Pub Date : 2024-12-31eCollection Date: 2025-02-01DOI: 10.1016/j.eclinm.2024.103035
Joseph Kim, Rui Zhao, Lawrence Richard Kleinberg, Kitai Kim
Background: Phosphodiesterase 5 (PDE5) inhibitors, owing to their mechanism of action, have been gaining recognition as a potential case of drug repurposing and combination therapy for diabetes treatment. We aimed to examine the effect of long and short half-life PDE5 inhibitors have on Haemoglobin A1c (HbA1c) levels.
Methods: A systematic review and meta-analysis was conducted of randomised controlled trials (RCTs) in people with elevated HbA1c (>6%) to assess mean difference in HbA1c levels from baseline versus controls after any PDE5 inhibitor intervention of ≥4 weeks, excluding multiple interventions. Cochrane CENTRAL, PMC Medline, ClinicalTrials.gov, and WHO ICTRP were searched without language restrictions up to September 30, 2024. Summary data from published data were extracted. PRISMA and Cochrane guidelines used to extract and assess data using a random-effects meta-analysis. This study is registered with the Research Registry, reviewregistry1733.
Findings: Among 1096 studies identified, in analysis of 13 studies with 1083 baseline patients, long half-life PDE5 inhibitors (tadalafil, PF-00489791) had decreases in HbA1c while short half-life PDE5 inhibitors (sildenafil, avanafil) had no change. Five (38.5%) studies had a low risk of bias, and eight (61.5%) had some concerns. Long half-life inhibitors had significant mean decrease of -0.40% ([-0.66, -0.14], p = 0.002, I2 = 82%, 7.70% baseline HbA1c). Short half-life inhibitors had insignificant mean difference of +0.08% ([-0.16, 0.33], p = 0.51, I2 = 40%, 7.73% baseline HbA1c). In ≥8-week trials with participants with type 2 diabetes (T2D) and mean HbA1c ≥ 6.5%, long half-life inhibitors had significant mean decrease of -0.50% ([-0.83, -0.17], I2 = 88%, p = 0.003); short half-life inhibitors had significant mean increase of +0.36% ([0.03, 0.68], I2 = 3%, p = 0.03).
Interpretation: At the well-controlled HbA1c of the participants, previous literature shows current diabetes treatments have similar HbA1c decreases, so the HbA1c mean difference of long half-life PDE5 inhibitors may indeed be clinically relevant. This suggests future investigation into PDE5 inhibitors as part of combination therapy or as therapy for high HbA1c individuals is needed, especially because of variable risk of biases, homogeneity, and sample sizes in our study.
Funding: None.
{"title":"Effect of long and short half-life PDE5 inhibitors on HbA1c levels: a systematic review and meta-analysis.","authors":"Joseph Kim, Rui Zhao, Lawrence Richard Kleinberg, Kitai Kim","doi":"10.1016/j.eclinm.2024.103035","DOIUrl":"10.1016/j.eclinm.2024.103035","url":null,"abstract":"<p><strong>Background: </strong>Phosphodiesterase 5 (PDE5) inhibitors, owing to their mechanism of action, have been gaining recognition as a potential case of drug repurposing and combination therapy for diabetes treatment. We aimed to examine the effect of long and short half-life PDE5 inhibitors have on Haemoglobin A1c (HbA1c) levels.</p><p><strong>Methods: </strong>A systematic review and meta-analysis was conducted of randomised controlled trials (RCTs) in people with elevated HbA1c (>6%) to assess mean difference in HbA1c levels from baseline versus controls after any PDE5 inhibitor intervention of ≥4 weeks, excluding multiple interventions. Cochrane CENTRAL, PMC Medline, ClinicalTrials.gov, and WHO ICTRP were searched without language restrictions up to September 30, 2024. Summary data from published data were extracted. PRISMA and Cochrane guidelines used to extract and assess data using a random-effects meta-analysis. This study is registered with the Research Registry, reviewregistry1733.</p><p><strong>Findings: </strong>Among 1096 studies identified, in analysis of 13 studies with 1083 baseline patients, long half-life PDE5 inhibitors (tadalafil, PF-00489791) had decreases in HbA1c while short half-life PDE5 inhibitors (sildenafil, avanafil) had no change. Five (38.5%) studies had a low risk of bias, and eight (61.5%) had some concerns. Long half-life inhibitors had significant mean decrease of -0.40% ([-0.66, -0.14], p = 0.002, I<sup>2</sup> = 82%, 7.70% baseline HbA1c). Short half-life inhibitors had insignificant mean difference of +0.08% ([-0.16, 0.33], p = 0.51, I<sup>2</sup> = 40%, 7.73% baseline HbA1c). In ≥8-week trials with participants with type 2 diabetes (T2D) and mean HbA1c ≥ 6.5%, long half-life inhibitors had significant mean decrease of -0.50% ([-0.83, -0.17], I<sup>2</sup> = 88%, p = 0.003); short half-life inhibitors had significant mean increase of +0.36% ([0.03, 0.68], I<sup>2</sup> = 3%, p = 0.03).</p><p><strong>Interpretation: </strong>At the well-controlled HbA1c of the participants, previous literature shows current diabetes treatments have similar HbA1c decreases, so the HbA1c mean difference of long half-life PDE5 inhibitors may indeed be clinically relevant. This suggests future investigation into PDE5 inhibitors as part of combination therapy or as therapy for high HbA1c individuals is needed, especially because of variable risk of biases, homogeneity, and sample sizes in our study.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103035"},"PeriodicalIF":9.6,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751502/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31eCollection Date: 2025-02-01DOI: 10.1016/j.eclinm.2024.103029
Julien Bezin, Anne Bénard-Laribière, Emilie Hucteau, Marie Tournier, François Montastruc, Antoine Pariente, Jean-Luc Faillie
Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are extensively evaluated for the risk of suicidal behaviors or ideation; the influence of psychiatric history or obesity on this potential effect remains to be investigated. Therefore, we aimed to assess the association between GLP-1 RA and suicide or suicide attempt, considering these factors.
Methods: Patients ≥18 y who died by suicide or were hospitalized for suicide attempt (2013-2021) with at least one GLP-1 RA dispensing within the 180 preceding days were selected from the French National Health Data System (SNDS). A case-time-control design compared, for each patient, GLP-1 RA exposure in the 30 days preceding the outcome (composite of suicide or suicide attempt) to three earlier 30-day reference periods. Potential exposure trend bias was controlled using up to five time-controls matched on age, sex, psychiatric history, obesity, calendar time. Analyses were adjusted for time-varying confounders. Finally dipeptidyl peptidase-4 (DPP-4) inhibitors were studied as negative controls for potential biases.
Findings: This study included 1102 cases and 5494 controls. Mean case age was 57.4 years (SD 11.4); 44.6% were male, 67.6% had a recent psychiatric history and 51.3% had obesity. GLP-1 RA use was not associated with an increased risk of suicide or suicide attempt (OR, 0.62; 95% CI, 0.51-0.75), with consistent results for DPP-4 inhibitors (0.75; 0.67-0.84). Results obtained according to recent psychiatric history and obesity were comparable.
Interpretation: This large nationwide case-time-control study provides reassurance about the short-term psychiatric safety of GLP-1 RA, showing no specific risk for patients with psychiatric disorders or obesity.
Funding: French Medicines Agency.
{"title":"Suicide and suicide attempt in users of GLP-1 receptor agonists: a nationwide case-time-control study.","authors":"Julien Bezin, Anne Bénard-Laribière, Emilie Hucteau, Marie Tournier, François Montastruc, Antoine Pariente, Jean-Luc Faillie","doi":"10.1016/j.eclinm.2024.103029","DOIUrl":"10.1016/j.eclinm.2024.103029","url":null,"abstract":"<p><strong>Background: </strong>Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are extensively evaluated for the risk of suicidal behaviors or ideation; the influence of psychiatric history or obesity on this potential effect remains to be investigated. Therefore, we aimed to assess the association between GLP-1 RA and suicide or suicide attempt, considering these factors.</p><p><strong>Methods: </strong>Patients ≥18 y who died by suicide or were hospitalized for suicide attempt (2013-2021) with at least one GLP-1 RA dispensing within the 180 preceding days were selected from the French National Health Data System (SNDS). A case-time-control design compared, for each patient, GLP-1 RA exposure in the 30 days preceding the outcome (composite of suicide or suicide attempt) to three earlier 30-day reference periods. Potential exposure trend bias was controlled using up to five time-controls matched on age, sex, psychiatric history, obesity, calendar time. Analyses were adjusted for time-varying confounders. Finally dipeptidyl peptidase-4 (DPP-4) inhibitors were studied as negative controls for potential biases.</p><p><strong>Findings: </strong>This study included 1102 cases and 5494 controls. Mean case age was 57.4 years (SD 11.4); 44.6% were male, 67.6% had a recent psychiatric history and 51.3% had obesity. GLP-1 RA use was not associated with an increased risk of suicide or suicide attempt (OR, 0.62; 95% CI, 0.51-0.75), with consistent results for DPP-4 inhibitors (0.75; 0.67-0.84). Results obtained according to recent psychiatric history and obesity were comparable.</p><p><strong>Interpretation: </strong>This large nationwide case-time-control study provides reassurance about the short-term psychiatric safety of GLP-1 RA, showing no specific risk for patients with psychiatric disorders or obesity.</p><p><strong>Funding: </strong>French Medicines Agency.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103029"},"PeriodicalIF":9.6,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751538/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31eCollection Date: 2025-02-01DOI: 10.1016/j.eclinm.2024.103041
Nuzul Sri Hertanti, Trung V Nguyen, Yeu-Hui Chuang
Background: Fatigue during the acute phase of dengue infection can persist as post-infectious fatigue (PIF), potentially impacting quality of life. We aimed to determine the prevalence and risk factors of fatigue and PIF among dengue patients.
Methods: This systematic review and meta-analysis was registered in the PROSPERO (CRD42024543058). We searched PubMed, Ovid MEDLINE, Web of Science, Embase, and CINAHL from their inception to June 22, 2024. Observational studies reporting the prevalence of fatigue or PIF among dengue patients were included. We excluded case studies, review articles, conference abstracts, protocols, duplicate publications, and studies without full text. Quality assessment was performed using Hoy's risk of bias tool. Data were analyzed using R software version 4.3.3. A random-effects model pooled prevalence with 95% confidence intervals (CIs). Risk factors were identified using odd ratios (ORs) and 95% CIs or p values. Heterogeneity, moderator analysis, sensitivity analysis, and publication bias were also assessed.
Findings: From 715 identified studies, 40 were included for review. Of these, 37 studies were included in the meta-analysis for fatigue prevalence and nine studies for PIF prevalence, respectively involving 37,790 and 5045 dengue patients. The pooled prevalence of fatigue was 59.0% (95% CI 0.47-0.70), and that of PIF was 20.0% (95% CI 0.10-0.36), with significant heterogeneity but no significant moderators. Sensitivity analysis confirmed the robustness of this meta-analysis. Female sex (pooled OR = 1.65, 95% CI 1.27-2.14), dengue hemorrhagic fever (pooled OR = 1.80, 95% CI 1.02-3.16), and preexisting comorbidities (pooled OR = 2.14, 95% CI 1.36-3.38) were significant risk factors for PIF.
Interpretation: This meta-analysis highlights the high prevalence of fatigue and PIF among dengue patients, with several risk factors identified. Although the study has its limitations, these results can inform future studies to more standardized study designs, improved definitions, and systematic assessment methods for fatigue, PIF, and potential moderators. These are essential to better understand the mechanisms of fatigue in dengue patients and explore potential interventions.
Funding: None.
{"title":"Global prevalence and risk factors of fatigue and post-infectious fatigue among patients with dengue: a systematic review and meta-analysis.","authors":"Nuzul Sri Hertanti, Trung V Nguyen, Yeu-Hui Chuang","doi":"10.1016/j.eclinm.2024.103041","DOIUrl":"10.1016/j.eclinm.2024.103041","url":null,"abstract":"<p><strong>Background: </strong>Fatigue during the acute phase of dengue infection can persist as post-infectious fatigue (PIF), potentially impacting quality of life. We aimed to determine the prevalence and risk factors of fatigue and PIF among dengue patients.</p><p><strong>Methods: </strong>This systematic review and meta-analysis was registered in the PROSPERO (CRD42024543058). We searched PubMed, Ovid MEDLINE, Web of Science, Embase, and CINAHL from their inception to June 22, 2024. Observational studies reporting the prevalence of fatigue or PIF among dengue patients were included. We excluded case studies, review articles, conference abstracts, protocols, duplicate publications, and studies without full text. Quality assessment was performed using Hoy's risk of bias tool. Data were analyzed using R software version 4.3.3. A random-effects model pooled prevalence with 95% confidence intervals (CIs). Risk factors were identified using odd ratios (ORs) and 95% CIs or <i>p</i> values. Heterogeneity, moderator analysis, sensitivity analysis, and publication bias were also assessed.</p><p><strong>Findings: </strong>From 715 identified studies, 40 were included for review. Of these, 37 studies were included in the meta-analysis for fatigue prevalence and nine studies for PIF prevalence, respectively involving 37,790 and 5045 dengue patients. The pooled prevalence of fatigue was 59.0% (95% CI 0.47-0.70), and that of PIF was 20.0% (95% CI 0.10-0.36), with significant heterogeneity but no significant moderators. Sensitivity analysis confirmed the robustness of this meta-analysis. Female sex (pooled OR = 1.65, 95% CI 1.27-2.14), dengue hemorrhagic fever (pooled OR = 1.80, 95% CI 1.02-3.16), and preexisting comorbidities (pooled OR = 2.14, 95% CI 1.36-3.38) were significant risk factors for PIF.</p><p><strong>Interpretation: </strong>This meta-analysis highlights the high prevalence of fatigue and PIF among dengue patients, with several risk factors identified. Although the study has its limitations, these results can inform future studies to more standardized study designs, improved definitions, and systematic assessment methods for fatigue, PIF, and potential moderators. These are essential to better understand the mechanisms of fatigue in dengue patients and explore potential interventions.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103041"},"PeriodicalIF":9.6,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751573/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31eCollection Date: 2025-02-01DOI: 10.1016/j.eclinm.2024.103047
Min Du, Jie Deng, Wenxin Yan, Min Liu, Wannian Liang, Ben Niu, Jue Liu
<p><strong>Background: </strong>Vaccination hesitancy poses a serious threat to mpox vaccination programs. Historically, vaccine uptake in the African region has been low, and this trend may impact future vaccination efforts. Our aim was to investigate the relationships between mpox vaccination hesitancy, immunisation coverage for other vaccines, and vaccination readiness among African adults.</p><p><strong>Methods: </strong>A multinational commercial web panel survey was conducted among 1832 African adults across six countries (Uganda, Nigeria, Morocco, Egypt, Kenya, and South Africa) from October 1 to October 10, 2024. Mpox vaccination hesitancy for themselves and children was defined as the reluctance to receive vaccines against mpox (if vaccines were available) for themselves and for children (if they had children). Vaccination readiness was assessed via the 7Cs model, which includes confidence, complacency, constraints, calculation, collective responsibility, compliance, and conspiracy. Weighted logistic regression models with the set of calibration sampling weights were used to estimate odds ratios (ORs) with 95% confidence intervals (95% CIs). The analysis explored the effects of immunisation coverage for other vaccines and vaccination readiness on hesitancy toward mpox vaccination, including mediation and joint relationships. DerSimonian-Laird random-effects meta-analyses were utilised to pool the results from six countries.</p><p><strong>Findings: </strong>The pooled weighted rate of mpox vaccination hesitancy among participants was 32.7% (95% CI: 25.4-40.0, <i>I</i> <sup><i>2</i></sup> = 91.5%, p < 0.0001) for themselves and 38.9% (95% CI 30.2-47.6, <i>I</i> <sup><i>2</i></sup> = 93.7%, p < 0.0001) for children. After adjusting for covariates, the absence of immunisation coverage for other vaccines independently increased the risk of mpox vaccination hesitancy for themselves and for children, with a pooled OR of 2.66 (95% CI 1.67-4.26, <i>I</i> <sup><i>2</i></sup> = 25.8%, p = 0.241) and a pooled OR of 2.16 (95% CI 1.42-3.30, <i>I</i> <sup><i>2</i></sup> = 0%, p = 0.471), respectively. The pooled mediation proportions of vaccination readiness for the relationship between immunisation coverage for other vaccines and mpox vaccination hesitancy were 15.85% (95% CI 0.64-31.06, <i>I</i> <sup><i>2</i></sup> = 60.9%, p = 0.703) and 52.53% (95% CI 20.93-84.14, <i>I</i> <sup><i>2</i></sup> = 0%, p = 0.988) for themselves and for children, respectively. The pooled weighted rate of mpox vaccination hesitancy was highest among individuals with low vaccination readiness and no history of other vaccinations, with a pooled weighted rate of 62.7% (95% CI 44.7-80.7, <i>I</i> <sup><i>2</i></sup> = 82.8%, p < 0.0001) for themselves and 76.3% (95% CI 66.9-85.7, <i>I</i> <sup><i>2</i></sup> = 40.6%, p = 0.135) for children. Compared with the reference group (high vaccination readiness and a history of other vaccinations), populations that reported l
{"title":"Mpox vaccination hesitancy, previous immunisation coverage, and vaccination readiness in the African region: a multinational survey.","authors":"Min Du, Jie Deng, Wenxin Yan, Min Liu, Wannian Liang, Ben Niu, Jue Liu","doi":"10.1016/j.eclinm.2024.103047","DOIUrl":"10.1016/j.eclinm.2024.103047","url":null,"abstract":"<p><strong>Background: </strong>Vaccination hesitancy poses a serious threat to mpox vaccination programs. Historically, vaccine uptake in the African region has been low, and this trend may impact future vaccination efforts. Our aim was to investigate the relationships between mpox vaccination hesitancy, immunisation coverage for other vaccines, and vaccination readiness among African adults.</p><p><strong>Methods: </strong>A multinational commercial web panel survey was conducted among 1832 African adults across six countries (Uganda, Nigeria, Morocco, Egypt, Kenya, and South Africa) from October 1 to October 10, 2024. Mpox vaccination hesitancy for themselves and children was defined as the reluctance to receive vaccines against mpox (if vaccines were available) for themselves and for children (if they had children). Vaccination readiness was assessed via the 7Cs model, which includes confidence, complacency, constraints, calculation, collective responsibility, compliance, and conspiracy. Weighted logistic regression models with the set of calibration sampling weights were used to estimate odds ratios (ORs) with 95% confidence intervals (95% CIs). The analysis explored the effects of immunisation coverage for other vaccines and vaccination readiness on hesitancy toward mpox vaccination, including mediation and joint relationships. DerSimonian-Laird random-effects meta-analyses were utilised to pool the results from six countries.</p><p><strong>Findings: </strong>The pooled weighted rate of mpox vaccination hesitancy among participants was 32.7% (95% CI: 25.4-40.0, <i>I</i> <sup><i>2</i></sup> = 91.5%, p < 0.0001) for themselves and 38.9% (95% CI 30.2-47.6, <i>I</i> <sup><i>2</i></sup> = 93.7%, p < 0.0001) for children. After adjusting for covariates, the absence of immunisation coverage for other vaccines independently increased the risk of mpox vaccination hesitancy for themselves and for children, with a pooled OR of 2.66 (95% CI 1.67-4.26, <i>I</i> <sup><i>2</i></sup> = 25.8%, p = 0.241) and a pooled OR of 2.16 (95% CI 1.42-3.30, <i>I</i> <sup><i>2</i></sup> = 0%, p = 0.471), respectively. The pooled mediation proportions of vaccination readiness for the relationship between immunisation coverage for other vaccines and mpox vaccination hesitancy were 15.85% (95% CI 0.64-31.06, <i>I</i> <sup><i>2</i></sup> = 60.9%, p = 0.703) and 52.53% (95% CI 20.93-84.14, <i>I</i> <sup><i>2</i></sup> = 0%, p = 0.988) for themselves and for children, respectively. The pooled weighted rate of mpox vaccination hesitancy was highest among individuals with low vaccination readiness and no history of other vaccinations, with a pooled weighted rate of 62.7% (95% CI 44.7-80.7, <i>I</i> <sup><i>2</i></sup> = 82.8%, p < 0.0001) for themselves and 76.3% (95% CI 66.9-85.7, <i>I</i> <sup><i>2</i></sup> = 40.6%, p = 0.135) for children. Compared with the reference group (high vaccination readiness and a history of other vaccinations), populations that reported l","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103047"},"PeriodicalIF":9.6,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751503/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-31eCollection Date: 2025-02-01DOI: 10.1016/j.eclinm.2024.103024
Ayesha Shah, Liam Spannenburg, Parag Thite, Mark Morrison, Thomas Fairlie, Natasha Koloski, Purna C Kashyap, Mark Pimentel, Ali Rezaie, Gregory J Gores, Michael P Jones, Gerald Holtmann
Background: Small Intestinal Bacterial Overgrowth (SIBO) has been implicated in the pathophysiology of chronic liver disease (CLD). We conducted a systematic review and meta-analysis to assess and compare the prevalence of SIBO among CLD patients (with and without with complications of end stage liver disease) and healthy controls.
Methods: Electronic databases were searched from inception up to July-2024 for case-control studies reporting SIBO in CLD. Prevalence rates, odds ratios (ORs), and 95% confidence intervals (CIs) of SIBO in patients with CLD and controls were calculated utilizing a random-effects model. The protocol was prospectively registered with PROSPERO (CRD42022379578).
Findings: The final dataset included 34 case-control studies with 2130 CLD patients and 1222 controls. Overall, the odds for SIBO prevalence in CLD patients compared to controls was 6.7 (95% CI 4.6-9.7, p < 0.001). Although the prevalence of SIBO among patients with CLD with cirrhosis was higher at 42.9% (95% CI: 35.9-50.2) compared to 36.9% (95% CI: 27.4-47.6) in those without cirrhosis, this difference failed statistical significance. However, CLD patients with decompensated cirrhosis had a significantly higher prevalence of SIBO compared to those with compensated cirrhosis, with an OR of 2.6 (95% CI: 1.5-4.5, p < 0.001). Additionally, the prevalence of SIBO was significantly higher in CLD patients with portal hypertension (PHT) than in those without PHT, with an OR of 2.1 (95% CI: 1.4-3.1, p < 0.001). The highest prevalence of SIBO was observed in patients with spontaneous bacterial peritonitis (SBP) (57.7%, 95% CI 38.8-74.5), followed by patients with hepatic encephalopathy (41.0%, 95% CI 16.0-72.3) and patients with variceal bleed (39.5%, 95% CI 12.1-75.6).
Interpretation: Overall, there is a significantly increased prevalence of SIBO in CLD patients compared to controls. The prevalence is even higher in CLD patients with PHT, especially those with SBP. This meta-analysis suggests that SIBO is associated with complications of CLD and potentially linked to the progression of CLD.
Funding: National Health and Medical Research Council, Centre for Research Excellence (APP170993).
{"title":"Small intestinal bacterial overgrowth in chronic liver disease: an updated systematic review and meta-analysis of case-control studies.","authors":"Ayesha Shah, Liam Spannenburg, Parag Thite, Mark Morrison, Thomas Fairlie, Natasha Koloski, Purna C Kashyap, Mark Pimentel, Ali Rezaie, Gregory J Gores, Michael P Jones, Gerald Holtmann","doi":"10.1016/j.eclinm.2024.103024","DOIUrl":"10.1016/j.eclinm.2024.103024","url":null,"abstract":"<p><strong>Background: </strong>Small Intestinal Bacterial Overgrowth (SIBO) has been implicated in the pathophysiology of chronic liver disease (CLD). We conducted a systematic review and meta-analysis to assess and compare the prevalence of SIBO among CLD patients (with and without with complications of end stage liver disease) and healthy controls.</p><p><strong>Methods: </strong>Electronic databases were searched from inception up to July-2024 for case-control studies reporting SIBO in CLD. Prevalence rates, odds ratios (ORs), and 95% confidence intervals (CIs) of SIBO in patients with CLD and controls were calculated utilizing a random-effects model. The protocol was prospectively registered with PROSPERO (CRD42022379578).</p><p><strong>Findings: </strong>The final dataset included 34 case-control studies with 2130 CLD patients and 1222 controls. Overall, the odds for SIBO prevalence in CLD patients compared to controls was 6.7 (95% CI 4.6-9.7, p < 0.001). Although the prevalence of SIBO among patients with CLD with cirrhosis was higher at 42.9% (95% CI: 35.9-50.2) compared to 36.9% (95% CI: 27.4-47.6) in those without cirrhosis, this difference failed statistical significance. However, CLD patients with decompensated cirrhosis had a significantly higher prevalence of SIBO compared to those with compensated cirrhosis, with an OR of 2.6 (95% CI: 1.5-4.5, p < 0.001). Additionally, the prevalence of SIBO was significantly higher in CLD patients with portal hypertension (PHT) than in those without PHT, with an OR of 2.1 (95% CI: 1.4-3.1, p < 0.001). The highest prevalence of SIBO was observed in patients with spontaneous bacterial peritonitis (SBP) (57.7%, 95% CI 38.8-74.5), followed by patients with hepatic encephalopathy (41.0%, 95% CI 16.0-72.3) and patients with variceal bleed (39.5%, 95% CI 12.1-75.6).</p><p><strong>Interpretation: </strong>Overall, there is a significantly increased prevalence of SIBO in CLD patients compared to controls. The prevalence is even higher in CLD patients with PHT, especially those with SBP. This meta-analysis suggests that SIBO is associated with complications of CLD and potentially linked to the progression of CLD.</p><p><strong>Funding: </strong>National Health and Medical Research Council, Centre for Research Excellence (APP170993).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103024"},"PeriodicalIF":9.6,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-28eCollection Date: 2025-02-01DOI: 10.1016/j.eclinm.2024.102992
Lei Liu, Jiangang Liu, Qing Su, Yuening Chu, Hexia Xia, Ran Xu
Background: Cervical cytology screening and colposcopy play crucial roles in cervical intraepithelial neoplasia (CIN) and cervical cancer prevention. Previous studies have provided evidence that artificial intelligence (AI) has remarkable diagnostic accuracy in these procedures. With this systematic review and meta-analysis, we aimed to examine the pooled accuracy, sensitivity, and specificity of AI-assisted cervical cytology screening and colposcopy for cervical intraepithelial neoplasia and cervical cancer screening.
Methods: In this systematic review and meta-analysis, we searched the PubMed, Embase, and Cochrane Library databases for studies published between January 1, 1986 and August 31, 2024. Studies investigating the sensitivity and specificity of AI-assisted cervical cytology screening and colposcopy for histologically verified cervical intraepithelial neoplasia and cervical cancer and a minimum of five cases were included. The performance of AI and experienced colposcopists was assessed via the area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) through random effect models. Additionally, subgroup analyses of multiple diagnostic performance metrics in developed and developing countries were conducted. This study was registered with PROSPERO (CRD42024534049).
Findings: Seventy-seven studies met the eligibility criteria for inclusion in this study. The pooled diagnostic parameters of AI-assisted cervical cytology via Papanicolaou (Pap) smears were as follows: accuracy, 94% (95% CI 92-96); sensitivity, 95% (95% CI 91-98); specificity, 94% (95% CI 89-97); PPV, 88% (95% CI 78-96); and NPV, 95% (95% CI 89-99). The pooled accuracy, sensitivity, specificity, PPV, and NPV of AI-assisted cervical cytology via ThinPrep cytologic test (TCT) were 90% (95% CI 85-94), 97% (95% CI 95-99), 94% (95% CI 85-98), 84% (95% CI 64-98), and 96% (95% CI 94-98), respectively. Subgroup analysis revealed that, for AI-assisted cervical cytology diagnosis, certain performance indicators were superior in developed countries compared to developing countries. Compared with experienced colposcopists, AI demonstrated superior accuracy in colposcopic examinations (odds ratio (OR) 1.75; 95% CI 1.33-2.31; P < 0.0001; I2 = 93%).
Interpretation: These results underscore the potential and practical value of AI in preventing and enabling early diagnosis of cervical cancer. Further research should support the development of AI for cervical cancer screening, including in low- and middle-income countries with limited resources.
Funding: This study was supported by the National Natural Science Foundation of China (No. 81901493) and the Shanghai Pujiang Program (No. 21PJD006).
背景：宫颈细胞学筛查和阴道镜检查在宫颈上皮内瘤变（CIN）和宫颈癌预防中起着至关重要的作用。先前的研究已经提供证据表明，人工智能（AI）在这些程序中具有显着的诊断准确性。通过本系统综述和荟萃分析，我们旨在检查人工智能辅助宫颈细胞学筛查和阴道镜筛查宫颈上皮内瘤变和宫颈癌的准确性、敏感性和特异性。方法：在这项系统评价和荟萃分析中，我们检索了PubMed、Embase和Cochrane图书馆数据库中1986年1月1日至2024年8月31日发表的研究。研究了人工智能辅助宫颈细胞学筛查和阴道镜检查对组织学证实的宫颈上皮内瘤变和宫颈癌的敏感性和特异性，包括至少5例病例。通过随机效应模型，通过受试者工作特征曲线下面积（AUROC）、灵敏度、特异性、准确性、阳性预测值（PPV）和阴性预测值（NPV）对人工智能和经验丰富的阴道镜医师进行评估。此外，还对发达国家和发展中国家的多项诊断绩效指标进行了亚组分析。本研究已在PROSPERO注册（CRD42024534049）。结果：77项研究符合纳入本研究的资格标准。人工智能辅助宫颈细胞学巴氏涂片诊断参数汇总如下：准确率94% (95% CI 92-96)；灵敏度为95% (95% CI 91-98)；特异性为94% (95% CI 89-97)；Ppv, 88% (95% ci 78-96)；NPV为95% （95% CI 89-99）。人工智能辅助宫颈细胞学通过ThinPrep细胞学检查（TCT）的准确性、敏感性、特异性、PPV和NPV分别为90% （95% CI 85-94）、97% （95% CI 95-99）、94% （95% CI 85-98）、84% （95% CI 64-98）和96% （95% CI 94-98）。亚组分析显示，对于人工智能辅助宫颈细胞学诊断，发达国家的某些性能指标优于发展中国家。与经验丰富的阴道镜检查医师相比，人工智能在阴道镜检查中表现出更高的准确性(优势比（OR） 1.75；95% ci 1.33-2.31；p 2 = 93%)。这些结果强调了人工智能在预防和早期诊断宫颈癌方面的潜力和实用价值。进一步的研究应支持开发用于宫颈癌筛查的人工智能，包括在资源有限的低收入和中等收入国家。基金资助：本研究由国家自然科学基金（No. 81901493）和上海市浦江计划（No. 21PJD006）资助。
{"title":"Performance of artificial intelligence for diagnosing cervical intraepithelial neoplasia and cervical cancer: a systematic review and meta-analysis.","authors":"Lei Liu, Jiangang Liu, Qing Su, Yuening Chu, Hexia Xia, Ran Xu","doi":"10.1016/j.eclinm.2024.102992","DOIUrl":"10.1016/j.eclinm.2024.102992","url":null,"abstract":"<p><strong>Background: </strong>Cervical cytology screening and colposcopy play crucial roles in cervical intraepithelial neoplasia (CIN) and cervical cancer prevention. Previous studies have provided evidence that artificial intelligence (AI) has remarkable diagnostic accuracy in these procedures. With this systematic review and meta-analysis, we aimed to examine the pooled accuracy, sensitivity, and specificity of AI-assisted cervical cytology screening and colposcopy for cervical intraepithelial neoplasia and cervical cancer screening.</p><p><strong>Methods: </strong>In this systematic review and meta-analysis, we searched the PubMed, Embase, and Cochrane Library databases for studies published between January 1, 1986 and August 31, 2024. Studies investigating the sensitivity and specificity of AI-assisted cervical cytology screening and colposcopy for histologically verified cervical intraepithelial neoplasia and cervical cancer and a minimum of five cases were included. The performance of AI and experienced colposcopists was assessed via the area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) through random effect models. Additionally, subgroup analyses of multiple diagnostic performance metrics in developed and developing countries were conducted. This study was registered with PROSPERO (CRD42024534049).</p><p><strong>Findings: </strong>Seventy-seven studies met the eligibility criteria for inclusion in this study. The pooled diagnostic parameters of AI-assisted cervical cytology via Papanicolaou (Pap) smears were as follows: accuracy, 94% (95% CI 92-96); sensitivity, 95% (95% CI 91-98); specificity, 94% (95% CI 89-97); PPV, 88% (95% CI 78-96); and NPV, 95% (95% CI 89-99). The pooled accuracy, sensitivity, specificity, PPV, and NPV of AI-assisted cervical cytology via ThinPrep cytologic test (TCT) were 90% (95% CI 85-94), 97% (95% CI 95-99), 94% (95% CI 85-98), 84% (95% CI 64-98), and 96% (95% CI 94-98), respectively. Subgroup analysis revealed that, for AI-assisted cervical cytology diagnosis, certain performance indicators were superior in developed countries compared to developing countries. Compared with experienced colposcopists, AI demonstrated superior accuracy in colposcopic examinations (odds ratio (OR) 1.75; 95% CI 1.33-2.31; P < 0.0001; I<sup>2</sup> = 93%).</p><p><strong>Interpretation: </strong>These results underscore the potential and practical value of AI in preventing and enabling early diagnosis of cervical cancer. Further research should support the development of AI for cervical cancer screening, including in low- and middle-income countries with limited resources.</p><p><strong>Funding: </strong>This study was supported by the National Natural Science Foundation of China (No. 81901493) and the Shanghai Pujiang Program (No. 21PJD006).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"102992"},"PeriodicalIF":9.6,"publicationDate":"2024-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11743870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-27eCollection Date: 2025-02-01DOI: 10.1016/j.eclinm.2024.103027
Yunhai Li, Ying Huang, Hongbo Huang, Tingting Wei, Aijie Zhang, Lei Xing, Xuedong Yin, Hongyuan Li, Guosheng Ren, Fan Li
Background: Male breast cancer (MBC) is a rare malignancy that has been under-investigated, with limited global epidemiological research dedicated to it. A comprehensive estimate of the global, regional, and national burden of MBC is valuable for policy planning. This study aims to evaluate the burden of MBC across 204 countries and territories.
Methods: MBC data were collected from the 2021 Global Burden of Diseases, Injuries, and Risk Factors (GBD) Study estimates spanning from 1990 to 2021. The global incidence, prevalence, deaths, and disability-adjusted life-years (DALYs) attributed to MBC, as well as corresponding age-standardized rates, were calculated. Temporal trends, projections of incidence and mortality to 2050, lifetime risk, and risk factors of MBC were also estimated according to regions and countries.
Findings: In 2021, there were 38,827 (95% uncertainty interval [UI], 24,650-47,846) new cases, 320,459 (95% UI, 220,533-384,317) prevalent cases, 13,274 (95% UI, 9074-16,240) deaths, and 380,917 (95% UI, 252,922-476,417) DALYs attributed to MBC worldwide, with the highest disease burden observed in the Eastern Sub-Saharan Africa region. From 1990 to 2021, the age-standardized incidence and mortality rates of MBC significantly increased, but they are projected to decrease over the next 30 years. High-middle Socio-demographic Index (SDI) quintile had the highest lifetime risk of developing MBC, while the low SDI quintile had the highest lifetime risk of dying from MBC. Dietary risk and alcohol use were identified as important risk factors for MBC deaths and DALYs globally.
Interpretation: The global burden of MBC significantly increased from 1990 to 2021, with notable geographic disparities. Efforts aimed at MBC prevention and control strategies should take into account the inequities in its global distribution.
Funding: This study was supported by the National Natural Science Foundation of China (grant numbers 82372996 and 82202913) and the Chongqing Natural Science Foundation (grant number CSTB2023NSCQ-MSX0480).
{"title":"Global, regional, and national burden of male breast cancer in 204 countries and territories: a systematic analysis from the global burden of disease study, 1990-2021.","authors":"Yunhai Li, Ying Huang, Hongbo Huang, Tingting Wei, Aijie Zhang, Lei Xing, Xuedong Yin, Hongyuan Li, Guosheng Ren, Fan Li","doi":"10.1016/j.eclinm.2024.103027","DOIUrl":"10.1016/j.eclinm.2024.103027","url":null,"abstract":"<p><strong>Background: </strong>Male breast cancer (MBC) is a rare malignancy that has been under-investigated, with limited global epidemiological research dedicated to it. A comprehensive estimate of the global, regional, and national burden of MBC is valuable for policy planning. This study aims to evaluate the burden of MBC across 204 countries and territories.</p><p><strong>Methods: </strong>MBC data were collected from the 2021 Global Burden of Diseases, Injuries, and Risk Factors (GBD) Study estimates spanning from 1990 to 2021. The global incidence, prevalence, deaths, and disability-adjusted life-years (DALYs) attributed to MBC, as well as corresponding age-standardized rates, were calculated. Temporal trends, projections of incidence and mortality to 2050, lifetime risk, and risk factors of MBC were also estimated according to regions and countries.</p><p><strong>Findings: </strong>In 2021, there were 38,827 (95% uncertainty interval [UI], 24,650-47,846) new cases, 320,459 (95% UI, 220,533-384,317) prevalent cases, 13,274 (95% UI, 9074-16,240) deaths, and 380,917 (95% UI, 252,922-476,417) DALYs attributed to MBC worldwide, with the highest disease burden observed in the Eastern Sub-Saharan Africa region. From 1990 to 2021, the age-standardized incidence and mortality rates of MBC significantly increased, but they are projected to decrease over the next 30 years. High-middle Socio-demographic Index (SDI) quintile had the highest lifetime risk of developing MBC, while the low SDI quintile had the highest lifetime risk of dying from MBC. Dietary risk and alcohol use were identified as important risk factors for MBC deaths and DALYs globally.</p><p><strong>Interpretation: </strong>The global burden of MBC significantly increased from 1990 to 2021, with notable geographic disparities. Efforts aimed at MBC prevention and control strategies should take into account the inequities in its global distribution.</p><p><strong>Funding: </strong>This study was supported by the National Natural Science Foundation of China (grant numbers 82372996 and 82202913) and the Chongqing Natural Science Foundation (grant number CSTB2023NSCQ-MSX0480).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"80 ","pages":"103027"},"PeriodicalIF":9.6,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11741047/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-27eCollection Date: 2025-01-01DOI: 10.1016/j.eclinm.2024.103014
Si Chen, Wei Huang, Min Zhang, Yan Song, Chunshan Zhao, Hongwei Sun, Yanyu Wang, Jihong Wang, Yali Sun, Lei Zhou, Yan Zhu, HongYuan Wang, ZhengYang Xu, YuRui Bai, Cheng Chang
<p><strong>Background: </strong>Anxiety disorders is a significant contributor to the Global Burden of Diseases (GBD), particularly in the aftermath of the COVID-19 pandemic, which has exacerbated the issue. Previous studies have not examined the impact of the COVID-19 pandemic on anxiety disorders over the entire time series, nor have they offered predictions regarding future trends of global anxiety disorders in the aftermath of the pandemic. This study aims to present the Age-Standardized Prevalence Rates (ASPR), Age-Standardized Incidence Rates (ASIR), and disability-adjusted life years (DALYs) associated with anxiety disorders from 1990 to 2021 across 204 countries and regions, emphasizing the age structure and the disease burden following the pandemic. Additionally, it examines the relationship between the burden of anxiety disorders and the COVID-19 pandemic, as well as trend predictions for the incidence of anxiety disorders from 2022 to 2050.</p><p><strong>Methods: </strong>We analysed data from the GBD 2021 study, employed the GBD method to integrate epidemiological data on ASPR, ASIR, and DALYs to accurately assess the global burden of anxiety disorders across various regions, genders, and age groups. Additionally, joint point regression analysis was applied to rigorously examine the time trends of anxiety disorders from 1990 to 2021, calculating the annual percentage change (APC), annual average percentage change (AAPC), and their corresponding 95% confidence intervals (CIs). Furthermore, path analysis was utilized to investigate the impact pathways between the COVID-19 pandemic and anxiety disorders. Finally, a Bayesian age-period-cohort (BAPC) model was employed to predict the prevalence trends of anxiety disorders from 2022 to 2050.</p><p><strong>Findings: </strong>From 1990 to 2021, the ASPR, ASIR, and DALYs associated with anxiety disorders worldwide exhibited a significant upward trend, particularly evident from 2019 to 2021, during which all three metrics experienced a sharp increase. The most pronounced changes in the burden of anxiety disorders from 2019 to 2021 were observed in high socio-demographic index (SDI) regions, where the ASIR surpassed expected levels in tropical Latin America, high-income North America, and Australia in 2021. Bulgaria recorded the highest increase in anxiety disorders burden during this period, with a change rate of 0.32, while Bhutan experienced the smallest increase, with a total change rate of 0.02. Notably, the global anxiety disorders burden among women is greater than that among men. From 2019 to 2021, women aged 20-24 years were particularly impacted by the COVID-19 pandemic, with a change rate of 0.21. Additionally, the ASIR of COVID-19 pandemic in 2021 had a significant positive correlation with the prevalence of anxiety disorders, standardized path coefficient value of 0.224 (z = 2.708, P < 0.01). Projections indicate that by 2050, the number of individuals affected by anxiety disorders
{"title":"Dynamic changes and future trend predictions of the global burden of anxiety disorders: analysis of 204 countries and regions from 1990 to 2021 and the impact of the COVID-19 pandemic.","authors":"Si Chen, Wei Huang, Min Zhang, Yan Song, Chunshan Zhao, Hongwei Sun, Yanyu Wang, Jihong Wang, Yali Sun, Lei Zhou, Yan Zhu, HongYuan Wang, ZhengYang Xu, YuRui Bai, Cheng Chang","doi":"10.1016/j.eclinm.2024.103014","DOIUrl":"10.1016/j.eclinm.2024.103014","url":null,"abstract":"<p><strong>Background: </strong>Anxiety disorders is a significant contributor to the Global Burden of Diseases (GBD), particularly in the aftermath of the COVID-19 pandemic, which has exacerbated the issue. Previous studies have not examined the impact of the COVID-19 pandemic on anxiety disorders over the entire time series, nor have they offered predictions regarding future trends of global anxiety disorders in the aftermath of the pandemic. This study aims to present the Age-Standardized Prevalence Rates (ASPR), Age-Standardized Incidence Rates (ASIR), and disability-adjusted life years (DALYs) associated with anxiety disorders from 1990 to 2021 across 204 countries and regions, emphasizing the age structure and the disease burden following the pandemic. Additionally, it examines the relationship between the burden of anxiety disorders and the COVID-19 pandemic, as well as trend predictions for the incidence of anxiety disorders from 2022 to 2050.</p><p><strong>Methods: </strong>We analysed data from the GBD 2021 study, employed the GBD method to integrate epidemiological data on ASPR, ASIR, and DALYs to accurately assess the global burden of anxiety disorders across various regions, genders, and age groups. Additionally, joint point regression analysis was applied to rigorously examine the time trends of anxiety disorders from 1990 to 2021, calculating the annual percentage change (APC), annual average percentage change (AAPC), and their corresponding 95% confidence intervals (CIs). Furthermore, path analysis was utilized to investigate the impact pathways between the COVID-19 pandemic and anxiety disorders. Finally, a Bayesian age-period-cohort (BAPC) model was employed to predict the prevalence trends of anxiety disorders from 2022 to 2050.</p><p><strong>Findings: </strong>From 1990 to 2021, the ASPR, ASIR, and DALYs associated with anxiety disorders worldwide exhibited a significant upward trend, particularly evident from 2019 to 2021, during which all three metrics experienced a sharp increase. The most pronounced changes in the burden of anxiety disorders from 2019 to 2021 were observed in high socio-demographic index (SDI) regions, where the ASIR surpassed expected levels in tropical Latin America, high-income North America, and Australia in 2021. Bulgaria recorded the highest increase in anxiety disorders burden during this period, with a change rate of 0.32, while Bhutan experienced the smallest increase, with a total change rate of 0.02. Notably, the global anxiety disorders burden among women is greater than that among men. From 2019 to 2021, women aged 20-24 years were particularly impacted by the COVID-19 pandemic, with a change rate of 0.21. Additionally, the ASIR of COVID-19 pandemic in 2021 had a significant positive correlation with the prevalence of anxiety disorders, standardized path coefficient value of 0.224 (z = 2.708, P < 0.01). Projections indicate that by 2050, the number of individuals affected by anxiety disorders ","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"103014"},"PeriodicalIF":9.6,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11743809/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-27eCollection Date: 2025-01-01DOI: 10.1016/j.eclinm.2024.103020
Leiling Liu, Zhiqi Li, Wenrui Ye, Pu Peng, Yurong Wang, Luqing Wan, Jiangnan Li, Mei Zhang, Yihua Wang, Runqi Liu, Danyan Xu, Jingjing Zhang
<p><strong>Background: </strong>Overweight and obesity pose serious health challenges for individuals and societies. This study aims to facilitate personalised treatment of obesity by summarising recent research on weight-loss pharmacotherapies, with a focus on their effects on weight reduction, cardiometabolic health, psychological outcomes, and adverse events.</p><p><strong>Methods: </strong>This systematic review and meta-analysis included searches of Web of Science, PubMed, and Cochrane Central Register of Controlled Trials from inception to June 8, 2024. Randomised controlled trials evaluating weight-loss pharmacotherapies approved by the Food and Drug Administration (FDA) or European Medicines Agency (EMA) for treating overweight or obesity were included. Primary outcomes included changes in body weight, cardiometabolic indicators, psychological outcomes, and adverse events. Summary data was extracted from published reports. Random-effects meta-analyses were used to calculate weighted mean differences (WMDs), risk ratios (RRs), and 95% confidence intervals (CI). The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used to assess the certainty of evidence for each pooled analysis. PROSPERO registration: CRD42024547905.</p><p><strong>Findings: </strong>A total of 154 randomised controlled trials (n = 112,515 participants) were included. Tirzepatide had the greatest weight-loss effect (WMD -11.69, 95% CI -19.22 to -4.15; <i>P</i> = 0.0024; I<sup>2</sup> = 100.0%; moderate certainty), followed by semaglutide (-8.48, -12.68 to -4.27; <i>P</i> < 0.0001; I<sup>2</sup> = 100.0%; moderate certainty). Tirzepatide had the strongest antihypertensive effect on both systolic (WMD -5.74, -9.00 to -2.48; <i>P</i> = 0.0006; I<sup>2</sup> = 99.8%; moderate certainty) and diastolic blood pressure (WMD -2.91, -4.97 to -0.85; <i>P</i> = 0.0056; I<sup>2</sup> = 99.8%; moderate certainty) and best reduced triglycerides (WMD -0.77, -0.85 to -0.69; <i>P</i> < 0.0001; I<sup>2</sup> = 3.2%; high certainty), fasting glucose (WMD -3.06, -5.53 to -0.59; <i>P</i> = 0.015; I<sup>2</sup> = 100.0%; moderate certainty), insulin (WMD -4.91, -8.15 to -1.68; <i>P</i> = 0.0029; I<sup>2</sup> = 97.0%; moderate certainty), and glycated haemoglobin levels (WMD -1.27, -1.82 to -0.73; <i>P</i> < 0.0001; I<sup>2</sup> = 100.0%; moderate certainty). Semaglutide (RR 0.83, 0.74-0.92; <i>P</i> < 0.0001; I<sup>2</sup> = 0.0%; high certainty) and liraglutide (0.87, 0.79-0.96; <i>P</i> = 0.0059; I<sup>2</sup> = 0.0%; high certainty) reduced the risk of major adverse cardiovascular events (MACEs). However, all three medications were associated with adverse gastrointestinal effects. Naltrexone/bupropion increased the risk of elevated blood pressure (RR 1.72, 1.04-2.85; <i>P</i> = 0.036; I<sup>2</sup> = 0.0%; high certainty). Topiramate increased depression risk (RR 1.62, 1.14 to 2.30; <i>P</i> = 0.0077; I<sup>2</sup> = 0.0%; high certainty), and phentermin
{"title":"Safety and effects of anti-obesity medications on weight loss, cardiometabolic, and psychological outcomes in people living with overweight or obesity: a systematic review and meta-analysis.","authors":"Leiling Liu, Zhiqi Li, Wenrui Ye, Pu Peng, Yurong Wang, Luqing Wan, Jiangnan Li, Mei Zhang, Yihua Wang, Runqi Liu, Danyan Xu, Jingjing Zhang","doi":"10.1016/j.eclinm.2024.103020","DOIUrl":"10.1016/j.eclinm.2024.103020","url":null,"abstract":"<p><strong>Background: </strong>Overweight and obesity pose serious health challenges for individuals and societies. This study aims to facilitate personalised treatment of obesity by summarising recent research on weight-loss pharmacotherapies, with a focus on their effects on weight reduction, cardiometabolic health, psychological outcomes, and adverse events.</p><p><strong>Methods: </strong>This systematic review and meta-analysis included searches of Web of Science, PubMed, and Cochrane Central Register of Controlled Trials from inception to June 8, 2024. Randomised controlled trials evaluating weight-loss pharmacotherapies approved by the Food and Drug Administration (FDA) or European Medicines Agency (EMA) for treating overweight or obesity were included. Primary outcomes included changes in body weight, cardiometabolic indicators, psychological outcomes, and adverse events. Summary data was extracted from published reports. Random-effects meta-analyses were used to calculate weighted mean differences (WMDs), risk ratios (RRs), and 95% confidence intervals (CI). The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used to assess the certainty of evidence for each pooled analysis. PROSPERO registration: CRD42024547905.</p><p><strong>Findings: </strong>A total of 154 randomised controlled trials (n = 112,515 participants) were included. Tirzepatide had the greatest weight-loss effect (WMD -11.69, 95% CI -19.22 to -4.15; <i>P</i> = 0.0024; I<sup>2</sup> = 100.0%; moderate certainty), followed by semaglutide (-8.48, -12.68 to -4.27; <i>P</i> < 0.0001; I<sup>2</sup> = 100.0%; moderate certainty). Tirzepatide had the strongest antihypertensive effect on both systolic (WMD -5.74, -9.00 to -2.48; <i>P</i> = 0.0006; I<sup>2</sup> = 99.8%; moderate certainty) and diastolic blood pressure (WMD -2.91, -4.97 to -0.85; <i>P</i> = 0.0056; I<sup>2</sup> = 99.8%; moderate certainty) and best reduced triglycerides (WMD -0.77, -0.85 to -0.69; <i>P</i> < 0.0001; I<sup>2</sup> = 3.2%; high certainty), fasting glucose (WMD -3.06, -5.53 to -0.59; <i>P</i> = 0.015; I<sup>2</sup> = 100.0%; moderate certainty), insulin (WMD -4.91, -8.15 to -1.68; <i>P</i> = 0.0029; I<sup>2</sup> = 97.0%; moderate certainty), and glycated haemoglobin levels (WMD -1.27, -1.82 to -0.73; <i>P</i> < 0.0001; I<sup>2</sup> = 100.0%; moderate certainty). Semaglutide (RR 0.83, 0.74-0.92; <i>P</i> < 0.0001; I<sup>2</sup> = 0.0%; high certainty) and liraglutide (0.87, 0.79-0.96; <i>P</i> = 0.0059; I<sup>2</sup> = 0.0%; high certainty) reduced the risk of major adverse cardiovascular events (MACEs). However, all three medications were associated with adverse gastrointestinal effects. Naltrexone/bupropion increased the risk of elevated blood pressure (RR 1.72, 1.04-2.85; <i>P</i> = 0.036; I<sup>2</sup> = 0.0%; high certainty). Topiramate increased depression risk (RR 1.62, 1.14 to 2.30; <i>P</i> = 0.0077; I<sup>2</sup> = 0.0%; high certainty), and phentermin","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"103020"},"PeriodicalIF":9.6,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11743856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-27eCollection Date: 2025-01-01DOI: 10.1016/j.eclinm.2024.103005
Safoora Gharibzadeh, Ash Routen, Cameron Razieh, Francesco Zaccardi, Claire Lawson, Clare Gillies, Simon Heller, Melanie Davies, Helen Atkins, Stephen C Bain, Nazir L Lone, Krisnah Poinasamy, Tunde Peto, Elizabeth Robertson, Bob Young, Desmond Johnston, Jennifer Quint, Jonathan Valabhji, Khalida Ismail, Michael Marks, Alex Horsley, Annemarie Docherty, Ewen Harrison, James Chalmers, Ling-Pei Ho, Betty Raman, Chris Brightling, Omer Elneima, Rachel Evans, Neil Greening, Victoria C Harris, Linzy Houchen-Wolloff, Marco Sereno, Aarti Shikotra, Amisha Singapuri, Louise Wain, Claudia Langenberg, John Dennis, John Petrie, Naveed Sattar, Olivia Leavy, Mattew Richardson, Ruth M Saunders, Anne McArdle, Hamish McASuley, Tom Yates, Kamlesh Khunti
Background: People with diabetes are at increased risk of hospitalisation, morbidity, and mortality following SARS-CoV-2 infection. Long-term outcomes for people with diabetes previously hospitalised with COVID-19 are, however, unknown. This study aimed to determine the longer-term physical and mental health effects of COVID-19 in people with and without diabetes.
Methods: The PHOSP-COVID study is a multicentre, long-term follow-up study of adults discharged from hospital between 1 February 2020 and 31 March 2021 in the UK following COVID-19, involving detailed assessment at 5 and 12 months after discharge. The association between diabetes status and outcomes were explored using multivariable linear and logistic regressions.
Findings: People with diabetes who survived hospital admission with COVID-19 display worse physical outcomes compared to those without diabetes at 5- and 12-month follow-up. People with diabetes displayed higher fatigue (only at 5 months), frailty, lower physical performance, and health-related quality of life and poorer cognitive function. Differences in outcomes between diabetes status groups were largely consistent from 5 to 12-months. In regression models, differences at 5 and 12 months were attenuated after adjustment for BMI and presence of other long-term conditions.
Interpretation: People with diabetes reported worse physical outcomes up to 12 months after hospital discharge with COVID-19 compared to those without diabetes. These data support the need to reduce inequalities in long-term physical and mental health effects of SARS-CoV-2 infection in people with diabetes.
Funding: UK Research and Innovation and National Institute for Health Research. The study was approved by the Leeds West Research Ethics Committee (20/YH/0225) and is registered on the ISRCTN Registry (ISRCTN10980107).
{"title":"Long term health outcomes in people with diabetes 12 months after hospitalisation with COVID-19 in the UK: a prospective cohort study.","authors":"Safoora Gharibzadeh, Ash Routen, Cameron Razieh, Francesco Zaccardi, Claire Lawson, Clare Gillies, Simon Heller, Melanie Davies, Helen Atkins, Stephen C Bain, Nazir L Lone, Krisnah Poinasamy, Tunde Peto, Elizabeth Robertson, Bob Young, Desmond Johnston, Jennifer Quint, Jonathan Valabhji, Khalida Ismail, Michael Marks, Alex Horsley, Annemarie Docherty, Ewen Harrison, James Chalmers, Ling-Pei Ho, Betty Raman, Chris Brightling, Omer Elneima, Rachel Evans, Neil Greening, Victoria C Harris, Linzy Houchen-Wolloff, Marco Sereno, Aarti Shikotra, Amisha Singapuri, Louise Wain, Claudia Langenberg, John Dennis, John Petrie, Naveed Sattar, Olivia Leavy, Mattew Richardson, Ruth M Saunders, Anne McArdle, Hamish McASuley, Tom Yates, Kamlesh Khunti","doi":"10.1016/j.eclinm.2024.103005","DOIUrl":"10.1016/j.eclinm.2024.103005","url":null,"abstract":"<p><strong>Background: </strong>People with diabetes are at increased risk of hospitalisation, morbidity, and mortality following SARS-CoV-2 infection. Long-term outcomes for people with diabetes previously hospitalised with COVID-19 are, however, unknown. This study aimed to determine the longer-term physical and mental health effects of COVID-19 in people with and without diabetes.</p><p><strong>Methods: </strong>The PHOSP-COVID study is a multicentre, long-term follow-up study of adults discharged from hospital between 1 February 2020 and 31 March 2021 in the UK following COVID-19, involving detailed assessment at 5 and 12 months after discharge. The association between diabetes status and outcomes were explored using multivariable linear and logistic regressions.</p><p><strong>Findings: </strong>People with diabetes who survived hospital admission with COVID-19 display worse physical outcomes compared to those without diabetes at 5- and 12-month follow-up. People with diabetes displayed higher fatigue (only at 5 months), frailty, lower physical performance, and health-related quality of life and poorer cognitive function. Differences in outcomes between diabetes status groups were largely consistent from 5 to 12-months. In regression models, differences at 5 and 12 months were attenuated after adjustment for BMI and presence of other long-term conditions.</p><p><strong>Interpretation: </strong>People with diabetes reported worse physical outcomes up to 12 months after hospital discharge with COVID-19 compared to those without diabetes. These data support the need to reduce inequalities in long-term physical and mental health effects of SARS-CoV-2 infection in people with diabetes.</p><p><strong>Funding: </strong>UK Research and Innovation and National Institute for Health Research. The study was approved by the Leeds West Research Ethics Committee (20/YH/0225) and is registered on the ISRCTN Registry (ISRCTN10980107).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"103005"},"PeriodicalIF":9.6,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11743801/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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