Assessing bias in studies of harms: a case study of Primodos and congenital malformations

  In a recent systematic review, we assessed the use of Primodos, an oral hormone pregnancy test (HPT) marketed between 1958 and 1978, and the associated risk of congenital malformations. This post discusses the assessment of quality in assessing associations of harms.  Carl Heneghan We found oral HPTs in pregnancy was associated with an increased […]

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Gender-affirming hormone in children and adolescents

  Gender dysphoria occurs when a person experiences discomfort or distress because of a mismatch between their biological sex and gender identity.  Gender dysphoria can arise in childhood and adolescent which raises many questions about how best to handle the condition. This post sets out the current evidence for gender-affirming hormones in adolescents and children […]

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Pregabalin in neuropathic pain

Pregabalin has some beneficial effects in the management of neuropathic pain. However, there is an increased risk of adverse events and discontinuation because of adverse events. Igho Onakpoya In our recent systematic review [1], we searched for evidence from human trials that compared pregabalin with dummies in patients with neuropathic pain. We included studies of neuropathic […]

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Updated EU Medical Device Regulations: do they make a difference?

  I’ve taken a look at the new EU medical device regulation including the clinical evidence required, the postmarketing data needed and the proposed device database and how it might be interpreted. Carl Heneghan The International Consortium of Investigative Journalist (ICIJ) has published the “Implant Files.” Their global investigation, which I’ve been a part of,  […]

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