title: Self-reported quality of life in complementary and alternative medicine treatment of chronic rhinosinusitis among African Americans: a preliminary, open-label pilot study.
abstract: 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.
  
  
  METHODS
  The study design was a preliminary, open-label, pilot study.
  
  
  METHODS
  Volunteers were drawn from Morehouse School of Medicine's outpatient clinics, community multipurpose senior centers, and churches in Fulton and DeKalb Counties, GA.
  
  
  METHODS
  One hundred (100) African American volunteers were prescreened, of whom 55 with a clinical diagnosis of CRS met entrance criteria.
  
  
  METHODS
  Volunteers self-administered Breathe Easy herbal tea for a duration of 6 weeks.
  
  
  METHODS
  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.affiliation: Department of Pharmacology and Toxicology, Morehouse School of Medicine, Atlanta, GA, USA.
authors.forename: Yvonne G
authors.initials: YG
authors.lastname: Hipps
authors.forename: Yolanda E
authors.initials: YE
authors.lastname: Hacker
authors.forename: David L
authors.initials: DL
authors.lastname: Hoffmann
authors.forename: Josef A
authors.initials: JA
authors.lastname: Brinckmann
authors.forename: Robin R
authors.initials: RR
authors.lastname: Socci
authors.forename: Denine
authors.initials: D
authors.lastname: Rogers
mesh_terms: D000328:Adult; D001741:Black or African American; D000368:Aged; D001628:Beverages; D002908:Chronic Disease; D000529:Complementary Therapies; D005260:Female; D005845:Georgia / Q000208:ethnology; D006304:Health Status; D006306:Health Surveys; D006801:Humans; D019684:Magnoliopsida; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use*; D011788:Quality of Life; D012651:Self Medication; D012852:Sinusitis / Q000188:drug therapy* / Q000208:ethnology
chemical_list: D010936:Plant Extracts