Efficacy and Safety of Deep Needling in the Treatment of Severe Functional Constipation：A Blind Randomized Controlled Trial

ZHANG Hong; FU Lixin

doi:10.13288/j.11-2166/r.2023.03.009

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Efficacy and Safety of Deep Needling in the Treatment of Severe Functional Constipation：A Blind Randomized Controlled Trial

更新时间：2023-01-29

- Efficacy and Safety of Deep Needling in the Treatment of Severe Functional Constipation：A Blind Randomized Controlled Trial
- Journal of Traditional Chinese Medicine Vol. 64, Issue 3, Pages: 260-268(2023)
- 作者机构：
  
  1.天津市海河医院，天津市津南区津沽路890号，300350
  2.天津中医药大学第一附属医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2023.03.009
  CLC：
- Received：02 January 2022，
  
  Revised：2022-11-19，
  
  Published：02 February 2023
- 稿件说明：
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张虹,傅立新.电针深刺治疗严重功能性便秘有效性及安全性评价——随机对照盲法试验[J].中医杂志,2023,64(03):260-268.

ZHANG Hong,FU Lixin.Efficacy and Safety of Deep Needling in the Treatment of Severe Functional Constipation：A Blind Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2023,64(03):260-268.
张虹,傅立新.电针深刺治疗严重功能性便秘有效性及安全性评价——随机对照盲法试验[J].中医杂志,2023,64(03):260-268. DOI： 10.13288/j.11-2166/r.2023.03.009.

ZHANG Hong,FU Lixin.Efficacy and Safety of Deep Needling in the Treatment of Severe Functional Constipation：A Blind Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2023,64(03):260-268. DOI： 10.13288/j.11-2166/r.2023.03.009.

摘要

目的

评价电针治疗严重功能性便秘（SFC）的有效性与安全性。

方法

将70例SFC患者随机分为电针组和假电针组各35例。电针组予电针深刺双侧天枢、腹结及上巨虚，假电针组予假电针浅刺双侧天枢旁、腹结旁及浅刺上巨虚旁，两组均每日治疗1次，前两周每周连续治疗5次，休息2天，后六周每周3次，隔日治疗1次，连续8周，共治疗28次。基线期2周内、治疗期8周内，患者每日自行记录当天24 h内的排便状况，包括每次完全自主排便（CSBM）次数，每次自主排便（SBM）次数，每次大便的布里斯托大便性状（BSFS）评分，每次排便时的困难程度评分，随访12周记录完全自主排便（CSBM）次数。以治疗期与基线期和随访期与基线期平均周CSBM次数差值，以及治疗期与基线期的平均周SBM评分差值为主要疗效指标，以治疗期与基线期的平均周BSFS评分差值、治疗期与基线期的平均周排便困难程度评分差值、治疗第4周末期与基线期末和治疗第8周末期与基线期末的便秘生存质量量表（PAC-QOL）评分差值、治疗期和随访期的通便药/其他辅助排便措施使用次数为次要疗效指标。记录两组严重不良事件和不良反应的发生情况，评价患者对电针方案的接受度。

结果

最终电针组34例、假电针组33例纳入统计分析。电针组治疗期和随访期平均周CSBM次数均较基线期显著增加（

＜0.01），假电针组差异无统计学意义（

＞0.05），电针组治疗期与基线期的平均周CSBM差值和随访期与基线期间平均周CSBM差值均显著高于假电针组（

＜0.01）；电针组治疗期平均周SBM次数均较基线期显著改善（

＜0.01），假电针组平均周SBM次数亦较基线期增加（

＜0.05），电针组治疗期与基线期平均周SBM次数差值优于假电针组（

＜0.01）。电针组治疗期平均周BSFS评分、平均周排便困难程度评分、PAC-QOL评分均较基线期有明显改善（

＜0.01），假电针组仅治疗第4周末PAC-QOL评分较基线期有改善（

＜0.05）；电针组治疗期与基线期的平均周BSFS评分差值、平均周排便困难程度评分差值、PAC-QOL评分差值均显著高于假电针组（

＜0.01）；治疗期和随访期内，电针组通便药物及措施使用次数均明显少于假电针组（

＜0.01）。患者对电针方案的接受度主要集中在可以接受（31.3%）和易于接受（31.3%）。两组在研究期间均未发生严重不良事件。电针组共出现7例不良反应，与电针治疗的相关性均为可能有关。除脱落病例外，其余不良反应均未影响继续治疗，无后遗症。假电针组未发现不良反应。经Bang's index盲化评价，结果提示电针组盲法失败，假电针组盲法成功。

结论

电针深刺双侧天枢、腹结及针刺上巨虚对SFC有效，能明显改善患者的临床排便症状，提高生存质量，并具有后治疗效应，且临床应用安全性良好，容易被患者接受。

Abstract

Objective

To evaluate the efficacy and safety of electroacupuncture for severe functional constipation （SFC）.

Methods

Seventy SFC participants were randomly assigned into electroacupuncture （EA） group and the sham electroacupuncture（SEA） group， each with 35 cases. The EA group received the true-electroacupuncture with deep needling at bilateral Tianshu （ST 25）， Fujie （SP 14） and Shangjuxu （ST 37）， while the SEA group received light skin penetration at the corresponding sham acupoints with sham-electroacupuncture.The course was 8 weeks with a total of 28 treatments，i.e. once a day， 5 times per week with 2 days' rest in the first two weeks， and once every other day， 3 times per week in the last six weeks. The study had the baseline period for 2 weeks， the treatment period for 8 weeks， and the follow-up period for 12 weeks. All participants recorded their daily defecation status within 24 hours every day， including the number of completely spontaneous bowel movements （CSBM）， the number of spontaneous bowel movements （SBM）， the Bristol Stool Form score （BSFS） of each stool， difficulty score of each defecation was recorded， as well as the number of completely voluntary defecation （CSBM） during the 12-week follow-up period. The primary outcome measures were the mean weekly CSBM difference between the treatment and baseline period， and the mean weekly SBM difference between the treatment and baseline period. The secondary outcome measures included the mean weekly BSFS score difference between the treatment and baseline period， the mean weekly defecation difficulty score difference between the treatment and baseline period， the PAC-QOL score difference between the end of the 4-week treatment and the end of the baseline period， as well as that between the end of 8-week treatment and end of baseline period， and also， the frequency of laxatives or other auxiliary defecation aids during the treatment and follow-up period. Meanwhile， the occurrence of serious adverse events or adverse reactions in both groups， the acceptance of electroacupuncture options were recorded.

Results

Finally， 34 cases in EA group and 33 cases in SEA group were included in statistical analysis. The mean weekly CSBM of the EA group in the treatment and follow-up period both significantly higher than that in baseline period （

＜0.01）， while the SEA group had no significant change （

＞0.05）. The mean weekly CSBM difference between the treatment and baseline period and between the follow up and baseline period were significantly higher in the EA group than in the SEA group （

＜0.01）. The mean weekly SBMs of the EA group in the treatment period significantly increased compared to the baseline period （

＜0.01）， while that in the SEA group also increased （

＜0.05）. The mean weekly SBM difference between the treatment and baseline period were significantly higher in the EA group than in the SEA group （

＜0.01）. The mean weekly BSFS score， the mean weekly defecation difficulty scores and PAC-QOL scores in EA group were significantly improved （

＜0.01） in the treatment period， while only the PAC-QOL score at the end of the 4-week treatment was improved in the SEA group （

＜0.05）. The difference of the mean weekly BSFS score， the mean weekly defecation difficulty score and the PAC-QOL score between the treatment and baseline period were significantly higher in the EA group than in the SEA group （

＜ 0.01）. During the treatment and follow-up period， the frequency of laxatives or other auxiliary defecation aids in the EA group was significantly lower than in the SEA group（

＜0.01）. The acceptability of electroacupuncture was mainly in “acceptable” （31.3%） and “easily accepted” （31.3%）. There was no serious adverse events occurred in either group， but 7 adverse reactions in the EA group may be related to electroacupuncture. Except the cases of detachment， the other adverse reactions didn't affect the continued treatment， and no sequelae happened. No adverse reactions were found in SEA group. According to the Bang's BI， the blinding of the EA group failed， but succeeded in SEA group.

Conclusion

Electroacupuncture with deep needling at bilateral Tianshu （ST 25）， Fujie （SP 14） and Shangjuxu （ST 37） is effective for SFC， by significantly improving the clinical symptoms of defecation， increasing the quality of life， and having a post-treatment effect. Meanwihle， the treatment options can be accepted easily by patients with high safety in clinical application.

关键词

Keywords

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