those who can not tolerate the western medicine or to those the effect of western medicine treatment is not obvious, acupuncture has good prospects and value of promotion
Purpose:
1. Through systematic review of previous literature, we can find evidence based medicine of acupuncture treatment for depression.
2. From the clinical aspects, we explore the effectiveness of acupuncture group of soothing the liver qi and regulating the spirit in the treatment of depression, and the role of improving patients'quality of life
Contents and methods:
1. Literature Evaluation:
(1) Trend analysis of the publication amount of the literature of acupuncture treatment for depression
To make "acupuncture and moxibustion" or "acupuncture" and "depression" as the search words, searched the relevant literature on the treatment of depression published in the official academic journals from January 1989 to December 2010 in the Chinese Biomedical Literature Database (CBM), Chinese web publishing academic literature pool (CAJD), China Academic Journal (CNKI), China Biomedical database (VIP), Articles on the Chinese Medical Association, use the method of bibliometric analysis to do the trend analysis of acupuncture treatment for depression
(2) systematic review of literature
To do the quality assessment and meta analysis of domestic and international RCT literature on acupuncture treatment of depression published from January 1999 to December 2010, and to objectively assess the clinical efficacy, research problems and directions for improvement. To make "acupuncture and moxibustion" or "acupuncture" and "depression" as the Chinese search words, searched the relevant literature on the treatment of depression published in the official academic journals from January 1989 to December 2010 in the Chinese Biomedical Literature Database (CBM), Chinese web publishing academic literature pool (CAJD), China Academic Journal (CNKI), China Biomedical database (VIP), Articles on the Chinese Medical Association. English key words are "Depression" or "Depressive Disorder" and "Acupuncture", English databases are PubMed database, Embase medicine database, Cochrane Central Register Database Collaboration, JSTOR Archive Library of Western, LISTA with Full Text Library Information and scientific and technical databases, Ovid platform medical electronic journals. Finally choose the literature which score is more than 3 by the standard of Jadad to do the further research.
2. Clinical Research:
The 163 patients who met the inclusion criteria were randomly divided into acupuncture group of soothing the liver qi and regulating the spirit, superficial acupuncture group and non-acupoint superficial acupuncture group.
For acupuncture group of soothing the liver qi and regulating the spirit,we used LR3 (bilateral), LI14 (bilateral), DU20, EX-HN3. For LR3 and LI14, the needle should be inserted with the depth of 10-12mm, four points needed to be inserted up and down and the manipulation of twist and turn until the qi was attained with the method of regulating qi. Then DU20 and EX-HN3 were inserted with the depth of 4-5mm, both taking even twisting, the total needle retention time was 30 minutes. Then do the direct moxa cone moxibustion on BL15 (bilateral) and BL18 (bilateral). When the cone burned closeto its 2/3 part and the patients had a sense of warm or mild burning pain, remove the remaining moxa cone, each point done the moxibustion of 5 mins. Last, buried intradermal needle on BL15 (bilateral), BL18(bilateral). Pierce the needle within the skin with the depth of 5mm horizontally with with the direcition from the lateral, leaving the needle handle outside the skin. Then paste the handle with medical tape, after a retention of 2 days, remove the intradermal needle.
For superficial acupuncture group, the points of acupuncture, moxibustion and buried intradermal needle were the same with the previous group, but LR3, LI14, DU20 and EX-HN3 would be inserted with depth of 2-3mm, and the sensation of qi was not required. When the cone burned closeto its 1/3, remove the remaining moxa cone. Intradermal needle would be buried with the depth of 1-2mm.
For Superficial acupuncture group of non-acupoint acupuncture, the operation of aucuncture, moxibustion, buried intradermal needle are the same with that of superficial acupuncture group, but the acupoints would be 10mm from the radial side of LI14(bilateral),10mm from the lateral side of LR3 (bilateral),10mm from the left side of DU20,10mm from the left side of EX-HN3, for moxibustion the acupoints would be 10mm from the lateral side of BL17(bilateral),10mm from the lateral side of BL19(bilateral), for intradermal needle, the acupoints would be 10mm from the lateral side of BL15(bilateral) and BL18(bilateral), for the lateral (double), gall Yu lateral 10mm (double); buried intradermal needle selection of points outside the Xinshu 10mm (double), liver Yu lateral 10mm (double).
Three groups' treatments are arranged as 2 times per week, and the time between every two treatments must be more than 48 hours, totally 12 weeks. To evaluate at 4 different time points:before the treatment, at the end of treatment, one month after the treatment, three months after the treatment with the Hamilton Depression Rating Scale (HAMD), SF-36 Quality of Life Scale, Symptom rating scale (SCL-90) and syndromes of depression. To use descriptive analysis,rank sum test and other statistical methods to compare clinical efficacy and quality of life improvements among the acupuncture group of soothing the liver qi and regulating the spirit, superficial acupuncture group and superficial acupuncture group of non-acupoint acupuncture.
Results:
1. Literature Evaluation
(1) Trend analysis of the amount of the literature of acupuncture treatment for depression
There are 2920 related literature of treating depression, among which there are 249 articles about acupuncture treatment during 22 years which are from 1989 to 2010, accounting for 8.53%, there are 86 RCT literature of acupuncture treating depression, which account for 34.54%, most of which (163, accounting for 65.46%) are non-randomized controlled literature.There are relatively fewer literature of clinical treatment published between 1989-1999, after 2002, research on depression is rising, but there are relatively few randomized, controlled documents, research quality is not high. (2) systematic review of literature
By using search strategy and literature screening methods, we can retrieve 283 randomized controlled documents published in official academic journals, including 248 Chinese literature and 35 English literature. To grade with the Jadad scale score after reading the title, abstract, full text and screen out 26 high-quality randomized controlled clinical literature with score of≥3 points, in which there are 20 Chinese literature and 6 English literature.
26 high-quality literature which contain 2269 patients were included into 15 trials, all using HAMD points rate reduction to calculate the efficacy rate, in which HAMD reduction rate is regarded as effective when it≥50% and <75%. Use fixed effect model, combined OR=2.25,95% CI of (1.66, 3.05), the value of combined effects of the test statistic Z=5.25, the efficacy rate difference between treatment group and control group was significant (P<0.01), we can consider that the efficacy of treatment group is better than that of control group.
16 studies were included for HAMD score, heterogeneity test (P<0.01) suggested that two groups are heterogeneous, therefore a random effects model would be used. WMD=-1.92,95% CI of (-3.27,-0.58), the difference between treatment group and control group was significant (P<0.01), the efficacy of treatment group is better than that of control group.
We also do the fixed effect model analysis and the results is the same with the random effects model, we can consider that the results have relatively high stability.
7 were included for SDS score. Use random effect model, WMD=-8.20,95% CI is (-11.24, -5.16), the difference of SDS scores between the two groups is statistically significant (P<0.01), therefore the efficacy of the treatment group is better than the control group.
4 were included for BDI score. Use random effect model, WMD=-1.15,95% CI is (-7.05,4.74), the difference of SDS score between the two groups is no significant (P>0.05), therefore the efficacy of the two groups are the same.
2. Clinical Research
(1) baseline information
The difference in terms of age, height, weight, disease duration, sex, educational level, occupation, whether living habits are regular, whether western medicine was taken and whether acupuncture treatment has been among 3 groups is no significant (P>0.05), so there is comparability; in the aspects of health care, family history and whether psychological treatment was received, because theoretical number is less than 5, after using fisher precise probability method, the difference was not statistically significant (P>0.05). And, the difference of scores of HAMD scale, SF-36 Quality of Life Scale, SCL-90 symptom scale and TCM syndrome rating scale among the three groups of depressed patients before treatment was not statistically significant (P>0.05), baseline level can be considered the same among the three groups.
(2) Total effective rate
Compare the total effective rate of the treatment group and superficial acupuncture group with that of non-acupoint superficial acupuncture group at 3 time points:after treatment,1 month after treatment,3 months after treatment, the difference was significant (P<0.01). At the time points of after treatment and 1 month after treatment, compare the efficacy rate of treatment group (93.62%) with that of the superficial acupuncture group (89.58%), the difference was not statistically significant (P> 0.05), prompting the effect of two groups are the same after treatment and 1 month after treatment; 3 months after treatment, compare the efficacy rate of treatment group (87.23%) with that of superficial acupuncture group (79.17%), the difference was statistically significant (P<0.01).
(3) HAMD scale
Compare the HAMD scores at each time point of the 3 groups with that of before the treatment, we found that the previous ones were higher than that of before treatment, the differences were statistically significant (P<0.05), prompted the three groups had improvement after treatment. We can see from the analysis of the HAMD score at each time point that the difference between the treatment group and superficial acupuncture group was not significant (P>0.05); The differences between treatment group and superficial non-acupoint acupuncture group were statistically significant, the differences between superficial acupuncture group and superficial non-acupoint acupuncture group were statistically significant (P<0.05).
In the evaluation of the the HAMD scale, the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit and the superficial acupuncture group are better than the superficial acupuncture group of non-acupoint, and the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit is the best.
(4) SF-36 scale
Compare the scores of the treatment group and superficial acupuncture group with that of non-acupoint superficial acupuncture group at 3 time points:after treatment,1 month after treatment,3 months after treatment, eight dimensions of quality of life in the SF-36 scale scores are all higher that that of before the treatment, the difference was significant (P<0.05). Compare the scores of the treatment group with that of superficial acupuncture group and non-acupoint superficial acupuncture group at 3 different time points, which are after the treatment, after 1 month after the treatment,3 months after treatment, the difference was significant (P<0.0125); compare the 8 dimension scores of superficial acupuncture group with that of non-acupoint superficial acupuncture group after the treatment, the differences were statistically significant (P<0.0125); Compare the SF-36 scores of superficial acupuncture group with that of non-acupoint superficial acupuncture group 1 month after treatment and 3 months after treatment, difference was not statistically significance, (Z=1.51, P=0.13), the differences other dimension scores were statistically significant (P<0.0125).
In the evaluation of the the SF-36 scale, the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit are better than the superficial acupuncture group and the superficial acupuncture group of non-acupoint in 8 aspects of the SF-36 scale.
(5) SCL-90 scale
In the evaluation of the the SCL-90 scale, the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit are better than the superficial acupuncture group of non-acupoint in 8 aspects of the SCL-90 scale, and they are better than the superficial acupuncture group in 3 aspects of the SCL-90 scale.
(6) Syndrome Rating Scale
In the evaluation of the Syndrome Rating Scale, the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit and the superficial acupuncture group are better than the superficial acupuncture group of non-acupoint, and the efficacy of the acupuncture group of soothing the liver qi and regulating the spirit is the best.
Conclusions:
1.The literature review found that the majority of literature report of acupuncture treatment of depression had low quality. Therefore we advocate the adoption of internationally recognized standards of CONSORT statement and STRICTA to do the standardized report of RCT research of acupuncture. After doing the systematic reviews of the 26 high-quality literature, we consider that the efficacy of acupuncture treatment for depression may be better than or equal to drugs and with fewer adverse reactions.
2. The acupuncture method of soothing liver qi and regulating the spirit is an academic idea with "treat with the liver qi, regulating qi first"as a core, combine the acupuncture, direct moxibustion with moxa cone and buried intradermal needle, this study shows that the treatment group can effectively improve the score of HAMD scale and SF-36 scale. In terms of short and long term efficacy and extent of the role, the treatment group is better than superficial acupuncture group and non-acupoint superficial acupuncture group, it is effective and safe in improving depression and quality of life of patients which has a good application and promotion prospects.
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