scholarly journals Is Homeopathic Arnica Effective for Postoperative Recovery? A Meta-analysis of Placebo-Controlled and Active Comparator Trials

2021 ◽  
Vol 8 ◽  
Author(s):  
Katharina Gaertner ◽  
Stephan Baumgartner ◽  
Harald Walach

Background: Homeopathic Arnica montana is used in surgery as prevention or treatment for the reduction of pain and other sequelae of surgery. Our aim was to perform a metaanalysis of clinical trials to assess efficacy of Arnica montana to reduce the inflammatory response after surgery.Method: We conducted a systematic review and metaanalysis, following a predefined protocol, of all studies on the use of homeopathic Arnica montana in surgery. We included all randomized and nonrandomized studies comparing homeopathic Arnica to a placebo or to another active comparator and calculated two quantitative metaanalyses and appropriate sensitivity analyses. We used “Hegde's g,” an effect size estimator which is equivalent to a standardized mean difference corrected for small sample bias. The PROSPERO registration number is CRD42020131300.Results: Twenty-three publications reported on 29 different comparisons. One study had to be excluded because no data could be extracted, leaving 28 comparisons. Eighteen comparisons used placebo, nine comparisons an active control, and in one case Arnica was compared to no treatment. The metaanalysis of the placebo-controlled trials yielded an overall effect size of Hedge's g = 0.18 (95% confidence interval −0.007/0.373; p = 0.059). Active comparator trials yielded a highly heterogeneous significant effect size of g = 0.26. This is mainly due to the large effect size of nonrandomized studies, which converges against zero in the randomized trials.Conclusion: Homeopathic Arnica has a small effect size over and against placebo in preventing excessive hematoma and other sequelae of surgeries. The effect is comparable to that of anti-inflammatory substances.

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
George A Diamond ◽  
Sanjay Kaul

Background A highly publicized meta-analysis of 42 clinical trials comprising 27,844 diabetics ignited a firestorm of controversy by charging that treatment with rosiglitazone was associated with a “…worrisome…” 43% greater risk of myocardial infarction ( p =0.03) and a 64% greater risk of cardiovascular death ( p =0.06). Objective The investigators excluded 4 trials from the infarction analysis and 19 trials from the mortality analysis in which no events were observed. We sought to determine if these exclusions biased the results. Methods We compared the index study to a Bayesian meta-analysis of the entire 42 trials (using odds ratio as the measure of effect size) and to fixed-effects and random-effects analyses with and without a continuity correction that adjusts for values of zero. Results The odds ratios and confidence intervals for the analyses are summarized in the Table . Odds ratios for infarction ranged from 1.43 to 1.22 and for death from 1.64 to 1.13. Corrected models resulted in substantially smaller odds ratios and narrower confidence intervals than did uncorrected models. Although corrected risks remain elevated, none are statistically significant (*p<0.05). Conclusions Given the fragility of the effect sizes and confidence intervals, the charge that roziglitazone increases the risk of adverse events is not supported by these additional analyses. The exaggerated values observed in the index study are likely the result of excluding the zero-event trials from analysis. Continuity adjustments mitigate this error and provide more consistent and reliable assessments of true effect size. Transparent sensitivity analyses should therefore be performed over a realistic range of the operative assumptions to verify the stability of such assessments especially when outcome events are rare. Given the relatively wide confidence intervals, additional data will be required to adjudicate these inconclusive results.


2021 ◽  
Author(s):  
Bastien Trémolière ◽  
Corentin J Gosling

Recent research has shown mixed evidence for the morning morality effect (i.e., the observation that individuals are less immoral in the morning than in the afternoon). In the present research, we target the morning morality effect in the context of moral utilitarianism, by reanalyzing observational data previously collected by our lab. These data include different tasks capturing moral utilitarianism (i.e., standard sacrificial dilemmas, an ecological utilitarian scale, and/or dilemmas involving the morality of autonomous vehicles). We report a meta-analysis of 6 studies which showed that participants became less utilitarian as the day goes on, but with a small effect size (r = -0.14) and a large heterogeneity. Exploration of this heterogeneity showed that such a conclusion was statistically significant for classic sacrificial dilemmas only. Notably, even when restricting the analysis to the classic sacrificial dilemmas, a moderate inconsistency remained. Post-hoc analysis of an individual study showed that this small effect did not survive the inclusion of potentially confounding variables, such as psychopathy trait and cognitive reflection. Implications and limitations are discussed.


2021 ◽  
Author(s):  
Megha Joshi ◽  
James E Pustejovsky ◽  
S. Natasha Beretvas

The most common and well-known meta-regression models work under the assumption that there is only one effect size estimate per study and that the estimates are independent. However, meta-analytic reviews of social science research often include multiple effect size estimates per primary study, leading to dependence in the estimates. Some meta-analyses also include multiple studies conducted by the same lab or investigator, creating another potential source of dependence. An increasingly popular method to handle dependence is robust variance estimation (RVE), but this method can result in inflated Type I error rates when the number of studies is small. Small-sample correction methods for RVE have been shown to control Type I error rates adequately but may be overly conservative, especially for tests of multiple-contrast hypotheses. We evaluated an alternative method for handling dependence, cluster wild bootstrapping, which has been examined in the econometrics literature but not in the context of meta-analysis. Results from two simulation studies indicate that cluster wild bootstrapping maintains adequate Type I error rates and provides more power than extant small sample correction methods, particularly for multiple-contrast hypothesis tests. We recommend using cluster wild bootstrapping to conduct hypothesis tests for meta-analyses with a small number of studies. We have also created an R package that implements such tests.


2019 ◽  
Vol 25 (1) ◽  
pp. 33-37 ◽  
Author(s):  
Julie McLellan ◽  
Clare R Bankhead ◽  
Jason L Oke ◽  
F D Richard Hobbs ◽  
Clare J Taylor ◽  
...  

BackgroundGUIDE-IT, the largest trial to date, published in August 2017, evaluating the effectiveness of natriuretic peptide (NP)-guided treatment of heart failure (HF), was stopped early for futility on a composite outcome. However, the reported effect sizes on individual outcomes of all-cause mortality and HF admissions are potentially clinically relevant.ObjectiveThis systematic review and meta-analysis aims to combine all available trial level evidence to determine if NP-guided treatment of HF reduces all-cause mortality and HF admissions in patients with HF.Study selectionEight databases, no language restrictions, up to November 2017 were searched for all randomised controlled trials comparing NP-guided treatment versus clinical assessment alone in adult patients with HF. No language restrictions were applied. Publications were independently double screened and extracted. Fixed-effect meta-analyses were conducted.Findings89 papers were included, reporting 19 trials (4554 participants), average ages 62–80 years. Pooled risk ratio estimates for all-cause mortality (16 trials, 4063 participants) were 0.87, 95% CI 0.77 to 0.99 and 0.80, 95% CI 0.72 to 0.89 for HF admissions (11 trials, 2822 participants). Sensitivity analyses, restricted to low risk of bias, produced similar estimates, but were no longer statistically significant.ConclusionsConsidering all the evidence to date, the pooled effects suggest that NP-guided treatment is beneficial in reducing HF admissions and all-cause mortality. However, there is still insufficient high-quality evidence to make definitive recommendations on the use of NP-guided treatment in clinical practice.Trial registration numberSystematic Review Cochrane Database Number: CD008966.


2018 ◽  
Vol 107 (4) ◽  
pp. 285-293 ◽  
Author(s):  
M. Saltychev ◽  
K. Laimi ◽  
P. Virolainen ◽  
M. Fredericson

Background and Aims: Even though hydrodilatation has been used for 50 years, the evidence on its effectiveness is not clear. Only one earlier review has strictly focused on this treatment method. The aims of this study are to evaluate the evidence on the effectiveness of hydrodilatation in treatment of adhesive capsulitis and, if appropriate, to assess the correlation between the effects of this procedure and the amount of fluid injected. Materials and Methods: A literature search on MEDLINE, Embase, Scopus, Cochrane Central, Web of Science, and CINAHL databases was done; random-effects meta-analysis and meta-regression were employed; and cost-effectiveness and safeness analyses were left outside the scope of the review. Results: Of the 270 records identified through search, 12 studies were included in qualitative and quantitative analysis and seven were included in a meta-analysis. The lower 95% confidence interval for the effect of hydrodilatation on pain severity was 0.12 indicating small effect size and mean number needed to treat 12. The pooled effect of hydrodilatation on disability level was insignificant 0.2 (95% confidence interval: −0.04 to 0.44). The lower 95% confidence interval for the effect of hydrodilatation on the range of shoulder motion was close to zero (0.07) indicating small effect size with mean number needed to treat 12. The amount of injected solution did not have a substantial effect on pain severity or range of shoulder motion. The heterogeneity level I2 was acceptable from 0% to 60%. Conclusion: According to current evidence, hydrodilatation has only a small, clinically insignificant effect when treating adhesive capsulitis.


2010 ◽  
Vol 104 (11) ◽  
pp. 1577-1585 ◽  
Author(s):  
Linda A. W. Jans ◽  
Erik J. Giltay ◽  
A. J. Willem Van der Does

Depressive symptoms are common during pregnancy and the post-partum period. Although essential n-3 PUFA may have beneficial effects on depression, it remains unclear whether they are also effective for perinatal depression. The purpose of the present study was to assess the efficacy of n-3 supplementation for perinatal depression, by performing a meta-analysis on currently available data. After a thorough literature search, we included seven randomised controlled trials in the meta-analysis, all with EPA and/or DHA supplementation. Most studies were judged to be of low-to-moderate quality, mainly due to small sample sizes and failure to adhere to Consolidated Standards of Reporting Trials guidelines. Some studies were not primarily designed to address perinatal depression. A total of 309 women on n-3 fatty acid supplementation were compared with 303 women on placebo treatment. n-3 Supplementation was not found to be significantly more effective than placebo at post-treatment with a pooled effect size (Hedges's g) of − 0·03 (95 % CI − 0·18, 0·13; P = 0·76) using a fixed-effects model. Heterogeneity was low-to-moderate (I2 = 30 %). In a subgroup analysis of three small studies of pregnant women with major depression, there was some indication of effectiveness (effect size 0·17; 95 % CI − 0·21, 0·55). In conclusion, the question of whether EPA and DHA administration is effective in the prevention or treatment of perinatal depression cannot be answered yet. Future research should focus on women who are clinically depressed (or at risk). The quality of research in this area needs to improve.


2006 ◽  
Vol 24 (1_suppl) ◽  
pp. 40-48 ◽  
Author(s):  
Adrian White ◽  
Nadine Foster ◽  
Mike Cummings ◽  
Panos Barlas

Objective To determine the effectiveness of acupuncture treatment for pain and function of patients with osteoarthritis of the knee. Methods A systematic review of randomised controlled trials was performed, including a meta-analysis which combined the results of trials that used adequate acupuncture treatment and used WOMAC scores to measure the effect. The internal validity (quality) and heterogeneity of studies were taken into account. Results Thirteen studies were available, of which eight, involving 2362 patients, could be combined. For both reduction of pain and improvement of function, acupuncture was significantly superior to sham acupuncture (P<0.05 for all comparisons) in both the short term and the long term. Compared with no additional intervention (usual care), acupuncture was again significantly superior for pain and function. The treatment effects were maintained after taking account of quality and heterogeneity in sensitivity analyses. Conclusion Acupuncture is an effective treatment for osteoarthritis of the knee. Its overall effect size is 0.8, and it can be considered instead of non-steroidal anti-inflammatory drugs for patients whose symptoms are not controlled by education, exercise, weight loss if appropriate and simple analgesics. Further research is necessary into the most efficient way of delivering acupuncture, and its longer term benefits.


10.2196/12967 ◽  
2019 ◽  
Vol 21 (8) ◽  
pp. e12967 ◽  
Author(s):  
Bhone Myint Kyaw ◽  
Pawel Posadzki ◽  
Sophie Paddock ◽  
Josip Car ◽  
James Campbell ◽  
...  

Background Effective communication skills are essential in diagnosis and treatment processes and in building the doctor-patient relationship. Objective Our aim was to evaluate the effectiveness of digital education in medical students for communication skills development. Broadly, we assessed whether digital education could improve the quality of future doctors’ communication skills. Methods We performed a systematic review and searched seven electronic databases and two trial registries for randomized controlled trials (RCTs) and cluster RCTs (cRCTs) published between January 1990 and September 2018. Two reviewers independently screened the citations, extracted data from the included studies, and assessed the risk of bias. We also assessed the quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluations assessment (GRADE). Results We included 12 studies with 2101 medical students, of which 10 were RCTs and two were cRCTs. The digital education included online modules, virtual patient simulations, and video-assisted oral feedback. The control groups included didactic lectures, oral feedback, standard curriculum, role play, and no intervention as well as less interactive forms of digital education. The overall risk of bias was high, and the quality of evidence ranged from moderate to very low. For skills outcome, meta-analysis of three studies comparing digital education to traditional learning showed no statistically significant difference in postintervention skills scores between the groups (standardized mean difference [SMD]=–0.19; 95% CI –0.9 to 0.52; I2=86%, N=3 studies [304 students]; small effect size; low-quality evidence). Similarly, a meta-analysis of four studies comparing the effectiveness of blended digital education (ie, online or offline digital education plus traditional learning) and traditional learning showed no statistically significant difference in postintervention skills between the groups (SMD=0.15; 95% CI –0.26 to 0.56; I2=86%; N=4 studies [762 students]; small effect size; low-quality evidence). The additional meta-analysis of four studies comparing more interactive and less interactive forms of digital education also showed little or no difference in postintervention skills scores between the two groups (SMD=0.12; 95% CI: –0.09 to 0.33; I2=40%; N=4 studies [893 students]; small effect size; moderate-quality evidence). For knowledge outcome, two studies comparing the effectiveness of blended online digital education and traditional learning reported no difference in postintervention knowledge scores between the groups (SMD=0.18; 95% CI: –0.2 to 0.55; I2=61%; N=2 studies [292 students]; small effect size; low-quality evidence). The findings on attitudes, satisfaction, and patient-related outcomes were limited or mixed. None of the included studies reported adverse outcomes or economic evaluation of the interventions. Conclusions We found low-quality evidence showing that digital education is as effective as traditional learning in medical students’ communication skills training. Blended digital education seems to be at least as effective as and potentially more effective than traditional learning for communication skills and knowledge. We also found no difference in postintervention skills between more and less interactive forms of digital education. There is a need for further research to evaluate the effectiveness of other forms of digital education such as virtual reality, serious gaming, and mobile learning on medical students’ attitude, satisfaction, and patient-related outcomes as well as the adverse effects and cost-effectiveness of digital education.


BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e026920
Author(s):  
Jinzhu Huang ◽  
Xiaohong Chen ◽  
Haiyan Xing ◽  
Lin Chen ◽  
Zhaolu Xie ◽  
...  

IntroductionPre-eclampsia is an important cause of death and complication for pregnant women and perinatal infant. Low-dose aspirin has been most commonly used to prevent pre-eclampsia in high-risk pregnant women. Recently, heparins have also been used alone or in combination with aspirin to prevent pre-eclampsia. However, the optimal doses and combination therapy of aspirin and heparins are not well established. Therefore, we aim to compare aspirin, heparins and their combination to prevent pre-eclampsia in a network meta-analysis.Methods and analysisWe will search the following electronic databases from the date of database establishment to 8 January 2019: PubMed, Embase, Cochrane Library, Web of Science and ProQuest. We will also search additional studies manually. There will be no restriction on the language of publications. Only randomised clinical trials will be eligible in our network meta-analysis. We will include pregnant women who have been recommended for aspirin according to the standard of the American Congress of Obstetricians and Gynecologists, or were designated as high risk in some recent studies. We will include studies comparing the effects of any single or combination of aspirin and heparins with placebo or observation or another intervention in pregnancy. We will include studies that reported one of the following outcomes: pre-eclampsia, severe pre-eclampsia, preterm delivery, perinatal death and full-term pre-eclampsia with delivery at ≥37 weeks. Traditional pairwise meta-analysis will be performed initially, and then network meta-analysis will be performed using frequency analysis method. Subgroup analyses and sensitivity analyses will be conducted to assess the robustness of the findings.Ethics and disseminationThis network meta-analysis does not require ethical certification. An overview and information on the prevention of pre-eclampsia in high-risk pregnant women will be provided by this network meta-analysis.PROSPERO registration numberCRD42018084248.


2020 ◽  
Vol 238 (4) ◽  
pp. 995-1009 ◽  
Author(s):  
Nicholas Paul Holmes ◽  
Dennis Martin ◽  
William Mitchell ◽  
Zeeshan Noorani ◽  
Amber Thorne

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