Objective

Aim of our study was to evaluate the therapeutic effect of laser treatment in vulvar lichen sclerosus, mainly the reduction of existing symptoms as itching, burning and pain. We asked about the different outcome by using different application doses.

Study design

We conducted a prospective randomized double-blind dose-controlled trial in our dysplasia unit specializing vulvar disorders. 67patients with active LS were included. LS was confirmed by biopsy or by the validated CSS (clinical scoring system of vulvar LS). Computer generated randomization resulted in two groups, each group received a different application dose.(LDG- low dose group, NDG- normal dose group) During the study period of 18 weeks all participants received three laser applications in three subsequent sessions of three weeks. Two follow-ups six and twelve weeks after the first application was performed. At every visit, the participants filled in the VAS (visual analogue scale) for recording the actual vulvar symptoms as itching burning or pain on a range from 0 to 10.

Results

Before treatment the mean VAS-Score was 4.3 (STD ± 2.4) in the NDG and 5.1(±2.6) in the LDG. After 18 weeks, the mean reduction was −2.4 (±2.3) for NDG and −2.7 (±2.8) for LDG. Four patients (two of each group) reported more pain after than before treatment. Both groups show significant lower VAS-Scores 18 weeks after the treatment than before therapy (p < 0.0001).

The reduction of symptoms after 18 weeks between NDG and LDG was not significant (p = 0.6244).

Conclusion

Laser treatment with the microablative CO2 laser leads to a significant improvement for symptoms of LS.

A higher dosage of laser radiation shows no benefit concerning the symptoms. We have not observed any serious adverse events during this study.

中文翻译：

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妇科激光治疗——针对有症状的硬化性苔藓女性的随机对照试验

客观的

我们研究的目的是评估激光治疗外阴硬化性苔藓的治疗效果，主要是减轻瘙痒、烧灼感和疼痛等现有症状。我们询问了使用不同剂量的不同结果。

学习规划

我们在专门研究外阴疾病的发育异常科进行了一项前瞻性随机双盲剂量对照试验。纳入了 67 名活动性 LS 患者。LS 通过活检或经过验证的 CSS（外阴 LS 临床评分系统）证实。计算机生成的随机化结果分为两组，每组接受不同的应用剂量。（LDG-低剂量组，NDG-正常剂量组）在18周的研究期间，所有参与者在三周的连续三个疗程中接受了三次激光应用。第一次应用后六周和十二周进行两次随访。每次访视时，参与者都会填写VAS（视觉模拟量表），记录外阴的实际症状，如瘙痒、烧灼感或疼痛，范围从0到10。

结果

治疗前，NDG 的平均 VAS 评分为 4.3 (STD ± 2.4)，LDG 的平均 VAS 评分为 5.1(±2.6)。18 周后，NDG 的平均减少量为 -2.4 (±2.3)，LDG 的平均减少量为 -2.7 (±2.8)。四名患者（每组两名）报告治疗后比治疗前疼痛更多。治疗后 18 周，两组的 VAS 评分均显着低于治疗前 (p < 0.0001)。

18 周后 NDG 和 LDG 之间的症状减轻并不显着 (p = 0.6244)。

结论

使用微消融 CO2 激光进行激光治疗可显着改善 LS 症状。

较高剂量的激光辐射对症状没有任何好处。在本研究期间我们没有观察到任何严重的不良事件。