OBJECTIVE: The southern U.S. region has among the highest incidence of chronic rhinosinusitis (CRS). Historically, African Americans in this region have been a difficult to reach population for clinical research participation. This study's aim was to observe any association between herbal tea consumption and CRS symptoms among African Americans. We recount the volunteers self-reporting of measurements associated with self-treatment of CRS symptoms. DESIGN: The study design was a preliminary, open-label, pilot study. SETTINGS: Volunteers were drawn from Morehouse School of Medicine's outpatient clinics, community multipurpose senior centers, and churches in Fulton and DeKalb Counties, GA. SUBJECTS: One hundred (100) African American volunteers were prescreened, of whom 55 with a clinical diagnosis of CRS met entrance criteria. INTERVENTION: Volunteers self-administered Breathe Easy herbal tea for a duration of 6 weeks. OUTCOME MEASURES: The Chronic Sinusitis Survey (CSS) scale was administered to assess sinus health at baseline and term and overall quality of life was assessed using the Short Form-36 (SF-36) index. RESULTS: Of the 55 volunteers who met entrance criteria, 41 completed the study; groups were q.i.d. (n = 27), t.i.d. (n = 4), b.i.d. (n = 5), and noncompliant (n = 5). For the q.i.d. group (n = 27), there was a significant increase in the CSS symptom score (difference in means 22.0 points; p = 0.020) and CSS total score (11.1 points; p = 0.020). Overall health status (SF-36) reported at baseline was 35% very good; 34% good; and 17% fair. After 6-weeks, the q.i.d. group showed a significant change to 44% good and 45% very good (p = 0.001). CONCLUSIONS: This preliminary pilot study suggests that q.i.d. self-administration of Breathe Easy was associated with improved volunteers' sinus health status (e.g., ability to fall sleep). Our results suggest that this herbal tea may contribute as a complementary therapy for management of CRS among African Americans. To further assess efficacy and applicability to other populations, randomized controlled trials in larger populations are warranted.
OBJECTIVE: The southern U.S. region has among the highest incidence of chronic rhinosinusitis (CRS). Historically, African Americans in this region have been a difficult to reach population for clinical research participation. This study's aim was to observe any association between herbal tea consumption and CRS symptoms among African Americans. We recount the volunteers self-reporting of measurements associated with self-treatment of CRS symptoms. DESIGN: The study design was a preliminary, open-label, pilot study. SETTINGS: Volunteers were drawn from Morehouse School of Medicine's outpatient clinics, community multipurpose senior centers, and churches in Fulton and DeKalb Counties, GA. SUBJECTS: One hundred (100) African American volunteers were prescreened, of whom 55 with a clinical diagnosis of CRS met entrance criteria. INTERVENTION: Volunteers self-administered Breathe Easy herbal tea for a duration of 6 weeks. OUTCOME MEASURES: The Chronic Sinusitis Survey (CSS) scale was administered to assess sinus health at baseline and term and overall quality of life was assessed using the Short Form-36 (SF-36) index. RESULTS: Of the 55 volunteers who met entrance criteria, 41 completed the study; groups were q.i.d. (n = 27), t.i.d. (n = 4), b.i.d. (n = 5), and noncompliant (n = 5). For the q.i.d. group (n = 27), there was a significant increase in the CSS symptom score (difference in means 22.0 points; p = 0.020) and CSS total score (11.1 points; p = 0.020). Overall health status (SF-36) reported at baseline was 35% very good; 34% good; and 17% fair. After 6-weeks, the q.i.d. group showed a significant change to 44% good and 45% very good (p = 0.001). CONCLUSIONS: This preliminary pilot study suggests that q.i.d. self-administration of Breathe Easy was associated with improved volunteers' sinus health status (e.g., ability to fall sleep). Our results suggest that this herbal tea may contribute as a complementary therapy for management of CRS among African Americans. To further assess efficacy and applicability to other populations, randomized controlled trials in larger populations are warranted.
Authors: Koosha Ghazi-Moghadam; Hasan Mete Inançlı; Nazanin Bazazy; Peter K Plinkert; Thomas Efferth; Serkan Sertel Journal: Pharmaceuticals (Basel) Date: 2012-08-20