Use of Sham Interventions in Randomized Controlled Trials in Neurosurgery

2020 ◽  
Vol 81 (05) ◽  
pp. 456-462
Author(s):  
Rodrigo Panico Gorayeb ◽  
Maria João Forjaz ◽  
António Gonçalves Ferreira ◽  
Joaquim José Ferreira
Keyword(s):  
Randomized Controlled Trials ◽  
Peripheral Nerves ◽  
Brain Injuries ◽  
Controlled Trials ◽  
Ethical Concerns ◽  
Administration Routes ◽  
Randomized Controlled ◽  
Different Types ◽  
Double Blinded ◽  
Clinical Problems

Abstract Background The use of sham interventions in randomized controlled trials (RCTs) is essential to minimize bias. However, their use in surgical RCTs is rare and subject to ethical concerns. To date, no studies have looked at the use of sham interventions in RCTs in neurosurgery. Methods This study evaluated the frequency, type, and indication of sham interventions in RCTs in neurosurgery. RCTs using sham interventions were also characterized in terms of design and risk of bias. Results From a total of 1,102 identified RCTs in neurosurgery, 82 (7.4%) used sham interventions. The most common indication for the RCT was the treatment of pain (67.1%), followed by the treatment of movement disorders and other clinical problems (18.3%) and brain injuries (12.2%). The most used sham interventions were saline injections into spinal structures (31.7%) and peripheral nerves (10.9%), followed by sham interventions in cranial surgery (26.8%), and spine surgery (15.8%). Insertion of probes or catheters for a sham lesions was performed in 14.6%.In terms of methodology, most RCTs using sham interventions were double blinded (76.5%), 9.9% were single blinded, and 13.6% did not report the type of blinding. Conclusion Sham-controlled RCTs in neurosurgery are feasible. Most aim to minimize bias and to evaluate the efficacy of pain management methods, especially in spinal disorders. The greatest proportion of sham-controlled RCTs involves different types of substance administration routes, with sham surgery the less commonly performed.

Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors and Ezetimibe on Risk of New-Onset Diabetes: A Systematic Review and Meta-Analysis of Large, Double-Blinded Randomized Controlled Trials

2020 ◽  
Vol 25 (5) ◽  
pp. 409-417
Author(s):  
Sarah W. Chiu ◽  
Cristina M. Pratt ◽  
Richard Feinn ◽  
Saurav Chatterjee
Keyword(s):  
Randomized Controlled Trials ◽  
Incident Diabetes ◽  
Controlled Trials ◽  
Diabetes Incidence ◽  
Proprotein Convertase ◽  
Randomized Controlled ◽  
Onset Diabetes ◽  
Meta Analyses ◽  
Double Blinded ◽  
New Onset

Background: Previous meta-analyses have shown that statins may cause incident diabetes. This article reviews randomized controlled trials using proprotein convertase subtilisin/kexin 9 inhibitors (PCSK9i) or ezetimibe on the risk of new-onset diabetes. Methods: Eight trials involving PCSK9i and 3 trials of ezetimibe were selected for review. PubMed, Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov were thoroughly searched for relevant trials. Inclusion criteria included at least 100 patients per treatment arm, follow-up of at least 52 weeks, and at least double-blinded study design. Exclusion criteria included patients with previously diagnosed diabetes, nonrandomized, placebo-controlled, open-label, and crossover trials. The primary outcome was the number of incident diabetes cases. A random effects model was used. Heterogeneity in effect sizes was measured with I 2 parameter and the Q statistic was used to test for excessive between-study heterogeneity. Results: A total of 52 214 participants for the PCSK9i and a total of 20 084 for the ezetimibe meta-analyses were included. Participants randomized to PCSK9i did not differ from the control patients in diabetes incidence (risk ratio [RR] = 0.99, P = .87, 95% CI = 0.92-1.07). Participants randomized to ezetimibe did not differ from the control patients in diabetes incidence (RR = 1.05, P = .37, 95% CI = 0.95-1.15). Discussion: The use of PCSK9i and ezetimibe does not appear to impact the risk of incident diabetes mellitus when added to guideline-directed medical therapy.

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

2019 ◽  
Vol 2019 ◽  
pp. 1-15
Author(s):  
Yan-Jiao Chen ◽  
Gabriel Shimizu Bassi ◽  
Yong-Qing Yang
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Control Groups ◽  
Chinese Acupuncture ◽  
Randomized Controlled ◽  
Different Types ◽  
Better Than

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.

scholarly journals Therapeutic Risk and Benefits of Concomitantly Using Herbal Medicines and Conventional Medicines: From the Perspectives of Evidence Based on Randomized Controlled Trials and Clinical Risk Management

2017 ◽  
Vol 2017 ◽  
pp. 1-17 ◽  
Author(s):  
Xiu-lai Zhang ◽  
Meng Chen ◽  
Ling-ling Zhu ◽  
Quan Zhou
Keyword(s):  
Risk Management ◽  
Randomized Controlled Trials ◽  
Time Course ◽  
Herbal Medicines ◽  
Controlled Trials ◽  
Clinical Risk Management ◽  
Reminder System ◽  
Administration Routes ◽  
Randomized Controlled ◽  
Clinical Risk

Despite increased awareness of the potential of herb-drug interactions (HDIs), the lack of rigorous clinical evidence regarding the significance provides a challenge for clinicians and consumers to make rational decisions about the safe combination of herbal and conventional medicines. This review addressed HDIs based on evidence from randomized controlled trials (RCTs). Literature was identified by performing a PubMed search till January 2017. Risk description and clinical risk management were described. Among 74 finally included RCTs, 17 RCTs (22.97%) simply addressed pharmacodynamic HDIs. Fifty-seven RCTs (77.03%) investigated pharmacokinetic HDIs and twenty-eight of them showed potential or actual clinical relevance. The extent of an HDI may be associated with the factors such as pharmacogenomics, dose of active ingredients in herbs, time course of interaction, characteristics of the object drugs (e.g., administration routes and pharmacokinetic profiles), modification of herbal prescription compositions, and coexistence of inducers and inhibitors. Clinical professionals should enhance risk management on HDIs such as increasing awareness of potential changes in therapeutic risk and benefits, inquiring patients about all currently used conventional medicines and herbal medicines and supplements, automatically detecting highly substantial significant HDI by computerized reminder system, selecting the alternatives, adjusting dose, reviewing the appropriateness of physician orders, educating patients to monitor for drug-interaction symptoms, and paying attention to follow-up visit and consultation.

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