Placebo: a brief updated review.

Our aims were to provide updated information on placebo/nocebo effect and the potential use of placebo in clinical practice. This article can only provide a rough overview on the placebo and nocebo effect and is intended to serve as a starting point for the reader to go deeper into the corresponding literature. The placebo effect has been observed in multiple medical conditions, after oral administration, with manual therapies as well as with surgery and invasive procedures. The use of placebo in clinical trials is fundamental, although the ethics of its use is under discussion. The placebo may behave like a drug from the pharmacokinetic and pharmacodynamic point of view and can also be associated with adverse events (nocebo effect). Placebo can modify treatment by increasing or decreasing the effects of drugs. The factors associated with the occurrence of placebo effect are multiple, but in addition to those that depend on the placebo itself, the doctor-patient relationship would be the most important. As a result of findings that were published in the last two decades, the psycho-neurobiological basis of placebo is becoming better understood, although further studies are needed. In conclusion, the placebo effect in the clinic exhibits weak to moderate intensity. Placebo, in addition to its use in the clinical trial, should be considered another therapeutic remedy either as stand alone or in association with treatment, and could be useful in certain circumstances. The use of placebo should be regulated by the European health authorities through a guide in clinical practice that will improve patient care.

The impact of PIPs on mortality and readmissions in older adults: a retrospective cohort study.

PURPOSE: Our aim was to determine the impact of potentially inappropriate prescriptions (PIP), according to "Screening Tool of Older Persons' Prescriptions" criteria version 2 (STOPP-2), on mortality and hospital admissions. METHODS: Monocentric retrospective cohort study. Patients over 65 years of age and who were consecutively discharged from internal medicine at a Spanish university hospital in 2016 were included. The mortality and hospital admissions of the cohort of patients were analysed using their electronic health records within two years from the time of discharge. Analysis was done based on the type and number of STOPP-2 criteria as well as taking into account the total number of medications. The subdistribution hazard ratios (SHR) were estimated through a competing proportional hazards model. RESULTS: A total of 270 patients with a median age of 82 years (interquartile range/IQR 76-86 years), and 152 (56.3%) women were studied. It was found out that 28.3% of patients with PIP died compared to 17.2% of patients without it. Digoxin (B1 STOPP-2 criterion) with a subdistribution hazard ratio (SHR) 2.40 (95% CI 0.63-9.18), selective serotonin re-uptake inhibitors/SSRIs (D4) with a SHR 1.76 (95% CI 0.52-5.96) and neuroleptic drugs (K2) with a SHR 2.01 (95% CI 0.82-4.95) non-significantly increased the risk of death. Dementia (SHR 5.45; 95% CI 2.76-10.78) was then the only statistically significant risk factor for death. Sixty percent of patients with a PIP had shown at least one hospital admission compared to 51% of patients without it. The number of drugs at discharge (SHR 1.03; 95% CI 1.01-1.05) and having 1-2 STOPP-2 criteria (SHR 1.17; 95% CI 1.02-1.35) significantly increased the risk of hospital admission. CONCLUSION: The number of drugs at discharge and having any STOPP criteria significantly increased the risk of hospital admission in this cohort. PIP, only according to some specific STOPP-2 criteria involving digoxin, neuroleptics and SSRIs, might associate with a statistically non-significantly higher risk on mortality.

Comparative study of adverse drug reactions among direct-acting oral anticoagulants and vitamin K antagonists using the EudraVigilance database.

Our aim was to compare adverse drug reactions (ADRs) associated with direct-acting oral anticoagulants and vitamin K antagonists from the European EudraVigilance (EV) database. The EV database is the system for the analysis of information on suspected ADRs that are authorised, or being evaluated in clinical trials, in the European Economic Area. Registered ADRs (from the groups "Gastrointestinal disorders", "General disorders and administration site conditions", "Injury, poisoning and procedural complications", "Nervous system (NS) disorders" and "Vascular disorders") for apixaban, rivaroxaban, dabigatran and vitamin K antagonists (VKA) were collected by age group (< 65 years; 65-85 years and > 85 years) and by sex. The proportional reporting ratio (PRR) was used to compare ADRs in relation to the anticoagulants tested. A total of 274,693 ADRs were analysed. For gastrointestinal ADRs, patients treated with rivaroxaban and dabigatran (PRR 2.17 and 2.51, respectively) were at significantly higher risks than those treated with apixaban and VKA (PRR 1.27 and 1.47, respectively), while risks for vascular disorders were increased by all anticoagulants that were tested. Lastly, none of the anticoagulants significantly increased the risk of ADRs within the NS group. Rivaroxaban and dabigatran were associated with a significantly higher risk of gastrointestinal ADR than apixaban or VKA. All anticoagulants increased the risk of vascular pathology while none of them demonstrated significant increased risk of ADR to NS.

Potentially inappropriate prescribing according to STOPP-2 criteria among patients discharged from Internal Medicine: prevalence, involved drugs and economic cost.

AIM: This study aims to determine the prevalence of potentially inappropriate prescribing (PIP) among patients discharged from Internal Medicine, the drugs and factors associated and economic cost of PIP. METHODS: This retrospective cross-sectional, single-center study included participants aged ≥65 years consecutively discharged from the Internal Medicine Unit in a tertiary hospital of Southern Spain. PIP was defined by the Screening Tool for Older Persons Prescriptions (STOPP-2) criteria version 2 (2015 update). The association of PIP with chronic conditions was analyzed using multilevel logistic regression model. Data on economic cost associated to PIP were determined according to the computerized prescribing database of Andalusia ("Receta XXI"). RESULTS: Out of the 275 patients studied, a total of 249 PIPs were detected in 114 (41.5%) patients of whom 79 (28.7%) had one or two STOPP-2 criteria and 35 (12.7%) 3 or more criteria. The most involved drugs were benzodiazepines (45.5%); antithrombotics (14.5%), including anticoagulants or antiplatelets, and opioids (11.4%). The multivariate logistic regression analysis identified polypharmacy (OR=11.00; 95% CI 1.41-85.52) and extreme polypharmacy (OR=26.25; 95% CI 3.34-206.07) as independent risk factors for PIP. The mean cost of PIP was €18.75±4.24 per patient and month. Opioids accounted for the highest percentage expenditure of PIP (39.02%), followed by inhaled bronchodilator drugs (30.30%), antithrombotics (12.20%) and benzodiazepines (7.92%). CONCLUSIONS: PIP is frequent among patients discharged from Internal Medicine. The number of prescribed drugs was independently associated to PIP and benzodiazepines were the most involved drugs. PIP was associated to a significant economic cost.

Drug-related mortality among inpatients: a retrospective observational study.

PURPOSE: Hospital mortality related to adverse drug reactions (ADRs) is a relevant clinical problem with major health and economic consequences. We conducted a study to assess hospital mortality related to ADRs, the drugs most frequently involved, and the possible risk factors associated with fatal ADRs. METHODS: A retrospective observational study was conducted, reviewing the clinical records of 1388 consecutive adult patients (18-101 years) who died during a 22-month period in a tertiary hospital in Southern Europe (Granada, Spain). The main outcome was the prevalence of hospital death suspected to be related to administered drugs. RESULTS: Out of the 1388 adult deaths studied, 256 (18.4 %) were suspected of being related to drugs. Drugs were suspected of causing death in 146 inpatients (10.5 %) and contributing to death in 110 (7.9 %). Drugs related to death were administered during the hospital stay in 161 cases (11.5 %) and before hospital admission in 95 (6.84 %). The most frequent fatal ADRs were cardiac arrhythmia, gastrointestinal bleeding, and respiratory failure. The drugs most frequently involved in fatal ADRs were antithrombotics (anticoagulants or antiplatelets) (23 %), psychotropic drugs (21.2 %), and digoxin (11.3 %). Independent risk factors for ADR-related death were the presence of ≥4 diseases (OR = 1.43) and the receipt of ≥10 drugs (OR = 3.24), but no significant association with gender or age was found. CONCLUSIONS: A high percentage of hospital deaths were suspected of being associated with ADRs, especially in patients with comorbidity and/or polypharmacy. Antithrombotics, psychotropics, and digoxin were the drugs most frequently associated with in-hospital drug-related deaths.

Fever of unknown origin and leukemoid reaction as initial presentation of adult-onset Still's disease.

Adult Still's Disease has been reported as cause of Fever of Unknown Origin. Leukocytosis has been described as a common haematological abnormality in Adult Still's Disease. In some rare cases, leukemoid reaction has been reported associated to Still's Disease. We report the case of Adult Still's Disease presenting as Fever of Unknown Origin and leukemoid reaction in a patient with Down Syndrome. The patient needed high dosage of corticosteroids to control the disease and haematological findings.

Respuesta favorable al uso de inmunoglobulinas intravenosas en la mielinólisis central pontina / Favourable response to the use of intravenous immunoglobulins in central pontine myelinolysis

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[Favourable response to the use of intravenous immunoglobulins in central pontine myelinolysis]. / Respuesta favorable al uso de inmunoglobulinas intravenosas en la mielinolisis central pontina.

TITLE: Respuesta favorable al uso de inmunoglobulinas intravenosas en la mielinolisis central pontina.