The dose-dependent effects of transcutaneous electrical nerve stimulation for pain relief in individuals with fibromyalgia: a systematic review and meta-analysis.

ABSTRACT: Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological modality widely used to manage pain; however, its effectiveness for individuals with fibromyalgia (FM) has been questioned. In previous studies and systematic reviews, variables related to dose of TENS application have not been considered. The objectives of this meta-analysis were (1) to determine the effect of TENS on pain in individuals with FM and (2) determine the dose-dependent effect of TENS dose parameters on pain relief in individuals with FM. We searched the PubMed, PEDro, Cochrane, and EMBASE databases for relevant manuscripts. Data were extracted from 11 of the 1575 studies. The quality of the studies was assessed using the PEDro scale and RoB-2 assessment. This meta-analysis was performed using a random-effects model that, when not considering the TENS dosage applied, showed that the treatment had no overall effect on pain (d+ = 0.51, P > 0.050, k = 14). However, the moderator analyses, which were performed assuming a mixed-effect model, revealed that 3 of the categorical variables were significantly associated with effect sizes: the number of sessions ( P = 0.005), the frequency ( P = 0.014), and the intensity ( P = 0.047). The electrode placement was not significantly associated with any effect sizes. Thus, there is evidence that TENS can effectively reduce pain in individuals with FM when applied at high or at mixed frequencies, a high intensity, or in long-term interventions involving 10 or more sessions. This review protocol was registered at PROSPERO (CRD42021252113).

Effect of Fractional Carbon Dioxide vs Sham Laser on Sexual Function in Survivors of Breast Cancer Receiving Aromatase Inhibitors for Genitourinary Syndrome of Menopause: The LIGHT Randomized Clinical Trial.

Importance: Survivors of breast cancer present more severe symptoms of genitourinary syndrome of menopause (GSM) than patients without history of breast cancer. Recently, new treatments, such as vaginal laser therapy, have appeared, but evidence of their efficacy remains scarce. Objective: To assess the safety and efficacy of carbon dioxide (CO2) vs sham vaginal laser therapy after 6 months of follow-up in survivors of breast cancer with GSM receiving aromatase inhibitors. Design, Setting, and Participants: This prospective double-blind sham-controlled randomized clinical trial with two parallel study groups was performed during October 2020 to March 2022 in a tertiary referral hospital. Survivors of breast cancer using aromatase inhibitors were assessed for eligibility, and eligible patients were randomized into the 2 treatment groups. Follow-up was conducted at 6 months. Data were analyzed in July 2022. Interventions: All patients from both groups were instructed to use the first-line treatment (FLT) based on nonhormonal moisturizers and vaginal vibrator stimulation. Patients for each group were allocated to 5 monthly sessions of fractional CO2 laser therapy (CLT) or sham laser therapy (SLT). Main Outcomes and Measures: The primary outcome was sexual function, evaluated through Female Sexual Function Index (FSFI) score. Other subjective measures of efficacy included a visual analog scale of dyspareunia, vaginal pH, a Vaginal Health Index, quality of life (assessed via Short-Form 12), and body image (assessed with the Spanish Body Image Scale). Objective measures of efficacy included vaginal maturation index, vaginal epithelial elasticity (measured in Pascals) and vaginal epithelial thickness (measured in millimeters). Measures were assessed before and after the intervention. Tolerance (measured on a Likert scale), adverse effects, and estradiol levels were recorded. Results: Among 211 survivors of breast cancer assessed, 84 women were deemed eligible and 72 women (mean [SD] age, 52.6 [8.3] years) were randomized to CLT (35 participants) or SLT (37 participants) and analyzed. There were no statistically significant differences between groups at baseline. At 6 months, both groups showed improvement in FSFI (mean [SD] score at baseline vs 6 months: CLT, 14.8 [8.8] points vs 20.0 [9.5] points; SLT, 15.6 [7.0] points vs 23.5 [6.5] points), but there was no significant difference between CLT and SLT groups in the improvement of sexual function evaluated through the FSFI test overall (mean [SD] difference, 5.2 [1.5] points vs 7.9 [1.2] points; P = .15) or after excluding women who were not sexually active (mean [SD] difference, 2.9 [1.4] points vs 5.5 [1.1] points; P = .15). There were also no differences between improvement of the 2 groups at 6 months of follow-up in the other assessed subjective outcomes, including dyspareunia (mean [SD] difference, -4.3 [3.4] vs -4.5 [2.3]; P = .73), Vaginal Health Index (mean [SD] difference, 3.3 [4.1] vs 5.0 [4.5]; P = .17), body image (mean [SD] difference, -3.7 [4.5] vs -2.7 [4.8]; P = .35), and quality of life (mean [SD] difference, -0.3 [3.6] vs -0.7 [3.2]; P = .39). Similarly, there were no differences in improvements in objective outcomes, including vaginal pH (mean [SD] difference, -0.6 [0.9] vs -0.8 [1.2]; P = .29), vaginal maturation index (mean [SD] difference, 10.2 [17.4] vs 14.4 [17.1]; P = .15), vaginal epithelial thickness (mean [SD] difference, 0.021 [0.014] mm vs 0.013 [0.012] mm; P = .30), vaginal epithelial elasticity (mean [SD] difference, -1373 [3197] Pascals vs -2103 [3771] Pascals; P = .64). There were significant improvements in the overall analysis regardless of group in many outcomes. The 2 interventions were well tolerated, but tolerance was significantly lower in the CLT group than the SLT group (mean [SD] Likert scale score, 3.3 [1.3] vs 4.1 [1.0]; P = .007). No differences were observed in complications or serum estradiol levels. Conclusions and Relevance: In this randomized clinical trial, vaginal laser treatment was found to be safe after 6 months of follow-up, but no statistically significant differences in efficacy were observed between CLT and SLT. Trial Registration: ClinicalTrials.gov identifier: NCT04619485.

Vaginal laser therapy for genitourinary syndrome of menopause - systematic review.

BACKGROUND: Genitourinary syndrome of menopause (GSM) can have a great impact on the quality of life (QOL), and affects between 53.8% and 90% of postmenopausal women. The literature suggests that vaginal laser therapy could be an effective treatment for GSM symptoms, but its efficacy and safety have not been established and international societies do not endorse its use. Despite that, there has been an increase in the use of vaginal laser therapy globally over the last decade. OBJECTIVE: The objective of this review is to evaluate the literature which assesses the efficacy and safety of the vaginal laser therapy in the treatment of GSM. METHODS: A comprehensive literature search was conducted electronically using Embase and PubMed to retrieve studies assessing evidence for the efficacy and safety of vaginal laser therapy for GSM or vulvovaginal atrophy up to June 2021. RESULTS: A total of 64 studies were finally included in the review. There were 10 controlled intervention studies, 7 observational cohort and cross-sectional studies and 47 before-after studies without a control group. CONCLUSION: Vaginal laser seems to improve scores on the Visual Analogue Scale (VAS), Female Sexual Function Index (FSFI) and Vaginal Health Index (VHI) in GSM over the short term. Safety outcomes are underreported and short-term. Further well-designed clinical trials with sham-laser control groups and evaluating objective variables are needed to provide the best evidence on efficacy.

Falacias sobre el valor p compartidas por profesores y estudiantes universitarios / Fallacies about p-Value Shared by Professors and University Students

Resumen La "Práctica Basada en la Evidencia" requiere a los profesionales valorar de forma crítica los resultados de las investigaciones psicológicas. Sin embargo, las interpretaciones incorrectas de los valores p de probabilidad son abundantes y repetitivas. Estas interpretaciones incorrectas pueden afectar las decisiones profesionales y poner en riesgo la calidad de las intervenciones y la acumulación de un conocimiento científico válido. Por lo tanto, identificar el tipo de falacia que subyace a las decisiones estadísticas es fundamental para abordar y planificar estrategias de educación estadística dirigidas a intervenir sobre las interpretaciones incorrectas. En consecuencia, el objetivo de este estudio es analizar la interpretación del valor p en estudiantes y profesores universitarios de psicología. La muestra estuvo formada por 161 participantes (43 profesores y 118 estudiantes). La antigüedad media como profesor fue de 16.7 años (DE = 10.07). La edad media de los estudiantes fue de 21.59 (DE = 1.3). Los hallazgos sugieren que los estudiantes y profesores universitarios no conocen la interpretación correcta del valor p. La falacia de la probabilidad inversa presentó mayores problemas de comprensión. Además, se confundieron la significación estadística y la significación práctica o clínica. Estos resultados destacan la necesidad de la educación estadística y reeducación estadística.

Abstract The "Evidence Based Practice" requires professionals to critically assess the results of psychological research. However, incorrect interpretations of p values of probability are abundant and repetitive. These misconceptions may affect professional decisions and compromise the quality of interventions and the accumulation of a valid scientific knowledge. Therefore, identifying the types of fallacies that underlying statistical decisions is fundamental for approaching and planning statistical education strategies designed to intervene in incorrect interpretations. Consequently, the aim of this study is to analyze the interpretation of p value among university students of psychology and academic psychologists. The sample was composed of 161 participants (43 academics and 118 students). The mean number of years as academic was 16.7 (SD = 10.07). The mean age of university students was 21.59 years (SD = 1.3). The findings suggest that college students and academics do not know the correct interpretation of p values. The inverse probability fallacy presented major problems of comprehension. In addition, the participants confused statistical significance and practical significance or clinical or the findings. There is a need for statistical education and statistical re-education.