SummaryBackgroundResults of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.MethodsFOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762.FindingsBetween Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months.InterpretationFluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.FundingUK Stroke Association and NIHR Health Technology Assessment Programme.
Background Coronavirus disease 2019 (COVID-19) caused by the novel coronavirus-infected millions globally. Despite a wide range of advised options for the treatment of COVID-19, a single strategy to tackle this pandemic remains elusive, thus far. That is why we are conducting a clinical trial to find out the efficacy of iodine complex to clear a viral load of severe respiratory syndrome coronavirus-2 (SARS-CoV-2) along with a reduction in time taken to alleviate symptoms. Method The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a closed-label and adaptive with sample size reassessment, multi-centered design with a 1:1:1:1 allocation ratio and superiority framework. It will be conducted in Shaikh Zayed Post-Graduate Medical Complex, Ali Clinic, and Doctors Lounge, Lahore, Pakistan. This study will have three arms of mild to moderately symptomatic COVID-19 patients (50 patients in each) which will receive ionic-iodine polymer complex with 200 mg of elemental iodine: interventional arm A will have encapsulated, arm B will receive suspension syrup form, arm C will get throat spray, while arm X will be standard care with placebo. Data will be collected on self-constructed, close-ended questionnaires after obtaining written consent. Data will be analyzed using SAS version 9.4. COVID-19 patients will be monitored by RT-PCR and HRCT (high-resolution computed tomography) chest. In addition to these, the duration of the symptomatic phase and mortality benefits will be analyzed in both groups. Discussion The study is designed to measure the superior efficacy of the iodine complex as an add-on in treating COVID-19-positive patients with mild to moderate symptoms. This combination is hypothesized to improve various parameters like rapid viral load reduction, clinical and radiological improvement, lower mortality, and reduction in hospitalization. The trial will aid in devising a better strategy to cope with COVID-19 in a relatively inexpensive and accessible way. The implications are global, and this could prove itself to be the most manageable intervention against COVID-19 especially for patients from limited-resource countries with deprived socioeconomic status. Trial registration ClinicalTrials.govNCT04473261. Registered on July 16, 2020.
Objective: To evaluate the effects of structured resistance exercises on cognition level among patients with mild cognitive impairment. Methods: A quasi experimental trial was conducted on thirty patients with mild cognitive impairment (MCI) from September 2020 to February 2021 at Ibn e Siena hospital, Multan. The total sample was randomly divided into two equal groups containing fifteen patients each; Group-A (Conventional pharmacological treatment) and Group-B (Resisted exercises). Group-A participants were treated with conventional pharmacological treatment cholinesterase inhibitors along with regular physical exercise while Group-B participants were treated with resistance exercises along with conventional pharmacological treatment. The standardized tools were used for data collection including Standardized mini mental state examination (SMMSE), Montreal cognitive assessment (MOCA), Trial making test A (TMT-A) and Trial making test B (TMT-B). Data was entered and analyzed by using SPSS 21. Results: Independent samples T-test showed statistically significant difference after intervention for measures of cognitive performance. There was significant difference (p<0.01) between pre and post intervention score of SMMSE (20.60 ± 1.75 and 23.20 ± 1.69) and MOCA (17.60 ± 1.35 and 21.93 ± 1.57). There was also significant difference between (p<0.01) pre and post intervention score of TMT-A (1.47 ± 0.34 & 1.23 ± 0.04) and TMT-B (2.51 ± 0.04 and 2.08 ± 0.04). Conclusion: Resistance exercises increases the cognitive levels of Mild Cognitive impairment patients. Key Words: Cognitive dysfunction, Exercises, Dementia.
Background and Aims Elevated plasma total homocystiene (tHcy) levels are associated with atherosclerotic diseases in coronary, cerebral and peripheral blood vessels. It is possible that hyperhomocysteinemia may lead to intrarenal arteriosclerotic lesions and decline in GFR or impaired renal function. Aim of this study was to elucidate the association of plasma homocystiene level with renal function and cardiovascular risk factors in rural population. Method A well defined rural area was selected. Study subjects were identified by computer generated random numbers after entering household listings and then Kish table was used to choose a participant. Adult subjects (≥18 years) were only included. The approached participant was explained the purpose, if consented, then given an appointment to be present at a research hospital on a separate date for clinical and biochemical evaluation. A face to face interview was conducted. Clinical history, physical examination anthropometrics were recorded on data sheet. Fasting blood sample and morning spot urine was collected. Then serum tHcy was measured by chemiluminescent microparticle immunoassay (CMIA) technology. Study population were investigated with Spot urine ACR, Fasting glucose, serum lipid profile, creatinine, homocysteinine , Folic acid and Vit B12. Results Early results of 234 random subjects are presented here. The mean age was 41 ± 13(18-92) years with male 33% and female 67%. Mean eGFR was 99± 26 ml/min, tHcy 11.6 ± 5.9 μmol/l, Vit B12 329 ± 187 pg/ml and Folic Acid 5.57 ± 2.63 ng/ml. A tHcy cut-off value in study subjects ≥15 μmol/l was seen in 17 % and <15 μmol/l in 83%. Serum creatinine, Uric Acid, Cholesterol, LDL was significantly higher and Vit B12, Folic acid lower in tHcy ≥15 μmol/l group. Further grouping showed tHcy level was significantly higher in Vit B12<200 pg/ml and Folic acid <3ng/l group. Correlation studies showed homocystiene positively correlated with age, systolic blood pressure, creatinine, LDL and negatively with Folic acid and Vit B12. Conclusion Our findings suggest that elevated plasma homocystiene level might influence and are associated with altered markers of renal, cardiac and metabolic risk factors in rural population. Preventive approaches are required towards this issue as larger population segment belongs to rural areas.
To determine the knowledge about TENS usage among professional physical therapists of Lahore city. Methods: In this study cross sectional survey was conducted in Physiotherapy department of UOL Teaching Hospital, CMH, Ghurki Teaching Hospital and Social Security Hospital, Lahore. The sample size of 117physical therapist participated in this study. Questionnaire was used to determine response of participants. Results: 117 questionnaires were filled by physical therapists, using electrotherapy (TENS) in their setup. Only 81.2% physical therapist found TENS effective as a sole treatment for acute pain, while 36.8% founds it effective as a sole treatment for chronic pain. Physical therapists 70% in Lahore prefer using gels/lotions with TENS about for prolonged relief. Majority of physical therapists (84.6%) were satisfied with the effectiveness of TENS applying with other modalities. Conclusion: TENS is frequently used among Physical Therapist aged more than 26 years. Most of physical therapist found it effective for both short and long term care. Physical therapist were frequently using it for the management of frozen shoulder pain.
To determine the knowledge about TENS usage among professional physical therapists of Lahore city. Methods: In this study cross sectional survey was conducted in Physiotherapy department of UOL Teaching Hospital, CMH, Ghurki Teaching Hospital and Social Security Hospital, Lahore. The sample size of 117physical therapist participated in this study. Questionnaire was used to determine response of participants. Results: 117 questionnaires were filled by physical therapists, using electrotherapy (TENS) in their setup. Only 81.2% physical therapist found TENS effective as a sole treatment for acute pain, while 36.8% founds it effective as a sole treatment for chronic pain. Physical therapists 70% in Lahore prefer using gels/lotions with TENS about for prolonged relief. Majority of physical therapists (84.6%) were satisfied with the effectiveness of TENS applying with other modalities. Conclusion: TENS is frequently used among Physical Therapist aged more than 26 years. Most of physical therapist found it effective for both short and long term care. Physical therapist were frequently using it for the management of frozen shoulder pain.
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