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Neurologia Medico-chirurgica Oct 2021Schwannomas of the trochlear nerve are relatively rare, and most patients present with preoperative diplopia because of trochlear nerve palsy. We describe the case of a...
Schwannomas of the trochlear nerve are relatively rare, and most patients present with preoperative diplopia because of trochlear nerve palsy. We describe the case of a 61-year-old male patient with a trochlear nerve schwannoma and no pre- and postoperative diplopia, despite his trochlear nerve being cut during the operation. We aimed to investigate the frequency of postoperative diplopia associated with intraoperative trochlear nerve disturbance by reviewing previous case reports, wherein postoperative diplopia did not occur after the trochlear nerve was cut intraoperatively. We recorded the frequency of diplopia because of intraoperative trochlear nerve disturbance, such as the trochlear nerve being cut, in cases without pre- and postoperative diplopia. We searched the PubMed, Medline, and Google Scholar databases for works published from 1976 to 2020 and followed the preferred reporting items for systematic reviews and meta-analyses guidelines. We reviewed 36 publications and found 92 cases of trochlear nerve schwannoma. Surgical resection was performed for 43 patients, of whom 40 were kept under observation and 9 were treated with radiation therapy. Of the 43 cases, 9 without preoperative diplopia underwent gross total resection. We analyzed ten cases (including ours) without preoperative diplopia to check for postoperative diplopia. In total, four cases, including ours, did not display postoperative diplopia despite the trochlear nerve being cut. This may be attributed to the preoperatively acquired motor and sensory fusion in the patient's vision because of tumor progression. Our findings may benefit neurosurgeons who treat patients with schwannomas and help them predict patients' outcomes.
Topics: Humans; Male; Middle Aged; Cranial Nerve Neoplasms; Diplopia; Neurilemmoma; Trochlear Nerve; Trochlear Nerve Diseases
PubMed: 34321383
DOI: 10.2176/nmc.oa.2021-0079 -
World Journal of Otorhinolaryngology -... Mar 2022As exclusively endoscopic endonasal resection of benign orbital tumors has become more widespread, high-quality outcomes data are lacking regarding the decision of when... (Review)
Review
OBJECTIVE
As exclusively endoscopic endonasal resection of benign orbital tumors has become more widespread, high-quality outcomes data are lacking regarding the decision of when and how to reconstruct the medial orbital wall following resection. The goal of this study was to systematically review pertinent literature to assess clinical outcomes relative to orbital reconstruction practices.
METHODS
Data Sources: PubMed, EMBASE, Web of Science. A systematic review of studies reporting exclusively endoscopic endonasal resections of benign orbital tumors was conducted. Articles not reporting orbital reconstruction details were excluded. Patient and tumor characteristics, operative details, and outcomes were recorded. Variables were compared using , Fisher's exact, and independent tests.
RESULTS
Of 60 patients included from 24 studies, 34 (56.7%) underwent orbital reconstruction following resection. The most common types of reconstruction were pedicled flaps ( = 15, 44.1%) and free mucosal grafts ( = 11, 32.4%). Rigid reconstruction was uncommon ( = 3, 8.8%). Performance of orbital reconstruction was associated with preoperative vision compromise ( < 0.01). The tendency to forego orbital reconstruction was associated with preoperative proptosis ( < 0.001), larger tumor size ( = 0.001), and operative exposure of orbital fat ( < 0.001) and extraocular muscle ( = 0.035). There were no statistically significant differences between the reconstruction and nonreconstruction groups in terms of short- or long-term outcomes when considering all patients. In patients with intraconal tumors, however, there was a higher rate of short-term postoperative diplopia when reconstruction was foregone ( = 0.041). This potential benefit of reconstruction did not persist: At an average of two years postoperatively, all patients for whom reconstruction was foregone either had improved or unchanged diplopia.
CONCLUSION
Most outcomes assessed did not appear affected by orbital reconstruction status. This general equivalence may suggest that orbital reconstruction is not a necessity in these cases or that the decision to reconstruct was well-selected by surgeons in the reported cases included in this systematic review.
PubMed: 35619927
DOI: 10.1002/wjo2.13 -
CNS Drugs Nov 2020Cenobamate is a novel tetrazole-derived carbamate compound with a dual mechanism of action. This drug can enhance the inactivated state of voltage-gated sodium channels,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cenobamate is a novel tetrazole-derived carbamate compound with a dual mechanism of action. This drug can enhance the inactivated state of voltage-gated sodium channels, preferentially inhibiting the persistent component of the sodium channel current, and acts as a positive allosteric modulator of GABA receptors, binding at a non-benzodiazepine site.
OBJECTIVE
We assessed the efficacy and safety of adjunctive cenobamate for the treatment of focal-onset seizures in adult patients with epilepsy using meta-analytical techniques.
METHODS
We systematically searched (May, week 4, 2020) MEDLINE (accessed by PubMed), the Cochrane Central Register of Controlled Trials (CENTRAL), and the US National Institutes of Health Clinical Trials Registry ( http://www.clinicaltrials.gov ). There were no date limitations or language restrictions. Randomized, placebo-controlled, single or double-blinded, add-on trials of cenobamate in adult patients with uncontrolled focal-onset seizures were identified. Main outcomes included the proportion of patients with ≥ 50 and 100% reduction in seizure frequency during the maintenance treatment period compared with baseline and the incidence of treatment withdrawal and adverse events (AEs). Risk ratio (RR) with 95% confidence interval (CI) was estimated for each outcome.
RESULTS
Two trials were included, overall enrolling 659 patients (442 for the add-on cenobamate group and 217 for the add-on placebo group). Seizure frequency reduction by at least 50% occurred during the maintenance phase in 50.1% of the patients randomized to cenobamate and 23.5% of the placebo-treated participants (RR 2.18, 95% CI 1.67-2.85; p < 0.001). The pooled estimated RR to achieve seizure freedom for the cenobamate group in comparison with placebo was 3.71 (95% CI 1.93-7.14; p < 0.001). Withdrawal from randomized treatment occurred in 16.7 and 11.1% of participants receiving cenobamate and placebo, respectively (RR 1.34, 95% CI 0.85-2.09; p = 0.205). Treatment was discontinued due to AEs in 12.2 and 4.1% of the patients in the active and control arms (RR 2.27, 95% CI 1.08-4.79; p = 0.031). AEs were reported in 76.9 and 66.8% of the patients during treatment with cenobamate and placebo (RR 1.14, 95% CI 1.02-1.26; p = 0.021). The cenobamate-associated AEs included somnolence, dizziness, fatigue, balance disorder, and diplopia.
CONCLUSIONS
Adjunctive cenobamate in adult patients with uncontrolled focal-onset seizures is associated with a greater reduction in seizure frequency and a higher rate of AEs than placebo.
Topics: Adult; Anticonvulsants; Carbamates; Chlorophenols; Drug Therapy, Combination; Epilepsy; Humans; Randomized Controlled Trials as Topic; Seizures; Tetrazoles; Treatment Outcome
PubMed: 32851590
DOI: 10.1007/s40263-020-00759-9 -
Complementary Therapies in Medicine Dec 2022To evaluate the safety and efficacy of acupuncture in the treatment of oculomotor nerve palsy (ONP). (Meta-Analysis)
Meta-Analysis
BACKGROUND
To evaluate the safety and efficacy of acupuncture in the treatment of oculomotor nerve palsy (ONP).
METHODS
The following database will be required from PubMed, Cochrane Library, Medline, Chinese Biomedical Literature Database, China National Knowledge Infrastructure (CNKI), Wanfang data. Randomized controlled trials (RCTs) comparing acupuncture alone versus no treatment/another active therapy/sham acupuncture or comparing acupuncture with another active therapy versus the same active therapy were included. Meta-analysis was conducted according to the 2020 PRISMA guidelines. Data was analyzed using RevMan 5.4 software. Results were reported as risk ratios (RR) for dichotomous outcomes or mean differences (MD) for continuous outcomes, with 95 % confidence intervals (CI). The Cochrane risk of bias tool was used to access the methodological quality of the trails.
RESULTS
Eighteen RCTs with 1150 participants comparing acupuncture versus other therapies were included. The results showed a significant differences in the clinical efficiency rate (RR = 1.30, 95 %CI = 1.23-1.37, P < 0.001), scores of diplopia (MD = - 0.78, 95 %CI = - 1.39 to - 0.77, P < 0.001), palpebral fissure size (MD = 1.04, 95 %CI = 0.41-1.68, P = 0.001), the pupil diameter (MD = - 0.56, 95 %CI = - 0.70 to - 0.42, P < 0.001), quality of life (MD = 8.96, 95 %CI = 6.79-11.13, P < 0.001) between the experiment and control groups. However, there were no significant differences in the adverse effects (RR = 0.52, 95 %CI = 0.22-1.22, P = 0.13). The quality of the evidence test by GRADE was low or very low.
CONCLUSION
Most included studies suggested that acupuncture was more effective than the control group in the treatment of ONP. However, the quality evidence of most of the studies was low and most of them were performed in China.
Topics: Humans; Acupuncture Therapy; Quality of Life; Oculomotor Nerve Diseases; China
PubMed: 36152935
DOI: 10.1016/j.ctim.2022.102888 -
The Cochrane Database of Systematic... Feb 2022Current treatments for amblyopia, typically patching or pharmacological blurring, have limited success. Less than two-thirds of children achieve good acuity of 0.20... (Review)
Review
BACKGROUND
Current treatments for amblyopia, typically patching or pharmacological blurring, have limited success. Less than two-thirds of children achieve good acuity of 0.20 logMAR in the amblyopic eye, with limited improvement of stereopsis, and poor adherence to treatment. A new approach, based on presentation of movies or computer games separately to each eye, may yield better results and improve adherence. These treatments aim to balance the input of visual information from each eye to the brain. OBJECTIVES: To determine whether binocular treatments in children, aged three to eight years, with unilateral amblyopia result in better visual outcomes than conventional patching or pharmacological blurring treatment.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE, Embase, ISRCTN, ClinicalTrials.gov, and the WHO ICTRP to 19 November 2020, with no language restrictions.
SELECTION CRITERIA
Two review authors independently screened the results of the search for relevant studies. We included randomised controlled trials (RCTs) that enrolled children between the ages of three and eight years old with unilateral amblyopia. Amblyopia was classed as present when the best-corrected visual acuity (BCVA) was worse than 0.200 logMAR in the amblyopic eye, with BCVA 0.200 logMAR or better in the fellow eye, in the presence of an amblyogenic risk factor, such as anisometropia, strabismus, or both. To be eligible, children needed to have undergone cycloplegic refraction and ophthalmic examination, including fundal examination and optical treatment, if indicated, with stable BCVA in the amblyopic eye despite good adherence with wearing glasses. We included any type of binocular viewing intervention, on any device (e.g. computer monitors viewed with liquid-crystal display shutter glasses; hand-held screens, including mobile phones with lenticular prism overlay; or virtual reality displays). Control groups received standard amblyopia treatment, which could include patching or pharmacological blurring of the better-seeing eye. We included full-time (all waking hours) and part-time (between 1 and 12 hours a day) patching regimens. We excluded children who had received any treatment other than optical treatment; and studies with less than 8-week follow-up.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. The primary outcome of the review was the change from baseline of distance BCVA in the amblyopic eye after 16 (± 2) weeks of treatment, measured in logMAR units on an age-appropriate acuity test.
MAIN RESULTS
We identified one eligible RCT of conventional patching treatment versus novel binocular treatment, and analysed a subset of 68 children who fulfilled the age criterion of this review. We obtained data for the mean change in amblyopic eye visual acuity, adverse events (diplopia), and adherence to prescribed treatment at 8- and 16-week follow-up intervals, though no data were available for change in BCVA after 52 weeks. Risk of bias for the included study was considered to be low. The certainty of evidence for the visual acuity outcomes at 8 and 16 weeks of treatment and adherence to the study intervention was rated moderate using the GRADE criteria, downgrading by one level due to imprecision. The certainty of evidence was downgraded by two levels and rated low for the proportion of participants reporting adverse events due to the sample size. Acuity improved in the amblyopic eye in both the binocular and patching groups following 16 weeks of treatment (improvement of -0.21 logMAR in the binocular group and -0.24 logMAR in the patching group, mean difference (MD) 0.03 logMAR (95% confidence interval (CI) -0.10 to 0.04; 63 children). This difference was non-significant and the improvements in both the binocular and patching groups are also considered clinically similar. Following 8 weeks of treatment, acuity improved in both the binocular and patching groups (improvement of -0.18 logMAR in the patching group compared to -0.16 logMAR improvement in the binocular-treatment group) (MD 0.02, 95% CI -0.04 to 0.08). Again this difference was statistically non-significant, and the differences observed between the patching and binocular groups are also clinically non-significant. No adverse event of permanent diplopia was reported. Adherence was higher in the patching group (47% of participants in the iPad group achieved over 75% compliance compared with 90% of the patching group). Data were not available for changes in stereopsis nor for contrast sensitivity following treatment.
AUTHORS' CONCLUSIONS
Currently, there is only one RCT that offers evidence of the safety and effectiveness of binocular treatment. The authors are moderately confident that after 16 weeks of treatment, the gain in amblyopic eye acuity with binocular treatment is likely comparable to that of conventional patching treatment. However, due to the limited sample size and lack of long term (52 week) follow-up data, it is not yet possible to draw robust conclusions regarding the overall safety and sustained effectiveness of binocular treatment. Further research, using acknowledged methods of visual acuity and stereoacuity assessment with known reproducibility, is required to inform decisions about the implementation of binocular treatments for amblyopia in clinical practice, and should incorporate longer term follow-up to establish the effectiveness of binocular treatment. Randomised controlled trials should also include outcomes reported by users, adherence to prescribed treatment, and recurrence of amblyopia after cessation of treatment.
Topics: Amblyopia; Child; Child, Preschool; Eyeglasses; Humans; Strabismus; Video Games; Visual Acuity
PubMed: 35129211
DOI: 10.1002/14651858.CD011347.pub3 -
World Neurosurgery Jun 2023Transorbital neuroendoscopic surgery (TONES) comprises a group of approaches with indications expanding from orbital tumors to more complex skull base lesions. We...
BACKGROUND
Transorbital neuroendoscopic surgery (TONES) comprises a group of approaches with indications expanding from orbital tumors to more complex skull base lesions. We analyzed the role of the endoscopic transorbital approach (eTOA) for spheno-orbital tumors, reporting the results of our clinical series and of a systematic review of the literature.
MATERIALS AND METHODS
All patients operated on from 2016 to 2022 at our institution for a spheno-orbital tumor through an eTOA were included in a clinical series, and a systematic review of the literature was performed.
RESULTS
Our series consisted of 22 patients (16 females, mean age 57 ± 13 years). Gross tumor removal was achieved in 8 patients (36.4%) after the eTOA and in 11 (50.0%) after a multistaged strategy combining the eTOA with the endoscopic endonasal approach. Complications included 1 chronic subdural hematoma and 1 permanent extrinsic ocular muscle deficit. Patients were discharged after 2.4 ± 1.3 days. The most common histotype was meningioma (86.4%). Proptosis improved in all cases, visual deficit in 66.6%, and diplopia in 76.9%. These results were confirmed by the review of the 127 cases reported in the literature.
CONCLUSIONS
Despite its recent introduction, a significant number of spheno-orbital lesions treated with an eTOA are being reported. Its main advantages are favorable patient outcome and optimal cosmetic results, with minimal morbidity and quick recovery. This approach can be combined with other surgical routes or adjuvant therapies for complex tumors. However, it is a technically demanding procedure, requiring specific skills in endoscopic surgery, that should be reserved to dedicated centers.
PubMed: 37331478
DOI: 10.1016/j.wneu.2023.06.026 -
The Cochrane Database of Systematic... Jun 2021This is an update of a review first published in 2011, and last updated in 2017. Most people with epilepsy have a good prognosis, but up to 30% of people continue to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This is an update of a review first published in 2011, and last updated in 2017. Most people with epilepsy have a good prognosis, but up to 30% of people continue to have seizures despite several regimens of antiepileptic drugs. In this review, we summarized the current evidence regarding eslicarbazepine acetate (ESL) when used as an add-on treatment for drug-resistant focal epilepsy.
OBJECTIVES
To evaluate the efficacy and tolerability of ESL when used as an add-on treatment for people with drug-resistant focal epilepsy.
SEARCH METHODS
For this update, we searched the following databases on 10 September 2020: Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid). CRS Web includes randomized or quasi-randomized, controlled trials from Specialized Registers of Cochrane Review Groups including Epilepsy, CENTRAL, PubMed, Embase, ClinicalTrials.gov and the WHO ICTRP. There were no language restrictions. We reviewed the reference lists of retrieved studies and contacted the manufacturers of ESL and experts in the field for information about any unpublished or ongoing studies.
SELECTION CRITERIA
Randomized placebo-controlled double-blind add-on trials of ESL in people with drug-resistant focal epilepsy.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials for inclusion and extracted data. Outcomes investigated included 50% or greater reduction in seizure frequency, seizure freedom, treatment withdrawal, adverse effects and drug interactions. Primary analyses were by intention to treat (ITT). The dose-response relationship was evaluated in regression models.
MAIN RESULTS
We included seven trials (2185 participants, aged 2 to 77 years), which were at low or unclear risk of bias apart from a high risk of attrition bias; all studies were funded by the pharmaceutical company, BIAL. The overall risk ratio (RR) for 50% or greater reduction in seizure frequency was 1.57 (95% confidence interval (CI) 1.34 to 1.83). For adults, the RR was 1.71 (95% CI 1.42 to 2.05; 5 studies, 1799 participants; moderate-certainty evidence); for children aged six to 18 years, the RR was 1.35 (95% CI 0.98 to 1.87; 2 studies, 322 participants; moderate-certainty evidence). Dose regression analysis showed evidence that ESL reduced seizure frequency with an increase in efficacy with increasing doses of ESL. ESL was associated with seizure freedom (RR 3.16, 95% CI 1.73 to 5.78; 6 studies, 1922 participants; moderate-certainty evidence). Participants were more likely to have ESL withdrawn for adverse effects (RR 2.72, 95% CI 1.66 to 4.46; 7 studies, 2185 participants; moderate-certainty evidence), but not for any reason (RR 1.25, 95% CI 0.93 to 1.70; 7 studies, 2185 participants; moderate-certainty evidence). The following adverse effects were associated with ESL: dizziness (RR 2.77, 99% CI 1.85 to 4.15); nausea (RR 2.55, 99% CI 1.39 to 4.67); somnolence (RR 1.75, 99% CI 1.18 to 2.61); diplopia (RR 4.07, 99% CI 1.86 to 8.89); and vomiting (RR 2.37, 99% CI 1.19 to 4.74). Overall, the certainty of the evidence was moderate due to a high discontinuation rate in studies of adults.
AUTHORS' CONCLUSIONS
ESL reduces seizure frequency when used as an add-on treatment for adults with drug-resistant focal epilepsy. The trials included in this review were of short-term duration. In addition, this update found that ESL may reduce seizure frequency in children from 6 to 18 years of age; however the results are inconclusive.
Topics: Adolescent; Adult; Age Factors; Aged; Anticonvulsants; Bias; Child; Dibenzazepines; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, Partial; Humans; Intention to Treat Analysis; Middle Aged; Randomized Controlled Trials as Topic; Withholding Treatment; Young Adult
PubMed: 34155624
DOI: 10.1002/14651858.CD008907.pub4 -
Acta Ophthalmologica Sep 2022To compare the effects of different treatment modalities on active, moderate-to-severe Graves' orbitopathy (GO). We searched PubMed and Embase for randomized controlled... (Meta-Analysis)
Meta-Analysis Review
To compare the effects of different treatment modalities on active, moderate-to-severe Graves' orbitopathy (GO). We searched PubMed and Embase for randomized controlled trials published up to 30 Nov 2020, of different modalities for the treatment of active, moderate-to-severe GO. We performed Bayesian network meta-analyses. This study is registered with PROSPERO (CRD42020166287). Fifteen RCTs were identified. Network meta-analysis showed that in comparison with placebo, teprotumumab, mycophenolate plus intravenous glucocorticoids (IVGCs), mycophenolate, rituximab, azathioprine, IVGCs, orbital radiotherapy, oral glucocorticoids (OGCs) were effective treatments (ordered from most effective to least effective). Teprotumumab was more efficacious in reducing proptosis than IVGCs. No significant difference in changes in diplopia grade was recorded between teprotumumab, rituximab, orbital radiotherapy and IVGCs. Low (4.5-5 g), middle (6 g) and high (7-8 g) cumulative doses of IVGCs were shown to be more effective than OGC in improving the overall response rate, but the very low-group (<3 g) seemed to have a lower risk of adverse events. We found that teprotumumab offered the highest level of efficacy in terms of the overall response rate and was more efficacious in reducing proptosis than IVGCs. With regard to different dosages of IVGCs, the cumulative dose of 4.5-5 g of IVGCs seems to be the most appropriate schedule in terms of efficacy and safety outcomes. Due to the limited number of patients treated with teprotumumab and the lack of comparison with other effective therapeutics, teprotumumab might not become the standard first-line therapy for active, moderate-to-severe GO.
Topics: Bayes Theorem; Exophthalmos; Glucocorticoids; Graves Ophthalmopathy; Humans; Network Meta-Analysis; Rituximab
PubMed: 34918472
DOI: 10.1111/aos.15074 -
Frontiers in Oncology 2021Intraorbital tumor could be approached by numerous surgical methods. The neuroendoscopic endonasal approach could provide a feasible corridor for indicated tumors....
Intraorbital tumor could be approached by numerous surgical methods. The neuroendoscopic endonasal approach could provide a feasible corridor for indicated tumors. Herein we present a series of 6 consecutive intraorbital tumors from April 2018 to October 2020, which received endonasal endoscopic resection. Cadaveric dissection was performed for the intraconal approach, and the literature was also reviewed. Five tumors were located intraconally, while one extraconally. The pathology revealed 1 angioleiomyoma, 1 cavernous hemangioma, 1 pilocytic astrocytoma, 1 meningioma, and 2 schwannomas. Five of the six achieved gross total resection, including 3 tumors with lateral extension beyond the optic nerve. Preoperative visual deterioration was observed in 4 of the 6 patients, and all got improvement postoperatively. Transient oculomotor nerve palsy was presented in one patient postoperatively. No cerebrospinal fluid leakage, enophthalmos, or strabismus was observed. The median follow-up time is 27 months (11~41 months). At the 6-month follow-up, the visual acuity remained unchanged compared with that at discharge. Proptosis was resolved in 2 of the 3 patients; diplopia was improved in one patient. In conclusion, endoscopic endonasal intraconal approach could be suitable for selected pathological conditions, and for both medial or beyond medial extraconal and intraconal orbital tumors.
PubMed: 35047399
DOI: 10.3389/fonc.2021.780551 -
The Cochrane Database of Systematic... Jul 2020This is an updated version of the original Cochrane Review published in 2008 and updated in 2013. Epilepsy is a common neurological condition which affects up to 1% of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This is an updated version of the original Cochrane Review published in 2008 and updated in 2013. Epilepsy is a common neurological condition which affects up to 1% of the population. Approximately 30% of people with epilepsy do not respond to treatment with currently available drugs. The majority of these people have focal epilepsy. Vigabatrin is an antiepileptic drug licensed for use in drug-resistant epilepsy.
OBJECTIVES
To assess the efficacy and tolerability of vigabatrin as an add-on therapy for people with drug-resistant focal epilepsy.
SEARCH METHODS
For the latest update of this review, we searched the following databases on 1 November 2018: Cochrane Register of Studies (CRS Web), MEDLINE (Ovid 1946 to 31 October 2018), ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. The Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL) are both included in the Cochrane Register of Studies (CRS Web). We checked reference lists of retrieved studies for additional reports of relevant studies and contacted Hoechst Marion Roussel (manufacturers of vigabatrin) in 2000.
SELECTION CRITERIA
We included randomised, double-blind, placebo-controlled, fully published trials of vigabatrin in people of any age with drug-resistant focal epilepsy.
DATA COLLECTION AND ANALYSIS
Two review authors assessed trials for inclusion and extracted data using the standard methodological procedures expected by Cochrane. Primary analysis was by intention-to-treat (ITT). We evaluated: 50% or greater reduction in seizure frequency, treatment withdrawal, adverse effects, dose-response analysis, cognitive outcomes and quality of life. We presented results as risk ratios (RR) with 95% or 99% confidence intervals (CI).
MAIN RESULTS
We identified 11 trials that included 756 participants (age range: 10 to 64 years). The trials tested vigabatrin doses between 1 g/day and 6 g/day. All 11 trials displayed a risk of bias across at least three risk of bias domains. Predominantly, the risk of bias was associated with: allocation concealment (selection bias), blinding of outcome assessment (detection bias) and incomplete outcome data (attrition bias). Participants treated with vigabatrin may be two to three times more likely to obtain a 50% or greater reduction in seizure frequency compared with those treated with placebo (RR 2.60, 95% CI 1.87 to 3.63; 4 studies; low-certainty evidence). Those treated with vigabatrin may also be three times more likely to have treatment withdrawn although we are uncertain (RR 2.86, 95% CI 1.25 to 6.55; 4 studies; very low-certainty evidence). Compared to placebo, participants given vigabatrin were more likely to experience adverse effects: dizziness/light-headedness (RR 1.74, 95% CI 1.05 to 2.87; 9 studies; low-certainty evidence), fatigue (RR 1.65, 95% CI 1.08 to 2.51; 9 studies; low-certainty evidence), drowsiness (RR 1.70, 95% CI 1.18 to 2.44; 8 studies) and depression (RR 3.28, 95% CI 1.30 to 8.27; 6 studies). Although the incidence rates were higher among participants receiving vigabatrin compared to those receiving placebo, the effect was not significant for the following adverse effects: ataxia (RR 2.76, 95% CI 0.96 to 7.94; 7 studies; very low-certainty evidence), nausea (RR 3.57, 95% CI 0.63 to 20.30; 4 studies), abnormal vision (RR 1.64, 95% CI 0.67 to 4.02; 5 studies; very low-certainty evidence), headache (RR 1.23, 95% CI 0.79 to 1.92; 9 studies), diplopia (RR 1.76, 99% CI 0.94 to 3.30) and nystagmus (RR 1.53, 99% CI 0.62 to 3.76; 2 studies; low-certainty evidence). Vigabatrin had little to no effect on cognitive outcomes or quality of life.
AUTHORS' CONCLUSIONS
Vigabatrin may significantly reduce seizure frequency in people with drug-resistant focal epilepsy. The results largely apply to adults and should not be extrapolated to children under 10 years old. Short-term follow-up of participants showed that some adverse effects were associated with its use. Analysis of longer-term observational studies elsewhere, however, has demonstrated that vigabatrin use can lead to the development of visual field defects.
Topics: Adolescent; Adult; Anticonvulsants; Child; Dizziness; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, Partial; Fatigue; Humans; Middle Aged; Nystagmus, Pathologic; Randomized Controlled Trials as Topic; Seizures; Vigabatrin; Vision Disorders; Young Adult
PubMed: 32730657
DOI: 10.1002/14651858.CD007302.pub3