Effect of effervescent paracetamol on blood pressure: a crossover randomized clinical trial.

OBJECTIVE: To evaluate the effect of effervescent paracetamol on office and ambulatory blood pressure (BP) compared with noneffervescent paracetamol in hypertensive patients. DESIGN: This was a multicenter open crossover randomized clinical trial. SETTING: Primary care centers in Catalonia and the Basque Country. PARTICIPANTS: Inclusion criteria were office BP 150/95 mmHg or less and daytime ambulatory BP 140/90 mmHg or less, stable pharmacologic or nonpharmacologic antihypertensive treatment, and concomitant chronic osteoarticular pain. INTERVENTIONS: Baseline randomized assignment to 3-week periods of effervescent paracetamol (1 g three times a day) first and noneffervescent paracetamol later, or inversely, during a 7-week study period. At the start and end of each treatment period, 24-h ambulatory BP monitoring was performed. MAIN OUTCOME MEASURES: Differences in 24-h SBP between baseline and end of both treatment periods. The main analyses were performed according to the intention-to-treat principle. RESULTS: In intention-to-treat analysis, 46 patients were analyzed, 21 were treated with paracetamol effervescent and noneffervescent later, and 25 followed the opposite sequence. The difference in 24-h SBP between the two treatments was 3.99 mmHg (95% confidence interval 1.35-6.63; P = 0.004), higher in the effervescent paracetamol treatment period. Similarly, the per-protocol analysis showed a difference in 24-h SBP between the two groups of 5.04 mmHg (95% confidence interval 1.80-8.28; P = 0.004), higher in the effervescent paracetamol treatment period. Self-reported pain levels did not differ between groups and did not vary by treatment period. No serious adverse events were reported in either study arm. CONCLUSION: Effervescent paracetamol tablets are responsible for a significant daytime and overall increase in ambulatory 24-h SBP. TRIAL REGISTRATION: NCT: 02514538 EudraCT: 2010-023485-53.

Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial.

BACKGROUND: Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of that risk factor. Therefore, the objective of this study is to evaluate the effect on blood pressure of effervescent paracetamol compared to non-effervescent, in hypertensive patients. METHODS/DESIGN: This is the protocol of a phase IV multicenter clinical trial, randomized, controlled, crossover, open, which will compare the effect of two different formulations of paracetamol (effervescent or non-effervescent) in the blood pressure of hypertensive patients, with a seven weeks follow up. 49 controlled hypertensive patients will be included (clinical BP lower than 150 and 95 mmHg, and lower than 135 mmHg and 85 mmHg in patients with diabetes or a history of cardiovascular event, and daytime ambulatory measurements lower than 140 and 90 mmHg) and mild to moderate pain (Visual Analog Scale between 1 and 4). The study was approved by the ethics committee of the Fundació Jordi Gol i Gurina and following standards of good clinical practice. The primary endpoint will be the variations in systolic BP in 24 h Ambulatory Blood Pressure Monitoring, considering significant differences 2 or more mmHg among those treated with non-effervescent and effervescent formulations. Intention-to-treat and per-protocol analysis will be held. DISCUSSION: Despite the broad recommendation not to use effervescent drugs in patients with hypertension, there are relatively little studies that show exactly this pressor effect due to sodium in salt that gives the effervescence of the product. This is the first clinical trial designed to study the effect of effervescence compared to the non-effervescent, in well-controlled hypertensive patients with mild to moderate pain, performed in routine clinical practice. TRIAL REGISTRATION: NCT 02514538.

Eficacia y seguridad de tamsulosina para el tratamiento conservador del cólico nefrítico: revisión sistemática con metaanálisis de ensayos clínicos aleatorizados / Tamsulosin efficacy and safety for conservative management of renal colic: Systematic review and meta-analysis of randomized controlled trials

Fundamento y objetivo: El objetivo fue evaluar la eficacia y seguridad de tamsulosina, comparada con otro tratamiento estándar o con placebo, en la expulsión de las litiasis ureterales distales. Material y métodos: Se realizaron búsquedas sistemáticas en PubMed, SCOPUS y The Cochrane Library para identificar los ensayos clínicos aleatorizados y controlados en pacientes tratados con tamsulosina con resultados de expulsión de litiasis ureteral y de episodios adversos, publicados hasta diciembre de 2014, sin limitaciones de idioma. Se calculó el efecto de los tratamientos junto con el intervalo de confianza del 95% (IC 95%) utilizando el método de la inversa de la variancia para efectos aleatorios. La heterogeneidad se determinó mediante el estadístico I2. El sesgo de publicación se evaluó mediante la prueba de Egger. Resultados: La búsqueda identificó 480 artículos. Treinta y ocho cumplían los criterios de selección, con un total de 3.107 participantes. El riesgo relativo (RR) de expulsión de litiasis de los pacientes tratados con tamsulosina comparado con el tratamiento control fue de 1,53 (IC 95% 1,38-1,69; I2 = 71%). El RR de cualquier episodio adverso de tamsulosina fue de 1,79 (IC 95% 1,19-2,71; I2 = 0%). Conclusiones: El tratamiento con tamsulosina parece favorecer la expulsión de litiasis renales, aunque con un riesgo no desdeñable de efectos secundarios (AU)

Background and objective: The aim is to evaluate tamsulosin efficacy and safety on the expulsion of distal ureteral stones compared to a standard therapy. Material and methods: Systematic searches were conducted on PubMed, SCOPUS and The Cochrane Library so as to identify randomized and controlled clinical trials in patients treated with tamsulosin with ureteral stone expulsion and adverse events published until 2014 December, without language restriction. Treatment effect was calculated along with the 95% confidence interval (95% CI), using the variance inverse method for random effects. Heterogeneity was determined by I2. Publication bias was assessed by Egger test. Results: The search identified 480 articles. Thirty-eight met the selection criteria, a total of 3,107 patients. The relative risk (RR) of expulsion was 1.53 (95% CI 1.38-1.69; I2 = 71%.), while the RR of adverse effects was 1.79 (95% CI 1.19-2,71; I2 = 0). Conclusions: Tamsulosin treatment seems to bring on the expulsion of distal ureteral stones, although at the expense of an appreciable risk of side effects (AU)

[Tamsulosin efficacy and safety for conservative management of renal colic: systematic review and meta-analysis of randomized controlled trials]. / Eficacia y seguridad de tamsulosina para el tratamiento conservador del cólico nefrítico: revisión sistemática con metaanálisis de ensayos clínicos aleatorizados.

BACKGROUND AND OBJECTIVE: The aim is to evaluate tamsulosin efficacy and safety on the expulsion of distal ureteral stones compared to a standard therapy. MATERIAL AND METHODS: Systematic searches were conducted on PubMed, SCOPUS and The Cochrane Library so as to identify randomized and controlled clinical trials in patients treated with tamsulosin with ureteral stone expulsion and adverse events published until 2014 December, without language restriction. Treatment effect was calculated along with the 95% confidence interval (95% CI), using the variance inverse method for random effects. Heterogeneity was determined by I(2). Publication bias was assessed by Egger test. RESULTS: The search identified 480 articles. Thirty-eight met the selection criteria, a total of 3,107 patients. The relative risk (RR) of expulsion was 1.53 (95% CI 1.38-1.69; I(2)=71%.), while the RR of adverse effects was 1.79 (95% CI 1.19-2,71; I(2)=0). CONCLUSIONS: Tamsulosin treatment seems to bring on the expulsion of distal ureteral stones, although at the expense of an appreciable risk of side effects.

Consumo de infusiones y su relación con la incontinencia urinaria / Herbal tea consumption and its relationship to urinary incontinence

El objetivo de este estudio fue evaluar la relación entre el consumo de infusiones de plantas medicinales y la presencia de incontinencia urinaria (IU), así como establecer cuáles son las plantas más frecuentemente utilizadas y si existe alguna asociación entre éstas y los distintos tipos de IU. Se diseñó un estudio descriptivo, transversal, multicéntrico en cinco Centros de Salud Urbanos del área metropolitana de Barcelona. Participaron 392 mujeres, elegidas sistemáticamente a partir de la consulta diaria. Las variables de estudio fueron: edad, antecedentes patológicos y farmacológicos y actividad física. Se utilizó un cuestionario autoadministrado de frecuencia de consumo de infusiones y un cuestionario validado para evaluar presencia y tipo de incontinencia. Resultados: un 33,6%% de las mujeres participantes en el estudio padecía IU, de ellas un 29,7% presentaban IU de esfuerzo, IU de urgencia un 32,8% e IU mixta un 31,3%. La infusión más consumida fue la de manzanilla (44,9%). La ingesta de café fue superior en las mujeres incontinentes pero no alcanzó significación estadística. El consumo de infusiones se asoció significativamente con la IU (44,3% frente a 24,9%, p<0,0001). La IU más frecuente entre las consumidoras fue la de urgencia. Se encontró una relación entre la frecuencia de consumo de poleo y la presencia de IU, mientras que con la salvia aparecía una relación inversa. El análisis multivariante mostró que el consumo de infusiones y el número de plantas distintas fueron los factores más relacionados con la presencia de IU (OR de toma de infusiones: 2,7; IC95%:1,69; 4,40). Conclusiones: La manzanilla es la infusión más utilizada. El consumo de infusiones se asocia con mayor frecuencia de incontinencia. El consumo de poleo y tila aumenta la frecuencia de incontinencia, mientras que el de salvia la disminuye. El tipo de IU más relacionado con la toma de infusiones de plantas medicinales es la IU de urgencia (AU)

The aim of this study was to evaluate the relationship between the consumption of herbal teas and the presence of urinary incontinence (UI), and establish which plants are most frequently used and whether any association exists between them and the different types of UI. A descriptive, cross-sectional, multicenter study was performed in five urban Health Centers of greater Barcelona. Participants were 392 women, systematically selected from daily practice. The study variables were: age, pathological and pharmacological history and physical activity. A self-administered questionnaire on herbal tea consumption frequency and a validated questionnaire to assess the presence and type of incontinence were used. Results: 33.6% of the women in the study suffered from IU, of which 29.7% was stress UI, 32.8% urge UI and 31.3% mixed UI. The most consumed herbal tea was chamomile (44.9%). Coffee intake was higher in incontinent women but did not reach statistical significance. Tea consumption was significantly associated with UTI (44.3 % vs. 24.9%, p <0.0001). Urge UI was the most common UI among herbal tea consumer women. A relationship between the frequency of pennyroyal consumption and the presence of UI was found, while an inverse relationship was found the case of sage. Multivariate analysis showed that herbal tea consumption and the number of different plants were the factors most related to the presence of UI (OR for herbal tea consumption: 2.7; 95% CI: 1.69; 4.40). Conclusions: Chamomile tea is the most widely used. Herbal tea consumption is associated with to an increased frequency of UI. Pennyroyal and lime flower consumption increases UI frequency, whereas sage decreases it. Urge UI is the UI type most associated with herbal tea consumption (AU)

[Is the action taken by Catalonian primary care doctors adequate in view of the insufficient reduction in blood pressure levels in hypertensive patients? DISEHTAC-2001 study]. / Es adecuada la actitud que adoptan los médicos de atención primaria en Cataluña ante la insuficiente reducción de cifras de presión arterial en los pacientes hipertensos? Estudio DISEHTAC-2001.

OBJECTIVE: To determine the attitude to therapy of primary care staff in view of the lack of reduction in blood pressure. To describe the most commonly used antihypertensives. DESIGN: Descriptive, longitudinal, retrospective study during the year 2001. SETTING: Primary care, Spain. PARTICIPANTS: We analysed 990 hypertensive patients from 12 health centres picked from the 31 participants in the DISEHTAC-1996 study. METHODS: Age, sex, weight, and height were analysed, along with blood pressure values throughout the year 2001, therapeutic attitude (increase/replacement/combination) with poor control (more than 2 consecutive visits with blood pressure>139 and/or 89 mm Hg), screening and prevalence of cardiovascular risk factors (CVRF), and drugs used. RESULTS: There were 58.9% females; mean age: 65.4 (13.01) years, and 43.8% received 2 or more antihypertensives. The most common antihypertensives prescribed were diuretics (47.6%), and angiotensin-converting enzyme (ACE) inhibitors plus diuretics was the most used combination (22.1%). When there was poor control, some change in treatment was made in 76.8% (95% confidence interval [CI], 73.6-80) of cases. The most common was a combination of drugs (49.6%). The expected action was more frequent in those over 65 years and with a grade I of arterial hypertension (systolic blood pressure [SBP] between 140-150 and diastolic blood pressure [DBP] between 90-99 mm Hg (P<.001). CONCLUSIONS: Combined therapy is used in almost half of hypertensive patients, with the most common action being a drug combination.

¿Es adecuada la actitud que adoptan los médicos de atención primaria en Cataluña ante la insuficiente reducción de cifras de presión arterial en los pacientes hipertensos? Estudio DISEHTAC-2001 / Is the action taken by catalonian primary care doctors adequate in view of the insufficient reduction in blood pressure levels in hypertensive patients? DISEHTAC-2001 study

Objetivo. Determinar la actitud terapéutica delos profesionales de atención primaria antela falta de reducción de la presión arterial.Describir los tratamientos antihipertensivosmás utilizados.Diseño. Estudio descriptivo, longitudinaly retrospectivo llevado a cabo duranteel año 2001.Emplazamiento. Atención primaria.Participantes. Se incluyó a 990 pacienteshipertensos pertenecientes a 12 centros desalud, escogidos entre los 31 participantesen el estudio DISEHTAC-1996.Métodos. Se analizaron: edad, sexo, peso ytalla; valores de presión arterial recogidosdurante todo el año 2001; actitud terapéutica(aumento/sustitución/combinación) ante elmal control (más de 2 visitas consecutivascon presión arterial > 139 y/o 89 mmHg);cribado y prevalencia de factores de riesgocardiovascular (FRCV), y fármacosutilizados.Resultados. El 58,9% de los pacientesincluidos eran mujeres, con una edad mediade 65,4 ± 13,01 años. El 43,8% recibía 2 omás antihipertensivos. Los más prescritosfueron los diuréticos (47,6%) y lacombinación más usada fue la de uninhibidor de la enzima conversiva de laangiotensina (IECA) más un diurético(22,1%). Ante cifras de mal control, en el76,8% de los casos (intervalo de confianza[IC] del 95%, 73,6-80) se realizó algúncambio en el tratamiento, con frecuencia, seutilizó la combinación de fármacos (49,6%).La actitud expectante fue más frecuenteen los pacientes con edades ≥ 65 añosy con hipertensión arterial (HTA) de grado I(presión arterial sistólica [PAS] comprendidaentre 140 y 150 mmHg y presión arterialdiastólica [PAD] comprendida entre 90y 99 mmHg (p < 0,001).Conclusiones. La terapia combinada se utilizaen casi la mitad de los pacientes hipertensos.Es destacable la actitud activa de los médicosante la detección de reiterados controles depresión arterial elevados, y la actitud másfrecuente es la combinación de fármacos

Objective. To determine the attitudeto therapy of primary care staff in viewof the lack of reduction in blood pressure.To describe the most commonly usedantihypertensives.Design. Descriptive, longitudinal,retrospective study during the year 2001.Setting. Primary care, Spain.Participants.We analysed 990 hypertensivepatients from 12 health centres picked fromthe 31 participants in the DISEHTAC-1996 study.Methods. Age, sex, weight, and height wereanalysed, along with blood pressure valuesthroughout the year 2001, therapeuticattitude (increase/replacement/combination)with poor control (more than 2 consecutivevisits with blood pressure >139 and/or89 mm Hg), screening and prevalenceof cardiovascular risk factors (CVRF),and drugs used.Results. There were 58.9% females; meanage: 65.4 (13.01) years, and 43.8% received2 or more antihypertensives. The mostcommon antihypertensives prescribedwere diuretics (47.6%), and angiotensinconvertingenzyme (ACE) inhibitors plusdiuretics was the most used combination(22.1%).When there was poor control, somechange in treatment was made in 76.8%(95% confidence interval [CI], 73.6-80) ofcases. The most common was a combinationof drugs (49.6%). The expected action wasmore frequent in those over 65 years andwith a grade I of arterial hypertension(systolic blood pressure [SBP] between140-150 and diastolic blood pressure [DBP]between 90-99 mm Hg (P<.001).Conclusions. Combined therapy is used inalmost half of hypertensive patients, withthe most common action being a drugcombination