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BackgroundMany patients with amyotrophic lateral sclerosis (ALS) experience cramps during the course of the disease but so far, none of the medications used has been of proven benefit. The objective was to determine the effect of orally administered tetrahydrocannabinol (THC) on cramps in ALS patients.MethodsThe authors conducted a randomised, double-blind, placebo-controlled crossover trial in 27 ALS patients suffering from moderate to severe (visual analogue scale (VAS); VAS≥4) daily cramps. There were 7 women and 20 men with a mean age of 57 years and a mean functional ALS score (ALSFRS-R) of 38.4. Patients were randomly assigned to receive 5 mg THC twice daily followed by placebo or vice versa. Each treatment period lasted for 2 weeks and was preceded by a 2-week drug-free observation period (run-in, wash-out period respectively). The primary outcome measure was change in cramp intensity as assessed by a VAS. Secondary outcome measures included the number of cramps per day, number of cramps during daytime and bedtime, intensity of fasciculations (VAS) as well as validated measures of quality of life (ALSAQ-40), quality of sleep (SDQ), appetite (FAACT) and depression (HADS).ResultsComplete data were available from 22 patients. THC was well tolerated. There was no evidence for a treatment effect on cramp intensity, number of cramps, fasciculation intensity or any of the other secondary outcome measures.ConclusionsThis interventional study with orally administered THC 5 mg twice daily did not demonstrate subjective improvement of cramp intensity in ALS patients.

Background : Eperisone hydrochloride is a centrally acting muscle relaxant inhibiting the pain reflex pathway, having a vasodilator effect. Aims : To evaluate the efficacy and tolerability of eperisone in patients with acute musculoskeletal spasm associated with low back pain. Settings and Design : Prospective, randomized, double-blind, placebo-controlled, multicentric trial conducted at five tertiary care orthopedic centers across India. Materials and Methods : It was planned to enroll 240 patients of either sex between 18-60 years with acute musculoskeletal spasm (AMSP) with low back pain (LBP) due to spondylosis deformans, prolapsed disc or muscle sprain. Patients with other associated unrelated spasm conditions were excluded. Assessments were done for finger-to-floor distance (FFD), lumbar pain, Lasegue's sign, tenderness of vertebral muscles, need for rescue medication and response to therapy for efficacy and tolerability. Statistical Analysis : Parametric data were analyzed by 't' test and ANOVA, and non-parametric data were analyzed using Mann-Whitney 'U' test and Kruskall-Wallis test. Proportions were compared using Fischer's (Chi-square) test. Results : Two hundred and forty patients were randomized to receive eperisone 150 mg/day in three divided doses (n=120) or placebo (n=120) for 14 days, of which 15 patients did not complete and 225 patients completed the study (eperisone, 112 and placebo, 113). Significantly greater improvement in FFD (P<0.001) from baseline on Day 14 was seen with eperisone (150.66 to 41.75) compared to placebo (138.51 to 101.60). Improvements in other parameters were greater with the eperisone group. For 89 (79.46%) patients the therapy was rated as good-excellent with eperisone compared to 43 (38.05%) patients with placebo. Nausea, abdominal pain, headache and dizziness were the common adverse events with both therapies. Rescue drug was needed by 40 (35.71%) eperisone patients and 83 (73.45%) placebo patients. Conclusions : Eperisone hydrochloride was effective and well tolerated for the treatment of patients with AMSP with LBP. [PUBLICATION ABSTRACT]

Background: Cyclobenzaprine hydrochloride is a muscle relaxant that is effective in improving muscle spasm, reducing local pain and tenderness, and increasing range of motion in acute, painful musculoskeletal conditions. Sedation is the most common adverse event associated with its use at the usual dosage of 10 mg TID. Studies in healthy adults sugges that a lower dose may produce less sedation. Because cyclobenzaprine's duration of action is 4 to 6 hours, reducing the dosing frequency to 10 mg BID would create a potentially painful untreated interval between doses. The alternative is administration of a lower dose (eg, 5 or 2.5 mg) TID. Objective: These studies were designed to assess the efficacy and tolerability of cyclobenzaprine 2.5, 5, and 10 mg TID compared with placebo in patients with acute musculoskeletal spasm. Methods: In 2 randomized, double-blind, placebo-controlled, parallel-group trials conducted at primary care centers in the United States, adult patients with acute painful muscle spasm of the lumbar or cervical region were randomly assigned to receive treatment with 2.5, 5, or 10 mg cyclobenzaprine TID or placebo for 7 days (study 1: cyclobenzaprine 5 or 10 mg TID or placebo; study 2: cyclobenzaprine 2.5 or 5 mg TID or placebo). The primary efficacy measures were patient-rated clinical global impression of change, medication helpfulness, and relief from starting backache. Neither study included a nonsteroidal anti-inflammatory drug (NSAID) as an active control. Although physicians frequently prescribe an analgesic or NSAID in addition to cyclobenzaprine, these studies were not designed to assess whether adding cyclobenzaprine provides a benefit over that of an analgesic. Results: One thousand four hundred five patients (737 study 1; 668 study 2), two thirds with low back pain and one third with neck pain, were randomized to treatment. Their mean age was 42 years, and ∼89% were white. In both studies, patients receiving cyclobenzaprine 5 or 10 mg had significantly higher mean scores on the primary efficacy measures compared with those receiving placebo (study 1—P≤0.001 cyclobenzaprine 5 and 10 mg vs placebo, all measures at visits 2 and 3; study 2—P≤0.03 cyclobenzaprine 2.5 mg vs placebo, relief from starting backache on day 3 only; cyclobenzaprine 5 mg vs placebo, patient-rated clinical global impression of change, medication helpfulness, and relief from starting backache at visit 3 or day 7 only). On day 7, significantly more patients receiving cyclobenzaprine 5 or 10 mg reported relief compared with placebo recipients (P < 0.05 all cyclobenzaprine groups vs placebo). Onset of relief was apparent within 3 or 4 doses of the 5-mg regimen. In the subanalysis of the proportion of responders in the pooled 5-mg groups who did and did not report somnolence, a meaningful treatment effect was observed on all primary efficacy variables in patients who did not report somnolence, suggesting that efficacy was indendependent of sedation. Cyclobenzaprine was well tolerated. Somnolence and dry mouth, the most common adverse effects, were mild and dose related. Overall, ≥ 1 adverse event was reported in 54.1%, 61.8%, and 35.4% of patients receiving cyclobenzaprine 5 or 10 mg or placebo, respectively, in study 1 and by 43.9%, 55.9%, and 35.4% of patients receiving cyclobenzaprine 2.5 or 5 mg or placebo, respectively, in study 2. Adverse events were the primary reason for discontinuation of treatment in the cyclobenzaprine 5- and 10-mg groups in both studies. In study 2, ineffectiveness of therapy was the main reason for discontinuation of therapy in the group receiving cyclobenzaprine 2.5 mg. Conclusions: Cyclobenzaprine 2.5 mg TID was not significantly more effective than placebo. The cyclobenzaprine 5- and 10-mg TID regimens were associated with significantly higher mean efficacy scores compared with placebo. Cyclobenzaprine 5 mg TID was as effective as 10 mg TID, and was associated with a lower incidence of sedation.

Computed tomography (CT)-guided percutaneous stylomastoid foramen puncture radiofrequency ablation for the treatment of hemifacial spasm has a significant clinical effect; however, related risk factors for recurrence have not been studied. To investigate the risk factors for the recurrence of hemifacial spasm after radiofrequency ablation and construct a model for predicting recurrence. This is a single-center retrospective observational study. The study was conducted at the Pain Department of the Affiliated Hospital of Jiaxing College in Jiaxing, China. A retrospective analysis was performed on 99 patients diagnosed with primary hemifacial spasm (HFS) admitted to the Affiliated Hospital of Jiaxing University between August 2018 and December 2021. All patients underwent CT-guided percutaneous stylomastoid foramen radiofrequency ablation. Kaplan-Meier survival analysis, log-rank test, and Cox proportional risk regression model were used to analyze the clinical factors that affect the recurrence of patients with HFS after radiofrequency ablation, and a recurrence prediction model was established. Follow-up was 3-12 months; recurrence rates were 20.2%, 36.4%, and 71.9% at 3, 6, and 12 months postoperatively, respectively. Univariate analysis showed that puncture approach, operation time, and facial paralysis level were factors influencing recurrence in patients with HFS after radiofrequency ablation (P < 0.05). The multivariate Cox proportional risk regression model showed that the operative time and facial paralysis grade were independent factors for recurrence after radiofrequency ablation in patients with facial spasms. The recurrence risk function model of patients with facial spasms after radiofrequency ablation was expressed as h(t) = h0exp(-0.619X1-2.589X2), where X1 and X2 represent the operation time and facial paralysis grade, respectively. The likelihood ratio of the model was statistically significant (chi squared = 55.769, P < 0.001). We look forward to increasing the sample size in follow-up studies and exploring relevant conclusions in randomized controlled trials. Long operation times and high-grade facial paralysis can reduce the risk of recurrence in patients with facial spasms. The constructed recurrence prediction model could serve as a reference for clinical diagnosis and treatment.

Vasospastic angina (VSA) refers to chest pain experienced as a consequence of myocardial ischaemia caused by epicardial coronary spasm, a sudden narrowing of the vessels responsible for an inadequate supply of blood and oxygen. Coronary artery spasm is a heterogeneous phenomenon that can occur in patients with non-obstructive coronary arteries and obstructive coronary artery disease, with transient spasm causing chest pain and persistent spasm potentially leading to acute myocardial infarction (MI). VSA was originally described as Prinzmetal angina or variant angina, classically presenting at rest, unlike most cases of angina (though in some patients, vasospasm may be triggered by exertion, emotional, mental or physical stress), and associated with transient electrocardiographic changes (transient ST-segment elevation, depression and/or T-wave changes). Ischaemia with non-obstructive coronary arteries (INOCA) is not a benign condition, as patients are at elevated risk of cardiovascular events including acute coronary syndrome, hospitalization due to heart failure, stroke and repeat cardiovascular procedures. INOCA patients also experience impaired quality of life and associated increased healthcare costs. VSA, an endotype of INOCA, is associated with major adverse events, including sudden cardiac death, acute MI and syncope, necessitating the study of the most effective treatment options currently available. The present literature review aims to summarize current data relating to the diagnosis and management of VSA and provide details on the sequence that treatment should follow. Plain language summary Diagnosis and treatment of epicardial coronary artery spasm Vasospastic angina (VSA) refers to chest pain experienced as a consequence of a sudden narrowing of the epicardial coronary arteries. VSA can occur in patients with non-obstructive coronary arteries and obstructive coronary artery disease, with transient spasm causing chest pain and persistent spasm potentially leading to acute myocardial infarction. Reduced blood and oxygen supply in patients with non-obstructive coronary arteries is not a benign condition, as patients are at elevated risk of adverse cardiovascular events. These patients also experience impaired quality of life and associated increased healthcare costs. This review aims to summarise current data relating to the diagnosis of VSA and provides details on treatment strategies.

IntroductionInfantile spasms (IS) is a type of severe epileptic encephalopathy that occurs in infancy and early childhood. IS is characterised clinically by epileptic spasms, often accompanied by sleep disorder and abnormal circadian rhythm. The endogenous circadian rhythm disorder, in turn, can make spasms worse. Melatonin has also been found to have anticonvulsant and neuroprotective properties by adjusting the circadian rhythm. However, there are lack of relevant studies on controlling IS by using melatonin. This study aims to analyse the therapeutic effect of melatonin supplementation for the treatment of IS.Methods and analysisThis is a triple-blinded (trial participant, outcome assessor and the data analyst), prospective, randomised controlled trial to be conducted in the Department of Paediatrics, The First Medical Center of Chinese PLA General Hospital, Beijing, China from November 2020. Patients (n=70) aged 3 months to 2 years with IS will be recruited in this study after receiving written consent from their parents or guardians. Patients will be randomly divided into two equal groups and treated with a combination of adrenocorticotropic hormone, magnesium sulfate and either melatonin or placebo. Clinical data from the patients in the two groups before and after the treatment will be collected and compared. The primary outcome will be assessed 2 weeks later by seizure diaries and reported as the average reduced rate of spasms frequency. Secondary outcomes include the response rate (the rate of spasms-free), electroencephalogram hypsarrhythmia assessment and the psychomotor development assessment (Denver Developmental Screening Test). Sleep quality and safety will also be assessed.Ethics and disseminationThe protocol for this study was approved by the Ethics Committee of Chinese PLA General Hospital (reference number S2020-337-01) and was reported according to the Standard Protocol Items: Recommendations for Interventional Trials statement. Findings of this research will be disseminated through national and international meetings, conferences and peer-reviewed journals.Trial registration numberChiCTR2000036208.

Infantile spasms, newly classified as infantile epileptic spasm syndrome (IESS), occur in children under 2 years of age and present as an occur as brief, symmetrical, contractions of the musculature of the neck, trunk, and extremities. When infantile spasms occur with a concomitant hypsarrhythmia on electroencephalogram (EEG) and developmental regression, it is known as West Syndrome. There is no universally accepted mainstay of treatment for this condition, but some options include synthetic adrenocorticotropic hormone (ACTH), repository corticotropin injection (RCI/Acthar Gel), corticosteroids, valproic acid, vigabatrin, and surgery. Without effective treatment, infantile spasms can cause an impairment of psychomotor development and/or cognitive and behavioral functions. The first-line treatment in the USA is ACTH related to high efficacy for cessation of infantile spasms long-term and low-cost profile. Acthar Gel is a repository corticotropin intramuscular injection that became FDA-approved for the treatment of IESS in 2010. Though it is believed that ACTH, Acthar Gel, and corticosteroids all work via a negative feedback pathway to decrease corticotropin-releasing hormone (CRH) release, their safety and efficacy profiles all vary. Vigabatrin and valproic acid are both anti-seizure medications that work by increasing GABA concentrations in the CNS and decreasing excitatory activity. Acthar Gel has been shown to have superior efficacy and a diminished side effect profile when compared with other treatment modalities.

Infantile epileptic spasms syndrome (IESS) is a devastating developmental epileptic encephalopathy (DEE) consisting of epileptic spasms, as well as one or both of developmental regression or stagnation and hypsarrhythmia on EEG. A myriad of aetiologies are associated with the development of IESS; broadly, 60% of cases are thought to be structural, metabolic or infectious in nature, with the remainder genetic or of unknown cause. Epilepsy genetics is a growing field, and over 28 copy number variants and 70 single gene pathogenic variants related to IESS have been discovered to date. While not exhaustive, some of the most commonly reported genetic aetiologies include trisomy 21 and pathogenic variants in genes such as TSC1, TSC2, CDKL5, ARX, KCNQ2, STXBP1 and SCN2A. Understanding the genetic mechanisms of IESS may provide the opportunity to better discern IESS pathophysiology and improve treatments for this condition. This narrative review presents an overview of our current understanding of IESS genetics, with an emphasis on animal models of IESS pathogenesis, the spectrum of genetic aetiologies of IESS (i.e., chromosomal disorders, single-gene disorders, trinucleotide repeat disorders and mitochondrial disorders), as well as available genetic testing methods and their respective diagnostic yields. Future opportunities as they relate to precision medicine and epilepsy genetics in the treatment of IESS are also explored.

Data comparing outcomes of distal radial (DR) and traditional radial (TR) access of coronary angiography and percutaneous coronary intervention (PCI) are limited. Online databases including Medline and Cochrane Central databases were explored to identify studies that compared DR and TR access for PCI. The primary outcome was the rate of radial artery occlusion (RAO) and access failure. Secondary outcomes included access site hematoma, access site bleeding, access site pain, radial artery spasm, radial artery dissection, and crossover. Unadjusted odds ratios (ORs) with a random-effect model, 95% confidence interval (CI), and p <0.05 were used for statistical significance. Metaregression was performed for 16 studies with 9,973 (DR 4,750 and TR 5,523) patients were included. Compared with TR, DR was associated with lower risk of RAO (OR 0.51, 95% CI 0.29 to 0.90, I2 = 42.6%, p = 0.02). RAO was lower in DR undergoing coronary angiography rather than PCI. Access failure rate (OR 1.77, 95% CI 0.69 to 4.55, I2 87.36%, p = 0.24), access site hematoma (OR 1.11, 95% CI 0.68 to 1.83, I2 0%, p = 0.68), access site pain (OR 2.22, 95% CI 0.28 to 17.38, I2 0%, p = 0.45), access site bleeding (OR 1.11, 95% CI 0.16 to 7.62, I2 85.11%, p = 0.91), radial artery spasm (OR 0.79, 95% CI 0.49 to 1.29, I2 0%, p = 0.35), radial artery dissection (OR 1.63, 95% CI 0.46 to 5.84, I2 0%, p = 0.45), and crossover (OR 1.54, 95% CI 0.64 to 3.70, I2 25.48%, p = 0.33) did not show any significant difference. DR was associated with lower incidence RAO when compared with TR, whereas other procedural-related complications were similar.

Radial artery spasm (RAS) is the most common cause of transradial access site crossover and is a common intra‐procedural complication. RAS incidence can lead to radial artery occlusion (RAO) postprocedure, preventing the radial artery as a future access site. We evaluated the efficacy of nitroglycerin preventing RAS and RAO during transradial catheterization discussing the different routes of administration, including topical, subcutaneous, and intra‐arterial. A systematic review and meta‐analysis included all relevant articles until April 23, 2022. We searched six databases Google Scholar, Web of Science, SCOPUS, EMBASE, PubMed (MEDLINE), and CENTRAL. We registered our review protocol in PROSPERO with ID: CRD42022330356. We included 11 trials with 5814 patients. Compared to placebo, the pooled analysis favored subcutaneous nitroglycerin in preventing RAS (risk ratio [RR]: 0.57 with 95% confidence interval [CI] [0.43–0.77], p = .0003) and RAO (RR: 0.39 with 95% CI [0.16–0.98], p = .05). In contrast to the intra‐arterial nitroglycerin that showed nonstatistically significant results in preventing RAS and RAO (RR: 0.8 with 95% CI [0.63–1.02], p = .07)‐ (RR: 0.78 with 95% CI [0.6–1.01], p = .06)), respectively. Also, topical nitroglycerin did not prevent RAS (RR: 0.73 with 95% CI [0.42–1.24], p = .24). Compared with placebo, subcutaneous nitroglycerin during transradial catheterization reduced the incidence of RAS and RAO. Meanwhile, Intra‐arterial and topical nitroglycerin did not show statistically significant outcomes. Subcutaneous nitroglycerin may be a practical and cost‐effective technique to facilitate transradial catheterization; however, more RCTs are needed to evaluate the subcutaneous versus intra‐arterial nitroglycerin administration.