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International Journal of Clinical... Oct 2020Intramuscular or, more rarely, local drug injection is occasionally followed by immediate local pain, livedoid skin lesions and, some days later, the development of...
AIM
Intramuscular or, more rarely, local drug injection is occasionally followed by immediate local pain, livedoid skin lesions and, some days later, the development of ischemic lesions. This very uncommon but potentially severe reaction, termed Nicolau syndrome, is traditionally associated with bismuth and β-lactam antimicrobials. The aim of this report was to review the literature associating Nicolau syndrome with the administration of non-steroidal anti-inflammatory drugs.
METHODS
The National Library, Excerpta Medica, Web of Science and Cochrane library databases were used.
RESULTS
Sixty-two cases (40 females and 22 males aged from 13 to 81, median 57 years) of Nicolau syndrome were published after 1992. Fifty-three cases occurred after diclofenac. The remaining nine cases were associated with ketoprofen (N = 2), ketorolac (N = 2), phenylbutazone (N = 2), etofenamate (N = 1), ibuprofen (N = 1) and piroxicam (N = 1).
CONCLUSION
Although Nicolau syndrome is extremely uncommon, physicians must be aware of this complication after intramuscular administration of non-steroidal anti-inflammatory drugs and should avoid unnecessary injections.
Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Drug Eruptions; Female; Humans; Injections, Intramuscular; Male; Middle Aged; Nicolau Syndrome; Young Adult
PubMed: 32479658
DOI: 10.1111/ijcp.13567 -
Journal of Clinical Epidemiology Mar 2022To assess whether drug regulatory agencies decided on applications for extended-release methylphenidate for use in adult ADHD based on select samples of trials.
OBJECTIVES
To assess whether drug regulatory agencies decided on applications for extended-release methylphenidate for use in adult ADHD based on select samples of trials.
STUDY DESIGN AND SETTING
Case series of publicly available regulatory documents. We matched an index of extended-release methylphenidate trials for adult ADHD with trials appearing in regulatory documents of extended-release methylphenidate applications. Trials and regulatory documents were identified as part of this systematic review (https://doi.org/10.1002/14651858.CD012857). We sought to identify missing trials in the regulatory documents and to clarify regulatory submission requirements.
RESULTS
We indexed 18 trials and matched those with 13 drug applications (11 approved, 2 rejected) published by 7 agencies. There were trials missing in 7 (54%) of 13 applications, median 4 trials (range 1-6). The median proportion of missing trial participants was 45% (range 23% - 72%). Regulators seemingly require that all trials must be included in new drug applications, but wording is ambiguous.
CONCLUSION
In this sample of extended-release methylphenidate drug applications for adult ADHD, 7 of 13 regulatory decisions were missing entire trials according to public documents, even though regulatory requirements seem to stipulate that all available trials should be included in drug applications.
Topics: Adult; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Delayed-Action Preparations; Humans; Methylphenidate; Treatment Outcome
PubMed: 34752938
DOI: 10.1016/j.jclinepi.2021.10.027 -
European Review For Medical and... Nov 2021This systematic review with network meta-analysis was performed to compare the effectiveness of oral anti-inflammatory drugs used in Brazil for osteoarthritis. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This systematic review with network meta-analysis was performed to compare the effectiveness of oral anti-inflammatory drugs used in Brazil for osteoarthritis.
PATIENTS AND METHODS
Randomized clinical trials evaluating ultramicronised diclofenac, diclofenac, celecoxib, etodolac and placebo in patients with osteoarthritis were identified. A search was conducted in May 2021 through PubMed, Scopus and Web of Science databases. A network meta-analysis was developed for efficacy outcome related to analgesia measured by the pain subscale of the Western Ontario and McMaster Universities tool. In addition, surface under the cumulative ranking was performed to rank the drugs in relation to this outcome.
RESULTS
Twelve randomized clinical trials were included. Overall, ultramicronised diclofenac 105 mg/day (UD105) was better than all the others, including ultramicronised diclofenac 70 mg/day (UD70). In addition, surface under the cumulative ranking resulted in the following order: 1) ultramicronised diclofenac 105 mg/day (100%), 2) ultramicronised diclofenac 70 mg/day (80%), 3) celecoxib 200 mg/day (49%), 4) diclofenac 100 mg/day (48%), 5) placebo (19%) and 6) diclofenac 150 mg/day (6%).
CONCLUSIONS
Ultramicronised diclofenac demonstrated superior efficacy compared to other conventional anti-inflammatory drugs and placebo in relieving osteoarthritis pain.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Diclofenac; Humans; Network Meta-Analysis; Osteoarthritis; Pain; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 34859865
DOI: 10.26355/eurrev_202111_27252 -
Evidence-based Mental Health Aug 2019The comparative efficacy and tolerability of methylphenidate (MPH) and neurofeedback (NF) in individuals with attention-deficit/hyperactivity disorder (ADHD) remains... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The comparative efficacy and tolerability of methylphenidate (MPH) and neurofeedback (NF) in individuals with attention-deficit/hyperactivity disorder (ADHD) remains uncertain. This study aimed to fill this gap by means of a systematic review/meta-analysis.
METHODS
PubMed, OVID, ERIC, Web of Science, ClinialTrials.gov and a set of Chinese databases were searched until 22 August 2018. Standardised mean differences (SMD) were pooled using comprehensive meta-analysis software.
RESULTS
18 randomised controlled trials (RCTs) were included (778 individuals with ADHD in the NF arm and 757 in the MPH group, respectively; 13 studies in Chinese, five in English). At the study first endpoint, MPH was significantly more efficacious than NF on ADHD core symptoms (ADHD symptoms combined: SMD=-0.578, 95% CI (-1.063 to -0.092)) and on two neuropsychological parameters (inattention:-0.959 (-1.711 to -0.208); inhibition:-0.469 (-0.872 to -0.066)). Dropouts were significantly lower in NF versus MPH (OR=0.412, 0.186 to 0.913). Results were robust to sensitivity analyses, with two important exceptions: removing Chinese studies and non-funded studies, no differences emerged between MPH and NF, although the number of studies was small. At the study follow-up, MPH was superior to NF in some outcomes, but results were inconsistent across raters.
CONCLUSIONS
Due to the risk of bias of included studies, the results of the sensitivity analysis excluding Chinese and non-funded studies, and the mixed findings on at the follow-up endpoint, further high quality studies are needed to assess the comparative efficacy and acceptability of NF and MPH in individuals with ADHD.
TRIAL REGISTRATION NUMBER
CRD42018090256.
Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Humans; Methylphenidate; Neurofeedback; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic
PubMed: 31221690
DOI: 10.1136/ebmental-2019-300088 -
Scientific Reports Nov 2019Attention-deficit/hyperactivity disorder (ADHD) frequently co-occurs with intellectual disability in children, and may further compromise learning. Methylphenidate is a... (Meta-Analysis)
Meta-Analysis
Therapeutic effects of methylphenidate for attention-deficit/hyperactivity disorder in children with borderline intellectual functioning or intellectual disability: A systematic review and meta-analysis.
Attention-deficit/hyperactivity disorder (ADHD) frequently co-occurs with intellectual disability in children, and may further compromise learning. Methylphenidate is a first-line treatment for ADHD, however no previous meta-analysis has evaluated its overall efficacy for ADHD in children with comorbid intellectual disability (ID) or borderline intellectual functioning. The PubMed/MEDLINE, Cochrane CENTRAL and ScienceDirect databases were systematically searched from inception through 2018/7/15 for clinical studies that investigated the effects of methylphenidate in children with ADHD and ID. A random-effects model meta-analysis was used for data synthesis. Eight studies (average Jadad score = 2.5) enrolling 242 participants receiving methylphenidate and 181 participants receiving placebo were included. The meta-analysis showed that methylphenidate led to a significant improvement in ADHD symptoms relative to placebo (Hedges' g = 0.878, p < 0.001). Meta-regression analysis pointed to an association between the dose of methylphenidate and overall improvement in ADHD severity (slope = 1.334, p < 0.001). Finally, there was no significant difference in drop-out rate [odds ratio (OR) = 1.679, p = 0.260] or rate of treatment discontinuation due to adverse events (OR = 4.815, p = 0.053) between subjects receiving methylphenidate and those taking placebos. Our study suggests that methylphenidate retains its efficacy in children with ADHD and borderline intellectual functioning or ID.
Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Humans; Intellectual Disability; Methylphenidate; Odds Ratio; Placebo Effect; Severity of Illness Index; Treatment Outcome
PubMed: 31685858
DOI: 10.1038/s41598-019-52205-6