A prospective multicenter clinical trial of medical and surgical treatment for chronic rhinosinusitis

Objective To demonstrate the clinical outcomes of maximal medical therapy （MMT） and functional endoscopic sinus surgery ＋ maximal medical therapy （FESS ＋ MMT） for moderate to severe chronic rhinosinusitis without nasal polyps （CRSsNP） in China, to provide clinical evidence for treatment recommendation. Methods A prospective muhicentcr case control study consisting of 90 strictly selected CRSsNP patients were carried out by ENT Hospital of SUN Yet-sen university and 7 other university affiliated hospitals across China from March 2011 to October 2012. All patients were selected to MMT group or FESS ＋ MMT group followed by 3 months treatment and 6 months follow up. Treatment efficacy evaluation indicators included improvement of visual analogue scale （VAS） score, quality of life, CT score and post-operative nasal endoscopic evaluations. SPSS 16.0 software was used to analyze the data. Results All patients enrolled complied with moderate to severe CRSsNP evaluation criteria. There were no significant differences found in the baseline data between two groups （P > 0. 05）. ①At the 3 time points （pre-treatment, 3 months and 6 mongths after treatment）, VAS overall symptom score in MMT group were 6.52±2.61,2.66 ±2.10, 2.40 ± 1.56, significant differences were found among them （t value were 2.083 and 2.295, both P < 0.05）; in FESS ＋ MMT group the values were 6.99 ±2.70, 0.95 ±0.84, 0.60 ±0.81, significant differences were found among them （t value were 3.582 and 5.196, both P < 0.05）; SNOT-20 score in MMT group were 38.61±17.36, 18.59±14.04, 18.40 ± 8.91, significant differences were found among them （t value were 2.737 and 2.657, both P < 0.05 ） ; in FESS ＋ MMT group the values were 38.21 ± 19.61, 5.94±5.01, 2.65 ±2.31, significant differences were found among them （t value were 3.247, 3.319,both P <0.05）. ②FESS ＋ MMT group relative to the MMT group in VAS overall symptom score and quality of life improvements appeared earlier and were more pronounced. ③Overall treatment efficacy showed that in MMT group： complete control 14 cases （30.4%）, partially control 31 cases （67.4%）, uncontrolled 1 cases （2.2%）; In FESS ＋ MMT group： complete control 17 cases （38.6%）, partially control 26 cases （59.1%）, uncontrolled 1 cases （2.3%）. ④Patients' satisfaction survey showed that the number of the patients who were very satisfied with the efficacy in the FESS ＋ MMT group were 2 times higher than the MMT group, Conclusions ①For moderate to severe CRSsNP, both MMT and FESS ＋ MMT treatment can effectively control the overall symptoms and classified symptoms, reduce CT scores and significantly improve the quality of life, the ineffective rate is less than 5%. ②FESS ＋ MMT group in terms of improving symptoms and the onset time are better than MMT group, especially in improving the stuffy nose, head and face fullness, and mental and physical symptoms are better than MMT group. ③FESS ＋ MMT group showed better results in patient satisfaction survey compared to the MMT group. Therefore for moderate to severe CRSsNP patients, FESS ＋ MMT therapy could be recommended as the preferred treatment. Key words: Sinusitis; Drug therapy; Endoscopy; Otorhinolaryngologic surgical procedures; Treatment outcome; Combined modality therapy