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Clinical Therapeutics Mar 2023Pharmacologic cardioversion is an effective clinical strategy for fibrillation. Vernakalant is a novel drug used to treat atrial fibrillation (AF). This study aimed to... (Meta-Analysis)
Meta-Analysis
PURPOSE
Pharmacologic cardioversion is an effective clinical strategy for fibrillation. Vernakalant is a novel drug used to treat atrial fibrillation (AF). This study aimed to evaluate the efficacy- and tolerability-related data on vernakalant from clinical trials.
METHODS
Literature from PubMed and the Cochrane Library was systematically reviewed, and 139 eligible studies were found after specific key words were identified. Twelve randomized clinical trials discussing vernakalant cardioversion in patients with AF were chosen for the meta-analysis after scrutiny. Ten of the 12 trials used placebo while two reported data on active and established drugs to compare the effects of vernakalant. Three of the 12 trials included relevant clinical states in addition to AF.
FINDINGS
In this meta-analysis of data from 12 studies (2365 patients, 887 events), the rate of cardioversion from AF to sinus rhythm (SR) was significantly greater with vernakalant compared with placebo and active comparators (risk ratio = 5.60; 95% CI, 2.83-11.09; I test for heterogeneity, 92%). Tolerability-related data revealed that dysgeusia, paresthesia, atrial flutter, and hypotension were major adverse events that occurred with vernakalant use, but the data were not clinically significant compared to placebo and active drug (risk ratio = 1.13; 95% CI, 0.86-1.47). Eleven deaths were reported in 4 trials, with vernakalant directly implicated in two deaths. Vernakalant was well tolerated and effective in patients with rapid-onset AF.
IMPLICATIONS
Vernakalant appears to be a good choice when AF is manifested postoperatively or exists with ischemic heart disease and valvular states. Tolerability-related data are promising, but a specific trial may be required to identify the causes of the deaths considered unrelated to vernakalant use.
Topics: Humans; Atrial Fibrillation; Anti-Arrhythmia Agents; Electric Countershock; Treatment Outcome; Infusions, Intravenous; Pyrrolidines
PubMed: 36828756
DOI: 10.1016/j.clinthera.2023.01.014 -
Oncology Nursing Forum Jan 2019To summarize and critique the literature for nonpharmacologic complementary approaches to manage gastrointestinal (GI) symptoms attributed to chemotherapy.
PROBLEM IDENTIFICATION
To summarize and critique the literature for nonpharmacologic complementary approaches to manage gastrointestinal (GI) symptoms attributed to chemotherapy.
LITERATURE SEARCH
A literature search was conducted using CINAHL®, MEDLINE®, and PsycINFO® from database inception through January 2018.
DATA EVALUATION
Studies were independently appraised by each author regarding inclusion eligibility and summary of GI symptom outcomes and the nonpharmacologic complementary intervention.
SYNTHESIS
57 studies met inclusion criteria. GI symptoms most commonly evaluated as a chemotherapy outcome were nausea and vomiting and nausea alone. GI symptoms infrequently evaluated as outcomes included diarrhea, anticipatory nausea, and dysgeusia. Ten GI symptoms associated with chemotherapy were not evaluated by any study. Nonpharmacologic interventions included 15 different interventions.
IMPLICATIONS FOR RESEARCH
Studies evaluating nonpharmacologic interventions for managing chemotherapy-related GI symptoms have been growing but tend to focus on nausea and vomiting to the exclusion of other relevant GI symptoms. Studies evaluating nonpharmacologic effects on other GI symptoms may make great strides in reducing patient symptom burden.
Topics: Antineoplastic Agents; Complementary Therapies; Drug-Related Side Effects and Adverse Reactions; Gastrointestinal Diseases; Humans; Nausea; Neoplasms; Practice Guidelines as Topic; Vomiting
PubMed: 30547953
DOI: 10.1188/19.ONF.E1-E21 -
Clinical and Experimental Medicine May 2021Zinc is a trace element that plays an important role in the immune system and cell growth. The role of zinc in cancer treatment has been discussed for some time, however...
Zinc is a trace element that plays an important role in the immune system and cell growth. The role of zinc in cancer treatment has been discussed for some time, however without reaching an evidenced-based consensus. Therefore, we aim to critically examine and review existing evidence on the role of zinc during cancer treatment. In January 2019, a systematic search was conducted searching five electronic databases (Embase, Cochrane, PsychINFO, CINAHL and PubMed) to find studies concerning the use, effectiveness and potential harm of zinc therapy on cancer patients. Out of initial 5244 search results, 19 publications concerning 23 studies with 1230 patients were included in this systematic review. The patients treated with zinc were mainly diagnosed with head and neck cancer and underwent chemo-, radio- or concurrent radio-chemotherapy. Interventions included the intake of different amounts of zinc supplements and oral zinc rinses. Outcomes (primary endpoints) investigated were mucositis, xerostomia, dysgeusia, pain, weight, dermatitis and oral intake of nutrients. Secondary endpoints were survival data, quality of life assessments and aspects of fatigue, immune responses and toxicities of zinc. The studies were of moderate quality reporting heterogeneous results. Studies have shown a positive impact on the mucositis after radiotherapy. No protection was seen against mucositis after chemotherapy. There was a trend to reduced loss of taste, less dry mouth and oral pain after zinc substitution. No impact was seen on weight, QoL measurements, fatigue, and survival. The risk of side effects from zinc appears to be relatively small. Zinc could be useful in the prevention of oral toxicities during irradiation. It does not help in chemotherapy-induced side effects.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Complementary Therapies; Dysgeusia; Female; Humans; Male; Middle Aged; Mucositis; Neoplasms; Quality of Life; Xerostomia; Young Adult; Zinc
PubMed: 33496846
DOI: 10.1007/s10238-020-00677-6 -
Vestnik Otorinolaringologii 2023The presented systematic review contains basic information about the frequency, characteristic features of the course and pathogenesis of olfactory, gustatory and...
The presented systematic review contains basic information about the frequency, characteristic features of the course and pathogenesis of olfactory, gustatory and auditory disorders that occur with COVID-19, with which an otorhinolaryngologist meets in his practice. These disorders are often the first, and sometimes the only, manifestations of the underlying disease, which determines their role in early diagnosis and timely detection of the underlying disease. The article includes original articles, clinical case reports and literary reviews.
Topics: Humans; COVID-19; SARS-CoV-2; Olfaction Disorders; Smell; Early Diagnosis
PubMed: 38153895
DOI: 10.17116/otorino20238806161 -
Nature and Science of Sleep 2019Laser-assisted uvulopalatoplasty (LAUP) has been used as a treatment option for snoring and obstructive sleep apnea for almost three decades. It has been previously...
Laser-assisted uvulopalatoplasty (LAUP) has been used as a treatment option for snoring and obstructive sleep apnea for almost three decades. It has been previously reported that some patient's sleep-disordered breathing worsened following surgery. The aim of this paper is to further elucidate the specific complications of LAUP. A systematic search of the electronic databases MEDLINE/PubMed, Google Scholar, and Embase. The PRISMA statement was followed. Databases were searched from inception through September 2, 2018. The following search was applied to MEDLINE/PubMed ((laser AND uvul*) OR (LAUP) OR (LAVP) OR (laser AND (apnea OR apnoea OR sleep))). Forty-two studies with a mean follow-up of 16.1 months reported complications on 3,093 total patients who underwent LAUP. The percentages and associated complications of LAUP are as follows: bleeding (2.6%), candidiasis (0.3%), dryness (7.2%), dysgeusia (0.3%), dysosmia (0.2%), globus sensation (8.2%), surgical site infection (1.3%), velopharyngeal (VP) insufficiency (3.9%), and VP stenosis (1.6%). The mean duration of patient-reported pain in studies that reported pain was 11.65 days. Only globus and VP insufficiency had a significant incidence compared with either the general population or the post-oropharyngeal surgery population with relative risks of 1.48 and 2.25, respectively. Overall, there were approximately 26 complications per 100 patients who underwent LAUP. LAUP is associated with a statistically significant rate of VP insufficiency and globus sensation; however, studies lack details of surgical approaches, suggesting that in a population identified as good candidates, a tissue-sparing approach may result in fewer complications.
PubMed: 31213936
DOI: 10.2147/NSS.S178540 -
The Cochrane Database of Systematic... Nov 2015Pouchitis occurs in approximately 50% of patients following ileal pouch-anal anastomosis (IPAA) for chronic ulcerative colitis. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pouchitis occurs in approximately 50% of patients following ileal pouch-anal anastomosis (IPAA) for chronic ulcerative colitis.
OBJECTIVES
The primary objective was to determine the efficacy and safety of medical therapies (including antibiotics, probiotics, and other agents) for prevention or treatment of acute or chronic pouchitis.
SEARCH METHODS
We searched MEDLINE, EMBASE and the Cochrane Library from inception to October 2014.
SELECTION CRITERIA
Randomized controlled trials of prevention or treatment of acute or chronic pouchitis in adults who underwent IPAA for ulcerative colitis were considered for inclusion.
DATA COLLECTION AND ANALYSIS
Two authors independently screened studies for eligibility, extracted data and assessed study quality. Methodological quality was assessed using the Cochrane risk of bias tool. The overall quality of the evidence supporting the outcomes was evaluated using the GRADE criteria. The primary outcome was the proportion of patients with clinical improvement or remission of pouchitis in patients with acute or chronic pouchitis, or the proportion of patients with no episodes of pouchitis after IPAA. The proportion of patients who developed at least one adverse event was a secondary outcome. We calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for each dichotomous outcome.
MAIN RESULTS
Thirteen studies (517 participants) were included in the review. Four studies assessed treatment of acute pouchitis. One study (16 participants) compared ciprofloxacin and metronidazole; another (26 participants) compared metronidazole to budesonide enemas; another (18 participants) compared rifaximin to placebo; and the fourth study (20 participants) compared Lactobacillus GG to placebo. Four studies assessed treatment of chronic pouchitis. One study (19 participants) compared glutamine to butyrate suppositories; another (40 participants) compared bismuth enemas to placebo; and two studies (76 participants) compared VSL#3 to placebo. Five studies assessed prevention of pouchitis. One study (40 participants) compared VSL#3 to placebo; another (28 participants) compared VLS#3 to no treatment; one study (184 participants) compared allopurinol to placebo; another (12 participants) compared the probiotic Bifidobacterium longum to placebo; and one study (38 participants) compared tinidazole to placebo. Three studies were judged to be of high quality. Two studies were judged to be low quality and the quality of the other studies was unclear. Treatment of acute pouchitis: The results of one small study (16 participants) suggest that ciprofloxacin may be more effective than metronidazole for the treatment of acute pouchitis. One hundred per cent (7/7) of ciprofloxacin patients achieved remission at two weeks compared to 33% (3/9) of metronidazole patients. A GRADE analysis indicated that the overall quality of the evidence supporting this outcome was very low due to high risk of bias (no blinding) and very sparse data (10 events). There was no difference in the proportion of patients who had at least one adverse event (RR 0.18, 95% CI 0.01 to 2.98). Adverse events included vomiting, dysgeusia or transient peripheral neuropathy. There were no differences between metronidazole and budesonide enemas in terms of clinical remission, clinical improvement or adverse events. Adverse events included anorexia, nausea, headache, asthenia, metallic taste, vomiting, paraesthesia, and depression. There were no differences between rifaximin and placebo in terms of clinical remission, clinical improvement, or adverse events. Adverse events included diarrhea, flatulence, nausea, proctalgia, vomiting, thirst, candida, upper respiratory tract infection, increased hepatic enzyme, and cluster headache. There was no difference in clinical improvement between Lactobacillus GG and placebo. The results of these studies are uncertain due to very low quality evidence. Treatment of chronic pouchitis: A pooled analysis of two studies (76 participants) suggests that VSL#3 may be more effective than placebo for maintenance of remission. Eighty-five per cent (34/40) of VLS#3 patients maintained remission at 9 to 12 months compared to 3% (1/36) of placebo patients (RR 20.24, 95% CI 4.28 to 95.81). A GRADE analysis indicated that the quality of evidence supporting this outcome was low due to very sparse data (35 events). Adverse events included abdominal cramps, vomiting and diarrhea. There was no difference in effectiveness between glutamine and butyrate suppositories for maintenance of remission. There was no difference in clinical improvement or adverse event rates between bismuth carbomer foam enemas and placebo. Adverse events included diarrhea, worsening symptoms, cramping, sinusitis, and abdominal pain. The results of these studies are uncertain due to very low quality evidence. Prevention of pouchitis: The results of one small study (40 participants) suggest that VSL#3 may be more effective than placebo for prevention of pouchitis. Ninety per cent (18/20) of VSL#3 patients had no episodes of acute pouchitis during the 12 month study compared to 60% (12/20) of placebo patients (RR 1.50, 95% CI 1.02 to 2.21). A GRADE analysis indicated that the quality of evidence supporting this outcome was low due to very sparse data (30 events). Another small study (28 participants) found that VLS#3 was not more effective than no treatment for prevention of pouchitis. Bifidobacterium longum, allopurinol and tinidazole were not more effective than placebo for prevention of pouchitis. The results of these studies are uncertain due to very low quality evidence.
AUTHORS' CONCLUSIONS
For acute pouchitis, very low quality evidence suggests that ciprofloxacin may be more effective than metronidazole. For chronic pouchitis, low quality evidence suggests that VSL#3 may be more effective than placebo for maintenance of remission. For the prevention of pouchitis, low quality evidence suggests that VSL#3 may be more effective than placebo. Well designed, adequately powered studies are needed to determine the optimal therapy for the treatment and prevention of pouchitis.
Topics: Adult; Budesonide; Ciprofloxacin; Colitis, Ulcerative; Enema; Gastrointestinal Agents; Humans; Metronidazole; Postoperative Complications; Pouchitis; Randomized Controlled Trials as Topic; Remission Induction; Rifamycins; Rifaximin; Suppositories
PubMed: 26593456
DOI: 10.1002/14651858.CD001176.pub3 -
Journal of the American Nutrition... 2023Hyponatremia is the most common electrolyte disturbance among hospitalized adults. Oral urea is currently recommended in Europe in the treatment of chronic hyponatremia;...
Hyponatremia is the most common electrolyte disturbance among hospitalized adults. Oral urea is currently recommended in Europe in the treatment of chronic hyponatremia; no published systematic review investigating oral urea for acute hyponatremia among hospitalized adults exists. An oral urea supplement became available in the United States in 2016. This was a systematic review investigating the use of oral urea in the treatment of acute hyponatremia among hospitalized adults. Pubmed, CINAHL, Scopus, Web of Science, and Cochrane databases were searched for studies published between 1998 and 2021. Risk of bias was assessed using the ROBINS-I tool; strength of the evidence was assessed using GRADE criteria. Changes in serum sodium and measures of safety and tolerance were reported. Eight studies were identified that met inclusion criteria, which included a total of 296 patients. Seven studies were retrospective. All studies found an increase in serum sodium levels associated with oral urea supplementation. Side effects were minimal; one patient discontinued urea due to a side effect (dysgeusia). Urea dose/duration varied among the studies. Based on the serious risk of bias and GRADE criteria, the strength of the evidence was considered low. Oral urea supplementation was associated with increases in serum sodium concentrations among hospitalized adults with hyponatremia, and appears to be safe and well tolerated in this population. Prospective controlled trials are needed to establish the efficacy, comparative effectiveness, and potential cost savings of this therapy.Key teaching pointsHyponatremia is associated with negative clinical outcomes among hospitalized adults.Oral urea is now available in the United States, and is currently recommended in Europe to treat chronic hyponatremia.This systematic review shows that oral urea supplementation may be associated with increases in serum sodium levels among hospitalized adults with hyponatremia, and appears safe and well-tolerated; however, the studies reviewed here are at high risk of bias and the available evidence is of low quality, making any recommendation drawn from this data weak.Prospective controlled trials are needed to establish the efficacy, comparative effectiveness, and potential cost savings of oral urea supplementation for hyponatremia.
Topics: Humans; Adult; Hyponatremia; Urea; Retrospective Studies; Prospective Studies; Sodium; Dietary Supplements
PubMed: 35512769
DOI: 10.1080/07315724.2022.2036267 -
Journal of Oral & Facial Pain and...To assess the efficacy of nonpharmacologic treatments for burning mouth syndrome (BMS).
AIMS
To assess the efficacy of nonpharmacologic treatments for burning mouth syndrome (BMS).
METHODS
PubMed, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials were systematically searched. Reference lists from the latest systematic reviews (2015 to 2020) on BMS treatment in the PubMed, Scopus, Web of Science, and Cochrane Library databases were also scrutinized. Randomized controlled trials (RCTs) or clinical controlled trials (CCTs) in English were considered eligible. Trials on photobiomodulation were excluded to avoid redundancy with recent publications. Risk of bias was established through the Cochrane Risk of Bias tool for RCTs and the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS-I) tool for CCTs.
RESULTS
This review included 27 RCTs and 6 open clinical trials (OCTs) describing 14 different nonpharmacologic interventions. Eleven trials experimented with 600 to 800 mg/day of alpha-lipoic acid for 30 to 120 days, with 7 placebo-controlled studies showing significant pain relief. Four trials tested topical and systemic capsaicin for 7 to 30 days, with 2 placebo-controlled studies revealing significant efficacy. Four of the 5 trials testing acupuncture offered favorable evidence of pain relief. Two trials reported significant pain relief after a 2- to 3-month regimen with tongue protectors and showed no difference after aloe vera addition. Short-term pain relief was reported in anecdotal placebo-controlled trials deploying tocopherol, catuama, ultramicronized palmitoylethanolamide, group psychotherapy, cognitive therapy, and repetitive transcranial magnetic stimulation of the prefrontal cortex. Most therapies were safe.
CONCLUSION
Evidence was collected from highly biased, short-term, heterogenous studies mainly focused on BMS-related pain, with scarce data on quality of life, psychologic status, dysgeusia, and xerostomia. Long-term effectiveness of nonpharmacologic treatments should be further investigated, with a more rigorous, bias-proof study design.
Topics: Acupuncture Therapy; Burning Mouth Syndrome; Capsaicin; Humans; Pain; Quality of Life
PubMed: 34609377
DOI: 10.11607/ofph.2868 -
Chemotherapy 2022Crizotinib and alectinib are the 2 most commonly used anaplastic lymphoma kinase (ALK) inhibitors for ALK-positive non-small cell lung cancer (NSCLC). We compared their... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Crizotinib and alectinib are the 2 most commonly used anaplastic lymphoma kinase (ALK) inhibitors for ALK-positive non-small cell lung cancer (NSCLC). We compared their antitumor efficacies and adverse effects based on a pooled analysis of the ALEX, ALESIA, and J-ALEX clinical trials.
METHODS
Seven databases were searched for eligible articles. The primary endpoints included overall survival (OS), progression-free survival (PFS), central nervous system (CNS)-PFS, drug responses, and adverse effects (AEs).
RESULTS
Seven articles on 3 randomized controlled clinical trials (ALEX, ALESIA, and J-ALEX) that included 697 patients were included. Compared with crizotinib, alectinib exhibited superior efficacy in PFS (HR [hazard ratio]: 0.35 [0.25-0.49], p < 0.00001), OS (HR: 0.66 [0.47-0.92], p = 0.02), CNS-PFS (HR: 0.17 [0.11-0.24], p < 0.00001), duration of response (HR: 0.31 [0.23-0.42], p < 0.00001), objective response rate (risk ratio [RR]: 0.87 [0.80-0.94], p = 0.0003), partial response (RR: 0.88 [0.81-0.96], p = 0.004), and grade 3-5 AEs (RR: 1.43 [1.09-1.87], p = 0.009). Additionally, compared with crizotinib, alectinib exhibited a survival advantage that increased with its prolongation of survival time. The disease control rate, complete response, and total AEs were comparable between the 2 groups. The crizotinib group reported higher rates of constipation, nausea, diarrhea, vomiting, peripheral edema, dysgeusia, visual impairment, and levels of alanine aminotransferase and aspartate aminotransferase as well as greater decreases in appetite and neutrophil count.
CONCLUSIONS
In both antitumor efficacy and safety, alectinib appears to be superior to crizotinib for the treatment of ALK-positive NSCLC.
Topics: Anaplastic Lymphoma Kinase; Carbazoles; Carcinoma, Non-Small-Cell Lung; Crizotinib; Humans; Lung Neoplasms; Piperidines; Protein Kinase Inhibitors; Randomized Controlled Trials as Topic
PubMed: 34915469
DOI: 10.1159/000521452 -
Revista Cientifica Odontologica... 2021To assess the prevalence of taste disorders in children and adolescents diagnosed with coronavirus infection according to the evidence reported in the scientific...
AIM
To assess the prevalence of taste disorders in children and adolescents diagnosed with coronavirus infection according to the evidence reported in the scientific literature.
MATERIALS AND METHODS
A systematic review of articles published between December 19, 2019, and December 20, 2020 in the Medline, Lilacs, BVS, Cochrane, SCOPUS and ScienceDirect databases. The information search strategy was based on the classic PRISMA flow diagram. The Newcastle-Ottawa scale was used to assess the risk of bias.
RESULTS
443 articles were found in six databases, and a total of 7 articles were included after evaluation according to the selection criteria. The articles addressed the variable of taste disorders in three ways: ageusia, dysgeusia and hypogeusia; finding that this clinical manifestation was present from the beginning of the infection.
CONCLUSIONS
The prevalence of taste disorders in children and adolescents diagnosed with coronavirus infection is from 3.3% to 26.9%.
PubMed: 38465279
DOI: 10.21142/2523-2754-0902-2021-061