Classic Chinese Acupuncture versus Different Types of Control Groups for the Treatment of Chronic Pain: Review of Randomized Controlled Trials (2000–2018)

Objective. To review the effectiveness of classic Chinese acupuncture in the treatment of chronic pain by comparing treatment groups with different types of control groups in accordance with the newly published guidelines for systematic reviews. Methods. We searched EMBASE, PubMed, and the Cochrane Central Register of Controlled Trials databases from 2000 to 2018. We included randomized controlled trials that included acupuncture as the sole treatment or as an adjunctive treatment for chronic pain. The outcome was pain intensity measured by the visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, 11-point numeric rating scale (NRS), and other tools. Two researchers conducted the study selection, data extraction, and quality assessment processes independently. Disagreements were solved by discussion and reanalysis of the data. The quality of all included studies was evaluated using the CBNG (the Cochrane Back and Neck Group) and the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) checklists. Results. Sixty-one studies were fully analyzed and ranked based on the newest STRICTA and CBNG standards. We found good evidence that receiving acupuncture is better than not receiving treatment or being placed on a waiting list and reasonable evidence that it is better than conventional or usual care. Limited evidence was found regarding placebo treatments that involve the expectation of needling (real or fake). Conclusion. Sham acupuncture may not be appropriate as a control intervention for assessing the effectiveness of acupuncture. Acupuncture effectiveness in controlling chronic pain is still limited due to the low quality of the studies published.

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The Effectiveness of Tocilizumab in the Treatment of COVID-19 in Adults: A Meta-Analysis of Randomized Controlled Trials.

10.21203/rs.3.rs-551091/v1 ◽

2021 ◽

Author(s):

Chun Chen ◽

ZeMei Zhou ◽

Jing Zhang

Keyword(s):

Randomized Controlled Trials ◽

Hospital Discharge ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Composite Outcome ◽

Control Groups ◽

Randomized Controlled ◽

Serious Infection ◽

And Control

Abstract Background: Since December 2019, COVID-19 has spread to the world which leads to a global health threat. We aimed to investigate the effectiveness of tocilizumab on COVID-19 patients.Methods: We systematically searched PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL) and WHO international Clinical Trials Registry Platform (ICTRP) from their inception to March 10, 2021 for randomized controlled trials (RCTs) on tocilizumab supplementation in adults with COVID-19 disease. The primary outcomes were mortality at 28-30 day and 60-day, incidence of mechanical ventilation (MV), composite outcome of death or MV, time to hospital discharge, and intensive care unit (ICU) admissions. A random-effects meta-analysis model was used to pool studies. Results: Eleven studies with a total of 6,579 patients were included in our meta-analysis, of which 3,406 and 3,173 were respectively assigned to the tocilizumab and control groups. Tocilizumab could significantly reduce 28-30 day mortality (RR = 0.89, 95% CI 0.80-0.99, P = 0.04), incidence of MV (RR= 0.79, 95% CI 0.71-0.89, P = 0.0001), composition outcome of MV or death (RR = 0.81, 95% CI 0.72-0.90, P = 0.0002), time to hospital discharge (HR = 1.30, 95% CI 1.16-1.45, P ＜ 0.00001 ), ICU admissions (RR = 0.64, 95% CI 0.47-0.88, P = 0.006), serious infection (RR = 0.61, 95% CI 0.40-0.94, P = 0.02) and events of serious adverse advents (RR = 0.64, 95% CI 0.47-0.86, P = 0.004). There was no significant difference between tocilizumab and control groups in 60-day mortality and adverse events (AEs).Conclusions: Tocilizumab could reduce the short-term mortality, incidence of MV, composite outcome of death or MV, ICU admissions, serious infection and events of serious adverse advents, and shorten the time to hospital discharge in hospitalized patients with COVID-19. The optimal effective dose needs to be confirmed by further studies.

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A qualitative assessment of randomized controlled trials in otolaryngology

The Journal of Laryngology & Otology ◽

10.1017/s0022215100140770 ◽

1998 ◽

Vol 112 (5) ◽

pp. 460-463 ◽

Cited By ~ 30

Author(s):

K. W. Ah-See ◽

N. C. Molony

Keyword(s):

Randomized Controlled Trials ◽

Consort Statement ◽

Qualitative Assessment ◽

Controlled Trials ◽

Randomized Controlled ◽

Future Assessment ◽

The Consort Statement ◽

The Mean ◽

Better Than

AbstractIn 1996 the CONSORT statement made recommendations on the strict reporting of randomized controlled trials (RCT). This will facilitate the future assessment of such trials and will highlight those trials that have been performed suboptimally and whose results may be biased.We have devised a scoring system, based on CONSORT, to assess RCT quality and by reading each original paper in full we have now assessed the quality of trials published from 1966 to 1995.The mean score for trials identified was 7.3 out of a maximum 12 points. No one journal was significantly better than the others. Trials in rhinology are reported better than head and neck oncology trials (mean scores 7.6 and 6.5 respectively). The past 30 years has not seen an improvement in the quality of the trials.The reporting of RCTs in the ENT literature is poor. CONSORT guidelines now exist and trialists are encouraged to adopt them when conducting future clinical trials.

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The Analgesic Effect of Electroencephalographic Neurofeedback for People With Chronic Pain: Protocol for a Systematic Review and Meta-analysis

JMIR Research Protocols ◽

10.2196/22821 ◽

2020 ◽

Vol 9 (10) ◽

pp. e22821

Author(s):

Negin Hesam-Shariati ◽

Wei-Ju Chang ◽

James H McAuley ◽

Andrew Booth ◽

Zina Trost ◽

...

Keyword(s):

Systematic Review ◽

Chronic Pain ◽

Randomized Controlled Trials ◽

Analgesic Effect ◽

Meta Analysis ◽

Secondary Outcome ◽

Placebo Control ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomized Controlled

Background Chronic pain is a global health problem, affecting around 1 in 5 individuals in the general population. The understanding of the key role of functional brain alterations in the generation of chronic pain has led researchers to focus on pain treatments that target brain activity. Electroencephalographic neurofeedback attempts to modulate the power of maladaptive electroencephalography frequency powers to decrease chronic pain. Although several studies have provided promising evidence, the effect of electroencephalographic neurofeedback on chronic pain is uncertain. Objective This systematic review aims to synthesize the evidence from randomized controlled trials to evaluate the analgesic effect of electroencephalographic neurofeedback. In addition, we will synthesize the findings of nonrandomized studies in a narrative review. Methods We will apply the search strategy in 5 electronic databases (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycInfo, and CINAHL) for published studies and in clinical trial registries for completed unpublished studies. We will include studies that used electroencephalographic neurofeedback as an intervention for people with chronic pain. Risk-of-bias tools will be used to assess methodological quality of the included studies. We will include randomized controlled trials if they have compared electroencephalographic neurofeedback with any other intervention or placebo control. The data from randomized controlled trials will be aggregated to perform a meta-analysis for quantitative synthesis. The primary outcome measure is pain intensity assessed by self-report scales. Secondary outcome measures include depressive symptoms, anxiety symptoms, and sleep quality measured by self-reported questionnaires. We will investigate the studies for additional outcomes addressing adverse effects and resting-state electroencephalography analysis. Additionally, all types of nonrandomized studies will be included for a narrative synthesis. The intended and unintended effects of nonrandomized studies will be extracted and summarized in a descriptive table. Results Ethics approval is not required for a systematic review, as there will be no patient involvement. The search for this systematic review commenced in July 2020, and we expect to publish the findings in early 2021. Conclusions This systematic review will provide recommendations for researchers and health professionals, as well as people with chronic pain, about the evidence for the analgesic effect of electroencephalographic neurofeedback. Trial Registration International Prospective Register of Systematic Reviews (PROSPERO) CRD42020177608; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=177608 International Registered Report Identifier (IRRID) PRR1-10.2196/22821

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Randomized Controlled Trials in Medical AI A Methodological Critique

Philosophy of Medicine ◽

10.5195/philmed.2021.27 ◽

2021 ◽

Vol 2 (1) ◽

Author(s):

Konstantin Genin ◽

Thomas Grote

Keyword(s):

Randomized Controlled Trials ◽

Controlled Trials ◽

Randomized Controlled ◽

Methodological Challenges ◽

Clinical Benefits ◽

Better Than

Various publications claim that medical AI systems perform as well, or better, than clinical experts.However, there have been very few controlled trials and the quality of existing studies has been calledinto question. There is growing concern that existing studies overestimate the clinical benefits of AIsystems. This has led to calls for more, and higher-quality, randomized controlled trials of medicalAI systems. While this a welcome development, AI RCTs raise novel methodological challenges thathave seen little discussion. We discuss some of the challenges arising in the context of AI RCTs andmake some suggestions for how to meet them.

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The quality of subgroup analyses in chronic pain randomized controlled trials: a methodological review

The Korean Journal of Pain ◽

10.3344/kjp.2021.34.2.139 ◽

2021 ◽

Vol 34 (2) ◽

pp. 139-155

Author(s):

Mahmood AminiLari ◽

Vahid Ashoorian ◽

Alexa Caldwell ◽

Yasir Rahman ◽

Robby Nieuwlaat ◽

...

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trials ◽

Controlled Trials ◽

Methodological Review ◽

Randomized Controlled ◽

Subgroup Analyses

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Berberine for diarrhea in children and adults: a systematic review and meta-analysis

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284820961299 ◽

2020 ◽

Vol 13 ◽

pp. 175628482096129

Author(s):

Mingkun Yu ◽

Xuejing Jin ◽

Changhao Liang ◽

Fanlong Bu ◽

Deng Pan ◽

...

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Clinical Cure ◽

Clinical Cure Rate ◽

Controlled Trials ◽

Cure Rate ◽

Control Groups ◽

Quality Of Evidence ◽

Randomized Controlled

Background: Diarrhea is a ubiquitous digestive system disease, leading to loss of fluid and electrolytes, and may be life-threatening, especially in children and adults who are immunosuppressed or malnourished. Berberine has a broad-spectrum antibiotic activity and is very widely used to treat diarrhea in China. No systematic review has been carried out to evaluate the evidence presented in clinical trials. The aim of this study was to assess the effectiveness and safety of berberine in diarrhea treatment among children and adults. Methods: Seven databases and two clinical trial registries were searched on 1 September 2019. Randomized controlled trials were included, where participants were diagnosed (first diagnosed) as having diarrhea according to clear diagnostic criteria. Berberine alone or in combination with Western medication as intervention were included. Subgroup analyses were conducted based on children or adults, acute or persistent diarrhea, infectious or noninfectious and treatment courses. Primary outcomes were clinical cure rate and duration of diarrhea. The GRADE tool was used to assess the quality of evidence. Results: A total of 38 randomized controlled trials were included involving 3948 participants (including 27 trials on 2702 children) were included. Compared with antibiotics, berberine plus antibiotics showed better results in both adults and in children in general, especially when given for 7 days or 3 days in acute infectious diarrhea of children. Compared with the control groups, using berberine alone or in combination with montmorillonite, probiotics, and vitamin B increased the clinical cure rate of diarrhea. The use of berberine alone or berberine combined with montmorillonite reduced the duration of hospitalization. Using berberine had significantly better laboratory indicators (isoenzyme, inflammatory factors, myocardial enzyme, and fecal trait) and fewer systemic symptoms than the no berberine groups. Overall, 22 of 27 trials on children used berberine as an enema. No deaths and serious adverse events were reported. The quality of evidence of included trials was moderate to low or very low. The impact of different dosages, frequencies and treatment durations on the outcomes was not evaluated due to insufficient number of trials. Conclusion: This review demonstrated that berberine was generally effective in improving clinical cure rates and shortening the duration of diarrhea compared with control groups. No severe adverse event was reported. However, there is still a lack of high-quality evidence for evaluating the efficacy and safety of berberine. Trial registration: PROSPERO CRD42020151001 (available from http://www.crd.york.ac.uk/PROSPERO/ ).

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Dropout associated with osteopathic manual treatment for chronic noncancerous pain in randomized controlled trials

Journal of Osteopathic Medicine ◽

10.1515/jom-2020-0240 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Yasir Rehman ◽

Hannah Ferguson ◽

Adelina Bozek ◽

Joshua Blair ◽

Ashley Allison ◽

...

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Pooled Analysis ◽

Combination Group ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomized Controlled ◽

Manual Treatment

Abstract Context Reviews exploring harm outcomes such as adverse effects (AE), all-cause dropouts (ACD), dropouts due to inefficacy, and dropouts due to AE associated with osteopathic manipulative treatment (OMT) or osteopathic manual therapy (OMTh) are scant. Objectives To explore the overall AE, ACD, dropouts due to inefficacy, and AE in chronic noncancerous pain (CNCP) patients receiving OMTh through a systematic review of previous literature. Methods For this systematic review and meta-analysis, the authors searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Physiotherapy Evidence Database (PEDro), EMCare, and Allied and Complementary Medicine Database (AMED), and Ostmed.Dr, as well as the bibliographical references of previous systematic reviews evaluating OMTh for pain severity, disability, quality of life, and return to work outcomes. Randomized controlled trials with CNCP patients 18 years or older with OMTh as an active or combination intervention and the presence of a control or combination group were eligible for inclusion. In this sub-study of a previous, larger systematic review, 11 studies (n=1,015) reported data that allowed the authors to perform meta-analyses on ACD and dropouts due to AE. The risk of bias (ROB) was assessed with the Cochrane ROB tool and the quality of evidence was determined with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results The pooled analysis showed that ACD was not significantly different for visceral OMTh (vOMTh) vs. OMTh control (odds ratio [OR]=2.66 [95% confidence interval [[CI]], 0.28, 24.93]) or for OMTh vs. standard care (OR=1.26 [95% CI, 0.84, 1.89]; I2=0%). Single study analysis showed that OMTh results were nonsignificant in comparison with chemonucleolysis, gabapentin, and exercise. OMTh in combination with gabapentin (vs. gabapentin alone) and OMTh in combination with exercise (vs. exercise alone) showed nonsignificant ACD. Dropouts due to AE were not significantly different, but the results could not be pooled due to an insufficient number of studies. Conclusions Most articles did not explicitly report AEs, ACD rates, or dropouts due to AEs and inefficacy. The limited data available on dropouts showed that OMTh was well tolerated compared with control interventions, and that the ACD and dropouts due to AEs were not significantly different than comparators. Future trials should focus on explicit reporting of dropouts along with beneficial outcomes to provide a better understanding of OMTh efficacy.

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Autogenic Training for Reducing Chronic Pain: a Systematic Review and Meta-analysis of Randomized Controlled Trials

International Journal of Behavioral Medicine ◽

10.1007/s12529-021-10038-6 ◽

2021 ◽

Author(s):

Antonia Kohlert ◽

Katharina Wick ◽

Jenny Rosendahl

Keyword(s):

Systematic Review ◽

Chronic Pain ◽

Randomized Controlled Trials ◽

Passive Control ◽

Meta Analysis ◽

Autogenic Training ◽

Sensitivity Analyses ◽

Controlled Trials ◽

Control Groups ◽

Randomized Controlled

Abstract Background Autogenic training (AT) is frequently used as therapeutic approach in multimodal pain therapy. The aim of this systematic review and meta-analysis is to investigate the efficacy of AT in individuals suffering from chronic pain in comparison to passive and active control groups. Methods A comprehensive literature search in Medline, Web of Science, PsycInfo, and PubPsych and manual searches (last search April 7, 2021) were conducted to locate randomized controlled trials (RCTs). Treatment guidelines and references of relevant articles and previous reviews were checked. ProQuest Dissertations and Theses Full Text database, DART-Europe E-theses Portal, Networked Digital Library of Theses and Dissertations (NDLTD), and the Theses Database of the German National Library were screened to identify any unpublished material. Results A total of 13 eligible studies (k = 15 comparisons) including 576 participants were identified. Random-effects meta-analyses revealed a significantly positive, moderate effect of AT on the primary outcome pain compared to passive control groups (g = 0.58, 95% CI [0.36; 0.79], k = 9, I2 = 0%). In comparison with other psychological interventions, no difference was found (g = − 0.05, 95% CI [− 0.30; 0.20], k = 6, I2 = 0%). Sensitivity analyses proved the robustness of findings. Overall risk-of-bias judgment was ‘some concerns’ in the majority of studies. Conclusions Beneficial effects of AT on pain reduction were demonstrated, but findings are prone to bias. Furthermore, high methodological quality RCTs are needed to strengthen the promising evidence of AT for individuals with chronic pain.

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Effects of dexamethasone on postoperative cognitive dysfunction and delirium in adults following general anesthesia: a meta-analysis of randomized controlled trials

10.21203/rs.2.362/v1 ◽

2019 ◽

Author(s):

Li-Qin Li ◽

Cong Wang ◽

Mei-Dan Fang ◽

Hong-Yu Xu ◽

Hong-Liu Lu ◽

...

Keyword(s):

Randomized Controlled Trials ◽

General Anesthesia ◽

Cognitive Dysfunction ◽

Meta Analysis ◽

Postoperative Cognitive Dysfunction ◽

Cochrane Library ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomized Controlled

Abstract Background Several studies have investigated the effects of dexamethasone on postoperative cognitive dysfunction (POCD) or postoperative delirium (POD); however, their conclusions have not been consistent. So we conducted a meta-analysis to determine the effects of dexamethasone on POCD/POD in adults following general anesthesia. Methods Cochrane Central Register of Controlled Trials (CENTRAL, 2018, Issue 11 of 12) in the Cochrane Library (searched November 17, 2018); MEDLINE OvidSP (1946 to November 16, 2018); and Embase OvidSP (1974 to November 16, 2018) were searched for randomized controlled trials that evaluated the incidence of POCD/POD following dexamethasone administration, in adults (age ≥18 years) under general anesthesia. We used the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework to assess the quality of evidence. Results Five studies were included (three studies/1393 participants for the incidence of POCD, and two studies/809 participants for the incidence of POD). There was no significant difference between the dexamethasone group and the placebo group in terms of the incidence of POCD in 30 days after surgery (RR 1.00; 95% CI [0.51, 1.96], P = 1.00, I2 = 77%) or in the incidence of POD (RR 0.95; 95% CI [0.60, 1.50], P = 0.81, I2 = 0%). However, both analyses had some limitations, and we considered the quality of the evidence for the postoperative incidence of POCD and POD to be very low. Conclusions This meta-analysis revealed that prophylactic dexamethasone did not reduce the incidence of POCD and POD. However, additional large high-quality trials are still needed to determine the effects of dexamethasone on the incidence of POCD/POD in patients undergoing surgery.

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Dynamic Stabilization of Syndesmosis Injuries Reduces Complications and Reoperations as Compared With Screw Fixation: A Meta-analysis of Randomized Controlled Trials

The American Journal of Sports Medicine ◽

10.1177/0363546519849909 ◽

2019 ◽

Vol 48 (4) ◽

pp. 1000-1013 ◽

Cited By ~ 5

Author(s):

Alberto Grassi ◽

Kristian Samuelsson ◽

Pieter D’Hooghe ◽

Matteo Romagnoli ◽

Massimiliano Mosca ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Screw Fixation ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Quality Of Evidence ◽

Dynamic Fixation ◽

Randomized Controlled

Background: Several devices for obtaining dynamic fixation of the syndesmosis have been introduced in recent years, but their efficacy has been tested in only a few randomized controlled trials (RCTs), without demonstrating any clear benefit over the traditional static fixation with screws. Purpose: To perform a level 1 meta-analysis of RCTs to investigate the complications, subjective outcomes, and functional results after dynamic or static fixation of acute syndesmotic injuries. Study Design: Meta-analysis of RCTs. Methods: A systematic literature search was performed of the Medline/PubMed, Cochrane Central Register of Controlled Trials, and Embase electronic databases, as well as ClinicalTrials.gov for unpublished studies. Eligible studies were RCTs comparing dynamic fixation and static fixation of acute syndesmosis injuries. A meta-analysis was performed, while bias and quality of evidence were rated according to the Cochrane Database questionnaire and the Grading of Recommendations Assessment, Development and Evaluation guidelines. Results: Dynamic fixation had a significantly reduced relative risk (RR = 0.55, P = .003) of complications—in particular, the presence of inadequate reduction at the final follow-up (RR = 0.36, P = .0008) and the clinical diagnosis of recurrent diastasis or instability (RR = 0.10, P = .03). The effect was more evident when compared with permanent screws (RR = 0.10, P = .0001). The reoperation rate was similar between the groups (RR = 0.64, P = .07); however, the overall risk was reduced after dynamic fixation as compared with static fixation with permanent screws (RR = 0.24, P = .007). The American Orthopaedic Foot & Ankle Society score was significantly higher among patients treated with dynamic fixation—6.06 points higher ( P = .005) at 3 months, 5.21 points ( P = .03) at 12 months, and 8.60 points ( P < .00001) at 24 months—while the Olerud-Molander score was similar. The visual analog scale for pain score was reduced at 6 months (–0.73 points, P = .003) and 12 months (–0.52 points, P = .005), and ankle range of motion increased by 4.36° ( P = .03) with dynamic fixation. The overall quality of evidence ranged from “moderate” to “very low,” owing to a substantial risk of bias, heterogeneity, indirectness of outcome reporting, and evaluation of a limited number of patients. Conclusion: The dynamic fixation of syndesmotic injuries was able to reduce the number of complications and improve clinical outcomes as compared with static screw fixation—especially malreduction and clinical instability or diastasis—at a follow-up of 2 years. A lower risk of reoperation was found with dynamic fixation as compared with static fixation with permanent screws. However, the lack of patients or personnel blinding, treatment heterogeneity, small samples, and short follow-up limit the overall quality of this evidence.

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