A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures

BACKGROUND: Numerous agents are available for moderate sedation in endoscopy. OBJECTIVE: Our purpose was to compare efficacy, safety, and efficiency of agents used for moderate sedation in EGD or colonoscopy. DESIGN: Systematic review of computerized bibliographic databases for randomized trials of moderate sedation that compared 2 active regimens or 1 active regimen with placebo or no sedation. PATIENTS: Unselected adults undergoing EGD or colonoscopy with a goal of moderate sedation. MAIN OUTCOME MEASUREMENTS: Sedation-related complications, patient assessments (satisfaction, pain, memory, willingness to repeat examination), physician assessments (satisfaction, level of sedation, patient cooperation, examination quality), and procedure-related efficiency outcomes (sedation, procedure, or recovery time). RESULTS: Thirty-six studies (N = 3918 patients) were included. Sedation improved patient satisfaction (relative risk [RR] = 2.29, range 1.16-4.53) and willingness to repeat EGD (RR = 1.25, range 1.13-1.38) versus no sedation. Midazolam provided superior patient satisfaction to diazepam (RR = 1.18, range 1.07-1.29) and less frequent memory of EGD (RR = 0.57, range 0.50-0.60) versus diazepam. Adverse events and patient/physician assessments were not significantly different for midazolam (with or without narcotics) versus propofol except for slightly less patient satisfaction (RR = 0.90, range 0.83-0.97) and more frequent memory (RR = 3.00, range 1.25-7.21) with midazolam plus narcotics. Procedure times were similar, but sedation and recovery times were shorter with propofol than midazolam-based regimens. LIMITATIONS: Marked variability in design, regimens tested, and outcomes assessed; relatively poor methodologic quality (Jadad score 相似文献   

Hepatic vein pressure gradient reduction and prevention of variceal bleeding in cirrhosis: a systematic review

BACKGROUND & AIMS: A reduction of the hepatic venous pressure gradient (HVPG) to /=20% of baseline prevents variceal bleeding in cirrhosis. Because some inconsistent data have argued against the clinical application of these hemodynamic targets, we performed a systematic review of available studies from the Cochrane Library and MEDLINE. METHODS: Hemodynamic targets were HVPG reduction (1) to /=20% with final value >12 mm Hg; (3) by >/=20% or to /=20% or to /=20% significantly reduces the risk of bleeding, and a reduction of >/=20% significantly reduces mortality. These hemodynamic targets should be considered for clinical practice and for randomized controlled trials.     

A community screening program for Helicobacter pylori saves money: 10-year follow-up of a randomized controlled trial

BACKGROUND & AIMS: Population screening and treatment of Helicobacter pylori has been advocated as a means of reducing mortality from gastric cancer, as well as dyspepsia and dyspepsia-related resource use. Previous programs have failed to demonstrate a significant effect on mortality or resource use, but follow-up was only for 1 or 2 years. We aimed to determine the effect of screening for H pylori on dyspepsia and dyspepsia-related resource use over 10 years. METHODS: H pylori-positive individuals, aged 40-49 years, enrolled in a community screening program, randomized to eradication therapy or placebo in 1994, were sent a validated dyspepsia questionnaire by mail 10 years later, and primary care records were reexamined. Consultation, referral, prescribing, and investigation data related to dyspepsia were extracted. United Kingdom costs were applied to derive total cost per person (1 pound = 1.8 dollars). RESULTS: Of 2324 original participants, 1864 (80%) were traced and contacted. Of these, 1086 (47%) responded, and 919 (40%) agreed to a review of their primary care records. There was a 10-year mean saving in total dyspepsia-related costs of 117 dollars per person (95% confidence interval [CI] = 11 dollars-220 dollars, P = .03) with eradication therapy. Those symptomatic at baseline showed a nonsignificant trend toward resolution of symptoms at 10 years with eradication therapy (relative risk of remaining symptomatic, 0.89; 95% CI: 0.77-1.03). CONCLUSIONS: There were significant reductions in total dyspepsia-related health care costs. The savings made were greater than the initial cost of H pylori screening and treatment.     

A randomized, prospective trial of electrosurgical incision followed by rabeprazole versus bougie dilation followed by rabeprazole of symptomatic esophageal (Schatzki's) rings

BACKGROUND: Lower esophageal (Schatzki's) rings are a common cause of solid food dysphagia. Standard treatment involves passage of a single large bougie to disrupt the ring, but symptoms recur in the majority of patients. Electrosurgical incision of the ring may provide a longer duration of symptom improvement. There are no data on the treatment of Schatzki's rings in the presence of acid suppression treatment. OBJECTIVE: Our purpose was to compare the efficacy of bougie dilation with electrosurgical incision of symptomatic Schatzki's rings at 1-year follow-up in the presence of rabeprazole treatment. DESIGN: Randomized, prospective trial. SETTING: University of Utah Health Sciences Center and the Veterans Affairs Salt Lake. PATIENTS: Fifty patients referred for endoscopic evaluation of dysphagia between January 2002 and March 2005. MAIN OUTCOME MEASUREMENTS: Symptom-free survival time (in months), dysphagia, and GERD scores. RESULTS: Twenty-five patients each underwent bougie dilation and electrical incision and were followed up for 12 months. Symptom-free survival times were significantly longer in the incision group (7.99 months) compared with the bougie dilation group (5.86 months) (P = .03). Dysphagia and GERD scores significantly improved in each group comparing baseline with each time interval. The incision group had greater relief of dysphagia at 1 month (P = .05) compared with the bougie group. There was no difference between GERD scores in both groups. LIMITATIONS: Dysphagia and GERD symptoms were self-reported. CONCLUSIONS: Electrosurgical incision of Schatzki's rings is safe and offers longer symptom-free survival compared with bougie dilation. The addition of rabeprazole offered significant improvement in GERD scores in both groups.     

Comparative study of conventional colonoscopy and pan-colonic narrow-band imaging system in the detection of neoplastic colonic polyps: a randomized, controlled trial

Background. Detection and removal of adenomas by colonoscopy is an important means for preventing cancer; however, small adenomas may be missed during colonoscopy. The narrow-band imaging (NBI) system clearly enhances the microvasculature in neoplastic lesions, making it appear as a dark complex. Therefore, the NBI system may improve the detection of colonic neoplasias. However, no randomized, controlled trials have evaluated the efficacy of a pan-colonic NBI system in adenoma detection. We conducted a randomized, controlled trial to determine the efficacy of the pancolonic NBI system in adenoma detection. Methods. Two hundred forty-three patients were randomized, 121 to conventional colonoscopy and 122 to pan-colonic NBI system. Demographics, indication for colonoscopy, and quality of preparation were similar between groups. Results. Extubation time was not significantly different between the conventional colonoscopy and pan-colonic NBI system. The proportions of patients with at least one adenoma and those with multiple adenomas were not significantly different between groups. However, the pan-colonic NBI system significantly increased the total number of adenomas detected (P < 0.05) and the number of diminutive (<5 mm) adenomas detected (P < 0.05). The pan-colonic NBI system allowed detection of more diminutive adenomas in the distal colon than did conventional colonoscopy (P < 0.01), and more patients in the NBI group had at least one diminutive adenoma than in the control group (P < 0.05). Conclusions. The pan-colonic NBI system improves the total number of adenomas detected, including significantly more diminutive adenomas, without prolongation of extubation time. These results indicate that routine use of the NBI system for surveillance of diminutive adenomas may be recommended.     

Effects of exercise on C-reactive protein,inflammatory cytokine and adipokine in patients with type 2 diabetes: A meta-analysis of randomized controlled trials

Objective

C-reactive protein (CRP), inflammatory cytokines, and adipokines contribute to atherosclerosis, insulin resistance, and development of late-onset complication in patients with type 2 diabetes. We performed a systematic review to assess effects of exercise interventions on inflammatory markers/cytokines and adipokines.

Materials/Methods

We searched electronic databases (MEDLINE, EMBASE, and Cochrane Controlled Trials Registry) and reference lists in relevant papers for articles published in 1966–2013. We selected studies that evaluated the effects of exercise intervention on inflammatory markers/cytokines and adipokines in adult patients with type 2 diabetes. Weighted mean differences of exercise on outcomes were derived using fixed or random effect models; factors influencing heterogeneity were identified using meta-regression analysis.

Results

Fourteen randomized controlled trials (824 patients) were included in our meta-analysis. Exercise was associated with a significant in CRP = − 0.66 mg/l (95% CI, − 1.09 to − 0.23 mg/l; − 14% from baseline) and interleukin-6 (IL-6) = − 0.88 pg/ml (95% CI, − 1.44 to − 0.32 pg/ml; − 18% from baseline) but did not alter adiponectin or resistin levels; aerobic exercise program was associated with a significant change in leptin = − 3.72 ng/ml (95% CI, − 6.26 to − 1.18 ng/ml; − 24% from baseline). For IL-6, exercise was more effective in those with a longer duration in the program and larger number of sessions during study (p = 0.001).

Conclusions

Exercise decreases inflammatory cytokine (CRP and IL-6) in patients with type 2 diabetes. Exercise could be a therapeutic option for improving abnormalities in inflammation levels in patients with diabetes.     

Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society

Adenomatous polyps are the most common neoplastic findings discovered in people who undergo colorectal screening or who have a diagnostic work-up for symptoms. It was common practice in the 1970s for these patients to have annual follow-up surveillance examinations to detect additional new adenomas and missed synchronous adenomas. As a result of the National Polyp Study report in 1993, which showed clearly in a randomized design that the first postpolypectomy examination could be deferred for 3 years, guidelines published by a gastrointestinal consortium in 1997 recommended that the first follow-up surveillance take place 3 years after polypectomy for most patients. In 2003 these guidelines were updated and colonoscopy was recommended as the only follow-up examination, stratification at baseline into low risk and higher risk for subsequent adenomas was suggested. The 1997 and 2003 guidelines dealt with both screening and surveillance. However, it has become increasingly clear that postpolypectomy surveillance is now a large part of endoscopic practice, draining resources from screening and diagnosis. In addition, surveys have shown that a large proportion of endoscopists are conducting surveillance examinations at shorter intervals than recommended in the guidelines. In the present report, a careful analytic approach was designed to address all evidence available in the literature to delineate predictors of advanced pathology, both cancer and advanced adenomas, so that patients can be stratified more definitely at their baseline colonoscopy into those at lower risk or increased risk for a subsequent advanced neoplasia. People at increased risk have either 3 or more adenomas, high-grade dysplasia, villous features, or an adenoma 1 cm or larger in size. It is recommended that they have a 3-year follow-up colonoscopy. People at lower risk who have 1 or 2 small (<1 cm) tubular adenomas with no high-grade dysplasia can have a follow-up evaluation in 5-10 years, whereas people with hyperplastic polyps only should have a 10-year follow-up evaluation, as for average-risk people. There have been recent studies that have reported a significant number of missed cancers by colonoscopy. However, high-quality baseline colonoscopy with excellent patient preparation and adequate withdrawal time should minimize this and reduce clinicians concerns. These guidelines were developed jointly by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society to provide a broader consensus and thereby increase the use of the recommendations by endoscopists. The adoption of these guidelines nationally can have a dramatic impact on shifting available resources from intensive surveillance to screening. It has been shown that the first screening colonoscopy and polypectomy produces the greatest effects on reducing the incidence of colorectal cancer in patients with adenomatous polyps.     

Impact of the supine position versus left horizontal position on colonoscopy insertion: a 2-center,randomized controlled trial

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A randomized controlled trial of buprenorphine in the management of short-term ambulatory heroin withdrawal

ABSTRACT Aim To determine whether buprenorphine is more effective than clonidine and other symptomatic medications in managing ambulatory heroin withdrawal. Design Open label, prospective randomized controlled trial examining withdrawal and 4‐week postwithdrawal outcomes on intention‐to‐treat. Setting Two specialist, out‐patient drug treatment centres in inner city Melbourne and Sydney, Australia. Participants One hundred and fourteen dependent heroin users were recruited. Participants were 18 years or over, and with no significant other drug dependence, medical or psychiatric conditions or recent methadone treatment. One hundred and one (89%) participants completed a day 8 research interview examining withdrawal outcomes, and 92 (81%) completed day 35 research interview examining postwithdrawal outcomes. Interventions Participants randomized to control (n = 56) (up to 8 days of clonidine and other symptomatic medications) or experimental (n = 58) (up to 5 days of buprenorphine) withdrawal groups. Following the 8‐day withdrawal episode, participants could self‐select from range of postwithdrawal options (naltrexone, substitution maintenance, or counselling). Measurements Retention in withdrawal; heroin use during withdrawal; and retention in drug treatment 4 weeks after withdrawal. Secondary outcomes Withdrawal severity; adverse events, and heroin use in the postwithdrawal period. Findings The experimental group had better treatment retention at day 8 (86% versus 57%, P = 0.001, 95% CI for numbers needed to treat (NNT) = 3–8) and day 35 (62% versus 39%, P = 0.02, 95% CI for NNT = 4–18); used heroin on fewer days during the withdrawal programme (2.6 ± 2.5 versus 4.5 ± 2.3, P < 0.001, 95% CI = 1–2.5 days) and in the postwithdrawal period (9.0 ± 8.2 versus 14.6 ± 10, P < 0.01, 95% CI = 1.8–9.4); and reported less withdrawal severity. No severe adverse events reported. Conclusions Buprenorphine is effective for short‐term ambulatory heroin withdrawal, with greater retention, less heroin use and less withdrawal discomfort during withdrawal; and increased postwithdrawal treatment retention than symptomatic medications.     

A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain

Aims Because smoking cessation rates might be improved by combining drugs and by reducing post‐cessation weight gain, we tested the smoking cessation efficacy, safety and effect on body weight of adding the nicotine patch to rimonabant, a cannabanoid type‐1 receptor antagonist that reduces body weight. Design Randomized double‐blind placebo‐controlled trial. Setting Fifteen US research centers. Participants A total of 755 smokers (≥15 cigarettes/day). Intervention Rimonabant (20 mg daily) was given open‐label for 9 weeks. The 735 participants completing week 1 were randomized at day 8 (target quit day) to add a nicotine patch (n = 369) or placebo patch (n = 366) for 10 weeks (21 mg daily for 8 weeks plus a 2‐week taper). Participants received weekly smoking counseling and were followed for 24 weeks. Measurements Biochemically validated 4‐week continuous abstinence at end‐of‐treatment (weeks 6–9; primary end‐point); 7‐day point prevalence abstinence at weeks 9 and 24; sustained abstinence (weeks 6–24); change in body weight; and adverse events. Findings Rimonabant plus nicotine patch was superior to rimonabant plus placebo in validated continuous abstinence at weeks 6–9 (39.0% versus 21.3%; odds ratio 2.36, 95% confidence interval: 1.71–2.37; P < 0.01) and in all other efficacy measures. Mean end‐of‐treatment weight gain among quitters did not differ between groups (0.04 kg for combination versus 0.49 kg for rimonabant only, P = 0.15) and was similar in weight‐concerned smokers. Serious adverse event rates did not differ between groups. Depression‐ and anxiety‐related adverse events occurred in 32 (4.2%) and 44 (5.8%) subjects, respectively; eight (1.1%) and nine (1.2%) subjects stopped the drug due to depression and anxiety, respectively. Conclusions Adding a nicotine patch to rimonabant was well tolerated and increased smoking cessation rates over rimonabant alone. There was little post‐cessation weight gain in either group, even among weight‐concerned smokers, during drug treatment.     

The efficacy and safety of Yijinjing exercise in the adjuvant treatment of ankylosing spondylitis: A protocol of randomized controlled trial

Background:Ankylosing spondylitis (AS) is a chronic systemic autoimmune disease with high disability rate. Conventional treatment regimens have long medication cycles and are associated with adverse reactions. Therapeutic exercise is also considered to be an effective treatment for AS. Evidence suggests that Yijinjing as a low-energy exercise has advantages in adjuncting AS, but there is a lack of standard clinical studies to evaluate its efficacy and safety.Methods:This is a prospective randomized controlled trial to investigate the efficacy and safety of Yijinjing in the adjuvant treatment of AS. Approved by the Clinical Research Ethics Association of our hospital, patients were randomly divided into treatment or control groups in a ratio of 1:1. The treatment group received 4-month Yijinjing training on the basis of conventional treatment, while the control group received conventional treatment and maintained their current lifestyle. The outcome indicators included: activity index, functional ability, Bath Ankylosing Spondylitis Metrology Index, adverse reaction, etc. Finally, SPASS 22.0 software was used for statistical analysis of the data.Discussion:This study evaluated the clinical efficacy of Yijinjing exercise in the adjuvant treatment of AS, and the results of our study will provide a reference for the clinical use of Yijinjing exercise as an effective complementary alternative for the treatment of AS.     

Efficacy and safety of Shenkang injection in the treatment of chronic renal failure: A protocol of a randomized controlled trial

Background:Chronic renal failure (CRF) is the final outcome of the development of multiple kidney diseases, and there is no effective method at home and abroad. Traditional Chinese medicine is found to play a major role in the treatment of the non-replacement stage of CRF. Shenkang injection can not only nourish the kidney, but also promote blood circulation and remove blood stasis, which is suitable for the treatment of CRF. This study aims to explore the efficacy and safety of Shenkang injection for CRF and provide evidence for clinical practice.Methods:This was a prospective randomized controlled trial. One hundred four patients with CRF were randomly divided into treatment groups and control groups according to 1:1, with 52 patients in each group. The control group received basic treatment of western medicine and the treatment group was given Shenkang injection intravenously on the basis of control group. Both groups were given standard treatment for 4 weeks with concurrent follow-up for 1 month. The outcome indicators included: total efficiency, symptom scores, creatinine clearance rate, serum creatinine, blood urea nitrogen, CystatinC, liver function, blood routine, urine routine, incidence of adverse reactions, etc. Data analysis was performed using SPSS 25.0 software.Discussion:This study will evaluate the efficacy and safety of Shenkang injection for CRF, and the results of this trial will provide clinical evidence for the treatment of CRF.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/K9C5T.     

Efficacy and safety of Biqi capsule in the treatment of knee osteoarthritis: A protocol of a randomized controlled trial

Background:Knee osteoarthritis (KOA) is a chronic and degenerative bone and joint disease, with KOA, cartilage degeneration, destruction and subchondral bone remodeling as the main pathological features. Its clinical symptoms are knee pain, swelling, limited activity, and long course of disease can cause joint deformities. At present, the early treatment of Western medicine is mainly the use of nonsteroidal drugs for anti-inflammation and removing pain, but because the efficacy of these drugs is unstable, the disease is easy to repeat after treatment, and the clinical effect is not good. Although Biqi capsule has advantages in the treatment of KOA, there is a lack of standard clinical studies to verify it, so the purpose of this randomized controlled study is to evaluate the efficacy and safety of Biqi capsule in the treatment of KOA.Methods:This is a prospective randomized controlled trial to study the efficacy and safety of Biqi capsule in the treatment of KOA. The patients were randomly divided into a treatment group and a control group according to 1:1. Among them, treatment group: Biqi capsule combined with diclofenac sodium sustained release tablets; Control group: Diclofenac sodium sustained-release tablets alone. Both groups were treated with standard treatment for 2 weeks and were followed up for 30 days to pay attention to the efficacy and safety indexes. Observation indicators included: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Hospital for Special Surgery Knee Score (HSS), liver and kidney function, adverse reactions, and so on. SPSS 25.0 software is used for data analysis.Discussion:This study will evaluate the efficacy and safety of Biqi capsule in the treatment of KOA, and the results of this experiment will provide a clinical basis for Biqi capsule in the treatment of KOA.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/6HB9D