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.

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 Reporting of Quality of Life in Clinical Trials of Biologics for Plaque Psoriasis: A Systematic Review

2018 ◽  
Vol 2 (5) ◽  
Author(s):  
Giselle Prado ◽  
Anna J Nichols ◽  
Mercedes Florez-White ◽  
Francisco Kerdel
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Clinical Trials ◽  
Plaque Psoriasis ◽  
Dermatology Life Quality Index ◽  
Quality Index ◽  
Life Quality ◽  
Risk Of Bias ◽  
The Mean

Background: Psoriasis is a chronic remitting and relapsing skin disease. For many patients, improved quality of life (QoL) is as important as clinical improvement of lesions.Objective: To review reporting of Dermatology Life Quality Index (DLQI) in randomized controlled trials (RCTs) of biologics for adult patients with plaque psoriasis.Methods: A systematic review was conducted in 4 databases for RCTs that measured DLQI at baseline and endpoint. A data collection form was created for collecting study variables. Risk of bias was assessed using the Cochrane risk of bias tool.Results: Thirty-four RCTs enrolling 16,784 patients were included. Complete baseline and final mean DLQI data was retrieved for 24 studies (70.6%). The mean DLQI at baseline was reported in 79.4% of RCTs. The median at baseline was reported in 14.7% of RCTs. The mean DLQI at endpoint was reported in 23.5% of RCTs and the median DLQI at endpoint was reported in 5.9% of RCTs. The mean change in DLQI was reported in 64.7% of RCTs.Conclusions: DLQI was measured in most clinical trials assessing the efficacy of biologics for psoriasis. Studies did not adhere to uniform standards in publishing results, making analysis of the impact on DLQI challenging.Key Words: plaque psoriasis, quality of life, Dermatology Life Quality Index, Systematic Review, biologic therapy

Homeopathic aggravations: a systematic review of randomised, placebo-controlled clinical trials

Homeopathy ◽  
2003 ◽  
Vol 92 (02) ◽  
pp. 92-98
Author(s):  
S Grabia ◽  
E Ernst
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Randomised Clinical Trials ◽  
Controlled Clinical Trials ◽  
Double Blind ◽  
Literature Searches

AbstractHomeopathic aggravations have often been described anecdotally. However, few attempts have been made to scientifically verify their existence. This systematic review aimed at comparing the frequency of homeopathic aggravations in the placebo and verum groups of double-blind, randomised clinical trials. Eight independent literature searches were carried out to identify all such trials mentioning either adverse effects or aggravations. All studies thus found were validated and data were extracted by both authors. Twenty-four trials could be included. The average number of aggravations was low. In total, 50 aggravations were attributed to patients treated with placebo and 63 to patients treated with homoeopathically diluted remedies. We conclude that this systematic review does not provide clear evidence that the phenomenon of homeopathic aggravations exists.

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 Cannabidiol and the Management of Pediatric Neurological Disorders: A Systematic Review

2021 ◽  
Author(s):  
Caio de Almeida Lellis ◽  
Marco Alejandro Menacho Herbas ◽  
João Cesar Pereira da Cunha ◽  
Samyla Coutinho Paniago ◽  
Paulo Sérgio Machado Diniz
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Neurological Disorders ◽  
Pediatric Patients ◽  
Meta Analysis ◽  
Dravet Syndrome ◽  
Motor Disorder ◽  
Safety And Efficacy ◽  
Catholic University ◽  
Complex Motor

Introduction: Due to an increase in cases of neurological disorders refractory to conventional treatments in pediatrics patients, other therapies have been sought. Objectives: To analyze the safety and efficacy of CBD in the management of neurological disorders in children. Design and setting: A systematic review conducted at the Pontifical Catholic University of Goiás. Methods: This is a systematic review carried out in PubMed, Lilacs and MedLine databases, with the descriptors: “(Pediatric OR Neurology) AND (Cannabidiol OR Cannabis)”, being selected only the randomized studies, meta-analysis and clinical trials published in the last 10 years. Results: One randomized trial concluded that daily oral CBD solution reduced the frequency of seizures in pediatric patients with Lennox-Gastaut syndrome (LGS). In addition, another study concluded that CBD (20 mg/kg/day) is associated with up to a 50% decrease in seizures in children with SLG and Dravet syndrome. Furthermore, it was pointed out that the association of oral CBD (2 to 5 mg/kg/day) with antiepileptic drugs caused a mean reduction of 36.5% of severe seizures. Finally, CBD enriched with 0.25% THC reduced spasticity, dystonia and pain intensity in children with complex motor disorder. Conclusion: CBD was shown to be safe and effective as a treatment for refractory epilepsies and complex motor disorder in pediatric patients, with no serious side effects reported.

scholarly journals Acupuncture as a therapeutic option for tension-type headache: A Systematic Review

2021 ◽  
Author(s):  
Camila Puton, Caio de Almeida Lellis ◽  
Caio Reis Borges ◽  
Giovanna Garcia de Oliveira
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Relaxation Training ◽  
Randomized Clinical Trials ◽  
Therapeutic Option ◽  
Control Process ◽  
Tension Headache ◽  
Primary Headache ◽  
Tension Type Headache ◽  
Type Headache

Introduction: Tension headache (TTS), the most common type of primary headache, is characterized by tightness pain, typically bilateral, lasting hours or days, significantly impairing daily activities. Objectives: To review the literature on the use of acupuncture in the management of TTS, evaluating its safety and efficacy. Design and setting: A systematic review conducted at the Pontifical Catholic University of Goiás. Methods: A systematic literature review was performed in the PubMed, EMBASE and Virtual Health Library databases, with the terms: “Tension-Type Headache AND Acupuncture”. Randomized studies and clinical trials published in the last 10 years were selected. Results: Two studies, one clinical trial and one randomized trial, concluded that combining acupuncture with another therapy involving movement, such as stretching, physical therapy techniques, or relaxation training, led to reduced pain intensity and improved quality of life in patients with TTS. In contrast, other randomized clinical trials concluded that relaxation training decreased the intensity, frequency of attacks, and adjunctive symptoms of headache (sleep and vitality) more than acupuncture. Finally, acupuncture was compared with the simulated control process in the prevention of TTS, but there were no statistically significant differences between the two groups evaluated. Conclusion: The literature indicated that the combination of acupuncture with other therapeutic options was safe and effective in the management and prevention of TTS. Studies with greater scientific rigor should be conducted for a better understanding of this therapeutic option.

scholarly journals Short-Term Effectiveness and Safety of Biologics and Small Molecule Drugs for Moderate to Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis

Life ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. 927
Author(s):  
José-Juan Pereyra-Rodriguez ◽  
Sara Alcantara-Luna ◽  
Javier Domínguez-Cruz ◽  
Manuel Galán-Gutiérrez ◽  
Ricardo Ruiz-Villaverde ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Atopic Dermatitis ◽  
Adverse Effects ◽  
Small Molecules ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Severe Atopic Dermatitis ◽  
Cochrane Central Register ◽  
Number Of Patients

Background: Some Network Meta-analysis (NMA) has been published regarding atopic dermatitis (AD). These studies have considered drugs under investigation both in monotheraphy or in combination with topical corticosteroids, as well as systemic immunosuppressant therapies. The objective of this study is to evaluate the efficacy and safety of biological agents and small molecules in AD. Methods: A systematic review and NMA of biologics agents and small molecules in AD was performed. A literature search was performed using MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials for clinical trials and systematic reviews between January 2000 and 19 December 2020. Only randomized clinical trials (RCTs) were included. It was limited to English language and adult human subjects. Two networks were evaluated: monotherapy and combination with TCS. The two primary outcomes were Eczema Area and Severity Index (EASI) 75 and EASI 90 change from baseline to week 12–16, depending on source study cut-off. The Cochrane’s Risk of Bias tool 2011 update was used to analyze the risk of bias, focused on the primary objectives. Results: 30 RCTs (included in 26 publications) were included in the systematic review. Finally, 23 RCTs were included in the quantitative analysis (14 RCTs including 3582 patients in monotherapy; and 9 RCTs including 3686 patients with TCS). In monotherapy, a higher percentage of patients achieving EASI-75 was obtained with Upadacitinib 30 mg [OR: 18.90 (13.94; 25.62)] followed by Abrocitinib 200 mg [OR = 11.26 (7.02; 18.05)] and Upadacitinib 15 mg [OR: 10.89 (8.13; 14.59)]. These results were also observed in studies where the use of topical corticosteroid (TCS) was allowed (OR Upadacitinib 30 mg = 9.43; OR Abrocitinib 200 mg = 6.12; OR Upadacitinib 15 mg = 5.20). Regarding IGA, the percentage of patients achieving IGA0/1 was higher with both doses of Upadacitinib 30 mg [OR: 19.13 (13.14; 27.85)] and 15 mg [OR = 10.95 (7.52; 15.94). In studies where the use of TCS were allowed, however, the dose of Abrocitinib 200 mg [OR = 6.10 (3.94; 9.44)] showed higher efficacy than Upadacitinib 15 mg [OR = 5.47 (3.57; 8.41)]. Regarding safety, the drugs with the highest probability of presenting adverse effects were the Janus kinases (JAK) inhibitors, Upadacitinib and Abrocitinib in monotherapy and Baricitinib in combination with TCS. Discussion: Some risks of bias have been found, which must be taken into account when interpreting the results. The funnel plot shows a possible publication bias that may underestimate the efficacy of drugs. Upadacitinib and Abrocitinib are the drugs with the highest efficacy, both in monotherapy and in association with TCS. However, they were also those associated with the highest risk of adverse effects, showing monoclonal antibodies better safety profile. Limitations: We have included molecules still in the development phase as well studies completed and presented at conferences and with data available in Trialsgov® but not published yet. Several molecules’ development had included a small number of patients from 12 to 17 years of age, without being able to differentiate the results from the adult population. Other: Founding: None. PROSPERO database registration number CRD42021225793.

Sign in / Sign up

Export Citation Format

Share Document