Clinical Efficacy and Safety of Miniscalpel-Needle Treatment for Tension-Type Headache: A Systematic Review and Meta-Analysis

Objective: To investigate the clinical efficacy and safety of miniscalpel-needle (MSN) treatment for tension-type headache (TTH). Method: 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). Results: 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. Conclusions: 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.