Efficacy and tolerability of a spray with Salvia officinalis in the treatment of acute pharyngitis - a randomised, double-blind, placebo-controlled study with adaptive design and interim analysis.

OBJECTIVE: This randomised, double-blind, parallel group phase II/III study with adaptive two-stage design and interim analysis compared the efficacy and tolerability of spray (containing a Salvia officinalis fluid extract) against placebo in the treatment of patients with acute viral pharyngitis. - STUDY PARTICIPANTS: in two study parts, a total of 286 patients with subjective and objective evidence of pharyngitis were randomized. In the first study part 122 patients were enrolled. In the second study part 164 patients were included. The treatment duration per patient was 3 days, including one baseline visit and one final visit. - MAIN OUTCOME MEASURES: Area under Curve for change of throat pain intensity (spontaneous pain), documented every 15 minutes within the first 2 hours after the first application as compared to baseline using a visual analog scale (VAS 100 mm). - RESULTS: Following the interim analyses of the first study part the 15 % spray containing 140 microl sage extract per dose was the most promising preparation for the second study part (main study) whereas for the 30% and the 5% preparation results made superiority over placebo unlikely in the final analysis. Overall, the 15 % spray was significantly superior to placebo for the primary efficacy variable with regard to a reduction of the throat pain intensity score. Only minor side effects such as dry pharynx or burning of mild intensity were seen. - CONCLUSIONS: The efficacy and tolerability profile of a 15 % sage spray indicated that this preparation provides a convenient and safe treatment for patients with acute pharyngitis. A symptomatic relief occurred within the first two hours after first administration and was statistically significantly superior to placebo.

[Tumor oxygenation in combined whole body hyperthermia and polychemotherapy. Studies exemplified by recurrent carcinoma of the mouth cavity]. / Tumoroxygenierung unter kombinierter Ganzkörperhyperthermie und Polychemotherapie. Untersuchungen am Beispiel eines Rezidivkarzinoms der Mundhöhle.

BACKGROUND AND OBJECTIVE: Previous studies have reported synergistic effects of combined hyperthermia and chemotherapy and/or irradiation. The response to irradiation and chemotherapy of well-oxygenated and vascularized tumors generally is better than that of hypoxic tumors. Therefore, tumor oxygenation is recognized as an important predictive factor in the therapy of malignant tumors. In practice, the head and neck area remains outside of the hyperthermia chamber during whole-body hyperthermia. It was the aim of this study to evaluate if the head and neck region receives sufficient warmth and, if so, if tumor oxygenation increases accordingly. PATIENTS/METHODS: Whole-body hyperthermia, as heat radiation (Enthermics Medical Systems RHS-7500), was applied to the narcotised 60-year-old male patient with a local recurrence tumor pT3 pN2b M0 squamous cell carcinoma of the oral cavity. Tumor oxygenation and temperature were measured by LICOX catheters via one-point measurement during the entire hyperthermia treatment (3.5 h). Parallelly, chemotherapy (ifosfamide/Carboplatin) was given in four cycles (one cycle/month). RESULTS: With a latency of 10 min the increase of intratumoral temperature was comparable to temperatures achieved in the esophagus. The maximum intratumoral temperature was 41.8 degrees C. The average increase in tumor oxygenation was more than 100%. The clinical outcome in the case presented was a partial tumor remission (PR). CONCLUSIONS: During combined whole-body hyperthermia and polychemotherapy, tumor oxygenation is also significantly improved in the head and neck area, despite the fact that the head and neck area remained outside the hyperthermia chamber. The intratumoral temperature was comparable to esophageal and rectal temperatures.