5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment.

BACKGROUND: Cancer-related fatigue (CRF) is still undertreated in most patients, as evidence for pharmacological treatments is limited and conflicting. Also, the efficacy of the pharmacological agents relative to each other is still unclear. Therefore, medications that may potentially contribute to improving CRF will be investigated in this head-to-head trial. Our main objective is to compare the efficacy of methylphenidate vs. bupropion vs. ginseng vs. amantadine vs. placebo in patients with advanced cancer. METHODS: The 5-EPIFAT study is a 5-arm, randomized, multi-blind, placebo-controlled, multicenter trial that will use a parallel-group design with an equal allocation ratio comparing the efficacy and safety of four medications (Methylphenidate vs. Bupropion vs. Ginseng vs. Amantadine) versus placebo for management of CRF. We will recruit 255 adult patients with advanced cancer who experience fatigue intensity ≥ 4 based on a 0-10 scale. The study period includes a 4-week intervention and a 4-week follow-up with repeated measurements over time. The primary outcome is the cancer-related fatigue level over time, which will be measured by the functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. To evaluate safety, the secondary outcome is the symptomatic adverse events, which will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in cancer clinical trials (PRO-CTCAE). Also, a subgroup analysis based on a decision tree-based machine learning algorithm will be employed for the clinical prediction of different agents in homogeneous subgroups. DISCUSSION: The findings of the 5-EPIFAT trial could be helpful to guide clinical decision-making, personalization treatment approach, design of future trials, as well as the development of CRF management guidelines. TRIAL REGISTRATION: IRCT.ir IRCT20150302021307N6. Registered on 13 May 2023.

Therapeutic effect of ferrous sulfate in diabetic patients with iron deficiency anaemia: a randomised controlled trial.

Iron deficiency anaemia (IDA) and diabetes mellitus (DM) are most prevalent disease, that diabetic patients are more prone to IDA. Therefore, the main aim of this study was to investigate the relationship between patients with diabetes and IDA in relation to taking iron pills daily and every other day to reduce the effects related to it. Ninety-one participants were enroled and randomly divided into two groups, with a final analysis cohort of 72 patients. The primary focus was on changes in serum Hb and Ferritin levels. The screening phase lasted 24 weeks, leading to 72 eligible participants meeting the criteria for entry into the study. Additionally, the study examined alternations in Hb and Hb A1C levels after treating patients with iron deficiency. The Hb and ferritin level contrasts between groups were not significant (P = 0.096 and P = 0.500, respectively). The relationship between Hb A1C and Hb levels before and after treatment was positive and significant (r 2 = 0.187). The results of the present study show that although the effectiveness of using oral iron supplements did not have a significant difference in terms of increasing haemoglobin and ferritin, the use of oral iron once every other day was more effective than the use of oral iron every day, and also in this study Like other studies, this result concluded that there is a negative correlation between Hb A1C and Hb, and to check the status of Hb A1C in diabetics, the level of Hb should be considered first.

Validating a Drug-Related Problems Classification System in Outpatient Setting in Iran.

OBJECTIVE: Medication Therapy Management service (MTMs) has been introduced to improve cooperation among pharmacists and other healthcare professionals in the management of chronic diseases, drug therapy, and patients on polypharmacy. One part of MTMs is detection and resolution of possible drug-related problems (DRPs). Nowadays, numerous DRPs classification systems are available, but due to some defects none of them are currently accepted and implemented universally. The purpose of this study is to design and validate a comprehensive system for classification and documentation of possible DRPs for the Iranian patients. METHODS: In this methodological study, four classification systems were studied, and their differences were reviewed, compared. Ultimately, a comprehensive documentation system was developed and tested for validity using experts' opinions. FINDINGS: A comprehensive list of 53 DRPs under eight categories was developed and examined for validity. After collecting the data and validity assessment, questions with content validity ratio of <0.4 and content validity index of <70% were excluded and modified. Finally, with the exclusion and modification of eight DRPs, a modified DRPs list was created. CONCLUSION: According to the universality and validity assessment and based on consensus of 20 experts, this DRPs list can be used to regulate the standard operation procedure of outpatient clinics in Iran, and could act toward standardization of this service.

Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial.

Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapy-induced stomatitis and mucositis in a number of studies, but the results are contradictory. To answer such discrepancies, the present study was designed to evaluate the efficacy of sucralfate mouthwash in prevention of 5-fluorouracil (5-FU)-induced oral mucositis in patients with gastrointestinal malignancies. Patients with gastrointestinal cancers receiving 5-FU-based chemotherapy regimens were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate mouthwash (every 6 h) or placebo. The patients were visited at fifth and tenth day of trial; the presence and severity of oral mucositis and the intensity of pain were assessed. The patients receiving sucralfate experienced lower frequency and severity of mucositis (76% vs. 38.5%, P = 0.005 and 84 vs. 38.5%, P < 0.001, respectively) and less intense pain (2.5 ± 2.2 vs. 5.08 ± 3.82, P = 0.004 and 1.33 ± 0.86 vs. 4.12 ± 3.5, P = 0.001, respectively) compared with the placebo group both at day 5 and day 10. Within the sucralfate group, a decrease in frequency and severity of mucositis was observed throughout the trial period, while in the placebo group no such effect was observed. Sucralfate mouthwash reduced the frequency and severity of 5-FU-induced oral mucositis in patients with gastrointestinal malignancies compared with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis.

Developing an Appropriateness Criteria for Knee MRI Using the Rand Appropriateness Method (RAM)-2013.

BACKGROUND: Knee pain is one of the most common reasons patients visit their physician. In this regard Magnetic Resonance Imaging (MRI) is the tool of preference for diagnosis. The aim of this study was to determine appropriate guidelines for knee MRI administration using the RAND Appropriateness Method (RAM)-2013. METHODS: This qualitative study was done in the Mashhad University of Medical Sciences in 2013. The most appropriate approved knee MRI administration clinical guidelines were evaluated using Guidelines Evaluation and Research Appraisal (AGREE). Panel members consisting of six orthopedic and three rheumatologic doctors gave scores ranging from 1 to 9 for each scenario. The indications were grouped as appropriate, equivocal and inappropriate. Data were analyzed by descriptive statistics and SPSS ver. 18 software. RESULTS: Sixty-three scenarios were extracted from the guidelines and then the scenarios were evaluated in 26 indications. Thirty-two (50.79%) cases were considered appropriate, 12 (19.04%) cases uncertain and 19 (30.1%) cases inappropriate. CONCLUSIONS: The RAND appropriateness method is helpful in identifying the opinion of stakeholders in health care systems. Moreover, making practical use of clinical guidelines can improve patients' quality of care and prevent unnecessary costs.

Opening wedge high tibial osteotomy using tibial wedge allograft: a case series study.

High tibial osteotomy has been established as an effective surgical intervention in patients with unicompartment osteoarthritis of the knee associated with varus deformity and abnormal load through the medial compartment. The aims of this study were to report the result of open-wedge osteotomy performed with allograft bone and also to evaluate the postoperative clinical results in a series of patients. There are still little medical literatures regarding the use of an allograft bone transplant in open-wedge osteotomy. 37 consecutive cases that had undergone opening wedge osteotomy using allograft bone were studied. They were followed each 2 months after surgery until 6 month. There were 7 men and 30 women, aged ranging from 16 to 66. All patients were followed 6 months after surgery until clinical and radiographic healing of the osteotomy site. All patients could stand and walk on operated limb 6 months after operation, but 11 of them had still pain after this duration. There were no cases of non-union or osteotomy site collapse associated with the use of allograft. Moreover, no significant complication has been detected in these patients with choosing appropriate patients and performing good surgical technique, and the proximal tibial wedge allograft is a satisfactory choice that provides effective clinical and radiographic bone union.