A Systematic Review and Meta-analysis of Randomized Clinical Trials of Fire Needle Combined with ALA-PDT for the Treatment of Moderate-to- Severe Acne.

BACKGROUND: Moderate-to-severe acne affects people's health and quality of life. As first-line therapeutic medications, isotretinoin and antibiotics was used to treat moderate-to-severe acne.However,some patient does not tolerate pills. Thus, It is important to improve therapeutic tools for those people. Now, there are more and more clinical studies on the treatment of moderate-to-severe acne treated by the combination of fire needle and ALA-PDT, which provides us with a new idea for the treatment of moderate-to-severe acne. It is necessary to assess the clinical evidence supporting the use of fire needle combined with ALA-PDT in the treatment of moderate to severe acne in order to offer a foundation for clinical practice.This study evaluated the safety and effectiveness in the treatment of moderate-to-severe acne by the combination with fire needle and ALA-PDT.

METHODS: By July 2022, search PubMed, the Chinese Biomedical Literature Databas, the Cochrane Library, the Chinese Scientific Journal Database, the China National Knowledge Infrastructure, the Web of Science Datebase, Embase Datebase,VIP Database and WanFang Database. To gather RCTs of fire needle combination with ALA-PDT for the treatment of moderate-to-severe acne. A meta-analysis was performed according to the Handbook guidelines of Cochrane. Study selection, data extraction, and risk of bias evaluation were all governed by two reviewers, with the help of a third reviewer if needed. The meta-analysis was carried out with Review Manager Software 5.4.

RESULTS: There were a total of 9 RCTs with 862 participants. Clinical efficacy was recorded in nine trials, GAGS score was published in three studies, adverse events were documented in five studies, and recurrence rate was reported in two studies. Treatment lasted between four and twelve weeks. Combination therapy outperformed monotherapy in terms of clinical efficacy (OR:3.73; 95% CI:2.51, 5.53; p<0.00001). Additional subgroup analysis revealed that the combination therapy outperformed ALA-PDT alone in terms of clinical effect (OR: 3.20; 95% CI: 2.05, 4.99; p<0.00001). Additionally, combination therapy outperformed fire needle alone in terms of clinical efficacy (OR:3.74; 95% CI: 2.55, 5.48; p<0.00001). Studies have also indicated that combination therapy has a stronger benefit in lowering the GAGS score (MD:-3.35; 95% CI:-4.62, -2.09; p<0.00001). Additionally, there was no discernible difference in the occurrence of adverse events between the combined treatments and monotherapy (OR:1.43; 95% CI: 0.76, 2.69; p=0.26), and the combined treatment was able to control the recurrence rate (OR:0.18; 95% CI: 0.07, 0.45; P=0.0002).

CONCLUSIONS: The efficacy of fire needle combined with ALA-PDT in the treatment of moderate-to-severe acne is superior to that of ALA-PDT or fire needle alone. However, the conclusions of this study must be interpreted carefully due to the high risk and ambiguity of bias of the included trials.