Eficacia de la terapia herbal con melisa y valeriana en la deshabituación de benzodiacepinas en pacientes con insomnio primario / Efficacy of herbal therapy with melissa and valerian to treat benzodiazepine dependence in patients with primary insomnia

Introducción. La utilización de benzodiacepinas en pacientes con insomnio es una práctica habitual, y no es infrecuente una cierta inercia terapéutica que puede prolongar su consumo durante meses e incluso años. Aunque sus beneficios a corto plazo son evidentes, su uso prolongado conlleva a menudo un cierto grado de neuroadaptación, por ello disminuir los síntomas de abstinencia durante la retirada es importante para conseguir un mayor éxito en el abandono del fármaco. El uso de la terapia herbal puede ayudar a conseguir dichos objetivos. El objetivo del presente estudio es valorar la eficacia de la combinación valeriana y melisa en la mejoría de dichos síntomas y sobre los parámetros de sueño. Sujetos y métodos Estudio experimental randomizado con existencia de grupo control y sin enmascaramiento, realizado en la Clínica de Sueño Estivill sobre una muestra de 50 pacientes con insomnio primario, en tratamiento con 1 mg de lorazepam entre 6 meses y 2 años anteriores a su entrada en el estudio, que fueron asignados paritariamente a un grupo intervención (GI), que recibió una combinación de 120mg de extracto valeriana y 80 mg de extracto de melisa y a un grupo control (GC) realizándose visitas de seguimiento en consulta y autoregistros semanales para valorar parámetros relacionados con la calidad del sueño y descanso, así como la evolución de la sintomatología asociada más frecuentemente al abandono del fármaco. Resultados. Tras un seguimiento de 90 días, el grupo sometido a terapia herbal presentó una menor proporción de sujetos que manifestaron ansiedad ( GI 59%; GC 77%), irritabilidad ( GI 54%; GC 84%), inquietud (GI 52%; GC 62%) y trastornos del ánimo (GI 43%; GC 64%), así como un menor predominio de formas moderadas o severas en su presentación. Del mismo modo, el grupo tratado experimentó una disminución en el tiempo necesario para conciliar el sueño y de la vigilia intrasueño, así como un mayor tiempo de descanso medio tras la retirada, comparado con el grupo control. Aunque en el grupo tratado existió una mayor proporción de pacientes que manifestaron una mayor calidad en el sueño, y del descanso obtenido, las diferencias observadas no obtuvieron significación estadística. Conclusiones. A pesar de las limitaciones del estudio, los presentes resultados sugieren que la terapia herbal proporciona una mejoría subjetiva de la calidad de ciertos parámetros de sueño y de la presentación y severidad de los síntomas asociados a la retirada de benzodiacepinas en pacientes con insomnio primario, pudiendo constituir una alternativa eficaz en su abordaje (AU)

Introduction. The use of benzodiazepines in patients with insomnia is common practice, and it is not unusual to detect a degree of therapeutic inertia that can prolong the consumption of these agents for months or even years. Although they have clear short-term benefits, prolonged use often leads to a degree of neuroadaptation; it is therefore important to reduce the symptoms of abstinence during withdrawal in order to achieve greater success in the discontinuation of treatment. The use of herbal therapy can help to achieve these aims. The objective of the present study was to evaluate the efficacy of a combination of Valerian and Melissa on the reduction of symptoms of withdrawal and the effect of this combination on sleep parameters. Subjects and methods This was a randomised, controlled, unblinded experimental study performed in the Estevill Sleep Clinic on a sample of 50 patients with primary insomnia and on treatment with 1 mg of lorazepam for between 6 months and 2 years prior to recruitment. Patients were assigned in a 1-to-1 ratio to the intervention group (IG), which received a combination of 120 mg of extract of Valerian and 80 mg of extract of Melissa, or to the control group (CG). Outpatient follow-up visits and weekly patient diaries were used to evaluate the parameters related with the quality of sleep and rest and the severity of symptoms most commonly associated with drug withdrawal. Results. After a follow-up of 90 days, fewer subjects in the group receiving herbal therapy reported anxiety (IG, 59%; CG, 77%), irritability (IG, 54%; CG, 84%), restlessness (IG, 52%; CG, 62%), or mood disorders (IG, 43%; CG, 64%), and a smaller proportion of this group suffered moderate or severe forms of these symptoms. In addition, the IG presented a shorter time to onset of sleep and fewer episodes of waking compared with the CG, as well as a greater mean duration of sleep after withdrawal. Although a larger proportion of patients in the IG reported a better quality of sleep and of derived rest, the differences observed did not reach statistical significance. Conclusions. Despite the limitations of the study, the results suggest that herbal therapy gives rise to a subjective improvement in the quality of certain sleep parameters and a reduction in the onset and severity of symptoms associated with benzodiazepine withdrawal in patients with primary insomnia. This treatment could constitute an effective option in the management of benzodiazepine withdrawal (AU)

Treatment of restless legs syndrome with pregabalin: a double-blind, placebo-controlled study.

OBJECTIVES: To assess the therapeutic efficacy, required dose, and tolerability of pregabalin in patients with idiopathic restless legs syndrome (RLS). METHODS: This was a double-blind, placebo-controlled trial with polysomnographic control, providing Class II evidence. Ninety-eight patients underwent a 2-week single-blind period with placebo; 58 were randomized to receive pregabalin or placebo for 12 weeks under a flexible-dose schedule. Endpoints were mean change from baseline in the International Restless Legs Scale (IRLS) total score, Clinical Global Impression (CGI), and RLS-6 scales, as well as changes in periodic limb movements (PLMs) and sleep architecture. RESULTS: Patients under treatment with pregabalin had a greater improvement in IRLS score than under placebo (63% vs 38.2%; p < 0.05). The mean effective dose of pregabalin at the end of treatment was 322.50 mg/day (+/-98.77), although therapeutic effects were already seen at a mean dose of 139 mg/day. Similarly, improvements were observed on the CGI, RLS-6 scale, and the Medical Outcomes Study sleep scale (all p < 0.01) when compared to placebo. Treatment with pregabalin also resulted in a reduction of the mean (+/-SD) PLM index (p < 0.001). Furthermore, there was a marked improvement in sleep architecture with an increase in slow wave sleep (p < 0.01), and decreases in wake after sleep onset and stages 1 and 2 (p < 0.05). Pregabalin was generally well-tolerated. Adverse events were mild but common, and included unsteadiness, daytime sleepiness, and headache. CONCLUSIONS: This study shows significant therapeutic effects of pregabalin on both sensorial and motor symptoms in restless legs syndrome. Treatment with pregabalin was associated with an improvement of sleep architecture and periodic limb movements. Adverse events included unsteadiness and sleepiness and should be screened carefully in the working population, particularly when pregabalin is administered in the afternoon. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that pregabalin is effective for the treatment of restless legs syndrome and improves sleep architecture and periodic limb movements in placebo-unresponsive patients.

Traducción validada al español de cuestionarios de evaluación de pacientes con síndrome de piernas inquietas / Validated translation to Spanish of the evaluation questionnaire of patients with restless legs syndrome

Introducción. El síndrome de piernas inquietas (SPI) es un trastorno sensitivo y motor frecuente, caracterizado por una necesidad imperiosa de mover las piernas cuando el sujeto se encuentra sentado o tumbado, generalmente al final de la tarde o por la noche. Objetivo. Describir el proceso de adaptación al español de tres herramientas diferentes de estudio del SPI: los criterios para el diagnóstico, un cuestionario de detección de SPI por el clínico en atención primaria (Practitioner Screening Questionnaire, PSQ) y un conjunto básico de preguntas para estudios epidemiológicos (Basic Set of Questions for Epidemiological Studies, CBPEP). Se propone un procedimiento que puede ser adoptado para generar las herramientas en otros idiomas. Métodos. Se utilizó el método de traducción-retrotraducción. Participaron cinco traductores: dos para traducciones directas y dos para las inversas, y un quinto cuando se introdujeron cambios, trabajando de forma independiente en su lengua materna. Dos evaluadores expertos determinaron la equivalencia entre el instrumento original y la versión traducida. La comprensión de los cuestionarios adaptados fue evaluada mediante administración autoaplicada a una muestra de estudiantes y a otra administración heteroaplicada a pacientes con SPI. Resultados. El procedimiento seguido varió ligeramente según el uso previsto de cada instrumento: por profesionales de la salud (criterios de diagnóstico de una enfermedad) o para administración a pacientes (cuestionarios heteroaplicados o autoaplicados). El PSQ y CBPEP no presentaron importantes diferencias, tras su adaptación, con la versión original. Se ha buscado mantener la equivalencia conceptual para garantizar que el instrumento adaptado conservara la función y validez originales. Se utilizó una misma terminología en los diferentes instrumentos para proporcionarles coherencia si se usan conjuntamente. La versión española del PSQ ha ampliado el primer ítem con ejemplos de sensaciones para facilitar su comprensión por pacientes de diferentes partes de España. Conclusiones. Se han obtenido versiones españolas de tres cuestionarios como base para futuras validaciones psicométricas que permitan su uso en España. El instrumento adaptado en último lugar es el que mostró el mejor resultado, en cuanto a equivalencia, obtenido durante el proceso (AU)

Introduction. Restless legs syndrome (RLS) is a common sensory- motor condition, characterised by the irresistible need to move the legs while sitting or lying down, usually presenting late in the day, from the end of the afternoon into the night. Objective. To describe the translation process to Spanish of three different research RLS tools: the diagnosis criteria, the Practitioner Screening Questionnaire and the Basic Set of Questions for Epidemiological Studies. A procedure is proposed for the translation of these tools into other languages. Methods. The back translation method was employed. Five translators took part: two translated into their mother tongue and two into their foreign tongue, and once the translations were completed, a fifth independent translator introduced the changes using his mother tongue. Two expert analysts determined the equivalence between the original questionnaire and the translation. The clarity of the translated questionnaires was evaluated in a sample of students, who completed these themselves, and in RLS patients, for whom the doctor(s) or another authorised person filled them out. Results. The procedure undertaken varied according as to how each instrument were to be used either by health care professionals (diagnosis criteria) or to obtain information from patients (the questionnaire being directly completed by the patient directly or indirectly by a health care professional). No significant differences between the original and the translation of the practitioner screening questionnaire and the basic set of questions for epidemiological studies were found. The translators aimed to maintain concept equivalence function and validity of the original instrument were preserved in the trans lation. The same terminology was employed in the di fferent translations to make sure they were all consistent should they be used together. The Spanish version of the practitioner screening questionnaire has added terms to the first item by providing examples of sensations to ensure its understanding by patients from different parts of Spain. Conclusions. Spanish translated versions of three different questionnaires have been obtained to be used for RLS assessment in Spain, following appropriate psychometric validation. The instrument translated in the third place showed the closest equivalence with original (AU)

[Validated translation to Spanish of the evaluation questionnaire of patients with restless legs syndrome.]. / Traducción validada al español de cuestionarios de evaluación de pacientes con síndrome de piernas inquietas.

Introduction. Restless legs syndrome (RLS) is a common sensory- motor condition, characterised by the irresistible need to move the legs while sitting or lying down, usually presenting late in the day, from the end of the afternoon into the night. Objective. To describe the translation process to Spanish of three different research RLS tools: the diagnosis criteria, the Practitioner Screening Questionnaire and the Basic Set of Questions for Epidemiological Studies. A procedure is proposed for the translation of these tools into other languages. Methods. The back translation method was employed. Five translators took part: two translated into their mother tongue and two into their foreign tongue, and once the translations were completed, a fifth independent translator introduced the changes using his mother tongue. Two expert analysts determined the equivalence between the original questionnaire and the translation. The clarity of the translated questionnaires was evaluated in a sample of students, who completed these themselves, and in RLS patients, for whom the doctor(s) or another authorised person filled them out. Results. The procedure undertaken varied according as to how each instrument were to be used either by health care professionals (diagnosis criteria) or to obtain information from patients (the questionnaire being directly completed by the patient directly or indirectly by a health care professional). No significant differences between the original and the translation of the practitioner screening questionnaire and the basic set of questions for epidemiological studies were found. The translators aimed to maintain concept equivalence function and validity of the original instrument were preserved in the trans lation. The same terminology was employed in the di fferent translations to make sure they were all consistent should they be used together. The Spanish version of the practitioner screening questionnaire has added terms to the first item by providing examples of sensations to ensure its understanding by patients from different parts of Spain. Conclusions. Spanish translated versions of three different questionnaires have been obtained to be used for RLS assessment in Spain, following appropriate psychometric validation. The instrument translated in the third place showed the closest equivalence with original.

Tratamiento farmacológico del insomnio: ventajas e inconvenientes. Cómo sustituir la medicación hipnótica / Pharmacological treatment of insomnia: advantages and disadvantages. Replacing hypnotics

La prevalencia estimada indica que alrededor de un tercio de la población adulta manifiesta síntomas de insomnio, de los que en un 9-12% manifiestan consecuencias diurnas. De éstos, sólo el 10% son tratados de forma adecuada. El insomnio es la mayoría de las veces un síntoma. Descubrir la etiología será fundamental para aplicar un correcto tratamiento. Existe una alta comorbilidad entre el insomnio y otras patologías médicas. Además de las causas médicas, los factores sociales, del entorno, psicológicos, conductuales y cronobiológicos también pueden causar insomnio. Pero realmente, una de las causas más frecuentes de insomnio crónico es el llamado insomnio psicofisiológico. Consiste en la presencia de ansiedad diurna somatizada con la asociación de unos hábitos de sueño erróneos. El tratamiento del insomnio debe estar dirigido hacia la eliminación de la causa que produce el trastorno, y provocar una mejoría sintomática. El insomnio transitorio y de corta duración, puede ser tratado con fármacos hipnóticos. En el insomnio crónico siempre tendrá que tratarse la causa que lo produce y los fármacos hipnóticos se utilizarán como complemento. El insomnio crónico está asociado a un aumento del riesgo de depresión y un uso (o incluso abuso) crónico de hipnóticos (AU)

Estimates indicate that around one third of the adult population has insomnia symptoms, of which 9%-12% has diurnal consequences. Of these, only 10% receive adequate treatment. Insomnia is usually only a symptom. Discovering its etiology is fundamental in order to apply correct treatment .There is a high comorbidity between medical insomnia and other pathologies. In addition to medical causes, social, environmental, psychological, behavioral and chronobiological factors also can also cause insomnia. One of the frequent causes of chronic insomnia is psychophysical insomnia. It consists of the presence of externalized diurnal anxiety along with counterproductive sleep habits. The treatment of insomnia ust be directed towards the elimination of the causes that produce the problem, and to alleviate the symptoms. Transitory, shot term insomnia can be dealt with using hypnotics. In chronic insomnia, the root causes that produce it need to be treated and hypnotics us ed as a complement. Chronic insomnia is associated with an increased risk of depression and a chronic use (or even abuse) of hypnotics (AU)

[The use of olanzapine in sleep disorders. An open trial with nine patients]. / Uso de olanzapina en los trastornos del sueño. Estudio abierto con nueve pacientes.

INTRODUCTION: The impossibility of treating patients with sleep disorders adequately means that, as specialists, we have to look for new pharmacological treatments and for this reason we examined the information in the paper by Salin Pascual (1999) about the increase in deep sleep when olanzapine is used as an antipsychotic drug. CASE REPORTS: We decided to use this medication in six females and three males who were suffering from different sleep disorders that conditioned their chronic insomnia. The dosages of olanzapine used ranged from 2.5 and 10 mg in a single dose. The clinical history and progress were used to elaborate the results and conclusions. The result was positive in eight of the nine patients, five who were administered the medication as monotherapy and three as polytherapy. CONCLUSION: The population studied is insufficient to prove the effectiveness of the drug, but the fact that in eight of our patients the treatment clearly improved their symptoms leads us to think that this line of research must be continued.

Uso de la olanzapina en los trastornos del sueño. Estudio abierto con nueve pacientes / The use of olanzapine in sleep disorders. An open trialwWith nine patients

Introducción. La imposibilidad de tratar adecuadamente a los pacientes que presentan trastornos del sueño hace que los especialistas intentemos nuevas terapias farmacológicas, de acuerdo con la información del artículo de Salin-Pascual (1999) sobre el incremento del sueño profundo cuando se usaba la olanzapina como antipsicótico. Casos clínicos. Decidimos usar esta medicación en seis mujeres y tres varones, afectados de distintos problemas del sueño que condicionaban su insomnio crónico. Se utilizaron dosis de olanzapina que oscilaban entre los 2,5 y los 10 mg en dosis única. La anamnesis y la evolución clínica han sido nuestros criterios para elaborar los resultados y las conclusiones. El resultado fue positivo en ocho de los nueve pacientes, en cinco de ellos como monoterapia y en tres como politerapia. Conclusión. La población estudiada es insuficiente para establecer una probada eficacia del fármaco, pero el hecho de que en ocho de nuestros pacientes el tratamiento aportara una mejoría clara de la sintomatología, nos hace pensar que debe seguirse en esta línea de investigación (AU)

Introduction. The impossibility of treating patients with sleep disorders adequately means that, as specialists, we have to look for new pharmacological treatments and for this reason we examined the information in the paper by SalinPascual (1999) about the increase in deep sleep when olanzapine is used as an antipsychotic drug. Case reports. We decided to use this medication in six females and three males who were suffering from different sleep disorders that conditioned their chronic insomnia. The dosages of olanzapine used ranged from 2.5 and 10 mg in a single dose. The clinical history and progress were used to elaborate the results and conclusions. The result was positive in eight of the nine patients, five who were administered the medication as monotherapy and three as polytherapy. Conclusion. The population studied is insufficient to prove the effectiveness of the drug, but the fact that in eight of our patients the treatment clearly improved their symptoms leads us to think that this line of research must be continued (AU)

Spontaneous bacterial peritonitis due to Plesiomonas shigelloides.

Spontaneous bacterial peritonitis is a well known complication in cirrhotic patients with ascites. The etiological spectrum is broad. We report a case of spontaneous bacterial peritonitis due to Plesiomonas shigelloides.