Melatonin, vitamins and minerals supplements for the treatment of Covid-19 and Covid-like illness: A prospective, randomized, double-blind multicenter study.

BACKGROUND: Melatonin, zinc, and multivitamins are among most recommended supplements in the fight against coronavirus disease 2019 (COVID-19). We aimed to examine the efficacy and safety of this association in the treatment of COVID-19 and COVID-like illnesses. METHODS: We conducted a multicenter prospective, randomized, double-blind, controlled trial. Patients with no medical history consulting the emergency department for covid and covid-like illness and who were not hospitalized were included. Patients were assigned in a 1:1 ratio to the treatment or the placebo group. The primary outcome was studying the effectiveness of zinc multivitamin supplement and melatonin in the treatment of COVID and -like illnesses symptoms' according to the time from randomization to clinical improvement. The pre-specified secondary outcomes were date of disappearance of symptoms present on admission, appearance of an adverse effect due to the administration of the treatment, number of patients developing complications, requiring hospitalization, requiring respiratory support. RESULTS: One hundred sixty four patients were eligible for the study and were randomized to either the treatment group or the placebo group. Overall, 128 of the 164 patients had a PCR for SARS-CoV-2, yielding a positive PCR result in 49.1% of them. Regarding the disappearance of all initial presenting symptoms: on the 5th day of the follow-up, there was a significant difference between the two groups with a p value 0.04;On the 10th day, there was a significant difference too with p value of 0.038. There were no significant differences between the two groups in recovery during the 15th day of follow-up p>0.5. Finally, 100% of patients fully recovered in the treatment group vs 98.8% in the placebo group. No severe adverse events were reported throughout the trial. CONCLUSIONS: Our results showed that daily doses of Melatonin, zinc and vitamins did significantly reduce the duration of symptoms accelerating its disappearance among patients consulting with COVID-19 or COVID-19 like illness.

Value of inferior vena cava collapsibility index as marker of heart failure in chronic obstructive pulmonary disease exacerbation.

INTRODUCTION: Inferior vena cava (IVC) diameter variability with respiration measured by ultrasound was found to be useful for the diagnosis of heart failure (HF) in ED patients with acute dyspnea. Its value in identifying HF in acute exacerbation of chronic obstructive pulmonary disease exacerbation (AECOPD) was not specifically demonstrated. OBJECTIVE: To determine the value of ΔIVC in the diagnosis of HF patients with AECOPD. METHODS: This is a prospective study conducted in the ED of three Tunisian university hospitals including patients with AECOPD. During this period, 401 patients met the inclusion criteria. The final diagnosis of HF is based on the opinion of two emergency experts after consulting the data from clinical examination, cardiac echocardiography, and BNP level. The ΔIVC was calculated by two experienced emergency physicians who were blinded from the patient's clinical and laboratory data. A cut off of 15% was used to define the presence (< 15%) or absence of HF (≥ 15%). Left ventricular ejection fraction (LVEF) was also measured. The area under the ROC curve, sensitivity, specificity, and positive and negative predictive values were calculated to determine the diagnostic and predictive accuracy of the ΔIVC in predicting HF. RESULTS: The study population included 401 patients with AECOPD, mean age 67.2 years with male (68.9%) predominance. HF was diagnosed in 165 (41.1%) patients (HF group) and in 236 patients (58.9%) HF was excluded (non HF group). The assessment of the performance of the ΔIVC in the diagnosis of HF showed a sensitivity of 37.4% and a specificity of 89.7% using the threshold of 15%. The positive predictive value was 70.9% and the negative predictive value was 66.7%. The area under the ROC curve was 0.71(95%, CI 0.65-0.76). ΔIVC values were not different between HF patients with reduced LVEF and those with preserved LVEF. CONCLUSION: Our results showed that ΔIVC has a good value for ruling out HF in ED patients consulting for AECOPD.

Mobile Phone-Based Telemonitoring for Improving Adherence to Analgesic Treatment in Trauma Patients After Emergency Department Discharge: A Randomized Controlled Trial.

OBJECTIVE: To determine the impact of mobile-phone telemonitoring on patients' adherence and satisfaction with posttrauma pain treatment. MATERIALS AND METHODS: We conducted a prospective randomized clinical trial including patients with minor trauma discharged from the emergency department (ED) with analgesic treatment. Patients were randomized to one of 3 groups, the control group, where patients received a phone call on day-7, the short message service (SMS) group, where patients received a daily text message to remind them to take their treatment during 7 days, and the mobile-phone based telemonitoring (TLM) group. Patients' adherence to analgesic treatments using the Morisky Medication Adherence Scale, current pain by using a visual analogue scale, and patients' satisfaction were assessed. For the TLM group, the assessment was performed at day-2, 4 and 7. RESULTS: Good adherence was observed in 418 patients (92.9%) in the TLM group versus 398 patients (88.6%) in the SMS group and 380 patients (84.8%) in the control group ( P <0.001). The factor mostly associated with adherence was telemonitoring (OR 2.40 95% CI 1.55-3.71). The decrease in pain visual analogue scale was highest in the TLM group compared with SMS and control groups ( P <0.001). The percentage of patients' satisfaction at 7 days post-ED discharge was 93% in the TLM group versus 88% in the SMS group and 84% in the standard group ( P =0.02). DISCUSSION: Our findings suggest that mobile-phone-based telemonitoring is beneficial in the treatment of pain in trauma patients after ED discharge. This approach improved patients' adherence and satisfaction.

Analgesic Effect of Topical Piroxicam vs Phytotherapy Gel in the Treatment of Acute Soft Tissue Injuries: A Randomized Controlled Noninferiority Study.

OBJECTIVE: The study compared the efficacy and tolerability of piroxicam gel and a new topical combination of medicinal plant products (Soulagel®; Belpharma Tunisia) to treat pain caused by soft tissue injuries. METHODS: Patients (n = 1,525) were assigned to receive piroxicam gel or Soulagel. Efficacy assessments included a change of at least 50% in the pain-on-movement visual numeric scale rating from emergency department discharge (baseline) to day 7 final assessment, as well as the time required to reach pain resolution criteria, the need for rescue analgesia, patients' satisfaction, and the rate of adverse effects. RESULTS: At day 7, 1,216 patients (79.7%) achieved at least 50% reduction in visual numeric scale rating from baseline: 623 patients (82.4%) in the Soulagel group vs 593 patients (77.1%) in the piroxicam group (P = 0.01). Time to decrease pain on movement by 50% was significantly higher with piroxicam gel than with Soulagel (34 ± 1 vs 33 ± 1 days, respectively; P = 0.54). At day 7, 96.4% of patients in the Soulagel group declared being "very satisfied" to "satisfied," vs 68% in the piroxicam group (P < 0.001). There were no major adverse events in either group. CONCLUSIONS: Soulagel is not inferior to piroxicam gel for managing pain related to a soft tissue injuries. Further studies will help ascertain whether this new gel offers an alternative treatment option for this common emergency department condition.

30 day predicted outcome in undifferentiated chest pain: multicenter validation of the HEART score in Tunisian population.

BACKGROUND: Chest pain remains one of the most challenging serious complaints in the emergency department (ED). A prompt and accurate risk stratification tool for chest pain patients is paramount to help physcian effectively progrnosticate outcomes. HEART score is considered one of the best scores for chest pain risk stratification. However, most validation studies of HEART score were not performed in populations different from those included in the original one. OBJECTIVE: To validate HEART score as a prognostication tool, among Tunisian ED patients with undifferentiated chest pain. METHODS: Our prospective, multicenter study enrolled adult patients presenting with chest pain at chest pain units. Patients over 30 years of age with a primary complaint of chest pain were enrolled. HEART score was calculated for every patient. The primary outcome was major cardiovascular events (MACE) occurrence, including all-cause mortality, non-fatal myocardial infarction (MI), and coronary revascularisation over 30 days following the ED visit. The discriminative power of HEART score was evaluated by the area under the ROC curve. A calibration analysis of the HEART score in this population was performed using Hosmer-Lemeshow goodness of test. RESULTS: We enrolled 3880 patients (age 56.3; 59.5% males). The application of HEART score showed that most patients were in intermediate risk category (55.3%). Within 30 days of ED visit, MACE were reported in 628 (16.2%) patients, with an incidence of 1.2% in the low risk group, 10.8% in the intermediate risk group and 62.4% in the high risk group. The area under receiver operating characteristic curve was 0.87 (95% CI 0.85-0.88). HEART score was not well calibrated (χ2 statistic = 12.34; p = 0.03). CONCLUSION: HEART score showed a good discrimination performance in predicting MACE occurrence at 30 days for Tunisian patients with undifferentiated acute chest pain. Heart score was not well calibrated in our population.