Department of Obstetrics and Gynecology, Hadassah Hebrew University Medical Center, Jerusalem, Israel.
Department of Physical Therapy, Hadassah Hebrew University Medical Center, Jerusalem, Israel.
J Sex Med. 2017 Nov;14(11):1403-1411. doi: 10.1016/j.jsxm.2017.09.004. Epub 2017 Sep 29.
Low-level laser therapy (LLLT) is an emerging medical technology in which non-thermal laser irradiation is applied to treat pain. Because LLLT has been found effective in treating various pain syndromes without known side effects, we conducted a study evaluating the effect of LLLT on provoked vestibulodynia (PVD), a complex sexual pain disorder characterized by pain confined to the vulvar vestibule in response to contact or pressure.
To investigate the effectiveness of LLLT for PVD in a randomized, placebo-controlled, double-blinded trial.
Patients with PVD were randomly assigned to receive treatment with LLLT or sham treatment. Patients were treated twice weekly for 6 weeks, for a total of 12 LLLT or placebo sessions. Patients who showed improvement after LLLT were followed for 1 year by clinical pain report and Q-tip examination.
Change in pain scores obtained in response to the Q-tip test, clinical pain report, visual analog scale score, pain with tampon insertion, daily pain intensity, intercourse pain intensity, frequency of intercourse, and a battery of quality-of-life measures.
Thirty-four patients with PVD participated, 18 received LLLT and 16 received placebo. In the clinical pain report at study completion, 14 of 18 patients (78%) receiving LLLT reported improvement compared with 7 of 16 (44%) in the placebo group (P = .042). This effect was not apparent in other outcome measurements. None of the patients reported side effects during the study. At 1-year follow-up, eight patients (57%) reported lasting improvement.
Larger studies with various treatment protocols are needed to define which patients can benefit from LLLT therapy.
Strengths include a placebo-controlled, double-blinded design, measurement of a large number of multidimensional end points, and a follow-up period of 1 year. Limitations include the small number of patients recruited, no improvement in measurable parameters, a high improvement rate in the placebo group, the absence of use of validated questionnaires, and the lack of evaluation of psychological and interpersonal factors that might have influenced the results.
Given the results of this pilot study, LLLT cannot currently be recommended as a treatment for PVD. Further studies with a larger population, various treatment protocols, and evaluation of LLLT in different subgroups of PVD are needed to define which patients can benefit from this therapy. Lev-Sagie A, Kopitman A, Brzezinski A. Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial. J Sex Med 2017;14:1403-1411.
低水平激光疗法（LLLT）是一种新兴的医学技术，它采用非热激光照射来治疗疼痛。由于 LLLT 已被发现对各种疼痛综合征有效，且无已知的副作用，因此我们进行了一项研究，评估 LLLT 对诱发外阴痛（PVD）的疗效，PVD 是一种复杂的性疼痛障碍，其特征是外阴前庭部位在受到接触或压力时会出现疼痛。
在随机、安慰剂对照、双盲试验中研究 LLLT 对 PVD 的疗效。
患有 PVD 的患者被随机分配接受 LLLT 或假治疗。患者每周接受两次治疗，持续 6 周，共进行 12 次 LLLT 或安慰剂治疗。接受 LLLT 治疗后有改善的患者通过临床疼痛报告和 Q-tip 检查进行为期 1 年的随访。
34 名患有 PVD 的患者参与了研究，其中 18 名接受了 LLLT，16 名接受了安慰剂。在研究结束时的 Q-tip 测试、临床疼痛报告、视觉模拟评分、棉塞插入疼痛、日常疼痛强度、性交疼痛强度、性交频率以及一系列生活质量测量中，18 名接受 LLLT 的患者中有 14 名（78%）报告改善，而 16 名接受安慰剂的患者中仅有 7 名（44%）（P =.042）。在其他结果测量中，这种效果并不明显。在研究过程中，没有患者报告出现副作用。在 1 年的随访中，有 8 名患者（57%）报告持续改善。
需要进行更大规模的研究，采用不同的治疗方案，以确定哪些患者可以从 LLLT 治疗中受益。
本研究的优势包括采用了安慰剂对照、双盲设计，测量了大量多维终点，以及随访期为 1 年。局限性包括招募的患者数量较少，治疗后可测量参数无改善，安慰剂组的改善率较高，未使用经过验证的问卷，以及缺乏对可能影响结果的心理和人际关系因素的评估。
鉴于这项初步研究的结果，目前不能推荐 LLLT 作为 PVD 的治疗方法。需要进行更大规模的研究，采用不同的治疗方案，并评估 LLLT 在 PVD 的不同亚组中的应用，以确定哪些患者可以从这种治疗中受益。
