Systematic Evaluation and Trial Sequential Analysis of Therapeutic Effect of Needle Knife <italic>Versus</italic> Acupuncture on Cervical Spondylosis of Cervical Type

Abstract

<bold>Objective</bold> To systematically evaluate the effectiveness and safety of needle-knife in the treatment of cervical spondylosis of cervical type. <bold>Methods</bold> The VIP databases, Wanfang Data, CNKI, PubMed, and the Cochrane Library database were searched from inception to June 30, 2021. The clinical randomized controlled trials (RCTs) of needle-knife versus acupuncture (combined with other treatments) in the treatment of cervical spondylosis were included. The primary outcome measures were total effective rate and recovery rate, and the secondary outcome measures were visual analogue scale(VAS) score and numerical pain rating scale (NPRS) score after treatment. RevMan 5.1 software was used for data analysis, enumeration data was reported by relative odds ratio (OR) and 95% confidence interval (CI), while continuous data was described by the mean difference (MD) and 95% <italic>CI</italic>. If the included studies were heterogeneous (<italic>I</italic>²&gt;50%, <italic>P</italic>&lt;0.1), the random-effects model was used; if the included studies were homogeneous (<italic>I</italic>²≤50%, <italic>P</italic>≥0.1), the fixed effects model was used. TSA V 0.9 software was used for trial sequential analysis. <bold>Results</bold> A total of 10 RCTs were included with 750 cases. Meta-analysis results showed that the total effective rate of the experimental group was higher than that of the control group [<italic>OR</italic>=4.01，95% <italic>CI</italic>（2.57，6.25）, <italic>P</italic>&lt;0.001], and the TSA results showed that the cumulative <italic>Z</italic> value passed through the traditional boundary value and TSA boundary value, which indicated that the total sample size had reached the sample size required for Meta-analysis. Compared with the control group, the cure rate of the experiment group was higher [<italic>OR</italic>=2.64, 95% <italic>CI</italic> (1.92,3.64), <italic>P</italic>&lt;0.001], the VAS score was lower [<italic>MD</italic>= -1.15, 95% <italic>CI</italic> (-2.03, -0.28), <italic>P</italic>=0.009], and the NPRS score was lower [<italic>MD</italic>= -3.22, 95% <italic>CI</italic> (-3.71, -2.73), <italic>P</italic>&lt;0.001]. There was no significant difference in the incidence of adverse reactions between the two groups (<italic>P</italic>&gt;0.05). <bold>Conclusion</bold> Compared with acupuncture therapy, needle-knife therapy has definite curative effect and safety in the treatment of cervical spondylosis of cervical type, which is recommended for clinical application. However, due to the low quality of the included studies and small sample size, it is necessary to carry out large-sample, multi-center clinical randomized controlled studies to further verify the clinical efficacy of needle knife in the treatment of cervical spondylosis.