Add-on Probiotics in Patients With Persistent Allergic Rhinitis: A Randomized Crossover Clinical Trial

Objectives: Current medications  for allergic rhinitis  (AR) may have undesirable side effects that could affect quality of life (QoL). Probiotics  could be an alternative in these  patients.  The aim of this study  was to assess  the impact of add-on  probiotics on symptoms  and QoL of patients.

Methods: In this  randomized crossover  clinical trial, patients with  persistent AR were  included.  Each subject  received budesonide with  probiotic  supplements (BP)  or  budesonide with  placebo  for  8 weeks  (B), then  vice  versa  for  a  further 8 weeks.  There  was  an  8-week  washout.  The  primary  outcome  was  the  change  of the  Short  Form  36-Item  Health  Survey (SF-36) score. The secondary  outcomes  were assessed by the Sinonasal Outcome Test-22 (SNOT-22) and the Control of Allergic Rhinitis and Asthma Test (CARAT) questionnaires.

Results: A total of 152 subjects  (30.1 ± 7.6 years)  completed  the study. The SF-36 score in both groups showed improve- ment  compared  with baseline  values. Treatment BP was more  effective than  that  of B. The Cohen’s d and the number  needed to treat  for Physical Component  Scales of SF-36 were  0.40 and 10.77, respectively.  These values for Mental Component  Scales were 0.33 and 12.61, respectively.  Also, treatment BP showed  more reduction in the score of SNOT-22 and CARAT.

Conclusion: This study  showed  that the addition  of probiotics  to budesonide significantly improved  QoL in persistent AR patients.  However, the clinical situation  of these  patients may be not very representative of AR patients in general  population. Further  studies  are recommended.