Abstract：
BACKGROUND: Vitiligo remains a challenging condition to treat. Fire needle therapy, a traditional Chinese medicine technique, has potential as an alternative therapeutic strategy. However, rigorous evidence on its efficacy is lacking.
OBJECTIVE: We aimed to evaluate the efficacy and safety of fire needle therapy, alone and combined with topical tacrolimus ointment, for non-segmental stable vitiligo.
METHODS: In this 6-month randomized self-controlled trial, 35 vitiligo patients were enrolled, providing three similar lesions each. Lesions were randomly allocated to receive fire needle monotherapy, 0.1% tacrolimus ointment monotherapy, or combined fire needle and tacrolimus ointment therapy. The main outcome was change in vitiligo surface area.
RESULTS: In total, 29 patients completed the 6-month follow-up. The combination therapy group showed significantly greater reductions in vitiligo surface area compared to monotherapy groups starting at months 4 and 5. By the end of the study, combination therapy resulted in remarkably higher repigmentation responses, with 89.7% of lesions showing at least mild (≥25%) repigmentation and 51.7% showing good (≥50%) repigmentation. This significantly exceeded the outcomes with topical tacrolimus ointment alone, which only achieved 6.9% mild response and 6.9% good response. Fire needle monotherapy also demonstrated steady repigmentation over time, with 69% of lesions attaining a mild response by month 6. Importantly, no major adverse events occurred.
CONCLUSIONS: This study provides promising preliminary evidence supporting the use of fire needle therapy, alone or in combination with topical tacrolimus ointment, for inducing repigmentation in non-segmental stable vitiligo. As a non-pharmacological approach, fire needle therapy warrants further study as an alternative vitiligo treatment.
OBJECTIVE: We aimed to evaluate the efficacy and safety of fire needle therapy, alone and combined with topical tacrolimus ointment, for non-segmental stable vitiligo.
METHODS: In this 6-month randomized self-controlled trial, 35 vitiligo patients were enrolled, providing three similar lesions each. Lesions were randomly allocated to receive fire needle monotherapy, 0.1% tacrolimus ointment monotherapy, or combined fire needle and tacrolimus ointment therapy. The main outcome was change in vitiligo surface area.
RESULTS: In total, 29 patients completed the 6-month follow-up. The combination therapy group showed significantly greater reductions in vitiligo surface area compared to monotherapy groups starting at months 4 and 5. By the end of the study, combination therapy resulted in remarkably higher repigmentation responses, with 89.7% of lesions showing at least mild (≥25%) repigmentation and 51.7% showing good (≥50%) repigmentation. This significantly exceeded the outcomes with topical tacrolimus ointment alone, which only achieved 6.9% mild response and 6.9% good response. Fire needle monotherapy also demonstrated steady repigmentation over time, with 69% of lesions attaining a mild response by month 6. Importantly, no major adverse events occurred.
CONCLUSIONS: This study provides promising preliminary evidence supporting the use of fire needle therapy, alone or in combination with topical tacrolimus ointment, for inducing repigmentation in non-segmental stable vitiligo. As a non-pharmacological approach, fire needle therapy warrants further study as an alternative vitiligo treatment.
摘要：
背景：白癜风仍然是一种具有挑战性的治疗条件。火针疗法,一种传统的中医技术，具有作为替代治疗策略的潜力。然而,缺乏关于其功效的严格证据。
目的：我们旨在评估火针疗法的疗效和安全性，单独和外用他克莫司软膏，非节段稳定型白癜风。
方法：在这项为期6个月的随机自我对照试验中，纳入35例白癜风患者，提供三个相似的病变。病变随机分配接受火针单一疗法，0.1%他克莫司软膏单一疗法，或联合火针和他克莫司软膏治疗。主要结果是白癜风表面积的变化。
结果：总计，29例患者完成了6个月的随访。在第4个月和第5个月开始，与单一治疗组相比，联合治疗组的白癜风表面积明显减少。在研究结束时,联合治疗导致明显更高的色素沉着反应，89.7％的病变显示至少轻度（≥25％）色素沉着，51.7％显示良好（≥50％）色素沉着。这显著超过了单独使用他克莫司软膏的结果，仅达到6.9%的轻度反应和6.9%的良好反应。火针单一疗法也显示出稳定的色素沉着随着时间的推移，到第6个月，69%的病变达到轻度反应。重要的是,无重大不良事件发生.
结论：这项研究提供了有希望的初步证据，支持使用火针疗法，单独或与他克莫司软膏外用组合，用于诱导非节段稳定性白癜风的色素沉着。作为一种非药理学方法，火针疗法作为白癜风的替代治疗值得进一步研究。
目的：我们旨在评估火针疗法的疗效和安全性，单独和外用他克莫司软膏，非节段稳定型白癜风。
方法：在这项为期6个月的随机自我对照试验中，纳入35例白癜风患者，提供三个相似的病变。病变随机分配接受火针单一疗法，0.1%他克莫司软膏单一疗法，或联合火针和他克莫司软膏治疗。主要结果是白癜风表面积的变化。
结果：总计，29例患者完成了6个月的随访。在第4个月和第5个月开始，与单一治疗组相比，联合治疗组的白癜风表面积明显减少。在研究结束时,联合治疗导致明显更高的色素沉着反应，89.7％的病变显示至少轻度（≥25％）色素沉着，51.7％显示良好（≥50％）色素沉着。这显著超过了单独使用他克莫司软膏的结果，仅达到6.9%的轻度反应和6.9%的良好反应。火针单一疗法也显示出稳定的色素沉着随着时间的推移，到第6个月，69%的病变达到轻度反应。重要的是,无重大不良事件发生.
结论：这项研究提供了有希望的初步证据，支持使用火针疗法，单独或与他克莫司软膏外用组合，用于诱导非节段稳定性白癜风的色素沉着。作为一种非药理学方法，火针疗法作为白癜风的替代治疗值得进一步研究。
