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BMJ Clinical Evidence May 2007Essential tremor is one of the most common movement disorders throughout the world, with prevalence in the general population of 0.4-3.9%. Although most people with... (Review)
Review
INTRODUCTION
Essential tremor is one of the most common movement disorders throughout the world, with prevalence in the general population of 0.4-3.9%. Although most people with essential tremor are only mildly affected, those who seek medical care are disabled to some extent, and most are socially handicapped by the tremor.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of drug treatments in people with essential tremor of the hand? We searched: Medline, Embase, The Cochrane Library and other important databases up to December 2006 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 41 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: adding mirtazepine to other antitremor drugs; benzodiazepines; beta-blockers other than propranolol; botulinum A toxin-haemagglutinin complex; calcium channel blockers; carbonic anhydrase inhibitors; clonidine; flunarizine; gabapentin; isoniazid; Phenobarbital; primidone; propranolol; and topiramate.
Topics: Double-Blind Method; Essential Tremor; Humans; Primidone; Propranolol; Tremor
PubMed: 19454072
DOI: No ID Found -
Journal of Managed Care Pharmacy : JMCP 2006Clinical practice guidelines (CPGs) are intended not only to provide supportive information for health care providers but also to act as a guide for health care policy... (Comparative Study)
Comparative Study Review
OBJECTIVE
Clinical practice guidelines (CPGs) are intended not only to provide supportive information for health care providers but also to act as a guide for health care policy decisions. However, extant CPGs do not always reach the same conclusions. The objective of this study was to compare recommendations for initial pharmacological treatment of new-onset epilepsy in adults as stated within published CPGs.
METHODS
We performed a systematic review of CPGs, which were published by prominent national organizations between January 2000 and June 2005, regarding the initial pharmacological treatment of epilepsy in adults.
RESULTS
Five CPGs and 1 evidence report were identified that focus on pharmaceutical management in epilepsy. The 3 guidelines most relevant to the question of new-onset epilepsy treatment in adults were developed by the American Academy of Neurology (AAN), Scottish Intercollegiate Guidelines Network (SIGN), and National Institute for Health and Clinical Excellence (NICE). AAN recommends the use of both recently introduced antiepileptic drugs (AEDs: gabapentin, lamotrigine, topiramate, and oxcarbazepine) and standard agents (carbamazepine, phenytoin, valproic acid/divalproex, and phenobarbital) in newly diagnosed epilepsy, i.e., a nontiered approach. Alternatively, NICE recommends using newer AEDs (lamotrigine, topiramate, and oxcarbazepine) only in patients who derive no benefit from older agents--a tiered approach. SIGN notes that all AEDs licensed for monotherapy have similar efficacy in newly diagnosed epilepsy--a recommendation for a nontiered approach. The newer AEDs (lamotrigine and oxcarbazepine) are recommended as first-line initial treatment as are standard agents (carbamazepine and valproic acid/divalproex). The NICE guideline includes economic and quality-of-life evidence in their recommendations while AAN and SIGN do not. In these regards, current data fails to show superiority for newer agents.
CONCLUSION
In the past 5 years, several CPGs have been published in epilepsy management. Only 3 guidelines have explicit recommendations for initial pharmacological treatment of adults with epilepsy. With some variation regarding which medications are recommended from each group, all CPGs promote standard and newer AEDs as having similar clinical efficacy. Until efficacy, quality of life, or cost data for the newer agents demonstrates a superior outcome, older AEDs remain viable options as first-line for monotherapy in newly diagnosed patients and may provide cost benefits over newer agents.
Topics: Adult; Anticonvulsants; Epilepsy; Humans; Practice Patterns, Physicians'; United States
PubMed: 16420108
DOI: 10.18553/jmcp.2006.12.1.55 -
Tropical Medicine & International... Nov 2005Randomized controlled clinical trials (RCTs) of adjunctive treatment to reduce the high-mortality associated with cerebral malaria (CM) have so far failed to show any... (Review)
Review
BACKGROUND
Randomized controlled clinical trials (RCTs) of adjunctive treatment to reduce the high-mortality associated with cerebral malaria (CM) have so far failed to show any benefit. This may be due in part to improperly designed and/or conducted trials. Therefore a systematic review of quality of RCTs for the treatment of CM with mortality as either primary or secondary outcome published between 1980 and 2000, was conducted.
METHODS
RCTs from the peer-reviewed literature using electronic searches. Methodological quality was assessed using an individual component approach (adequacy of concealment of allocation schedule, generation of allocation sequence, double blinding and analysis of participant as randomized). Sample sizes were recalculated for the ability of reviewed trials to detect 25% and 50% reductions in mortality.
RESULTS
Nine trials satisfied the inclusion criteria and were reviewed. Only two had sufficient power to detect a 50% reduction in mortality, and none could detect a 25% reduction. All the trials had inadequate methodological quality in one or more of the components, although in two trials these deficiencies were few.
CONCLUSION
There is a need for researchers and donors to ensure proper planning and implementation of RCTs in developing countries. In CM, demonstration of worthwhile reduction in mortality by a single intervention will require a large number of subjects, which a single centre may not be able to recruit.
Topics: Anticonvulsants; Deferoxamine; Dexamethasone; Double-Blind Method; Enzyme Inhibitors; Humans; Malaria, Cerebral; Pentoxifylline; Phenobarbital; Randomized Controlled Trials as Topic; Sample Size; Siderophores; Tumor Necrosis Factor-alpha
PubMed: 16262742
DOI: 10.1111/j.1365-3156.2005.01505.x -
Arquivos de Neuro-psiquiatria Dec 2003Convulsions triggered by fever are the most common type of seizures in childhood, and 20% to 30% of them have recurrence. The prophylactic treatment is still... (Meta-Analysis)
Meta-Analysis Review
UNLABELLED
Convulsions triggered by fever are the most common type of seizures in childhood, and 20% to 30% of them have recurrence. The prophylactic treatment is still controversial, so we performed a systematic review to find out the effectiveness of continuous phenobarbital and intermittent diazepam compared to placebo for febrile seizure recurrence.
METHOD
Only randomized, double-blind, placebo-controlled trials were analyzed. The recurrence of febrile seizure was assessed for each drug.
RESULTS
Ten eligible clinical trials were included. Febrile seizure recurrence was smaller in children treated with diazepam or phenobarbital than in placebo group. Prophylaxis with either phenobarbital or diazepam reduces recurrences of febrile seizures. The studies were clinical, methodological, and statistically heterogeneous.
CONCLUSION
The effectiveness of phenobarbital and diazepam could not be demonstrated because clinical trials were heterogeneous, and the recommendation for treatment recurrence should rely upon the experience of the assistant physician yet.
Topics: Anticonvulsants; Diazepam; Follow-Up Studies; Humans; Odds Ratio; Phenobarbital; Placebos; Randomized Controlled Trials as Topic; Secondary Prevention; Seizures, Febrile; Time Factors
PubMed: 14762586
DOI: 10.1590/s0004-282x2003000600001 -
Epilepsia 2003Prevention of posttraumatic epilepsy (PTE) is of primary importance to reduce the degree of functional morbidity following traumatic brain injury (TBI). However, the... (Review)
Review
PURPOSE
Prevention of posttraumatic epilepsy (PTE) is of primary importance to reduce the degree of functional morbidity following traumatic brain injury (TBI). However, the effects of antiepileptic drugs (AEDs) in patients with TBI must be assessed separately in terms of prevention and control of provoked seizures (which include immediate and early posttraumatic seizures) and prevention of subsequent unprovoked seizures (late posttraumatic seizures or PTE).
METHODS
Potential mechanisms for prevention of epileptogenesis as well as reports and systematic reviews were evaluated to determine strategies and results of attempts to reduce or prevent the development of epilepsy following TBI.
RESULTS
In observational studies, after a period ranging from 6 months to 13 years, the proportion of cases developing seizures was 0-10% in patients receiving treatment compared to 2-50% in those who were left untreated. In randomized clinical trials, the difference between active treatment [phenytoin (PHT), phenobarbital, or carbamazepine (CBZ)] and placebo was less remarkable after a follow-up ranging from 3 to 60 months and was virtually lacking for the prevention of PTE. In a Cochrane systematic review of 890 patients from 10 RCTs assessing PHT or CBZ, the pooled relative risk (RR) for prevention of early seizures was 0.33 (95% CI 0.21-0.52). By contrast, the RR for prevention of late seizures was 1.28 (95% CI 0.90-1.81). Mortality and neurological disability were similar in the two treatment groups. The use of PHT was followed by an increased (nonsignificant) risk of skin rashes. In addition, cognitive performance was significantly affected by PHT in severely injured patients at 1 month and treatment withdrawal was followed by improvement in cognitive function.
CONCLUSIONS
The failure to influence the risk of PTE in studies of patients with TBI are similar to findings of meta-analysis of randomized clinical trials on seizure prevention in other conditions, such as febrile seizures, cerebral malaria, craniotomy, and excessive alcohol intake. For these reasons, the prophylactic use of AEDs should be short-lasting and limited to the prevention of immediate and early seizures. Chronic treatment should be considered only after a diagnosis of PTE.
Topics: Animals; Anticonvulsants; Brain Injuries; Epilepsy, Post-Traumatic; Humans; Randomized Controlled Trials as Topic; Risk Factors
PubMed: 14511391
DOI: 10.1046/j.1528-1157.44.s10.1.x -
The Cochrane Database of Systematic... 2002Cerebral malaria is a common complication of Plasmodium falciparum infection, and kills over a million people every year. People with cerebral malaria become... (Review)
Review
BACKGROUND
Cerebral malaria is a common complication of Plasmodium falciparum infection, and kills over a million people every year. People with cerebral malaria become unconscious, and often have protracted convulsions. It is unclear whether giving anticonvulsant drugs routinely to people with cerebral malaria will improve the outcome of treatment and prevent death.
OBJECTIVES
To evaluate the effect of routine anticonvulsant drugs in people with cerebral malaria.
SEARCH STRATEGY
We searched the Cochrane Infectious Diseases Group specialized trials register (November 2001), The Cochrane Controlled Trials Register (Issue 4, 2001), MEDLINE (1966 to November 2001), EMBASE (1988 to October 2001), LILACS (2001, 40a Edition CD-ROM), Science Citation Index (November 2001), African Index Medicus (1999), reference lists of articles, and research organizations. We also contacted the authors for addtional information.
SELECTION CRITERIA
Randomized and quasi-randomized controlled trials of people with cerebral malaria. The trials compared anticonvulsant drugs started on admission to hospital with no anticonvulsant drug or placebo.
DATA COLLECTION AND ANALYSIS
Two reviewers independently extracted data from those trials eligible for inclusion. We assessed the methodological quality of the included trials by considering allocation sequence, concealment of allocation, blinding, and inclusion of all randomized participants. We used Review Manager (version 4.1) for the meta-analysis and also explored possible sources of heterogeneity.
MAIN RESULTS
Three trials with a total of 573 participants met the inclusion criteria. These trials all compared phenobarbitone with placebo or no treatment. In the two trials with adequate allocation concealment, death was more common in the anticonvulsant group (Relative Risk 2.0; 95% confidence interval 1.20 to 3.33; fixed effect model). In all three trials, phenobarbitone compared with placebo or no treatment was associated with fewer convulsions (Relative Risk 0.30; 95% confidence interval 0.19 to 0.45; fixed effect model).
REVIEWER'S CONCLUSIONS
Routine phenobarbitone in cerebral malaria is associated with fewer convulsions but possibly more deaths. Further trials with adequate design, more participants, and different doses of anticonvulsant drugs are needed.
Topics: Anticonvulsants; Humans; Malaria, Cerebral; Phenobarbital; Randomized Controlled Trials as Topic; Seizures
PubMed: 12076440
DOI: 10.1002/14651858.CD002152 -
The Cochrane Database of Systematic... 2001Worldwide, phenytoin and phenobarbitone are commonly used antiepileptic drugs. They are more likely to be used in the developing world than the developed world,... (Review)
Review
BACKGROUND
Worldwide, phenytoin and phenobarbitone are commonly used antiepileptic drugs. They are more likely to be used in the developing world than the developed world, primarily because they are inexpensive. The aim of this review is to summarise data from existing trials comparing phenytoin and phenobarbitone.
OBJECTIVES
To review the effects of phenobarbitone compared to phenytoin when used as monotherapy in patients with partial onset seizures or generalized tonic-clonic seizures with or without other generalized seizure types.
SEARCH STRATEGY
Our search strategy has included: a) MEDLINE 1966 to 1998, b) the controlled trials register of the Cochrane Library, c) hand-searching relevant journals, d) the pharmaceutical industry, e) researchers in the field.
SELECTION CRITERIA
Randomized controlled trials in children or adults with partial onset seizures or generalized onset tonic-clonic seizures. Trials must have included a comparison of phenobarbitone monotherapy with phenytoin monotherapy.
DATA COLLECTION AND ANALYSIS
This was an individual patient data review. Outcomes were time to a) withdrawal of allocated treatment, b) 12 month remission, and c) first seizure post randomization. Data were analysed using a stratified logrank analysis with results expressed as hazard ratios (HR) and 95% confidence intervals (95% CI), where a HR>1 indicates an event is more likely to occur earlier on phenobarbitone than phenytoin.
MAIN RESULTS
To date, data have been obtained for four of ten studies meeting the inclusion criteria, amounting to 599 patients, or approximately 65% of the potential data. The main overall results (HR, 95% CI) were: a) time to treatment withdrawal 1.62 (1.22 to 2.14), b) time to 12 month remission 0.93 (0.70 to 1.23), c) time to first seizure 0.84 (0.68 to 1.05). These results indicate a statistically significant clinical advantage for phenytoin in terms of treatment withdrawal and a non-significant advantage in terms of 12 month remission. Results for time to first seizure suggest a non-significant clinical advantage for phenobarbitone.
REVIEWER'S CONCLUSIONS
The results of this review favour phenytoin over phenobarbitone, as phenobarbitone was significantly more likely to be withdrawn than phenytoin. Given that no significant differences for seizure outcomes were found, the higher withdrawal rate with phenobarbitone may be due to side effects.
Topics: Anticonvulsants; Epilepsies, Partial; Epilepsy, Generalized; Humans; Phenobarbital; Phenytoin; Randomized Controlled Trials as Topic; Seizures
PubMed: 11687150
DOI: 10.1002/14651858.CD002217