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1.
Int Braz J Urol ; 45(6): 1209-1215, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31808410

RESUMO

PURPOSE: To compare the efficacy and safety of available selective serotonin reuptake inhibi-tors (SSRIs) in order to find the most effective drug with the least number of side effects in treatment of premature ejaculation (PE). MATERIALS AND METHODS: This study was a randomized clinical trial. Four hundred and eighty pati-ents with PE in the 4 groups referred to Imam Reza hospital Tehran, Iran from July 2018 to Fe-bruary 2019 were enrolled in the study. The patients received sertraline 50mg, fluoxetine 20mg, paroxetine 20mg and citalopram 20mg, every 12 hours daily. The intravaginal ejaculatory laten-cy time (IELT) before treatment, fourth and eighth weeks after treatment was recorded by the patient's wife with a stopwatch. RESULTS: Mean IELT before, 4 and 8 weeks after treatment in four groups were: sertraline 69.4±54.3, 353.5±190.4, 376.3±143.5; fluoxetine 75.5±64.3, 255.4±168.2, 314.8±190.4; paroxeti-ne 71.5±69.1, 320.7±198.3, 379.9±154.3; citalopram 90.39±79.3, 279.9±192.1, 282.5±171.1 seconds, respectively. The ejaculation time significantly increased in all groups (p <0.05), but there was no significant difference between the groups (P=0.75). Also, there was no significant difference in drugs side effects between groups (p >0.05). The most common side effects were drowsiness and dyspepsia, which were not severe enough to cause discontinuation of the drug. CONCLUSIONS: All available SSRIs were effective and usually had no serious complications. In patients who did not respond to any of these drugs, other SSRI drugs could be used as a salvage therapy.


Assuntos
Citalopram/uso terapêutico , Fluoxetina/uso terapêutico , Paroxetina/uso terapêutico , Ejaculação Precoce/tratamento farmacológico , Inibidores de Captação de Serotonina/uso terapêutico , Sertralina/uso terapêutico , Adulto , Idoso , Ejaculação/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Tempo de Reação/efeitos dos fármacos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
2.
Transl Psychiatry ; 9(1): 182, 2019 08 02.
Artigo em Inglês | MEDLINE | ID: mdl-31375659

RESUMO

The identification of biomarkers of response might speed drug development and set the premises to assist clinical practice in psychiatry. In this work, we evaluated a panel of peripheral biomarkers (including IL-6, IL-10, TNF-α, TNFRII, BDNF, CRP, MMP9 and PAI1) in depressed patients receiving paroxetine, venlafaxine, or placebo. Samples were obtained from two randomised placebo-controlled studies evaluating the efficacy and tolerability of a novel drug candidate, using either paroxetine or venlafaxine as active comparators. In both studies, the biomarker candidates were analysed in plasma collected at randomization and after 10 weeks of treatment with either placebo or active comparator (for a total of 106 and 108 subjects in the paroxetine and venlafaxine study, respectively). Data were obtained by multiplexing sandwich-ELISA system. Data were subjected to statistical analysis to assess their correlation with baseline severity and with response outcome. Increases in biomarker levels were correlated with reduction in depression severity for TNF-α, IL-6 IL-10 and CRP. Response to paroxetine treatment correlated with baseline IL-10, IL-6 and TNF-α levels, with the strongest signal being observed in males. In the venlafaxine study, a correlation was observed only between CRP level at randomisation and response, suggesting differences between the two active treatments and the two studies. Our investigations suggest that a combination of pro- and anti-inflammatory cytokines may predict response outcome in patients treated with paroxetine. The potential for IL-10, IL-6 and TNF-α as response biomarkers for a wider range of antidepressants warrants further investigations in clinical trials with other monoamine reuptake inhibitors.


Assuntos
Proteína C-Reativa/análise , Transtorno Depressivo Maior/tratamento farmacológico , Interleucina-10/sangue , Interleucina-6/sangue , Paroxetina/uso terapêutico , Fator de Necrose Tumoral alfa/sangue , Cloridrato de Venlafaxina/uso terapêutico , Adulto , Biomarcadores/sangue , Transtorno Depressivo Maior/sangue , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem
3.
Lancet Psychiatry ; 6(9): 745-752, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31303567

RESUMO

BACKGROUND: Reports claiming that antidepressants are effective only in patients with severe depression have affected treatment guidelines but these reports usually use a disputed measure of improvement, a decrease in the sum-score of the 17-item Hamilton Depression Rating Scale (HDRS-17), and are based on group-level rather than patient-level data. METHOD: In this item-based, patient-level, post-hoc analysis, we pooled data from all completed, acute-phase, placebo-controlled, industry-sponsored, HDRS-based trials of the SSRIs citalopram, paroxetine, or sertraline in adult major depression. Patient-level data were pooled and subjected to item-based post-hoc analyses to assess the effect of baseline severity of depression on the response to treatment as assessed with HDRS-17 sum score, the depressed mood item of the HDRS, a six-item HDRS subscale (HDRS-6), and the remaining 11 HDRS items not included in this subscale (non-HDRS-6). Patients were defined as having non-severe depression if they had a baseline HDRS-17 sum score of 18 points or less and as having severe depression if they had a score of 27 points or more. FINDINGS: Our study population consisted of 8262 patients from 28 placebo-controlled SSRI trials. Participants were treated with either citalopram (n=744), paroxetine (n=2981), sertraline (n=1202), fluoxetine (active-control group; n=754), or placebo (n=2581). 654 patients were defined as having non-severe depression and 1377 as having severe depression. Patients with non-severe and severe depression did not differ with respect to SSRI-induced decrease in depressed mood and other HDRS symptoms belonging to the HDRS-6 subscale. However, after exclusion of patients with rare extreme baseline values, a positive association was seen between severity and efficacy when using HDRS-17 sum score as the effect parameter. This result was largely due to a more pronounced response to treatment with respect to non-HDRS-6 items in patients with severe depression than in those with non-severe depression. This outcome could be explained by non-HDRS-6 items, more so than HDRS-6 items, being more severe and prevalent at baseline in severe than in non-severe cases; hence, less room was left for improvement in these areas in patients with non-severe depression. INTERPRETATION: The use of an outcome measure that includes symptoms that rate low at baseline in patients with non-severe depression might result in the interpretation that SSRIs are ineffective in these patients. With respect to alleviation of HDRS-6 items, SSRIs appear to be as effective in patients with non-severe depression as in those with severe depression. FUNDING: Swedish Medical Research Council, AFA Insurance, Swedish Brain Foundation, Sahlgrenska University Hospital (Avtal om Läkarutbildning och Forskning), Bertil Hållsten's Foundation, and Söderberg's Foundation.


Assuntos
Depressão/tratamento farmacológico , Transtorno Depressivo Maior/tratamento farmacológico , Inibidores de Captação de Serotonina/uso terapêutico , Antidepressivos/administração & dosagem , Antidepressivos/uso terapêutico , Citalopram/administração & dosagem , Citalopram/uso terapêutico , Ensaios Clínicos como Assunto , Depressão/psicologia , Transtorno Depressivo Maior/psicologia , Fluoxetina/administração & dosagem , Fluoxetina/uso terapêutico , Humanos , Estudos Longitudinais , Paroxetina/administração & dosagem , Paroxetina/uso terapêutico , Placebos/administração & dosagem , Escalas de Graduação Psiquiátrica/estatística & dados numéricos , Reprodutibilidade dos Testes , Inibidores de Captação de Serotonina/administração & dosagem , Sertralina/administração & dosagem , Sertralina/uso terapêutico , Índice de Gravidade de Doença
4.
Neuropsychobiology ; 78(3): 136-144, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31189175

RESUMO

BACKGROUND: Glycogen synthase kinase-3ß (GSK-3ß) polymorphisms are known to influence hippocampal brain tissue volume in individuals with major depressive disorder (MDD). However, the effects of the GSK-3ß gene single nucleotide polymorphisms (SNPs) in those receiving antidepressant therapy are unknown. OBJECTIVES: In the present study, we examined the relationship between brain volume-related SNPs of the GSK-3ß gene and antidepressant treatment effects in patients with MDD. METHODS: Paroxetine, fluvoxamine, or milnacipran was administered to 143 Japanese patients with MDD. Two SNPs of the GSK-3ß gene (rs6438552 and rs12630592) that influence brain volume in the hippocampus were genotyped. For the primary outcome, the relationship between genetic variations in the SNPs and the percent change in the Hamilton Rating Scale for Depression (HAM-D) score at week 6 was examined. In addition, rs334558, which has been reported repeatedly, was also genotyped. RESULTS: There was a significant correlation between the two SNPs and the percent change in the HAM-D scores at week 6 (rs6438552 A/A vs. A/G + G/G: p = 0.016; rs12630592 G/G vs. G/T + T/T: p = 0.016). There was high linkage disequilibrium between the rs6438552 and rs12630592 SNPs. The correlation between high therapeutic response over time and the two SNPs were also confirmed (rs6438552 A/A vs. others: p = 0.031; rs12630592 G/G vs. others: p = 0.031). CONCLUSIONS: Our results suggest that two GSK-3ß variants that influence brain volume were associated with changes in the HAM-D scores at week 6 in patients with MDD.


Assuntos
Antidepressivos/uso terapêutico , Transtorno Depressivo Maior/genética , Transtorno Depressivo Maior/patologia , Glicogênio Sintase Quinase 3 beta/genética , Hipocampo/patologia , Adulto , Transtorno Depressivo Maior/tratamento farmacológico , Feminino , Fluvoxamina/uso terapêutico , Predisposição Genética para Doença , Genótipo , Humanos , Desequilíbrio de Ligação , Masculino , Pessoa de Meia-Idade , Paroxetina/uso terapêutico , Polimorfismo de Nucleotídeo Único
5.
Cochrane Database Syst Rev ; 3: CD010677, 2019 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-30921478

RESUMO

BACKGROUND: Panic disorder is characterised by recurrent unexpected panic attacks consisting of a wave of intense fear that reaches a peak within a few minutes. Panic disorder is a common disorder, with an estimated lifetime prevalence of 1% to 5% in the general population and a 7% to 10% prevalence in primary care settings. Its aetiology is not fully understood and is probably heterogeneous.Panic disorder is treated with psychological and pharmacological interventions, often used in combination. Although benzodiazepines are frequently used in the treatment of panic disorder, guidelines recommend antidepressants, mainly selective serotonin reuptake inhibitors (SSRIs), as first-line treatment for panic disorder, particularly due to their lower incidence of dependence and withdrawal reaction when compared to benzodiazepines. Despite these recommendations, benzodiazepines are widely used in the treatment of panic disorder, probably because of their rapid onset of action. OBJECTIVES: To assess the efficacy and acceptability of benzodiazepines versus placebo in the treatment of panic disorder with or without agoraphobia in adults. SEARCH METHODS: We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR Studies and References), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1950-), Embase (1974-), and PsycINFO (1967-) up to 29 May 2018. We handsearched reference lists of relevant papers and previous systematic reviews. We contacted experts in the field for supplemental data. SELECTION CRITERIA: All double-blind (blinding of patients and personnel) controlled trials randomising adults with panic disorder with or without agoraphobia to benzodiazepine or placebo. DATA COLLECTION AND ANALYSIS: Two review authors independently checked the eligibility of studies and extracted data using a standardised form. Data were then entered data into Review Manager 5 using a double-check procedure. Information extracted included study characteristics, participant characteristics, intervention details, settings, and outcome measures in terms of efficacy, acceptability, and tolerability. MAIN RESULTS: We included 24 studies in the review with a total of 4233 participants, of which 2124 were randomised to benzodiazepines and 1475 to placebo. The remaining 634 participants were randomised to other active treatments in three-arm trials. We assessed the overall methodological quality of the included studies as poor. We rated all studies as at unclear risk of bias in at least three domains. In addition, we judged 20 of the 24 included studies as having a high risk of bias in at least one domain.Two primary outcomes of efficacy and acceptability showed a possible advantage of benzodiazepines over placebo. The estimated risk ratio (RR) for a response to treatment was 1.65 (95% confidence interval (CI) 1.39 to 1.96) in favour of benzodiazepines, which corresponds to an estimated number needed to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 7). The dropout rate was lower among participants treated with benzodiazepines (RR 0.50, 95% CI 0.39 to 0.64); the estimated NNTB was 6 (95% CI 5 to 9). We rated the quality of the evidence as low for both primary outcomes. The possible advantage of benzodiazepine was also seen for remission (RR 1.61, 95% CI 1.38 to 1.88) and the endpoint data for social functioning (standardised mean difference (SMD) -0.53, 95% CI -0.65 to -0.42), both with low-quality evidence. We assessed the evidence for the other secondary outcomes as of very low quality. With the exception of the analyses of the change score data for depression (SMD -0.22, 95% CI -0.48 to 0.04) and social functioning (SMD -0.32, 95% CI -0.88 to 0.24), all secondary outcome analyses showed an effect in favour of benzodiazepines compared to placebo. However, the number of dropouts due to adverse effects was higher with benzodiazepines than with placebo (RR 1.58, 95% CI 1.16 to 2.15; low-quality evidence). Furthermore, our analyses of adverse events showed that a higher proportion of participants experienced at least one adverse effect when treated with benzodiazepines (RR 1.18, 95% CI 1.02 to 1.37; low-quality evidence). AUTHORS' CONCLUSIONS: Low-quality evidence shows a possible superiority of benzodiazepine over placebo in the short-term treatment of panic disorders. The validity of the included studies is questionable due to possible unmasking of allocated treatments, high dropout rates, and probable publication bias. Moreover, the included studies were only short-term studies and did not examine the long-term efficacy nor the risks of dependency and withdrawal symptoms. Due to these limitations, our results regarding the efficacy of benzodiazepines versus placebo provide only limited guidance for clinical practice. Furthermore, the clinician's choice is not between benzodiazepines and placebo, but between benzodiazepines and other agents, notably SSRIs, both in terms of efficacy and adverse effects. The choice of treatment should therefore be guided by the patient's preference and should balance benefits and harms from treatment in a long-term perspective.


Assuntos
Benzodiazepinas/uso terapêutico , Transtorno de Pânico/tratamento farmacológico , Adulto , Idoso , Agorafobia/complicações , Agorafobia/tratamento farmacológico , Buspirona/uso terapêutico , Humanos , Imipramina/uso terapêutico , Pessoa de Meia-Idade , Números Necessários para Tratar , Transtorno de Pânico/complicações , Paroxetina/uso terapêutico , Pacientes Desistentes do Tratamento/estatística & dados numéricos , Placebos/uso terapêutico , Propranolol/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Adulto Jovem
6.
J Affect Disord ; 250: 419-424, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30878654

RESUMO

BACKGROUND: It is clinically important to know who are likely to respond more or less to antidepressants. However, meaningful effect modifiers (variables associated with differential response depending on the treatment) are yet to be identified. METHODS: We conducted individual participant data (IPD) meta-analysis and meta-regression to explore effect modifiers in placebo-controlled antidepressant trials conducted so far in Japan. RESULTS: We obtained access to IPD from seven placebo-controlled trials comparing bupropion, duloxetine, escitalopram, mirtazapine, paroxetine or venlafaxine with placebo in the acute phase treatment of major depression (total n = 2803). The higher the guilt subscale score of the baseline Hamilton Rating Scale for Depression (HRSD), the greater the difference in reduction in depression severity between the antidepressants and placebo at week 6, while the older the current age or the age at onset, the smaller the difference. At week 8, the guilt subscale score of HRSD and presence of suicidal ideation at baseline predicted greater, and the anhedonia subscale and insomnia subscale scores of HRSD and early response at week 2 predicted smaller, difference in reduction. LIMITATIONS: Different studies measured different sets of baseline variables and we were able to analyze only a limited set of candidate variables for effect modification. CONCLUSION: Age, age at onset, several HRSD subscales including guilt, anhedonia and insomnia, presence of suicidal ideation at baseline and early response are potential effect modifiers for response to antidepressants in the acute phase antidepressant treatment of major depression. Future trials need to measure these and additional variables in concerted efforts to enable matching of treatments with individual characteristics in depression.


Assuntos
Antidepressivos de Segunda Geração/uso terapêutico , Transtorno Depressivo Maior/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto , Bupropiona/uso terapêutico , Citalopram/uso terapêutico , Depressão/tratamento farmacológico , Método Duplo-Cego , Cloridrato de Duloxetina/uso terapêutico , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Mirtazapina/uso terapêutico , Paroxetina/uso terapêutico , Escalas de Graduação Psiquiátrica , Resultado do Tratamento , Cloridrato de Venlafaxina/uso terapêutico
7.
J Clin Psychopharmacol ; 39(2): 153-157, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30640209

RESUMO

BACKGROUND: Posttraumatic stress disorder (PTSD) is often a chronic, disabling illness for which antidepressant medications (ie, SSRI) are considered the primary psychopharmacological treatment. However, many patients remain refractory to antidepressants alone or in combination with psychotherapy. Safe and effective treatments for individuals with refractory PTSD are needed. This study aimed to examine ziprasidone augmentation of SSRI treatment of PTSD. METHODS: This was a 2-phase study. In phase 1, subjects were treated with paroxetine or sertraline for 8 weeks. Individuals refractory to the SSRI treatment then entered into phase II of the study and were randomized, in a double-blind fashion, to 8 weeks of treatment with either ziprasidone or placebo. The primary outcome measure was change in Clinician Administered PTSD Scale total scores with the intent-to-treat sample. Secondary outcome measures included Positive and Negative Syndrome Scale scores, measures of depression and anxiety, and safety measures. RESULTS: No significant differences were observed on the Clinician Administered PTSD Scale, Positive and Negative Syndrome Scale, or other outcome measures between ziprasidone and placebo groups. No significant differences were observed for safety measures including metabolic profiles, extrapyramidal symptoms/movement disorder rating scales, nor study dropout. CONCLUSIONS: Although no significant differences were noted in efficacy or safety measures between ziprasidone and placebo in this pilot study, the small sample size prevents definitive conclusions.


Assuntos
Antipsicóticos/administração & dosagem , Piperazinas/administração & dosagem , Inibidores de Captação de Serotonina/administração & dosagem , Transtornos de Estresse Pós-Traumáticos/tratamento farmacológico , Tiazóis/administração & dosagem , Antipsicóticos/uso terapêutico , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Paroxetina/administração & dosagem , Paroxetina/uso terapêutico , Projetos Piloto , Piperazinas/uso terapêutico , Escalas de Graduação Psiquiátrica , Inibidores de Captação de Serotonina/uso terapêutico , Sertralina/administração & dosagem , Sertralina/uso terapêutico , Transtornos de Estresse Pós-Traumáticos/fisiopatologia , Tiazóis/uso terapêutico , Resultado do Tratamento
8.
BMC Urol ; 19(1): 2, 2019 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-30606186

RESUMO

BACKGROUND: Paroxetine is one of the selective serotonin reuptake inhibitors (SSRIs) used in the treatment of premature ejaculation (PE). However, this use is not approved in many countries. The purpose of this systematic review and meta-analysis is to review the efficacy and safety of paroxetine for PE patients. METHODS: We searched relevant randomized, controlled trials through May 2018, using PubMed, Embase and Cochrane Central Register. The main endpoint included intra-vaginal ejaculatory latency time (IELT) and side effects in the treatment of PE. Cochrane Collaboration's Revman software, version 5.3, was used for statistical analysis. RESULTS: Out of 493 unique articles, a total of 19 randomized, controlled trials (RCTs) were reviewed. Quite a few RCTs were considered to have unclear risk of bias because of limited information. Pooled outcomes suggested that paroxetine was more effective than placebo, fluoxetine and escitalopram at increasing IELT (all p < 0.05). However, there existed a high level of heterogeneity in the paroxetine vs. fluoxetine groups and the paroxetine vs. placebo groups. Comparing paroxetine with tramadol, sertraline, phosphodiesterase 5 inhibitors (PDE5Is), local lidocaine gel, behaviour therapy or dapoxetine, we found that the increase in IELT was not statistically significant between groups. Paroxetine combined with tadalafil or behaviour therapy was more efficacious than paroxetine alone (all p < 0.05). Although the side effects in the combination group were more common than in the paroxetine alone group, the most common adverse events, such as nausea, muscle soreness, palpitation and flushing, were mild and tolerable. The main limitations of this systematic review and meta-analysis were the different definitions of PE and short follow-up times. CONCLUSIONS: According to this systematic review and meta-analysis, paroxetine provided better efficacy than placebo, fluoxetine and escitalopram in the treatment of PE, with well-tolerated side effects. The combination group had better efficacy than the paroxetine alone group. TRIAL REGISTRATION: This review was reported in agreement with the PRISMA statement and was registered on PROSPERO 2018CRD42018097014 .


Assuntos
Paroxetina/uso terapêutico , Ejaculação Precoce/tratamento farmacológico , Inibidores de Captação de Serotonina/uso terapêutico , Humanos , Masculino , Ejaculação Precoce/diagnóstico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Resultado do Tratamento
9.
J Affect Disord ; 245: 508-516, 2019 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-30439678

RESUMO

BACKGROUND: The University of California San Diego Performance-based Skills Assessment (UPSA) has been validated as a functional measure in patients with major depressive disorder (MDD). The study herein aims to both replicate and extend the initial validation incorporating data sets from two additional studies. METHODS: NCT02279966 and NCT02272517 were multinational, double-blind, placebo-controlled studies in adult outpatients with moderate-to-severe MDD and a current major depressive episode of ≥3 months and less than 1 year, respectively. Subjects were randomized to vortioxetine (10 or 20 mg), placebo or active reference drug (paroxetine [20 mg], or escitalopram [10 or 20 mg]) for 8 weeks. Pearson correlation coefficients were estimated for baseline UPSA-Brief (UPSA-B), demographic/disease characteristics, Montgomery-Åsberg Depression Rating Scale (MADRS), Perceived Deficit Questionnaire-20 items (PDQ-20), and Digit Symbol Substitution Test (DSST), to examine construct validity. Distribution- and anchor-based methods examined clinically important difference (CID) threshold. A pooled analysis with data from NCT01564862 (initial validation study) was performed to increase the statistical power of the estimations. RESULTS: In pooled analysis of the two new studies, UPSA-B score correlated with the DSST (r = 0.32, P < 0.0001), but not the MADRS (r = -0.07, p = 0.302) or the PDQ-20 (r = -0.10, p = 0.109), replicating initial validation results. Estimated CID range was 7.1-11.2 and 5.5-6.1 points for anchor- and distribution-based methods, respectively. In pooled analyses of all three studies, the CID was 7.0 and 6.4 for anchor- and distribution-based methods, respectively. CONCLUSIONS: These results confirm the construct validity of UPSA for assessing functional capacity in patients with MDD. Estimated CID using UPSA is approximately 6-7 points. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01564862; NCT02272517; NCT02279966.


Assuntos
Atividades Cotidianas/psicologia , Transtorno Depressivo Maior/psicologia , Inquéritos e Questionários/normas , Adulto , Idoso , Citalopram/uso terapêutico , Transtorno Depressivo Maior/tratamento farmacológico , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Paroxetina/uso terapêutico , Psicometria , Ensaios Clínicos Controlados Aleatórios como Assunto , Vortioxetina/uso terapêutico
10.
J Affect Disord ; 246: 148-156, 2019 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-30580200

RESUMO

BACKGROUND: Antenatal depressive and anxiety symptoms are common and may persist over time after delivery, with negative consequences on the mothers and their children. Evidence on the efficacy of psychological and pharmacological interventions during pregnancy aimed at preventing post-partum depression is controversial. METHODS: A consecutive sample of 318 women presenting for scheduled obstetric visits during pregnancy was screened for risk factors and anxiety or depressive symptoms. Based on the screening results, women were classified into three groups at increasing risk of post-partum depression (PPD) and were offered different interventions. RESULTS: Depressive or anxiety symptoms were found in 91 (28.6%) women, 89 (28.0%) had low risk of PPD and 138 (43.4%) had no risk of PPD. The multidisciplinary psychosocial interventions offered to women with clinical symptoms were well accepted, with an uptake of 76/91 (83.5%). Thirty-three women who did not improve with psychotherapy were offered sertraline or paroxetine as a second-line treatment: 7 accepted and 26 (78.8%) refused. Eleven women already on medication at baseline continued their treatment along with the MPI. The MPI interventions had some positive effects in terms of post-partum recovery, symptom reduction, and in preventing a new onset of depression. Among the 227 non-symptomatic during pregnancy, only 5 (2.2%) developed symptoms in the post-partum period. At 12 months post-partum, 84.6% of women who were symptomatic at 2 months post-partum recovered. LIMITATIONS: Our results should be interpreted in light of important limitations, including the lack of a control group that was not offered the MPI, the lack of information on the reasons for refusal and discontinuation and on the number of psychotherapy sessions attended. CONCLUSIONS: Our findings underscore the potential usefulness of MPI in recognizing early signs or symptoms during pregnancy and the advantage of building specific interventions for preventing post-natal depression. The MPI has positive effects on women with depressive or anxiety symptoms during pregnancy, that however did not exceed significantly those observed in women who refused the intervention. Thus, in the absence of a control group, our results are preliminary and warrant confirmation and testing in future randomized clinical trials.


Assuntos
Ansiedade/terapia , Depressão/terapia , Mães/psicologia , Assistência Perinatal/métodos , Complicações na Gravidez/terapia , Adulto , Antidepressivos/uso terapêutico , Ansiedade/diagnóstico , Ansiedade/psicologia , Terapia Combinada , Depressão/diagnóstico , Depressão/psicologia , Depressão Pós-Parto/diagnóstico , Depressão Pós-Parto/prevenção & controle , Depressão Pós-Parto/psicologia , Feminino , Humanos , Estudos Longitudinais , Paroxetina/uso terapêutico , Aceitação pelo Paciente de Cuidados de Saúde , Gravidez , Complicações na Gravidez/diagnóstico , Complicações na Gravidez/psicologia , Psicoterapia , Fatores de Risco , Sertralina/uso terapêutico , Resultado do Tratamento
11.
J Gastroenterol Hepatol ; 34(4): 713-719, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29971822

RESUMO

AIMS: The aims of this study were to better define the relationship between irritable bowel syndrome (IBS) and psychiatric disorders and to examine the efficacy of paroxetine in the treatment of IBS patients. METHODS: One hundred fifty subjects with diagnosis of IBS (Roma III criteria) and relative sub-classification (constipated, diarrhea, and mixed) were assessed for psychopathological features and gastrointestinal symptoms using IBS Symptom Severity Score and were consecutively enrolled. Fifty patients assumed paroxetine for 16 weeks and were longitudinally evaluated. RESULTS: The entire sample had a moderate/severe gastrointestinal symptomatology (IBS-SSS 285.1 ± 98.6). The IBS subtypes were diarrhea (47.3%), constipated (32%), and mixed (20.7%). Panic disorder was found in 17.4% and major depressive episode in 14.7%. More than 50% of the patients showed "psychopathological features." This group showed more severe gastrointestinal symptoms and worse quality of life than the group without any psychiatric comorbidity (44%). Psychiatric patients also showed a significant impairment of physical state, subjective feeling of well-being, and leisure activities when compared with no psychiatric patients. When the IBS-SSS > 300 group was subgrouped in psychiatric (67.2%) and no psychiatric (32.8%), we found significant differences in all clinician-administered and self-reported scales with more severe psychopathological features in psychiatric group (P < 0.01). Among the patients treated with paroxetine, 34 (68%) completed the longitudinal evaluation showing a significant improvement of both psychiatric and gastrointestinal symptoms. CONCLUSIONS: This study confirms a high presence of psychiatric comorbidities, emphasizing the need for psychiatric screening in all patients with IBS; moreover, the longitudinal evaluation of patients treated with paroxetine showed a significant improvement of both psychiatric and gastrointestinal symptoms.


Assuntos
Síndrome do Intestino Irritável/tratamento farmacológico , Síndrome do Intestino Irritável/psicologia , Transtornos Mentais/tratamento farmacológico , Transtornos Mentais/etiologia , Paroxetina/uso terapêutico , Adulto , Idoso , Feminino , Humanos , Síndrome do Intestino Irritável/complicações , Síndrome do Intestino Irritável/fisiopatologia , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Índice de Gravidade de Doença , Resultado do Tratamento , Adulto Jovem
12.
Cochrane Database Syst Rev ; 12: CD012346, 2018 12 19.
Artigo em Inglês | MEDLINE | ID: mdl-30566235

RESUMO

BACKGROUND: Studies report that up to 80% of individuals with chronic obstructive pulmonary disease (COPD) may struggle with symptoms of depression. However, this major comorbidity in COPD is rarely managed effectively. A number of recent studies indicate that left untreated, COPD-related depression is associated with worse quality of life, worse compliance with COPD treatment plan, increased exacerbations, hospital admissions, and healthcare costs when compared to individuals with COPD without depression. Regrettably, COPD practice guidelines do not provide conclusive treatment recommendations for the use of antidepressants in patients with COPD, and base their guidelines on findings from trials in the general population. This may be problematic, as there is an elevated risk of respiratory issues associated with antidepressant treatment and COPD. Evaluating effectiveness and safety of pharmacological interventions specifically for patients with COPD and depression was therefore paramount. OBJECTIVES: To assess the effectiveness and safety of pharmacological interventions for the treatment of depression in patients with COPD. SEARCH METHODS: The last search was performed on 26 November 2018. We initially searched the following databases via the Specialised Trials Registers of the Cochrane Airways and Common Mental Disorders Groups (to June 2016): MEDLINE, Embase, PsycINFO, CINAHL, AMED, and the Cochrane Library trials register (CENTRAL). Searches from June 2016 to November 2018 were performed directly on Ovid MEDLINE, Embase, PsycINFO and the Cochrane Library (Issue 11, 2018). We searched ClinicalTrials.gov, the ISRCTN registry, and the World Health Organization International Clinical Trials Registry Platform to 26 November 2018. We searched the grey literature databases to identify studies not indexed in major databases and the reference lists of studies initially identified for full-text screening. SELECTION CRITERIA: All published and unpublished randomised controlled trials (RCTs) comparing the efficacy of pharmacological interventions with no intervention, placebo or co-intervention in adults with diagnosed COPD and depression were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed articles identified by the search for eligibility. Our primary outcomes were change in depressive symptoms and adverse events. The secondary outcomes were: change in quality of life, change in dyspnoea, change in forced expiratory volume in one second (FEV1), change in exercise tolerance, change in hospital utilisation (length of stay and readmission rates), and cost-effectiveness. For continuous outcomes, we calculated the pooled mean difference (MD) or standardised mean difference (SMD) with 95% confidence interval (CI) as appropriate. For dichotomous outcomes, we calculated the pooled odds ratio (OR) and corresponding 95% CI using a random-effects model. We assessed the quality of evidence using the GRADE framework. MAIN RESULTS: Of the 1125 records screened for eligibility, four RCTs (N = 201 participants), and one on-going study, met the inclusion criteria. Two classes of antidepressants were investigated in two separate comparisons with placebo: a tricyclic antidepressant (TCA) and selective serotonin reuptake inhibitors (SSRIs).TCA versus placeboOnly one RCT (N = 30 participants) provided results for this comparison.Primary outcomesThe TCA (nortriptyline) reduced depressive symptoms post-treatment compared to placebo (MD -10.20, 95% CI -16.75 to -3.65; P = 0.007; very low-quality evidence), as measured by the Hamilton Depression Rating Scale (HAM-D). Three participants withdrew from the trial due to adverse events related to the tested antidepressant (dry mouth, sedation, orthostatic hypotension).Secondary outcomesThe overall results post-treatment indicated that nortriptyline was not effective in improving the quality of life of individuals with COPD, as measured by the Sickness Impact Profile (MD -2.80, 95% CI -11.02 to 5.42; P = 0.50; very low-quality evidence).The results for the change in dyspnoea for the domains examined (e.g. dyspnoea scores for 'most day-to-day activities') post-treatment showed no improvement in the intervention group (MD 9.80, 95% CI -6.20 to 25.80; P = 0.23; very low-quality evidence).No data were reported for change in FEV1, change in exercise tolerance, change in hospital utilisation, or cost-effectiveness. The TCA study provided short-term results, with the last follow-up data collection at 12 weeks.The quality of the evidence for all the outcomes evaluated was very low due to a small sample size, imprecision, attrition, and selection and reporting bias.SSRIs versus placeboThree RCTs (N = 171 participants) provided results for this comparison.Primary outcomesThe pooled results for two studies showed no difference for the change in depressive symptoms post-intervention (SMD 0.75, 95% CI -1.14 to 2.64; 148 participants; 2 studies; P = 0.44; very low-quality evidence). High heterogeneity was observed (I² = 95%), limiting the reliability of these findings.While it was not possible to meta-analyse the total adverse events rates across the studies, it was possible to combine the results for two medication-specific adverse effects: nausea and dizziness. There were no significant post-treatment group differences for nausea (OR 2.32, 95% CI 0.66 to 8.12; 171 participants; 3 studies; P = 0.19; very low-quality evidence) or dizziness (OR 0.61, 95% CI 0.09 to 4.06; 143 participants; 2 studies; P = 0.61; very low-quality evidence).Secondary outcomesThe pooled analysis of two trials reporting data for the change in quality of life did not show improvement post-treatment in the intervention group compared to placebo (SMD 1.17, 95% CI -0.80 to 3.15; 148 participants; 2 studies; P = 0.25; very low-quality evidence).There was no difference between groups in change in FEV1 post-treatment (MD 0.01, 95% CI -0.03 to 0.05; 148 participants; 2 studies; P = 0.60; low-quality evidence). However, two trials reported improvement in exercise tolerance in the SSRI group versus the placebo group (MD 13.88, 95% CI 11.73 to 16.03; 148 participants; 2 studies; P < 0.001; very low-quality evidence).The trials included in this comparison did not report data related to the change in dyspnoea, hospital utilisation rates, or cost-effectiveness. AUTHORS' CONCLUSIONS: There is insufficient evidence to make definitive statements about the efficacy or safety of antidepressants for treating COPD-related depression. New RCTs are needed; with better methodological quality and more accurate reporting of the methods used. Moreover, longer-term follow-up data collection is needed, including outcomes such as adverse events, hospital utilisation and cost-effectiveness.


Assuntos
Antidepressivos Tricíclicos/uso terapêutico , Depressão/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/psicologia , Inibidores de Captação de Serotonina/uso terapêutico , Antidepressivos Tricíclicos/efeitos adversos , Depressão/etiologia , Tontura/induzido quimicamente , Dispneia/tratamento farmacológico , Tolerância ao Exercício/efeitos dos fármacos , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Náusea/induzido quimicamente , Nortriptilina/efeitos adversos , Nortriptilina/uso terapêutico , Paroxetina/efeitos adversos , Paroxetina/uso terapêutico , Placebos/uso terapêutico , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Inibidores de Captação de Serotonina/efeitos adversos , Sertralina/efeitos adversos , Sertralina/uso terapêutico
14.
J Psychiatry Neurosci ; 43(6): 407-415, 2018 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-30375835

RESUMO

Background: Laboratory-based research with community samples has suggested changes in affective, behavioural and cognitive processes as possible explanations for the effects of serotonergic medications. Examining the effects of serotonergic medications using an ecological momentary measure (such as event-contingent recording) in the daily lives of people with social anxiety disorder would contribute to establishing the effects of these medications on affect, behaviour and one form of cognition: perception of others' behaviour. Methods: The present study assessed changes in affect, interpersonal behaviour and perception of others' behaviour in adults with social anxiety disorder using ecological momentary assessment at baseline and over 4 months of a single-arm, uncontrolled, open-label trial of treatment with the selective serotonin reuptake inhibitor paroxetine. Results: Anxiety and concurrent depressive symptoms decreased. Participants also reported increased positive and decreased negative affect; increased agreeable and decreased quarrelsome behaviour; increased dominant and decreased submissive behaviour; and increased perception that others behaved agreeably toward them. Moreover, participants demonstrated reduced intraindividual variability in affect, interpersonal behaviour and perception of others' behaviour. Limitations: Limitations included the lack of a placebo group, the inability to identify the temporal order of changes and the restricted assessment of extreme behaviour. Conclusion: The results of the present study demonstrate changes during pharmacotherapy in the manifestation of affect, interpersonal behaviour and interpersonal perception in the daily lives of people with social anxiety disorder. Given the importance of interpersonal processes to social anxiety disorder, these results may guide future research seeking to clarify mechanisms of action for serotonergic medications.


Assuntos
Afeto/efeitos dos fármacos , Antidepressivos de Segunda Geração/uso terapêutico , Relações Interpessoais , Paroxetina/uso terapêutico , Fobia Social/tratamento farmacológico , Fobia Social/psicologia , Inibidores de Captação de Serotonina/uso terapêutico , Percepção Social , Adulto , Ansiedade/tratamento farmacológico , Depressão/tratamento farmacológico , Depressão/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Escalas de Graduação Psiquiátrica , Comportamento Social , Adulto Jovem
15.
J Clin Sleep Med ; 14(11): 1849-1857, 2018 11 15.
Artigo em Inglês | MEDLINE | ID: mdl-30373688

RESUMO

STUDY OBJECTIVES: A single-item sleep quality scale (SQS) was developed as a simple and practical sleep quality assessment and psychometrically evaluated. METHODS: SQS measurement characteristics were evaluated using the Pittsburgh Sleep Quality Index (PSQI) and morning questionnaire-insomnia (MQI) according to prespecified analysis plans in separate clinical studies of patients with insomnia and depression. Patients with insomnia (n = 70) received 4 weeks' usual care with an FDA-approved hypnotic agent; patients with depression (n = 651) received 8 weeks' active or experimental therapy. RESULTS: Concurrent criterion validity (correlation with measures of a similar construct) was demonstrated by strong (inverse) correlations between the SQS and MQI (week 1 Pearson correlation -.76) and PSQI (week 8 Goodman-Kruskal correlation -.92) sleep quality items in populations with insomnia and depression, respectively. In patients with depression, stronger correlations between the SQS and PSQI core sleep quality components versus other items supported convergent/divergent construct validity (similarity/dissimilarity to related/unrelated measures). Known-groups validity was evidenced by decreasing mean SQS scores across those who sleep normally, those borderline to having sleep problems, and those with problems sleeping. Test-retest reliability (intraclass correlation coefficient) was .62 during a 4-week period of sleep stability in patients with insomnia and .74 in stable patients with depression (1 week). Effect sizes (standardized response means) for change from baseline were 1.32 (week 1) and .67 (week 8) in populations with insomnia and depression, respectively. Mean SQS changes from baseline to week 8 convergently decreased across groups of patients with depression categorized by level of PSQI sleep quality improvement. CONCLUSIONS: The SQS possesses favorable measurement characteristics relative to lengthier or more frequently administered sleep questionnaires in patients with insomnia and depression. CLINICAL TRIAL REGISTRATION: Registry: ClincalTrials.gov, Title: Treatment of Patients With Major Depressive Disorder With MK0869, Identifier: NCT00034983, URL: https://clinicaltrials.gov/ct2/show/NCT00034983.


Assuntos
Aprepitanto/uso terapêutico , Transtorno Depressivo Maior/diagnóstico , Paroxetina/uso terapêutico , Psicometria/estatística & dados numéricos , Distúrbios do Início e da Manutenção do Sono/diagnóstico , Inquéritos e Questionários , Adulto , Idoso , Comorbidade , Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Maior/psicologia , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Hipnóticos e Sedativos/uso terapêutico , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico , Distúrbios do Início e da Manutenção do Sono/psicologia
16.
CNS Neurosci Ther ; 24(11): 1073-1083, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30277663

RESUMO

AIMS: This study assessed whether antidepressant drug treatment has a common effect on gray matter (GM) volume in MDD patients with and without childhood maltreatment (CM). METHODS: T1-weighted structural magnetic resonance imaging data were collected from 168 participants, including 51 MDD patients with CM, 31 MDD patients without CM, 48 normal controls with CM, and 38 normal controls without CM. MDD patients received 6 months of treatment with paroxetine, and 24 patients with CM, and 16 patients without CM received a second MRI scan. A whole-brain voxel-based morphometry approach was used to estimate GM volume in each participant at two time points. Two-way analysis of variance (ANOVA) was used to determine the effects of MDD and CM on GM volume at baseline. Repeated measures two-way ANOVA was used to determine the treatment-by-CM interactive effect and main effect of treatment during paroxetine treatment. We further investigated the relationship between GM volume and clinical variables. RESULTS: At baseline, significant MDD-by-CM interactive effects on GM volume were mainly observed in the left parahippocampal gyrus, left entorhinal cortex, and left cuneus. GM volume was significantly lower mainly in the right middle temporal gyrus in patients with MDD than in normal controls. We did not find any significant treatment-by-CM interactive effects. However, a treatment-related increase in GM was found in the right middle temporal gyrus in both MDD groups. CONCLUSIONS: These results suggest that paroxetine treatment operates via a shared neurobiological mechanism in MDD patients with and without CM.


Assuntos
Antidepressivos de Segunda Geração/uso terapêutico , Maus-Tratos Infantis/psicologia , Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Maior/psicologia , Substância Cinzenta/efeitos dos fármacos , Paroxetina/uso terapêutico , Adulto , Criança , Transtorno Depressivo Maior/diagnóstico por imagem , Feminino , Substância Cinzenta/diagnóstico por imagem , Humanos , Processamento de Imagem Assistida por Computador , Imagem por Ressonância Magnética , Masculino , Escalas de Graduação Psiquiátrica , Resultado do Tratamento
17.
J Clin Psychiatry ; 79(5)2018 09 18.
Artigo em Inglês | MEDLINE | ID: mdl-30257081

RESUMO

OBJECTIVE: Fluoxetine, paroxetine, sertraline, topiramate, and venlafaxine have consistently shown efficacy for posttraumatic stress disorder (PTSD) in meta-analyses of randomized controlled trials. However, no study has compared the effectiveness of these agents in routine clinical practice. We conducted a retrospective comparative effectiveness study of these 5 medications using electronic medical record data. METHODS: We identified 2,931 Department of Veterans Affairs outpatients initiating treatment for PTSD between fiscal years 2004 and 2013 who received 1 of the 5 medications at an adequate dose and duration, combined with baseline and endpoint PTSD Checklist (PCL) measurements. Patients were identified based on clinical diagnoses of PTSD (DSM-IV criteria). We weighted participants in order to balance pretreatment characteristics. We compared continuous changes on total PCL score, symptom cluster scores, and sleep items, as well as categorical changes including reliable improvement and loss of PTSD diagnosis, using weighted regression analyses. We conducted exploratory analysis to determine whether any patient characteristics or service use variables predicted loss of PTSD diagnosis. RESULTS: Patients improved by a mean of 5-6 points on the PCL over approximately 6 months of treatment. While half of patients had a reliable improvement of 5 points or more on the PCL, less than a fifth achieved loss of PTSD diagnosis. There were no differences between medications. The only significant (P < .001) predictor of loss of PTSD diagnosis was concurrent treatment with evidence-based psychotherapy. CONCLUSIONS: Available evidence-based medications for PTSD are equally effective in clinical practice. Although effective, our data suggest that patients choosing medication treatment for PTSD should consider concurrent treatment with evidence-based psychotherapy in order to maximize their chances of meaningful improvement.


Assuntos
Fluoxetina/uso terapêutico , Registros Médicos/estatística & dados numéricos , Paroxetina/uso terapêutico , Sertralina/uso terapêutico , Transtornos de Estresse Pós-Traumáticos/tratamento farmacológico , Topiramato/uso terapêutico , Cloridrato de Venlafaxina/uso terapêutico , Adulto , Anticonvulsivantes/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pacientes Ambulatoriais/estatística & dados numéricos , Estudos Retrospectivos , Inibidores de Captação de Serotonina/uso terapêutico , Resultado do Tratamento , Estados Unidos , United States Department of Veterans Affairs/estatística & dados numéricos
18.
Am J Case Rep ; 19: 1068-1070, 2018 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-30185769

RESUMO

BACKGROUND Depressive patients are considerably more likely to suffer cardiovascular disease (CVD), and in patients with CVD, depression is a predictor of poor outcome. Recent findings suggest higher rates of depression and anxiety in patients with coronary slow flow (CSF). However, there is no research investigating whether the antidepressant treatment can mitigate psychiatric symptoms and cardiac conditions in CSF patients comorbid with depression. CASE REPORT The patient was a 52-year-old Chinese female with frequent chest pain. The patient had serious TIMI (thrombolysis in myocardial infarction) grade 2 flow without any coronary stenosis, but comorbid with depression and anxiety. The CSF was very likely associated with her mental health condition, given that the chest distress and intermittent chest pain followed psychological stress and disturbed sleep. Therefore, paroxetine was used under the circumstances of the poor effect of cardiovascular active drugs. We found that the adjunctive use of paroxetine not only improved the psychiatric symptoms, but also alleviated the cardiac conditions. CONCLUSIONS Our findings strengthen the importance of the treatment of psychiatric symptoms in patients with CSF and this finding should promote randomized controlled trials in a larger population to confirm the beneficial effects of antidepressant treatment on psychiatric symptoms and cardiac conditions in CSF patients with psycho-cardiac conditions.


Assuntos
Antidepressivos/efeitos adversos , Ansiedade/tratamento farmacológico , Depressão/tratamento farmacológico , Infarto do Miocárdio/tratamento farmacológico , Paroxetina/uso terapêutico , Antidepressivos/uso terapêutico , Comorbidade , Feminino , Humanos , Pessoa de Meia-Idade , Infarto do Miocárdio/fisiopatologia
19.
Kennedy Inst Ethics J ; 28(2): 119-144, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30100597

RESUMO

Sponsorship bias occurs when the financial interests of funders of scientific research influence claims made by scientists, especially in peer-reviewed publications. This article examines the relationship between sponsorship bias and misleading claims, understood as claims that are not necessarily false but which encourage those exposed to them to infer false conclusions. Misleading claims are relevant to how the term "bias" should be understood and thereby to evaluating a recent dispute about whether there is evidence of sponsorship bias in clinical research on statins. The concept of inferential asymmetry is introduced as an aid for understanding the relationship between misleading claims and sponsorship bias.


Assuntos
Viés , Conflito de Interesses , Decepção , Indústria Farmacêutica/ética , Apoio Financeiro/ética , Pesquisadores/ética , Indústria Farmacêutica/economia , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Paroxetina/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/ética
20.
Perspect Biol Med ; 61(2): 201-214, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30146519

RESUMO

When Congress amended the Food, Drug, and Cosmetic Act in 1962 to ensure the efficacy of drugs before they reach the market, it imposed a standard of evidence distinctly weaker than the reasonable one of preponderance. The difference is material. Some drugs now on the market may or may not have a preponderance of trial evidence of efficacy. An obstacle to a finding of efficacy is the well-known nemesis of drug makers with a definite interest in favorable trials: the placebo effect. Trials where the placebo effect runs high are vulnerable to negative findings, and trials with such findings all too often find their way to burial sites like regulatory archives. Publication bias-the preferential reporting of positive findings-has been abetted by a regulatory standard that does not require a preponderance of evidence and discounts negative trials, provided only that two trials show positive results.


Assuntos
Aprovação de Drogas/legislação & jurisprudência , Aprovação de Drogas/métodos , United States Food and Drug Administration/normas , Ensaios Clínicos como Assunto , Humanos , Síndrome do Intestino Irritável/tratamento farmacológico , Paroxetina/efeitos adversos , Paroxetina/uso terapêutico , Efeito Placebo , Viés de Publicação , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudência
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