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Anticonvulsant drugs for migraine prophylaxis.

BACKGROUND: Anticonvulsant drugs seem to be useful in clinical practice for the prophylaxis of migraine. This might be explained by a variety of actions of these drugs in the central nervous system that are probably relevant to the pathophysiology of migraine. OBJECTIVES: To describe and assess the evidence from controlled trials on the efficacy and tolerability of anticonvulsants for preventing migraine attacks in adult patients with migraine. SEARCH STRATEGY: We searched MEDLINE (from 1966 on) and the Cochrane Central Register of Controlled Trials (CENTRAL). Date of most recent search: April 2003. Additional information was gained from hand-searching specialist headache journals; correspondence with pharmaceutical companies, authors of reports, and experts in the field; and a wide variety of review articles and book chapters. SELECTION CRITERIA: Studies were required to be prospective, controlled trials of self-administered drug treatments taken regularly to prevent the occurrence of migraine attacks and/or to reduce the intensity of those attacks. DATA COLLECTION AND ANALYSIS: Studies were selected and data extracted by two independent reviewers. For migraine frequency data, standardized mean differences (SMDs) were calculated for individual studies and pooled across studies. For dichotomous data on significant reduction in migraine frequency, odds ratios (ORs) and numbers-needed-to-treat (NNTs) were similarly calculated. Adverse events were analyzed by calculating numbers-needed-to-harm (NNHs) for studies using similar agents. MAIN RESULTS: Fifteen papers were included in the review. Of these, 14 reported trials comparing anticonvulsants with placebo, as follows: four trials of divalproex sodium, three trials of topiramate, two trials of sodium valproate, two trials of gabapentin, and one trial each of carbamazepine, clonazepam, and lamotrigine. One paper reported a trial of sodium valproate versus an active comparator, flunarizine, and one trial of divalproex sodium versus placebo included a comparison against propranolol, also an active comparator. Data from 2024 patients were considered. Analysis of data from eight trials (n = 841) demonstrates that anticonvulsants, considered as a class, reduce migraine frequency by about 1.4 attacks per 28 days as compared to placebo (SMD -0.60; 95% confidence interval [CI] -0.93 to -0.26). Data from 10 trials (n = 1341) show that anticonvulsants, considered as a class, also more than double the number of patients for whom migraine frequency is reduced by 50% or more, relative to placebo (OR 3.90; 95% CI 2.61 to 5.82; NNT 3.8; 95% CI 3.2 to 4.6). For seven trials of sodium valproate and divalproex sodium, NNHs for five clinically important adverse events ranged from 6.6 to 16.3. For the three trials of topiramate, NNHs for eight adverse events (100-mg dose) ranged from 2.4 to 32.9. REVIEWERS' CONCLUSIONS: Anticonvulsants appear to be both effective in reducing migraine frequency and reasonably well tolerated. There is noticeable variation among individual agents, but there are insufficient data to know whether this is due to chance or variation in true efficacy. Neither clonazepam nor lamotrigine was superior to placebo (one trial each). Relatively few robust trials are available for agents other than sodium valproate/divalproex sodium. Two recently published and large trials of topiramate demonstrated reasonable efficacy, and one further trial of this agent is anticipated in the near future.

Adult↗

Anticholinergics for symptomatic management of Parkinson's disease.

BACKGROUND: Anticholinergics were the first drugs available for the symptomatic treatment of Parkinson's disease and they are still widely used today, both as monotherapy and as part of combination regimes. They are commonly believed to be associated with a less favourable side effect profile than other antiparkinsonian drugs, in particular with respect to neuropsychiatric and cognitive adverse events. They have been claimed to exert a better effect on tremor than on other parkinsonian features. OBJECTIVES: To determine the efficacy and tolerability of anticholinergics in the symptomatic treatment of Parkinson's disease compared to placebo or no treatment. SEARCH STRATEGY: The literature search included electronic searches of the Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2001), MEDLINE (1966 to 2001), Old Medline (1960-1965), Index Medicus (1927 - 1959), as well as handsearching the neurology literature including the reference lists of identified articles, other reviews and book chapters. SELECTION CRITERIA: Randomised controlled trials of anticholinergic drugs versus placebo or no treatment in de-novo or advanced Parkinson's disease, either as monotherapy or as an add-on to other antiparkinsonian drugs were included. Trials of anticholinergic drugs that were never in general clinical use were excluded. DATA COLLECTION AND ANALYSIS: Data was abstracted independently by two authors. Differences were settled by discussion among all authors. Data collected included patient characteristics, disease duration and severity, concomitant medication, interventions including duration and dose of anticholinergic treatment, outcome measures, rates of and reasons for withdrawals, and neuropsychiatric and cognitive adverse events. MAIN RESULTS: The initial search yielded 14 potentially eligible studies, five of which were subsequently excluded. In three cases this was because they dealt with substances that had never been marketed or had not been licensed for as far as could be traced back. One trial had been published twice in different languages. One study was excluded based on the assessment of its methodological quality. The remaining nine studies were all of double-blind cross-over design and included 221 patients. Trial duration was between five and 20 weeks and drugs investigated were benzhexol (mean doses: 8 to 20 mg/d), orphenadrine (mean dose not reported), benztropine (mean dose not reported), bornaprine (8 to 8.25 mg/d), benapryzine (200 mg/d), and methixine (45 mg/d). Only one study involved two anticholinergic drugs. Outcome measures varied widely across studies and in many cases, the scales applied were the authors' own and were not defined in detail. Incomplete reporting of methodology and results was frequent. The heterogeneous study designs as well as incomplete reporting precluded combined statistical analysis. Five studies used both tremor and other parkinsonian features as outcome measures. Outcome measures in these five studies were too different for a combined analysis and results varied widely, from a significant improvement in tremor only to significant improvement in other features but not in tremor. All studies except one (dealing with methixine) found a significant improvement from baseline on the anticholinergic drug in at least one outcome measure. The difference between placebo and active drug was reported in four studies and was found to be significant in all cases. No study failed to show superiority of the anticholinergic over placebo. The occurrence of neuropsychiatric and cognitive adverse events was reported in all but three studies (in 35 patients on active drug versus 13 on placebo). The most frequently reported reason for drop-outs from studies was in patients on placebo due to withdrawal from pre-trial anticholinergic treatment. REVIEWER'S CONCLUSIONS: As monotherapy or as an adjunct to other antiparkinsonian drugs, anticholinergics are more effective than placebo in improving motor function in Parkinson's disease. Neuropsychiatric and cognitive adverse events occur more frequently on anticholinergics than on placebo and are a more common reason for withdrawal than lack of efficacy. Results regarding a potentially better effect of the anticholinergic drug on tremor than on other outcome measures are conflicting and data do not strongly support a differential clinical effect on individual parkinsonian features. Data is insufficient to allow comparisons in efficacy or tolerability between individual anticholinergic drugs.

Cholinergic Antagonists↗

Vasectomy occlusion techniques for male sterilization.

BACKGROUND: Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide including various vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), vas irrigation and fascial interposition. Vasectomy guidelines largely rely on information from observational studies. Ideally, the choice of vasectomy techniques should be based on the best available evidence from randomized controlled trials. OBJECTIVES: The objective of this review was to compare the effectiveness, safety, acceptability and costs of vasectomy techniques for male sterilization. SEARCH STRATEGY: We searched the computerized databases the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Popline and LILACS. In addition, we searched the reference lists of relevant articles and book chapters. SELECTION CRITERIA: We included randomized controlled trials and controlled clinical trials comparing vasectomy techniques. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts located in the literature searches and two reviewers independently extracted articles identified for inclusion. Data were presented in the text of the review. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. MAIN RESULTS: Two trials compared vas occlusion with clips versus a conventional vasectomy technique; both were of poor quality. Neither trial found a difference between the two groups with regard to the primary outcome of failure to reach azoospermia. Four trials examined vas irrigation: three compared water irrigation with no irrigation and one compared water irrigation with euflavine. All of the trials were of poor quality. None of the trials found a significant difference between the groups with respect to the primary outcome of time to azoospermia. However, one trial found that the median number of ejaculations to azoospermia was significantly lower in the euflavine group compared to the water irrigation group. The one trial that compared vasectomy with fascial interposition versus vasectomy without fascial interposition was a high quality, large study that has only been partially reported at the time of this review. The fascial interposition group was significantly more likely to be related to vasectomy success (azoospermia) at 22 weeks. However, fascial interposition also was associated with significantly more surgical difficulties. REVIEWERS' CONCLUSIONS: No conclusions can be made about the effectiveness, safety, acceptability and costs of vas occlusion technique or vas irrigation as studies that examined these were of low quality and underpowered. Fascial interposition is associated with improved vasectomy success but is associated with some increased surgical difficulty. Randomized controlled trials examining other vasectomy techniques were not available. More research is required to examine vasectomy techniques.

Humans↗

Scalpel versus no-scalpel incision for vasectomy.

BACKGROUND: Currently, the two most common surgical techniques for approaching the vas during vasectomy are the incisional method and the no-scalpel technique. Whereas the conventional incisional technique involves the use of a scalpel to make one or two incisions, the no-scalpel technique uses a sharp-pointed, forceps-like instrument to puncture the skin. The no-scalpel technique aims to reduce adverse events, especially bleeding, bruising, hematoma, infection and pain and to shorten the operating time. OBJECTIVES: The objective of this review was to compare the effectiveness, safety, and acceptability of the incisional versus no-scalpel vasectomy approach to the vas. SEARCH STRATEGY: We searched the computerized databases of CENTRAL, MEDLINE, EMBASE, POPLINE and LILACS in May 2006. In addition, we searched the reference lists of relevant articles and book chapters. SELECTION CRITERIA: Randomized controlled trials and controlled clinical trials were included in this review. No language restrictions were placed on the reporting of the trials. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts located in the literature searches and two authors independently extracted data from the articles identified for inclusion. Outcome measures included safety, acceptability, operating time, contraceptive efficacy, and discontinuation. MAIN RESULTS: Two randomized controlled trials evaluated the no-scalpel technique and differed in their findings. The larger trial demonstrated less perioperative bleeding (Odds ratio (OR) 0.49; 95% Confidence Interval (CI) 0.27 to 0.89) and pain during surgery (OR 0.75; 95% CI 0.61 to 0.93), scrotal pain (OR 0.63; 95% 0.50 to 0.80), and incisional infection (OR 0.21; 95% CI 0.06 to 0.78) during follow up than the standard incisional group. Both studies found less hematoma with the no-scalpel technique (OR 0.23; 95% CI 0.15 to 0.36). Operations using the no-scalpel approach were faster and had a quicker resumption of sexual activity. The smaller study did not find these differences; however, the study could have failed to detect differences due to a small sample size as well as a high loss to follow up. Neither trial found differences in vasectomy effectiveness between the two approaches to the vas. AUTHORS' CONCLUSIONS: The no-scalpel approach to the vas resulted in less bleeding, hematoma, infection, and pain as well as a shorter operation time than the traditional incision technique. Although no difference in effectiveness was found between the two approaches, the sample sizes might have been too small to detect actual differences. Additional well-conducted randomized trials would help answer this question.

Controlled Clinical Trials as Topic↗

Why don't cancer patients enter clinical trials? A review.

Despite widespread agreement about the value of clinical trials, the proportion of patients who are enrolled in such trials is often considered to be too low. A comprehensive literature search was carried out for the period 1980 to the present, in order to review current data on barriers and facilitators to the development of multicentre clinical trials. Of 364 articles initially identified, 35 articles and 1 book were selected in order to assess the reasons that doctors and/or patients participate in clinical trials. This review emphasises the fact that doctors play a key role in the development and non-development of clinical trials. More studies, in particular studies outside the United States of America (USA), are needed in order better to understand doctors' attitudes towards clinical trials. Such studies should combine multivariate analyses and comparative approaches in order to associate doctors' behaviours with their individual characteristics, with the organisational context of their working environment and with the healthcare system.

Attitude of Health Personnel↗

Occupational rhinitis.

OBJECTIVE: To define occupational rhinitis, classify its various causes, review the steps in diagnosis, and describe the nonpharmacologic and pharmacologic management principles. DATA SOURCES: A review of MEDLINE articles in English on occupation rhinitis for January 1, 1970, through December 31, 2001, was performed. In addition, references were identified from bibliographies of relevant articles and books. STUDY SELECTION: The expert opinion of the author was used to select the relevant articles for the review. RESULTS: Occupational rhinitis is the episodic, work-related occurrence of sneezing, nasal discharge, and nasal obstruction. It frequently coexists with asthma but may present alone. Occupational rhinitis can be caused by heightened olfactory awareness, nonspecific inflammation of the nose, exposure to a high concentration of irritating and soluble chemical gases, or IgE mechanisms. The history and physical examination are the most important components to the workup of the patient. A site visit to the specific work area may give helpful insights to the patients' exposure. In the case of IgE-mediated allergic occupational rhinitis, skin testing or serologic testing may be useful. Greater objectivity to the diagnosis can be obtained through nasal challenge and the rapidly developing technique of rhinomanometry. Nonpharmacologic management (environmental control) and pharmacotherapy, such as that used in allergic rhinitis, should both be instituted. CONCLUSIONS: Although it does not have the same impact as occupational asthma, occupational rhinitis causes distress, discomfort, and work inefficiency. Attention to principles of management involving nonpharmacologic and pharmacologic measures will spare the patient the symptoms of occupational rhinitis.

Humans↗

Fatigue associated with stroke and other neurologic conditions: Implications for stroke rehabilitation.

OBJECTIVES: To examine the general phenomenon of fatigue in stroke and other neurologic disorders and to review what is currently known about its occurrence, including its frequency, duration, severity, and associated factors, to develop a strategy for treatment. DATA SOURCES: Computerized databases (eg, PubMed, PsycInfo, Science Citation Index, Ovid EMBASE, Ovid MEDLINE) searched from inception to May 2002. Additional references were identified from bibliographies of pertinent articles and books. STUDY SELECTION: Over 1000 articles were identified as relevant to fatigue experienced by patients with neurologic or nonneurologic disorders. Articles on fatigue in stroke and neurologic disorders, mechanisms, and/or treatment were selected for inclusion. DATA EXTRACTION: Authors reviewed the articles and assessed the purpose, study design, and conclusions for validity and relevance to the topic of fatigue in stroke. DATA SYNTHESIS: Fatigue is a common complaint among patients with neurologic disorders including stroke. Few studies have documented the high frequency of fatigue in poststroke patients and its negative impact on daily functioning and quality of life. Little is known about associated factors or about therapeutic strategies that may be used to alleviate it. Examination of fatigue in other neurologic populations suggests common characteristics and associated factors that may be useful in the development of potential therapeutic strategies. Pharmacologic and nonpharmacologic therapeutic interventions, such as stimulants, amantadine, or sleep and stress-management education, have been used with some success in neurologic and other patient populations (eg, multiple sclerosis, human immunodeficiency virus, acquired immune deficiency syndrome, cancer), but evidence of effectiveness based on randomized clinical trials is rare. CONCLUSIONS: Poststroke fatigue is common. Therapeutic strategies have been used to treat fatigue in other patient populations, but it is unclear whether these will be beneficial to poststroke patients. Frequency, severity, duration, impact, predisposing factors, and causes of poststroke fatigue, as well as the development of effective treatment, require further research. Criteria for assessment of fatigue and potential therapeutic interventions are outlined as a first step for stimulating further research.

Activities of Daily Living↗

Core library.

Explore the source record for details and available documents.

Book Selection↗

Reaction reading: a tool for providing fantasy imagery for long-term care facility residents.

Reaction reading, the choral reading of poetry in small groups, gives mentally alert long-term care residents an opportunity to react to poetry with knowledge, opinion, emotion, and imagination. The activity can be led by a nonprofessional. Residents are encouraged to share their reflective fantasy (memory of past places and events) and projective fantasy (ideas of places beyond the contemporary setting) as inspired by poetic images. Application of the reaction reading method and its benefits are described.

Aged↗

Adam Politzer (1835-1920) and the description of otosclerosis.

In 1893, Adam Politzer was the first to describe otosclerosis as a specific disease fixating the stapes. The aim of this study is to follow Politzer's research to understand how he finally explained the mechanism responsible for the fixation of the stapes. Politzer conducted his preliminary research from 1862 to 1893. From the concept of a dry catarrh of the middle ear, the fixation of the stapes became progressively associated with a specific ossification in and around the footplate. Politzer presented his first results in 1893. He completed his research by concluding in 1901 that otosclerosis had become an independent disease and should have the right to its own chapter in otologic books. He selected the word otosclerosis to describe this new pathologic entity.

Ear, Inner↗

Monitoring progression in Alzheimer's disease.

OBJECTIVE: To compare several clinical methods of following change in Alzheimer's disease (AD) over time. DATA SOURCES: MEDLINE search (restricted to English language); bibliographies of pertinent articles or books. STUDY SELECTION: Studies included only if aim was to follow a cohort of AD patients; diagnosis of AD used DSM-III-R or NINCDS-ADRDA guidelines; techniques or scales used for serial assessment were well-established in terms of validity and reliability. DATA EXTRACTION: All 3 authors reviewed all studies cited and reached consensus about interpretation. RESULTS: Global instruments detect long term deterioration in AD and describe distinct through possibly artificial stages. Cognitive screening tests decline at a consistent rate for groups of AD patients but show considerable variability. Scales measuring activities of daily living (ADLs) need further study to determine annual rate of change. Instrumental ADLs decline early in AD and reach a floor before cognitive screening tests. Electrophysiologic or radiographic techniques do not necessarily change over time and are not superior to clinical methods for following AD. Variability in rate of cognitive change and prognosis in AD has not been adequately explained. CONCLUSIONS: Cognitive screening tests provide useful measures of rate of change in AD for clinical and therapeutic studies. Further studies should take advantage of longer follow-up and more sophisticated statistical techniques to optimize use of these measures.

Activities of Daily Living↗