Phlebotonics for venous insufficiency.

BACKGROUND: Chronic venous insufficiency (CVI) is a common condition caused by valvular dysfunction with or without associated obstruction, usually in the lower limbs. It might result in considerable discomfort with symptoms such as pain, itchiness and tiredness in the legs. Patients with CVI may also experience swelling and ulcers. Phlebotonics are a class of drugs often used to treat CVI. This is an update of a review first published in 2005. OBJECTIVES: To assess the efficacy and safety of phlebotonics administered both orally and topically for treatment of signs and symptoms of lower extremity CVI. SEARCH METHODS: For this update, the Cochrane Vascular Trials Search Co-ordinator (TSC) searched the Specialised Register (August 2015), as well as the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 7). The reference lists of the articles retrieved by electronic searches were searched for additional citations. We also contacted pharmaceutical companies and searched the World Health Organization (WHO) International Clinical Trials Registry Platform Search Portal for ongoing studies (last searched in August 2015). SELECTION CRITERIA: Randomised, double-blind, placebo-controlled trials (RCTs) assessing the efficacy of rutosides, hidrosmine, diosmine, calcium dobesilate, chromocarbe, Centella asiatica, disodium flavodate, french maritime pine bark extract, grape seed extract and aminaftone in patients with CVI at any stage of the disease. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the quality of included RCTs. We estimated the effects of treatment by using risk ratios (RRs), mean differences (MDs) and standardised mean differences (SMDs), according to the outcome assessed. We calculated 95% confidence interval (CIs) and percentage of heterogeneity (I(2)). Additionally, we performed sensitivity analyses. MAIN RESULTS: We included 66 RCTs of oral phlebotonics, but only 53 trials provided quantifiable data (involving 6013 participants; mean age 50 years) for the efficacy analysis: 28 for rutosides, 10 hidrosmine and diosmine, nine calcium dobesilate, two Centella asiatica, two aminaftone, two french maritime pine bark extract and one grape seed extract. No studies evaluating topical phlebotonics, chromocarbe, naftazone or disodium flavodate fulfilled the inclusion criteria.Moderate-quality evidence suggests that phlebotonics reduced oedema in the lower legs compared with placebo. Phlebotonics showed beneficial effects among participants including reduced oedema (RR 0.70, 95% CI 0.63 to 0.78; I(2) = 20%; 1245 participants) and ankle circumference (MD -4.27 mm, 95% CI -5.61 to -2.93 mm; I(2) = 47%; 2010 participants). Low-quality evidence reveals no difference in the proportion of ulcers cured with phlebotonics compared with placebo (RR 0.94, 95% CI 0.79 to 1.13; I(2) = 5%; 461 participants). In addition, phlebotonics showed greater efficacy for trophic disorders, cramps, restless legs, swelling and paraesthesia, when compared with placebo. We identified heterogeneity for the variables of pain, itching, heaviness, quality of life and global assessment by participants. For quality of life, it was not possible to pool the studies because heterogeneity was high. However, high-quality evidence suggests no differences in quality of life for calcium dobesilate compared with placebo (MD -0.60, 95% CI -2.15 to 0.95; I(2) = 40%; 617 participants), and low-quality evidence indicates that in the aminaftone group, quality of life was improved over that reported in the placebo group (MD -10.00, 95% CI -17.01 to - 2.99; 79 participants). Moderate-quality evidence shows that the phlebotonics group had greater risk of non-severe adverse events than the placebo group (RR 1.21, 95% CI 1.05 to 1.41; I(2) = 0; 3975 participants). Gastrointestinal disorders were the most frequently reported adverse events. AUTHORS' CONCLUSIONS: Moderate-quality evidence shows that phlebotonics may have beneficial effects on oedema and on some signs and symptoms related to CVI such as trophic disorders, cramps, restless legs, swelling and paraesthesia when compared with placebo but can produce more adverse effects. Phlebotonics showed no differences compared with placebo in ulcer healing. Additional high-quality RCTs focused on clinically important outcomes are needed to improve the evidence base.

[Teaching Bioethics to Students of Medicine with Problem-Based Learning (PBL)]. / Enseñar Bioética a Estudiantes de Medicina Mediante el Aprendizaje Basado en Problemas (ABP).

We present the experience of the introduction of the subject of bioethics in a medical school in order to give to the 73 students of 5th degree skills to handle ethical conflicts in their practice. The main teaching method used was problem-based learning (PBL). Skills objectives are described. The course was structured with a theoretical seminar (2 hours of duration), a workshop (2 hours of duration), 4 cases of PBL (24 hours of duration in total) and a role playing workshop (2 hours of duration). The seminar was aimed at the acquisition of theoretical knowledge. The PBL cases provided critical appraisal, obtaining knowledge, and application. The Role Playing set out for the practical demonstration of skills acquired in a simulated environment. A continuous assessment of students was performed throughout their practice on the PBL cases (40% of the final score) and also a final evaluation of the course was carried out via exam (60% of the final score). Students completed a course and faculty evaluation anonymously, which came out with positive results (median score of 8.5/10).

Preliminary efficacy and safety of an oromucosal standardized cannabis extract in chemotherapy-induced nausea and vomiting.

AIMS: Despite progress in anti-emetic treatment, many patients still suffer from chemotherapy-induced nausea and vomiting (CINV). This is a pilot, randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the tolerability, preliminary efficacy, and pharmacokinetics of an acute dose titration of a whole-plant cannabis-based medicine (CBM) containing delta-9-tetrahydrocannabinol and cannabidiol, taken in conjunction with standard therapies in the control of CINV. METHODS: Patients suffering from CINV despite prophylaxis with standard anti-emetic treatment were randomized to CBM or placebo, during the 120 h post-chemotherapy period, added to standard anti-emetic treatment. Tolerability was measured as the number of withdrawals from the study during the titration period because of adverse events (AEs). The endpoint for the preliminary efficacy analysis was the proportion of patients showing complete or partial response. RESULTS: Seven patients were randomized to CBM and nine to placebo. Only one patient in the CBM arm was withdrawn due to AEs. A higher proportion of patients in the CBM group experienced a complete response during the overall observation period [5/7 (71.4%) with CMB vs. 2/9 (22.2%) with placebo, the difference being 49.2% (95% CI 1%, 75%)], due to the delayed period. The incidence of AEs was higher in the CBM group (86% vs. 67%). No serious AEs were reported. The mean daily dose was 4.8 sprays in both groups. CONCLUSION: Compared with placebo, CBM added to standard antiemetic therapy was well tolerated and provided better protection against delayed CINV. These results should be confirmed in a phase III clinical trial.

Scientific drug information in newspapers: sensationalism and low quality. The example of therapeutic use of cannabinoids.

OBJECTIVE: We aimed to analyse the quality of newspaper articles (NAs) concerning the therapeutic use of cannabis published in Spanish newspapers. METHODS: A preliminary questionnaire of the Index of Scientific Quality was used [scores ranged from 0 (no misleading) to 14 (misinformation in each item)]. RESULTS: Of the 29 NAs analysed, 16 (55.2%) were scored as 4 or lower, and 6 (20.7%) scored 7 or higher. Up to 23 NAs (79.3%) did not manage the knowledge related to cannabinoids; 20 (69%) gave a sensationalist message; 11 (37.9%) were able to wrongly influence clinical decision taking; and 8 (27.6%) misled medical concepts. CONCLUSION: The leading medical journals could play an especially relevant role while preparing their press releases if they specify study limitations and context.

Uso terapéutico del cannabis: resultados de una entrevista prospectiva en Cataluña / Therapeutic use of cannabis: results of a prospective survey in Catalonia (Spain)

No disponible

[News about therapeutic use of Cannabis and endocannabinoid system]. / Novedades sobre las potencialidades terapéuticas del Cannabis y el sistema cannabinoide.

Growing basic research in recent years led to the discovery of the endocannabinoid system with a central role in neurobiology. New evidence suggests a therapeutic potential of cannabinoids in cancer chemotherapy-induced nausea and vomiting as well as in pain, spasticity and other symptoms in multiple sclerosis and movement disorders. Results of large randomized clinical trials of oral and sublingual Cannabis extracts will be known soon and there will be definitive answers to whether Cannabis has any therapeutic potential. Although the immediate future may lie in plant-based medicines, new targets for cannabinoid therapy focuses on the development of endocannabinoid degradation inhibitors which may offer site selectivity not afforded by cannabinoid receptor agonists.

Novedades sobre las potencialidades terapéuticas del Cannabis y el sistema cannabinoide / News about therapeutic use of Cannabis and endocannabinoid system

Durante la última década una rica investigación básica ha permitido caracterizar el sistema cannabinoide. Comienzan a acumularse pruebas de que los cannabinoides podrían ser eficaces en el tratamiento de las náuseas y vómitos por quimioterápicos antineoplásicos, el dolor, la espasticidad y otros síntomas de la esclerosis múltiple y algunas alteraciones del movimiento. Hay que esperar la publicación de los resultados de los ensayos clínicos en curso con extractos de Cannabis por vía oral y sublingual para definir de manera precisa su lugar en terapéutica en estas y otras indicaciones. Actualmente se están desarrollando nuevas vías de administración como la rectal, sublingual o transdérmica para evitar los efectos perjudiciales del humo del Cannabis fumado. Aunque el futuro inmediato parece basarse en medicamentos derivados directamente del Cannabis, la investigación actual tiende a desarrollar por un lado nuevos fármacos que actúen potenciando o inhibiendo los efectos de los cannabinoides endógenos y por otro, fármacos sintéticos agonistas y antagonistas de los receptores cannabinoides (AU)