Comparison and review of abrasive bronchial brushing versus non-abrasive aspiration, lavage and washing - Higher sensitivity but with risk of over-diagnosis for bronchial brushing.

Bronchial exfoliative cytology is classified as non-abrasive (washing, aspiration and bronchoalveolar lavage) and abrasive (brushing). Brush abrasion dislodges epithelial cells but can induce bleeding and cytomorphologic artifacts. In this study, the largest cohort to date of bronchial cytology specimens were referenced against bronchial biopsy as the reference standard. Findings in the study will be useful for selecting biopsy modality and reducing necessary procedural risks. All consecutive bronchial cytology and bronchial biopsy from 1995 to 2022 were retrieved. The diagnoses were reviewed and categorized into five-tiered diagnostic categories to compare diagnostic agreement and concordance. Review of 14,148 specimens yielded 3963 non-abrasive, 2378 abrasive cytology specimens matched to biopsy, with 4355 matches between non-abrasive and abrasive cytology specimens. Agreement between non-abrasive and abrasive cytology was moderate (κ = 0.580), and similar when referenced against biopsy (κ = 0.456 (non-abrasive), κ = 0.498 (abrasive)). Abrasive bronchial cytology showed a higher percentage of malignant diagnosis (20.95 % vs. 12.63 %, p < 0.001) and over-diagnosis rate (36.40 % vs. 29.79 %, p < 0.001), but higher sensitivity (0.747 vs. 0.572, p = 0.002). For subgroup analysis of transbronchial biopsies, matched abrasive cytology showed higher discordant rates (p < 0.05) and lower accuracy (0.907 vs. 0.873, p = 0.020). With the added bleeding risk associated with brushing, abrasive techniques may only be preferable in cases with clinical or bronchoscopic suspicion of malignancy, in particular endobronchial mucosal lesions. For routine bronchoscopy, non-abrasive bronchial cytology appears to be adequate.

Digital image comparison of cellular yield in bronchial brushing, pre- and post-biopsy lavage cytology.

Background Bronchoscopy is a useful diagnostic tool capable of performing core biopsy, forceps biopsy, bronchoalveolar lavage, and bronchial brushing. This study compares the cellularity of bronchial cytology including pre- and post-biopsy lavage by digital image analysis, aiming to increase diagnostic and tumor yield by optimizing the sequence and combination of bronchial biopsy and cytology. Methods Alveolar macrophage, bronchial epithelium, and tumor cell cellularity from liquid-based cytology preparations of bronchial brushing and pre-biopsy and post-biopsy bronchoalveolar lavage were annotated on digitized whole-slide images and compared. Secondary analysis on the relationship of tumor cell and non-lesional cell yield was performed. Results 118 cytology specimens from 43 patients were retrieved in total. Bronchial epithelium count was higher in pre-biopsy than post-biopsy lavage (p<0.01) but not for alveolar macrophages nor tumor cell (p>0.05). Tumor cell count was higher for bronchial brushing cytology samples than lavage (p=0.018). The alveolar macrophage count was higher in post-biopsy lavage than bronchial brushing (p=0.033), otherwise brushing showed consistently higher bronchial epithelium and tumor cell counts. There were 33 false negative (tumor cell absent) specimens, and the combination of bronchial brushing and pre-biopsy lavage yielded the lowest false negative cases. Correlation between bronchial epithelium and alveolar macrophage counts with tumor cell count were weak (correlation coefficient=-0.168-0.203) except for post-biopsy lavage (correlation coefficient=0.412-0.479, p<0.05). Conclusion Bronchial brushing yields a greater amount of tumor cell than lavage, and timing lavage before or after core biopsy does not affect tumor cell yield. Combining bronchial brushing and pre-biopsy lavage results in the lowest false negative rate.

Detection of early (T1) lung cancers and lepidic adenocarcinomas in sputum and bronchial cytology.

BACKGROUND: The lung is an extensively epithelialized organ, producing ample exfoliated material for sputum and bronchial cytology. In view of the updates in the World Health Organization classification of early (T1/≤ 3 cm) lung cancer with respect to adenocarcinomas with lepidic pattern, this study retrospectively reviews sputum and bronchial cytology paired with resection-confirmed lung cancers. METHODS: A computerized search for all lung resection specimens of carcinomas over a 20-year period was performed. Cytologic diagnoses of corresponding sputum and bronchial cytology were classified into five-tiered categories (C1-insufficient/inadequate, C2-benign, C3-atypia, C4-suspicious and C5-malignant). Reports and slides of the resection specimen were reviewed for reclassification of T1 cancers. RESULTS: Totally 472 and 383 sputum and bronchial cytology specimens respectively were included. Sensitivity for T1 lesions on sputum cytology were 10.6 %, 2.1 % and 0.5 % at cutoffs of atypia/C3, suspicious/C4 and malignant/C5 categories, lower than bronchial cytology (35.1 %, 15.5 %, 8.1 %; p < 0.001). T1 lesions correlated with lower detection rates, whereas squamous cell carcinoma histology, larger size and bronchial invasion were associated with increased detection rates in sputum and bronchial cytology (p < 0.050). Detection rates for abrasive bronchial cytology (brushing) were overall higher (p = 0.018- < 0.001), but on subgroup comparison, non-abrasive (aspiration, lavage and washing) cytology demonstrated favorable trends (p = 0.063-0.088) in detecting T1 lesions. Adenocarcinomas with lepidic pattern had lower suspicious/C4 (p = 0.040) or above and malignant/C5 (p = 0.019), but not atypia/C3 or above (p = 0.517) rates. CONCLUSIONS: Most adenocarcinomas with lepidic pattern are only diagnosed as atypia/C3 on cytology. With its modest sensitivity, interpretation of negative and indeterminate cytology results mandates caution.

1-Year Prospective Study of the Relationship of Serial Exhaled Nitric Oxide Level and Asthma Control.

Background and Objective: Previous studies found that the fractional nitric oxide concentration in exhaled breath (FeNO) levels in healthy Chinese adults was higher than in White adults. More understanding of serial changes of FeNO levels with asthma control in a real-life clinical setting would be important to explore the utility of this biomarker in routine asthma management. This study assessed the FeNO levels of Chinese asthma subjects with different levels of asthma control and the serial changes with respect to the changes in asthma control over 1 year. Methods: A 12-month prospective study (subjects recruited between November 2019 and January 2021) with serial measurement of FeNO levels at baseline, 4, 8 and 12 months. Asthma control was assessed by the Global Initiative for Asthma classification, Asthma Control Test (ACT) and Asthma Control Questionnaire (ACQ). Results: Altogether, 136 subjects (mean age 51.51±15.09 years, 46[33.8%] male) had successful baseline FeNO measurements. At baseline, the FeNO levels did not show a statistically significant difference for controlled, partly controlled and uncontrolled asthma according to GINA classification, ACT and ACQ. FeNO levels decreased with improving asthma control and stayed at similar levels with unchanged or worsening asthma control for all subjects. For subjects with baseline blood eosinophil levels ≥300 cells/µL(n=59), FeNO levels decreased with improving asthma control, stayed similar without change for asthma control and increased with worsening asthma control. Receiver operating characteristic (ROC) analysis with the highest area under curve (AUC) for changes in FeNO levels for improving asthma control was between ≤ -10 to -25 ppb at various time points in the 12-month study. Conclusion: Changes in FeNO levels over time were associated with changes in clinical asthma control, particularly in those with higher blood eosinophil count and are likely more useful than a single time point measurement in managing asthma.

Phenotyping empyema by pleural fluid culture results and macroscopic appearance: an 8-year retrospective study.

Background: The clinical impact of phenotyping empyema is poorly described. This study was designed to evaluate clinical characteristics and outcomes based on the two readily available parameters, pleural fluid culture status and macroscopic fluid appearance. Methods: A retrospective study was conducted on patients with empyema hospitalised between 2013 and 2020. Empyema was classified into culture-positive empyema (CPE) or culture-negative empyema (CNE) and pus-appearing empyema (PAE) or non-pus-appearing empyema (non-PAE) based on the pleural fluid culture status and macroscopic fluid appearance, respectively. Results: Altogether, 212 patients had confirmed empyema (CPE: n=188, CNE: n=24; PAE: n=118, non-PAE: n=94). The cohort was predominantly male (n=163, 76.9%) with a mean age of 65.0±13.6 years. Most patients (n=180, 84.9%) had at least one comorbidity. Patients with CPE had higher rates of in-hospital mortality (19.1% versus 0.0%, p=0.017) and 90-day mortality (18.6% versus 0.0%, p=0.017) and more extrapulmonary sources of infection (29.8% versus 8.3%, p=0.026) when compared with patients with CNE. No significant difference in mortality rate was found between PAE and non-PAE during the in-hospital stay and at 30 days and 90 days. Patients with PAE had less extrapulmonary sources of infection (20.3% versus 36.2%, p=0.010) and more anaerobic infection (40.9% versus 24.5%, p=0.017) than those with non-PAE. The median RAPID (renal, age, purulence, infection source, and dietary factors) scores were higher in the CPE and non-PAE groups. After adjusting for covariates, culture positivity was not independently associated with mortality on multivariable analysis. Conclusion: Empyema is a heterogeneous disease with different clinical characteristics. Phenotyping empyema into different subclasses based on pleural fluid microbiological results and macroscopic fluid appearance provides insight into the underlying bacteriology, source of infection and subsequent clinical outcomes.

A comparative study of diagnostic accuracy in 3026 pleural biopsies and matched pleural effusion cytology with clinical correlation.

BACKGROUND: Pleural effusion can be caused by a wide range of benign and malignant conditions. Pleural biopsy and effusion cytology represent two key methods of pathological diagnosis. To compare the performance these two methods, a large cohort of matched pleural biopsy and effusion cytology with clinical follow-up was reviewed. METHODS: Pleural biopsies and effusion cytology specimens over a period of 18 years were retrieved. Cytology specimens collected within 7 days of pleural biopsy were matched. Reports were reviewed, and the cause for pleural effusion was determined by hospital disease coding and clinical data. RESULTS: Totally, 3026 cases were included. The leading cause of benign effusion was tuberculosis (n = 650). Malignant pleural effusion (MPE) was more common in older females (p < 0.001) and mostly due to lung cancer (n = 959), breast cancer (n = 64), and mesothelioma (n = 48). The inadequate/insufficient (B1/C1) rate of biopsy was higher than cytology (15.6% vs. 0.3%) but the rates for other diagnostic categories were similar. Biopsy and cytology showed a correlation coefficient of 0.315, improving to 0.449 when inadequate/insufficient (B1/C1) cases were excluded. The ROM for benign cytology (C2) was lower than biopsy (B2) (p < 0.001). Compared with biopsy, the diagnostic accuracy was higher in cytology overall and for metastatic carcinomas (p < 0.001) but lower for hematolymphoid malignancies (p = 0.014) and mesotheliomas (p = 0.002). CONCLUSIONS: These results suggest that effusion cytology may be better for confirming benignity and diagnosing carcinomatous MPE. In these cases, pleural biopsy may be withheld to reduce procedural risks. However, for suspected hematolymphoid malignancies and mesothelioma, biopsy should be considered.

Changing pleural fluid triglyceride levels in cirrhotic chylothorax.

Chylothorax is an uncommon disease entity, but it occasionally poses a diagnostic challenge to physicians. Pleural fluid triglyceride level has been advocated as a screening test to diagnose chylothorax. However, its level can be depressed if there is an additional pathology driving the process of pleural fluid production. We report a case of high-volume pleural fluid output due to dual pathologies, cirrhotic hydrothorax and chylothorax, causing an initial failure to diagnose chylothorax due to low pleural fluid triglyceride level. The fluid triglyceride levels were unmasked after the treatment for underlying portal hypertension. These findings were further substantiated by positive lipoprotein electrophoresis for chylomicron. In this patient, lipoprotein electrophoresis of his pleural fluid specimen helps distinguish chylothorax as a second pathology amidst the underlying cirrhotic hydrothorax.

Blood eosinophil count as a predictor of hospital length of stay in COPD exacerbations.

BACKGROUND AND OBJECTIVE: Airway inflammation accompanying exacerbations varies among individuals with some having neutrophilic, while others showing eosinophilic inflammation. This study assessed the cut-off values of blood eosinophil count for identifying subjects with longer hospital length of stay (LOS) with acute exacerbations of chronic obstructive pulmonary disease (AECOPD). METHODS: Patients were recruited at presentation to the hospital with an AECOPD. Complete blood picture with differential count was taken on admission. Patients were treated with a standard course of systemic corticosteroid and antibiotic and evaluated at 8 weeks post-exacerbation for lung function measurement and 6-min walk. They were followed up in 1 year for any readmissions or mortality. Cut-off values of eosinophils for assessment of longer LOS were calculated using receiver operating characteristic (ROC) curve analysis. RESULTS: A total of 346 patients with admission eosinophil count were included in the analysis (333 (96.2%) were males; mean ± SD age: 74.9 ± 7.8 years; mean forced expiratory volume in 1 s (FEV1 ): 43.4 ± 16.3% predicted). The median (interquartile range (IQR)) of the absolute peripheral eosinophil count, percent eosinophil count and LOS were 0.11 (0.25) × 109 /L, 1 (3) % and 5 (7) days, respectively. Using the median LOS of ≥5 days as the cut-off, ROC analysis of the cut-off value of eosinophil count associated with longer LOS was at <2% (area under the curve (AUC): 0.666, P < 0.001) while absolute eosinophil count was at <0.144 × 109 /L (AUC: 0.645, P < 0.001). These eosinophil cut-off values could predict longer LOS independent of age, lung function and previous hospital admissions, but had no association with readmissions for AECOPD and mortality at 12 months. CONCLUSION: An eosinophil value of <0.144 × 109 /L on admission or <2% was associated with longer hospital LOS for AECOPD.

Author Correction: A randomized controlled trial of an ambulatory approach versus the hospital-based approach in managing suspected obstructive sleep apnea syndrome.

A correction has been published and is appended to both the HTML and PDF versions of this paper. The error has not been fixed in the paper.

Use of Berlin questionnaire in comparison to polysomnography and home sleep study in patients with obstructive sleep apnea.

BACKGROUND: Obstructive sleep apnea syndrome (OSAS) is a common disorder with significant morbidity and mortality. We aimed to evaluate the predictive accuracy of the Berlin questionnaire in patients with suspected OSAS undergoing PSG in the sleep laboratory setting against those going through the Embletta™ portable diagnostic system (Embletta PDS) at home. METHODS: Patients with suspected OSAS were recruited from respiratory clinics to complete Berlin questionnaire and Epworth Sleepiness Score (ESS). Patients were randomized to undergo either home-based sleep test (group A) or hospital-based polysomnography (PSG) (group B). RESULTS: Three hundreds and sixteen subjects with newly referred suspected OSAS were recruited and randomized into group A (n = 157) and group B (n = 159). The prevalence of moderate to severe OSAS defined as apnea-hypopnea index (AHI) ≥ 15/h was 54%. The Berlin questionnaire identified 69.7% (n = 99) of subjects as high risk in group A and 77.5% (n = 100) in group B. The sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) of the questionnaire to predict an AHI ≥ 15/h as diagnosed by PSG was 78, 23, 67 and 35%. When compared with Embletta PDS, the specificity and NPV increased to 48 and 63%. The area under the Receiver Operator Curve (ROC) based on PSG (AUC = 0.539, 95%CI 0.417, 0.661) and based on home Embletta (AUC = 0.712, 95%CI 0.617, 0.907). CONCLUSIONS: The questionnaire was not reliable in predicting OSAS through PSG AHI whereas there was some predictive ability in discriminating patients with OSAS from normal subjects based on home Embletta sleep test. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (Identifier: NCT01828216) on 10 April 2013.

Continuous positive airway pressure for obstructive sleep apnoea does not improve asthma control.

BACKGROUND AND OBJECTIVE: Unrecognized obstructive sleep apnoea syndrome (OSAS) may lead to poor asthma control despite optimal therapy. We assessed asthma control, airway responsiveness, daytime sleepiness and health status at baseline and 3 months after continuous positive airway pressure (CPAP) treatment among asthma patients with nocturnal symptoms and OSAS. METHODS: Patients with nocturnal asthma symptoms despite receiving at least moderate-dose inhaled corticosteroid and long-acting bronchodilators underwent a home sleep study using 'Embletta' portable diagnostic system. Patients with significant OSAS (apnoea-hypopnoea index (AHI) ≥10/h) were randomized to receive either CPAP or conservative treatment for 3 months. RESULTS: Among 145 patients recruited, 122 underwent sleep study with 41 (33.6%) having AHI ≥10/h. Patients with significant OSAS had higher BMI (27.4 (5.1) vs 25.1 (4.5) kg/m2 , P = 0.016), bigger neck circumference (36.6 (3.1) vs 34.8 (3.6) cm, P = 0.006) and lower minimum SaO2 (80.7 (6.6) vs 87.2 (3.9) %, P < 0.001). Using intention-to-treat analysis among 37 patients with AHI ≥10/h (CPAP group (n = 17) vs control group (n = 20)), there was no significant difference in Asthma Control Test score (CPAP 3.2 (2.7) vs control 2.4 (5.7), P = 0.568) but the CPAP group had a greater improvement in Epworth Sleepiness Scale (-3.0 (4.5) vs 0.5(3.8), P = 0.014), Asthma Quality of Life Questionnaire (0.6 (0.8) vs 0.02 (0.7), P = 0.022) and vitality domain in the SF-36 questionnaire (14.7 (16.8) vs 0.3 (16.2), P = 0.012) after 3 months. Data are presented as mean (SD) unless otherwise stated. CONCLUSION: A high prevalence of OSAS was found among patients with asthma and snoring. CPAP therapy for 3 months did not enhance asthma control but improved daytime sleepiness, quality of life and vitality.

Utility of GeneXpert in analysis of bronchoalveolar lavage samples from patients with suspected tuberculosis in an intermediate-burden setting.

OBJECTIVES: To explore the clinical role of GeneXpert in managing pulmonary tuberculosis (TB) in an intermediate burden city. METHODS: Sputum acid-fast-bacilli (AFB) smear negative patients underwent bronchoscopy for bronchial alveolar lavage (BAL). Fluids collected were examined for AFB smear, TB culture, TB polymerase chain reaction (PCR) (Cobas Taqman) and for GeneXpert. RESULTS: From October 2015 to February 2017, 227 BAL samples were collected. Cough and haemoptysis were the presenting symptoms in 70.0% and 37.4%, respectively. Apical shadows on chest X-rays (CXR) and apical cavitations on computed tomography (CT) were commoner in GeneXpert positive cases (p = 0.01 and 0.02, respectively). Sensitivity and specificity of GeneXpert for TB diagnosis was 80% and 98% respectively. Positive and negative predictive value of the test was 92.3 and 95.1%, respectively. There were 9 false negative GeneXpert samples (8 were Cobas Taqman TB PCR negative): 6 were diagnosed by BAL culture, 2 by biopsy and one by Cobas Taqman TB PCR. There were 3 false positive cases with negative culture; 2 were put on empirical treatment with favourable clinical responses, while one defaulted follow-p. CONCLUSION: GeneXpert in BAL samples has high sensitivity and specificity. It enabled timely initiation of anti-TB treatment in clinical suspicious cases.

A randomized controlled trial of an ambulatory approach versus the hospital-based approach in managing suspected obstructive sleep apnea syndrome.

Comparisons of home-based versus hospital-based approach in managing patients with suspected obstructive sleep apnoea syndrome(OSAS). A prospective, controlled CPAP parallel study of new referrals with suspected OSAS randomized into group A) home-based or B) hospital-based approach. Following detection of AHI ≥ 15/hr by Embletta sleep study (group A) or polysomnography (group B), patients received CPAP for 3 months after an overnight autoCPAP titration at home or in hospital respectively. Modified intention-to-treat analysis of those with AHI ≥ 15/hr on CPAP (n = 86 vs 86) showed no difference in Epworth sleepiness score, the primary endpoint, but greater improvement in Sleep-Apnoea-Quality-of-Life-Index[difference 0.3,(95%CI 0.02, 0.6), p = 0.033] at 3 months in group A. The mean costs for the patients in group A and group B were HK$8479(989) and HK$22,248(2407) respectively. The mean difference between groups was HK$-13,769(USD 1770 equivalent) per patient with 95% CI. (-14324, -13213), p < 0.001. The waiting time of patients with AHI ≥ 15/hr who were started on CPAP treatment from the first clinic consultation to the diagnostic sleep test, autoCPAP titration, and CPAP treatment was 189.6, 148.8 and 145.0 days shorter in group A than group B respectively. Home-based approach is non-inferior to hospital-based approach in managing patients with suspected OSAS, with shorter waiting time, and substantial cost savings.

Effects of CPAP therapy on visceral fat thickness, carotid intima-media thickness and adipokines in patients with obstructive sleep apnoea.

BACKGROUND AND OBJECTIVE: Obstructive sleep apnoea (OSA) is associated with an increased prevalence of metabolic syndrome. This study explores the effects of continuous positive airway pressure (CPAP) for patients with OSA on visceral and mesenteric fat thickness, carotid intima-media thickness (IMT) and adipokines. METHODS: A randomized controlled study was conducted at a teaching hospital on 90 patients newly diagnosed with OSA to receive either therapeutic CPAP or subtherapeutic CPAP for 3 months. Visceral fat thickness and carotid IMT were measured with B-mode ultrasound; adipokine levels were assessed at baseline and 3 months. RESULTS: Altogether, 45 patients received therapeutic CPAP and 45 received subtherapeutic CPAP without significant differences in age 50.3 (10.1) versus 48.7 (9.0) years, BMI 28.2 (3.9) versus 28.2 (4.5) kg/m2 , Epworth Sleepiness Scale (ESS) 12.4 (5.9) versus 11.3 (4.7), apnoea-hypopnoea index (AHI) 30.6 (21.4) versus 35.2 (25.5) /h, minimum SaO2 79.6 (10.8) versus 76.7 (12.4) % and existing co-morbidities. CPAP usage was therapeutic 4.2 (2.1) versus subtherapeutic 4.1 (2.0) h/night over 3 months. Adiponectin and irisin levels changed significantly following therapeutic CPAP for 3 months versus subtherapeutic CPAP (-1.6 vs 7.3, P = 0.042; 0.1 vs -0.1, P = 0.028 respectively) while only serum level of monocyte chemotactic protein 1 (MCP-1) at baseline was positively correlated with AHI (r = 0.278). No significant changes were observed in other adipokines, visceral fat thickness and IMT. CONCLUSION: Short-term therapeutic CPAP versus subtherapeutic CPAP does not significantly reduce visceral fat thickness and IMT, although it reduces adiponectin and increases irisin.

Mesenteric fat thickness is associated with metabolic syndrome independently of Apnoea-Hypopnoea Index in subjects with obstructive sleep apnoea.

BACKGROUND AND OBJECTIVE: Mesenteric fat thickness (MFT) was associated with metabolic syndrome (MetS) and obstructive sleep apnoea (OSA) in separate studies. This study aimed to assess whether the association of MFT with MetS was independent of OSA in subjects with suspected OSA. METHODS: Two hundred forty-two subjects (men: 181; women: 61) with suspected OSA underwent ultrasound examinations for measurements of mesenteric, subcutaneous and preperitoneal fat thicknesses after overnight polysomnography. Anthropometric measurements and metabolic risk profile were assessed. RESULTS: Two hundred twenty-one (91%) subjects were confirmed to have OSA with Apnoea-Hypopnoea Index (AHI) >5/h. MFT had significant correlation (P < 0.01) with AHI and most MetS components. In partial correlation with adjustment for AHI, MFT had significant correlation (P < 0.01) with most MetS components including fasting plasma glucose (r = 0.25), triglycerides (r = 0.24), HDL cholesterol (r = -0.29) and waist circumference (r = 0.56). In multivariate logistic regression with adjustments for the confounding variables including AHI, MFT was the only variable independently associated with MetS, with the odds ratio of 5.48 (95% CI: 1.5-20.0) for every 1 cm increase of MFT. When the subjects were subdivided into obese (BMI ≥ 27.5 kg/m(2) ) and non-obese (BMI < 27.5 kg/m(2) ) groups, the positive association of MFT with MetS persisted in the non-obese group only, with the odds ratio of 22 (95% CI 2.8-174.1) for every 1 cm increase of MFT. The AHI had significant association with MetS in male subjects only. CONCLUSION: MFT, rather than AHI, is the major independent determinant of MetS in subjects with suspected OSA, particularly in non-obese subjects. See Editorial, page 408.

A Randomized Controlled Study to Examine the Effect of a Lifestyle Modification Program in OSA.

BACKGROUND: Obesity is an important risk factor for OSA. This study aimed to assess the effect of weight reduction through a lifestyle modification program (LMP) on patients with moderate to severe OSA. METHODS: This was a parallel group, randomized controlled trial. Altogether, 104 patients with moderate to severe OSA diagnosed on portable home sleep monitoring were randomized to receive a dietician-led LMP or usual care for 12 months. The primary outcome was reduction of apnea-hypopnea index (AHI) at 12 months as assessed by portable home sleep monitoring. RESULTS: In the intention-to-treat analysis (ITT), LMP (n = 61) was more effective in reducing AHI from baseline (16.9% fewer events in the LMP group vs 0.6% more events in the control group, P = .011). LMP was more effective in reducing BMI (-1.8 kg/m2, 6.0% of the initial BMI; -0.6 kg/m2, 2.0% of the initial BMI in control group; P < .001). The reduction in daytime sleepiness as assessed by Epworth Sleepiness Scale was not significant in ITT but was more in the LMP group (-3.5 in the LMP group vs -1.1 in the control group, P = .004) by treatment per protocol analysis. There was modest improvement in mental health in the Short Form Health Survey. Eating behavior was improved with increased intake of protein and fiber. These changes were observed 4 months after the initial intensive diet counseling and persisted at 12 months. CONCLUSIONS: LMP was effective in reducing the severity of OSA and daytime sleepiness. The beneficial effect was sustained in 12 months. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01384760; URL: www.clinicaltrials.gov.