-
Efficacy and safety of odanacatib for osteoporosis treatment: a systematic review and meta-analysis.Archives of Osteoporosis May 2023Osteoporosis is a metabolic bone disease that commonly results in middle-aged and elderly people following fractures. Odanacatib (ODN), a potential osteoporosis... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Osteoporosis is a metabolic bone disease that commonly results in middle-aged and elderly people following fractures. Odanacatib (ODN), a potential osteoporosis medication, was stopped in the Long-term Odanacatib Fracture Trial (LOFT) phase III study because it increased the risk of stroke. Herein, we conducted a systematic review and meta-analysis to further assess the efficacy and safety of ODN in osteoporosis treatment.
METHODS
We searched the PubMed, EMBASE, Cochrane Library, and Web of Science, using the core search terms "osteoporosis" and "odanacatib." The primary outcomes were the percentage change in markers of bone turnover and bone formation as well as that in the bone mineral density (BMD) of the lumbar spine, hip, femoral neck, and greater trochanter. The secondary outcome was the risk of adverse events (AEs), used to explore the safety of ODN.
RESULTS
Ten articles-all double-blinded, randomized, placebo-controlled trials-were included. All trials were considered to be of high quality if they met the inclusion and exclusion criteria. We found that ODN increases BMD in the lumbar spine, total hip, and femoral neck, whereas it decreases the concentration of serum C-telopeptides of type I collagen (sCTx) and urinary N-telopeptide/creatinine ratio (uNTx/Cr). We found no significant differences in total, drug-related, serious, or skin AEs between the ODN and control groups. However, significant differences in fracture and stroke AEs were found between the ODN and control groups.
CONCLUSION
ODN is an appealing long-term osteoporosis treatment method; however, further research should focus on the potential increased risk of fracture and stroke.
Topics: Aged; Female; Middle Aged; Humans; Bone Density Conservation Agents; Osteoporosis, Postmenopausal; Double-Blind Method; Osteoporosis; Bone Density; Fractures, Bone; Stroke
PubMed: 37169994
DOI: 10.1007/s11657-023-01261-7 -
Schizophrenia Bulletin Jul 2023Psychotic experiences (PEs) are associated with increased risk for mental disorders, in particular persistent PEs. PEs therefore might be useful within intervention... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND HYPOTHESIS
Psychotic experiences (PEs) are associated with increased risk for mental disorders, in particular persistent PEs. PEs therefore might be useful within intervention research. We sought to systematically determine the incidence and persistence of PEs in the general population.
STUDY DESIGN
A double-blind search of databases (Embase, Pubmed PMC, Psychinfo, Medline, and Web of Science) from inception to January 2023 and data extraction, were conducted. Study quality was assessed using the NIH assessment tool. Random effects models were conducted to calculate pooled incidence rate per person-year and proportion of persistent PEs per year. Age and study design were all examined using subgroup analyses. Demographic, risk factors, and outcomes for incidence and persistence of PEs were reported in a narrative synthesis.
STUDY RESULTS
Using a double-blind screening method for abstract (k = 5763) and full text (k = 250) were screened. In total 91 samples from 71 studies were included, of which 39 were included in a meta-analysis (incidence: k = 17, n = 56 089; persistence: k = 22, n = 81 847). Incidence rate was 0.023 per person-year (95% CI [0.0129;0.0322]). That is, for every 100 people, 2 reported first onset PEs in a year. This was highest in adolescence at 5 per 100(13-17 years). The pooled persistence rate for PEs was 31.0% (95% CI [26.65,35.35]) This was highest in adolescence at 35.8%. Cannabis was particularly associated with incidence of PEs, and persistence of PEs were associated with multiple mental disorders.
CONCLUSIONS
Each year incidence of PEs is 2 of every 100 people, and persists each year in 31% of cases, this risk is highest in adolescents.
Topics: Adolescent; Humans; Psychotic Disorders; Incidence; Mental Disorders; Risk Factors; Randomized Controlled Trials as Topic
PubMed: 37402250
DOI: 10.1093/schbul/sbad056 -
The Cochrane Database of Systematic... Mar 2022This is an updated version of the Cochrane Review previously published in 2019. Epilepsy is one of the most common neurological disorders. It is estimated that up to 30%... (Review)
Review
BACKGROUND
This is an updated version of the Cochrane Review previously published in 2019. Epilepsy is one of the most common neurological disorders. It is estimated that up to 30% of individuals with epilepsy continue to have epileptic seizures despite treatment with an antiepileptic drug. These patients are classified as drug-resistant and require treatment with a combination of multiple antiepileptic drugs. Brivaracetam is a third-generation antiepileptic drug that is a high-affinity ligand for synaptic vesicle protein 2A. In this review we investigated the use of brivaracetam as add-on therapy for epilepsy.
OBJECTIVES
To evaluate the efficacy and tolerability of brivaracetam when used as add-on treatment for people with drug-resistant epilepsy.
SEARCH METHODS
For the latest update we searched the following databases on 7 September 2021: the Cochrane Register of Studies (CRS Web); MEDLINE (Ovid) 1946 to 3 September 2021. CRS Web includes randomised controlled trials (RCTs) and quasi-RCTs from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, the Cochrane Central Register of Controlled Trials (CENTRAL), and the specialised registers of Cochrane Review Groups including Cochrane Epilepsy.
SELECTION CRITERIA
We searched for parallel-group RCTs that recruited people of any age with drug-resistant epilepsy. We accepted studies with any level of blinding (double-blind, single-blind, or unblinded).
DATA COLLECTION AND ANALYSIS
In accordance with standard Cochrane methodological procedures, two review authors independently assessed trials for inclusion before evaluating trial quality and extracting relevant data. The primary outcome to be assessed was 50% or greater reduction in seizure frequency. Secondary outcomes were: seizure freedom, treatment withdrawal for any reason, treatment withdrawal due to adverse events, the proportion of participants who experienced any adverse events, and drug interactions. We used an intention-to-treat population for all primary analyses, and presented results as risk ratios (RRs) with 95% confidence intervals (CIs).
MAIN RESULTS
We did not identify any new studies for this update, therefore the results and conclusions of the review are unchanged. The previous review included six studies involving a total of 2411 participants. Only one study included participants with both focal and generalised onset seizures; the other five trials included participants with focal onset seizures only. Study participants were aged 16 to 80 years. Treatment periods ranged from 7 to 16 weeks. We judged two studies to have low risk of bias and four to have unclear risk of bias. Details on the method used for allocation concealment and how blinding was maintained were insufficient in one study each. One study did not report all outcomes prespecified in the trial protocol, and there were discrepancies in reporting in a further study. Participants receiving brivaracetam add-on were more likely to experience a 50% or greater reduction in seizure frequency than those receiving placebo (RR 1.81, 95% CI 1.53 to 2.14; 6 studies; moderate-certainty evidence). Participants receiving brivaracetam were more likely to attain seizure freedom; however, the evidence is of low certainty (RR 5.89, 95% CI 2.30 to 15.13; 6 studies). The incidence of treatment withdrawal for any reason was slightly greater for participants receiving brivaracetam compared to those receiving placebo (RR 1.27, 95% CI 0.94 to 1.74; 6 studies; low-certainty evidence). The risk of participants experiencing one or more adverse events did not differ significantly following treatment with brivaracetam compared to placebo (RR 1.08, 95% CI 1.00 to 1.17; 5 studies; moderate-certainty evidence). However, participants receiving brivaracetam did appear to be more likely to withdraw from treatment due to adverse events compared with those receiving placebo (RR 1.54, 95% CI 1.02 to 2.33; 6 studies; low-certainty evidence).
AUTHORS' CONCLUSIONS
When used as add-on therapy for individuals with drug-resistant epilepsy, brivaracetam may be effective in reducing seizure frequency and may aid patients in achieving seizure freedom. However, add-on brivaracetam is probably associated with a greater proportion of treatment withdrawals due to adverse events compared with placebo. It is important to note that only one of the eligible studies included participants with generalised epilepsy. None of the included studies involved participants under the age of 16, and all studies were of short duration. Consequently, the findings of this review are mainly applicable to adult patients with drug-resistant focal epilepsy. Future research should focus on investigating the tolerability and efficacy of brivaracetam during longer-term follow-up, as well as assess the efficacy and tolerability of add-on brivaracetam in managing other types of seizures and in other age groups.
Topics: Adult; Anticonvulsants; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsy, Generalized; Humans; Pyrrolidinones; Randomized Controlled Trials as Topic; Seizures
PubMed: 35285519
DOI: 10.1002/14651858.CD011501.pub3 -
Pediatric Dermatology 2023Dupilumab is the first biologic approved for the treatment of moderate-to-severe atopic dermatitis (AD) in children and adolescents. Previous systematic reviews explored... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Dupilumab is the first biologic approved for the treatment of moderate-to-severe atopic dermatitis (AD) in children and adolescents. Previous systematic reviews explored the effectiveness and safety of dupilumab in adults with AD. However, the underlying mechanisms of AD can vary among different age groups, emphasizing the need for separate investigation into the use of dupilumab in children and adolescents with AD.
OBJECTIVE
To evaluate the efficacy and safety of dupilumab in children and adolescents with AD based on evidence from clinical trials and observational studies.
METHODS
The process of meta-analysis was conducted according to preferred reporting items for systematic reviews and meta-analyses guidelines.
RESULTS
Seven clinical trials and 11 observational studies involving 1275 children and adolescents with AD were eligible for quantitative analysis. Overall, the pooled percentages of eczema area and severity index (EASI) 50, EASI 75, EASI 90, EASI 100, and investigator's global assessment (IGA) 0/1 were 72.9% (95% CI: 61.6%-81.9%), 57.4% (48.1%-66.2%), 31.3% (24.0%-39.7%), 29.7% (23.3%-37.0%), and 35.2% (29.3%-41.5%). With prolonged treatment time, an increase was seen in the pooled rate of EASI response, indicating that dupilumab may provide sustained benefits for children and adolescents over the long term. The reported adverse events were primarily mild and manageable, with an overall incidence rate of 7.2% across clinical trials and 7.6% across observational studies.
CONCLUSION
Dupilumab was an effective and safe treatment option for children and adolescents with AD, with positive results observed from long-term use and an acceptable safety profile. More long-term, high-quality, controlled studies in different regions are needed for further verification.
Topics: Adult; Humans; Adolescent; Child; Dermatitis, Atopic; Injections, Subcutaneous; Treatment Outcome; Severity of Illness Index; Double-Blind Method
PubMed: 37529963
DOI: 10.1111/pde.15398 -
The impact of double-blind peer review on gender bias in scientific publishing: a systematic review.American Journal of Obstetrics and... Jul 2022Gender-based bias during journal peer review can lead to publication biases and perpetuate gender inequality in science. Double-blind peer review, in which the names of... (Review)
Review
OBJECTIVE
Gender-based bias during journal peer review can lead to publication biases and perpetuate gender inequality in science. Double-blind peer review, in which the names of authors and reviewers are masked, may present an opportunity for scientific literature to increase equity and reduce gender-based biases. This systematic review of studies evaluates the impact of double-blind vs single-blind peer review on the publication rates by perceived author gender.
DATA SOURCES
The PubMed, Embase, Web of Science, and Scopus electronic databases were searched using the terms "blind," "peer review," "gender," "woman," and "author." All published literature in the English language from database inception through 2020 was queried.
STUDY ELIGIBILITY CRITERIA
Prospective experimental and observational studies comparing double-blind to single-blind peer review strategies examining impact on publication decisions by author gender were included.
STUDY APPRAISAL AND SYNTHESIS METHODS
The extracted data were primarily descriptive and included information on study design, sample size, primary outcome, major findings, and scientific discipline. The studies were characterized on the basis of design and whether the results demonstrated an impact of double-blind peer review on review scores and publication decision by perceived author gender. This study was registered with the International Prospective Register of Systematic Reviews or PROSPERO.
RESULTS
In total, 1717 articles were identified, 123 were reviewed, and 8 were included, encompassing 5 prospective experimental studies and 3 observational studies. Four studies demonstrated a difference in the acceptance rate or review score on the basis of perceived author gender, whereas the other 4 studies demonstrated no differences when the author gender was anonymized.
CONCLUSION
Studies evaluating the impact of double-blind peer review on author gender demonstrate mixed results, but there is reasonable evidence that gender bias may exist in scientific publishing and that double-blinding can mitigate its impact. Further evaluation of the processes in place to create the body of evidence that clinicians and researchers rely on is essential to reduce bias, particularly in female-majority fields such as obstetrics and gynecology.
Topics: Female; Humans; Male; Double-Blind Method; Peer Review; Publishing; Sexism; Single-Blind Method
PubMed: 35120887
DOI: 10.1016/j.ajog.2022.01.030 -
Journal of Endocrinological... Mar 2024The effect of sodium-glucose cotransporter 2 (SGLT2) inhibitors on cancer has yet to be fully elucidated.
BACKGROUND
The effect of sodium-glucose cotransporter 2 (SGLT2) inhibitors on cancer has yet to be fully elucidated.
OBJECTIVE
This systematic review and meta-analysis investigated the effects of SGLT2 inhibitors on cancer.
METHODS
We searched the PubMed and ClinicalTrials.gov databases up to July 15, 2023, to identify eligible randomized, double-blind, placebo-controlled trials that lasted at least ≥24 weeks. The primary outcome was the overall cancer incidence, and the secondary outcomes were the incidences of various types of cancer. We used the Mantel-Haenszel method, fixed effects model, risk ratio (RR) and 95% confidence interval (CI) to analyze dichotomous variables. Subgroup analysis was performed based on the SGLT2 inhibitor type, baseline conditions, and follow-up duration. All meta-analyses were performed using RevMan5.4.1 and Stata MP 16.0.
RESULTS
A total of 58 publications (59 trials) were included, comprising 113,909 participants with type 2 diabetes mellitus and/or chronic kidney disease and/or high cardiovascular risk and/or heart failure (SGLT2 inhibitor group, 63864; placebo group, 50045). Compared to the placebo SGLT2 inhibitors did not significantly increase the overall incidence of cancer (RR 1.01; 95% CI 0.94-1.08; p = 0.82). However, ertugliflozin did significantly increase the overall incidence of cancer (RR 1.29; 95% CI 1.01-1.64; p = 0.04). SGLT2 inhibitors did not increase the risks of bladder or breast cancer. However, dapagliflozin did significantly reduce the risk of bladder cancer by 47% (RR 0.53; 95% CI 0.35-0.81; p = 0.003). SGLT2 inhibitors had no significant effect on the risks of gastrointestinal, thyroid, skin, respiratory, prostate, uterine/endometrial, hepatic and pancreatic cancers. Dapagliflozin reduced the risk of respiratory cancer by 26% (RR 0.74; 95% CI 0.55-1.00; p = 0.05). SGLT2 inhibitors (particularly mediated by dapagliflozin and ertugliflozin but not statistically significant) were associated with a greater risk of renal cancer than the placebo (RR 1.39; 95% CI 1.04-1.87; p = 0.03).
CONCLUSION
SGLT2 inhibitors did not significantly increase the overall risk of cancer or the risks of bladder and breast cancers. However, the higher risk of renal cancer associated with SGLT2 inhibitors warrants concern.
PubMed: 38530620
DOI: 10.1007/s40618-024-02351-0 -
The Cochrane Database of Systematic... Aug 2022This is an updated version of the Cochrane Review first published in 2011, and most recently updated in 2019. Epilepsy is a chronic and disabling neurological disorder,... (Review)
Review
BACKGROUND
This is an updated version of the Cochrane Review first published in 2011, and most recently updated in 2019. Epilepsy is a chronic and disabling neurological disorder, affecting approximately 1% of the population. Up to 30% of people with epilepsy have seizures that are resistant to currently available antiepileptic drugs and require treatment with multiple antiepileptic drugs in combination. Felbamate is a second-generation antiepileptic drug that can be used as add-on therapy to standard antiepileptic drugs.
OBJECTIVES
To evaluate the efficacy and tolerability of felbamate versus placebo when used as an add-on treatment for people with drug-resistant focal-onset epilepsy.
SEARCH METHODS
For the latest update, we searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid, 1946 to 13 July 2021) on 15 July 2021. There were no language or time restrictions. We reviewed the reference lists of retrieved studies to search for additional reports of relevant studies. We also contacted the manufacturers of felbamate and experts in the field for information about any unpublished or ongoing studies.
SELECTION CRITERIA
We searched for randomised placebo-controlled add-on studies of people of any age with drug-resistant focal seizures. The studies could be double-blind, single-blind or unblinded and could be of parallel-group or cross-over design.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies for inclusion and extracted information. In the case of disagreements, a third review author arbitrated. Review authors assessed the following outcomes: 50% or greater reduction in seizure frequency; absolute or percentage reduction in seizure frequency; treatment withdrawal; adverse effects; quality of life.
MAIN RESULTS
We included four randomised controlled trials, representing a total of 236 participants, in the review. Two trials had parallel-group design, the third had a two-period cross-over design, and the fourth had a three-period cross-over design. We judged all four studies to be at an unclear risk of bias overall. Bias arose from the incomplete reporting of methodological details, the incomplete and selective reporting of outcome data, and from participants having unstable drug regimens during experimental treatment in one trial. Due to significant methodological heterogeneity, clinical heterogeneity and differences in outcome measures, it was not possible to perform a meta-analysis of the extracted data. Only one study reported the outcome of 50% or greater reduction in seizure frequency, whilst three studies reported percentage reduction in seizure frequency compared to placebo. One study claimed an average seizure reduction of 35.8% with add-on felbamate whilst another study claimed a more modest reduction of 4.2%. Both studies reported that seizure frequency increased with add-on placebo and that there was a significant difference in seizure reduction between felbamate and placebo (P = 0.0005 and P = 0.018, respectively). The third study reported a 14% reduction in seizure frequency with add-on felbamate but stated that the difference between treatments was not significant. There were conflicting results regarding treatment withdrawal. One study reported a higher treatment withdrawal for placebo-randomised participants, whereas the other three studies reported higher treatment withdrawal rates for felbamate-randomised participants. Notably, the treatment withdrawal rates for felbamate treatment groups across all four studies remained reasonably low (less than 10%), suggesting that felbamate may be well tolerated. Felbamate-randomised participants most commonly withdrew from treatment due to adverse effects. The adverse effects consistently reported by all four studies were headache, dizziness and nausea. All three adverse effects were reported by 23% to 40% of felbamate-treated participants versus 3% to 15% of placebo-treated participants. We assessed the evidence for all outcomes using GRADE and rated the evidence as very low certainty, meaning that we have little confidence in the findings reported. We mainly downgraded evidence for imprecision due to the narrative synthesis conducted and the low number of events. We stress that the true effect of felbamate could likely be significantly different from that reported in this current review update.
AUTHORS' CONCLUSIONS
In view of the methodological deficiencies, the limited number of included studies and the differences in outcome measures, we have found no reliable evidence to support the use of felbamate as an add-on therapy in people with drug-resistant focal-onset epilepsy. A large-scale, randomised controlled trial conducted over a longer period of time is required to inform clinical practice.
Topics: Anticonvulsants; Drug Resistant Epilepsy; Drug Therapy, Combination; Drug-Related Side Effects and Adverse Reactions; Epilepsies, Partial; Felbamate; Humans; Quality of Life; Randomized Controlled Trials as Topic; Seizures; Single-Blind Method
PubMed: 35914010
DOI: 10.1002/14651858.CD008295.pub6 -
Medicine Sep 2020Unintended pregnancy is popular all over the world, accounting for 40% to 50% of all pregnancies. The condition not only exerts pressure on the relationship of couples... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Unintended pregnancy is popular all over the world, accounting for 40% to 50% of all pregnancies. The condition not only exerts pressure on the relationship of couples and severely impacts the quality of life, but also imposes a heavy burden on the health of women and child. Recently, more than 220 million couples have chosen to be sterilized to obtain contraception, 47.3% of married couples select sterilization, of which vasectomy accounts for 17.1%. Vasectomy is currently the most convenient and effective method of male contraception. We will perform the systematic review and meta-analysis to assess the correlation between vasectomy and male sex dysfunction and provide evidence-based evidence for the couple METHODS:: The electronic databases of MEDLINE, PubMed, Web of Science, EMBASE, Clinicaltrials.org., China National Knowledge Infrastructure Database (CNKI), Wan fang Database, China Biology Medicine Database (CBM), VIP Science Technology Periodical Database, Chinese Clinical Trial Registry, and Cochrane Library will be retrieved before November 20, 2021. We will search English literature and Chinese literature with proper Medical Subject Heading or text key words. RevMan 5.3 and Stata 14.0 will be used for Systematic review and Meta-analysis. This protocol reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement, and we will report the systematic review by following the PRISMA statement.
CONCLUSION AND DISSEMINATION
The aim of this study was to evaluate the effect of vasectomy on the sexual function of patients after operation. The results will be published in a public issue journal to provide evidence-based medical evidence for urologists and andrologists to make clinical decisions.
REGISTRATION INFORMATION
INPLASY202080014.
Topics: Double-Blind Method; Humans; Male; Mental Health; Postoperative Complications; Randomized Controlled Trials as Topic; Research Design; Sexual Dysfunctions, Psychological; Vasectomy
PubMed: 32925772
DOI: 10.1097/MD.0000000000022149 -
The Cochrane Database of Systematic... Dec 2021Epilepsy is one of the most common neurological disorders. Many people with epilepsy are drug-resistant and require add-on therapy, meaning that they concomitantly take... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Epilepsy is one of the most common neurological disorders. Many people with epilepsy are drug-resistant and require add-on therapy, meaning that they concomitantly take multiple antiepileptic drugs. Carisbamate is a drug which is taken orally and inhibits voltage-gated sodium channels. Carisbamate may be useful for drug-resistant focal epilepsy.
OBJECTIVES
To evaluate the efficacy and tolerability of carisbamate when used as an add-on therapy for drug-resistant focal epilepsy.
SEARCH METHODS
We searched the following databases on 8 April 2021: Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid) 1946 to April 07, 2021. CRS Web includes randomised or quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, WHO ICTRP, the Cochrane Central Register of Controlled Trials (CENTRAL), and the specialised registers of Cochrane review groups including Epilepsy. We also searched ongoing trials registers, checked reference lists, and contacted authors of the included trials.
SELECTION CRITERIA
Double-blind randomised controlled trials (RCTs) comparing carisbamate versus placebo or another antiepileptic drug, as add-on therapy for drug-resistant focal epilepsy. Trials could have a parallel-group or cross-over design.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected the trials for inclusion, assessed trial quality, and extracted data. The primary outcome was 50% or greater reduction in seizure frequency (responder rate). The secondary outcomes were: seizure freedom, treatment withdrawal (for any reason and due to adverse events); adverse events, and quality of life. We analysed data using the Mantel-Haenszel statistical method and according to the intention-to-treat population. We presented results as risk ratios (RRs) with 95% confidence intervals (CIs).
MAIN RESULTS
We included four RCTs involving a total of 2211 participants. All four trials compared carisbamate with placebo for drug-resistant focal epilepsy. Participants in all trials were over 16 years of age and received at least one other antiepileptic drug concomitantly. We detected substantial risk of bias across the included trials. All four trials were at high risk of attrition bias due to the incomplete reporting of attrition and the high treatment withdrawal rates noted, especially with higher doses. All four trials also had unclear risk of detection bias, as they did not specify whether outcome assessors were blinded. Meta-analysis suggested that carisbamate produced a higher responder rate compared to placebo (RR 1.36, 95% CI 1.14 to 1.62; 4 studies; moderate-certainty evidence). More participants in the carsibamate group achieved seizure freedom (RR 2.43, 95% CI 0.84 to 7.03; 1 study); withdrew from treatment for any reason (RR 1.32, 95% CI 0.82 to 2.12; 4 studies); and withdrew from treatment due to adverse events (RR 1.80, 95% CI 0.78 to 4.17; 4 studies) than in the placebo group. However, the evidence for the three outcomes was very low-certainty. There was no difference between treatment groups for the proportion of participants experiencing at least one adverse event (RR 1.10, 95% CI 0.93 to 1.30; 2 studies; low-certainty evidence). More participants in the carisbamate group than in the placebo group developed dizziness (RR 2.06, 95% CI 1.23 to 3.44; 4 studies; very low-certainty evidence) and somnolence (RR 1.82, 95% CI 1.28 to 2.58; 4 studies; low-certainty evidence), but not fatigue (RR 1.11, 95% CI 0.73 to 1.68; 3 studies); headache (RR 1.13, 95% CI 0.92 to 1.38; 4 studies); or nausea (RR 1.19, 95% CI 0.81 to 1.75; 3 studies). None of the included trials reported quality of life.
AUTHORS' CONCLUSIONS
The results suggest that carisbamate may demonstrate efficacy and tolerability as an add-on therapy for drug-resistant focal epilepsy. Importantly, the evidence for all outcomes except responder rate was of low to very low certainty, therefore we are uncertain of the accuracy of the reported effects. The certainty of the evidence is limited by the significant risk of bias associated with the included studies, as well as the statistical heterogeneity detected for some outcomes. Consequently, it is difficult for these findings to inform clinical practice. The studies were all of short duration and only included adult study populations. There is a need for further RCTs with more clear methodology, long-term follow-up, more clinical outcomes, more seizure types, and a broader range of participants.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, Partial; Humans; Pharmaceutical Preparations; Randomized Controlled Trials as Topic
PubMed: 34870321
DOI: 10.1002/14651858.CD012121.pub2 -
Journal of Behavioral Addictions Oct 2023Compulsive buying-shopping disorder (CBSD) is mentioned as an example of other specified impulse control disorders in the ICD-11 coding tool, highlighting its clinical... (Review)
Review
BACKGROUND AND AIMS
Compulsive buying-shopping disorder (CBSD) is mentioned as an example of other specified impulse control disorders in the ICD-11 coding tool, highlighting its clinical relevance and need for treatment. The aim of the present work was to provide a systematic update on treatment studies for CBSD, with a particular focus on online CBSD.
METHOD
The preregistered systematic review (PROSPERO, CRD42021257379) was performed in accordance with the PRISMA 2020 statement. A literature search was conducted using the PubMed, Scopus, Web of Science and PsycInfo databases. Original research published between January 2000 and December 2022 was included. Risk of reporting bias was evaluated with the CONSORT guideline for randomized controlled trials. Effect sizes for primary CBSD outcomes were calculated.
RESULTS
Thirteen studies were included (psychotherapy: 2 open, 4 waitlist control design; medication: 2 open, 3 placebo-controlled, 2 open-label phase followed by a double-blind discontinuation phase; participants treatment/control 349/149). None of the studies addressed online CBSD. Psychotherapy studies suggest that group cognitive-behavioral therapy is effective in reducing CBSD symptoms. Pharmacological studies with selective serotonin re-uptake inhibitors or topiramate did not indicate superiority over placebo. Predictors of treatment outcome were rarely examined, mechanisms of change were not studied at all. Risk of reporting bias was high in most studies.
DISCUSSION
Poor methodological and low quality of reporting of included studies reduce the reliability of conclusions. There is a lack of studies targeting online CBSD. More high-quality treatment research is needed with more emphasis on the CBSD subtype and mechanisms of change.
Topics: Humans; Reproducibility of Results; Compulsive Behavior; Compulsive Personality Disorder; Disruptive, Impulse Control, and Conduct Disorders; Psychotherapy; Randomized Controlled Trials as Topic
PubMed: 37450373
DOI: 10.1556/2006.2023.00033