Intranasal Treatments for Children With Sleep-Disordered Breathing: The MIST+ Randomized Clinical Trial

Importance: Symptoms of obstructive sleep apnea are common in childhood and associated with significant comorbidity. Surgical treatment with adenotonsillectomy is first-line treatment but medical treatments show potential to improve symptoms and reduce the need for surgery.

Objective: To determine the efficacy of 6 weeks of intranasal steroid (INS) compared with saline in children with obstructive sleep-disordered breathing (OSDB) with persistent symptoms after a 6-week intranasal saline run-in.

Design, setting, and participants: This was a double-blind, placebo-controlled, randomized clinical trial involving specialist clinic waitlists at 2 sites in Australia. Included were children aged 3 to 12 years. Study data were analyzed from January to June 2025.

Interventions: All children received once-daily intranasal saline for 6 weeks (run-in). Those with persisting symptoms (SDB score ≥-1) were randomized to either once-daily intranasal mometasone furoate, 50 µg, (INS) or continued saline for a further 6 weeks.

Main outcomes and measures: The primary outcome was symptom resolution (SDB score <-1). Secondary outcomes included behavior, quality of life, and parental perception of need for surgery. Analyses were adjusted for site and baseline measures.

Results: A total of 150 children (mean [SD] age, 6.2 [2.3] years; 93 male [62%]) were recruited. Of 139 children who completed the run-in phase, 41 (29.5%) had symptom resolution after saline run-in. Among 93 children randomized to intervention groups (47 INS; 46 saline), symptom resolution occurred in 35.6% (95% CI, 22.9%-50.6%) and 36.4% (95% CI, 23.5%-51.6%) of the INS and saline group, respectively, with no evidence for a clinically significant difference between groups (risk difference, -0.9%; 95% CI, -20.7% to 19.0%; P = .93). No group differences were found in secondary outcomes. Subgroup analysis did not reveal a group more or less likely to respond to medical treatment.

Conclusions and relevance: Results of this randomized clinical trial show that 6 weeks of intranasal saline resolved OSDB symptoms in nearly one-third of children. An additional 6-week course of INS or saline led to resolution in another one-third (total resolution around 50%), with no added benefit from INS. Intranasal saline is an effective short-term first-line treatment for OSDB before consideration of polysomnography or surgical intervention. Results suggest that saline should be recommended for 3 months before assessing the need for specialist referral.

Trial registration: ClinicalTrials.gov Identifier: NCT05382494.

Author/s:

Gillian M. Nixon, Deborah Anderson, Alice Baker

Uterine Fibroids

Alex Haga — Tue, 23 Apr 2024 17:28:25 +0000

Date Added:

April 23, 2024

Journal/Publication:

JAMA

Publisher:

JAMA

Publication Date:

April 10, 2024

URL:

Uterine Fibroids

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2024.0447

Keywords

MeSH

A review of current knowledge regarding uterine fibroids and what to do about them. James W. Mold, MPH

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Uterine fibroids are sex–steroid responsive benign tumors primarily composed of smooth muscle cells and extracellular matrix that develop in the wall of the uterus.1 They are one of the most common neoplasms in reproductive-aged women. Lifetime prevalence estimates in premenopausal women range from 40% to 89%, depending on the method of detection, the study population, and the ages of those studied. Fibroids can range in size from less than 1 cm to more than 20 cm. Although not all individuals with fibroids have symptoms, typical symptoms include abnormal uterine bleeding/heavy menstrual bleeding (AUB/HMB), pelvic bulk symptoms (protruding abdomen, pressure on bladder and bowels), pain, and reproductive morbidity (ie, infertility). Due to their high prevalence and associated symptoms, fibroids are the leading cause of hysterectomy in the US and account for up to $34 billion annually in direct and indirect costs.

Author/s:

Marsh, E.E., Wegienka, G., Williams, D.R.