Objective To evaluate the efficacy of fire-needle therapy for acne to provide an objective basis for clinical decisions.Method Pub Med,Chinese Biomedical Medicine disc（CBM）,Chinese National knowledge infrastructure（CNKI）,and Wanfang database were searched to include eligible randomized controlled trails.Bias risk was assessed and data were extracted.Meta-analysis was performed and as was subgroup analysis.Results Thirty-three RCTs involving 3362 patients were included.Most of them had a high risk or unclear risk of bias regarding allocation concealment,incomplete outcome data and selective reporting.Compared with control groups,meta-analysis revealed that fireneedle therapy had an overall higher total effectiveness rate（RR=1.19,95% CI：1.16–1.22,P0.000 01）.Subgroup analysis showed fire-needle therapy was associated with an increased total effective rate（RR=1.20,95%CI：1.14–1.28,P0.000 01）,when compared against drug therapy.Fire-Needle therapy was associated with an increased total effective rate（RR=1.18,95%CI：1.12–1.24,P0.000 01）,when fire-needle plus other TCM therapy was compared against other therapy.fire-needle therapy was associated with an increased total effective rate（RR=1.18,95%CI：1.13–1.24,P0.000 01）,when fire-needle plus Chinese herb therapy was compared against Chinese herb therapy alone.fireneedle therapy was associated with an increased total effective rate（RR=1.28,95%CI：1.18–1.39,P0.000 01）,when compared fire-needle plus Western drug therapy against western drug therapy alone.Adverse events were not reported in most articles.Conclusion Our study showed that fire-needle appears to be an effective therapy for treating acne,but the evidence is currently insufficient due to the poor quality of the studies.The safety of fire-needle therapy is also uncertain due to the small sample size and the lack of reporting in included articles.Larger sample,higher quality studies are needed.
