Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial

Background Trials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to show if daily oral fluoxetine for 6 months after stroke improves functional outcome in an ethnically diverse population. Methods AFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial done in 43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten). Eligible patients were adults (aged ≥18 years) with a clinical diagnosis of acute stroke in the previous 2–15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more. Patients were randomly assigned 1:1 via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20 mg capsules or matching placebo for 6 months. Patients, carers, investigators, and outcome assessors were masked to the treatment allocation. The primary outcome was functional status, measured by the mRS, at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Primary and safety analyses were done according to the patient's treatment allocation. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12611000774921. Findings Between Jan 11, 2013, and June 30, 2019, 1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706), of whom 642 were randomly assigned to fluoxetine and 638 were randomly assigned to placebo. Mean duration of trial treatment was 167 days (SD 48·1). At 6 months, mRS data were available in 624 (97%) patients in the fluoxetine group and 632 (99%) in the placebo group. The distribution of mRS categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0·94, 95% CI 0·76–1·15; p=0·53). Compared with patients in the placebo group, patients in the fluoxetine group had more falls (20 [3%] vs seven [1%]; p=0·018), bone fractures (19 [3%] vs six [1%]; p=0·014), and epileptic seizures (ten [2%] vs two [<1%]; p=0·038) at 6 months. Interpretation Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures. These results do not support the use of fluoxetine to improve functional outcome after stroke

Dorsal spinous process impingement syndrome (‘kissing spine’) in a cat: imaging appearance and surgical management

Spinal pain is an important clinical presentation in feline patients, but the underlying causes can often be difficult to elucidate. Dorsal spinous process impingement syndrome ([`]kissing spine' or in human patients [`]Baastrup syndrome') is a significant cause of spinal pain in equine and human patients and radiographically is characterised by a close approximation of adjacent spinous processes with reactive bone sclerosis affecting these spinous processes. In this report we describe the first reported case of dorsal spinous process impingement syndrome in a cat causing spinal pain, and successful surgical management of the syndrome. The affected cat presented at 5 years of age for evaluation of a 7-month history of progressive thoracolumbar pain. Radiographs revealed close approximation of the dorsal spinous processes of the seventh, eighth and ninth thoracic vertebrae (T7, T8 and T9), with associated reactive bone sclerosis. Surgical resection of the T8 dorsal spinous process resulted in complete resolution of the clinical signs with no evidence of recurrence 9 months after surger

Gender-Informed Family Planning Perceptions and Decision-Making in Rural Chiapas, Mexico: A Mixed-Methods Study

Compared to other Mexican states, Chiapas possessed the lowest rate of contraception use among women 15−49 years old (44.6%) in 2018. This convergent mixed-methods study assessed family planning use, perceptions, and decision-making processes among women and men in rural communities where Compañeros En Salud (CES) works in Chiapas, Mexico. We conducted surveys of reproductive-aged women and semi-structured interviews with reproductive-aged women, men, and physicians completing their social-service year in CES communities from 2016 to 2017. Of the 625 survey respondents, 368 (58.9%) reported using contraception. The most common methods were female sterilization (27.7%), bimonthly injection (10.9%), and the implant (10.9%). Interviews were completed with 27 women, 24 men, and 5 physicians and analyzed through an inductive approach. Common reasons for contraception use were preventing pregnancy, lack of resources for additional children, and birth spacing. Adverse effects, influence of male partners, and perceived lack of need emerged as reasons for non-use. Male partners often made the final decision about contraceptive use, while women often chose what method. Physicians reported adverse effects, misconceptions about methods, and lack of women’s autonomy as barriers to contraception use. Given misconceptions about contraception methods and the dominant role of men in contraception decision-making, our study illustrates the importance of effective counseling and equitable gender dynamics for family planning programming in rural Chiapas