针刺治疗慢性功能性便秘疗效的系统评价
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摘要
研究目的
通过使用循证医学的方法系统评价针刺治疗慢性功能性便秘的有效性及安全性。资料与方法
以便秘,大便难,秘结,针刺,电针,火针,温针,梅花针,头针,耳针,芒针,穴位注射,皮内针等为检索词。检索Cochrane Library、PubMed、Embase,中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、中国科技期刊全文数据库(VIP)、中国博士学位论文全文数据库、中国优秀硕士学位论文全文数据库、中国重要会议论文全文数据库等。纳入所有关于针刺治疗慢性功能性便秘,观察对象符合现有的任何慢性便秘诊断标准(罗马Ⅱ、罗马Ⅲ,中华医学会外科分会便秘标准,中药新药临床研究指导原则,中医内科学等),病程至少2个月的成人慢性功能性便秘的临床随机对照试验。以治疗前后每周自主排便次数差值、总有效率、结肠传输功能变化等为主要结局指标,治疗前后便秘评分量表(Cleveland Clinic Score, CCS)差值、症状积分差值、生活质量评分差值、焦虑、抑郁量表差值等为次要结局指标,并统计不良事件指标。由2位研究者根据纳入标准,单独进行临床试验文献的阅读,鉴定和选择,独立进行数据提取并填写数据提取表,试验的真实性和文献未提及或表达有歧义的数据通过与作者联系获得。完成后2位研究者独立进行方法学质量评价,全部评价完成后交叉核对评价结果,遇到任何不一致的评价结果都要通过讨论达到意见一致,如有分歧则通过第三者协助解决。使用Cochrane协作网提供的RevMan5.1统计软件。对纳入的临床试验首先进行异质性检验,检验水准α=0.1,再据I2值估计异质性程度决定是否对临床研究进行Meta分析及亚组分析。分类变量采用相对危险度(Relative Risk, RR)表示,数值变量则用标准化均数差(Standardized Mean Difference, SMD)表示,二者均给出95%可信区间(confidence intervals, CI)。各组的Meta分析均采用随机效应模型计算。若文献数量充分(该组纳入分析的文献数≥10),则采用漏斗图分析其潜在的发表偏倚。若亚组分析后仍存在明显的异质性,经多次检查数据录入等方面未发现异质性原因,则进行敏感性分析：排除掉异质性较大的低质量研究后,重新进行Meta分析并探讨结果的可靠性。
结果
通过严格的筛选,最终纳入15篇符合标准的随机对照试验,文献报道全部为中文,共涉及纳入对象1256例。Meta分析结果显示,针刺治疗慢性功能性便秘有效率及一周自主排便次数改善程度不亚于口服药物疗法,优于安慰针疗法；对于改善结肠运转试验,针刺疗法疗效与口服药物疗法相当,高于安慰针疗法；对于改善便秘评分量表(CCS)总分的近、远期疗效,针刺疗法与口服药物疗法相当,其中腹部腧穴深刺疗效优于浅刺及一般深度针刺；对于改善症状积分,针刺疗法的近远期疗效优于安慰针疗法；针刺治疗慢性功能性便秘未发现明显不良事件。
结论
针刺治疗慢性功能性便秘是安全的,其各方面疗效均不亚于口服药物疗法,针刺疗法的疗效与安全范围内的针刺深度具有相关性,与电针频率的高低无明显关系。但本系统评价所得结论仍需要更多高质量的随机对照试验来进一步证实。
Objective
This study was mainly designed to evaluate the efficacy and safety of acupuncture for chronic functional constipation by the use of systematic review.
Methods
Keywords such as constipation, acupuncture, electroacupuncture, fire needling, warm needling, pyonex, scalp acupuncture, auricular acupuncture, elongated needle, point injecting, intradermal needling were used to search for the clinical trials in several databases, including Cochrane Library, PubMed, Embase, CNKI, CBM, VIP, etc. Randomized controlled trials, of which the adult patients met the diagnosis criteria of chronic functional constipation, such as Rome Ⅲ, Rome Ⅱ, etc., and the disease courses were longer than2months, were included in the study. The primary outcome was the change from baseline in the number of weekly complete spontaneous bowel movements (CSBMs), colonic transit test (CTT) and total effective rate. The secondary outcome was the difference of Cleveland Clinic Score (CCS), symptom scores, health related quality of life score, etc. The adverse events were also analyzed. Researches were read, identified, selected by2researchers according to the inclusion criteria. The data were extracted and evaluated independently. The authenticity and the unclear data were connected with the authors of the research literature. The different results were discussed and judged by the third-party. Meta-analysis was done by the use of RevMan5.1software. The included clinical trials took heterogeneity test first (α=0.1). It was decided to use Meta-analysis or subgroup-analysis according to the I2value. Categorical variables were shown by Relative Risk (RR). Continuous variable were shown by Standardized Mean Difference (SMD). Both variables were given95%Confidence Intervals (95%CI. Meta-analysis was calculated by random effects models. Funnel plot was used to analyze publication bias if the included trials were enough (≥10).
Results
After strict screening,15randomized controlled trials were included, containing1256participants. All of the trials were performed in China. Meta-analysis indicated that acupuncture for chronic functional constipation was as effective as drug therapy and more effective than placebo acupuncture in total effective rate and the change of weekly complete spontaneous bowel movements (CSBMs). For the colonic transit test (CTT), the efficacy of acupuncture was the same as drug therapy and better than placebo acupuncture. For the change of Cleveland Clinic Score (CCS), the efficacy of acupuncture was the same as drug therapy and the deep acupuncture was better than normal depth acupuncture and shallow acupuncture in abdominal region. Acupuncture improving symptom scores was better than placebo acupuncture. There was no obvious adverse event of acupuncture for chronic functional constipation.
Conclusion
Acupuncture for chronic functional constipation was safe. Its efficacy in several aspects was the same as drug therapy. The efficacy of acupuncture for constipation had a positive correlation with the depth of acupuncture in abdominal region (within the security range). The efficacy of electroacupuncture for constipation had no relationship with the current frequency. However, further large scale randomized controlled trials should be required to prove the efficacy of acupuncture of chronic functional acupuncture.
通过使用循证医学的方法系统评价针刺治疗慢性功能性便秘的有效性及安全性。资料与方法
以便秘,大便难,秘结,针刺,电针,火针,温针,梅花针,头针,耳针,芒针,穴位注射,皮内针等为检索词。检索Cochrane Library、PubMed、Embase,中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、中国科技期刊全文数据库(VIP)、中国博士学位论文全文数据库、中国优秀硕士学位论文全文数据库、中国重要会议论文全文数据库等。纳入所有关于针刺治疗慢性功能性便秘,观察对象符合现有的任何慢性便秘诊断标准(罗马Ⅱ、罗马Ⅲ,中华医学会外科分会便秘标准,中药新药临床研究指导原则,中医内科学等),病程至少2个月的成人慢性功能性便秘的临床随机对照试验。以治疗前后每周自主排便次数差值、总有效率、结肠传输功能变化等为主要结局指标,治疗前后便秘评分量表(Cleveland Clinic Score, CCS)差值、症状积分差值、生活质量评分差值、焦虑、抑郁量表差值等为次要结局指标,并统计不良事件指标。由2位研究者根据纳入标准,单独进行临床试验文献的阅读,鉴定和选择,独立进行数据提取并填写数据提取表,试验的真实性和文献未提及或表达有歧义的数据通过与作者联系获得。完成后2位研究者独立进行方法学质量评价,全部评价完成后交叉核对评价结果,遇到任何不一致的评价结果都要通过讨论达到意见一致,如有分歧则通过第三者协助解决。使用Cochrane协作网提供的RevMan5.1统计软件。对纳入的临床试验首先进行异质性检验,检验水准α=0.1,再据I2值估计异质性程度决定是否对临床研究进行Meta分析及亚组分析。分类变量采用相对危险度(Relative Risk, RR)表示,数值变量则用标准化均数差(Standardized Mean Difference, SMD)表示,二者均给出95%可信区间(confidence intervals, CI)。各组的Meta分析均采用随机效应模型计算。若文献数量充分(该组纳入分析的文献数≥10),则采用漏斗图分析其潜在的发表偏倚。若亚组分析后仍存在明显的异质性,经多次检查数据录入等方面未发现异质性原因,则进行敏感性分析：排除掉异质性较大的低质量研究后,重新进行Meta分析并探讨结果的可靠性。
结果
通过严格的筛选,最终纳入15篇符合标准的随机对照试验,文献报道全部为中文,共涉及纳入对象1256例。Meta分析结果显示,针刺治疗慢性功能性便秘有效率及一周自主排便次数改善程度不亚于口服药物疗法,优于安慰针疗法；对于改善结肠运转试验,针刺疗法疗效与口服药物疗法相当,高于安慰针疗法；对于改善便秘评分量表(CCS)总分的近、远期疗效,针刺疗法与口服药物疗法相当,其中腹部腧穴深刺疗效优于浅刺及一般深度针刺；对于改善症状积分,针刺疗法的近远期疗效优于安慰针疗法；针刺治疗慢性功能性便秘未发现明显不良事件。
结论
针刺治疗慢性功能性便秘是安全的,其各方面疗效均不亚于口服药物疗法,针刺疗法的疗效与安全范围内的针刺深度具有相关性,与电针频率的高低无明显关系。但本系统评价所得结论仍需要更多高质量的随机对照试验来进一步证实。
Objective
This study was mainly designed to evaluate the efficacy and safety of acupuncture for chronic functional constipation by the use of systematic review.
Methods
Keywords such as constipation, acupuncture, electroacupuncture, fire needling, warm needling, pyonex, scalp acupuncture, auricular acupuncture, elongated needle, point injecting, intradermal needling were used to search for the clinical trials in several databases, including Cochrane Library, PubMed, Embase, CNKI, CBM, VIP, etc. Randomized controlled trials, of which the adult patients met the diagnosis criteria of chronic functional constipation, such as Rome Ⅲ, Rome Ⅱ, etc., and the disease courses were longer than2months, were included in the study. The primary outcome was the change from baseline in the number of weekly complete spontaneous bowel movements (CSBMs), colonic transit test (CTT) and total effective rate. The secondary outcome was the difference of Cleveland Clinic Score (CCS), symptom scores, health related quality of life score, etc. The adverse events were also analyzed. Researches were read, identified, selected by2researchers according to the inclusion criteria. The data were extracted and evaluated independently. The authenticity and the unclear data were connected with the authors of the research literature. The different results were discussed and judged by the third-party. Meta-analysis was done by the use of RevMan5.1software. The included clinical trials took heterogeneity test first (α=0.1). It was decided to use Meta-analysis or subgroup-analysis according to the I2value. Categorical variables were shown by Relative Risk (RR). Continuous variable were shown by Standardized Mean Difference (SMD). Both variables were given95%Confidence Intervals (95%CI. Meta-analysis was calculated by random effects models. Funnel plot was used to analyze publication bias if the included trials were enough (≥10).
Results
After strict screening,15randomized controlled trials were included, containing1256participants. All of the trials were performed in China. Meta-analysis indicated that acupuncture for chronic functional constipation was as effective as drug therapy and more effective than placebo acupuncture in total effective rate and the change of weekly complete spontaneous bowel movements (CSBMs). For the colonic transit test (CTT), the efficacy of acupuncture was the same as drug therapy and better than placebo acupuncture. For the change of Cleveland Clinic Score (CCS), the efficacy of acupuncture was the same as drug therapy and the deep acupuncture was better than normal depth acupuncture and shallow acupuncture in abdominal region. Acupuncture improving symptom scores was better than placebo acupuncture. There was no obvious adverse event of acupuncture for chronic functional constipation.
Conclusion
Acupuncture for chronic functional constipation was safe. Its efficacy in several aspects was the same as drug therapy. The efficacy of acupuncture for constipation had a positive correlation with the depth of acupuncture in abdominal region (within the security range). The efficacy of electroacupuncture for constipation had no relationship with the current frequency. However, further large scale randomized controlled trials should be required to prove the efficacy of acupuncture of chronic functional acupuncture.
引文
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