Sumac-rose water mouthwash versus benzydamine to prevent radiation-induced oral mucositis in head and neck cancers: a phase II randomized trial.

BACKGROUND: Radiation-induced oral mucositis (OM) largely impairs the quality of life (QoL) of patients with head and neck cancer (HNC). Few choices with limited efficacy are available to prevent this adverse effect. This randomized trial was conducted to compare the efficacy of benzydamine (standard) and a new combination (sumac and rose water) in preventing radiation-induced OM. METHODS: This was a phase II, triple-blind, active-controlled, randomized trial. The primary endpoint was OM, and the secondary endpoints were oral pain and QoL. Besides, the possible variables defining the outcomes were analyzed using the chi-squared test (univariate analysis) and binomial regression model (multivariate analysis). RESULTS: Sumac-rose group had fewer high-grade OM (33% vs. 63%, odds ratio [OR] 0.28, 95% confidence interval [CI 95%] 0.08-0.93, P = 0.03) and better QoL (P < 0.05). Multivariate analysis confirmed these findings. Sumac-rose rinsing could also postpone the start of oral pain (hazard ratio [HR] 0.02, CI 95% 0.001-0.32, P = 0.001) and high-grade OM (HR 0.28, P = 0.03) compared with benzydamine. CONCLUSIONS: The sumac-rose group had a lower OM rate and grade and higher QoL than the benzydamine group. In addition, the experimental group developed high-grade OM and oral pain later during the radiotherapy course. Further studies need to be conducted to assess the role of sumac and rose water in reducing grade 3-4 mucositis in patients who undergo chemoradiation for head and neck cancer.

The Streptokinase Therapy Complications and its Associated Risk Factors in Patients with Acute ST Elevation Myocardial Infarction.

Acute myocardial infarction (AMI) is one of the main leading causes of mortality and morbidity. Despite the progress in the treatment of AMI, streptokinase is still being used in many countries. Because of the critical condition of patients with AMI and complications of streptokinase therapy, this study was performed to evaluate the pattern of adverse drug reaction (ADRs) induced by streptokinase and its associated risk factors in patients with acute ST elevation MI. A prospective cross-sectional study in a 14-month period was done at the university affiliated referral cardiovascular center. The Naranjo probability scale and Food and drug administration (FDA) criteria for severity of ADRs were performed for assessing the ADRs. The linear and logistic regression tests were used to evaluate the correlation between ADRs and study risk factors. During the study period, 217 patients who received streptokinase were entered. The majority of patients (n = 191) experienced at least one ADR. Six patients died in-hospital mainly because of cardiac causes. The history of drug allergy was the main predictor in occurring of ADRs (Odds ratio: 3.26; 95% CI: 1.48-457.6; p =0.026). The most serious ADR was hemorrhagic stroke with a 1.4% incidence. Hypotension was one of the most occurred ADR (n = 75). Anaphylactic shock was not detected in this study. In summary, our study showed that the history of drug allergy is the main predictor in occurring of ADRs by streptokinase. Furthermore, streptokinase therapy was associated with a higher rate of hemorrhagic stroke in Iranian population.