Probiotics as adjunctive treatment for chronic rhinosinusitis: a randomized controlled trial.

2009-02
Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery 140(2)
- Shraddha S Mukerji
- Melissa A Pynnonen
- Hyungjin Myra Kim
- Andrew Singer
- Mark Tabor
- Jeffrey E Terrell

PubMed: 19201289
DOI: 10.1016/j.otohns.2008.11.020

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 77
Population: 77 patients with chronic inflammatory rhinosinusitis
Methods: Prospective, randomized, double-blind, placebo-controlled trial; oral probiotic Lactobacillus rhamnosus R0011 strain (500 million active cells/tablet twice daily) or oral placebo for 4 weeks
Blinding: Double-blind
Duration: 4 weeks
Funding: Unclear

Objective

To determine if oral probiotics as adjunctive treatment are more effective than placebo in improving quality of life in patients with chronic inflammatory rhinosinusitis.

Design

Prospective, randomized, double-blind, placebo-controlled trial.

Methods

A total of 77 patients with chronic inflammatory rhinosinusitis were randomly assigned to receive oral probiotic Lactobacillus rhamnosus R0011 strain (500 million active cells/tablet twice daily) (n = 39) or oral placebo treatment (n = 38) for 4 weeks.

Results

In the probiotic group, the mean change from baseline in the SNOT-20 scores was significant at 4 weeks (P = 0.002) but not at 8 weeks (P = 0.37). Rhinological domain improved by 9.3 percent (P = 0.004) in probiotics group but returned to baseline level at 8 weeks. No significant differences were found between the probiotic and placebo groups in mean changes from baseline to 4 weeks (P = 0.79) or from baseline to 8 weeks (P = 0.23). No changes in symptom frequency were noted, either within each group or between treatment groups at 4 and 8 weeks. There was no difference in medication use or side effects between the two study groups.

Conclusion

Oral use of the probiotic strain L rhamnosus R0011 did not improve sinonasal quality-of-life scores in patients with chronic inflammatory rhinosinusitis compared with placebo.

Research Insights

Lactobacillus rhamnosus R0011→Improved Sinonasal Quality of Life
No significant differences were found between the probiotic and placebo groups in mean changes from baseline to 4 weeks (P = 0.79) or from baseline to 8 weeks (P = 0.23).
Effect
Neutral
Effect size
Small
Dose
500 million active cells/tablet twice daily
Lactobacillus rhamnosus R0011→Reduced Rhinological Symptoms
Rhinological domain improved by 9.3 percent (P = 0.004) in probiotics group but returned to baseline level at 8 weeks. No significant differences were found between the probiotic and placebo groups in mean changes from baseline to 4 weeks (P = 0.79) or from baseline to 8 weeks (P = 0.23).
Effect
Neutral
Effect size
Small
Dose
500 million active cells/tablet twice daily
Lactobacillus rhamnosus R0011→Reduced Symptom Frequency
No changes in symptom frequency were noted, either within each group or between treatment groups at 4 and 8 weeks.
Effect
Neutral
Effect size
Small
Dose
500 million active cells/tablet twice daily

Adverse Events Reported

Lactobacillus rhamnosus R0011→Overall tolerability
No difference in medication use or side effects between the two study groups.
Finding
No significant difference
Significant
No