Does caffeine reduce methotrexate intolerance in patients with rheumatoid arthritis: a randomized controlled study

Abstract Background Intolerance to MTX is the most common cause of non-compliance that leads to poor disease control. Treatment is usually discontinued due to intolerance which interferes with compliance of the patient to long-term treatment. Caffeine causes most of its biological effects via antagonizing all types of adenosine receptors (ARs). Our aim was to investigate the effect of caffeine intake on reducing symptoms of MTX intolerance in patients with RA. Methods Ninety patients were diagnosed as RA with MTX intolerance divided into 2 groups. Sixty patients were prescribed caffeine or dark chocolate. Control group included 30 patients who will continue MTX regimen without addition of any extra caffeine. Results Group A (caffeine group): There was no statistically significant difference between patients and controls at the start of the study. There was statistically significant decrease in methotrexate intolerance severity score (MISS) all over the study period (P = 0.001), and also MISS was statistically significantly lower in each follow-up time when compared with time 0 (P = 0.001). Group B (control group): There was statistically significant increase in MISS all over the study period (P = 0.017); also, MISS was statistically significantly higher in follow-up time 2 and time 3 when compared with time 0 (P = 0.033). We found that after 3 months, 80% of group A patients showed complete relief, 6.7% showed partial relief, 10% showed minimal relief, and 3.3% got worse. Conclusion Adding caffeine to management regimen can reduce the symptoms of MTX intolerance in RA patients. Caffeine relieved the symptoms of MTX intolerance in 80% of RA patients after 3 months of adding caffeine to management regimen.

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Efficacy and Safety of Fenofibrate in Uncomplicated Hyperbilirubinemia in Newborn: A Randomized Trial, with a 6-month Follow-up

Asian Journal of Pediatric Research ◽

10.9734/ajpr/2020/v4i230147 ◽

2020 ◽

pp. 37-42

Author(s):

Jayendra R. Gohil ◽

Vishal S. Rathod ◽

Bhoomika D. Rathod

Keyword(s):

Single Dose ◽

Serum Bilirubin ◽

Total Serum Bilirubin ◽

Total Serum ◽

Control Group ◽

Term Neonates ◽

Significant Difference ◽

Group A ◽

Group B

Objective: To study the effect and safety of Fenofibrate in uncomplicated hyperbilirubinemia in newborn with 6-month follow-up. Materials and Methods: This is a randomized controlled clinical trial conducted in 60 normal term neonates admitted for uncomplicated hyperbilirubinemia in NICU at Sir T G Hospital, Bhavnagar from January 2012 to December 2012. The data included: age, sex, total serum bilirubin (TSB), weight and duration of phototherapy. All neonates enrolled in the study received phototherapy. They were divided in two groups of 30 each: control group A and group B receiving Fenofibrate (100 mg/kg single dose). There was statistically insignificant difference between the parameters of age, sex, weight and TSB between the two groups at hospitalization. Data was analyzed by using appropriate statistical methods. Results: Mean values for total serum bilirubin in Fenofibrate group B at 24 and 48 hours after admission were significantly lower than those for control group A (p<0.0001, p=0.0001). There was no significant difference in fall of TSB between 24 and 48 hours. The mean duration of phototherapy in Fenofibrate group (44.8h: 24-72h) was significantly shorter than that in control group (55.2 h: 24‐96 h) (P=0.02). There were no side effects of the drug observed during the study and during 6 months follow up period. Conclusion: Fenofibrate as a single 100 mg/kg dose in healthy full term neonates, is effective and a safe drug (till six-month follow-up) for neonatal hyperbilirubinemia, that can decrease the time needed for phototherapy and hence hospitalization. Effect of a single dose seems to wane after 24 hours.

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Allogeneic platelet-derived growth factors local injection in treatment of tennis elbow: a prospective randomized controlled study

International Orthopaedics ◽

10.1007/s00264-022-05300-9 ◽

2022 ◽

Author(s):

Mahmoud Ibrahim Kandil ◽

Abdel-Salam Abdel-Aleem Ahmed ◽

Rasha Shaker Eldesouky ◽

Sherif Eltregy

Keyword(s):

Growth Factors ◽

Treatment Group ◽

Tennis Elbow ◽

Local Injection ◽

Controlled Study ◽

Saline Control ◽

Control Group ◽

Patient’S Satisfaction ◽

Significant Difference

Abstract Purpose The purpose of this study aimed to evaluate the efficacy of local injection of allogeneic platelet-derived growth factors in treatment of patients with tennis elbow. Patients and methods This study included 120 tennis elbow patients randomly divided into two groups. The patients were locally injected with allogeneic growth factors (treatment group) or with normal saline (control group). The outcomes were assessed using Patient-Related Tennis Elbow Evaluation (PRTEE) and quick Disabilities of the Arm, Shoulder and Hand (qDASH) scales. The clinical outcomes were accordingly classified as excellent, good and poor. The patient’s satisfaction and adverse effects were also recorded. Results There was no statistically significant difference between the two groups regarding the age, gender, dominant arm or the pre-injection scores. At three month follow-up, the reductions in the mean PRTEE and qDASH scores were 88.7% and 70.6% in the treatment group versus 21.8% and 14.9% in the control group, respectively. At the last follow-up, the outcomes in the treatment group were excellent in 85% of patients and good in 15%, versus 8% and 32% in the control group. Overall, 95% were satisfied in the treatment group compared to 25% in control group. Forty patients in the treatment group experienced mild transient post-injection pain. Conclusion This study strongly suggests that local injection of allogeneic platelet-derived growth factors could be a promising safe treatment option for tennis elbow with significant pain relief, functional improvement and patient’s satisfaction. Yet, additional larger studies are needed to assess the durability of these outcomes.

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The Efficacy and Safety of Transcutaneous Acupoint Interferential Current Stimulation for Cancer Pain Patients With Opioid-Induced Constipation: A Prospective Randomized Controlled Study

Integrative Cancer Therapies ◽

10.1177/1534735417734910 ◽

2017 ◽

Vol 17 (2) ◽

pp. 437-443 ◽

Cited By ~ 3

Author(s):

Hua-dong Zhu ◽

Zhen Gong ◽

Bing-wei Hu ◽

Qiao-ling Wei ◽

Jun Kong ◽

...

Keyword(s):

Quality Of Life ◽

Cancer Pain ◽

Controlled Study ◽

Control Group ◽

Efficacy And Safety ◽

Significant Difference ◽

Interferential Current ◽

Pain Patients

Introduction. Opioid-induced constipation (OIC) is a principal complication secondary to analgesic therapy for cancer pain patients who suffer moderate to severe pain. In this study, we observe the efficacy and safety of transcutaneous acupoint interferential current (IFC) stimulation in those patients with OIC. Methods. A total of 198 patients were randomly allocated to the IFC group and control group in a 1:1 ratio. Finally, 98 patients in the IFC group received 14 sessions administered over 2 weeks, whereas 100 patients in the control group took lactulose orally during the same period. Observation items were documented at management stage and at follow-up stage according to Cleveland Constipation Scales (CCS), pain Numeric Rating Scales (NRS) and Patient Assessment of Constipation Quality of Life (PAC-QoL). Results. The total curative effects of the IFC group and the control group were indistinguishable (76.5% vs 70.0%, P = .299). Regarding CCS and PAC-QoL scores, no significant difference was observed between the 2 groups during the management time and at the follow-up stage of week 3 ( P > .05, respectively), but groups were distinguished at the follow-up stage of week 4 ( P < .001 and P = .031, respectively). The pain NRS decreased significantly at management stage week 2 and follow-up stage week 3 and week 4 ( P = .013, P = .041, P = .011, respectively). Conclusions. Transcutaneous acupoint IFC therapy over acupoints of Tianshu (ST25) and Zhongwan (RN12) may improve constipation and quality of life in cancer patients receiving opiates; further studies are worthwhile.

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Modified completely intrafascial radical cysprostatectomy for bladder cancer: a single-center, blinded, controlled study

BMC Cancer ◽

10.1186/s12885-021-08568-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Xiao Wang ◽

Jia Guo ◽

Lei Wang ◽

Min Wang ◽

Xiaodong Weng ◽

...

Keyword(s):

Bladder Cancer ◽

Erectile Function ◽

Functional Outcomes ◽

Cancer Control ◽

Controlled Study ◽

Control Group ◽

Single Center ◽

Significant Difference ◽

Urinary Control

Abstract Background We have proposed a modified, completely intrafascial radical cysprostatectomy (RC) to treat bladder cancer patients with the aim of preserving the patients’ post-surgical urinary control and erectile function. This study aimed to evaluate the oncological and functional outcomes of this innovation relatively to that with the conventional technique. Methods A retrospective, single-center, blinded, and controlled study was conducted using the medical data of patients since the past 5 years from the hospital database. A total of 44 patients were included, including 20 who received complete intrafascial cysprostatectomy and 24 who received conventional interfascial surgeries. The patients’ continent and sexual information of 1-year follow-up after the surgery were extracted. The oncological and functional outcomes of the 2 groups were compared and analyzed. Results The demographics parameters of the 2 groups showed no significant difference. The results of follow-up of the oncological outcomes did not reveal any significant difference between the completely intrafascial group and the conventional interfascial group in terms of the positive surgical margins, local recurrences, and distant metastasis. Patients following neobladder diversion in the intrafascial group showed a faster recovery of the urinary control, with a 76.9% (10/13) daytime continent rate at 3-month, as well as 46.2% (6/13) and 58.3% (7/12) nighttime continent rates at 3-month and 6-month, respectively. Regarding the sexual functions, our results revealed significant advantages in favor of completely intrafascial technique on the post-surgical International Index of Erectile Function (IIEF)-5 score at 3-, 9-, and 12-month follow-up relative to that with the conventional interfascial process. Thus, the IIEF score of patients in the intrafascial group was 11.4 ± 3.5 at 3-month, 14.1 ± 3.6 at 9-month, and 15.2 ± 3.8 at 12-month follow-up after the cystectomy, which was significantly greater than that of the patients in the control group. Conclusions Our novel data illustrated that the modified completely intrafascial technique could result in a better sexual function and faster continence recovery for patients following RC, without any compromise in the cancer control. Thus, this technique could be considered as an alternative extirpative technique for bladder cancer treatment in a clinical setting.

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A Randomized Placebo-Controlled Study on the Effectiveness of the “Three Good Things for Others” Intervention

Frontiers in Psychology ◽

10.3389/fpsyg.2021.661336 ◽

2021 ◽

Vol 12 ◽

Author(s):

Mariola Laguna ◽

Michał Kȩdra ◽

Zofia Mazur-Socha

Keyword(s):

Negative Affect ◽

Prosocial Behavior ◽

Controlled Trial ◽

Controlled Study ◽

Control Group ◽

Placebo Control ◽

General Tendency ◽

Childhood Memories ◽

Group A

The aim of our study was to test the effectiveness of the “three good things for others” intervention. We used the randomized controlled trial method, with four measurements (pretest, posttest, follow-up after 2 weeks, follow-up after 4 weeks) and with random assignment of participants to experimental and placebo control groups. We investigated the effects of the intervention on prosocial behavior, and in addition on positive and negative affect, and positive orientation (a general tendency to approach reality in a positive way). The results showed an increase in positive affect and a decrease in negative affect in the experimental group a day after the intervention. These effects, however, did not endure over the next 2 or 4 weeks. We also observed a statistically significant increase in prosocial behavior in the placebo control group, in which participants were engaged in a task of recalling childhood memories. The results are discussed and recommendations for future studies are proposed.

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A Comparative Study on the Efficacy of Kantkari and Vasa Lozenges in Children with Kasa (Cough)-Study Protocol

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i31b31685 ◽

2021 ◽

pp. 25-33

Author(s):

Sabir Ali ◽

Renu Rathi ◽

Bharat Rathi

Keyword(s):

Comparative Study ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

Abnormal Sound ◽

Sequence Method ◽

Group A ◽

Objective Outcomes ◽

Group B

Background: Kasa is the outcome due to release of obstructed Vayu resulting in the production of abnormal sound, which may be productive or dry. Kasa is one of the primary diseases of Pranavaha srotas, and can cause disturbances in other body functions. Prevalence of cough in India is 5% to 10% while acute cases of cough is 39% and chronic cases of cough is 29% reported in Maharashtra. This research drug is taken to check its efficacy on both the types of cough, dry as well as productive with acute or chronic origin. It has a good palatability and liked by children as it appears as candy. Many studies have been carried out on Kasa with different formulations so far like vati, churna, ghrita but they have no fast and long lasting action with different level of efficacy. Many lozenges are also available in the market but no studies have been done. Objective: Comparative Study on the efficacy of Kantakari lozenges with Vasa lozenges in the clinical features of Kasa by subjective criteria such as Peenasa-(running nose), Kasa, Aruchi-(taste impliedness), kanthkandu(throat itching), kaphnishthivan (Sputum) and objective criteria as adventitious sound and AEC-absolute eosinophil count, TLC-total leucocytes count, and DLC-differential leucocyte count. Materials and Methods: The present study is designed as a Double Blind, Randomized Controlled Study in which total 60 patients will be enrolled. Patients will be randomly divided (by computer generated sequence method) in two with 30 patients in each group. In group A, Vasa lozenges and in group B Kantkari lozenges will be given for 7 days. Assessment of the patients will be done on 3rd and 7th day during study after intervention and post treatment follow up will be taken on 14th& 21st day from the enrolled date. Results: Efficacy of both the lozenges will be observed in subjective and objective outcomes. Conclusion: Kantkari lozenges (trial group) is expected to be more effective than Vasa lozenges (control group) in the management of Kasa as Vata, Kapha are more dominant in the pathology of Kasa in children and Kantakari is a good Vatakaphahar drug added with Pippali to act synergistically.

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Modified technique of end to side distal radio-cephalic shunt to overcome juxta-anastomotic stenosis

International Surgery Journal ◽

10.18203/2349-2902.isj20191060 ◽

2019 ◽

Vol 6 (4) ◽

pp. 1029

Author(s):

Haitham Atif ◽

Nehad Abdou Zaid ◽

Abd El-Mieniem Fareed Mohamed ◽

Yehia Mohamed Alkhateep

Keyword(s):

Patency Rate ◽

Intervention Group ◽

Anastomotic Stenosis ◽

Control Group ◽

P Value ◽

Modified Technique ◽

Significant Difference ◽

Group A ◽

Group B

Background: Juxta-anastomotic stenosis (JAS) is one of the predominant causes of arteriovenous fistula (AVF) failure, with the reported incidence of 65%, so that technical modification to alter the outflow vein configuration using the modified technique has been applied to prevent JAS and improve AVF maturation. The aim of the study to evaluate the modified technique of end-to-side distal radiocephalic A-V fistula regarding maturation, patency rate and the resultant juxta-anastomotic stenosis.Methods: This prospective study was carried out on 80 patients with end stage renal disease (ESRD) at vascular surgery unit in general surgery department, Menoufia university hospital that prepared for dialysis. 40 patients "intervention group" underwent the modified technique to establish a functioning radiocephalic fistula; the other group (40 patients, control group) had the conventional technique of end to side radiocephalic fistula. Follow up of patients was over 6 months regarding function, patency rate and development of juxta-anastomotic stenosis.Results: There was statistically significant difference between 2 groups regarding primary failure, patency and JAS. Primary failure was detected in 2 patients in group A and in 5 patients in group B (p-value is 0.04). Considering patency rate, after 3 months the ratio between group A and group B was 37:34 with significant P value of 0.02, and after 6 months the ratio was 35:33 with P value of 0.03. Regarding JAS, by the end of follow up period, 4 patients diagnosed with JAS in group A, while group B had 8 patients, with p value of 0.01.Conclusions: Modified technique of end to side anastomosis for primary radio-cephalic fistula creation has better patency rate and low incidence of JAS than conventional method.

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Mindfulness-Based Intervention for Children with Mental Health Problems: a 2-Year Follow-up Randomized Controlled Study

Mindfulness ◽

10.1007/s12671-021-01771-w ◽

2021 ◽

Author(s):

Katarina Laundy ◽

Peter Friberg ◽

Walter Osika ◽

Yun Chen

Keyword(s):

Mental Health ◽

Disruptive Behavior ◽

Mental Health Problems ◽

Intervention Group ◽

Health Problems ◽

Controlled Study ◽

Control Group ◽

Registration Number ◽

Group A

Abstract Objectives Moderate mental health problems are highly prevalent and increasing in Swedish schoolchildren, elevating risk for future mental and somatic disability. The aim of this study was to determine whether an 8-week mindfulness-based intervention, Training for Mindfulness and Resilience (TMR), mitigates mental health symptoms and increases resilience during a 2-year follow-up. Methods Schoolchildren (aged 9–14 years) reporting moderate mental health problems were randomized into either TMR intervention group (N = 22) or control group, receiving best current practice (N = 12). We used validated questionnaires to measure anxiety, depression, anger, disruptive behavior, self-concept, resilience, stress, and mindfulness before treatment with either TMR or control, as well as at 6 months, 1 year, and 2 years follow-up. Results We found a statistically significant effect of TMR intervention vs control, on resilience, anxiety, anger, and disruptive behavior. Compared to baseline, TMR increased the level of resilience at 6 months (p < .001); anxiety at 1 (p < = .033) and 2 years (p = .04); anger at 6 months (p = .004) and 2 years (p = .039); disruptive behavior at 6 months (p = .006). In the control group, a decrease in resilience between 6 months and 2 years (p = .05) was observed. No other significant effects were found in the control group. Conclusions This study suggested that TMR improved mental health in schoolchildren with effects on anxiety and anger lasting for 2 years, and on resilience and disruptive behavior lasting for 6 months. Trial Registration Number NCT04806542, date of registration 18th of March 2021, retrospectively registered.

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Long term (five-year) survival following radical surgical treatment plus adjuvant chemotherapy (FAM) in advanced gastric cancer: a controlled study

Revista do Hospital das Clínicas ◽

10.1590/s0041-87812000000400004 ◽

2000 ◽

Vol 55 (4) ◽

pp. 129-136 ◽

Cited By ~ 5

Author(s):

Cláudio Bresciani ◽

Joaquim Gama-Rodrigues ◽

Victor Strassmann ◽

Dan L. Waitzberg ◽

Mitsunori Matsuda ◽

...

Keyword(s):

Gastric Cancer ◽

Surgical Treatment ◽

Survival Rate ◽

Tnm Classification ◽

Controlled Study ◽

Hematological Toxicity ◽

Control Group ◽

Significant Difference ◽

The Impact

Several drugs and their associations are being used for adjuvant or complementary chemotherapy with the aim of improving results of gastric cancer treatment. The objective of this study was to verify the impact of these drugs on nutrition and on survival rate after radical treatment of 53 patients with gastric cancer in stage III of the TNM classification. A control group including 28 patients who had only undergone radical resection was compared to a group of 25 patients who underwent the same operative technique followed by adjuvant polychemotherapy with FAM (5-fluorouracil, Adriamycin, and mitomycin C). In this latter group, chemotherapy toxicity in relation to hepatic, renal, cardiologic, neurological, hematologic, gastrointestinal, and dermatological functions was also studied. There was no significant difference on admission between both groups in relation to gender, race, macroscopic tumoral type of tumor according to the Borrmann classification, location of the tumor in the stomach, length of the gastric resection, or response to cutaneous tests on delayed sensitivity. Chemotherapy was started on average, 2.3 months following surgical treatment. Clinical and laboratory follow-up of all patients continued for 5 years. The following conclusions were reached: 1) The nutritional status and incidence of gastrointestinal manifestation were similar in both groups; 2) There was no occurrence of cardiac, renal, neurological, or hepatic toxicity or death due to the chemotherapeutic method per se; 3) Dermatological alterations and hematological toxicity occurred exclusively in patients who underwent polychemotherapy; 4) There was no significant difference between the rate and site of tumoral recurrence, the disease-free interval, or the survival rate of both study groups; 5) Therefore, we concluded, after a 5-year follow-up, chemotherapy with the FAM regimen did not increase the survival rate.

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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.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.5_suppl.lba266 ◽

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.

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