In a prospective, randomised, double-blinded controlled study, we compared the efficacy and safety of two different treatment options with the herbal medicines cineole and a combination of five different components for acute viral rhinosinusitis. One hundred and fifty patients with acute and viral rhinosinusitis (75 patients in each treatment group) were enrolled. The diagnosis rhinosinusitis was made according to a defined symptoms-sum-score which was based on rhinoscopic and clinical signs which are characteristic for rhinosinusitis. The primary endpoint was the amelioration of the symptoms-sum-score, which includes all relevant characteristics for rhinosinusitis as headache on bending, frontal headache, sensitivity of pressure points of trigeminal nerve, impairment of general condition, nasal obstruction, rhino-secretion, secretion quantity, secretion viscosity and fever in a treatment period of 7 days. The mean reduction of the symptoms-sum-score after 4 days was 6.7 (+/-3.4) and after 7 days 11.0 (+/-3.3) in the cineole group and 3.6 (+/-2.8) after 4 days and 8.0 (+/-3.0) after 7 days in the control group. The differences between both groups were clinically relevant and statistically significant after 4 and 7 days (P < 0.0001). This result is validated by the amelioration of the secondary endpoints headache on bending, frontal headache, sensitivity of pressure points of trigeminal nerve, impairment of general condition, nasal obstruction and rhino-secretion. These findings correlate with the statistically significant difference of the estimation of B-scan ultrasonography. It is safe to use both medications for 7 days in patients with acute viral rhinosinusitis. Treatment with cineole is clinically relevant and statistically significant, more effective in comparison to the alternative herbal preparation with five different components.
Xerostomia is the most debilitating side effect induced by irradiation of head and neck tumours and is caused by irradiation damage to the salivary glands. The aim of this study was to correlate structural histomorphological damages and sialoscintigraphical findings during fractioned radiotherapy. The head and neck area of 27 WAG/RijH rats was irradiated with 60Co-gamma rays (60 Gy/30f 6 weeks). To evaluate salivary gland function, a port system was implanted, and 99mTc-pertechnetate was applied at different stages of irradiation (0, 16, 30, 46, 60 and 6 months post-irradiation). In the course of treatment the parotid glands were examined histopathologically. Rat salivary glands developed a dose-dependent radiosialadenitis. After a dose of 16 Gy an intra- and extra-cellular oedema developed in the salivary glands. Progressive vacuolisation (30 Gy) developed into lipomatosis (46 Gy) and necrotic changes (60 Gy) in the parotid glands. Six months after irradiation treatment, the chronic histomorphological damages corresponded to stage II according to Seifert. The corresponding loss in gland function investigated by measurement of the 99mTc-pertechnetate uptake of the salivary glands was 13% (16 Gy), 26% (30 Gy), 57% (46 Gy), 75% (60 Gy) and 66.5% (6 months post-irradiation). The presented animal model is suitable to demonstrate the correlation of histomorphological and sialoscintigraphical findings.
Background: Radiotherapy of head and neck tumors often leads to acute reactions of the adjacent normal tissues resulting e.g. in mucositis and xerostomia. Therefore, radioprotective drugs have been developed to reduce these effects. Studies on a tumor model using amifostine and sodium selenite adjuvant to fractionated irradiation should show whether the radioprotective effect on normal tissue leads to an increase of radioresistance in the tumor and its metastatic potential. Methods: Rhabdomyosarcomas R1H of the rat growing subcutaneously in the right flank of male adult WAG/RijH rats were irradiated with 60Co-gamma rays (60 Gy/30 fractions/6 weeks). Amifostine (375 mg/m²), sodium selenite (15 µg/kg), and equivalent volumes of 0.9% saline were administered intraperitoneally 30 min before each irradiation. Tumor response was determined. Statistical analysis was performed using the post-hoc-test. Results: Irradiation alone inhibited R1H tumor growth (AUC 86.8±18.3). The efficacy of irradiation during radiotherapy was significantly improved by amifostine (AUC 63.1±15.8) in comparison to the irradiated controls. The radiosensitizing effect of sodium selenite (AUC 73.6±21.3) as well as irradiation and amifostine plus sodium selenite (AUC 68.3±7.8) was less compared to the irradiated controls and not statistically significant. However, tumor growth delay and metastasis rate were not changed by the radioprotective drugs. Further, the administration of amifostine and amifostine plus sodium selenite induced an enhanced decrease of animal body weight except for sodium selenite in comparison to the controls. Conclusion: The application of amifostine and sodium selenite to conventionally fractionated irradiation have no influence on the radiosensitivity of the rhabdomyosarcoma R1H. The systemic toxicity of amifostine might be of importance for the radiation treatment of a patient.
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