Alessandro Finkelsztejn

The quality of reporting of trial abstracts is suboptimal: Survey of major general medical journals

OBJECTIVE To evaluate the quality of reporting of abstracts describing randomized controlled trials (RCTs) published in four major general medical journals. STUDY DESIGN AND SETTING Systematic survey of published RCT abstracts, with two reviewers independently extracting data. We searched MEDLINE and identified 227 RCT abstracts published in the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), British Medical Journal (BMJ), and The Lancet in the year 2006. RESULTS Most abstracts identified the study as a randomized trial (98.7%), reported the objectives (92.5%), described the population (90.3%), detailed the intervention (81.5%), and defined the primary outcome (71.3%). Methodological quality was poorly reported: one (0.4%) described allocation concealment; 21 (9.3%) clearly specified blinding; 51 (22.5%) described intention-to-treat analysis; and 32 (14.1%) outlined losses to follow-up. Most of the abstracts reported the effect size and the confidence intervals (62.3%), but just half of them reported side effects or harms. CONCLUSION The quality of reporting of RCT abstracts published in main general medical journals is suboptimal. Space limitations notwithstanding, with the recent recommendations from the CONSORT for Abstracts, it is expected that the transparency of abstract reporting can and should improve.

Severe depression, suicide attempts, and ideation during the use of interferon beta by patients with multiple sclerosis.

Background:Interferon (IFN) beta is a safe and efficient drug for treating multiple sclerosis (MS). It is widely accepted that previously depressed patients may get worse when using IFN-beta. There are few reports on the association of IFN-beta and severe depression among patients without previous psychiatric history. Methods:Discussion of a case of a patient with MS who developed severe depression and attempted suicide while using IFN-beta encouraged us to review the subject. A group of neurologists in Brazil retrospectively gathered together their similar cases for the present paper. Results:The present paper reports on 11 cases of severe depression with suicide attempts or ideation among patients with MS who were using IFN-beta. These patients had no previous history of any psychiatric disease. Nine patients developed the symptoms over a relatively short period (4 months, on average). Two patients developed severe depression after more than 1 year of treatment with IFN-beta. Phobic, aggressive, behavioral, psychotic, and manic symptoms also were observed in these patients, thus suggesting the existence of a complex mood-behavior disorder associated with this drug. Interferon beta withdrawal led to complete remission of symptoms. The Naranjo algorithm established a highly probable association between IFN-beta and this adverse reaction in these patients. Conclusions:Although uncommon, severe depression with suicide ideation or attempts may be observed during treatment of MS with IFN-beta. This association should not discourage the use of this drug, but physicians need to be aware of this possible adverse event from IFN-beta.

Long-term use of glatiramer acetate by 11 pregnant women with multiple sclerosis: a retrospective, multicentre case series.

AbstractBackground: Glatiramer acetate is a US FDA category B drug with regard to use by pregnant women with multiple sclerosis (MS). There are no data currently available for the continuous use of glatiramer acetate during pregnancy. Objective: To assess the risks and benefits of glatiramer acetate used throughout pregnancy among women with active MS. Design: Retrospective and multicentre case series. Settings: Outpatient services of academic and private institutions caring for patients with MS in Brazil. Patients: Eleven women with MS and their children were assessed. Intervention: Retrospective evaluation of women with MS who received glatiramer acetate continuously for at least 7 months during pregnancy. This evaluation was performed by the neurologist responsible for the patient. Children aged 1 year and over, born to mothers who received glatiramer acetate during pregnancy, were assessed using the Denver II developmental screening test. Main Outcome Measurements: Obstetric, neonatal and developmental outcomes. Results: No drug-related obstetric complications were observed. No specific drug-related malformations, neonatal complications or developmental abnormalities were observed in the children. Postnatal MS relapse rates remained significantly lower than antenatal rates in these patients. Conclusions: No deleterious effects from glatiramer acetate were observed in these pregnant women with MS or in their offspring. No increment in postnatal relapse rate was observed. However, the use of glatiramer acetate during pregnancy should be restricted to the most difficult cases, in which the benefits clearly outweigh the risks.

Pregnancy and multiple sclerosis: the initial results from a Brazilian database

PURPOSE Pregnancy management poses an extra challenge to physicians and their multiple sclerosis (MS) patients. There are few papers reporting databases on the subject. METHOD Brazilian database from nine MS clinical and research units, with complete data on 47 pregnant women (49 pregnancies). RESULTS Despite relatively high exposure to MS medications, no birth defects were reported. Low birth weight and prematurity were similar to those for developing countries. Three complications may have been associated with these medications, while three others were considered to be of purely obstetric nature. CONCLUSION Our results confirm previous findings on lower relapse rate during pregnancy and add to the present literature informing on data related to drug exposure.

Clinical features of multiple sclerosis in the south of Brazil: a partial analysis

UNLABELLED There are no published studies on the characteristics of multiple sclerosis (MS) patients from the south of Brazil. OBJECTIVE To identify the clinical features of a series of MS patients and to compare to other Brazilian series. METHOD Retrospective study with 67 patients followed in The MS Reference Center - RS, Brazil during the year of 2008. We analyzed demographic and clinical data. RESULTS Most were women (74.6%), the general average age was 43.5 years old, and the general average EDSS score was 4.1. Of those patients, 81.8% had relapsing-remitting MS. Sexual dysfunction prevalence was 31.1% in men and 68.9% in women (p<0.01). We found a positive correlation (Spearman=0.444, p<0.05) between EDSS and depressive symptoms. CONCLUSION This study showed a very similar sample compared to other states of Brazil. Moreover, there was found a high prevalence of sexual dysfunction and a straight relation between EDSS and depressive symptoms.

The real-life experience with cardiovascular complications in the first dose of fingolimod for multiple sclerosis

Fingolimod is a new and efficient treatment for multiple sclerosis (MS). The drug administration requires special attention to the first dose, since cardiovascular adverse events can be observed during the initial six hours of fingolimod ingestion. The present study consisted of a review of cardiovascular data on 180 patients with MS receiving the first dose of fingolimod. The rate of bradycardia in these patients was higher than that observed in clinical trials with very strict inclusion criteria for patients. There were less than 10% of cases requiring special attention, but no fatal cases. All but one patient continued the treatment after this initial dose. This is the first report on real-life administration of fingolimod to Brazilian patients with MS, and one of the few studies with these characteristics in the world.

Restless legs syndrome and multiple sclerosis: a Brazilian multicenter study and meta-analysis of the literature

OBJECTIVE The increased prevalence of restless legs syndrome (RLS) in multiple sclerosis (MS) has recently been the subject of a few papers. The present study investigated the prevalence of RLS symptoms in MS patients and in controls in four Brazilian cities. Additionally, a systematic review and meta-analysis of the literature was carried out on the subject of RLS-MS. METHOD MS patients and controls were investigated regarding the presence of the four typical symptoms of RLS. A questionnaire assessing RLS severity was also used for patients and controls presenting the four RLS symptoms criteria. The systematic review and meta-analysis on the subject were carried out according to the strict international criteria. RESULTS In the present report, the RLS-MS association was confirmed as being more than fortuitous in Brazilian MS patients, in a multicenter case-control study. MS patients also presented RLS symptoms of greater severity than did the control population. A systematic review and meta-analysis of the literature showed that MS patients had a fourfold higher chance of presenting RLS than did the controls. CONCLUSION Although underlying mechanisms to explain the association RLS-MS are still a matter of discussion, there is a clear association of these two neurological conditions.

Prevalence of parafunctional habits and temporomandibular dysfunction symptoms in patients attending a tertiary headache clinic

OBJECTIVE To investigate the most prevalent forms of headache in a tertiary outpatient service, and to assess the frequency of associated parafunctional habits and temporomandibular dysfunction symptoms (TMD). METHOD All new patients referred to the Headache Outpatient Service in UNIMES during 2008 were prospectively assessed by the neurologist and the dental surgeon. RESULTS Eighty new patients were assessed; chronic migraine and episodic migraine without aura were the most prevalent conditions, accounting for 66.3% of all cases. There was significantly higher use of analgesics/days for the chronic migraine patients. The prevalence of parafunctional habits was 47.5% and the prevalence of TMD symptoms was 35%. CONCLUSION The high prevalence of primary headaches, parafunctional habits and TMD symptoms and the inadequate use of analgesic drugs suggest that primary healthcare units need further training in the field of headache and orofacial pain.

Multiple sclerosis starting before the age of 18 years: the Brazilian experience

Multiple sclerosis (MS) starting in childhood and adolescence poses a challenge for diagnosis and management of the disease. The aim of the present study was to assess the characteristics of early onset MS in Brazilian patients. Methods Retrospective data collection from specialized MS units. Results From 20 MS units in 11 Brazilian states, 117 cases of MS starting before the age of 18 years were collected. These patients had an average of 10 years of disease duration, still typically with low disability and one relapse every 2.5 years. The mean age for disease onset was 13.7 years. Conclusion The present study introduces a large series of Brazilian cases of pediatric MS. Although some patients presented a very severe form of MS, on the whole the group of patients with MS starting in childhood or adolescence presented a relatively mild form of this disease in Brazil.

The prevalence of multiple sclerosis in Santa Maria, Rio Grande do Sul, Brazil

Multiple sclerosis (MS) is one of the leading causes of neurologic deficits in young adults and can lead to physical, intellectual and emotional problems. Approved treatments are expensive and are among the 10 highest budgets of the Brazilian Health Ministry. Given the diverse prevalence of MS among Brazilian regions, it is important to determine prevalence rates across the country. Seven studies have assessed MS in Brazil and reported rates ranging from 15 cases to 18 cases per 100,000 inhabitants. It has been hypothesized that this rate is even higher in southern Brazil, which has a high proportion of European heritage (mostly German and Italian) immigrants. Here, we report that the prevalence of MS in the city of Santa Maria, Rio Grande do Sul, Brazil, is 27.2 cases/100,000 inhabitants.