scholarly journals Opioid-induced constipation in palliative care: state of the art

2020 ◽  
pp. 1116-1124
Author(s):  
Erlania do Carmo Freitas ◽  
Geslaney Reis da Silva ◽  
Rudval Souza da Silva ◽  
Rita Narriman Silva de Oliveira Boery ◽  
Maria Patricia Milagres
Keyword(s):  
Palliative Care ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Exploratory Study ◽  
Adverse Reactions ◽  
State Of The Art ◽  
Meta Analysis ◽  
Life Quality ◽  
Limited Data ◽  
Inclusion Criteria

OBJECTIVE: The study’s purpose has been to address the state of the art in investigations such as clinical trials, systematic reviews with meta-analysis and case studies, which report how to minimize opioid-induced constipation in patients undergoing palliative care. METHODS: This is an exploratory study through an integrative review of four databases addressing published articles from 2013 to 2017. RESULTS: A total of 117 publications were presented, which 17 presented the inclusion criteria. The studies describe the prevalence of constipation rates induced by the use of opioids. CONCLUSION: Although these drugs alleviate pain, the adverse reactions may generate discomfort and loss of the patient’s life quality. There are limited data on the treatment of constipation. It was observed that few authors mentioned diet as a helper on this situation, emphasizing the use of medications. Further studies should be encouraged aiming to find the balance between analgesia and reduction of adverse effects.

scholarly journals Cardiovascular Toxicities Secondary to Biotherapy and Molecular Targeted Therapies in Neuroendocrine Neoplasms: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials

Cancers ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 2159
Author(s):  
Charalampos Aktypis ◽  
Maria-Eleni Spei ◽  
Maria Yavropoulou ◽  
Göran Wallin ◽  
Anna Koumarianou ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Targeted Therapies ◽  
Safety Profile ◽  
Meta Analysis ◽  
Mtor Inhibitors ◽  
Risk Of Bias ◽  
Neuroendocrine Neoplasms ◽  
Controlled Trials

A broad spectrum of novel targeted therapies with prime antitumor activity and/or ample control of hormonal symptoms together with an overall acceptable safety profile have emerged for patients with metastatic neuroendocrine neoplasms (NENs). In this systematic review and quantitative meta-analysis, the PubMed, EMBASE, Cochrane Central Register of Controlled Trials and clinicaltrials.gov databases were searched to assess and compare the safety profile of NEN treatments with special focus on the cardiovascular adverse effects of biotherapy and molecular targeted therapies (MTTs). Quality/risk of bias were assessed using GRADE criteria. Placebo-controlled randomized clinical trials (RCTs) in patients with metastatic NENs, including medullary thyroid cancer (MTC) were included. A total of 3695 articles and 122 clinical trials registered in clinicaltrials.gov were screened. We included sixteen relevant RCTs comprising 3408 unique patients assigned to different treatments compared with placebo. All the included studies had a low risk of bias. We identified four drug therapies for NENs with eligible placebo-controlled RCTs: somatostatin analogs (SSAs), tryptophan hydroxylase (TPH) inhibitors, mTOR inhibitors and tyrosine kinase inhibitors (TKI). Grade 3 and 4 adverse effects (AE) were more often encountered in patients treated with mTOR inhibitors and TKI (odds ratio [OR]: 2.42, 95% CI: 1.87–3.12 and OR: 3.41, 95% CI: 1.46–7.96, respectively) as compared to SSAs (OR:0.77, 95% CI: 0.47–1.27) and TPH inhibitors (OR:0.77, 95% CI: 0.35–1.69). MTOR inhibitors had the highest risk for serious cardiac AE (OR:3.28, 95% CI: 1.66–6.48) followed by TKIs (OR:1.51, 95% CI: 0.59–3.83). Serious vascular AE were more often encountered in NEN patients treated with mTOR inhibitors (OR: 1.72, 95% CI: 0.64–4.64) and TKIs (OR:1.64, 95% CI: 0.35–7.78). Finally, patients on TKIs were at higher risk for new-onset or exacerbation of pre-existing hypertension (OR:3.31, 95% CI: 1.87–5.86). In conclusion, SSAs and TPH inhibitors appear to be safer as compared to mTOR inhibitors and TKIs with regards to their overall toxicity profile, and cardiovascular toxicities in particular. Special consideration should be given to a patient-tailored approach with anticipated toxicities of targeted NEN treatments together with assessment of cardiovascular comorbidities, assisting clinicians in treatment selection and early recognition/management of cardiovascular toxicities. This approach could improve patient compliance and preserve cardiovascular health and overall quality of life.

scholarly journals Comparative clinical trials in psychotherapy: Have large effects been replicated?

2020 ◽  
Vol 29 ◽  
Author(s):  
Nickolas D. Frost ◽  
Thomas W. Baskin ◽  
Bruce E. Wampold
Keyword(s):  
Clinical Trials ◽  
Treatment Efficacy ◽  
Literature Search ◽  
Meta Analysis ◽  
Effect Sizes ◽  
Depression And Anxiety ◽  
Inclusion Criteria ◽  
Average Quality ◽  
Meta Analyses

Abstract Aims The purpose of this review is to examine the replication attempts of psychotherapy clinical trials for depression and anxiety. We focus specifically on replications of trials that exhibit large differences between psychotherapies. The replicability of these trials is especially important for meta-analysis, where the inclusion of false-positive trials can lead to erroneous conclusions about treatment efficacy. Methods Standard replication criteria were developed to distinguish direct from conceptual replication methodologies. Next, an exhaustive literature search was conducted for published meta-analyses of psychotherapy comparisons. Trials that exhibited large effects (d > 0.8) were culled from these meta-analyses. For each trial, a cited replication was conducted to determine if the trial had been subsequently replicated by either ‘direct’ or ‘conceptual’ methods. Finally, a broader search was conducted to examine the extent of replication efforts in the psychotherapy literature overall. Results In the meta-analytic search, a total of N = 10 meta-analyses met the inclusion criteria. From these meta-analyses, N = 12 distinct trials exhibited large effect sizes. The meta-analyses containing more than two large effect trials reported evidence for treatment superiority. A cited replication search yielded no direct replication attempts (N = 0) for the trials with large effects, and N = 4 conceptual replication attempts of average or above average quality. However, of these four attempts, only two partially corroborated the results from their original trial. Conclusion Meta-analytic reviews are influenced by trials with large effects, and it is not uncommon for these reviews to contain several such trials. Since we find no evidence that trials with such large effects are directly replicable, treatment superiority conclusions from these reviews are highly questionable. To enhance the quality of clinical science, the development of authoritative replication criteria for clinical trials is needed. Moreover, quality benchmarks should be considered before trials are included in a meta-analysis, or replications are attempted.

Differences in Adverse Effect Profiles of Corticosteroids in Palliative Care Patients

2018 ◽  
Vol 36 (2) ◽  
pp. 158-168 ◽  
Author(s):  
Leanna R. Jaward ◽  
Thomas A. O’Neil ◽  
Adam Marks ◽  
Michael A. Smith
Keyword(s):  
Adverse Effect ◽  
Palliative Care ◽  
Adverse Effects ◽  
Symptom Management ◽  
Care Setting ◽  
Management Strategies ◽  
Common Factors ◽  
Inclusion Criteria ◽  
Pubmed Database ◽  
Palliative Care Setting

Background: Corticosteroids are frequently utilized in the palliative care setting to combat symptoms such as fatigue, dyspnea, pain, weakness, anorexia, cachexia, nausea, and vomiting. Often times, adverse effects arise with corticosteroid use, and it is unclear whether switching to another corticosteroid would reduce the risk of specific adverse effects or what measures can be taken to alleviate the adverse effects. Objective: This article aims to review the differentiating pharmacokinetics, potency, and adverse effect profiles of corticosteroids and summarize their clinical applicability. Methods: A literature review of “corticosteroids” and “palliative care” was performed using the PubMed database through July 2018. Original studies relevant to the purpose of this study were identified and those that met inclusion criteria were included. Results: Although corticosteroids share many common factors, including similar pharmacokinetic, pharmacodymanic, and adverse effect profiles, they have significant differences when the details of these variables are reviewed. Providers that prescribe corticosteroids for symptom management should be aware of these differences and the recommended management strategies. Conclusions: Recognition of corticosteroid induced adverse effect profiles and possible management strategies is crucial to optimal symptom management in palliative care patients.

scholarly journals Safety of Human Papillomavirus 9-Valent Vaccine: A Meta-Analysis of Randomized Trials

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Ana Paula Ferreira Costa ◽  
Ricardo Ney Oliveira Cobucci ◽  
Janine Medeiros da Silva ◽  
Paulo Henrique da Costa Lima ◽  
Paulo César Giraldo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Human Papillomavirus ◽  
Adverse Effects ◽  
Randomized Trials ◽  
Web Of Science ◽  
Meta Analysis ◽  
Developed Countries ◽  
Electronic Data ◽  
Tetravalent Vaccine ◽  
Significant Difference

Vaccination against human papillomavirus (HPV) has been progressively implemented in most developed countries for approximately 10 years. In order to increase the protection of the vaccines, a 9-valent vaccine (HPV9) was developed, which provides protection against nine types of the virus. Studies evaluating its safety are rare. Thus, we performed a meta-analysis of three clinical trials assessing adverse effects on women randomly vaccinated with HPV9 or tetravalent vaccine (HPV4), with the objective of analyzing whether the HPV9 is as safe as HPV4. An electronic data search was performed through the PubMed, Embase, Scopus, Web of Science, and SciELO databases. The studies selected 27,465 women who received one of the two vaccines. Pain (OR 1.72; 95% CI 1.62–1.82) and erythema (OR 1.29; 95% CI 1.21–1.36) occurred significantly more in the HPV9 group. However, there was no significant difference between the groups for the following adverse effects: headache (OR 1.07; 95% CI 0.99–1.15), dizziness (OR 1.09; 95% CI 0.93–1.27), and fatigue (OR 1.09; 95% CI 0.91–1.30), and the occurrence of serious events related to vaccination was similarly rare among those vaccinated. Therefore, our findings demonstrate that HPV9 in female patients is as safe as the tetravalent vaccine.

scholarly journals Acarbose for Postprandial Hypotension With Glucose Metabolism Disorders: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Biqing Wang ◽  
Junnan Zhao ◽  
Qiuxiao Zhan ◽  
Rongyanqi Wang ◽  
Birong Liu ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trials ◽  
Glucose Metabolism ◽  
Adverse Reactions ◽  
Meta Analysis ◽  
Control Group ◽  
Glucose Metabolism Disorders ◽  
Postprandial Hypotension ◽  
Randomized Controlled ◽  
Randomized Controlled Studies

Background: Postprandial hypotension (PPH) is an independent predictive factor of all-cause mortality in older people. Drug management has not achieved a satisfactory effect yet. In recent years, many studies have found that acarbose may be effective in the treatment of PPH with glucose metabolism disorders.Objective: To assess the efficacy and safety of acarbose on PPH with glucose metabolism disorders.Methods: PubMed (MEDLINE), Cochrane, EMBASE, Web of Science, Clinical Trials, and relevant Chinese databases were searched from inception to October 1, 2020. Randomized controlled studies of acarbose in the treatment of PPH with glucose metabolism disorders were included. Review Manager 5.3 software was used for quality evaluation and meta-analysis. GRADEpro GDT software was used to GRADE the evidence for the research objectives.Results: A total of 4 randomized controlled studies including 202 participants were identified after screening. The meta-analysis showed that acarbose significantly attenuated the decrease in postprandial systolic blood pressure [weighted mean difference (MD): −9.84, 95% CI: −13.34 to −6.33], diastolic blood pressure (MD: −6.86, 95% CI: −12.89 to −0.83), and mean arterial pressure (MD: −8.10, 95% CI: −12.40 to −3.49) compared with the control group. One study reported a case of adverse reactions that included mild abdominal distension in the acarbose group (4.8%, 1/21). No adverse reactions were reported in the other three studies.Conclusion: Acarbose may attenuate the decrease in postprandial blood pressure and avoid the occurrence of PPH in patients with PPH and abnormal glucose metabolism disorders. More clinical trials are needed to make a clear conclusion.Registration: PROSPERO CRD42020171335.

scholarly journals Methods and efficacy of social support interventions in preventing suicide: a systematic review and meta-analysis

2021 ◽  
pp. ebmental-2021-300318
Author(s):  
Xiaofei Hou ◽  
Jiali Wang ◽  
Jing Guo ◽  
Xinxu Zhang ◽  
Jiahai Liu ◽  
...  
Keyword(s):  
Social Support ◽  
Clinical Trials ◽  
Suicide Attempts ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Intervention Group ◽  
Inclusion Criteria ◽  
Support Providers ◽  
Study Selection ◽  
Randomised Controlled

QuestionSuicide is a global public and mental health problem. The effectiveness of social support interventions has not been widely demonstrated in the prevention of suicide. We aimed to describe the methods of social support interventions in preventing suicide and examine the efficacy of them.Study selection and analysisWe searched literature databases and conducted clinical trials. The inclusion criteria for the summary of intervention methods were as follows: (1) studies aimed at preventing suicide through method(s) that directly provide social support; (2) use of one or more method(s) to directly provide social support. The additional inclusion criteria for meta-analysis on the efficacy of these interventions included: (1) suicide, suicide attempt or social support-related outcome was measured; (2) randomised controlled trial design and (3) using social support intervention as the main/only method.FindingsIn total, 22 656 records and 185 clinical trials were identified. We reviewed 77 studies in terms of intervention methods, settings, support providers and support recipients. There was a total of 18 799 person-years among the ten studies measuring suicide. The number of suicides was significantly reduced in the intervention group (risk ratio (RR)=0.48, 95% CI 0.27 to 0.85). In 14 studies with a total of 14 469 person-years, there was no significant reduction of suicide attempts in the overall pooled RR of 0.88 (95% CI 0.73 to 1.07).ConclusionsSocial support interventions were recommended as a suicide prevention strategy for those with elevated suicide risk.

scholarly journals The Efficacy of Preoperative Gabapentin in Spinal Surgery: A Meta-Analysis of Randomized Controlled Trials

2017 ◽  
Vol 7 (20;7) ◽  
pp. 649-661
Author(s):  
Xin-long Ma
Keyword(s):  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Incidence Rate ◽  
Spinal Surgery ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Inclusion Criteria ◽  
Analog Scale ◽  
Randomized Controlled ◽  
Vas Scores

Background: Pain management after spinal surgery has been studied for years. Gabapentin is a third-generation antiepileptic drug that selectively affects the nociceptive process and has been used for pain relief after surgery. However, the relationship between gabapentin and postoperative pain in spinal surgery is still controversial. Objective: To assess the efficacy of the pre-emptive use of gabapentin in spinal surgery. Study Design: A meta-analysis of randomized controlled studies. Setting: The MEDLINE, EMBASE, ClinicalTrials.gov, and Web of Science databases were systematically searched. Methods: This meta-analysis of randomized controlled trials (RCTs) was performed to compare the use of gabapentin with placebo in spinal surgery regarding to the following: the mean difference (MD) of postoperative opioid requirements, the changes of visual analog scale (VAS) scores in 2 groups, and the incidence rate of adverse effects. An electronic-based search of all related literatures was conducted, and only RCTs for spinal surgery were included. The MD of postoperative opioid requirements and VAS scores and the relative risk (RR) of the incidence rate of adverse effects in the gabapentin group versus the placebo group were extracted throughout the study. Results: Ten trials, involving 827 patients, met the inclusion criteria and were included in this meta-analysis. The total morphine consumption was significantly lower over the first 24 hours postoperatively in the gabapentin group (P < 0.05). The VAS scores at 2, 4, 6, 12, and 24 hours were less in the gabapentin group (P < 0.05). The incidence rate of vomiting, pruritus, and urinary retention was significantly less in the gabapentin groups (RR = 0.53, 95% CI 0.32–0.86, P < 0.05; RR = 0.38, 95% CI 0.22–0.66, P < 0.05; RR = 0.57, 95% CI 0.34–0.98, P < 0.05, respectively). Limitations: All of the studies we screened were published online except for unpublished articles. Only 10 RCTs met our inclusion criteria, so the sample size was still relatively small. Conclusion: This meta-analysis suggests that the administration of gabapentin is effective in reducing postoperative opioid consumption, VAS scores, and some side effects after spinal surgery. Key words: Gabapentin, analgesia, spinal surgery, meta-analysis, randomized controlled trials, visual analog scale score, side effect

scholarly journals Cannabis Therapy in the Management of Fibromyalgia: A Systematic Review

2021 ◽  
Author(s):  
Yuri Borges Bitu de Freitas ◽  
Caio de Almeida Lellis ◽  
Jhenefr Ribeiro Brito ◽  
Rodrigo Souza Ramos ◽  
Maria Luiza Gonzaga de Oliveira
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Therapeutic Option ◽  
Life Quality ◽  
Pain Reduction ◽  
Catholic University ◽  
Randomized Studies ◽  
Starting Dose ◽  
Painful Syndrome

Introduction: Fibromyalgia is a painful syndrome of little known etiology, characterized by generalized pain with difficult management. Thus, cannabis therapy, a therapeutic option for other painful conditions, becomes an alternative. Objective: To review the literature on cannabis therapy in the treatment of fibromyalgia. Design and Setting: A systematic review conducted at the Pontifical Catholic University of Goiás. Methods: Systematic review. Randomized studies and clinical trials published between 01/2011 and 01/2021 were selected. Incomplete studies and those that did not fit the objectives were excluded. Results: When analyzing the combination of inhaled CBD and THC, it was concluded that, regardless of the dosage, neither showed significantly greater response than placebo. Studies pointed out that THC-rich cannabis oil, at starting dose of one drop a day, reduced pain, fatigue, and depression scores; moreover, the therapy proved tolerated and without serious adverse effects. Third-level evidence indicated better effects of nabilone on sleep than amitriptyline, without significant differences for pain, mood, and life quality. Conclusion: Different approaches to cannabis therapy for patients with fibromyalgia lead to diverse effects, with some not proving effective and others promoting pain reduction, sleep and life qualities improvements and satisfactory effects on depression and fatigue scores. Hence, scientifically relevant studies should be done on this subject.

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