Background: The placebo effect observed in clinical trials evaluating medical treatments for chronic rhinosinusitis (CRS) is not well understood. This systematic review and meta-analysis sought to characterize the placebo effect present within CRS outcomes.
Methods: A systematic review of PubMed, Scopus, and Cumulated Index in Nursing and Allied Health Nursing (CINAHL) was performed. Randomized controlled trials (RCTs) evaluating medical treatments for CRS versus placebo were included. We assessed patient-reported (sino-nasal outcome test 22 [SNOT-22], nasal obstruction, sense of smell, nasal obstruction visual analogue score [VAS], sense of smell VAS, anterior rhinorrhea, and postnasal drip) and objective (Lund-Mackay Computed tomography (CT) score, peak nasal inspiratory flow [PNIF], nasal polyp scores, 40-item Smell Identification Test, serum IgE, and blood eosinophil levels) outcomes.
Results: Twenty-one RCTs were included, comprising 1437 patients (mean age 49.2 years). Biologics were the most common treatment investigated (n = 9). Eleven studies administered background steroids along with placebo. Following placebo administration, multiple patient-reported outcomes significantly decreased, including SNOT-22 (mean difference -9.49, 95% confidence interval [CI] [-11.26, -7.73]), nasal obstruction (-0.33 [-0.54, -0.13]), sense of smell (-0.22 [-0.33, -0.11]), nasal obstruction VAS (-2.47 [-2.87, -2.06]), and loss of smell VAS (-2.31 [-4.14, -0.47]) scores. For objective measures, significant changes occurred in Lund-Mackay CT score (-0.82, [-1.48, -0.16]) and PNIF (4.70, [4.76, 24.64]) with placebo. Placebo arms had the greatest impact when no background medications were used.
Conclusions: Placebo treatments have a statistically and potentially clinically significant effect on patient-reported and some objective CRS outcomes. Further investigation is required to fully understand placebo effect, which could improve assessment of RCTs and impact patient care.
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http://dx.doi.org/10.1002/alr.23302 | DOI Listing |
J Craniofac Surg
December 2024
Department of Plastic Surgery, the Affiliated Friendship Plastic Surgery Hospital of Nanjing Medical University.
Background: Nasal packing (NP), trans-septal suturing (TSS), and submucosal trans-septal suturing (STSS) are common techniques to avoid dead space after the deviated septum is corrected. However, there is rare data about surgical complications and discomfort of these techniques after septal extension grafts (SEG) with autogenous costicartilage.
Objective: To compare the complications and discomfort of NP, TSS, and STSS techniques after SEG with autogenous costicartilage.
J Craniofac Surg
December 2024
Konkuk University School of Medicine, Chungju City, Republic of Korea.
Purpose: To determine the association between the preoperative shape of the lacrimal sac and the postoperative shape of a rhinostomy in patients undergoing endoscopic dacryocystorhinostomy (DCR) for primary acquired nasolacrimal duct obstruction.
Material And Methods: This retrospective study involved 180 cases among 129 patients. Preoperative dacryocystography (DCG) classified lacrimal sacs into constricted or cylindrical types based on their width relative to the nasolacrimal duct.
J Fr Ophtalmol
December 2024
Biostatistics and Research Methodology Unit, School of Medical Sciences, Health Campus, University Sains Malaysia, Kubang Kerian 16150, Kelantan, Malaysia.
Purpose: To correlate fluorescein dye disappearance test (FDDT) grades and endoscopic dye transit times (EDTT) in patients with patent osteotomies after nasolacrimal duct obstruction surgery (NLDO).
Design: Cross-sectional study.
Methods: All adult patients with patent osteotomies post-external dacryocystorhinostomy (Ex-DCR) or post-endoscopic dacryocystorhinostomy (EDCR) for NLDO were included in this cross-sectional investigation.
J Patient Rep Outcomes
December 2024
Patient-Centered Outcomes, Adelphi Values, Bollington, Cheshire, UK.
Background: PRO measures of symptoms in clinical trials have historically utilized visual and numerical scales but verbal descriptors may make it easier for patients to clearly differentiate between response options. This study assessed content validity and meaningful change in five verbal response scales (VRSs) used to assess chronic rhinosinusitis with nasal polyp (CRSwNP) symptom severity.
Methodology: This qualitative, semi-structured interview study recruited adults from the US, Germany, and China with confirmed moderate-to-severe CRSwNP.
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