Prescrire international
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Benfluorex is an amphetamine appetite suppressant derived from fenfluramine. In France, about 30 cases of pulmonary arterial hypertension and a similar number of valve disorders, often involving several valves, were reported between 1998 and 2009. ⋯ The French National Pharmacovigilance Committee simply proposed "to await the results of planned and ongoing studies". However, it would be in patients' best interests to withdraw this drug from the market.
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Prescrire international · Dec 2009
Complex regional pain syndrome type 1. Some treatments assessed versus placebo, limited efficacy.
(1) Complex regional pain syndrome type 1 generally occurs after trauma and usually affects a limb; (2) How is complex regional pain syndrome type 1 diagnosed? What is its natural course? How safe and effective are available treatments? To answer these questions, we reviewed the literature using the standard Prescrire methodology; (3) Diagnosis is mainly based on clinical features, including pain disproportionate to the initial trauma, associated with cutaneous vasomotor, trophic and sweating disorders; (4) Some clinical signs call for additional examinations to help rule out another vascular, neurological, infectious or rheumatic disorder. Radiological evidence of bone demineralisation supports the diagnosis, but radiography, magnetic resonance imaging (MRI) and scintigraphy generally contribute little to the diagnosis of complex regional pain syndrome; (5) Some patients recover spontaneously after a few weeks, while others develop chronic pain or even severe disability after a period of years; (6) The results of small placebo-controlled trials suggest that corticosteroids are effective during the initial phase of this syndrome; (7) A very high oral dose of alendronic acid provided sustained pain relief in a randomised trial. Other studies suggest that bisphosphonates have some impact. ⋯ These methods have not been comparatively evaluated; (14) In practice, there is no truly effective treatment for complex regional pain syndrome. The few beneficial treatments have not been directly compared with one another. The advantages and disadvantages of the various treatment options must be discussed with each patient.
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(1) When an antidepressant is considered a necessary addition to psychological support in treating patients with depression, the first-line drug is a tricyclic such as clomipramine or a selective serotonin reuptake inhibitor (SSRI) such as paroxetine; (2) Agomelatine, a melatonin receptor agonist, is approved in the European Union for the treatment of depression; (3) Available evaluation does not include any clinical trials designed to compare the efficacy of agomelatine with that of a tricyclic or a selective serotonin reuptake inhibitor. Most data come from 7 placebo-controlled trials; (4) Agomelatine (25 mg/day) was statistically more effective (on a rating scale) than placebo in only 3 of these 7 trials. The clinical relevance of the score improvements is questionable. ⋯ Dizziness, gastrointestinal and cutaneous disorders have been observed. Agomelatine is probably hepatotoxic; (8) In summary, agomelatine has unproven efficacy and poorly documented adverse effects. It is better to continue to use older antidepressants such as tricyclics or serotonin reuptake inhibitors.