scholarly journals The impact of missing data on clinical trials: a re-analysis of a placebo controlled trial of Hypericum perforatum (St Johns wort) and sertraline in major depressive disorder

2013 ◽  
Vol 231 (9) ◽  
pp. 1987-1999 ◽  
Author(s):  
Anneke C. Grobler ◽  
Glenda Matthews ◽  
Geert Molenberghs
2016 ◽  
Vol 22 (2) ◽  
pp. 173-176
Author(s):  
Marija Sabaliauskaitė ◽  
Gediminas Brazaitis

Reikšminiai žodžiai: jonažolė, depresija. Paprastosios jonažolės, remiantis moksliniais tyrimais, šiuo metu gali būti skiriamos lengvai ir vidutinio sunkumo depresijai gydyti [6, 7]. Tačiau sergantieji sunkia depresija taip pat linkę jas vartoti, bet nauda yra abejotina [8]. Šio tyrimo tikslas yra išanalizuoti pastarųjų penkerių metų tyrimus apie jonažolių poveikį gydant sunkią depresiją, jį lyginant su sintetiniais antidepresantais ir placebu. Tyrimų, analizuojančių jonažolių poveikį gydant sunkią depresiją, paieška atlikta „PubMed“, „Embase“ ir „Cochrane“ duomenų bazėse. Atrinkti moksliniai darbai buvo ne senesni kaip penkerių metų. Tyrimai turėjo būti dvigubai akli, placebo – kontroliuojami, užtikrinta tiriamųjų randomizacija. Analizei atrinkti du tiriamieji darbai – Grobler A. J. (2014 m.) „The impact of missing data on clinical trials: A re-analysis of a placebo controlled trial of hypericum perforatum (St Johns Wort) and sertraline in Major Depressive Disorder“ ir Sarris J. (2012 m.) „St John’s wort (Hypericum perforatum) versus sertraline and placebo in major depressive disorder: continuation data from a 26-week RCT. Pharmacopsychiatry“ [20, 21]. Analizuotų tyrimų metu nustatyta, jog monoterapija jonažolių ekstraktu reikšmingai nesiskiria nuo placebo poveikio gydant sunkią depresiją. Todėl ši vaistažolė gydyti sunkią depresiją neturėtų būti skiriama viena, o pacientai, sergantys šia liga, perspėjami nevartoti jonažolių monoterapijai. Ateityje jonažolių poveikis gydant sunkią depresiją turėtų būti tiriamas labiau atsižvelgiant į šios vaistažolės ir sintetinių vaistų derinius.


2019 ◽  
Vol 16 (2) ◽  
pp. 232-238 ◽  
Author(s):  
Majid Anushiravani ◽  
Ali A. Manteghi ◽  
Ali Taghipur ◽  
Mahdi Eslami

Background: According to new studies, only 60% of depressed patients respond to pharmaceutical treatment while suffering from their side effects. Natural products as adjuvant or alternative therapies should be examined to find safer and more effective ways to cope with depression. Objective: To find out the potential benefits of a combined herbal drug based on Echium amoenum compared with citalopram in the treatment of Major Depressive Disorder. Design and Setting: In psychiatry clinics of Mashhad University of Medical Sciences, 50 patients who met the criteria for Major Depressive Disorder based on DSM-5 were studied in a parallel randomized controlled trial. Design and Setting: In psychiatry clinics of Mashhad University of Medical Sciences, 50 patients who met the criteria for Major Depressive Disorder based on DSM-5 were studied in a parallel randomized controlled trial. Intervention: Subjects were randomly assigned to receive Echium amoenum compound syrup (EACS) or citalopram tablet for 8 weeks. Outcome Measures: The efficacy of treatments and recurrence of disease were surveyed and compared according to Hamilton depression rating scale at weeks 0, 4, 8, 12. Results: Patients in both groups of citalopram and EACS showed remarkable reduction in scores of Hamilton questionnaire. At the eighth week of treatment, the mean scores in EACS group were significantly lower than citalopram group (p-value = 0.03). 52% of patients suffered from various complications in citalopram group while just 12% of patients in EACS group reported few complications. Conclusion: Clinical efficacy of this herbal drug was significantly higher than citalopram, and complications were also less and lower in EACS group. Further studies with larger groups and para-clinical assessments such as serologic tests and QEEG would improve our understanding of the impacts and mechanisms of EACS.


2020 ◽  
pp. 070674372097482
Author(s):  
Shane J. McInerney ◽  
Trisha Chakrabarty ◽  
Malgorzata Maciukiewicz ◽  
Benicio N. Frey ◽  
Glenda M. MacQueen ◽  
...  

Objectives: Major depressive disorder (MDD) is associated with impairments in both cognition and functioning. However, whether cognitive deficits significantly contribute to impaired psychosocial and occupational functioning, independent of other depressive symptoms, is not well established. We examined the relationship between cognitive performance and functioning in depressed patients before and after antidepressant treatment using secondary data from the first Canadian Biomarker Integration Network in Depression-1 study. Methods: Cognition was assessed at baseline in unmedicated, depressed participants with MDD ( n = 207) using the Central Nervous System Vital Signs computerized battery, psychosocial functioning with the Sheehan Disability Scale (SDS), and occupational functioning with the Lam Employment Absence and Productivity Scale (LEAPS). Cognition ( n = 181), SDS ( n = 175), and LEAPS ( n = 118) were reassessed after participants received 8 weeks of open-label escitalopram monotherapy. A series of linear regressions were conducted to determine (1) whether cognitive functioning was associated with psychosocial and occupational functioning prior to treatment, after adjusting for overall depressive symptom severity and (2) whether changes in cognitive functioning after an 8-week treatment phase were associated with changes in psychosocial and occupational functioning, after adjusting for changes in overall symptom severity. Results: Baseline global cognitive functioning, after adjusting for depression symptom severity and demographic variables, was associated with the SDS work/study subscale (β = −0.17; P = 0.03) and LEAPS productivity subscale (β = −0.17; P = 0.05), but not SDS total (β = 0.19; P = 0.12) or LEAPS total (β = 0.41; P = 0.17) scores. Although LEAPS and SDS scores showed significant improvements after 8 weeks of treatment ( P < 0.001), there were no significant associations between changes in cognitive domain scores and functional improvements. Conclusion: Cognition was associated with occupational functioning at baseline, but changes in cognition were not associated with psychosocial or occupational functional improvements following escitalopram treatment. We recommend the use of more comprehensive functional assessments to determine the impact of cognitive change on functional outcomes in future research.


Sign in / Sign up

Export Citation Format

Share Document