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

Secular trends in growth and nutritional status of Vietnamese adults in rural Red river delta after 30 years (1976-2006)

In order to assess secular trends in growth of the Vietnamese population following a period of rapid economic growth, a follow-up study on physical growth and nutritional status of adults was carried out in a rural section of the Red River delta, Vietnam 30 years after the original study. The initial study in 1976 found that average height and weight of Vietnamese adults was similar to data collected by French experts Huard and Bigot in 1938. Hence, no noticeable secular trends were observed in almost 40 years. However, the 2006 follow-up study revealed a positive secular trend in growth of adults, aged 16-60 years. The average increased rate in height of males was up to 1.1 cm/decade in the age group 26-40 years and up to 2.7 cm/decade in the age group 16-25 years. Nutritional status, as indicated by body mass index, increased in both sexes and in all age groups between 1976 and 2006.were observed. In 2006, average dietary intake of fat and animal protein was higher than that found in 1976. The percentage of energy from fat in the diet increased from 6% in 1976 to 16% in 2006. This study shows that Vietnam is entering the nutrition transition period

Food Systems Profile: Dong Anh, The peri-urban area - Vietnam. -

This Food Systems (FS) profile aims to provide a synopsis of the food system of the Dong Anh district in Hanoi, a peri-urban area in north Vietnam. This profile gives an overview of the main food system outcomes, constituent elements and drivers. It does so through a set of metrics that highlight key challenges and offers a baseline for the measurement and monitoring of future changes. It builds from the outcomes concerning residents’ diets, nutrition and health, socio-economics, and environment. It then traces back to the food supply chains, the food environment, consumer behavior and finally the underlying drivers. Ultimate, the profile’s goal is to help researcher and policy makers understand the existing challenges among the elements of the food systems to help develop actionable policy recommendations for local socio-economic development planning

Food Systems Profile - Along a rural-urban transect in North Vietnam

This food systems (FS) profile aims to provide a snapshot of the food system transformation along a rural-urban transect in North Vietnam, stretching from urban and peri-urban Hanoi all the way to Moc Chau. It does so through a set of metrics that provide an overview of the food system constituent elements, drivers and outcomes, while highlighting key challenges. It offers a baseline for measuring and monitoring future changes. Ultimately, the profile seeks to help policy makers understand the existing challenges among the elements of the food systems

Food Systems Profile: Moc Chau, The Rural Area - Vietnam

This Food Systems (FS) profile aims to provide a synopsis of the food system of the Moc Chau district in Son La province, a rural area in northwestern Vietnam. This profile gives an overview of the main food system outcomes, constituent elements and drivers. It does so through a set of metrics that highlight key challenges and offer a baseline for the measurement and monitoring of future changes. It builds from the outcomes concerning residents’ diets, nutrition and health, socio-economic, and environment. It then traces back to the food supply chains, the food environment, consumer behavior and finally the underlying drivers. Ultimate, the profile’s goal is to help researchers and policy makers understand the existing challenges among the elements of the food system help develop actionable policy recommendations for local socio-economic development planning

Impact of Infectious Disease after <i>Lactococcus lactis</i> Strain Plasma Intake in Vietnamese Schoolchildren: A Randomized, Placebo-Controlled, Double-Blind Study

Lactococcus lactis strain Plasma (LC-Plasma) is reported to have anti-viral effects via direct activation of plasmacytoid dendritic cells, which upregulate the production of type I and III interferons. A randomized, placebo-controlled, double-blind, parallel group study was designed for elementary schoolchildren, grades 1 to 3, in Vietnam. LC-Plasma or a control were administered to schoolchildren as a beverage (1.0 × 1011 count LC-Plasma/day/person). The primary endpoint was to determine the efficacy of LC-Plasma in reducing the cumulative days absent from school due to upper respiratory disease (URID) and gastrointestinal disease (GID), and the secondary endpoint was to evaluate the potency of LC-Plasma on URID/GID symptoms and general well-being scores. LC-Plasma intake significantly reduced the cumulative days absent from school due to URID/GID (Odds ratio (OR) = 0.57, p = 0.004) and URID alone (OR = 0.56, p = 0.005); LC-Plasma also significantly reduced the number of cumulative fever positive days during the first 4 weeks of intervention (OR = 0.58, p = 0.001) and cumulative days with diarrhea during the last 4 weeks of the intervention period (OR = 0.78, p = 0.01). The number of positive general wellbeing days was significantly improved in the LC-Plasma group compared with the control throughout the intervention period (OR = 0.93, 0.93, p = 0.03, 0.04 in the first and last 4 weeks of the intervention, respectively). These data suggest that LC-Plasma seems to improve the health condition of elementary schoolchildren and reduces school absenteeism due to infectious disease, especially URID

Food Systems Profile - Cau Giay, The Urban Area - Vietnam

This Food Systems (FS) profile aims to provide a synopsis of the food system of the Cau Giay district in Hanoi, an urban area in north Vietnam. This profile gives an overview of the main food system outcomes, constituent elements and drivers. It does so through a set of metrics that highlight key challenges and offer a baseline for the measurement and monitoring of future changes. It builds from the outcomes concerning residents’ diets, nutrition and health, socio-economic, and environment. It then traces back to the food supply chains, the food environment, consumer behavior and finally the underlying drivers. Ultimate, the profile’s goal is to help researchers and policy makers understand the existing challenges among the elements of the food system help develop actionable policy recommendations for local socio-economic development planning

Twelve-Month Outcomes of the AFFINITY Trial of Fluoxetine for Functional Recovery After Acute Stroke: AFFINITY Trial Steering Committee on Behalf of the AFFINITY Trial Collaboration

Background and Purpose: The AFFINITY trial (Assessment of Fluoxetine in Stroke Recovery) reported that 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 seizures. After trial medication was ceased at 6 months, survivors were followed to 12 months post-randomization. This preplanned secondary analysis aimed to determine any sustained or delayed effects of fluoxetine at 12 months post-randomization. Methods: AFFINITY was a randomized, parallel-group, double-blind, placebo-controlled trial in adults (n=1280) with a clinical diagnosis of stroke in the previous 2 to 15 days and persisting neurological deficit who were recruited at 43 hospital stroke units in Australia (n=29), New Zealand (4), and Vietnam (10) between 2013 and 2019. Participants were randomized to oral fluoxetine 20 mg once daily (n=642) or matching placebo (n=638) for 6 months and followed until 12 months after randomization. The primary outcome was function, measured by the modified Rankin Scale, at 6 months. Secondary outcomes for these analyses included measures of the modified Rankin Scale, mood, cognition, overall health status, fatigue, health-related quality of life, and safety at 12 months. Results: Adherence to trial medication was for a mean 167 (SD 48) days and similar between randomized groups. At 12 months, the distribution of modified Rankin Scale categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio, 0.93 [95% CI, 0.76–1.14]; P =0.46). Compared with placebo, patients allocated fluoxetine had fewer recurrent ischemic strokes (14 [2.18%] versus 29 [4.55%]; P =0.02), and no longer had significantly more falls (27 [4.21%] versus 15 [2.35%]; P =0.08), bone fractures (23 [3.58%] versus 11 [1.72%]; P =0.05), or seizures (11 [1.71%] versus 8 [1.25%]; P =0.64) at 12 months. Conclusions: Fluoxetine 20 mg daily for 6 months after acute stroke had no delayed or sustained effect on functional outcome, falls, bone fractures, or seizures at 12 months poststroke. The lower rate of recurrent ischemic stroke in the fluoxetine group is most likely a chance finding. REGISTRATION: URL: http://www.anzctr.org.au/ ; Unique identifier: ACTRN12611000774921