scholarly journals Hydrocortisone, ascorbic acid, and thiamine (HAT) for sepsis and septic shock: a meta-analysis with sequential trial analysis

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Weilan Na ◽  
Huili Shen ◽  
Yichu Li ◽  
Dong Qu
Keyword(s):  
Septic Shock ◽  
Ascorbic Acid ◽  
Sofa Score ◽  
Meta Analysis ◽  
Mean Difference ◽  
Hospital Length Of Stay ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Significant Difference ◽  
Sepsis And Septic Shock

Abstract Background Sepsis is a primary global health threat and costs a lot, requiring effective and affordable treatments. We performed this meta-analysis to explore the treatment of hydrocortisone, ascorbic acid, and thiamine (HAT) in sepsis and septic shock. Methods We searched Ovid MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from inception to August 14, 2021. We included randomized controlled trials (RCTs) that evaluated the HAT treatments in sepsis and septic shock. The primary outcome was the change in SOFA score over the 72 h. The second outcomes were the hospital, and 28-/30-day mortality, the duration of vasopressors, PCT clearance, hospital length of stay (LOS), and ICU LOS. We performed a subgroup analysis and a trial sequential analysis (TSA). The Der Simonian–Laird random-effects models were used to report the pooled risk ratios (RR) or mean difference (MD) with confidence intervals (CI). Results Nine RCTs, enrolling 1427 patients of sepsis and septic shock treated with HAT (717) or only standard care (710), were included. There was a significant difference between the two groups in the change in SOFA score over the first 72 h (MD 0.65, 95% CI 0.30 to 1.00), the duration of vasopressors (MD − 18.16, 95% CI − 25.65 to − 10.68) and the PCT clearance (MD 14.54, 95% CI 0.64 to 28.43). In addition, there was no significant difference in the hospital mortality (RR 1.07, 95% CI 0.85 to 1.34), the 28-/30-day mortality (RR 0.96, 95% CI 0.80 to 1.15), the hospital LOS (MD 0.78, 95% CI − 0.30 to 1.86), and ICU LOS (MD 0.12, 95% CI − 0.53 to 0.78). Conclusions The HAT combination improves the SOFA score in the first 72 h and reduces the duration of vasopressors in patients with sepsis. Given the minor mean difference of the change in SOFA score, the mortality benefit has not been observed. Trial registration PROSPERO, CRD42020203166.

scholarly journals Efficacy of tripterygium glycosides combined with ARB on diabetic nephropathy: a meta-analysis

2020 ◽  
Vol 40 (11) ◽  
Author(s):  
Xue Wu ◽  
Youye Huang ◽  
Yao Zhang ◽  
Chunling He ◽  
Yongli Zhao ◽  
...  
Keyword(s):  
Diabetic Nephropathy ◽  
Meta Analysis ◽  
Combined Treatment ◽  
Mean Difference ◽  
Biomedical Literature ◽  
Controlled Trials ◽  
Angiotensin Ii Receptor Blocker ◽  
Cochrane Central Register ◽  
Significant Difference ◽  
Tripterygium Glycosides

Abstract The purpose of this meta-analysis was to evaluate the beneficial and adverse effects of tripterygium glycosides (TGs) combined with angiotensin II receptor blocker (ARB) on diabetic nephropathy (DN). We searched for randomized controlled trials (RCTs) in PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Biomedical Literature Database, China Science and Technology Journal Database up to June 2017. Weighted mean difference (WMD) and standardized mean difference (SMD) were used for continuous variables and all variables were expressed by 95% confidence interval (CI). Twenty-three studies with 1810 DN patients were included in this meta-analysis. TG combined with ARB statistically significantly improved 24-h urinary total protein (24-h UTP) (SMD = −1.46; 95% CI = −1.84 to −1.09; P<0.00001), urinary albumin excretion rate (UAER) (SMD = −6.9; 95% CI = −9.65 to −4.14, P<0.00001), serum creatinine (SCr) (WMD = −7.65.14; 95% CI = −12.99 to −2.31; P=0.005) and albumin (Alb) (WMD = 5.7; 95% CI = 4.44 to 6.96; P<0.00001) more than did ARB alone. TG combined with ARB statistically significantly affected the level of serum glutamic pyruvic transaminase (SGPT) (WMD = 1.08; 95% CI = 0.04 to 2.12, P=0.04) more than did ARB alone. Compared with ARB alone, TG combined with ARB showed no significant difference in improving blood urea nitrogen (BUN) and hemoglobin A1c (HbA1c). Minor side effects from the combined treatment were observed and mainly focused on the abnormal liver function. TG combined with ARB offers a novel concept in treating DN, more high-quality RCTs are needed for better understanding and applying the combined treatment in DN.

scholarly journals Improved survival rate and functional recovery of TKA in cementless fixation compared with cemented component: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Yuan Liu ◽  
Yi Zeng ◽  
Yuangang Wu ◽  
Mingyang Li ◽  
Huiqi Xie ◽  
...  
Keyword(s):  
Functional Recovery ◽  
Meta Analysis ◽  
Standard Form ◽  
Oxford Knee Score ◽  
Mean Difference ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Knee Score ◽  
Cementless Fixation ◽  
Significant Difference

Abstract Background: Whether the cement could be given up in total knee arthroplasty (TKA) was still in controversy. We perform this meta-analysis to compare the rate of revision and functional recovery between two kinds of fixation in TKA. Methods: Randomized controlled trials (RCTs), prospective/retrospective observational studies from PubMed (on 2019 Sep), EMBASE (on 2019 Sep), and the Cochrane Central Register of Controlled Trials (CENTRAL) and Web of Science (on 2019 Sep) were searched. Continuous outcomes were presented as mean difference or standard mean difference with 95% CI and discontinuous outcomes were reported as relative risk (RR) with 95% CI. Random-effects or fixed-effects model was conducted to analyze the extracted data. The PRISMA guidelines and Cochrane Handbook were adopted to assess the quality of the results reported in included studies to ensure that the results of our meta-analysis were reliable and veritable. The continuous and dichotomous outcome were collected in a standard form, and the data were analysed by using Review Manager 5.3 software. Finally, the results were presented in the Forest plots. The rate of revision and reasons caused revision was the primary outcome of our study.Results: Twenty-six studies involving 2369 patients in cementless TKA and 2654 patients in cemented TKA were finally included in our meta-analysis. 26 studies were divided into three subgroups according to the length of follow-up. The studies in the first subgroup followed less than 5.5 years, the second followed less than 10.5 years, and the third followed more than 10.5 years. Cementless fixation significantly decreased the rate of aseptic loosing (p=0.0002) and revision (p=0.0002) in the first subgroup. Other reasons such as periprosthetic joint infection (PJI), instability and polyethylene wear were not significantly different between two groups. Significantly better functional recovery was got in cementless TKA in terms of Knee Society Score (p=0.004) and Oxford Knee Score (p=0.007). Significantly less patients in cementless group require manipulation under anesthesia (p=0.007). However, there was no significant difference regarding the rate of complication between two kinds of fixation in TKA.Conclusion: Not only the rate of aseptic loosing was decreased, rate of revision was also significantly decreased in cementless TKA within 5.5 years. In addition, the cementless TKA performed better in postoperative functional recovery according to Knee Society Function Score and Oxford Knee Score. However, the rate of complication was not significantly different in two kinds of fixation in TKA.

scholarly journals Steroid, ascorbic acid, and thiamine in adults with sepsis and septic shock: a systematic review and component network meta-analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ka Man Fong ◽  
Shek Yin Au ◽  
George Wing Yiu Ng
Keyword(s):  
Septic Shock ◽  
Mechanical Ventilation ◽  
Ascorbic Acid ◽  
Data Extraction ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Short Term ◽  
Short Term Mortality ◽  
Sepsis And Septic Shock

AbstractTo assess the effect from individual component in combinations of steroid, ascorbic acid, and thiamine on outcomes in adults with sepsis and septic shock with component network meta-analysis (NMA). We searched PubMed, EMBASE, and the Cochrane Library Central Register of Controlled Trials from 1980 to March 2021 for randomized controlled trials (RCT) that studied the use of glucocorticoid, fludrocortisone, ascorbic acid, and thiamine in patients with sepsis and septic shock. Citations screening, study selection, data extraction, and risk of bias assessment were independently performed by two authors. The primary outcome was short-term mortality. Secondary outcomes were longer-term mortality, time to resolution of shock and duration of mechanical ventilation. Thirty-three RCTs including 9898 patients presented on short-term mortality. In additive component NMA, patients on ascorbic acid alone (RR 0.74, 95% CI 0.57–0.97) or the combination of glucocorticoid and fludrocortisone (RR 0.89, 95% CI 0.80–0.99) had lower short-term mortality, but only the latter was associated with improved long-term mortality (RR 0.89, 95% CI 0.82–0.98). The use of glucocorticoid or the combination of glucocorticoid, ascorbic acid and thiamine hastened resolution of shock. Component NMA showed glucocorticoid (MD − 0.96, 95% CI − 1.61 to − 0.30) but not ascorbic acid or thiamine shortened the time to resolution of shock. Glucocorticoid shortened the duration of mechanical ventilation (MD − 1.48, 95% CI − 2.43 to − 0.52). In adults with sepsis and septic shock, the combination of glucocorticoid and fludrocortisone improved short-term and longer-term mortality. Glucocorticoid shortened the time to resolution of shock and duration of mechanical ventilation. There was no strong evidence supporting the routine use of thiamine and ascorbic acid, but they were associated with minimal adverse effects.

scholarly journals Improved survival rate and functional recovery of TKA in cementless fixation compared with cemented component: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Yuan Liu ◽  
Yi Zeng ◽  
Yuangang Wu ◽  
Mingyang Li ◽  
Huiqi Xie ◽  
...  
Keyword(s):  
Functional Recovery ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Standard Form ◽  
Mean Difference ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Cementless Fixation ◽  
Significant Difference

Abstract Background: Whether the cement could be given up in total knee arthroplasty (TKA) was still in controversy. We perform this meta-analysis to compare the rate of revision and functional recovery between two kinds of fixation in TKA. Methods: Randomized controlled trials (RCTs), prospective/retrospective observational studies from PubMed (on 2019 Sep), EMBASE (on 2019 Sep), and the Cochrane Central Register of Controlled Trials (CENTRAL) and Web of Science (on 2019 Sep) were searched. Continuous outcomes were presented as mean difference or standard mean difference with 95% CI and discontinuous outcomes were reported as relative risk (RR) with 95% CI. Random-effects or fixed-effects model was conducted to analyze the extracted data. The PRISMA guidelines and Cochrane Handbook were adopted to assess the quality of the results reported in included studies to ensure that the results of our meta-analysis were reliable and veritable. The continuous and dichotomous outcome were collected in a standard form, and the data were analysed by using Review Manager 5.3 software. Finally, the results were presented in the Forest plots. The rate of revision and reasons caused revision was the primary outcome of our study.Results: Twenty-six studies involving 2369 patients in cementless TKA and 2654 patients in cemented TKA were finally included in our meta-analysis. 26 studies were divided into three subgroups according to the length of follow-up. The studies in the first subgroup followed less than 5.5 years, the second followed less than 10.5 years, and the third followed more than 10.5 years. Cementless fixation significantly decreased the rate of aseptic loosing (p=0.0002) and revision (p=0.0002) in the first subgroup. Other reasons such as periprosthetic joint infection (PJI), instability and polyethylene wear were not significantly different between two groups. Significantly better functional recovery was got in cementless TKA in terms of Knee Society Function Score (p=0.01) when followed longer than 8.5 years. Significantly less patients in cementless group require manipulation under anesthesia (p=0.02) when duration was longer than 5.5 years. However, there was no significant difference regarding the rate of complication between two kinds of fixation in TKA.Conclusion: Not only the rate of aseptic loosing was decreased, rate of revision was also significantly decreased in cementless TKA within 5.5 years. In addition, the cementless TKA seemed performed better in postoperative functional recovery when had a long-term follow-up. However, the rate of complication was not significantly different in two kinds of fixation in TKA.

scholarly journals ICS-formoterol reliever versus ICS and SABA reliever in asthma: a systematic review and meta-analysis

2020 ◽  
pp. 00701-2020
Author(s):  
Lee Hatter ◽  
Pepa Bruce ◽  
Irene Braithwaite ◽  
Mark Holliday ◽  
James Fingleton ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Symptom Control ◽  
Treatment Algorithm ◽  
Mean Difference ◽  
Controlled Trials ◽  
Severe Exacerbation ◽  
Cochrane Central Register ◽  
Serious Adverse Events ◽  
Significant Difference

BackgroundThe Global Initiative for Asthma recommends as-needed inhaled corticosteroid (ICS)-formoterol as an alternative to maintenance ICS plus short-acting beta2-agonist (SABA) reliever at Step 2 of their stepwise treatment algorithm. Our aim was to assess the efficacy and safety of these two treatment regimens, with a focus on severe exacerbation prevention.MethodsWe performed a systematic review and meta-analysis of all randomised controlled trials (RCTs) comparing as-needed ICS-formoterol with maintenance ICS plus SABA. MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched from database inception to 12 December 2019. The primary outcome was time to first severe exacerbation. RCTs were excluded if they used as-needed budesonide-formoterol as part of a maintenance and reliever regimen, or did not report on severe exacerbations. The review is registered with PROSPERO (CRD42020154680).ResultsFour RCTs (n=8065 participants) were included in the analysis. As-needed ICS-formoterol was associated with a prolonged time to first severe exacerbation (hazard ratio 0.85, 95%CI 0.73 to 1.00; p=0.048) and reduced daily ICS dose (mean difference −177.3 mcg, 95%CI −182.2 to −172.4). Asthma symptom control was worse in the as-needed group (ACQ-5 mean difference 0.12, 95%CI 0.09 to 0.14), though did not meet the minimal clinically important difference of 0.50 units. There was no significant difference in serious adverse events (odds ratio 1.07 95%CI 0.84 to 1.36).ConclusionAs-needed ICS-formoterol offers a therapeutic alternative to maintenance low-dose ICS plus SABA in asthma and may be the preferred option if severe exacerbation prevention is the primary aim of treatment.

Vitamin C, Thiamine, and Hydrocortisone in the Treatment of Sepsis: A Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials

2021 ◽  
pp. 088506662098780
Author(s):  
Yazan Zayed ◽  
Bashar N. Alzghoul ◽  
Momen Banifadel ◽  
Hima Venigandla ◽  
Ryan Hyde ◽  
...  
Keyword(s):  
Septic Shock ◽  
Length Of Stay ◽  
Vitamin C ◽  
Sofa Score ◽  
Sequential Analysis ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Icu Length Of Stay ◽  
Significant Difference

Background: There is a conflicting body of evidence regarding the benefit of vitamin C, thiamine, and hydrocortisone in combination as an adjunctive therapy for sepsis with or without septic shock. We aimed to assess the efficacy of this treatment among predefined populations. Methods: A literature review of major electronic databases was performed to include randomized controlled trials (RCTs) evaluating vitamin C, thiamine, and hydrocortisone in the treatment of patients with sepsis with or without septic shock in comparison to the control group. Results: Seven studies met our inclusion criteria, and 6 studies were included in the final analysis totaling 839 patients (mean age 64.2 ± 18; SOFA score 8.7 ± 3.3; 46.6% female). There was no significant difference between both groups in long term mortality (Risk Ratio (RR) 1.05; 95% CI 0.85-1.30; P = 0.64), ICU mortality (RR 1.03; 95% CI 0.73-1.44; P = 0.87), or incidence of acute kidney injury (RR 1.05; 95% CI 0.80-1.37; P = 0.75). Furthermore, there was no significant difference in hospital length of stay, ICU length of stay, and ICU free days on day 28 between the intervention and control groups. There was, however, a significant difference in the reduction of SOFA score on day 3 from baseline (MD −0.92; 95% CI −1.43 to −.41; P < 0.05). In a trial sequential analysis for mortality outcomes, our results are inconclusive for excluding lack of benefit of this therapy. Conclusion: Among patients with sepsis with or without septic shock, treatment with vitamin C, thiamine, and hydrocortisone was not associated with a significant reduction in mortality, incidence of AKI, hospital and ICU length of stay, or ICU free days on day 28. There was a significant reduction of SOFA score on day 3 post-randomization. Further studies with a larger number of patients are needed to provide further evidence on the efficacy or lack of efficacy of this treatment.

scholarly journals Comparison of irinotecan and oxaliplatin as the first-line therapies for metastatic colorectal cancer: a meta-analysis

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sadayuki Kawai ◽  
Nozomi Takeshima ◽  
Yu Hayasaka ◽  
Akifumi Notsu ◽  
Mutsumi Yamazaki ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Cochrane Central Register ◽  
First Line ◽  
Anti Vegf ◽  
Significant Difference ◽  
High Incidence

Abstract Background Irinotecan (IRI) and oxaliplatin (Ox) are standard therapeutic agents of the first-line treatments for metastatic colorectal cancer (mCRC). Previous meta-analyses of randomized controlled trials (RCTs) showed that treatment with Ox-based compared with IRI-based regimens was associated with better overall survival (OS). However, these reports did not include trials of molecular targeting agents and did not take methods for the administration of concomitant drugs, such as bolus or continuous infusion of 5-fluorouracil, into account. A systematic literature review was performed to compare the efficacy and toxicity profiles between IRI- and Ox-based regimens as the first-line treatments for mCRC. Methods This meta-analysis used data from the Cochrane Central Register of Controlled Trials, PubMed, and SCOPUS. The primary endpoint was OS, and the secondary endpoints were progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs). Results Nineteen trials involving 4571 patients were included in the analysis. No statistically significant difference was observed between the two groups in terms of OS, PFS, and ORR. There was no significant heterogeneity. Regarding ≥ grade 3 AEs, IRI-based regimens were associated with a high incidence of leukopenia, febrile neutropenia, and diarrhea. Moreover, there was a high incidence of thrombocytopenia and peripheral sensory neuropathy in patients who received Ox-based regimens. In a subgroup analysis, IRI combined with bevacizumab was correlated with a better PFS (HR = 0.90, 95% CI = 0.82–0.98, P = 0.02), but not with OS (pooled HR = 0.91, 95% CI = 0.80–1.03, P = 0.15). Conclusion Although the safety profiles of IRI- and Ox-based regimens varied, their efficacy did not significantly differ. The combination of anti-VEGF antibody and IRI was associated with better PFS compared with anti-VEGF antibody and Ox. Both regimens could be used as the first-line treatments for mCRC with consideration of the patients’ condition or toxicity profiles.

scholarly journals Short Segment versus Long Segment Pedicle Screws Fixation in Management of Thoracolumbar Burst Fractures: Meta-Analysis

2017 ◽  
Vol 11 (1) ◽  
pp. 150-160 ◽  
Author(s):  
Tarek Ahmed Aly
Keyword(s):  
Pedicle Screw ◽  
Screw Fixation ◽  
Meta Analysis ◽  
Pedicle Screw Fixation ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Thoracolumbar Burst Fractures ◽  
Burst Fractures ◽  
Significant Difference

<p>Posterior pedicle screw fixation has become a popular method for treating thoracolumbar burst fractures. However, it remains unclear whether additional fixation of more segments could improve clinical and radiological outcomes. This meta-analysis was performed to evaluate the effectiveness of fixation levels with pedicle screw fixation for thoracolumbar burst fractures. MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Springer, and Google Scholar were searched for relevant randomized and quasirandomized controlled trials that compared the clinical and radiological efficacy of short versus long segment for thoracolumbar burst fractures managed by posterior pedicle screw fixation. Risk of bias in included studies was assessed using the Cochrane Risk of Bias tool. Based on predefined inclusion criteria, Nine eligible trials with a total of 365 patients were included in this meta-analysis. Results were expressed as risk difference for dichotomous outcomes and standard mean difference for continuous outcomes with 95% confidence interval. Baseline characteristics were similar between the short and long segment fixation groups. No significant difference was identified between the two groups regarding radiological outcome, functional outcome, neurologic improvement, and implant failure rate. The results of this meta-analysis suggested that extension of fixation was not necessary when thoracolumbar burst fracture was treated by posterior pedicle screw fixation. More randomized controlled trials with high quality are still needed in the future.</p>

Use of Prophylaxis for Prevention of Venous Thromboembolism in Patients with Isolated Foot or Ankle Surgery: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 119 (10) ◽  
pp. 1686-1694 ◽  
Author(s):  
Bavand Bikdeli ◽  
Renuka Visvanathan ◽  
David Jimenez ◽  
Manuel Monreal ◽  
Samuel Z. Goldhaber ◽  
...  
Keyword(s):  
Systematic Review ◽  
Venous Thromboembolism ◽  
Meta Analysis ◽  
Evidence Base ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Foot And Ankle ◽  
Vte Prophylaxis ◽  
Ankle Surgery ◽  
Significant Difference

AbstractAlthough prophylaxis for venous thromboembolism (VTE) is recommended after many surgeries, evidence base for use of VTE prophylaxis after foot or ankle surgery has been elusive, leading into varying guidelines recommendations and notable practice variations. We conducted a systematic review of the literature to determine if use of VTE prophylaxis decreased the frequency of subsequent VTE, including deep vein thrombosis (DVT) or pulmonary embolism (PE), compared with control. We searched PubMed, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov through May 2018, for randomized controlled trials (RCTs) or prospective controlled observational studies of VTE prophylaxis in patients undergoing foot and ankle surgery. Our search retrieved 263 studies, of which 6 were finally included comprising 1,600 patients. Patients receiving VTE prophylaxis had lower risk for subsequent DVT (risk ratio [RR]: 0.72; 95% confidence interval [CI]: 0.55–0.94) and subsequent VTE (RR: 0.72; 95% CI: 0.55–0.94). There was only one case of nonfatal PE, no cases of fatal PE, and no change in all-cause mortality (RR: 3.51; 95% CI: 0.14–84.84). There was no significant difference in the risk for bleeding (RR: 2.12; 95% CI: 0.53–8.56). Very few RCTs exist regarding the efficacy and safety of VTE prophylaxis in foot and ankle surgery. Prophylaxis appears to reduce the risk of subsequent VTE, but the event rates are low and symptomatic events are rare. Future studies should determine the subgroups of patients undergoing foot or ankle surgery in whom prophylaxis may be most useful.

scholarly journals Blinding integrity in randomized sham-controlled trials of repetitive transcranial magnetic stimulation for major depression: a systematic review and meta-analysis

2013 ◽  
Vol 16 (5) ◽  
pp. 1173-1181 ◽  
Author(s):  
Marcelo T. Berlim ◽  
Hannah J. Broadbent ◽  
Frederique Van den Eynde
Keyword(s):  
Systematic Review ◽  
Transcranial Magnetic Stimulation ◽  
Major Depression ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Treatment Allocation ◽  
Significant Difference

Abstract Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective treatment for major depression (MD). However, the perceived lack of a suitable sham rTMS condition might have compromised the success of blinding procedures in clinical trials. Thus, we conducted a systematic review and meta-analysis of randomized, double-blind and sham-controlled trials (RCTs) on high frequency (HF-), low frequency (LF-) and bilateral rTMS for MD. We searched the literature from January 1995 to July 2012 using Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials and Scopus. The main outcome measure was participants' ability to correctly guess their treatment allocation at study end. We used a random-effects model and risk difference (RD). Overall, data were obtained from seven and two RCTs on HF- and bilateral rTMS, respectively. No RCT on LF-rTMS reporting on blinding success was found. HF- and bilateral rTMS trials enrolled 396 and 93 depressed subjects and offered an average of approximately 13 sessions. At study end, 52 and 59% of subjects receiving HF-rTMS and sham rTMS were able to correctly guess their treatment allocation, a non-significant difference (RD = −0.04; z = −0.51; p = 0.61). Furthermore, 63.3 and 57.5% of subjects receiving bilateral and sham rTMS were able to correctly guess their treatment allocation, also a non-significant difference (RD = 0.05; z = 0.49; p = 0.62). In addition, the use of angulation and sham coil in HF-rTMS trials produced similar results. In summary, existing sham rTMS interventions appear to result in acceptable levels of blinding regarding treatment allocation.

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