Comparative efficacy of two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled trial in primary care.

BACKGROUND: Benzodiazepines are extensively used in primary care, but their long-term use is associated with adverse health outcomes and dependence. AIMS: To analyse the efficacy of two structured interventions in primary care to enable patients to discontinue long-term benzodiazepine use. METHOD: A multicentre three-arm cluster randomised controlled trial was conducted, with randomisation at general practitioner level (trial registration ISRCTN13024375). A total of 532 patients taking benzodiazepines for at least 6 months participated. After all patients were included, general practitioners were randomly allocated (1:1:1) to usual care, a structured intervention with follow-up visits (SIF) or a structured intervention with written instructions (SIW). The primary end-point was the last month self-declared benzodiazepine discontinuation confirmed by prescription claims at 12 months. RESULTS: At 12 months, 76 of 168 (45%) patients in the SIW group and 86 of 191 (45%) in the SIF group had discontinued benzodiazepine use compared with 26 of 173 (15%) in the control group. After adjusting by cluster, the relative risks for benzodiazepine discontinuation were 3.01 (95% CI 2.03-4.46, P<0.0001) in the SIW and 3.00 (95% CI 2.04-4.40, P<0.0001) in the SIF group. The most frequently reported withdrawal symptoms were insomnia, anxiety and irritability. CONCLUSIONS: Both interventions led to significant reductions in long-term benzodiazepine use in patients without severe comorbidity. A structured intervention with a written individualised stepped-dose reduction is less time-consuming and as effective in primary care as a more complex intervention involving follow-up visits.

[Quality of the publication of adverse drug reactions in the letters to the editor section of four Spanish internal medicine and general medicine journals]. / Calidad de la publicación de reacciones adversas a medicamentos en la sección de Cartas al Director de cuatro revistas españolas de medicina interna y medicina general.

OBJECTIVE: To assess the quality and relevance of adverse drug reactions (ADRs) published as Letters to the Editor (LE) in Spanish medical journals. DESIGN: Observational study. PARTICIPANTS: LE on adverse drug reactions published over 5 years (1994-98). SETTING: Four Spanish medical journals (Medicina Clínica, Revista Clínica Española, Atención Primaria and Anales de Medicina Interna). MAIN MEASUREMENTS: Patient characteristics, drugs, ADR, causality algorithm, minimum criteria, and publication relevance. RESULTS: Out of 2244 LE, 204 (9.1%) reported ADRs, which included 235 cases. The therapeutic subgroups most commonly implicated were anticoagulants and antiplatelet drugs, antibiotics, and antineoplastic agents; 20.4% of the drugs were recently marketed. ADRs most commonly involved the nervous system (13.6%), liver (10.2%), skin and appendages (9.8%), general reactions (9.8%), and the digestive system (8.1%). The reactions were moderate in 50.2% of cases and severe/fatal in 34%. The mean causality algorithm value (5.9+/-2.2) was similar among journals. Of the ADRs, 28 (11.9%) were definitive, 182 (77%) possible or probable, and 26 (11.1%) improbable or conditional; 10.2% were unknown. There were no differences in the mean minimum publication criteria (9.5+/-1.2). Publication relevance was 3.2+/-1.6 points, and higher in Medicina Clínica. CONCLUSIONS: ADRs constitute an important part of LE in the journals studied. The causal relationship is acceptable, the documentation quality is high, with few unknown reactions and ADRs to recently marketed drugs. Relevance is generally low, although greater in Medicina Clínica.

Calidad de la publicación de reacciones adversas a medicamentos en la sección de Cartas al Director / Quality of the publication of adverse drug reactions in the letters to the editor section

Objetivo. Conocer la calidad y la relevancia de las reacciones adversas a medicamentos (RAM) publicadas como Cartas al Director en las revistas médicas españolas. Diseño. Estudio descriptivo. Participantes. Cartas al director sobre RAM aparecidas durante 5 años (1994-98). Emplazamiento. Cuatro revistas españolas (Medicina Clínica, Revista Clínica Española, Atención Primaria y Anales de Medicina Interna). Mediciones principales. Las características de los pacientes, de los medicamentos, de las reacciones adversas, el algoritmo de causalidad, los criterios mínimos y la relevancia de la publicación. Resultados. De 2.244 cartas, 204 (9,1%) se referían a RAM e incluían 235 casos. Los subgrupos terapéuticos más implicados fueron: anticoagulantes y antiplaquetarios, antibióticos y antineoplásicos. El 20,4% de los medicamentos era reciente. Las RAM más frecuentes afectaron al sistema nervioso (13,6%), el hígado (10,2%), la piel y anejos (9,8%), reacciones generales (9,8%) y aparato digestivo (8,1%). El 50,2% fueron moderadas y el 34%, graves/mortales. El valor medio (5,9 ± 2,2) del algoritmo de causalidad fue similar entre revistas; las RAM fueron: 28 (11,9%) definidas, 182 (77%) posibles o probables y 26 (11,1%) improbables o condicionales; el 10,2% eran desconocidas. No se detectaron diferencias en la media (9,5 ± 1,2) de criterios mínimos de publicación. La relevancia de la publicación fue de 3,2 ± 1,6 puntos, superior en Medicina Clínica. Conclusiones. La publicación de RAM supone una parte importante de la sección de Cartas al Director en las revistas estudiadas. La relación de causalidad es aceptable y la calidad documental elevada, con pocas reacciones desconocidas y a medicamentos recientes. La relevancia ha sido escasa, aunque superior en Medicina Clínica

Objective. To assess the quality and relevance of adverse drug reactions (ADRs) published as Letters to the Editor (LE) in Spanish medical journals. Design. Observational study. Participants. LE on adverse drug reactions published over 5 years (1994-98). Setting. Four Spanish medical journals (Medicina Clínica, Revista Clínica Española, Atención Primaria, and Anales de Medicina Interna). Main measurements. Patient characteristics, drugs, ADR, causality algorithm, minimum criteria, and publication relevance. Results. Out of 2,244 LE, 204 (9.1%) reported ADRs, which included 235 cases. The therapeutic subgroups most commonly implicated were anticoagulants and antiplatelet drugs, antibiotics, and antineoplastic agents; 20.4% of the drugs were recently marketed. ADRs most commonly involved the nervous system (13.6%), liver (10.2%), skin and appendages (9.8%), general reactions (9.8%), and the digestive system (8.1%). The reactions were moderate in 50.2% of cases and severe/fatal in 34%. The mean causality algorithm value (5.9±2.2) was similar among journals. Of the ADRs, 28 (11.9%) were definitive, 182 (77%) possible or probable, and 26 (11.1%) improbable or conditional; 10.2% were unknown. There were no differences in the mean minimum publication criteria (9.5±1.2). Publication relevance was 3.2±1.6 points, and higher in Medicina Clínica. Conclusions. ADRs constitute an important part of LE in the journals studied. The causal relationship is acceptable, the documentation quality is high, with few unknown reactions and ADRs to recently marketed drugs. Relevance is generally low, although greater in Medicina Clínica

[Inadequate demand in a pediatric hospital emergency department: factors involved]. / Demanda inadecuada a un servicio de urgencias pediátrico hospitalario: factores implicados.

BACKGROUND: The massification of pediatric hospital emergency departments (PED) is due to bad use of the same by a large number of users. The causes related with this inadequate use have not been properly evaluated. METHODS: A sample representative of the population demanding medical care in a PED of a regional hospital was studied with the motives and sociodemographic and cultural factors presumably related with this inadequate demand being analyzed. RESULTS: 52% of the cases had had no previous contact with the primary level of health care and 79% had gone to the PED on their own initiative. With regard to consultations, 65.0 +/- 4.8% were catalogued as inadequate and a statistical relation was found with the age of the patient (less than one year), place of residence (urban) and the arrival by initiative of the patients themselves. CONCLUSIONS: Pediatric hospital emergency departments receive a high number of inadequate consultations at the second level of health care. The importance of the age of the patient, accessibility of pediatric hospital emergency departments and who takes the initiative to come must be emphasized as predictive variables of the bad use of these pediatric departments.

[Wilson's disease: difficulties in diagnosis and therapeutic management in our country]. / Enfermedad de Wilson: dificultades en el diagnóstico y manejo terapéutico en nuestro país.

The clinical analytical and therapeutic results of a retrospective study of 11 cases of Wilson's disease carried out in "La Fe" Hospital in Valencia are presented. The disease had a neurological onset in 5 cases, an hepatic onset in 4 cases (3 acute hepatitis and 1 chronic hypertransaminemia), 2 cases started as an acute hemolytic anemia; one of the outbreaks occurred during a period of treatment interruption. Diagnosis showed some difficulty in one case since the disease was associated with positive hepatitis B markers, positive anti HIV antibodies and initially normal ceruloplasminemia values. The diagnostic difficulties derived from the interpretation of ceruloplasminemia, and blood and urine copper levels are pointed out as well as the difficulties encountered in our environment to determine intrahepatic copper levels and to perform a kinetic study with radioactive copper both of which are of vital importance to confirm doubtful cases. Two patients became pregnant in the course of the disease having normal pregnancies and deliveries, without any apparent abnormalities in the newborns. Treatment with D-Penicillamine was started in 9 cases, observing a low to moderate intolerance in 7 cases; there was one case of severe intolerance for which treatment had to be interrupted. The new therapeutical approaches based on the use of trientine (not available in our country) are discussed, together with the expectations of liver transplant in this disease.