Financiado en parte por Procter and Gamble
Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial
Lev-Sagie A, Kopitman A, Brzezinski A
The journal of sexual medicine · 28 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Procter and Gamble
- Organización sin fines de lucro
- National Vulvodynia Association
Según 2 financiadores declarados.
Publicación
- Publicado
- 2017-09-29 · J Sex Med · vol. 14 · número 11 · págs. 1403–1411
- Editorial
- Elsevier BV
- Citado
- 44 citas · más que el 85% de estudios similares · 1.9× el promedio de su campo
- Referencias
- 42 trabajos
- Acceso
- De pago
- Áreas de investigación
- Laser Applications in Dentistry and Medicine · Sexual function and dysfunction studies · Pain Management and Treatment
- Palabras clave
- low-level laser therapy, provoked vestibulodynia, sexual pain disorders, pain management, Q-tip test, placebo effect, long-term follow-up, quality of life, treatment effectiveness, psychological factors in pain
- MeSH
- humans, pain measurement, treatment outcome, clinical protocols, pilot projects, sexual behavior, coitus, adult, middle aged, female, male, vulvodynia, surveys and questionnaires, low-level light therapy
3 autores
- Ahinoam Lev‐Sagie🇮🇱 · autor de correspondenciaHadassah Medical Center
- Asia Kopitman🇮🇱Hadassah Medical Center
- Amnon Brzezinski🇮🇱Hadassah Medical Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
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.
Aim
To investigate the effectiveness of LLLT for PVD in a randomized, placebo-controlled, double-blinded trial.
Methods
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.
Outcomes
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.
Results
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.
Clinical implications
Larger studies with various treatment protocols are needed to define which patients can benefit from LLLT therapy.
Strengths and limitations
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.
Conclusions
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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