Neuromyelitis optica spectrum disorder (NMOSD) often follows a relapsing course. As disability in NMOSD is attack-related, effective treatments are needed. We aimed to compare the efficacy of ...azathioprine (AZA) and rituximab (RIT) as maintenance therapy in NMOSD patients. An open, randomized clinical trial was conducted during September 2015 to December 2016, in Isfahan, Iran. Initially, 100 NMOSD patients were approached, 86 entered the study, and 68 cases completed the trial. All patients had a relapsing–remitting course with expanded disability extended scale (EDSS) ≤7 (median 2.75, range = 0–7). Patients were randomized into two groups, which did not differ according to age, gender distribution, and disease duration. In the AZA group, 35 patients 20 aquaporin-4 (AQP4)-IgG positive were started on 50 mg/day oral AZA and increased to 2–3 mg/kg/day (with oral prednisolone as adjunctive therapy). In the RIT group, 33 patients (13 aquaporin-4-IgG positive) received 1 g intravenous rituximab and repeated 2 weeks later and then every 6 months. Annualized relapse rate (ARR) was measured as the primary outcome and EDSS as the secondary outcome after 12 months of intervention. The mean ARR standard deviation (SD) in the AZA group decreased from 1 (0.38) to 0.51 (0.55) (
P
value <0.001) and in the RIT group decreased from 1.30 (0.68) to 0.21 (0.42) (
P
value <0.001). ARR after intervention minus ARR before intervention mean (SD) was 1.09 (0.72) in RIT group and 0.49 (0.59) in AZA group (
P
value <0.001). EDSS after intervention minus EDSS before intervention mean (SD) was 0.98 (1.14) in RIT group and 0.44 (0.54) in AZA group (
P
value <0.001). Nineteen patients (54.3%) in AZA group and 26 patients (78.8%) in RIT group became relapse-free after intervention (
P
value = 0.033). AZA and RIT can both effectively decrease ARR and EDSS in NMOSD patients. RIT was significantly more effective than AZA treatment.
Trial Registration
Name of registry: clinicaltrials.gov; ID: NCT03002038; URL:
https://clinicaltrials.gov/ct2/show/NCT03002038
.
Pharmacological interventions have not been successful in the treatment of childhood functional abdominal pain (FAP) hitherto. Buspirone is suggested to be efficacious in some of the abdominal ...pain-related functional gastrointestinal disorders based on evidences from the studies on adults. We aim to investigate the efficacy of buspirone on childhood FAP.
This randomized clinical trial was conducted on 117 patients with childhood FAP aged 6-18 years. We randomly assigned patients to receive buspirone or placebo for 4 weeks, with the adjusted dosage for age. Participants completed the questionnaires assessing pain, depression, anxiety, somatization, and sleep disturbances at baseline, at the end of the 4-week therapy (first follow-up), and at 8 weeks after medication discontinuation (second follow-up). The primary outcome was treatment response rate, defined as reduced pain score of ≥2 or reporting no pain at the follow-up assessments.
Ninety-five patients completed the 4-week therapy (48 and 47 in buspirone and placebo groups, respectively). Both buspirone and placebo reduced pain after 4 weeks of treatment, and these effects were persistent 8 weeks after medication discontinuation (P < 0.001 for both groups at weeks 4 and 12). Treatment response rates for buspirone and placebo were 58.3% and 59.6% at week 4 (P = 0.902) and 68.1% and 71.1% at week 12 (P = 0.753), respectively.
Buspirone effectively improves pain and associated psychological symptoms including depressive symptoms, anxiety, somatization, and sleep disturbances in childhood FAP but has no superiority over placebo. Further studies, with the higher doses of buspirone and longer follow-ups are recommended.
Abstract
Introduction
Psychological interventions are shown to be effective in migraine, but not utilized routinely yet. We aimed to evaluate the efficacy of transdiagnostic cognitive behavioral ...therapy (TCBT) on people with migraine (PwM).
Method
This study was conducted on 40 PwM aged 20–50 years. We randomly assigned participants to two groups of intervention, receiving 10 sessions of TCBT, and control, attending one session on relaxation and stress-management techniques. Days with headache, headache severity, migraine-related disability and effects on daily life, number of pain-relivers taken for headache, depression, and anxiety were assessed pre-intervention, post-intervention (three-month follow-up), and one-month after TCBT termination (four-month follow-up).
Results
Thirty-five participants suffering moderate to severe migraine completed the study (16 and 19 in TCBT and control groups, respectively). TCBT improved all measured items between study time-points (
p
< 0.05) in the intervention group, while such an improvement was not observed in the control group. Between group comparisons revealed superiority of TCBT group compared to the control group in most measured items at three- and four-month follow-ups (
p
< 0.05).
Conclusion
Ten sessions of TCBT improved migraine severity, associated disability, anxiety, and depression in PwM, with persistent effects after one month of therapy termination. However, the generalizability of these findings is limited due to the placebo effect in the intervention arm, given the more time each participant has spent with the therapist. TCBT could be an affordable, practical, and feasible intervention to be utilized for PwM and larger studies with equal number of sham therapy sessions are needed to further explore this.
Trial registration number:
The study protocol was registered in clinicaltrial.gov (
NCT03701477
) prior to enrollment.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Several studies showed that parenting intervention programs play a core component in early child development. Considering the limited healthcare resources in developing countries, group-session ...intervention based on care for child development (CCD) guideline might be cost-effective.
This randomized controlled trial was conducted at an outpatient public Pediatrics clinic in Isfahan, Iran. We included 210 pregnant women aged 18-45 years in their third trimester and followed their children for 18 months. The intervention group underwent 5 educational group sessions, each lasting for almost 45 minutes. The main outcomes were the children's development and socio-emotional behavior problems based on Bayley Scales of Infant and Toddler Development-III (BSID-III) at 12 months and the Children Behavior Checklist (CBCL) at 18 months.
Overall, data of 181 children were included in the current study, including 80 in the intervention group and 101 controls. The adjusted median/mean differences between intervention and control groups using median/linear regression were not significant for all BSID-III domains except for median differences for cognitive score based on BSID-III (β (SE): - 4.98(2.31), p:0.032) and mean differences for anxiety/depression score based on CBCL (β (SE): - 2.54(1.27), p:0.046).
In this study, parenting interventions through CCD group sessions were significantly effective on just one subscale of children's socio-emotional behavior domains based on CBCL and one domain of children's development based on BSID-III. There might be a ceiling or floor effects for the BSID-III and CBCL assessment, respectively, leaving little room for improvement as almost all children have achieved their full developmental potential in our study.
IRCT20190128042533N2, Date of registration: 16/01/2020, www.irct.ir.
Background
Because of the significant incidence and mortality of cancer in Iran, a Comprehensive National Cancer Control Program for the prevention and early detection of cancer was launched in 2007. ...However, cancer awareness and screening rates in Iran did not improve. This study aimed to evaluate public attitudes toward cancer and cancer patients in Iran.
Materials and Methods
We conducted a cross‐sectional survey among 953 non‐institutionalized individuals in Isfahan, Iran, from November 2014 to February 2015. We collected data on attitudes toward cancer in three domains (impossibility of recovery, cancer stereotypes, and discrimination), as well as questions on willingness to disclose a cancer diagnosis.
Results
Among all participants, 33.9% agreed that it is very difficult to regain one's health after a cancer diagnosis, 17.4% felt uncomfortable with a cancer patient, and 26.9% said that they would avoid marrying people whose family members had cancer. While 88.9% of study participants said that cancer patients deserve to be protected in society, 53.3% and 48.4% of participants agreed that they would not disclose a cancer diagnosis to neighbors and coworkers, respectively.
Conclusion
Negative attitudes with respect to impossibility of recovery and discrimination toward cancer and cancer patients were common among urban Iranians. Most people would not disclose a cancer diagnosis to others in spite of advancements in cancer diagnosis and treatment, reflecting unfavorable attitudes toward cancer and cancer patients in society. Successful implementation of cancer awareness and prevention programs in Iran may require social changes based on adequate information on cancer and cancer patients.
Implications for Practice
Public attitudes toward cancer and cancer patients are an important factor affecting cancer control programs as well as quality of life and recovery of cancer patients. The issue has not been studied in Iran and the surrounding countries in the Middle East. This is the first report presented on the subject. These findings can be used by health policy makers, health managers, and clinicians for better practice.
Previous studies have shown that cancer awareness and screening rates in Iran did not improve despite of the Comprehensive National Cancer Control Program launched in 2007. To better understand the public's attitude towards cancer, we conducted a general population survey for evaluating public attitudes toward cancer and cancer patients in Isfahan, Iran as the first report in Middle East.
There are ≈5 million annual dizziness visits to US emergency departments, of which vestibular strokes account for over 250 000. The head impulse, nystagmus, and test of skew eye examination can ...accurately distinguish vestibular strokes from peripheral dizziness. However, the eye-movement signs are subtle, and lack of familiarity and difficulty with recognition of abnormal eye movements are significant barriers to widespread emergency department use. To break this barrier, we sought to assess the accuracy of EyePhone, our smartphone eye-tracking application, for quantifying nystagmus.
We prospectively enrolled healthy volunteers and recorded the velocity of induced nystagmus using a smartphone eye-tracking application (EyePhone) and then compared the results with video oculography (VOG). Following a calibration protocol, the participants viewed optokinetic stimuli with incremental velocities (2-12 degrees/s) in 4 directions. We extracted slow phase velocities from EyePhone data in each direction and compared them with the corresponding slow phase velocities obtained by the VOG. Furthermore, we calculated the area under the receiver operating characteristic curve for nystagmus detection by EyePhone. We enrolled 10 volunteers (90% men) with an average age of 30.2±6 years. EyePhone-recorded slow phase velocities highly correlated with the VOG recordings (r=0.98 for horizontal and r=0.94 for vertical). The calibration significantly increased the slope of linear regression for horizontal and vertical slow phase velocities. Evaluating the EyePhone's performance using VOG data with a 2 degrees/s threshold showed an area under the receiver operating characteristic curve of 0.87 for horizontal and vertical nystagmus detection.
We demonstrated that EyePhone could accurately detect and quantify optokinetic nystagmus, similar to the VOG goggles.
Previous reports of cutaneous neoplastic lesions secondary to Fingolimod treatment among multiple sclerosis patients.
Reporting a case of cutaneous large cell lymphoma in a multiple sclerosis patient ...during Fingolimod treatment.
Case study.
Our patient developed CD30+ cutaneous large cell lymphoma two years after initiation of Fingolimod treatment and her symptoms regressed following the cessation of treatment.
This report indicates that cutaneous lymphoid neoplasms should be considered a possible side effect among patients receiving Fingolimod.
•A case of cutaneous anaplastic lymphoma during treatment by Fingolimod is presented.•The primary clinical presentation and progression of the lesion is reported.•The possible causal relation between Fingolimod and lesion is explained.
Smartphones have shown promise in the assessment of neuro-ophthalmologic and vestibular disorders. We have shown that the head impulse test results recorded using our application are comparable with ...measurements from clinical video-oculography (VOG) goggles. The smartphone uses ARKit's capability to acquire eye and head movement positions without the need of performing a calibration as in most eye-tracking devices. Here, we measure the accuracy and precision of the eye and head position recorded using our application.
We enrolled healthy volunteers and asked them to direct their eyes, their heads, or both to targets on a wall at known eccentricities while recording their head and eye movements with our smartphone application. We measured the accuracy as the error between the eye or head movement measurement and the location of each target and the precision as the standard deviation of the eye or head position for each of the target positions.
The accuracy of head recordings (15% error) was overall better than the accuracy of eye recordings (23% error). We also found that the accuracy for horizontal eye movements (17% error) was better than for vertical (27% error). Precision was also better for head movement (0.8 degrees) recordings than eye movement recordings (1.3 degrees) and variability tended to increase with eccentricity.
Our results provide basic metrics evaluating the utility of smartphone applications in the quantitative assessment of head and eye movements. While the new method may not replace the more accurate dedicated VOG devices, they provide a more accessible quantitative option. It may be advisable to include a calibration recording together with any planned clinical test to improve the accuracy.
Background
Comorbidity is a current area of interest in multiple sclerosis (MS) and is essential for multidisciplinary management. Although recent studies suggest that patients with MS have an ...elevated risk of developing inflammatory bowel diseases (IBD), this systematic review and meta-analysis aimed to estimate the overall risk of developing ulcerative colitis (UC), specifically in patients with MS.
Methods
In 2021, a comprehensive literature search was performed on PubMed, Scopus, Embase, and Web of Science to identify studies investigating the association between UC and MS. The selected papers were utilized to estimate the associations, risk ratios (RRs), and a 95% confidence interval (CI).
Results
The analysis revealed a slightly elevated risk of UC incidence in patients with MS compared to controls, but this finding was not statistically significant (RR: 1.27 95% CI: 0.96–1.67). In contrast, the study found that patients with UC have a significantly higher risk of developing MS than controls (RR: 1.66 95% CI: 1.15–2.40).
Conclusion
Our findings highlight that the presence of UC increases the risk of developing MS by more than 50%, whereas the presence of MS does not increase the risk of UC occurrence. These results underscore the importance of considering the potential development of UC in the clinical management and early diagnosis of patients with MS, as it may contribute to better therapeutic outcomes.