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ABSTRACT: Epilepsy is a common neurologic disorder, affecting approximately 50 million people worldwide; nearly a third of these people are not well controlled by a single antiepileptic drug and usually require treatment with a combination of two or more antiepileptic drugs. In recent years, many newer antiepileptic drugs have been investigated as add-on therapy for partial epilepsy; losigamone is one of these drugs and is the focus of this systematic review.
To investigate the efficacy and safety of losigamone when used as an add-on therapy for partial epilepsy.
We searched the Cochrane Epilepsy Group Specialized Register (1 May 2012), the Cochrane Central Register of Controlled Trials (CENTRAL Issue 4 of 12, The Cochrane Library, 2012) and MEDLINE (1 May 2012). We searched trials registers and contacted the manufacturer of losigamone and authors of included studies for additional information. There were no language restrictions.
Randomized controlled add-on trials comparing losigamone with placebo for partial epilepsy.
Two review authors independently assessed trial quality and extracted data. The primary outcomes were 50% or greater reduction in seizure frequency and seizure freedom; the secondary outcomes were treatment withdrawal and adverse events. Results are presented as risk ratios (RR) with 95% confidence intervals (CIs) or 99% CIs (for the individual listed adverse events to make an allowance for multiple testing).
Two trials involving a total of 467 patients were eligible for inclusion. Both trials assessed losigamone 1200 or 1500 mg/d as an add-on therapy for partial epilepsy. One trial was assessed as being of good methodologic quality while the other was of uncertain quality. For the efficacy outcomes, results did show patients taking losigamone were significantly more likely to achieve a 50% or greater reduction in seizure frequency (RR 1.75; 95% CI 1.14 to 2.72), but associated with a significant increase of treatment withdrawal when compared with those taking placebo (RR 2.16; 95% CI 1.28 to 3.67). For the safety outcomes, results indicated the proportion of patients who experienced adverse events in the losigamone group was higher than the placebo group (RR 1.34; 95% CI 1.00 to 1.80), dizziness was the only adverse event significantly in relation to losigamone (RR 3.82; 99% CI 1.69 to 8.64). The proportion of patients achieving seizure freedom was not reported in either trial report. A subgroup analysis according to different doses of losigamone showed that a higher dose of losigamone (1500 mg/d) is associated with a greater reduction in seizure frequency than lower doses, but is also associated with more dropouts due to adverse events.
The results of this review showed losigamone can reduce seizure frequency but was associated with more treatment withdrawals when used as an add-on therapy for people with partial epilepsy. However, trials included were of short-term duration and uncertain quality. Future well-designed randomized, double-blind, placebo-controlled trials with a longer-term duration are needed.
Cochrane database of systematic reviews (Online) 01/2012; 6:CD009324. · 5.72 Impact Factor
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ABSTRACT: The efficacy and safety of vigabatrin (VGB) as an add-on therapy for refractory epilepsy has been well established. However, this needs to be weighed against the risk of the development of visual field defects. Whether VGB monotherapy is an effective and safe treatment compared with the standard antiepileptic drug carbamazepine (CBZ) monotherapy for epilepsy has not been systematically reviewed.
To investigate the efficacy and safety of VGB versus CBZ monotherapy for epilepsy.
We searched the Cochrane Epilepsy Group Specialized Register (10 October 2011), the Cochrane Central Register of Controlled Trials (CENTRAL Issue 4 of 4, The Cochrane Library 2011) and MEDLINE (1948 to week 4, September 2011), EMBASE (1974 to January 2011) and the Chinese Biomedical Database (CBM) (1979 to January 2011). We searched trials registers and contacted the manufacturer of VGB and authors of included studies for additional information. There were no language restrictions.
Randomised controlled trials (RCTs) comparing VGB with CBZ monotherapy for epilepsy.
Two review authors independently assessed trial quality and extracted data. The primary outcome was time to treatment withdrawal. The secondary outcomes were time to achieve six- and 12-month remission after randomisation, time to first seizure after randomisation and adverse events. Results were presented as hazard ratio (HR) with 95% confidence intervals (CI) (time to event data) or risk ratio (RR) with 95%CI (adverse events).
Five studies involving a total of 734 participants were eligible for inclusion. We assessed only one study as having good quality while the other four were of poor quality. However, it was difficult to perform a meta-analysis by extracting aggregate data to synthesise the results as originally planned, mainly because not all the studies reported the same outcomes as those chosen for this review. There was no significant difference favouring either VGB or CBZ in terms of time to treatment withdrawal and time to achieve six-month remission after dose stabilisation from randomisation, but results did show a disadvantage for VGB on time to first seizure after randomisation. Compared with CBZ, taking VGB was associated with more occurrences of weight gain and less occurrences of skin rash and drowsiness. There were no differences in visual field defects and visual disturbances.
There is currently insufficient data to address the risk-benefit balance of using VGB versus CBZ monotherapy for epilepsy. Considering the high prevalence of visual field defects, reported in an existing systematic review of observational studies (Maguire 2010), the prescribing of VGB monotherapy for epilepsy should be used with caution and not considered as a first-line choice. If necessary, a frequent assessment of visual field is needed. Future research should focus on investigating the reasons for visual field defects and exploring the potential prevention strategies. Moreover, future monotherapy studies of epilepsy should report results according to the recommendation of International League Against Epilepsy (ILAE) Commission, and methodological quality should be improved.
Cochrane database of systematic reviews (Online) 01/2012; 1:CD008781. · 5.72 Impact Factor
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ABSTRACT: Hyperbaric oxygen therapy (HBOT) has been used to treat a variety of conditions and has shown possible efficacy for treating vascular dementia (VaD) in experimental and preliminary clinical studies.
To assess the efficacy and safety of HBOT for VaD, used alone or as an adjuvant treatment.
We searched ALOIS: the Cochrane Dementia and Cognitive Improvement Group Specialised Register on 20 December 2011 using the terms: hyperbaric OR oxygen OR HBO OR HBOT. ALOIS contains records of clinical trials identified from monthly searches of a number of major healthcare databases, numerous trial registries and grey literature sources. We also searched the Chinese Biomedical Database (CBM), the Chinese National Knowledge Infrastructure (CNKI) and the VIP Chinese Science and Technique Journals Database on 10 November 2011 using the terms 'gaoyayang', 'xueguanxingchidai' and 'chidai'. In addition, we contacted authors of included studies for additional information.
Trials were eligible for inclusion if they were randomised controlled trials comparing HBOT to no intervention or to sham HBOT, or comparing HBOT plus another treatment to the same other treatment in patients with VaD.
Two review authors independently assessed trial quality and extracted data.
One study involving 64 patients was included. It compared HBOT as an adjuvant to donepezil with donepezil alone. This one included study was judged to be of poor methodological quality. Patients receiving HBOT plus donepezil had significantly better cognitive function than the donepezil only group after 12 weeks of treatment, measured by the Mini-Mental State Examination (MMSE) (WMD 3.50; 95% CI 0.91 to 6.09) or by Hasegawa's Dementia Rating Scale (HDS) (WMD 3.10; 95% CI 1.16 to 5.04). There were no deaths or withdrawals, and the study did not mention safety assessment at all. Global function, behavioral disturbance and activities of daily living were not investigated in the study.
There is insufficient evidence to support HBOT as an effective treatment for patients with VaD. Future trials should be randomised, double-blind comparisons of HBOT to sham HBOT.
Cochrane database of systematic reviews (Online) 01/2012; 7:CD009425. · 5.72 Impact Factor
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ABSTRACT: Erectile dysfunction (ED) is a common sexual disease in male patients with multiple sclerosis (MS). Sildenafil citrate is considered as an effective drug in the treatment of male ED in the general population, but it has not been systematically reviewed in patients with MS.
To assess the efficacy and safety of sildenafil citrate for ED in patients with MS.
We searched the Cochrane (November 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4 of 4, 2011), MEDLINE (PubMed) (January 1966 to November 2011), EMBASE (January 1974 to November 2011) and the China Biological Medicine Database (CBM) (1979 to November 2011). We searched trials registers and conference proceedings and contacted pharmaceutical company and authors of included studies for additional data. There were no language restrictions.
Randomised controlled trials comparing sildenafil citrate with placebo or no treatment for ED in patients with MS.
Two review authors independently selected articles for inclusion, extracted data and assessed trial quality. Disagreements were resolved by discussion between review authors. Authors of included studies were contacted for additional information. Results were presented as relative risks (RR) or mean differences (MD) with 95% confidence intervals (CI).
Two randomised controlled trials involving a total of 420 patients were identified. Both trials investigated the short-term efficacy and safety of sildenafil citrate for ED in patients with MS. Patients taking sildenafil citrate were more likely to improve their ability to achieve and maintain an erection measured by International Index of Erectile Function and achieve vaginal penetration ( (RR 1.28, 95%CI 0.92 to 1.78) and complete intercourse measured by Sexual Encounter Profile diary (RR RR 1.38, 95%CI 1.00 to 1.90). and receive A global well respond measured by Global Assessment Question (RR 2.72, 95%CI 1.40 to 5.28) was reported. One trial showed sildenafil citrate is effective in quality of life improvement, while the other trial did not find any significant difference between both groups. Both included trials were judged as high risk of attrition bias. Adverse events were also reported: the most common were headache, flushing, rhinitis, visual disturbances and dyspepsia. Two patients suffered serious adverse events: one with coronary artery disease requiring triple bypass surgery and one with a cerebrovascular accident.
There is limited evidence to support sildenafil citrate as an effective treatment for ED in patients with MS. Future well designed randomised, double blinded, placebo-controlled trials with long-term duration are needed.
Cochrane database of systematic reviews (Online) 01/2012; 4:CD009427. · 5.72 Impact Factor
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ABSTRACT: Inspiratory muscle weakness has been observed in patients with stroke. Inspiratory muscle training is an intervention that has shown possible effects for functional recovery of patients with stroke.
To investigate the effect and safety of inspiratory muscle training for improving activities of daily living, respiratory muscle function, quality of life and cardiorespiratory fitness after stroke.
We searched the Cochrane Stroke Group's Trials Register (August 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, October Issue 4), MEDLINE (1948 to October 2011), EMBASE (1974 to October 2011), CINAHL (1982 to October 2011), AMED (1985 to October 2011), PEDro (October 2011) and four Chinese databases. In an effort to identify further published, unpublished and ongoing trials, we searched ongoing trials registers and conference proceedings, checked reference lists, and contacted authors of relevant studies and training devices manufactures. There were no language restrictions.
Randomised controlled trials (RCTs) comparing inspiratory muscle training with no intervention, sham inspiratory muscle training or other cardiorespiratory training for patients with stroke were eligible.
Two review authors independently assessed trial quality and extracted data. The primary outcomes were activities of daily living and respiratory muscle strength; the secondary outcomes were quality of life, cardiorespiratory fitness and adverse effects.
We included two trials involving a total of 66 patients in this review. Pooling analyses of data was not possible due to considerable heterogeneity between the trials and a lack of data in both trials. One study found a significant increase in respiratory muscle strength favouring inspiratory muscle training over sham inspiratory muscle training, but there was no significant difference between groups on quality of life. The other study showed that patients receiving inspiratory muscle training were more likely to improve their activities of daily living, quality of life and cardiorespiratory fitness than those patients who received no intervention. However, the main results were not compared directly with breathing retraining. Furthermore, neither of the trials assessed the safety and tolerance of inspiratory muscle training.
There is insufficient evidence to support inspiratory muscle training as an effective treatment to improve function after stroke, and no evidence relating to the safety of inspiratory muscle training. Further well-designed RCTs are required.
Cochrane database of systematic reviews (Online) 01/2012; 5:CD009360. · 5.72 Impact Factor
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ABSTRACT: Multiple sclerosis (MS) is an inflammatory demyelinating disease of the human central nervous system. Statins, prescribed as cholesterol lowering agents, have shown possible effects for treating MS in experimental and preliminary clinical studies.
To evaluate the efficacy and safety of statins administered alone or as add-on to approved treatments for MS.
The Trials Search Coordinator searched the Cochrane MS Group Trials Register (1 August 2011). We searched the Chinese National Knowledge Infrastructure (CNKI) (1979 to 1 August 2011), trials registers and conference proceedings. Pharmaceutical companies and authors of included studies were contacted for additional information.There were no language restrictions.
Randomised controlled trials comparing statins with placebo, or comparing statins in combination with approved treatments alone for patients with MS.
Three review authors independently assessed trial quality and extracted data.
Four trials involving 458 participants were included. All trials compared statins (two evaluating atorvastatin and two simvastatin) plus interferon beta-1a with interferon beta-1a alone for treating MS. The methodological quality was good for three studies and poor for remaining one. None of them showed statistically significant difference between both treatment groups in reducing relapses, preventing disease progression or developing new T2 or gadolinium-enhanced lesions on MRI after 9, 12, 24 months follow up period. Statins resulted to be safe and well tolerated, no serious adverse effects were reported. Changes on quality of life after receiving statins were not reported in the trials.
There is no convincing evidence to support the use of either atorvastatin or simvastatin as an adjunctive therapy in MS.
Cochrane database of systematic reviews (Online) 01/2011; · 5.72 Impact Factor
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ABSTRACT: Multiple sclerosis is an inflammatory demyelinating disease of the human central nervous system. Statins, prescribed as cholesterol lowering agents, have shown beneficial effects for treating MS in experimental and preliminary clinical studies.
To evaluate the efficacy and safety of statins administered alone or as add-on to approved treatments for MS.
We searched the Cochrane MS Group Trials Register (April 2010), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2010), MEDLINE (PubMed) (January 1966 to April 2010), EMBASE (January 1974 to April 2010), the Chinese Biomedical Database (CBM) (1979 to April 2010) and the Chinese National Knowledge Infrastructure (CNKI) (1979 to April 2010). We searched trials registers and conference proceedings and contacted pharmaceutical companies and authors of included studies included for additional information.There were no language restrictions.
Randomised controlled trials comparing statins with placebo, or comparing statins in combination with approved treatments alone in for patients with MS.
Three review authors independently assessed trial quality and extracted data.
Two trials involving 71 participants were included. Both trials compared atorvastatin plus beta interferon with beta interferon alone for treating MS. Only one was assessed of good methodological quality while the other one of poor methodological quality. Neither of them showed statistically significant difference between both treatment groups in reducing relapses, preventing disease progression or developing new T2 or gadolinium-enhanced lesions on MRI after 9 or 24 months follow up period. When combined with beta interferon, atorvastatin resulted to be safe and well tolerated, no serious adverse effects were reported. Changes on quality of life after receiving statins were not reported in the trials. Six trials which assess simvastatin or atorvastatin monotherapy or added to beta interferon for MS are still ongoing or awaiting publication.
There is insufficient evidence to support statins as an effective treatment for patients with MS. Future high quality randomised controlled trials are needed.Improvements in methodology in trials which are ongoing or awaiting publication, are required for meaningful synthesis of data.
Cochrane database of systematic reviews (Online) 01/2010; · 5.72 Impact Factor
