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.

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

Contesxto: La braquiterapia con alta tasa de dosis (HDR-BT) es un tratamiento de uso creciente en pacientes con cáncer de próstata (CP) localizado. Objetivo: Evaluar la eficacia y seguridad de HDR-BT como monoterapia en CP. Adquisición de evidencia: Revisión sistemática de la literatura mediante búsqueda en MEDLINE (PubMed), Cochrane Library, CDR, Clinicaltrials y EuroScan. Se evaluaron indicadores de eficacia y de seguridad. Síntesis de evidencia: Fueron seleccionadas 2 revisiones y 12 estudios no controlados, incluidos en estas 2revisiones. En términos de eficacia, el control local en 6 estudios es 97-100%. La supervivencia libre de progresión bioquímica varía: 85-100% en riesgo bajo y 79-92% en riesgo alto. La supervivencia libre de metástasis es >95% a 8 años, salvo en un estudio que es 87% a 5 años. La supervivencia global es ≥95% en 8 estudios. En relación con la seguridad, la mayoría de los estudios recogen complicaciones genitourinarias y gastrointestinales agudas y a largo plazo, especialmente de grado ≥ 2. Solo 3 estudios encuentran complicaciones grado 4. Excepto uno (sin complicaciones), en los 11 restantes las complicaciones complicaciones genitourinarias son más frecuentes y más graves que las gastrointestinales. Dos estudios evalúan la calidad de vida y muestran un descenso inicial en distintos dominios y posterior recuperación parcial o total, salvo en la esfera sexual. Conclusiones: La HDR-RT como monoterapia es eficaz, especialmente en riesgo bajo e intermedio. No existe suficiente información en pacientes de riesgo alto. La toxicidad a corto-medio plazo es aceptable. Consideramos necesario potenciar la investigación que aporte más información sobre eficacia y seguridad a largo plazo de este tratamiento

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

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.

Radioterapia hipofraccionada versus radioterapia convencional en cáncer de próstata: una revisión sistemática sobre eficacia y seguridad / Hypofractionated radiation therapy versus conventional radiation therapy in prostate cancer: A systematic review of its safety and efficacy

Contexto: Nuevas alternativas terapéuticas pueden mejorar la eficacia y seguridad del tratamiento del cáncer de próstata. Objetivo. Evaluar si la radioterapia hipofraccionada conlleva mejor eficacia y seguridad en el tratamiento del cáncer de próstata. Adquisición de la evidencia Revisión sistemática de la literatura con búsqueda en Pubmed, Cochrane Libarry, CRD, ClinicalTrials y Euroscan, recogiéndose indicadores de efectividad y seguridad. Síntesis de la evidencia: Se incluyeron 2 revisiones sistemáticas y un ensayo clínico. En relación con la eficacia existe una gran heterogeneidad entre los estudios, y no se encuentran resultados concluyentes de la superioridad de la opción hipofraccionada sobre la normofraccionada. En relación con la seguridad no se encuentran diferencias significativas en la aparición de complicaciones genitourinarias agudas entre ambos tratamientos. Sin embargo, una de las revisiones encuentra más complicaciones gastrointestinales agudas en los pacientes tratados con radioterapia hipofraccionada. En las complicaciones a largo plazo no se encuentran diferencias significativas según el tipo de radioterapia utilizada, aunque los estudios presentan limitaciones. Conclusiones: Hasta el momento no existen resultados concluyentes que demuestren que la radioterapia hipofraccionada es más eficaz o segura que la normofraccionada en el tratamiento del cáncer de próstata localizado

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

Efectividad y seguridad del sistema Urolift(R) para el tratamiento de los síntomas de la hiperplasia benigna de próstata: revisión sistemática / Efficacy and Safety of the Urolift(R) System for the Treatment of Benign Prostate Hyperplasia Symptoms: Systematic Review

Contexto: Interés por disponer de alternativas en el tratamiento de la hiperplasia benigna de próstata. Objetivo: Evaluar la efectividad y seguridad del sistema Urolift(R) para el tratamiento de los síntomas de la hiperplasia benigna de próstata. Adquisición de evidencia: Revisión sistemática de la literatura con búsqueda en PubMed, Cochrane Library, CRD, Clinical Trials y EuroScan, recogiéndose indicadores de efectividad y seguridad. Síntesis de evidencia: Se incluyeron 5 series de casos y un ensayo clínico. La edad media de los pacientes osciló entre 65-74,3 años, y el volumen prostático medio entre 41-55 cm3. El número medio de implantes Urolif(R) fue de 3,7-5,5. El seguimiento máximo en meses fue de 24, 12 (3 estudios) y uno (2 estudios). Se encontraron mejoras en: síntomas del tracto urinario inferior medidos con International Prostate Symptom Score, Benign Prostatic Hyperplasia Impact Index (BPHII), flujo urinario máximo (Qmax) y volumen residual postmiccional (PVR); síntomas de función sexual medidos con Sexual Health Inventory for Men (SHIM) y Male Sexual Health Questionnaire or Ejaculatory Dysfunction (MHSQ-EjD); y calidad de vida (QoL). En el ensayo clínico, las diferencias fueron significativas para International Prostate Symptom Score, BPHII, Qmax y QoL (p < 0,05). Los efectos adversos fueron leves. Conclusiones: Aunque la calidad de la evidencia es baja, Urolift(R) constituye una buena alternativa terapéutica para pacientes con hiperplasia benigna de próstata. Los resultados a corto/medio plazo muestran que la técnica contribuye a mejorar los síntomas del tracto urinario inferior, sin efectos secundarios relevantes, sin afectar la función sexual y mejorando la calidad de vida. Sería preciso continuar la investigación especialmente sobre resultados a largo plazo

Context: Interest in having alternatives in the treatment of benign prostate hyperplasia. Objectives: To assess the efficacy and safety of the Urolift(R) 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 41-55 cm3. The mean number of Urolif(R) 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

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.

Results from the monitoring use programme for endovascular repair of abdominal aortic aneurysms in Spain.

AIM: The aim of this study was to present the results from the Monitoring Use Programme (MUP) for endovascular repair (ER) of abdominal aortic aneurysms (AAA) using stent grafts in Spain, carried out to determine the procedure's effectiveness and safety. METHODS: This was a follow-up study carried out through a multicentric-case registry between 2001-2003. Variables were grouped into: 1) general information, 2) postoperative period and 3) follow-up period. RESULTS: The study enrolled 740 cases (97% males), from 32 hospitals. Mean age of patients was 72.7+/-7.3 years. Mean AAA diameter was 59.5+/-13.7 mm. Forty-seven percent of patients required additional intervention procedures; 19% patients presented intervention complications (53% were endoleaks). The endovascular intervention could not be completed in 6 patients, and in 2 patients the operation was changed to conventional surgery; 24% patients suffered, mostly minor, postoperative complications. Between 4-24 months, follow-up was normal in 81-85% cases with the most common complication being endoleaks (7%). After 24 months, and especially after 37, reinterventions and complications, in particular angulation and stent migration, increased, mainly associated to the Vanguard device. After 37 months, an increase in AAA size was observed. Among patients with preoperative AAA<50 mm, there was a greater proportion of individuals requiring additional procedures (60% vs 41%, P<0.01), suffering postoperative complications (26% vs 24%), and presenting more leaks (71% vs 52%), than among patients with AAA >or= 50 mm. CONCLUSIONS: ER of AAA shows favourable results in the short/medium term with regards to procedure safety and effectiveness. The appearance of some complications and increase in AAA size 2-3 years after ER raises the need for caution. Care should be taken when considering ER of small AAA.

[Use of pap smear for cervical cancer screening and factors related with its use in Spain]. / Uso de la citología de cribado de cérvix y factores relacionados con el uso de la prueba en España.

OBJECTIVE: To determine the percentage of women aged 40 to 70 years who had had at least one preventive Pap test (cytological examination) during the preceding 5 years, and the factors associated with use of the test. DESIGN: Population survey.Setting. Home interviews during October 2000. PARTICIPANTS: 2409 women aged 40 to 70 years residing in Spain. The nonresponse rate was 20.3%. MAIN MEASURES: The dependent variable was use of the Pap test, and independent factors examined were sociodemographic, social and health-related factors, information and attitude. Use of Pap tests was estimated with a 95% confidence interval (CI), and univariate and multivariate analysis were used to identify factors related with use of the test. RESULTS: Almost half (49.6%; 95% CI, 47.6%-51.6%) of the women had had a Pap test. The factors associated most strongly with use of the test were intention to have the test done (odds ratio [OR], 4.76; 95% CI, 3.40-6.65), not having the test done because of fear of the diagnosis (OR, 3.22; 95% CI, 1.77-5.85), earlier testing (OR, 2.59; 95% CI, 2.06-3.27), and doctor's advice (OR, 2.44; 95% CI, 1.93-3.09). Other associated factors were considering the text necessary, upper or middle-upper socioeconomic status, access to private or combined private-public health care, age 40 to 50 years, and residing in a city with a population greater than 100000. CONCLUSIONS: Half of all Spanish women aged 40 to 70 years had had a Pap test. Use of the test was related most clearly with the woman's attitude toward the test. Health care professionals should be aware of the importance of their role in encouraging Pap tests for screening.