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Health Science Reports Jun 2024The primary objective of this systematic review and meta-analysis was to assess the impact of dextrose prolotherapy on individuals diagnosed with knee osteoarthritis... (Review)
Review
BACKGROUND AND AIMS
The primary objective of this systematic review and meta-analysis was to assess the impact of dextrose prolotherapy on individuals diagnosed with knee osteoarthritis (KOA).
METHODS
To conduct a thorough investigation, a variety of leading international databases were checked, including PubMed (Medline), Scopus, Web of Sciences, EMBASE (Elsevier), ClinicalTrials.gov, and the Cochrane Library. The search covered a period from January 2000 to the end of June 2023, which facilitated the collection of relevant studies.
RESULTS
The findings of the study revealed that when the studies utilizing the Western Ontario McMaster Universities Index tool (WOMAC) were combined, patients with KOA who received prolotherapy experienced an improvement in function compared with those who received other treatments (SMD: 0.20; 95% Confidence Interval [1]: -0.11, 0.51; value SMD = 0.221; : 78.49%; < 0.001). Additionally, there was a decrease in mean pain and stiffness among patients who received prolotherapy compared with those who received other treatments or a placebo [(SMD: -0.95; 95% CI: -1.14, -0.76; value SMD < 0.001; : 59.35%; = 0.070) and (SMD: -0.21; 95% CI: -0.32, -0.10; value SMD < 0.001; : 88.11%; < 0.001)]. Furthermore, based on the Visual Analog Scale (VAS) score, there was a reduction of 0.81 units out of 10 in mean pain for patients with KOA who received prolotherapy (SMD: -0.81; 95% CI: -5.63, 4.10; value SMD = 0.693; : 48.54%; = 0.08).
CONCLUSION
Drawing from the data analysis performed in this meta-analysis, it is apparent that dextrose prolotherapy exhibits promising effectiveness in reducing joint pain and stiffness, as well as improving functional performance in individuals suffering from KOA. Furthermore, it is recommended that forthcoming studies incorporate follow-up periods to guide decisions concerning the duration of prolotherapy's effects.
PubMed: 38915358
DOI: 10.1002/hsr2.2145 -
Molecular Psychiatry Jun 2024There is a growing literature exploring the placebo response within specific mental disorders, but no overarching quantitative synthesis of this research has analyzed...
There is a growing literature exploring the placebo response within specific mental disorders, but no overarching quantitative synthesis of this research has analyzed evidence across mental disorders. We carried out an umbrella review of meta-analyses of randomized controlled trials (RCTs) of biological treatments (pharmacotherapy or neurostimulation) for mental disorders. We explored whether placebo effect size differs across distinct disorders, and the correlates of increased placebo effects. Based on a pre-registered protocol, we searched Medline, PsycInfo, EMBASE, and Web of Knowledge up to 23.10.2022 for systematic reviews and/or meta-analyses reporting placebo effect sizes in psychopharmacological or neurostimulation RCTs. Twenty meta-analyses, summarising 1,691 RCTs involving 261,730 patients, were included. Placebo effect size varied, and was large in alcohol use disorder (g = 0.90, 95% CI [0.70, 1.09]), depression (g = 1.10, 95% CI [1.06, 1.15]), restless legs syndrome (g = 1.41, 95% CI [1.25, 1.56]), and generalized anxiety disorder (d = 1.85, 95% CI [1.61, 2.09]). Placebo effect size was small-to-medium in obsessive-compulsive disorder (d = 0.32, 95% CI [0.22, 0.41]), primary insomnia (g = 0.35, 95% CI [0.28, 0.42]), and schizophrenia spectrum disorders (standardized mean change = 0.33, 95% CI [0.22, 0.44]). Correlates of larger placebo response in multiple mental disorders included later publication year (opposite finding for ADHD), younger age, more trial sites, larger sample size, increased baseline severity, and larger active treatment effect size. Most (18 of 20) meta-analyses were judged 'low' quality as per AMSTAR-2. Placebo effect sizes varied substantially across mental disorders. Future research should explore the sources of this variation. We identified important gaps in the literature, with no eligible systematic reviews/meta-analyses of placebo response in stress-related disorders, eating disorders, behavioural addictions, or bipolar mania.
PubMed: 38914807
DOI: 10.1038/s41380-024-02638-x -
Photodiagnosis and Photodynamic Therapy Jun 2024This study aimed to assess the effectiveness of photobiomodulation therapy (PBM) in enhancing bone integration with dental implants. (Review)
Review
AIM
This study aimed to assess the effectiveness of photobiomodulation therapy (PBM) in enhancing bone integration with dental implants.
METHOD
PubMed, ScienceDirect, the Cochrane Library, Scopus, and Google Scholar were searched. Studies assessing PBM effectiveness with defined intervention/control groups were included, while those lacking specified laser types, involving severe maxillofacial defects or surgery, and not reporting outcomes related to dental implant osseointegration post-PBM therapy were excluded. The studies' risk of bias was assessed using Robvis for randomized controlled trials (RCTs) and ROBINS-I for non-RCTs. The meta-analysis was conducted utilizing a random-effects model at a significance level of 0.01.
RESULTS
The study reviewed 26 papers involving 571 patients undergoing dental implant procedures with PBM/Low-Level Laser Therapy (LLLT) or placebo/control. Implant stability quotients (ISQ) analysis showed a non-significant difference (p=0.06, mean difference: 1.02, 95% CI: 0.28 to 1.75, I=28%), while the Periotest method indicated significant improvement in stability (p<0.01, mean difference: -0.51, 95% CI: -0.78 to -0.24, I=71%). PBM resulted in a significant bone density increase (p<0.01, mean difference: 26, 95% CI: 6.93 to 45.06, I=91%), but marginal bone loss showed no significant difference (p=0.11, mean difference: 0.00, 95% CI: -0.06 to 0.05, I=45%). Implant survival rate did not significantly differ (p=0.73, mean difference: 1.56, 95% CI: 0.38 to 6.46, I=0%). Most studies raised concerns regarding randomization.
CONCLUSION
PBM could improve implant stability, as assessed with Periotest, and increase bone density, enhancing osseointegration. However, implant stability assessed with ISQ, marginal bone loss, and implant survival rate were comparable between the study groups.
PubMed: 38914185
DOI: 10.1016/j.pdpdt.2024.104256 -
Pneumologie (Stuttgart, Germany) Jun 2024To show the importance of hypoglossal nerve stimulation (HGNS) as a treatment method for obstructive sleep apnea (OSA) in the German healthcare context and to better...
OBJECTIVE
To show the importance of hypoglossal nerve stimulation (HGNS) as a treatment method for obstructive sleep apnea (OSA) in the German healthcare context and to better assess the way patients who do not receive adequate care could benefit from HGNS.
METHODS
A systematic literature review in the Medline and Cochrane Library literature database was conducted, including publications using different stimulation technologies for HGNS. The efficacy of HGNS was assessed based on patient-relevant outcomes (daytime sleepiness, quality of life), treatment adherence and the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI). The safety of the treatment method was assessed based on adverse events (AEs).
RESULTS
Inclusion and analysis of 33 publications: 2 randomized controlled trials (RCTs, level Ib), 1 level IIb trial (n = 1) and 30 level IV trials with a study duration of up to 60 months. The RCTs showed better values for daytime sleepiness and quality of life when using HGNS than in the control group. AHI and ODI showed a deterioration under placebo stimulation or therapy withdrawal in the RCTs. Consistently high adherence was also reported in the long-term course. Severe AEs under HGNS were rare and could usually be resolved by repositioning electrodes or replacing device components. Other AEs were mostly transient or could be resolved by non-invasive measures. All investigated parameters showed similar results in the evaluated studies. The results of different stimulation systems are comparable in type and extent.
CONCLUSION
The comprehensive review of the literature shows consistent data that highlight the importance of HGNS as an effective and safe treatment for OSA after unsuccessful CPAP treatment. The evaluation also shows that the different stimulation systems make it possible to better tailor the therapy to the patient's individual requirements. A future systematic evaluation of real-world data on the use of HGNS would help gain additional insights into the relevance of the method in routine clinical practice.
PubMed: 38914119
DOI: 10.1055/a-2331-8978 -
Pain Medicine (Malden, Mass.) Jun 2024The administration of local anaesthesia in intraperitoneal space as part of the multi-modal analgesic regimen has shown to be effective in reducing postoperative pain....
OBJECTIVE
The administration of local anaesthesia in intraperitoneal space as part of the multi-modal analgesic regimen has shown to be effective in reducing postoperative pain. Recent studies demonstrated that intraperitoneal lidocaine may provide analgesic effects. Primary objective was to determine the impact of intraperitoneal lidocaine on postoperative pain scores at rest.
DESIGN
We carried out a systematic review and meta-analysis according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).
METHODS
Databases of MEDLINE, EMBASE, and CENTRAL were searched from their inception date until May 2023. Randomized clinical trials (RCT) comparing intraperitoneal lidocaine and placebo in adults undergoing surgery were included.
RESULTS
Our systematic review included 24 RCTs (n = 1,824). The intraperitoneal lidocaine group was significantly associated with lower postoperative pain scores at rest (MD: -0.87, 95% CI: -1.04 to -0.69) and at movement (MD: -0.50, 95% Cl: -0.93 to -0.08) among adult patients after surgery. Its administration also significantly decreased morphine consumption (MD: -6.42 mg, 95% Cl: -11.56 to -1.27), lowered the incidence of needing analgesia (OR: 0.22, 95% Cl: 0.14 to 0.35). Intraperitoneal lidocaine statistically reduced time to resume regular diet (MD: 0.16 days; 95% Cl: -0.31 to -0.01), and lowered postoperative incidence of nausea and vomiting (OR: 0.54, 95% Cl: 0.39 to 0.75).
CONCLUSIONS
In this review, our findings should be interpreted with caution. Future studies are warranted to determine the optimal dose of administering intraperitoneal lidocaine among adult patients undergoing surgery.
PubMed: 38913879
DOI: 10.1093/pm/pnae052 -
American Journal of Cardiovascular... Jun 2024Cardiovascular disease was the leading cause of death worldwide in 2021, with atherosclerotic cardiovascular disease, encompassing hypercholesterolemia, being a major...
BACKGROUND
Cardiovascular disease was the leading cause of death worldwide in 2021, with atherosclerotic cardiovascular disease, encompassing hypercholesterolemia, being a major contributing factor. A range of lipid-lowering medications is used for the management of hyperlipidemia, but the use of statins is considered as standard therapy. Unfortunately, some patients do not respond to this therapy, necessitating novel therapeutic approaches. Tafolecimab is a novel proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody that inhibits the binding of PCSK9 with low-density lipoprotein receptors (LDLRs) and increases LDLR recycling, and thus it indirectly lowers circulating low-density lipoprotein cholesterol (LDL-C) levels by increasing LDL-C uptake. The primary objective of this study is to assess the efficacy of tafolecimab in reducing LDL-C levels.
METHODS
A thorough search was conducted on Medline (PubMed), Cochrane CENTRAL, Scopus, and Google Scholar from inception until December 2023. Review Manager was used for statistical analysis. The random effects model was used to calculate risk ratios (RRs), mean differences (MDs), and 95% confidence intervals (CIs). Heterogeneity was assessed using the Higgins I index. The risk of bias was assessed using Cochrane's RoB 2 tool. This review has been registered with PROSPERO (CRD42023471020).
RESULTS
A total of four Chinese studies matched the inclusion criteria and were included in this review. A total of 726 patients were included in this review, out of which 476 patients were males. Out of four, three studies that studied the efficacy of 450 mg tafolecimab every 4 weeks in patients (n = 462) as compared to placebo (n = 224) were included in the meta-analysis. According to the pooled results, tafolecimab caused a significant decrease in LDL-C levels from baseline to week 12 as compared to placebo (MD = - 63.78, 95% CI - 65.88 to - 61.68, p value < 0.00001, I = 97%). The pooled results showed that more patients achieved ≥ 50% reductions in LDL-C levels (RR = 52.33, 95% CI 18.51-147.95, p value < 0.00001, I = 0%) and LDL-C < 1.8 mmol/L (RR = 17.27, 95% CI 9.59-31.11, p value < 0.00001, I = 0%) at week 12 in the tafolecimab group than the placebo group. Additionally, tafolecimab also caused a robust decrease in non-HDL-C, apolipoprotein B, and lipoprotein(a) levels from baseline to week 12 compared to placebo. The overall risk of bias was low, as determined by the RoB 2 tool.
CONCLUSIONS
Tafolecimab showed promising lipid-lowering efficacy and a well-tolerated safety profile. Our findings suggest its potential as an innovative therapeutic option for individuals with hypercholesterolemia; however, significant heterogeneity was observed in some results, making it difficult to come to a firm conclusion. Therefore, large-scale randomized trials are required to confirm our findings, particularly exploring the most effective dosage regimens across varied populations.
REGISTRATION
PROSPERO identifier number CRD42023471020.
PubMed: 38913274
DOI: 10.1007/s40256-024-00654-4 -
Cardiovascular Endocrinology &... Sep 2024Bempedoic acid (BA) has shown varied efficacy in managing hyperlipidemia. We conducted the most extensive up-to-date meta-analysis, the first to include recent studies... (Review)
Review
Efficacy and outcomes of bempedoic acid versus placebo in patients with hypercholesterolemia: an updated systematic review and meta-analysis of randomized controlled trials.
INTRODUCTION
Bempedoic acid (BA) has shown varied efficacy in managing hyperlipidemia. We conducted the most extensive up-to-date meta-analysis, the first to include recent studies by Nissen et al., which boast the largest sample size.
METHODS
Literature search was done on Medline, EMBASE, and Cochrane Library. The primary endpoint was a change in low-density lipoprotein-cholesterol (LDL-C) levels, while secondary endpoints encompassed changes in lipid parameters, clinical endpoints, and safety endpoints. The least-square mean (LSM) percent change was utilized for lipid changes, with statistical significance set at < 0.05.
RESULTS
This analysis included 12 randomized control trials with 22,249 participants. BA exhibited a substantial reduction in LDL-C levels [LSM % change, -24.34; 95% confidence interval (CI), -27.80 to -20.88; < 0.0001], total cholesterol levels (LSM % change, -16.62; 95% CI, -21.70 to -11.54; < 0.00001) and high-density lipoprotein-cholesterol (HDL-C) levels (LSM % change, -4.22; 95% CI, -5.51 to -2.92; < 0.00001) compared to the placebo.
CONCLUSIONS
BA significantly lowers LDL-C, total cholesterol, HDL-C, non-HDL-C, high sensitivity C reactive protein, and apolipoprotein levels.
PubMed: 38911912
DOI: 10.1097/XCE.0000000000000302 -
Journal of Neurology Jun 2024Chronic migraine (CM) significantly impacts both the physical and mental health of patients. Current studies on the safety and effectiveness of different pharmacological... (Review)
Review
BACKGROUND
Chronic migraine (CM) significantly impacts both the physical and mental health of patients. Current studies on the safety and effectiveness of different pharmacological prophylaxis interventions for CM are limited. To address this gap, we conducted a network meta-analysis (NMA) to compare and rank the efficacy and safety of various drugs in preventing CM.
METHODS
Two independent researchers systematically searched four databases from their inception to August 1, 2023, to identify eligible randomized controlled trials (RCTs). Subsequently, they performed data extraction and assessed the risk of bias. A NMA was then performed. Continuous outcomes and binary outcomes were displayed as weighted mean difference (WMD) and risk ratio (RR), respectively, and corresponding 95% confidence intervals (CI) were reported. The surface under the cumulative ranking curve (SUCRA) was used to rank each intervention separately.
RESULTS
24 RCTs involving 8789 patients were included. Compared to placebo, Botulinum toxin A demonstrated the most significant effect in reducing the monthly migraine days for CM patients (MD = 3.88, 95% CI 0.48, 7.28); in terms of improving the response rate by a 50% reduction in monthly migraine days, Topiramate (RR = 50.06, 95% CI 3.18, 787.30) was the most effective; there was no statistically significant difference between all preventive drugs and placebo in improving the migraine disability assessment (MIDAS) score; in terms of the incidence of adverse events, Eptinezumab (RR = 1.09, 95% CI 0.8, 1.54) exhibited the highest safety profile.
CONCLUSION
Among all the drugs for the preventive drugs for CM, Botulinum toxin A has the best efficacy and safety profile, closely followed by calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs).
PubMed: 38910144
DOI: 10.1007/s00415-024-12512-z -
International Journal of Antimicrobial... Jun 2024We systematically assessed benefits and harms of the use of ivermectin in non-hospitalized patients with early COVID-19. (Review)
Review
Efficacy and safety of ivermectin for treatment of non-hospitalized COVID-19 patients: a systematic review and meta-analysis of 12 randomized controlled trials with 7,035 participants.
INTRODUCTION
We systematically assessed benefits and harms of the use of ivermectin in non-hospitalized patients with early COVID-19.
METHODS
Five databases were searched until October 17, 2023, for randomized controlled trials (RCTs) in adult patients with COVID-19 treated with ivermectin against standard of care (SoC), placebo, or active drug. Primary outcomes were hospitalization, all-cause mortality, and adverse events (AEs). Secondary outcomes included mechanical ventilation (MV), clinical improvement, clinical worsening, viral clearance, and severe adverse events (SAEs). Random effects meta-analyses were performed, with quality of evidence (QoE) evaluated using GRADE methods. Pre-specified subgroup analyses (ivermectin dose, control type, risk of bias, follow-up, and country income) and trial sequential analysis (TSA) were performed.
RESULTS
Twelve RCTs (n=7,035) were included. The controls were placebo in nine RCTs, SoC in two RCTs, and placebo or active drug in one RCT. Ivermectin did not reduce hospitalization (relative risk [RR], 0.81, 95% confidence interval [95%CI] 0.64-1.03; 8 RCTs, low QoE), all-cause mortality (RR 0.98, 95%CI 0.73-1.33; 9 RCTs, low QoE), or AEs (RR 0.89, 95%CI 0.75-1.07; 9 RCTs, very low QoE) vs. controls. Ivermectin did not reduce MV, clinical worsening, or SAEs and did not increase clinical improvement and viral clearance vs. controls (very low QoE for secondary outcomes). Subgroup analyses were mostly consistent with main analyses, and TSA-adjusted risk for hospitalization was similar to main analysis.
CONCLUSIONS
In non-hospitalized COVID-19 patients, ivermectin did not have effect on clinical, non-clinical or safety outcomes versus controls. Ivermectin should not be recommended as treatment in non-hospitalized COVID-19 patients.
PubMed: 38908535
DOI: 10.1016/j.ijantimicag.2024.107248 -
Ear, Nose, & Throat Journal Jun 2024Evaluation of the effectiveness and posttreatment effects of intratympanic gentamicin and corticosteroids in treating patients with Ménière's disease (MD). Based on...
Evaluation of the effectiveness and posttreatment effects of intratympanic gentamicin and corticosteroids in treating patients with Ménière's disease (MD). Based on PubMed and Embase databases, randomized controlled trials using intratympanic injections of 4 drugs (gentamicin, methylprednisolone, dexamethasone, and placebo) for the treatment of MD were searched from 1995 to October 2023, and the literature was screened according to inclusion and exclusion criteria, and data were netted for meta-analysis using Stata 17. A total of 13 studies were selected, involving 559 participants, with follow-up time ranging from 3 to 28 months. Meta-analysis showed that there was no statistically significant difference in pure-tone average between gentamicin and dexamethasone [standardized mean difference (SMD) = 0.09, 95% confidence interval (CI) (-0.42, 0.24), < .05]. Compared to placebo, intratympanic injection of gentamicin [risk ratio (RR) = 1.18, 95% CI (0.43, 1.93)], methylprednisolone [RR = 0.88, 95% CI (0.07, 1.70)], and dexamethasone [RR = 0.70, 95% CI (-0.01, 1.41)] all showed better efficacy in treating vertigo. For the treatment of tinnitus, the SUCRA ranking results showed that dexamethasone was the most effective, followed by methylprednisolone and gentamicin. Pharmacological intervention is more effective than placebo in treating MD. Although gentamicin treatment shows significant effects in treating vertigo, corticosteroid combination therapy is markedly superior to gentamicin in controlling hearing loss and vertigo symptoms.
PubMed: 38907653
DOI: 10.1177/01455613241264421