Revisión sistemática sobre la eficacia y seguridad de los neuroestimuladores periféricos del ganglio esfenopalatino para el tratamiento de la cefalea crónica en racimos refractaria / Systematic review of the safety and effectiveness of peripheral neurostimulation of the sphenopalatine ganglion for the treatment of refractory chronic cluster headache

Introducción: El objetivo es evaluar la eficacia y seguridad de los neuroestimuladores periféricos del ganglio esfenopalatino (GEP) para el tratamiento de la cefalea en racimos crónica refractaria al tratamiento.DesarrolloRevisión sistemática de la literatura científica. Se identificaron estudios mediante una búsqueda en diferentes bases de datos. Las estrategias de búsqueda se realizaron hasta el 31 de octubre de 2016, incluyendo ensayos clínicos, revisiones sistemáticas o metaanálisis, informes de evaluación de tecnologías sanitarias y guías de práctica clínica que recogieran medidas de eficacia/efectividad o efectos adversos asociados al tratamiento. Se excluyeron estudios de cohortes, casos y controles, series de casos, revisiones narrativas, cartas al director, artículos de opinión, editoriales y estudios duplicados o desfasados por estudios posteriores de la misma institución. Respecto a la eficacia, los resultados son positivos tras la estimulación del GEP en relación con el alivio de dolor, el número de episodios, el uso de la medicación o la calidad de vida del paciente. En relación con la seguridad, hay un número importante de efectos adversos en los primeros 30 días de la intervención y en algunos pacientes fue necesaria la retirada del dispositivo. Los datos de seguimiento son a corto plazo y escasos.ConclusionesLos resultados resultan prometedores a pesar de que la evidencia disponible es limitada. Consideramos fundamental continuar con la investigación sobre la seguridad y eficacia de los neuroestimuladores del GEP en la cefalea en racimos crónica. En aquellos casos en que pueda estar indicada la intervención, el tratamiento debería realizarse supervisado en un estudio de monitorización. (AU)

Introduction: This study aimed to assess the safety and effectiveness of peripheral neurostimulation of the sphenopalatine ganglion (SPG) in the treatment of refractory chronic cluster headache.DevelopmentVarious medical databases were used to perform a systematic review of the scientific literature. The search for articles continued until 31 October 2016, and included clinical trials, systematic reviews and/or meta-analyses, health technology assessment reports, and clinical practice guidelines that included measurements of efficiency/effectiveness or adverse effects associated with the treatment. The review excluded cohort studies, case-control studies, case series, literature reviews, letters to the editor, opinion pieces, editorials, and studies that had been duplicated or outdated by later publications from the same institution. Regarding effectiveness, we found that SPG stimulation had positive results for pain relief, attack frequency, medication use, and patients’ quality of life. In the results regarding safety, we found a significant number of adverse events in the first 30 days following the intervention. Removal of the device was necessary in some patients. Little follow-up data, and no long-term data, is available.ConclusionsThese results are promising, despite the limited evidence available. We consider it essential for research to continue into the safety and efficacy of SPG stimulation for patients with refractory chronic cluster headache. In cases where this intervention may be indicated, treatment should be closely monitored. (AU)

Systematic review of the safety and effectiveness of peripheral neurostimulation of the sphenopalatine ganglion for the treatment of refractory chronic cluster headache.

INTRODUCTION: This study aimed to assess the safety and effectiveness of peripheral neurostimulation of the sphenopalatine ganglion (SPG) in the treatment of refractory chronic cluster headache. DEVELOPMENT: Various medical databases were used to perform a systematic review of the scientific literature. The search for articles continued until 31 October 2016, and included clinical trials, systematic reviews and/or meta-analyses, health technology assessment reports, and clinical practice guidelines that included measurements of efficiency/effectiveness or adverse effects associated with the treatment. The review excluded cohort studies, case-control studies, case series, literature reviews, letters to the editor, opinion pieces, editorials, and studies that had been duplicated or outdated by later publications from the same institution. Regarding effectiveness, we found that SPG stimulation had positive results for pain relief, attack frequency, medication use, and patients' quality of life. In the results regarding safety, we found a significant number of adverse events in the first 30 days following the intervention. Removal of the device was necessary in some patients. Little follow-up data, and no long-term data, is available. CONCLUSIONS: These results are promising, despite the limited evidence available. We consider it essential for research to continue into the safety and efficacy of SPG stimulation for patients with refractory chronic cluster headache. In cases where this intervention may be indicated, treatment should be closely monitored.

[Pharmacological treatment in uncertainty times: Hydroxychloroquine/chloroquine use in the COVID-19 treatment]. / Tratamiento farmacológico en tiempos de incertidumbre: uso de la hidroxicloroquina/cloroquina en el tratamiento de COVID-19.

BACKGROUND AND OBJECTIVES: In this moments, of extreme gravity in which we find ourselves, and in the uncertainty face about the most effective treatment against COVID-19 disease and with the aim of find the evidence that support the chloroquine/hydroxychloroquine use recommendation to treat COVID-19 disease, a systematic review of published studies and RCT studies publishes until April 28, 2020 was carried out. MATERIAL AND METHODS: A systematic search was carried out in PubMed with the keywords COVID-19 and their synonyms and hydroxychloroquine/chloroquine. The data selection and extraction was elaborated by two researchers, independently. The results were discussed with a Primary Care physicians clinical group and the results were synthesized using GRADE methodology. RESULTS: A good quality systematic review was found that includes articles with a high risk of bias. And 8 EC launched that will produce results beyond May 2020. CONCLUSIONS: Although the conclusions of the systematic review generate a low confidence in the results, and the clinical variables that show benefit are intermediate variables, the side effects are acceptable and could be minimized with the use of QT lengthening risk tools, so it is could make a weak recommendation in favor of the use of chloroquine/hydroxychloroquine in patients with mild-moderate stage COVID-19.

High-dose rate brachytherapy as monotherapy in prostate cancer: A systematic review of its safety and efficacy. / Braquiterapia de alta tasa de dosis como monoterapia en cáncer de próstata: una revisión sistemática sobre eficacia y seguridad.

CONTEXT: High-dose rate brachytherapy (HDR-BT) is an increasingly popular treatment for patients with localised prostate cancer (PC). OBJECTIVE: To assess the safety and efficacy of HDR-BT as monotherapy in PC. ACQUISITION OF EVIDENCE: A systematic literature review was conducted through searches on MEDLINE (PubMed), Cochrane Library, CDR, ClinicalTrials and EuroScan. We assessed safety and efficacy indicators. SUMMARY OF THE EVIDENCE: We selected 2 reviews and 12 uncontrolled studies, included in these 2 reviews. In terms of efficacy, local control in 6 studies was 97-100%. The biochemical progression-free survival varied as follows: 85-100% for low risk and 79-92% for high risk. Survival free of metastases was >95% at 8 years, except in one study where the survival rate was 87% at 5 years. The overall survival was ≥95% in 8 studies. In terms of safety, most of the studies recorded acute and long-term genitourinary and gastrointestinal complications, especially grade ≥2. Only 3 studies found grade 4 complications. All studies, except for one without complications, observed genitourinary complications that were more frequent and severe than the gastrointestinal complications. Two studies assessed the quality of life and showed an initial reduction in various domains and subsequent partial or total recovery, except in the sexual domain. CONCLUSIONS: HDR-BT is effective as monotherapy, especially in cases of low to intermediate risk. There is insufficient information on high-risk patients. The short to medium-term toxicity was acceptable. Further research needs to be funded to provide more information on the long-term safety and efficacy of this treatment.

Hypofractionated radiation therapy versus conventional radiation therapy in prostate cancer: A systematic review of its safety and efficacy.

CONTEXT: New therapeutic alternatives can improve the safety and efficacy of prostate cancer treatment. OBJECTIVES: To assess whether hypofractionated radiation therapy results in better safety and efficacy in the treatment of prostate cancer. ACQUISITION OF EVIDENCE: Systematic review of the literature through searches on PubMed, Cochrane Library, CRD, ClinicalTrials and EuroScan, collecting indicators of safety and efficacy. SYNTHESIS OF THE EVIDENCE: We included 2 systematic reviews and a clinical trial. In terms of efficacy, there is considerable heterogeneity among the studies, and no conclusive results were found concerning the superiority of the hypofractionated option over the normal fractionated option. In terms of safety, there were no significant differences in the onset of acute genitourinary complications between the 2 treatments. However, one of the reviews found more acute gastrointestinal complications in patients treated with hypofractionated radiation therapy. There were no significant differences in long-term complications based on the type of radiation therapy used, although the studies did have limitations. CONCLUSIONS: To date, there are no conclusive results that show that hypofractionated radiation therapy is more effective or safer than normal fractionated radiation therapy in the treatment of localized prostate cancer.

Efficacy and safety of the urolift® system for the treatment of benign prostate hyperplasia symptoms: systematic review.

CONTEXT: Interest in having alternatives in the treatment of benign prostate hyperplasia. OBJECTIVES: To assess the efficacy and safety of the Urolift® system for treating the symptoms of benign prostate hyperplasia. ACQUISITION OF EVIDENCE: Systematic review of the literature through searches on PubMed, Cochrane Library, CRD, Clinical Trials and EuroScan, collecting indicators of efficacy and safety. SUMMARY OF THE EVIDENCE: We included 5 case series and one clinical trial. The patients' mean age ranged from 65-74.3 years, and the mean prostate volume was 41-55cm3. The mean number of Urolif® implants was 3.7-5.5. The maximum follow-up in months was 24, 12 (3 studies) and one (2 studies). Improvements were found in lower urinary tract symptoms, as measured with the International Prostate Symptom Score, Benign Prostatic Hyperplasia Impact Index (BPHII), maximum urinary flow (Qmax) and postvoid residual (PVR) volume. Improvements were in found sexual dysfunction symptoms, as measured with the Sexual Health Inventory for Men (SHIM) and the Male Sexual Health Questionnaire or Ejaculatory Dysfunction (MHSQ-EjD), and in quality of life (QoL). In the clinical trial, the differences were significant for International Prostate Symptom Score, BPHII, Qmax and QoL (p<.05). The adverse effects were mild. CONCLUSIONS: Although the quality of evidence is low, Urolift® constitutes a good therapeutic alternative for patients with benign prostate hyperplasia. The short to medium-term results show that the technique contributes to improving lower urinary tract symptoms, with no relevant side effects, does not affect sexual function and improves quality of life. Further research is required, especially on long-term results.

Hormone replacement therapy for preventing cardiovascular disease in post-menopausal women.

BACKGROUND: There is apparently compelling evidence, from observational studies, that hormone replacement therapy (HRT) may have benefits in reducing cardiovascular events in post-menopausal women. However, these observational data are subject to biases and confounding and require support from formally designed randomised controlled trials of the effects of HRT on cardiovascular disease risk. OBJECTIVES: To assess the effects of HRT for the primary and secondary prevention of cardiovascular diseases in post-menopausal women. SEARCH STRATEGY: We searched MEDLINE (1998 to December 2002)), EMBASE (1998 to December 2002), the Cochrane Controlled Trials Register (CCTR) (Issue 4 2002), the National Research Register (1998 to present), Clinical Trials.gov (1998 to present), and the database of Spanish Clinical Trials (1998 to present) and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials comparing HRT with controls (placebo or no treatment) with a minimum follow up of 6 months for treating or preventing cardiovascular disease in postmenopausal women with or without cardiovascular disease. DATA COLLECTION AND ANALYSIS: Three independent reviewers extracted information from the articles, solving discrepancies by consensus. All outcomes studied were dichotomous. Risk ratios and 95% confidence intervals (CI) were calculated for each study and plotted. Random effects meta-analysis was used in efficacy outcomes (cardiovascular events) and fixed-effects meta-analysis in variables regarding side effects (deep venous thrombosis). MAIN RESULTS: No protective effect of HRT was seen for any of the cardiovascular outcomes assessed: all cause mortality, cardiovascular death, non-fatal MI, venous thromboemboli or stroke. Higher risks of venous thromboembolic events (Relative risk (RR) 2.15, 95% CI 1.61 to 2.86), pulmonary embolus (RR 2.15, 95% CI 1.41 to 3.28), and stroke (RR 1.44, 95% CI 1.10 to 1.89) was found in those randomised to HRT compared with placebo. No substantial heterogeneity (p <0.1) was detected in any of the outcomes studied. AUTHORS' CONCLUSIONS: At present, a recommendation for initiating HRT for the reason of preventing cardiovascular events in post-menopausal women (with or without cardiovascular disease) should not be made. Women with other risk factors for venous thromboembolic events should be discouraged from using HRT if the sole goal is to prevent cardiovascular events.