Kwon Chan-Young, Yoon Sang-Hoon, Chung Sun-Yong, Kim Jong Woo
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, 02447, Republic of Korea.
Chung-Yeon Central Institute, Gwang-ju, Republic of Korea.
Chin J Integr Med. 2020 Sep;26(9):713-720. doi: 10.1007/s11655-020-3179-3. Epub 2020 Mar 13.
To investigate the clinical efficacy and safety of miniscalpel-needle (MSN) treatment for tension-type headache (TTH).
Seven medical databases were searched to identify randomized controlled trials (RCTs) evaluating the effect and safety of MSN treatment. All articles published up to November 15, 2018 were retrieved. A meta-analysis was conducted for the included studies, and the risk of bias was assessed. Primary outcomes were visual analogue scale (VAS) or numeric rating scale (NRS) score. Secondary outcomes were clinical effective rates including total effective rate (TER), markedly effective rate (MER), and totally cured rate (TCR) determined by improvement in clinical symptoms or VAS scores, the frequency of adverse events (AEs) that occurred during the study, and participant quality of life (QOL).
Seven RCTs involving 724 participants were included. MSN treatment showed significantly higher MER and TCR [relative risk (RR) 1.27, 95% confidence interval (CI) 1.01 to 1.61; RR 1.31, 95% CI 1.09 to 1.57, respectively], but not TER (RR 1.03, 95% CI 0.96 to 1.10) compared to acupuncture. MSN treatment plus conventional treatment showed significant lower VAS and higher TER, MER, and TCR (mean difference -3.54, 95% CI -3.80 to -3.28; RR 1.14, 95% CI 1.06 to 1.23; RR 2.31, 95% CI 1.50 to 3.58; RR 3.01, 95% CI 2.25 to 4.02, respectively) compared to conventional treatment.
According to current evidence, MSN treatment as a monotherapy or as an adjunctive treatment to other existing treatments might have benefits on treating TTH. However, since the number and the sample size of studies included were both small and the methodological quality was poor, the findings of this review should be interpreted with great caution, and our confidence in the results is low. A high quality RCT using objective outcomes should be performed on this topic.
探讨小针刀治疗紧张型头痛（TTH）的临床疗效及安全性。
检索七个医学数据库，以识别评估小针刀治疗效果和安全性的随机对照试验（RCT）。检索截至2018年11月15日发表的所有文章。对纳入研究进行荟萃分析，并评估偏倚风险。主要结局指标为视觉模拟评分法（VAS）或数字评定量表（NRS）评分。次要结局指标为临床有效率，包括根据临床症状改善或VAS评分确定的总有效率（TER）、显效率（MER）和治愈率（TCR），研究期间发生的不良事件（AE）频率，以及参与者的生活质量（QOL）。
纳入7项RCT，共724名参与者。与针灸相比，小针刀治疗的显效率和治愈率显著更高[相对危险度（RR）分别为1.27，95%置信区间（CI）为1.01至1.61；RR为1.31，95%CI为从1.09至1.57]，但总有效率无显著差异（RR为1.03，95%CI为0.96至1.10）。与传统治疗相比，小针刀联合传统治疗的VAS显著更低，总有效率、显效率和治愈率更高（平均差值为-3.54，95%CI为-3.80至-3.28；RR为1.14，95%CI为1.06至1.23；RR为2.31，95%CI为1.50至3.58；RR为3.01，95%CI为2.25至4.02）。
根据现有证据，小针刀作为单一疗法或作为其他现有治疗的辅助治疗可能对治疗紧张型头痛有益。然而，由于纳入研究的数量和样本量均较小，且方法学质量较差，本综述的结果应谨慎解读，我们对结果的信心较低。应针对该主题开展使用客观结局指标的高质量随机对照试验。
