scholarly journals AB1309-HPR EFFICACY OF ADDING CAFFEINE TO THE TREATMENT REGIMEN IN REDUCING METHOTREXATE INTOLERANCE IN PATIENTS WITH RHEUMATOID ARTHRITIS: A RANDOMIZED CONTROLLED STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1945.1-1945
Author(s):  
A. Fehr ◽  
F. El Noby ◽  
N. Fathi ◽  
R. Lotfy
Keyword(s):  
Rheumatoid Arthritis ◽  
Severity Score ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Base Line ◽  
Clinical Rheumatology ◽  
Randomized Controlled ◽  
Significant Difference

Background:Rheumatoid arthritis is one of common form of chronic inflammatory arthritis. Methotrexate has remained anchor treatment because of its potent efficacy1. Intolerance to Methotrexate is a common cause of non-compliance2&3.Objectives:To investigate the effect of adding caffeine orally as Methylxanthines (Caffeine), act as adenosine receptor antagonists4to reduce symptoms of moderate to severe methotrexate intolerance in patients with Rheumatoid Arthritis5.Methods:A prospective, randomized controlled study conducted at Aswan University Hospital, Egypt from Jan 2018 till may 2019. Sixty patients with Rheumatoid arthritis who have had experienced moderate to severe methotrexate intolerance was enrolled in the study. The methotrexate intolerance severity score (MISS)6was evaluated at base line before initiation of study then at the next three months consecutively. Patients were randomly assigned by closed envelope method into 2 groups each containing 30 patients:Group (A); 30 patients was prescribed caffeine (coffee or dark chocolate) as an antidote to methotrexate intolerance7.Group (B); 30 matched patients acted as control group that included who will continue methotrexate regimen without addition of any extra caffeine.Results:Twenty four patients (80%) at time three follow up visit showed full improvement of symptoms of methotrexate-intolerance compared to ten patients (33.3%) at 2nd month follow up visit and seven patients (23%) at 1st month follow up visit with statistically significant difference all over the study period (P=0.005). half of study group patients discontinued anti-emetic and other drugs while none in control group did.Conclusion:Adding caffeine to management regimen can reduce the symptoms of severe methotrexate-intolerance in Rheumatoid Arthritis patients.References:[1]Friedman, B., & Cronstein, B. (2019). Methotrexate Mechanism in Treatment of Rheumatoid Arthritis. Joint Bone Spine, 86(3):301-307[2]Wang, W., Zhou, H., & Liu, L. (2018). Side effects of methotrexate therapy for rheumatoid arthritis: a systematic review. European journal of medicinal chemistry. Volume 158, 502-516[3]Bulatović, M., Heijstek, M. W., Verkaaik, M., van Dijkhuizen, E. P., Armbrust, W., Hoppenreijs, E. P., ... & Rademaker, C. M. (2011). High prevalence of methotrexate intolerance in juvenile idiopathic arthritis: development and validation of a methotrexate intolerance severity score. Arthritis & Rheumatism, 63(7), 2007-2013.[4]Malaviya, A., Baghel, S., Verma, S., Thakran, R., & Messi, C. (2019). Use of coffee for alleviating methotrexate intolerance in rheumatic diseases. Indian Journal of Rheumatology, 14(1), 79-79.[5]Ribeiro, J. A., & Sebastiao, A. M. (2010). Caffeine and adenosine. Journal of Alzheimer’s Disease, 20(s1), S3-S15.[6]Fatimah, N., Salim, B., Nasim, A., Hussain, K., Gul, H., & Niazi, S. (2016). Frequency of methotrexate intolerance in rheumatoid arthritis patients using methotrexate intolerance severity score (MISS questionnaire). Clinical rheumatology, 35(5), 1341-1345.[7]Malaviya, A. N. (2017). Methotrexate intolerance in the treatment of rheumatoid arthritis (RA): effect of adding caffeine to the management regimen. Clinical rheumatology, 36(2), 279-285.Disclosure of Interests:None declared

scholarly journals Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized–controlled study

2019 ◽  
Vol 8 (1) ◽  
pp. 31-35 ◽  
Author(s):  
Stephanie L Hansel ◽  
Joseph A Murray ◽  
Jeffrey A Alexander ◽  
David H Bruining ◽  
Mark V Larson ◽  
...  
Keyword(s):  
Small Bowel ◽  
Capsule Endoscopy ◽  
Bowel Preparation ◽  
Diagnostic Yield ◽  
Completion Rate ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background Capsule endoscopy (CE) is frequently hindered by intra-luminal debris. Our aim was to determine whether a combination bowel preparation would improve small-bowel visualization, diagnostic yield, and the completion rate of CE. Methods Single-blind, prospective randomized–controlled study of outpatients scheduled for CE. Bowel-preparation subjects ingested 2 L of polyethylene glycol solution the night prior to CE, 5 mL simethicone and 5 mg metoclopramide 20 minutes prior to CE and laid in the right lateral position 30 minutes after swallowing CE. Controls had no solid food after 7 p.m. the night prior to CE and no liquids 4 hours prior to CE. Participants completed a satisfaction survey. Capsule readers completed a small-bowel-visualization assessment. Results Fifty patients were prospectively enrolled (56% female) with a median age of 54.4 years and 44 completed the study (23 patients in the control group and 21 in the preparation group). There was no significant difference between groups on quartile-based small-bowel visualization (all P > 0.05). There was no significant difference between groups in diagnostic yield (P = 0.69), mean gastric (P = 0.10) or small-bowel transit time (P = 0.89). The small-bowel completion rate was significantly higher in the preparation group (100% vs 78%; P = 0.02). Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%; P = 0.01). Conclusions Combined bowel preparation did not improve small-bowel visualization but did significantly increase patient discomfort. The CE completion rate improved in the preparation group but the diagnostic yield was unaffected. Based on our findings, a bowel preparation prior to CE does not appear to improve CE performance and results in decreased patient satisfaction (ClinicalTrials.gov, No. NCT01243736).

The impact of pharmacist telephone calls after discharge on satisfaction of oncology patients: A randomized controlled study

2017 ◽  
Vol 24 (5) ◽  
pp. 359-364 ◽  
Author(s):  
Sewar S Salmany ◽  
Lujeen Ratrout ◽  
Abdallah Amireh ◽  
Randa Agha ◽  
Noor Nassar ◽  
...  
Keyword(s):  
Emergency Room ◽  
Hospital Readmissions ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Emergency Room Visits ◽  
Oncology Patients ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Impact

Purpose The aim of the study was to determine the impact of telephone follow-up calls on satisfaction in oncology patients after hospital discharge. Method A randomized controlled study, in which patients were randomized into two groups: The experimental group with the telephone follow-up (TFU) calls (intervention) and the control group (no intervention). The telephone follow-up call was conducted within 72 h after discharge. During the call, patients were asked about their medications, namely, whether they received them, understood how to take them, and whether they developed any medication-related adverse effect. Both groups were contacted by phone two weeks later to assess their satisfaction with the discharge medication instructions and the provided pharmaceutical services, using the 5-point Likert scale. In addition, hospital records were reviewed for emergency room visits and hospital readmissions within 30 days after discharge. Results There was no difference in the percentage of patients who reported being very satisfied between both the intervention and the control groups (45% intervention vs. 48% control, P = 0.68). The mean time of the intervention phone call was 3 ± 1.7 (SD) min. During the telephone follow-up call, medication-related problems were identified in 20% of the patients. There was no significant difference in emergency room visits and hospital readmissions in the intervention group vs. control (44% vs. 53%, P = 0.123) and (37% vs. 43%, P = 0.317), respectively. Conclusion Telephone follow-up calls conducted by a pharmacist to discharged oncology patients did not improve patients' satisfaction, emergency room visits or hospital readmissions; however, they helped to identify medication-related adverse effects in the oncology patients.

scholarly journals Effects of a randomized controlled study on the behaviors of overweight schoolchildren

2021 ◽  
Vol 26 ◽  
Author(s):  
Anastácio Neco de Souza Filho ◽  
Thaynã Alves Bezerra ◽  
Paulo Felipe Ribeiro Bandeira ◽  
Luciana Gatto Azevedo Cabral ◽  
José Fernando Vila Nova de Moraes ◽  
...  
Keyword(s):  
Physical Activity ◽  
Behavioral Therapy ◽  
Vigorous Physical Activity ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Daily Routine ◽  
Randomized Controlled ◽  
School Based ◽  
Significant Difference

This study aimed to determine the effects of a school-based multi-component intervention on accelerometer- measured physical activity (PA) and sedentary behavior (SB) in schoolchildren overweight. This is a randomized controlled study with overweight schoolchildren, allocated to experimental group (EG; n = 13; 7.6 ± 0.8 years; 42.9% boys) and control group (CG; n = 17; 8.2 ± 0.9 years; 26.7% boys). The EG was submitted to a 10-week school-based intervention, comprised of PA and psychological sessions (behavioral therapy), and nutritional guidance. The CG followed the daily routine of life. The time of PA and SB were measured using accelerometers used for seven days. To compare mean SB, moderate to vigorous physical activity (MVPA) and total physical activity (TPA), generalized estimation equations (GEE) were used. It was observed that the average time in MVPA and TPA increased significantly in EG at the weekend (+ 40.9 min / day, p < 0.001; and + 51.6 min/day, p = 0.035, respectively) and at full week (+ 62.9 min/day, p < 0.001; and + 225.0 9 min/day, p = 0.038, respectively). There was no significant difference in time spent in SB after the intervention in both groups. Thus, it was concluded that the proposed school-based multicomponent intervention was effective in increasing levels of MVPA and TPA in overweight schoolchildren. This finding can optimize future interventions to promote a healthy lifestyle for schoolchildren in the school environment.

scholarly journals Effect of the Use of WeChat to Disseminate Preoperative Health Education to Parents of Children with Restrictive Ventricular Septal Defects: A Prospective Randomized Controlled Study

2020 ◽  
Vol 23 (6) ◽  
pp. E897-E901
Author(s):  
Qiliang Zhang ◽  
Ning Xu ◽  
Shuting Huang ◽  
Qiang Chen ◽  
Hua Cao
Keyword(s):  
Health Education ◽  
Ventricular Septal Defect ◽  
Septal Defect ◽  
Preoperative Care ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Loss To Follow Up ◽  
Randomized Controlled

Background: This study explored the clinical effect of implementing WeChat-based preoperative health education for parents of children with restrictive ventricular septal defect. Methods: A prospective randomized controlled study was conducted in a provincial hospital on the southeast coast of China. Participants were randomly divided into an intervention (WeChat) group (n = 35) and a control group (leaflet) group (n = 35). The study explored the parents’ knowledge of preoperative care, the follow-up rate, and complications of children with restrictive ventricular septal defect. Results: The score of preoperative care knowledge of the WeChat group (66.9 ± 3.5) was significantly higher than that of the leaflet group (47.3 ± 6.3) (P = .006). Compared with the score of care knowledge at the first visit, the score of the WeChat group at the preoperation was significantly higher (P < .05), whereas the increase in the score of the leaflet group was not significant. The rate of lost follow-up in the WeChat group (0%) was significantly lower than in the leaflet group (16.7%) (P = .02). The complications in the leaflet group were significantly higher than in the WeChat group. Conclusions: Using WeChat to provide preoperative health education to parents of children with restrictive ventricular septal defect can effectively enhance the parents’ knowledge of preoperative care and reduce the occurrence of complications and loss to follow-up.

Single or two instillations of pirarubicin as prophylaxis for recurrence after transurethral resection of Ta and T1 transitional cell bladder cancer: A prospective, randomized controlled study.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. LBA266-LBA266
Author(s):  
Takashi Saika ◽  
Tomoyasu Tsushima ◽  
Yasutomo Nasu ◽  
Hiromi Kumon ◽  
Keyword(s):  
Transurethral Resection ◽  
Intravesical Instillation ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Group A ◽  
Muscle Invasive ◽  
Group B

LBA266 Background: Although single intravesical instillation chemotherapy immediately after transurethral resection (TUR) is the standard treatment for non-muscle-invasive bladder tumors, 40% to 80% of tumors show intravesical recurrence. In this prospective randomized controlled study, we try to evaluate the prophylactic efficacy and safety of twice intravesical instillation using pirarubicin (THP) administered immediately after TUR and on the next day following TUR by comparison with single instillation immediately after TUR. Methods: Between 2005 and 2009, 250 patients with Ta and T1 solitary bladder carcinoma were enrolled in this study. Patients were randomized into two groups. Group A patients were treated with two intravesical instillations of THP 30 mg/50 ml saline immediately after TUR and within 24 hours. Group B patients were treated with single instillation of the same dose immediately after TUR as a control group. The primary endpoint was duration to the first recurrence, and the secondary endpoint was safety. Results: The enrollment was closed on 2009, and the follow-up phase is in process. Of the 250 patients, 125 in Group A and 125 in Group B could be evaluated as full analysis set. One hundred eight male and 17 female were in Group A, on the other hands, one hundred five male and 20 female were in Group B. Eighty-six cases (69%) in group A, and 88 cases (70%) in group B were primary tumor. Fifty-seven cases (46%) in group A, and 56 cases (45%) in group B were small tumor (less than 10mm). There was no difference between backgrounds of both groups. The randomization worked well. In this ad interim report, median follow up was 48 months. Two-year recurrence-free rates were 76.8% in group A and 67.5% in group B. Adverse reactions related to instillation were observed in about 20% of the patients. These toxicities were mild and transient. Only the incidence of frequency in group A was higher than that in group B (20% vs. 8%, p=0.0106). Conclusions: Intravesical instillation of THP 30 mg twice within 24 hours after TUR was effective as prophylactic therapy for non-muscle-invasive cancer with tolerable toxicity problems.

scholarly journals The effect of virtual reality glasses on anxiety during surgery under spinal anesthesia: a randomized controlled study

2021 ◽  
Vol 25 (2) ◽  
Author(s):  
Ayse Zeynep Turan ◽  
Mehmet Yilmaz ◽  
Tolga Saracoglu
Keyword(s):  
Virtual Reality ◽  
Spinal Anesthesia ◽  
Trait Anxiety ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Care Group ◽  
Control Group ◽  
State Trait Anxiety Inventory ◽  
Randomized Controlled ◽  
Significant Difference

Background & objectives: Surgery–related anxiety can be observed due to several factors in patients undergoing surgery. With developing technology virtual reality (VR) glasses have begun to be used to reduce anxiety in the preoperative period. We aimed to investigate the effect of using VR glasses on operation anxiety and sedation requirement in patients during operation under spinal anesthesia.    Methodology: We enrolled 97 patients between 18–75 y of age, ASA class I–II, in this study. Participants were randomized into VR glasses group or the standard care group. The State-Trait Anxiety Inventory for Trait Anxiety (STAI–TA) and State-Trait Anxiety Inventory for State Anxiety (STAI–SA) scores preoperatively and anxiety score on VAS scale during surgery were obtained. Patients watched a movie via VR glasses (BOBO® VR Z4) after spinal anesthesia and the surgical operation was commenced thereafter. In the control group, the surgery was begun without any additional procedure. Results: Both groups were similar in terms of demographic and hemodynamic data. There was no statistically significant difference between groups in terms of preoperative anxiety levels, STAI–SA and STAI–TA scores. However, the VAS and relative risk (RR) values were significantly lower in the study group in all measurements (p < 0.05). Conclusion: We believe that the use of VR glasses decreases perioperative anxiety and sedation requirements in patients undergoing a surgical procedure under spinal anesthesia. Key words: Spinal Anesthesia; Virtual Reality; Anxiety; Sedation Citation: Turan AZ, Yilmaz M, Saracoglu T. The effect of virtual reality glasses on anxiety during surgery under spinal anesthesia: a randomized controlled study. Anaesth pain intensive care 2021;25(2):170-175. DOI: 10.35975/apic.v25i2.1469 Received: 31 January 2021, Reviewed: 22, 25 February 2021, Accepted: 27 February 2021

The Effect of Exercise on Sleep and Fatigue in Rheumatoid Arthritis: A Randomized Controlled Study

2014 ◽  
Vol 41 (10) ◽  
pp. 1966-1973 ◽  
Author(s):  
Laura Durcan ◽  
Fiona Wilson ◽  
Gaye Cunnane
Keyword(s):  
Rheumatoid Arthritis ◽  
Sleep Quality ◽  
Exercise Intervention ◽  
Intervention Group ◽  
Exercise Program ◽  
Chronic Fatigue ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled

Objective.Sleep disturbance and chronic fatigue are common in rheumatoid arthritis (RA) and contribute to disability, symptomatology, and healthcare use. It has long been recognized in other populations that exercise can improve sleep and diminish fatigue. The effect of exercise on sleep quality and fatigue in RA has not been evaluated.Methods.Ours is a randomized controlled study in RA to determine the effect of an exercise program on sleep quality and fatigue. These were measured using the Pittsburgh Sleep Quality Index and the Fatigue Severity Scale. Patients were randomized to either a 12-week, home-based exercise intervention or usual care. The exercise program consisted of specific exercises to target individual deficiencies identified using the Health Assessment Questionnaire (HAQ) with cardiovascular work as per the guidelines. The intervention group was evaluated on a 3-week basis. Full evaluation was carried out at baseline and at 12 weeks.Results.Forty patients were randomized to the intervention with 38 controls. In the exercise intervention group, there was a statistically significant improvement in HAQ (p = 0.00), pain (p = 0.05), stiffness (p = 0.05), sleep quality (p = 0.04), and fatigue (p = 0.04). In our control group, there was a statistically significant improvement demonstrated in their overall perceptions of the benefits of exercise, but none of the other variables.Conclusion.Our study demonstrates that an exercise program resulted in significant improvement in sleep quality and fatigue. This is particularly interesting given the importance of fatigue as an outcome measure in RA and gives us yet another reason to prescribe exercise in this population.

scholarly journals Effectiveness of Text Messaging as an Incentive to Maintain Physical Activity after Cardiac Rehabilitation: A Randomized Controlled Pilot Study

2021 ◽  
Vol 18 (12) ◽  
pp. 6645
Author(s):  
Giulia Foccardi ◽  
Marco Vecchiato ◽  
Daniel Neunhaeuserer ◽  
Michele Mezzaro ◽  
Giulia Quinto ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cardiac Rehabilitation ◽  
Exercise Testing ◽  
Text Messages ◽  
Control Group ◽  
Stand Test ◽  
Randomized Controlled ◽  
Sit To Stand ◽  
Significant Difference

Although the efficacy of cardiac rehabilitation (CR) is proven, the need to improve patients’ adherence has emerged. There are only a few studies that have investigated the effect of sending text messages after a CR period to stimulate subjects’ ongoing engagement in regular physical activity (PA). A randomized controlled pilot trial was conducted after CR, sending a daily PA text message reminder to an intervention group (IG), which was compared with a usual care control group (CG) during three months of follow-up. Thirty-two subjects were assessed pre- and post-study intervention with GPAQ, submaximal iso-watt exercise testing, a 30 s sit-to-stand test, a bilateral arm curl test, and a final survey on a seven-point Likert scale. A statistically significant difference in the increase of moderate PA time (Δ 244.7 (95% CI 189.1, 300.4) minutes, p < 0.001) and in the reduction of sedentary behavior time (Δ −77.5 (95% CI 104.9, −50.1) minutes, p = 0.004) was shown when the IG was compared with the CG. This was associated with an improvement in heart rate, blood pressure, and patients’ Borg rating on the category ratio scale 10 (CR10) in iso-watt exercise testing (all p < 0.05). Furthermore, only the IG did not show a worsening of the strength parameters in the follow-up leading to a change of the 30 s sit-to-stand test with a difference of +2.2 (95% CI 1.23, 3.17) repetitions compared to CG (p = 0.03). The telemedical intervention has been appreciated by the IG, whose willingness to continue with regular PA emerged to be superior compared to the CG. Text messages are an effective and inexpensive adjuvant after phase 2 CR that improves adherence to regular PA. Further studies are needed to confirm these results in a larger patient population and in the long term.

scholarly journals Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-Pelvic Stability and Adductor Strength in Female Soccer Players. A Randomized Controlled Study

2021 ◽  
Vol 18 (4) ◽  
pp. 1528
Author(s):  
Héctor Guerrero-Tapia ◽  
Rodrigo Martín-Baeza ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Repeated Measures ◽  
Gluteus Medius ◽  
Soccer Players ◽  
Controlled Study ◽  
Control Group ◽  
Extrinsic Factors ◽  
Randomized Controlled ◽  
Limb Injuries ◽  
Experimental Group

Background. Abdominal and lumbo-pelvic stability alterations may be the origin of lower limb injuries, such as adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: In this randomized controlled trial over 8 weeks, 25 female footballers were randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). Evaluations were performed at baseline, at the end of the intervention and after a 4-week follow-up period. The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbar-pelvic stability and adductor strength. Results: After the intervention, there was an increase in lumbo-pelvic stability in both groups, being greater in the control group than in the experimental group (mean differences [MD]: 4.84 vs. MD: 9.58; p < 0.01) with differences in the analysis of repeated measures (p < 0.001), but not in group interaction (p = 0.26). Changes were found in adductor strength in the experimental group (MD: −2.48; p < 0.001 in the left adductor; MD: −1.48; p < 0.01 in right adductor) and control group (MD: −1.68; p < 0.001 in the left adductor; MD: −2.05; p < 0.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p < 0.001) and right (p < 0.001) adductor strength. Conclusions: An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength, while improvements in both variables are maintained at four weeks follow-up.

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