手法治疗腰椎间盘突出症
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摘要
手法治疗腰椎间盘突出症——基于文献的疗效评价和临床试验研究
腰椎间盘突出症(Lumbar disc herniation, LDH),是骨科的常见病、多发病,是腰腿痛最常见的原因,给患者带来很大的痛苦,如工作能力、学习能力、生活质量下降,甚至失能残疾。临床上对于非手术指征的LDH患者使用的保守方法种类丰富,传统中医又有着独到见解和办法,如手法推拿、内服中药方剂、外用中药膏剂、针灸等,都已成为被医生、患者接受的好办法。但中医办法的众多,也给规范化治疗带来了一定的弊端。应用现代医学的科研手段,客观评价中医药治疗LDH方案,挖掘出一套规范的、有效的、经济的、安全的中医药治疗方案,对于本病规范化诊疗体系的建立、基层的推广应用,以至于中医骨伤学科标准的建立具有一定的意义。
本论文遵循循证医学的思想,从文献学的角度,应用系统评价的方法,系统整理、分析近十年国内中医药治疗LDH的随机对照试验文献,挖掘出一套规范、可信、实效的手法治疗LDH的方案。再通过流行病学调查问卷的形式,对国内专科医生进行该方案的问卷论证,以获得专业人士的认可和意见。最后将得到的优化的诊疗方案再运用于临床实践,通过多中心、大样本、随机对照试验进行进一步有效性和安全性的临床验证,以获得有中医特色和明确疗效的中医诊疗方案,并向基层推广应用。
第一部分文献学研究
一、近十年中医药治疗腰椎间盘突出症的随机对照试验文献质量评价
1研究方法
广泛收集、整理国内十年来中医药治疗腰椎间盘突出症的随机对照试验文献,评价文献质量,为进一步深入挖掘中医药治疗该病的规范化研究做好准备。
2研究结果
纳入2000年～2009年6月中医药治疗LDH的RCT文献共392篇。文献的发表年代近五年有递增的趋势。有近半数的RCT文献发表于单核或者双核期刊,仅8%的研究提到有基金支持。大部分的研究没有提及随机化的方法。平均样本量为170人。约1/3的文献提及了本研究的纳入标准或排除标准,约1/4的文献交代了组间基线的可比性。剔除病例和脱落病例的报道、安全性的观察情况、不良反应发生和处理情况的报道还很少。
有1/3的随机对照研究文献没有交代诊断标准的来源,半数的诊断标准来源于论著或者是中医药国家标准/行业标准。被参考次数最多是《中医病证诊断疗效标准》,被联合参考最多次数的是《中医病证诊断疗效标准》和胡有谷《腰椎间盘突出症》。
中医药治疗腰椎间盘突出症的疗程大多集中在1周～4周,手法治疗的疗程集中在3周。
有近2/3的研究根据症状体征的改善情况,使用了“优、良、中、差”、“治愈、显效、有效、未愈”、“治愈、好转、无效”等四级或三级指标来评判疗效；有约1/5的文献使用了视觉模拟评分法(VAS)、各种量表的方法进行疗效的评定；还有少部分研究使用了更为客观的指标,如镇痛起效时间、下肢体感诱发电位、神经体液因子改变情况来判断疗效。
对于疗效评定标准,有1/3的文献没有交代具体出处；有近六成的研究中的疗效标准出自一本论著或国家／行业标准。被参考次数最多是《中医病证诊断疗效标准》,被联合参考最多次数的是《中医病证诊断疗效标准》和JOA。
有1/10的研究报道了随访情况,随访时间最多的是6个月。
卫生经济学指标是文献中较少提及的部分。
二、近十年手法治疗腰椎间盘突出症的随机对照治疗性文献的Meta分析
1研究方法
全面收集、分析近十年以中医手法为主要干预措施治疗LDH的RCT文献,对手法与其他保守治疗方法相比较的疗效进行Meta分析,从高质量文献的角度评价中医手法治疗该病的有效性。
2结果
2.1单纯手法组与牵引组治疗比较的Meta分析
提示单纯手法治疗腰椎间盘突出症比单纯牵引治疗更加有效。
2.2单纯手法组与中药组治疗比较的Meta分析
提示单纯手法治疗腰椎间盘突出症的疗效并不优于单纯中药治疗。
2.3单纯手法组与针灸组治疗比较的Meta分析
提示单纯手法治疗腰椎间盘突出症的疗效并不优于单纯针灸治疗。
2.4特色手法组与传统手法组治疗比较的Meta分析
提示特色手法治疗腰椎间盘突出症的疗效优于传统手法治疗。
2.5手法+中药综合组与单纯中药治疗比较的Meta分析
提示手法+中药综合治疗腰椎间盘突出症的疗效优于单纯中药治疗。
2.6手法+针灸综合组与单纯针灸治疗比较的Meta分析
提示手法+针灸综合治疗腰椎间盘突出症的疗效优于单纯针灸治疗。
3结论
依据文献的Meta分析结果,显示单纯手法治疗腰椎间盘突出症比单纯牵引治疗更有效；特色手法治疗比传统手法更有效,文献中提及的特色手法主要有：斜扳法、旋转法和整脊法；单纯手法治疗的疗效并不优于单纯中药治疗,但手法与中药综合治疗的疗效优于单纯中药治疗；单纯手法治疗的疗效并不优于单纯针灸治疗,但手法与针灸综合治疗优于单纯针灸治疗。但也值得注意,依据“漏斗图”显示,各项Meta分析的结果均存在一定的“发表偏倚”。
第二部分临床流行病学研究
中医药保守治疗腰椎间盘突出症的现况调查
1研究方法
基于文献研究和专家经验,通过调查问卷的形式,对国内常用的中医药保守治疗LDH的方法进行调查,对名老中医治疗LDH的规范手法的接受程度进行调查,为制定安全、有效、经济、适用的中医药保守治疗腰椎间盘突出症方案提供参考信息。
2结果
本次调查结果显示揉捻法、按压法和滚法是最常使用的理筋手法(放松手法)；侧卧位斜扳法、扳腿推腰法和扳肩推腰法是最常使用的治疗手法。具备高级职称的被调查者选择以上手法的比例也明显高于中级职称者和初级职称者。绝大多数被调查者认可手法的安全性。年龄越大、职称越高、学历越高的被调查者更接受我们给出的LDH规范手法的治疗方案。
第三部分临床试验研究
腰椎规范手法治疗腰椎间盘突出症的多中心、临床随机对照试验研究
1研究方法
采用多中心、随机对照试验方法,2008年12月30日—2009年12月21日期间选择符合本研究入选标准的门诊LDH患者176例,分试验组(规范手法组)和对照组(牵引组),进行治疗期内及随访期内的疗效观察。最终169例患者完成3周疗程期内的观察,其中有143名患者完成了6周的随访。
2结果
2.1治疗期结束两组疗效比较
试验组总有效率为91.76%,对照组为86.90%。差异有统计学意义,说明试验组有效人数多于对照组。
2.2随访期结束两组复发率比较
试验组复发率为6.85%,对照组为12.86%。差异无统计学意义,尚不能说明试验组复发率少于对照组。
2.3两组的JOA评分改善率比较
治疗、随访结束时两组的JOA评分差异分别都有统计学意义,说明治疗结束、随访结束时试验组JOA评分均优于对照组。
2.4两组在各时点疗效变化趋势
在各个观察时点,两组“控制”、“显效”、“无效/复发”人数差别没有统计学意义,“有效”人数差别有统计学意义(P=0.026),说明治疗组各时点“有效”人数优于对照组。
2.5两组在治疗期和随访期各疗效指标的改善情况组间比较
两组治疗一周各疗效指标的改善情况无统计学意义。
治疗两周后的JOA评分/直腿抬高试验角度变化与治疗一周后的差值均无统计学意义,RMD评分/VAS评分与一周后的差值有统计学意义,说明试验组治疗两周后的RMD评分/VAS评分优于对照组。
治疗三周后的RMD评分/直腿抬高试验角度变化与治疗两周后的差值均无统计学意义,JOA评分/VAS评分与两周后的差值有统计学意义,说明试验组治疗三周后的RMD评分/VAS评分优于对照组。
两组随访期的的四项指标与治疗结束后的差值均有统计学意义,说明试验组随访期四项指标的变化优于对照组。
3结论
3.1腰椎规范手法与骨盆牵引治疗相比较,前者是一种安全、优效的治疗方法,在改善腰椎间盘突出症患者腰腿痛症状、体征和日常生活能力方面有显著的疗效,总有效率为91.76%,统计学检验显示明显优于牵引疗法。
3.2随访期的复发情况统计显示,腰椎规范手法治疗组的复发人数少于骨盆牵引治疗组,但是从统计学角度并不能说明两组间的复发率有差异。
3.3通过对治疗期三个等分时点和随访期的疗效变化趋势显示,腰椎规范手法治疗控制、显效的人数多于骨盆牵引组,复发人数少于骨盆牵引组。说明腰椎规范手法在疗程的每个阶段的疗效均优于牵引疗法,疗效较稳定,控制性较好,同时也说明腰椎规范手法比骨盆牵引治疗能够更快更有效地改善腰椎间盘突出症患者腰腿痛症状、体征和日常生活能力。
3.4通过疼痛量表、生活量表、功能改善情况定量评价等多种疗效评价手段综合应用,可以看出在研究的全程这些疗效指标的变化情况不尽相同。RMD和VAS是变化较灵敏的指标,在治疗的第二周已经有统计学差异,但VAS的变化比RMD更为稳定；JOA涉及了日常生活的评价内容,在治疗第三周开始有了明显的变化,稳定保持到随访期；直腿抬高角度是变化最为缓慢的指标,在治疗期间并不能显示出变化的差异性,但是在随访期变化有统计学意义。说明了JOA、RMD、VAS三种常用于评价腰椎间盘突出症疗效的量化指标,在治疗期间和随访期间的评价可信度基本一致,而直腿抬高角度的测量可以作为随访阶段的评价指标。
English Abstract
Manipulation treatment for lumbar disc herniation-Evaluation of the effect based on literature research and clinical trials
Lumbar disc herniation (Lumbar disc herniation, LDH), is a common disease, is the most common cause of low back pain. The disease has brought great suffering to patients and lead to his working ability, learning ability, decreased quality of life, and even disability. Clinical indications for non-surgical patients with LDH wide variety of conservative methods, traditional Chinese medicine also has unique perspectives and approaches, such as massage, taking herbs and prescription, topical creams traditional Chinese medicine, acupuncture, etc., have become a doctor, patients received a good way. However, many Chinese medicine approach, but also to bring some standardization of the drawbacks of the treatment. Application of scientific methods of modern medicine, Chinese medicine treatment of LDH objective evaluation of the program, tap a set of standardized, effective, economical and safe treatment in Chinese medicine for the treatment of this disease system, the establishment of standardized grass-roots promotion applications to The Chinese bone-setting academic standards for the establishment of a certain significance.
This thesis follows the thinking of evidence-based medicine, from the perspective of philology, application evaluation methods, systems, analyze the past ten years Traditional Chinese Medicine in Treatment of randomized control trials of LDH, digging out a set of standardized, credible and effective LDH manual therapy program. And through epidemiological survey in the form of domestic specialists to carry out the demonstration program questionnaire to obtain professional recognition and advice. Finally, the optimization of the treatment program be re-used in clinical practice, through a multi-center, large sample, randomized controlled trials of efficacy and safety of further clinical validation, to obtain a clear effect of Chinese character and Chinese medicine treatment options, and to promote the use of grass-roots level.
PartⅠResearch Literature
A. Chinese medicine in recent years the treatment of lumbar disc herniation
Quality Assessment of Randomized Controlled Trials
1 Research Methods
Extensive collection, collation, analysis years of Chinese medicine treatment of lumbar disc herniation randomized control trials, quality assessment, in order to further tap the standardization of Chinese medicine treatment of the disease to prepare.
2 results
2.1 The situation of literature selected
Included in the 2000 to 2009, six months medical treatment of lumbar disc herniation randomized control trials of 392.
2.2 The general literature
Documents released last five years there is increasing trend. Nearly half of the literature on randomized controlled single-core or dual-core journals, only 8% of the studies mentioned Fund. Most of the studies did not mention the method of randomization, only two documents can be hidden random program. Taking into account the practices of Chinese medicine such as acupuncture, etc. in the special treatment, is mostly blind outcome measurements and statistical analysis based blind. Sample size estimation problem is that these documents exist in the absence of uniform, judging from the distribution of sample size, the average sample size was 170. About 1/3 of literature referred to the study exclusion criteria included standards or conditions, about 1/4 of the document explained the baseline comparability between groups. Excluding cases and loss of cases reported observation on the safety conditions, adverse reaction reports and deal with the situation, little.
1/3 of the randomized controlled literature does not explain the source of diagnostic criteria, half of the diagnostic criteria derived from the theory of Chinese medicine with or national standards/industry standards. The single most frequently referenced book/standards promulgated by the State Administration of Traditional Chinese Medicine "TCM Lung Cancer"; is the most co-reference is issued by the State Administration of Traditional Chinese Medicine "TCM Lung Cancer," and Hu Gu "lumbar disc herniation."
Reported in the literature of Chinese medicine treatment of lumbar disc herniation mainly concentrated in the 1 week to 4 weeks.
Nearly 2/3 of the improvement in symptoms and signs according to the use of "excellent, good, and poor," "cured, markedly effective, effective, not cured," "cured, improved, invalid" and 4 or 3 indicators to judge its efficacy; about 1/5 of the literature using a visual analogue scale (VAS), a variety of scales assessed efficacy of the method; are few studies using more objective indicators, such as the analgesic effect onset time, under the somatosensory evoked potentials, nerve humoral factors to determine the effect of changes in circumstances.
For the evaluation standard,1/3 of the literature does not explain the specific source; have around sixty percent of the study of the efficacy of standard or from one of the country/industry standards. Most of the or by reference to national/industry standards promulgated by the State Administration of Traditional Chinese Medicine "TCM Lung Cancer." Most are co-referenced standards are promulgated by the State Administration of Traditional Chinese Medicine "TCM Lung Cancer" and the JOA.
1/10 studies reported follow-up cases were followed up from 2 months to 3 years, and most were used in follow-up time is 6 months, followed by 1 year, again in three months.
Health Economics indicators are rarely mentioned in the literature section.
B. Practices in recent years treatment of lumbar disc herniation in the treatment of Meta-analysis of literature
1 Research Methods
Comprehensive collection, analysis methods of Chinese medicine in recent years as the main interventions for lumbar disc herniation randomized controlled trial, on the other conservative treatment methods and compared the efficacy of Meta-analysis to high-quality literature from the perspective of Chinese medicine practice evaluation effectiveness of treatment of the disease.
2 Results
2.1 simply means the treatment group compared with the traction group Meta-Analysis
Suggest a simple approach for lumbar disc herniation is more effective than simple traction.
2.2 simply means the treatment group compared with the Chinese group Meta-Analysis
Suggest a simple approach for lumbar disc herniation is not better than traditional Chinese medicine.
2.3 simply means the treatment group compared with the acupuncture group Meta-Analysis
Suggest a simple approach for lumbar disc herniation is not better than acupuncture.
2.4 characteristics and traditional practices group practices Group Meta-analysis of comparative therapy
Suggest features used in lumbar disc herniation treated better than the traditional approach.
2.5 Integrated approach with traditional Chinese medicine treatment group compared with the simple Meta-Analysis of Traditional Chinese Medicine
Tips integrated approach with traditional Chinese medicine treatment of lumbar disc herniation was better than traditional Chinese medicine.
2.6 Integrated approach+acupuncture group compared with the simple Meta-analysis of acupuncture
Tips practices+Acupuncture and the treatment of lumbar disc herniation was better than acupuncture.
3 Conclusion
Meta-analysis according to the literature, show that a simple approach for lumbar disc herniation is more effective than simple traction; characteristics of manual therapy more effective than traditional methods, the characteristics mentioned in the literature methods are:oblique pulling, rotation, and chiropractic France; simple effect of manual therapy is not better than traditional Chinese medicine, but traditional Chinese medicine techniques and the efficacy of combined therapy better than traditional Chinese medicine; simple method of treatment efficacy is not better than acupuncture, but way better than the combined treatment with acupuncture simple acupuncture. But also noteworthy, according to "funnel plot" shows the results of the Meta analysis have certain "publication bias."
PartⅡClinical Epidemiology
Chinese Medicine Conservative Treatment of Lumbar Disc Herniation Current Status
1 Research Methods
Based on literature research and expert experience, through the questionnaire in the form of Chinese medicine on the municipal common conservative treatment of lumbar disc herniation method to investigate practices of the characteristics of famous traditional Chinese treatment of the disease to investigate the degree of acceptance for the development of safe, effective, economic, and applicable Chinese medicine program of conservative treatment of lumbar disc herniation to provide reference information.
2 Results
The survey results show that rolling method, compression method and the rolling method is most commonly used tendon technique (relaxation techniques), lateral position oblique pulling, pulling legs, waist and pull push push back shoulder is the most commonly used method treatment practices. Have senior professional titles of the respondents choose these types of practices was significantly higher than the proportion of intermediate grade and junior professional titles. Awareness of safety practices for the vast majority of respondents recognized at a reasonable standard to use under way, Chinese medicine treatment methods are safe. The older title of higher education the higher of the respondents given more to accept our standard practices of lumbar disc herniation treatment programs, and more willing to participate in training to master the law, is willing to promote the use of the law.
PartⅢClinical trials
Treatment of lumbar disc herniation standard manipulation of multi-center, randomized controlled trial
1 Research Methods
A multicenter, randomized controlled trial, in the period of December 30,2008-December 21,2009 chosen for this study, the patient inclusion criteria 176 patients with lumbar disc herniation were divided into experimental group (standard manipulation group) and control group (traction therapy group) for three weeks during treatment and follow-up period Cancer. Final 169 patients completed 3 weeks of observation during the course of treatment, of which 143 patients completed 6 weeks of follow-up.
2 Results
2.1 The two groups efficacy Comparison in the end of the treatment
The test group the total effective rate was 91.76%, control group was 86.90% effective. Theχ2 test between two groups was statistically significant, indicating the number of test group effective than the control group.
2.2 The end of follow-up period compared two groups of recurrence
The test group the recurrence rate was 6.85%, the recurrence rate was 12.86% in control group. Recurrence by theχ2 test groups showed no significant difference, yet the recurrence rate can not explain the experimental group than the control group.
2.3 Comparison of JOA score improvement rate in both groups
Treatment, follow-up JOA score at the end of the two groups were both statistically significant difference, indicating the end of treatment, follow-up JOA score at the end of the test group were better than the control group.
2.4 The effect of two trends in the various time points
In each observation point, two groups of "control", "markedly", "Invalid / recurrence" no significant difference between the number of "effective" number of statistically significant difference (P=0.026), explain the treatment group de facto " effective "number than the control group.
2.5 The efficacy between two groups in the treatment period and follow-up indicators of improvement
Clinical indicators of two groups each week, no significant improvement in the situation.
Treatment after two weeks of the JOA score / straight leg raising test angle and the week after treatment, no significant difference, RMD score/VAS score and the week after there was significant difference between the shows two weeks of the treatment group RMD after the score/VAS score than the control group.
Treatment after three weeks RMD rating/straight leg raising test angle and two weeks after treatment no significant difference, JOA score/VAS score and two weeks later there was significant difference, indicating the treatment group After three weeks RMD rating/VAS score than the control group.
Two follow-up period of the four indicators and the end of treatment showed significant difference, indicating the test group of four indicators of change in follow-up than the control group.
3 Conclusion
3.1 Compared with pelvic traction the lumbar standard manipulation is a safe, effective treatment superior in improving symptoms of lumbar disc herniation in patients with lowback pain, signs and activities of daily living have a significant effect, the total effective rate 91.76%, statistical tests show the effective rate superior traction therapy.
3.2 Follow-up period of recurrence statistics, standard lumbar manual therapy group than the number of recurrent pelvic traction group, but from a statistical point of view can not explain the relapse rate between the two groups are different.
3.3 On the treatment of the three other time-points and follow-up period of efficacy trends show that standard lumbar manual therapy control, markedly effective rate more than the number of pelvic traction group, recurrence is less than the number of pelvic traction group. Standard approach in the treatment of lumbar description of each phase of the superior efficacy of traction therapy, efficacy of a more stable, better controlled, but also shows pelvic traction than the standard approach to faster and more effectively improve the patients with lumbar disc herniation low back pain symptoms, signs and activities of daily living.
3.4 Through the pain scale, life scale, function improvement Clinical evaluation of quantitative evaluation of various means of integrated applications, can be seen throughout the study the changes in these outcome measures differ. RMD and the VAS is more sensitive indicators of change, in the second week of treatment have been significantly different, but the change in VAS is more stable than the RMD; JOA involved in the evaluation of daily life, the contents of the third week of treatment has been changed, and stability to keep the follow-up period; straight leg raising angle is the most slowly changing the target, during treatment and can not show changes in the difference However, changes in the follow-up period was statistically significant.This shows that the JOA, RMD, VAS of three commonly used in the evaluation of lumbar disc herniation of the quantitative targets for treatment and follow-up evaluation of the credibility of the period is consistent, and straight leg raising angle measurement can be used as follow-up phase of the evaluation indicators.
腰椎间盘突出症(Lumbar disc herniation, LDH),是骨科的常见病、多发病,是腰腿痛最常见的原因,给患者带来很大的痛苦,如工作能力、学习能力、生活质量下降,甚至失能残疾。临床上对于非手术指征的LDH患者使用的保守方法种类丰富,传统中医又有着独到见解和办法,如手法推拿、内服中药方剂、外用中药膏剂、针灸等,都已成为被医生、患者接受的好办法。但中医办法的众多,也给规范化治疗带来了一定的弊端。应用现代医学的科研手段,客观评价中医药治疗LDH方案,挖掘出一套规范的、有效的、经济的、安全的中医药治疗方案,对于本病规范化诊疗体系的建立、基层的推广应用,以至于中医骨伤学科标准的建立具有一定的意义。
本论文遵循循证医学的思想,从文献学的角度,应用系统评价的方法,系统整理、分析近十年国内中医药治疗LDH的随机对照试验文献,挖掘出一套规范、可信、实效的手法治疗LDH的方案。再通过流行病学调查问卷的形式,对国内专科医生进行该方案的问卷论证,以获得专业人士的认可和意见。最后将得到的优化的诊疗方案再运用于临床实践,通过多中心、大样本、随机对照试验进行进一步有效性和安全性的临床验证,以获得有中医特色和明确疗效的中医诊疗方案,并向基层推广应用。
第一部分文献学研究
一、近十年中医药治疗腰椎间盘突出症的随机对照试验文献质量评价
1研究方法
广泛收集、整理国内十年来中医药治疗腰椎间盘突出症的随机对照试验文献,评价文献质量,为进一步深入挖掘中医药治疗该病的规范化研究做好准备。
2研究结果
纳入2000年～2009年6月中医药治疗LDH的RCT文献共392篇。文献的发表年代近五年有递增的趋势。有近半数的RCT文献发表于单核或者双核期刊,仅8%的研究提到有基金支持。大部分的研究没有提及随机化的方法。平均样本量为170人。约1/3的文献提及了本研究的纳入标准或排除标准,约1/4的文献交代了组间基线的可比性。剔除病例和脱落病例的报道、安全性的观察情况、不良反应发生和处理情况的报道还很少。
有1/3的随机对照研究文献没有交代诊断标准的来源,半数的诊断标准来源于论著或者是中医药国家标准/行业标准。被参考次数最多是《中医病证诊断疗效标准》,被联合参考最多次数的是《中医病证诊断疗效标准》和胡有谷《腰椎间盘突出症》。
中医药治疗腰椎间盘突出症的疗程大多集中在1周～4周,手法治疗的疗程集中在3周。
有近2/3的研究根据症状体征的改善情况,使用了“优、良、中、差”、“治愈、显效、有效、未愈”、“治愈、好转、无效”等四级或三级指标来评判疗效；有约1/5的文献使用了视觉模拟评分法(VAS)、各种量表的方法进行疗效的评定；还有少部分研究使用了更为客观的指标,如镇痛起效时间、下肢体感诱发电位、神经体液因子改变情况来判断疗效。
对于疗效评定标准,有1/3的文献没有交代具体出处；有近六成的研究中的疗效标准出自一本论著或国家／行业标准。被参考次数最多是《中医病证诊断疗效标准》,被联合参考最多次数的是《中医病证诊断疗效标准》和JOA。
有1/10的研究报道了随访情况,随访时间最多的是6个月。
卫生经济学指标是文献中较少提及的部分。
二、近十年手法治疗腰椎间盘突出症的随机对照治疗性文献的Meta分析
1研究方法
全面收集、分析近十年以中医手法为主要干预措施治疗LDH的RCT文献,对手法与其他保守治疗方法相比较的疗效进行Meta分析,从高质量文献的角度评价中医手法治疗该病的有效性。
2结果
2.1单纯手法组与牵引组治疗比较的Meta分析
提示单纯手法治疗腰椎间盘突出症比单纯牵引治疗更加有效。
2.2单纯手法组与中药组治疗比较的Meta分析
提示单纯手法治疗腰椎间盘突出症的疗效并不优于单纯中药治疗。
2.3单纯手法组与针灸组治疗比较的Meta分析
提示单纯手法治疗腰椎间盘突出症的疗效并不优于单纯针灸治疗。
2.4特色手法组与传统手法组治疗比较的Meta分析
提示特色手法治疗腰椎间盘突出症的疗效优于传统手法治疗。
2.5手法+中药综合组与单纯中药治疗比较的Meta分析
提示手法+中药综合治疗腰椎间盘突出症的疗效优于单纯中药治疗。
2.6手法+针灸综合组与单纯针灸治疗比较的Meta分析
提示手法+针灸综合治疗腰椎间盘突出症的疗效优于单纯针灸治疗。
3结论
依据文献的Meta分析结果,显示单纯手法治疗腰椎间盘突出症比单纯牵引治疗更有效；特色手法治疗比传统手法更有效,文献中提及的特色手法主要有：斜扳法、旋转法和整脊法；单纯手法治疗的疗效并不优于单纯中药治疗,但手法与中药综合治疗的疗效优于单纯中药治疗；单纯手法治疗的疗效并不优于单纯针灸治疗,但手法与针灸综合治疗优于单纯针灸治疗。但也值得注意,依据“漏斗图”显示,各项Meta分析的结果均存在一定的“发表偏倚”。
第二部分临床流行病学研究
中医药保守治疗腰椎间盘突出症的现况调查
1研究方法
基于文献研究和专家经验,通过调查问卷的形式,对国内常用的中医药保守治疗LDH的方法进行调查,对名老中医治疗LDH的规范手法的接受程度进行调查,为制定安全、有效、经济、适用的中医药保守治疗腰椎间盘突出症方案提供参考信息。
2结果
本次调查结果显示揉捻法、按压法和滚法是最常使用的理筋手法(放松手法)；侧卧位斜扳法、扳腿推腰法和扳肩推腰法是最常使用的治疗手法。具备高级职称的被调查者选择以上手法的比例也明显高于中级职称者和初级职称者。绝大多数被调查者认可手法的安全性。年龄越大、职称越高、学历越高的被调查者更接受我们给出的LDH规范手法的治疗方案。
第三部分临床试验研究
腰椎规范手法治疗腰椎间盘突出症的多中心、临床随机对照试验研究
1研究方法
采用多中心、随机对照试验方法,2008年12月30日—2009年12月21日期间选择符合本研究入选标准的门诊LDH患者176例,分试验组(规范手法组)和对照组(牵引组),进行治疗期内及随访期内的疗效观察。最终169例患者完成3周疗程期内的观察,其中有143名患者完成了6周的随访。
2结果
2.1治疗期结束两组疗效比较
试验组总有效率为91.76%,对照组为86.90%。差异有统计学意义,说明试验组有效人数多于对照组。
2.2随访期结束两组复发率比较
试验组复发率为6.85%,对照组为12.86%。差异无统计学意义,尚不能说明试验组复发率少于对照组。
2.3两组的JOA评分改善率比较
治疗、随访结束时两组的JOA评分差异分别都有统计学意义,说明治疗结束、随访结束时试验组JOA评分均优于对照组。
2.4两组在各时点疗效变化趋势
在各个观察时点,两组“控制”、“显效”、“无效/复发”人数差别没有统计学意义,“有效”人数差别有统计学意义(P=0.026),说明治疗组各时点“有效”人数优于对照组。
2.5两组在治疗期和随访期各疗效指标的改善情况组间比较
两组治疗一周各疗效指标的改善情况无统计学意义。
治疗两周后的JOA评分/直腿抬高试验角度变化与治疗一周后的差值均无统计学意义,RMD评分/VAS评分与一周后的差值有统计学意义,说明试验组治疗两周后的RMD评分/VAS评分优于对照组。
治疗三周后的RMD评分/直腿抬高试验角度变化与治疗两周后的差值均无统计学意义,JOA评分/VAS评分与两周后的差值有统计学意义,说明试验组治疗三周后的RMD评分/VAS评分优于对照组。
两组随访期的的四项指标与治疗结束后的差值均有统计学意义,说明试验组随访期四项指标的变化优于对照组。
3结论
3.1腰椎规范手法与骨盆牵引治疗相比较,前者是一种安全、优效的治疗方法,在改善腰椎间盘突出症患者腰腿痛症状、体征和日常生活能力方面有显著的疗效,总有效率为91.76%,统计学检验显示明显优于牵引疗法。
3.2随访期的复发情况统计显示,腰椎规范手法治疗组的复发人数少于骨盆牵引治疗组,但是从统计学角度并不能说明两组间的复发率有差异。
3.3通过对治疗期三个等分时点和随访期的疗效变化趋势显示,腰椎规范手法治疗控制、显效的人数多于骨盆牵引组,复发人数少于骨盆牵引组。说明腰椎规范手法在疗程的每个阶段的疗效均优于牵引疗法,疗效较稳定,控制性较好,同时也说明腰椎规范手法比骨盆牵引治疗能够更快更有效地改善腰椎间盘突出症患者腰腿痛症状、体征和日常生活能力。
3.4通过疼痛量表、生活量表、功能改善情况定量评价等多种疗效评价手段综合应用,可以看出在研究的全程这些疗效指标的变化情况不尽相同。RMD和VAS是变化较灵敏的指标,在治疗的第二周已经有统计学差异,但VAS的变化比RMD更为稳定；JOA涉及了日常生活的评价内容,在治疗第三周开始有了明显的变化,稳定保持到随访期；直腿抬高角度是变化最为缓慢的指标,在治疗期间并不能显示出变化的差异性,但是在随访期变化有统计学意义。说明了JOA、RMD、VAS三种常用于评价腰椎间盘突出症疗效的量化指标,在治疗期间和随访期间的评价可信度基本一致,而直腿抬高角度的测量可以作为随访阶段的评价指标。
English Abstract
Manipulation treatment for lumbar disc herniation-Evaluation of the effect based on literature research and clinical trials
Lumbar disc herniation (Lumbar disc herniation, LDH), is a common disease, is the most common cause of low back pain. The disease has brought great suffering to patients and lead to his working ability, learning ability, decreased quality of life, and even disability. Clinical indications for non-surgical patients with LDH wide variety of conservative methods, traditional Chinese medicine also has unique perspectives and approaches, such as massage, taking herbs and prescription, topical creams traditional Chinese medicine, acupuncture, etc., have become a doctor, patients received a good way. However, many Chinese medicine approach, but also to bring some standardization of the drawbacks of the treatment. Application of scientific methods of modern medicine, Chinese medicine treatment of LDH objective evaluation of the program, tap a set of standardized, effective, economical and safe treatment in Chinese medicine for the treatment of this disease system, the establishment of standardized grass-roots promotion applications to The Chinese bone-setting academic standards for the establishment of a certain significance.
This thesis follows the thinking of evidence-based medicine, from the perspective of philology, application evaluation methods, systems, analyze the past ten years Traditional Chinese Medicine in Treatment of randomized control trials of LDH, digging out a set of standardized, credible and effective LDH manual therapy program. And through epidemiological survey in the form of domestic specialists to carry out the demonstration program questionnaire to obtain professional recognition and advice. Finally, the optimization of the treatment program be re-used in clinical practice, through a multi-center, large sample, randomized controlled trials of efficacy and safety of further clinical validation, to obtain a clear effect of Chinese character and Chinese medicine treatment options, and to promote the use of grass-roots level.
PartⅠResearch Literature
A. Chinese medicine in recent years the treatment of lumbar disc herniation
Quality Assessment of Randomized Controlled Trials
1 Research Methods
Extensive collection, collation, analysis years of Chinese medicine treatment of lumbar disc herniation randomized control trials, quality assessment, in order to further tap the standardization of Chinese medicine treatment of the disease to prepare.
2 results
2.1 The situation of literature selected
Included in the 2000 to 2009, six months medical treatment of lumbar disc herniation randomized control trials of 392.
2.2 The general literature
Documents released last five years there is increasing trend. Nearly half of the literature on randomized controlled single-core or dual-core journals, only 8% of the studies mentioned Fund. Most of the studies did not mention the method of randomization, only two documents can be hidden random program. Taking into account the practices of Chinese medicine such as acupuncture, etc. in the special treatment, is mostly blind outcome measurements and statistical analysis based blind. Sample size estimation problem is that these documents exist in the absence of uniform, judging from the distribution of sample size, the average sample size was 170. About 1/3 of literature referred to the study exclusion criteria included standards or conditions, about 1/4 of the document explained the baseline comparability between groups. Excluding cases and loss of cases reported observation on the safety conditions, adverse reaction reports and deal with the situation, little.
1/3 of the randomized controlled literature does not explain the source of diagnostic criteria, half of the diagnostic criteria derived from the theory of Chinese medicine with or national standards/industry standards. The single most frequently referenced book/standards promulgated by the State Administration of Traditional Chinese Medicine "TCM Lung Cancer"; is the most co-reference is issued by the State Administration of Traditional Chinese Medicine "TCM Lung Cancer," and Hu Gu "lumbar disc herniation."
Reported in the literature of Chinese medicine treatment of lumbar disc herniation mainly concentrated in the 1 week to 4 weeks.
Nearly 2/3 of the improvement in symptoms and signs according to the use of "excellent, good, and poor," "cured, markedly effective, effective, not cured," "cured, improved, invalid" and 4 or 3 indicators to judge its efficacy; about 1/5 of the literature using a visual analogue scale (VAS), a variety of scales assessed efficacy of the method; are few studies using more objective indicators, such as the analgesic effect onset time, under the somatosensory evoked potentials, nerve humoral factors to determine the effect of changes in circumstances.
For the evaluation standard,1/3 of the literature does not explain the specific source; have around sixty percent of the study of the efficacy of standard or from one of the country/industry standards. Most of the or by reference to national/industry standards promulgated by the State Administration of Traditional Chinese Medicine "TCM Lung Cancer." Most are co-referenced standards are promulgated by the State Administration of Traditional Chinese Medicine "TCM Lung Cancer" and the JOA.
1/10 studies reported follow-up cases were followed up from 2 months to 3 years, and most were used in follow-up time is 6 months, followed by 1 year, again in three months.
Health Economics indicators are rarely mentioned in the literature section.
B. Practices in recent years treatment of lumbar disc herniation in the treatment of Meta-analysis of literature
1 Research Methods
Comprehensive collection, analysis methods of Chinese medicine in recent years as the main interventions for lumbar disc herniation randomized controlled trial, on the other conservative treatment methods and compared the efficacy of Meta-analysis to high-quality literature from the perspective of Chinese medicine practice evaluation effectiveness of treatment of the disease.
2 Results
2.1 simply means the treatment group compared with the traction group Meta-Analysis
Suggest a simple approach for lumbar disc herniation is more effective than simple traction.
2.2 simply means the treatment group compared with the Chinese group Meta-Analysis
Suggest a simple approach for lumbar disc herniation is not better than traditional Chinese medicine.
2.3 simply means the treatment group compared with the acupuncture group Meta-Analysis
Suggest a simple approach for lumbar disc herniation is not better than acupuncture.
2.4 characteristics and traditional practices group practices Group Meta-analysis of comparative therapy
Suggest features used in lumbar disc herniation treated better than the traditional approach.
2.5 Integrated approach with traditional Chinese medicine treatment group compared with the simple Meta-Analysis of Traditional Chinese Medicine
Tips integrated approach with traditional Chinese medicine treatment of lumbar disc herniation was better than traditional Chinese medicine.
2.6 Integrated approach+acupuncture group compared with the simple Meta-analysis of acupuncture
Tips practices+Acupuncture and the treatment of lumbar disc herniation was better than acupuncture.
3 Conclusion
Meta-analysis according to the literature, show that a simple approach for lumbar disc herniation is more effective than simple traction; characteristics of manual therapy more effective than traditional methods, the characteristics mentioned in the literature methods are:oblique pulling, rotation, and chiropractic France; simple effect of manual therapy is not better than traditional Chinese medicine, but traditional Chinese medicine techniques and the efficacy of combined therapy better than traditional Chinese medicine; simple method of treatment efficacy is not better than acupuncture, but way better than the combined treatment with acupuncture simple acupuncture. But also noteworthy, according to "funnel plot" shows the results of the Meta analysis have certain "publication bias."
PartⅡClinical Epidemiology
Chinese Medicine Conservative Treatment of Lumbar Disc Herniation Current Status
1 Research Methods
Based on literature research and expert experience, through the questionnaire in the form of Chinese medicine on the municipal common conservative treatment of lumbar disc herniation method to investigate practices of the characteristics of famous traditional Chinese treatment of the disease to investigate the degree of acceptance for the development of safe, effective, economic, and applicable Chinese medicine program of conservative treatment of lumbar disc herniation to provide reference information.
2 Results
The survey results show that rolling method, compression method and the rolling method is most commonly used tendon technique (relaxation techniques), lateral position oblique pulling, pulling legs, waist and pull push push back shoulder is the most commonly used method treatment practices. Have senior professional titles of the respondents choose these types of practices was significantly higher than the proportion of intermediate grade and junior professional titles. Awareness of safety practices for the vast majority of respondents recognized at a reasonable standard to use under way, Chinese medicine treatment methods are safe. The older title of higher education the higher of the respondents given more to accept our standard practices of lumbar disc herniation treatment programs, and more willing to participate in training to master the law, is willing to promote the use of the law.
PartⅢClinical trials
Treatment of lumbar disc herniation standard manipulation of multi-center, randomized controlled trial
1 Research Methods
A multicenter, randomized controlled trial, in the period of December 30,2008-December 21,2009 chosen for this study, the patient inclusion criteria 176 patients with lumbar disc herniation were divided into experimental group (standard manipulation group) and control group (traction therapy group) for three weeks during treatment and follow-up period Cancer. Final 169 patients completed 3 weeks of observation during the course of treatment, of which 143 patients completed 6 weeks of follow-up.
2 Results
2.1 The two groups efficacy Comparison in the end of the treatment
The test group the total effective rate was 91.76%, control group was 86.90% effective. Theχ2 test between two groups was statistically significant, indicating the number of test group effective than the control group.
2.2 The end of follow-up period compared two groups of recurrence
The test group the recurrence rate was 6.85%, the recurrence rate was 12.86% in control group. Recurrence by theχ2 test groups showed no significant difference, yet the recurrence rate can not explain the experimental group than the control group.
2.3 Comparison of JOA score improvement rate in both groups
Treatment, follow-up JOA score at the end of the two groups were both statistically significant difference, indicating the end of treatment, follow-up JOA score at the end of the test group were better than the control group.
2.4 The effect of two trends in the various time points
In each observation point, two groups of "control", "markedly", "Invalid / recurrence" no significant difference between the number of "effective" number of statistically significant difference (P=0.026), explain the treatment group de facto " effective "number than the control group.
2.5 The efficacy between two groups in the treatment period and follow-up indicators of improvement
Clinical indicators of two groups each week, no significant improvement in the situation.
Treatment after two weeks of the JOA score / straight leg raising test angle and the week after treatment, no significant difference, RMD score/VAS score and the week after there was significant difference between the shows two weeks of the treatment group RMD after the score/VAS score than the control group.
Treatment after three weeks RMD rating/straight leg raising test angle and two weeks after treatment no significant difference, JOA score/VAS score and two weeks later there was significant difference, indicating the treatment group After three weeks RMD rating/VAS score than the control group.
Two follow-up period of the four indicators and the end of treatment showed significant difference, indicating the test group of four indicators of change in follow-up than the control group.
3 Conclusion
3.1 Compared with pelvic traction the lumbar standard manipulation is a safe, effective treatment superior in improving symptoms of lumbar disc herniation in patients with lowback pain, signs and activities of daily living have a significant effect, the total effective rate 91.76%, statistical tests show the effective rate superior traction therapy.
3.2 Follow-up period of recurrence statistics, standard lumbar manual therapy group than the number of recurrent pelvic traction group, but from a statistical point of view can not explain the relapse rate between the two groups are different.
3.3 On the treatment of the three other time-points and follow-up period of efficacy trends show that standard lumbar manual therapy control, markedly effective rate more than the number of pelvic traction group, recurrence is less than the number of pelvic traction group. Standard approach in the treatment of lumbar description of each phase of the superior efficacy of traction therapy, efficacy of a more stable, better controlled, but also shows pelvic traction than the standard approach to faster and more effectively improve the patients with lumbar disc herniation low back pain symptoms, signs and activities of daily living.
3.4 Through the pain scale, life scale, function improvement Clinical evaluation of quantitative evaluation of various means of integrated applications, can be seen throughout the study the changes in these outcome measures differ. RMD and the VAS is more sensitive indicators of change, in the second week of treatment have been significantly different, but the change in VAS is more stable than the RMD; JOA involved in the evaluation of daily life, the contents of the third week of treatment has been changed, and stability to keep the follow-up period; straight leg raising angle is the most slowly changing the target, during treatment and can not show changes in the difference However, changes in the follow-up period was statistically significant.This shows that the JOA, RMD, VAS of three commonly used in the evaluation of lumbar disc herniation of the quantitative targets for treatment and follow-up evaluation of the credibility of the period is consistent, and straight leg raising angle measurement can be used as follow-up phase of the evaluation indicators.
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