Table 5.
Study | Year | LOE (1a to 5) | Study design | Study groups | Clinical end-point efficacy | Conclusion |
---|---|---|---|---|---|---|
Alobid et al. | 2014 | 1b | Prospective non-blinded RCT | Adult CRSwNP patients treated with intranasal budesonide 800 μg daily for 2 weeks in combination with oral prednisone (30 mg daily for 4 days followed by a 2-day reduction of 5 mg) (n = 67) or nothing (n = 22) |
1. Polyp grade measured by CT 2. Nasal congestion 3. Loss of sense of smell 3. Polyp tissue eosinophils 4. Nasal nitric oxide |
Combined oral and intranasal corticosteroids improve smell and nasal congestion, decrease tissue eosinophilia and increased detection of nNO |
Benitez et al. | 2006 | 1b | Prospective non-blinded RCT | Adult CRSwNP patients treated with oral prednisone, 30 mg for 4 days and a 2-day reduction of 5 mg for a total duration 14 days followed by intranasal budesonide for 12 weeks (n = 63) or no treatment (n = 21) |
1. Disease individual symptom scoring of nasal obstruction, loss of sense of smell, rhinorrhoea and sneezing 2. Polyp size measured by endoscopy 3. Nasal flow measurements |
14 days of oral steroids improved all nasal symptoms, polyp size, and nasal flow, which is maintained by intranasal steroid |
Ecevit et al. | 2015 | 1b | Prospective double-blind RCT | Adult CRSwNP patients treated with oral prednisolone, 60 mg/day (6 tablets per day) for 7 days, then reduced to 10 mg (1 tablet) taken every other day, stopping on day 17 (n = 11) or placebo (n = 10) |
1. Visual analogue scale for sense of smell, nasal discharge, nasal obstruction and pressure over the sinuses 2. Smell testing 3. Peak nasal inspiratory peak flow |
The improvement in the corticosteroid group in the VAS scores, smell tests and PNIF values showed statistically significant differences compared to the placebo group |
Hissaria et al. | 2006 | 1b | Prospective double-blind RCT | Adult CRSwNP patiets treated with prednisolone, 50 mg/day for 14 days (n = 20) or placebo (n = 21) |
1. Health-related quality of life (RSOM-31) 2. Physician assessment of nasal symptoms (congestion, hyposmia, rhinorrhoea, sneezing, postnasal drip and itch) 3. Polyps size measured by endoscopy 4.MRI of the paranasal sinuses |
The prednisolone-treated group showed significant improvement in nasal symptoms. The RSOM-31 improved in both groups, but the prednisolone-treated group had significantly greater improvement than the placebo group. There was significant reduction in polyp size, as noted with nasendoscopy (P < 0.001) and MRI (P < 0.001), only in the prednisolone-treated group |
Kapucu et al. | 2012 | 2b | Prospective unblinded RCT | Adult CRSwNP patients treated with oral methylprednisolone 1 mg/kg/day. The dose was applied for 3 days and tapered gradually, with a reduction rate of 8 mg/3 days (n = 12) or no medication (n = 12) | Apoptotic index | Statistically significant differences in apoptotic index were found between each steroid-medicated group and the control group |
Kirtsreesakul et al. | 2012 | 1b | Prospective double-blind RCT | Adult CRSwNP patients treated with oral prednisolone 50 mg daily for 14 days (n = 67) or placebo (n = 47) |
1. Symptom scoring for blocked nose, runny nose, sneezing, nasal itching, hyposmia, postnasal drip, cough and sinonasal pain 2. Nasal polyp size measured by endoscopy |
The prednisolone-treated group showed significantly greater improvements in all nasal symptoms, nasal flow and polyp size than the placebo-treated group |
Vaidyanathan et al. | 2011 | 1b | Prospective double-blind RCT | Adult CRSwNP patients treated with prednisolone tablets, 25 mg/day, 2 weeks (n = 30) or placebo (n = 30) in patients on intranasal steroids |
1. Juniper mini rhinoconjunctivitis Quality of Life Questionnaire 2. Total nasal symptoms score 3. Sense of smell 4. Nasal polyp score by endoscopy 5. Peak nasal inspiratory flow rate 6. Serum eosinophil-derived neurotoxin 7. High-sensitivity C-reactive protein levels |
Short oral steroid therapy followed by topical steroid therapy is significantly more effective over 6 months than topical steroid therapy alone in decreasing polyp size and improving olfaction in CRSwNP patients with at least moderate nasal polyps |
Van Zele et al. | 2010 | 1b | Prospective double-blind RCT | Adult CRSwNP patients treated with oral methylprednisolone (32 mg/day on days 1 to 5; 16 mg/day on days 6 to 10; 8 mg/day on days 11 to 20) (n = 14) or placebo (n = 19) |
1. Polyps size measured by endoscopy 2. Nasal peak inspiratory flow 3. Blood analysis for eosinophils, eosinophilic cationic protein and soluble IL-5 receptor 4. Nasal secretion analysis for eosinophilic cationic protein, IL-5, IgE, matrix metalloproteinase-9, myeloperoxidase 5. Need for rescue surgery and need for rescue nasal steroids |
Methylprednisolone significantly decreased nasal polyp size compared with placebo. The effect was maximal at week 3 and lasted until week 8. Methylprednisolone significantly reduced levels of ECP, IL-5, and IgE in nasal secretions |
RCT randomized controlled trial, CRS chronic rhinosinusitis, CRSwNP chronic rhinosinusitis with nasal polyps