scholarly journals Opioids in Chronic Noncancer Pain: More Faces from the Crowd

2012 ◽  
Vol 17 (4) ◽  
pp. 263-275 ◽  
Author(s):  
C Peter N Watson
Keyword(s):  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Functional Status ◽  
Present Article ◽  
Controlled Trials ◽  
High Dose ◽  
Chronic Noncancer Pain ◽  
Randomized Controlled ◽  
Noncancer Pain

BACKGROUND: The use of opioids for chronic noncancer pain (CNCP) remains very controversial. There are several randomized controlled trials, mostly in neuropathic pain, reporting efficacy and safety in the short term, but more long-term data are needed. Randomized controlled trials may be limited in providing data about the patients who benefit from often high-dose opioids over the long term. The present article provides details of these patients and adds to a previous case series.METHODS: The present article contains 17 case reports of 11 CNCP conditions (followed to 2011) selected to illustrate specific issues from a survey of 84 patients with intractable CNCP treated with opioids and followed every three months for a median of 11 years. The previous published survey of this group reported outcomes of pain severity, adverse effects, pain relief, satisfaction, mood, problematic opioid use, tolerance, physical dependency, functional status, health-related quality of life (HRQL), immune status and sexual function. The outcome measures for that study included a numerical rating scale for pain, the Hospital Anxiety and Depression Scale, the Brief Pain Inventory Interference Scale, the Pain Disability Index and, for HRQL, the Short-Form Health Survey 12 version 2. Most patients in the total sample reported 50% or greater relief and a moderate improvement in disability. Scores for functional status and HRQL were not severely affected. Problematic use, tolerance and serious adverse effects, including constipation, were not major issues. These selected patient reports were chosen, not to illustrate optimal results, but rather important aspects of the diagnoses, opioids and doses, the paucity of intolerable adverse effects, particular issues (concurrent addiction history, bipolar disorder and combination therapy), disease-specific and other outcomes and duration of follow-up with complex pain problems.RESULTS: Opioids were found to be safe and useful in the long term for these particular patients, as well as in the larger group from which they originated.INTERPRETATION: These 17 reports of patients with intractable CNCP treated with opioids with some success over many years puts a face on more of the participants in the larger survey of 84 subjects, suggesting that this approach is effective and safe for some patients over many years.

Safety of ciclesonide in children with asthma: A review of randomized controlled trials

2021 ◽  
Vol 42 (6) ◽  
pp. 471-480 ◽  
Author(s):  
Michael Blaiss ◽  
William Berger ◽  
Bradley Chipps ◽  
Vivian Hernandez-Trujillo ◽  
Wanda Phipatanakul ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Hpa Axis ◽  
Growth Velocity ◽  
Controlled Trials ◽  
Short Term ◽  
Randomized Controlled ◽  
Children With Asthma ◽  
Asthma In Children

Background: Parental concerns about the adverse effects of asthma medications can lead to nonadherence and uncontrolled asthma in children. Ciclesonide (CIC) is a prodrug, with low oropharyngeal deposition and bioavailability that may minimize the risk of local and systemic adverse effects. CIC is U.S. Food and Drug Administration approved for asthma in children ages ≥ 12 years. Objective: To summarize safety results from the 13 phase II or III randomized controlled trials conducted in children with asthma during CIC clinical development. Methods: Four 12- to 24-week trials compared the safety of once-daily CIC 40, 80, or 160 µg/day with placebo; four 12-week trials compared the safety of CIC 80 or 160 µg/day with either fluticasone or budesonide; one 12-month trial compared the long-term safety of CIC 40, 80, or 160 µg/day with fluticasone; one 12-month trial compared growth velocity of CIC 40 or 160 µg/day with placebo; and three cross-over trials compared short-term growth velocity and hypothalamic-pituitary-adrenal (HPA) axis effects of CIC 40, 80, or 160 µg/day with placebo or fluticasone. Results: In all, 4399 children were treated with CIC. The incidence of treatment-emergent adverse events (AE) was similar among the CIC doses and between CIC and placebo in short-term studies and between CIC and fluticasone in the long-term safety study. No CIC-related serious AEs were reported in any study. The incidence of treatment-related oral candidiasis was low and similar between CIC (≤0.5%) and placebo (≤0.7%) or active controls (≤0.5%) in the short-term studies. There was no clinically relevant HPA axis suppression or reduction in growth velocity associated with CIC. Conclusion: Data from 13 studies demonstrate that CIC is associated with low rates of oropharyngeal AEs, with no indication of clinically relevant systemic effects in children with asthma. The favorable safety profile and demonstrated improvements in asthma control make CIC an ideal inhaled corticosteroid for the treatment of asthma in children.

scholarly journals EFFICACY AND SAFETY OF CURCUMA LONGA EXTRACT IN THE TREATMENT OF OSTEOARTHRITIS: A SYSTEMATIC REVIEW

2019 ◽  
pp. 140-145
Author(s):  
ALESSA FAHIRA ◽  
ALLYSA SORAYA ◽  
ARMAND ACHMADSYAH ◽  
RANI WARDANI HAKIM
Keyword(s):  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
Visual Analog Scale ◽  
Curcuma Longa ◽  
Control Group ◽  
Controlled Trials ◽  
Analog Scale ◽  
Randomized Controlled ◽  
Natural Remedies

Objective: Osteoarthritis (OA) is a chronic disease caused by inflammation of the tissue and bony structure of the joint, which affects more than 235 million people worldwide. Due to the adverse effects caused by the long-term use of standard treatment of OA, the attempt to find natural remedies to treat chronic diseases continues to rise. Curcuma longa is known to have anti-inflammatory effects, which may impact the pathophysiology of OA. While many randomized controlled trials show the efficacy of Curcuma longa extract in the treatment of OA, there has been no comprehensive review of this evidence. Methods: We systematically searched PubMed, Cochrane, Scopus, ProQuest, EBSCOhost, and ScienceDirect for randomized controlled trials that evaluated Curcuma longa extract (CE extract) vs. control (placebo or other therapy). Three trials were identified. Data were then extracted from the studies and summarized descriptively. Results: Across all trials, Curcuma longa therapy was proven to reduce Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores significantly compared to the control group. Adverse effects were less likely to appear in patients treated with Curcuma longa extract compared to other groups. Conclusion: CL extract is beneficial as an alternative medication for OA treatment, shown by the reduced scores of the Visual Analog Scale (VAS) and WOMAC in all studies we reviewed.

scholarly journals Magnesium for the Management of Chronic Noncancer Pain in Adults: Protocol for a Systematic Review (Preprint)

2018 ◽  
Author(s):  
Rex Park ◽  
Anthony M-H Ho ◽  
Gisèle Pickering ◽  
Lars Arendt-Nielsen ◽  
Mohammed Mohiuddin ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Adverse Effects ◽  
Controlled Trials ◽  
High Dose ◽  
Number Needed To Treat ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Chronic Noncancer Pain ◽  
Noncancer Pain

BACKGROUND Chronic pain is a highly prevalent and complex health problem that is associated with a severe symptom burden, as well as substantial economic and social impact. Many patients with chronic pain still suffer from unrelieved or undertreated pain due to the incomplete efficacy and dose-limiting adverse effects of current therapies. Long-term and high-dose opioid use has considerably increased in the past 20 years despite limited evidence supporting its effectiveness in several chronic pain conditions, and serious concerns have emerged regarding adverse effects and potential misuse. Until recently, the steady increase in opioid prescribing rates has been associated with rising opioid-related mortality and other serious problems, emphasizing the need for better nonopioid therapies. Emerging evidence supports the safe use of magnesium in controlling chronic pain, but its overall efficacy and safety is still unclear. OBJECTIVE This paper aims to assess the efficacy and safety of magnesium compared with a placebo for the treatment of chronic noncancer pain. METHODS We will conduct a detailed search on Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE from their inception until the date the searches are run to identify relevant randomized controlled trials. The reference lists of retrieved studies as well as Web-based trial registries will also be searched. We will include randomized double-blind trials comparing magnesium (at any dose, frequency, or route of administration) with placebo using participant-reported pain assessment. Two reviewers will independently evaluate studies for eligibility, extract data, and assess trial quality and potential bias. Risk of bias will be assessed using criteria outlined in the Cochrane Handbook for Systematic Review of Interventions. Primary outcomes for this review will include any validated measure of pain intensity or pain relief. Dichotomous data will be used to calculate the risk ratio and number needed to treat or harm. The quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS This protocol is grant-funded and has undergone a peer-review process through the Queen’s University Department of Anesthesiology and Perioperative Medicine Vandewater Endowed Studentship. This project is also supported, in part, by the Chronic Pain Network of the Canadian Institutes of Health Research Strategy for Patient-Oriented Research. The electronic database search strategies are currently being developed and modified. The entire review is expected to be completed by January 1, 2019. CONCLUSIONS The completion of this review is expected to identify available high-quality evidence describing the efficacy and safety of magnesium for the treatment of chronic noncancer pain. INTERNATIONAL REGISTERED REPOR PRR1-10.2196/11654

scholarly journals Nutrition in infancy and long-term risk of obesity: evidence from 2 randomized controlled trials

2010 ◽  
Vol 92 (5) ◽  
pp. 1133-1144 ◽  
Author(s):  
Atul Singhal ◽  
Kathy Kennedy ◽  
Julie Lanigan ◽  
Mary Fewtrell ◽  
Tim J Cole ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Randomized Controlled

Acetazolamide to Prevent Adverse Altitude Effects in COPD and Healthy Adults

NEJM Evidence ◽  
2021 ◽  
Author(s):  
Michael Furian ◽  
Maamed Mademilov ◽  
Aline Buergin ◽  
Philipp M. Scheiwiller ◽  
Laura Mayer ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Older Persons ◽  
Healthy Adults ◽  
Controlled Trials ◽  
Health Events ◽  
Randomized Controlled ◽  
Adverse Health ◽  
Adverse Health Events

Furian and colleagues report on the results of two randomized controlled trials testing the use of acetazolamide to prevent the adverse effects of altitude on healthy older persons and in people with COPD. They find that acetazolamide decreased the incidence of altitude related adverse health events (primarily hypoxemia) in both populations with no evidence of adverse events.

scholarly journals S90. A SYSTEMATIC REVIEW AND META-ANALYSIS OF PHARMACOLOGICAL INTERVENTIONS FOR REDUCTION OF WEIGHT GAIN IN PEOPLE WITH SCHIZOPHRENIA: 2019 UPDATE

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S68-S68
Author(s):  
Sri Mahavir Agarwal ◽  
Nicolette Stogios ◽  
Zohra Ahsan ◽  
Jonathan Lockwood ◽  
Markus Duncan ◽  
...  
Keyword(s):  
Weight Loss ◽  
Weight Gain ◽  
Adverse Effects ◽  
Randomized Controlled Trials ◽  
First Episode ◽  
Controlled Trials ◽  
Inclusion Criteria ◽  
Pharmacological Interventions ◽  
Randomized Controlled ◽  
Modest Weight Loss

Abstract Background Weight gain and obesity are common problems encountered by patients with schizophrenia. This is partially attributable to use of second-generation antipsychotics that are associated with weight gain and other metabolic disturbances. The significance of this prevalence and its impact on premature mortality and morbidity requires better consensus on its management. The objective of this review is to determine the effects of adjunctive pharmacological interventions aimed at reducing weight gain in schizophrenia. Methods We searched the Cochrane Schizophrenia Group’s Trials Register which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. Inclusion criteria consisted of all randomized controlled trials examining any adjunctive pharmacological intervention for weight loss in patients with schizophrenia or schizophrenia-like illnesses. The primary outcome of each study had to be body weight or a weight related measure. We reliably selected, quality assessed, and extracted data from studies. As endpoint and change data was combined in the analysis, mean differences (MD) of the change from baseline were calculated using Review Manager 5.3. Results Sixty-one randomized controlled trials met inclusion criteria for this review (pooled n = 3328). Metformin is effective in bringing about modest weight loss (Weight: MD -3.40 kg, 95% CI -4.63 to -2.16; participants = 731; studies = 12; BMI: MD -1.39, 95% CI -1.94 to -0.85; participants = 879; studies = 13). Heterogeneity was reduced by dividing populations into first episode psychosis (FEP) and chronic populations, where FEP patients appeared to benefit most from early metformin intervention (Weight: MD -5.18 kg, 95% CI -6.22 to -4.14; BMI: MD -1.87 kg/m2, 95% CI -2.19 to -1.56; participants = 214; studies = 3) as compared to chronic patients (Weight: MD -2.22 kg, 95% CI -3.07 to -1.37; participants = 517; studies = 9; BMI: MD -1.18 kg/m2, 95% CI -1.89 to -0.48; participants = 665; studies = 10). However, ethnicity could be a confounder for the apparent effect of illness stage, as all first episode metformin intervention studies were conducted in patients with Chinese ethnicity. Metformin as a treatment for weight gain may be associated with additional adaptive changes in fasting insulin levels and insulin resistance. The frequency of adverse effects did not differ between metformin and placebo groups. Moreover, glucagon-like peptide agonists (GLP-1RAs), such as liraglutide and exenatide, were also effective in reducing weight (Weight: MD -3.95 kg, 95% CI -7.08 to -0.83; participants = 165; studies = 3; BMI -1.26 kg/m2, 95% CI -2.21 to -0.30; participants = 165; studies = 3; waist circumference: MD -3.25, 95% CI -5.93 to -0.57; participants = 165, studies = 3). The frequency of adverse effects did not differ between GLP-1RA and placebo groups. Topiramate 200 mg was also effective for weight reduction (Weight: MD=-6.61 kg, 95% CI -9.62 to -3.61; BMI: MD=-2.72, 95% CI -3.25 to -2.20; participants = 181, studies = 3). Discussion This review highlights the promise of pharmacological interventions for decreasing weight gain associated with antipsychotic use. Of the drugs studied, metformin has the most evidence and was most effective in bringing about modest weight loss. Topiramate and GLP-1RA also have accumulating evidence supporting efficacy in reducing weight. Interpretation for other agents is limited by the small number of studies, sample size, and short study duration. Future studies that are adequately powered, with longer treatment duration, will be needed in evaluating the efficacy and safety of interventions for managing weight gain further.

The use of high venous ligation as an adjunct to endovenous therapy in the management of great saphenous vein incompetence: A systematic review and meta-analysis of randomized controlled trials

2019 ◽  
Vol 34 (7) ◽  
pp. 433-444
Author(s):  
Thomas M Aherne ◽  
Mekki Medani ◽  
Shaheel Sahebally ◽  
Elrasheid Kheirelseid ◽  
Edward Mulkern ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Hybrid Approach ◽  
Outcome Data ◽  
Operative Intervention ◽  
Controlled Trials ◽  
Recurrence Rates ◽  
Randomized Controlled ◽  
Venous Surgery

Background In recent years, endovenous intervention has emerged as a minimally invasive alternative to open venous surgery. However, endovenous intervention does not formally disconnect the deep and superficial venous systems and it is hypothesized that recurrence may be greater in the absence of high venous ligation. This study aims to compare the efficacy of a hybrid endovenous approach with adjuvant high venous ligation and standard operative intervention in the management of great saphenous incompetence. Methods In March 2018, Medline and Embase were systematically searched for relevant randomized controlled trials. All randomized controlled trials comparing a hybrid approach with standard operative intervention were included. Studies were required to include at least one pre-defined outcome. Data were extracted and assessed by two independent reviewers. Pooled risk ratios were calculated using a random effects model. Additional subgroup analyses were performed. Results Eight randomized controlled trials including 1244 patients were analysed. Pooled standardized data revealed no difference in overall recurrence (pooled RR = 1.00 [95% CI = 0.57, 1.77]), major operative morbidity (RR = 0.43 [95% CI = 0.06, 2.89]), or re-interventions (RR = 0.94 [95% CI = 0.12, 7.24]) for the hybrid group compared with standard operative intervention alone. Subgroup analysis revealed comparable short-, medium- and long-term recurrence rates between both cohorts. Furthermore, no difference in recurrence was identified when the hybrid approach was compared to open surgery alone (RR = 1.01 [95% CI = 0.63, 1.61]) or endovenous monotherapy (RR = 0.67 [95% CI = 0.04, 12.24]). Conclusion The use of a hybrid approach in the management of great saphenous incompetence appears to offer no recurrence, re-intervention or morbidity benefit when compared to standard operative intervention.

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