We compared headache frequency trajectories between clinical trial participants who received cognitive-behavioral therapy (CBT) and amitriptyline (CBT+A) or headache education (HE) and amitriptyline ...(HE+A) to determine if there was a differential time course of treatment response between the groups. One hundred thirty-five patients (age 10-17 years) diagnosed with chronic migraine participated, attending 8 one-hour one-on-one CBT or HE sessions with a trained psychologist for 8 weekly sessions, 2 sessions at weeks 12 and 16, and a post-treatment visit at week 20. Participants kept daily headache diaries and completed take-home assignments between visits. Data from daily headache diaries are presented for each day and according to 28-day periods. Trajectories of improvement indicate initial decrease in headache days began during the first month of treatment, for both groups, and continued to decrease throughout treatment. The CBT+A group had greater daily improvement than the HE+A group. A significantly greater proportion of the CBT+A group had a ≥50% reduction in headache days each month, and a significantly greater proportion of the CBT+A group had ≤4 headache days per month in months 3 through 5. Results indicate the trajectory of decrease in headache days is significantly better for patients receiving CBT+A versus HE+A.
This article presents daily information about headache frequency over a 20-week clinical trial. Youth with chronic migraine who received CBT+A improved faster than those in the control group. Findings provide clinicians with evidence-based expectations for treatment response over time and ways of monitoring treatment success.
clinicaltrials.gov identifier NCT00389038.
IntroductionThis meta-analysis was conducted to assess the safety and efficacy of aspiration thrombectomy versus stent retriever thrombectomy for acute ischemic stroke (AIS).MethodsWe queried online ...databases for original studies comparing aspiration thrombectomy with stent retriever thrombectomy in patients with AIS. After article selection, data were extracted on multiple baseline characteristics and prespecified endpoints. Dichotomous data were presented as risk ratios (RRs) and corresponding 95% confidence intervals (CIs); continuous data as mean differences and 95% CIs. The data were pooled using a random-effects model. Subgroup analysis was conducted based on study type, site of occlusion, and age.ResultsWe shortlisted nine relevant studies (n=1453 patients; n=690 receiving aspiration thrombectomy and n=763 receiving stent retriever thrombectomy). Meta-analysis demonstrated no significant difference between the two groups in the rates of successful recanalization (RR: 0.96 0.87, 1.06; p=0.42), excellent functional outcome (RR: 0.90 0.80, 1.01; p=0.06), or procedure time (weighted mean difference (WMD): -5.39 minutes -11.81, 1.04; p=0.10). However, when removing the study by Nishi et al., sensitivity analysis resulted in a significant reduction in procedure time with aspiration (WMD: -11.01 -15.54, -6.49; p<0.0001). No significant difference was observed in safety outcomes, including all-cause mortality (RR: 0.82 0.57, 1.19; p=0.30), intracranial hemorrhage (RR: 0.93 0.55, 1.59; p=0.80), symptomatic intracranial hemorrhage (RR: 0.720.42, 1.21; p=0.57), or embolization to new territory (RR: 0.71 0.42, 1.19; p=0.19). Subgroup analysis revealed that aspiration thrombectomy led to significantly better outcomes in patients with a mean age ≤65 (RR: 1.15 1.03, 1.29; p=0.001), and stent retriever thrombectomy led to increased recanalization success in patients with a mean age >65 (RR: 0.89 0.80, 1.00; p=0.05).ConclusionsOur updated meta-analysis reveals that both aspiration and stent retriever thrombectomy are comparably effective in the management of AIS. Shorter procedure times may potentially be attained with aspiration thrombectomy, and outcomes with each procedure may be age-dependent.
IMPORTANCE Early, safe, effective, and durable evidence-based interventions for children and adolescents with chronic migraine do not exist. OBJECTIVE To determine the benefits of cognitive ...behavioral therapy (CBT) when combined with amitriptyline vs headache education plus amitriptyline. DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial of 135 youth (79% female) aged 10 to 17 years diagnosed with chronic migraine (≥15 days with headache/month) and a Pediatric Migraine Disability Assessment Score (PedMIDAS) greater than 20 points were assigned to the CBT plus amitriptyline group (n = 64) or the headache education plus amitriptyline group (n = 71). The study was conducted in the Headache Center at Cincinnati Children’s Hospital between October 2006 and September 2012; 129 completed 20-week follow-up and 124 completed 12-month follow-up. INTERVENTIONS Ten CBT vs 10 headache education sessions involving equivalent time and therapist attention. Each group received 1 mg/kg/d of amitriptyline and a 20-week end point visit. In addition, follow-up visits were conducted at 3, 6, 9, and 12 months. MAIN OUTCOMES AND MEASURES The primary end point was days with headache and the secondary end point was PedMIDAS (disability score range: 0-240 points; 0-10 for little to none, 11-30 for mild, 31-50 for moderate, >50 for severe); both end points were determined at 20 weeks. Durability was examined over the 12-month follow-up period. Clinical significance was measured by a 50% or greater reduction in days with headache and a disability score in the mild to none range (<20 points). RESULTS At baseline, there were a mean (SD) of 21 (5) days with headache per 28 days and the mean (SD) PedMIDAS was 68 (32) points. At the 20-week end point, days with headache were reduced by 11.5 for the CBT plus amitriptyline group vs 6.8 for the headache education plus amitriptyline group (difference, 4.7 95% CI, 1.7-7.7 days; P = .002). The PedMIDAS decreased by 52.7 points for the CBT group vs 38.6 points for the headache education group (difference, 14.1 95% CI, 3.3-24.9 points; P = .01). In the CBT group, 66% had a 50% or greater reduction in headache days vs 36% in the headache education group (odds ratio, 3.5 95% CI, 1.7-7.2; P < .001). At 12-month follow-up, 86% of the CBT group had a 50% or greater reduction in headache days vs 69% of the headache education group; 88% of the CBT group had a PedMIDAS of less than 20 points vs 76% of the headache education group. Measured treatment credibility and integrity was high for both groups. CONCLUSIONS AND RELEVANCE Among young persons with chronic migraine, the use of CBT plus amitriptyline resulted in greater reductions in days with headache and migraine-related disability compared with use of headache education plus amitriptyline. These findings support the efficacy of CBT in the treatment of chronic migraine in children and adolescents. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00389038
There is a paucity of data on the prognostic impact of mitral annular calcification (MAC) in patients who underwent transcatheter aortic valve implantation (TAVI) with conflicting results being ...reported by the studies that are published. Therefore, we performed a meta-analysis to assess the short-term and long-term outcomes of MAC in patients after TAVI. Of 25,407 studies identified after the initial database search, 4 observational studies comprising 2,620 patients (2,030 patients in the nonsevere MAC arm and 590 patients in the severe MAC arm) were included in the final analysis. Compared with patients with nonsevere MAC, the severe MAC group was associated with significantly higher incidences of overall bleeding (0.75 0.57 to 0.98, p = 0.03, I2 = 0%) at 30 days. However, no significant difference was observed between the 2 groups for the rest of the 30-day outcomes: all-cause mortality (0.79 0.42 to 1.48, p = 0.46, I2 = 9%), myocardial infarction (1.62 0.37 to 7.04, p = 0.52, I2 = 0%), cerebrovascular accident or stroke (1.22 0.53 to 2.83, p = 0.64, I2 = 0%), acute kidney injury (1.48 0.64 to 3.42, p = 0.35, I2 = 0%), and pacemaker implantation (0.70 0.39 to 1.25, p = 0.23, I2 = 68%). Similarly, follow-up outcomes also showed no significant difference between the 2 groups: all-cause mortality (0.69 0.46 to 1.03, p = 0.07, I2 = 44%), cardiovascular mortality (0.52 0.24 to 1.13, p = 0.10, I2 = 70%) and stroke (0.83 0.41 to 1.69, p = 0.61, I2 = 22%). The sensitivity analysis, however, demonstrated significant results for all-cause mortality (0.57 0.39 to 0.84, p = 0.005, I2 = 7%) by removing the study by Okuno et al5 and cardiovascular mortality (0.41 0.21 to 0.82, p = 0.01, I2 = 66%) by removing the study by Lak et al.7 In conclusion, our meta-analysis corroborates the notion that isolated MAC is not an independent predictor of long-term mortality after TAVI and determines severe MAC to be a predictor of mortality at follow-up because of the higher incidence of mitral valve dysfunction associated with it.
Respected Editor, Pakistan is one of the Afro Asian countries where the incidence of stone diseases is consistently high because of its presence in Stone Belt countries 1. Karachi has a hot and arid ...climate with summer season persisting for the longest time of the year which plays a vital factor in the prevalence of renal stones in our population. A bulk of our dietary consumption is mainly animal protein, contributing to increased uric acid production. Moreover, oxalate concentration also rises with the increased intake of beets, chocolate, tea, nuts, spinach and cola leading to nephrolithiasis. The Dietary Approaches to Stop Hypertension (DASH) diet is used to manage hypertension. It has also been associated with a reduced incidence of renal stone formation 2. The DASH diet focuses on adequate intake of vegetables and fruits, low-fat dairy products, low animal protein diet which has a decreased amount of cholesterol and fats 2. Fruits and vegetables are an integral part of DASH style diet. They contain high oxalate content which is a known precipitating agent for calcium oxalate stones, nevertheless, fruits and vegetables also increase levels of citrate in urine which is an important inhibitor and protective factor for calcium stones 2. Studies have shown that Phytate (Myo-inositol hexaphosphate), a factor in plant matter and a major part of the DASH diet, reduces the risk of stone development 3. Low intake of animal protein, as recommended in the DASH diet leads to decrease uric acid production and increased urinary pH consequently decreasing the risk of uric acid stone 2. High urinary pH can lead to the formation of calcium phosphate crystals thus the impact of the DASH diet on the development of calcium phosphate stones is still a topic of much conjecture. Stroke and coronary heart diseases, which are prevalent among our population, can be well managed and prevented with DASH-style diet 4. Adherence to this diet can also lead to a marked reduction in the likelihood of Type 2 diabetes in a certain population 5. In conclusion, DASH-style diet is easy to adhere, harmless, affordable and can be proven exponentially beneficial in healthcare like ours, where the cost of treatment has to be borne directly by the patients and patients’ affordability is still a vital drawback. However, it should be catered according to the morbidity of the patient. Counseling of healthy individuals about foods that increase the risk of kidney stones should be carried our to reduce stone related morbidities. Further researches should be conducted in order to determine the efficacy of a DASH-style diet and if established true, this diet should be integrated for the prevention of nephrolithiasis. For, prevention is better than cure.
This meta-analysis was conducted to assess the safety and efficacy of sonothrombolysis along with intravenous recombinant tissue plasminogen activator, alteplase (IV rtPA), in the management of acute ...ischemic stroke. Electronic databases were searched under different meSH terms without the restriction of time and language. 1415 studies were analyzed and seven studies that matched the inclusion criteria were selected. Multiple safety and efficacy outcomes were extracted. Our pooled analysis demonstrated that there is no significant difference between sonothrombolysis group and control group in preventing mortality (RR 1.10 0.81, 1.50; p = 0.55; I
2
= 0%) and intracranial hemorrhage (RR 1.11 0.76, 1.63; p = 0.59; i
2
= 0%), however, among the efficacy outcomes; complete recanalization after 60-120 min was achieved more effectively in the sonothrombolysis group (RR 2.11 1.48, 3.03; p ≤ 0.0001; I
2
= 0%). The rest of the efficacy outcomes like neurological improvement at 24 h (RR 1.20 0.92, 1.57; p = 0.18; I
2
= 40%) and excellent functional outcome after 3 months (RR 1.19 0.93, 1.52; p = 0.17; I
2
= 35%) showed no significant differences between the two groups. In subgroup analysis, we found that sonothrombolysis led to a better neurological improvement in patients who were less than 65 years of age (RR 1.20 0.92, 1.57; p = 0.05; I
2
= 40%). Moreover, there were no significant differences in the following of the subgroups assessed: (a) microsphere or microbubble use, (b) Ultrasound frequency (2 MHz or < 2 MHz), (c) transcranial Doppler (TCD) duration (1 h or 2 h), (d) age (≤ 65 or > 65).
Respected Editor, Stroke is one of the highest contributors to mortality in South East Asia. Its prevalence in Pakistan is assessed to be 250/100,000 population with 350,000 new cases per annum 1. ...Stroke is a leading cause of disability where 20-40% of stroke survivors are affected by spasticity, a complication of upper motor neurons 2. Spastic paralysis secondary to stroke leads to functional limitations due to ataxia, gait disturbances, joint contracture, and pain that deteriorates the quality of life. Post-stroke spasticity management requires a mix of pharmacological and certain rehabilitative treatments, of which the prevalent ones in Pakistan are virtual reality, early mobilization, movement therapy induced by force and gait training and non-invasive brain stimulation. For the treatment of spasticity, focal muscle vibration (FMV) is more affordable, user-friendly, with no known adverse effects 3. Despite its promising results, focal muscle vibration has not yet been introduced in Pakistan probably due to lack of literature. Focal muscle vibration (FMV), an effective neuro- rehabilitative procedure, requires the focal application of vibration of appropriate frequency (variable according to the muscle) on the muscle belly. This stretches the muscle by producing muscle waves. The propagation of muscle waves results in muscle stretch which induces the tonic vibration reflex via spinal circuits 4. Tonic vibration reflex is a phenomenon where vibration induces involuntary contraction in vibrated muscle and a relaxation of its antagonist 5. Effectiveness of FMV was proven by Costantino C, et al. in their randomized control trial (RCT) published in 2017. A total of 32 post-stroke patients with chronic upper limb spasticity were divided into two groups. The experimental group (17 patients) was given low amplitude (2 mm), high frequency (300 Hz) vibrations for 30 minutes, thrice a week for a month. The control group received sham therapy. Statistically significant difference existed between two groups in modified ashworth scale (MAS) for shoulder (p= 0.007), elbow (p=0.003), and wrist (p < 0.001) 6. Further promising results were proved in RCT conducted by Oh J, et al. which was published in late 2017. They included hemiplegic patients with calf muscle spasticity and applied 80 Hz vibration with an amplitude of 0.3 mm. It was found that FMV had an antispastic effect on Gastrocnemius. The angle of ankle dorsiflexion and range of movement of the ankle was increased after the application of FMV 7. Moreover, the use of FMV was found to reduce the risk of falling in the elderly by improving balance 8. Studies show that FMV has a promising outcome and it can significantly reduce spasticity which can improve quality of life in stroke patients. Further trials should be carried out in our population as well to develop a better understanding of the potential efficacy of FMV. The rehabilitative physicians should be vigilant of newer techniques and modalities being developed across the world and should aim to initiate the use of new scientifically proven beneficial techniques in their practice.
Background and objectives A flare-up in coronavirus disease 2019 (COVID-19) cases threatens the health of people, and though there is no proven pharmacological treatment, many analytical studies have ...suggested that interleukin-6 (IL-6) levels are elevated in cases of severe COVID-19 and that the anti-IL-6 biologic agent tocilizumab may be beneficial. This is a critical review of studies aiming to assess the safety and efficacy of tocilizumab as compared to the standard regimen in patients with COVID-19. Materials and methods Online databases (PubMed and Cochrane) were searched until June 29, 2020, for original articles investigating the immunological response in COVID-19 and its treatment with tocilizumab. Data on multiple baseline characteristics and pre-specified endpoints were extracted and pooled using a random effect model. We used Review Manager version 5.3 (The Nordic Cochrane Centre, The Cochrane Collaboration, 2014, Denmark) and Stata 11.0 (Stata Corporation LP, College Station, TX) for all analyses. Risk ratios (RR) and the weighted mean difference (WMD) with the corresponding 95% confidence interval (CI) were calculated. Results From a total of 1,246 identified articles, 13 studies were included after duplicate removal and narrowing based on title and abstract. Of the 13 included studies, seven case-control studies were shortlisted for meta-analysis (quantitative) and six-single arm studies were used in the discussion (qualitative). These studies had 766 patients (351 in the tocilizumab arm and 414 in the control arm). Their pooled analysis demonstrated that mortality was significantly lower in the tocilizumab group (RR=0.56 0.34, 0.92; p=0.02; I2=76%), as was the need for artificial invasive ventilation (RR=0.34 0.12, 0.99; p=0.05; I2=0%) as compared to the control group. No significant differences were observed between tocilizumab and control group in intensive care unit admissions (RR=0.73 0.15, 3.59; p=0.70; I2=60%) and risks of post-drug infection (RR=1.29 0.41, 4.04; p=0.66; I2=88%). In terms of efficacy outcome, improved oxygen saturation (RR=1.13 1.04, 1.65; p=0.02; I2=0%) was reported to be markedly significant in tocilizumab patients when compared with the standard care group. Conclusions Our results based on pooled studies show tocilizumab to be safe and efficacious in reducing mortality among critically ill COVID-19 patients. However, due to the limited number of observational studies, the positive findings should be viewed cautiously and warrant further investigation.
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