The clinical outcomes of medical therapies in chronic rhinosinusitis are independent of microbiomic outcomes: a double-blinded, randomised placebo-controlled trial

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Cherian LM, Bassiouni A, Cooksley CM, Vreugde S, Wormald PJ, Psaltis AJ
BACKGROUND: Oral and topical corticosteroids, and antibiotics form the mainstay medical treatment of chronic rhinosinusitis (CRS). Clinical outcomes vary depending on the chosen therapy, resident microbiome and disease phenotype. We conducted a double- blinded, placebo-controlled Randomised Controlled Trial (RCT) to investigate effects of medical therapy on clinical outcomes and associated microbiome shifts. METHODOLOGY: Fifty eligible patients (CRS with and without polyps) were treated for 3 weeks after randomisation into 3 arms: na- mely oral prednisolone, topical budesonide irrigations and oral doxycycline; each with appropriate placebo. Clinical scoring and microbiome swabs were performed on enrolment, at treatment completion and 3-weeks post treatment completion. Microbiome analysis was performed using the llumina-MiSeq next generation sequencing platform and QIME-2 pipeline. RESULTS: Significant improvement in clinical scores was observed in prednisolone and budesonide arms at treatment completion but not with antibiotic. Sub-group analysis showed more pronounced effects in patients with polyposis. Corynebacterium and Staphylococcus species predominated, with variable bacterial relative abundance among different treatments at all time-points. The only significant microbiome finding was an increase in bacterial diversity in topical budesonide group immediately after treatment, which returned to baseline 3-weeks post treatment. CONCLUSION: Clinical improvement was significant with oral and topical steroid but not empirical antibiotic. Although there were some associated microbiome changes with the various treatments, we could not ascertain the consistency of these and whether they do have a clinical significance at all.

Experiment 1

Needs review

Curated date: 2022/02/24

Curator: Maryemzaki

Revision editor(s): Maryemzaki, Lwaldron, Aiyshaaaa


Location of subjects
Host species Species from which microbiome was sampled (if applicable)
Homo sapiens

Group 0 name Corresponds to the control (unexposed) group for case-control studies
Healthy controls-without polyps
Group 1 name Corresponds to the case (exposed) group for case-control studies
Patients with chronic rhinosinusitis
Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group
There were 3 treatment arms: oral steroid, tropical steroid, and oral antibiotic
Group 0 sample size Number of subjects in the control (unexposed) group
Group 1 sample size Number of subjects in the case (exposed) group
Antibiotics exclusion Number of days without antibiotics usage (if applicable) and other antibiotics-related criteria used to exclude participants (if any)
Patients on any oral steroid, topical steroid or oral antibiotic in a

6-weeks period prior to enrolment, below the age of 18, had a history of sinus surgery, documented doxycycline or steroid allergy, using CYP450 inhibitors, immunosuppression, uncontrolled diabetes.

Lab analysis

Sequencing type
16S variable region One or more hypervariable region(s) of the bacterial 16S gene
Sequencing platform Manufacturer and experimental platform used for quantifying microbial abundance

Statistical Analysis

Statistical test
Significance threshold p-value or FDR threshold used for differential abundance testing (if any)