Laparoscopic sleeve gastrectomy combined with montelukast for obese patients with secretory otitis media

Abstract

BACKGROUND

Obesity is associated with increased risk of otitis media with effusion (OME), potentially due to peritubal fat accumulation and chronic inflammation. Laparoscopic sleeve gastrectomy (LSG) effectively reduces weight but achieves slow early middle ear effusion resolution. Montelukast, a leukotriene receptor antagonist, possesses anti-inflammatory properties that may promote OME recovery. However, rapid weight loss may paradoxically induce patulous eustachian tube, complicating outcome interpretation. We hypothesized that combining LSG with montelukast would accelerate middle ear effusion clearance and improve eustachian tube function without compromising weight loss efficacy.

AIM

To evaluate LSG combined with montelukast for obese patients with OME regarding recovery, eustachian tube function, and weight loss.

METHODS

This retrospective cohort study enrolled 112 obese OME patients treated at a tertiary hospital between January 2020 and March 2025. Groups: Control (n = 48, LSG alone) and observation (n = 64, LSG plus oral montelukast 10 mg/day for one month). Outcomes included total weight loss, excess weight loss, middle ear effusion resolution time, air-bone gap, Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) score, 36-Item Short Form Health Survey (SF-36), and adverse events. Assessors were blinded. Inter-group comparisons used t tests and χ² tests.

RESULTS

Baseline characteristics were comparable between groups (P > 0.05). Weight loss outcomes at 1 months and 6 months showed no significant inter-group differences (P > 0.05). Middle ear effusion clearance was significantly faster in the observation group compared to controls (28.39 ± 6.51 days vs 42.10 ± 8.32 days, P < 0.001). At one month postoperatively, the observation group demonstrated superior air-bone gap reduction (18.92 ± 4.65 dB vs 22.04 ± 4.57 dB, P = 0.001) and lower ETDQ-7 scores (2.63 ± 0.97 vs 3.75 ± 1.16, P < 0.001). SF-36 scores favored the observation group at 1 month and 3 months (P < 0.01). Adverse event rates were comparable between groups (7.81% vs 4.17%, P > 0.05).

CONCLUSION

LSG combined with montelukast significantly accelerates middle ear effusion resolution, improves auditory function and quality of life in obese OME patients, with maintained weight loss and favorable short-term safety.

Key Words: Laparoscopic sleeve gastrectomy; Montelukast; Obesity; Secretory otitis media; Eustachian tube function; Quality of life

Core Tip: This study first demonstrates that adding short-term montelukast after laparoscopic sleeve gastrectomy significantly accelerates middle ear effusion resolution and improves Eustachian tube function in obese patients with secretory otitis media, without affecting weight loss outcomes. This combined strategy offers a safe, effective approach for comprehensive management of this specific population.

INTRODUCTION

Obesity has become a global public health problem, and its prevalence is on the rise. In addition to having a strong correlation with metabolic conditions like diabetes and cardiovascular disease, obesity can also result in multi-system dysfunction[1,2]. In recent years, the association between obesity and otolaryngological diseases has gradually attracted attention, among which otitis media with effusion (OME) associated with obesity is not uncommon in clinical practice[3]. Studies have shown that obese patients are prone to poor drainage of the middle ear due to the accumulation of fat tissue around the eustachian tube, edema of the eustachian tube mucosa and dysfunction, which can induce or aggravate OME[4,5]. In addition, obesity-related chronic inflammatory state may also participate in the inflammatory response of the middle ear mucosa, further affecting the disease outcome[6].

OME is characterized by middle ear effusion and conductive hearing loss. If not treated in time, it can lead to persistent hearing loss, language development disorders and a decline in quality of life[7]. At present, the treatment of OME mainly includes observation and waiting, drug treatment (such as mucolytic agents, glucocorticoids, etc.) and surgical treatment (such as tympanocentesis, tympanostomy tube insertion, etc.)[8]. However, for obese patients with OME, treatment targeting the middle ear alone is often difficult to achieve ideal results, because its etiology involves the systemic metabolic state and eustachian tube dysfunction, and a comprehensive intervention strategy is required[4].

Laparoscopic sleeve gastrectomy (LSG) is one of the most widely used weight loss procedures. It achieves weight loss by limiting gastric volume and can significantly improve obesity-related metabolic disorders[9]. Studies have shown that patients can improve their eustachian tube function and middle ear condition to some extent after weight loss surgery[10]. However, the resolution of middle ear effusion in the early postoperative period is still slow, and the recovery effect of some patients is not ideal[11,12]. Therefore, how to further promote the recovery of OME on the basis of LSG has become a clinical concern.

Montelukast, as a selective leukotriene receptor antagonist, is widely used in the treatment of bronchial asthma and allergic rhinitis, and has anti-inflammatory and mucosal edema-reducing effects[13-15]. In recent years, some studies have applied it to the adjunctive treatment of OME, and it has shown the potential to promote the absorption of middle ear effusion and improve eustachian tube function[16]. However, its application effect in obese patients with OME, especially the comprehensive efficacy in combination with LSG, is still unclear.

Building upon these considerations, this research endeavors to assess the therapeutic impact of integrating LSG with montelukast on convalescence quality, auditory tube functionality, and body mass decline among overweight individuals suffering from OME, ultimately contributing to optimized multidisciplinary care strategies for this patient demographic.

MATERIALS AND METHODS

General information

This retrospective cohort study enrolled a total of 112 obese individuals diagnosed with OME and managed at our institution between January 2020 and March 2025. To minimize selection bias, we employed a consecutive inclusion strategy, enrolling all eligible patients who met the criteria during the study period. Participants were categorized into two arms based on the therapeutic protocol they received postoperatively: A reference cohort (n = 48) undergoing LSG alone (control group), and an experimental cohort (n = 64) receiving LSG plus montelukast supplementation (observation group). The imbalance in sample size reflects real-world clinical practice and patient/physician preferences regarding adjunctive pharmacotherapy. Despite this, baseline characteristics were compared and confirmed to be statistically comparable, ensuring satisfactory group comparability for the main outcome measures. The research protocol underwent comprehensive ethical scrutiny by our institutional review board and secured formal authorization.

Eligibility requirements comprised: (1) Adult status (≥ 18 years); (2) Obesity, defined as body mass index (BMI) ≥ 30 kg/m²[17]; (3) Fulfillment of established OME diagnostic benchmarks[18]; and (4) Intact cognitive function with adequate communication capacity.

Disqualifying conditions encompassed: (1) Active malignancy; (2) Comorbidities including diabetes mellitus or immunological disorders; (3) Psychiatric conditions; and (4) Treatment discontinuation or inter-facility transfer.

Methods

All patients underwent laparoscopic surgery. After establishing pneumoperitoneum using the four-port method and exploring the abdominal cavity, LSG was performed. Key intraoperative procedures included: Incising the omentum on the greater curvature of the stomach, freeing the posterior wall and fundus of the stomach; inserting a 32-36 Fr balloon endotracheal tube orally as intragastric support; and gradually severing the stomach body to near the His angle by initiating a linear cutting closure device 2-6 cm from the pylorus. The stump was sutured and buried, and the greater omentum was covered over the incision margin. Postoperatively, the residual stomach was tubular with a volume of approximately 80 mL. Postoperative management included a standardized nursing pathway for both groups, covering prophylactic anti-infection treatment, acid suppression and gastric protection, early nutritional support, and dietary transition guidance. Early ambulation within 24 hours postoperatively was emphasized to facilitate overall postoperative recovery.

Patients in the control group received routine bariatric surgical care and basic observational care for OME (eustachian tube dysfunction) postoperatively. If patients complained of significant ear fullness, they were instructed to perform the standard Valsalva maneuver to assist eustachian tube ventilation, but montelukast or other leukotriene receptor antagonists were not used; they were only treated as needed for other complications. Patients in the observation group received the same treatment as the control group, plus montelukast (10 mg/tablet) starting on postoperative day 1. The specific dosing regimen was: 10 mg orally once nightly for one month.

Observation indicators

General information: Baseline demographics (age, sex, BMI, disease duration) were compared between cohorts to verify comparability.

Weight loss effect: Weight reduction was assessed via percentage of total weight loss (%TWL) and percentage of excess weight loss (%EWL) at 1.6 months post-surgery.

Ear-related outcomes: Middle ear effusion resolution time was recorded (otoscopy/tympanometry); hearing recovery was measured by air-bone gap on audiometry pre- and post-operatively; eustachian tube function was evaluated using Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7)[19] (higher scores = worse function).

Quality of life: Quality of life was quantified with 36-Item Short Form Health Survey (SF-36)[20] at baseline and 1.3 months (higher scores = better outcomes).

Safety performance: Safety was monitored through surgical complications and adverse drug events.

Blinding of outcome assessment: Importantly, to ensure objectivity and minimize measurement bias, all outcome assessors (including audiologists conducting the hearing tests, nurses administering the SF-36 and ETDQ-7 questionnaires, and the statistician performing the data analysis) were blinded to the patients' group allocations. The blinding was maintained throughout the data collection and analysis process.

Statistical analysis

Statistical analyses were executed using SPSS 22.0. Continuous variables are presented as mean ± SD. Intra-group differences were analyzed via paired t tests, while inter-group comparisons employed independent t tests. Dichotomous variables are reported as frequencies and proportions, with group contrasts assessed using χ² tests. Statistical significance was defined as P < 0.05.

RESULTS

General information

A total of 112 obese OME patients were enrolled, allocated into a control arm (n = 48) and an intervention arm (n = 64). Baseline characteristics-including age, sex distribution, illness duration, and BMI-demonstrated no significant inter-group disparities (P > 0.05), confirming satisfactory group comparability (Table 1).

Table 1 Comparison of general information, n (%)/mean ± SD.

Group	n	Age (years)	Gender		OME disease course (months)	BMI (kg/m2)
			Male	Female
Control group	48	35.60 ± 8.60	18 (37.50)	30 (62.50)	8.25 ± 3.85	35.71 ± 3.94
Observation group	64	36.30 ± 9.18	26 (40.63)	38 (59.37)	8.36 ± 4.21	36.11 ± 4.15
t/χ2		0.406	0.112		0.141	0.520
P value		0.685	0.738		0.888	0.604

OME: Otitis media with effusion; BMI: Body mass index.

Weight loss effect

At 1-month and 6-month follow-ups, %TWL and %EWL marginally favored the intervention arm, yet lacked statistical significance (P > 0.05). Montelukast supplementation neither enhanced nor impeded post-LSG weight reduction, with comparable adipose loss efficiency across cohorts (Table 2).

Table 2 Comparison of weight loss indicators at different time points after surgery, mean ± SD.

Group	n	%TWL		%EWL
		1 month after surgery	6 months after surgery	1 month after surgery	6 months after surgery
Control group	48	9.26 ± 2.15	21.20 ± 4.87	18.87 ± 4.01	42.31 ± 6.15
Observation group	64	9.43 ± 2.34	21.76 ± 4.21	19.08 ± 4.10	44.16 ± 6.74
t		0.387	0.655	0.276	1.487
P value		0.700	0.514	0.783	0.140

%TWL: Percentage of total weight loss; %EWL: Percentage of excess weight loss.

Time to resolution of middle ear effusion, improvement in hearing and eustachian tube function

Middle ear effusion clearance occurred markedly faster in the intervention cohort (P < 0.001). Preoperative air-bone gaps were comparable (P > 0.05); however, postoperative values were significantly reduced in the montelukast arm at 1 month (P < 0.05), suggesting enhanced effusion resorption and auditory recovery. Additionally, ETDQ-7 scores favored the intervention group at 1 month (P < 0.001), corroborating improved tubal patency with adjunctive therapy (Table 3).

Table 3 Comparison of the time for middle ear effusion to resolve, and the improvement in hearing and eustachian tube function, mean ± SD.

Group	n	Time for fluid accumulation to subside (days)	Air-bone conductance difference (dB)		ETDQ-7 (points)
			Preoperative	1 month after surgery	Preoperative	1 month after surgery
Control group	48	42.10 ± 8.32	28.56 ± 6.39	22.04 ± 4.57a	4.54 ± 1.22	3.75 ± 1.16a
Observation group	64	28.39 ± 6.51	29.09 ± 5.95	18.92 ± 4.65a	4.47 ± 1.17	2.63 ± 0.97a
t		9.787	0.453	3.539	0.321	5.595
P value		< 0.001	0.651	0.001	0.749	< 0.001

^aP < 0.05 vs preoperative values in this group.

ETDQ-7: Eustachian Tube Dysfunction Questionnaire-7.

Quality of life before and after surgery

Baseline quality of life was comparable between cohorts (P > 0.05). Both groups demonstrated significant postoperative improvement at 1.3 months, with the montelukast arm achieving superior scores (P < 0.05), indicating adjunctive therapy enhances patient-reported wellbeing beyond surgery alone (Table 4).

Table 4 Comparison of quality of life before and after surgery, mean ± SD (points).

Group	n	Preoperative	1 month after surgery	3 months after surgery
Control group	48	37.48 ± 3.56	51.34 ± 5.34a	60.33 ± 5.33a
Observation group	64	36.27 ± 3.23	54.29 ± 5.43a	63.23 ± 5.42a
t		1.882	2.872	2.829
P value		0.062	0.005	0.006

^aP < 0.05 vs preoperative values in this group.

Safety performance analysis

Regarding surgical complications, two cases of incision infection occurred in the control group, while one case occurred in the observation group; both healed after dressing changes. Regarding adverse drug reactions, three patients in the observation group experienced mild gastrointestinal discomfort (nausea, abdominal distension), and one patient experienced mild headache; all did not require discontinuation of the medication and were relieved after symptomatic treatment. No neuropsychiatric adverse events were observed. Adverse event rates were comparable between cohorts (P > 0.05), demonstrating acceptable safety of montelukast co-administration (Table 5).

Table 5 Comparison of adverse reactions and complications, n (%).

Group	n	Surgical complications	Drug-related adverse reactions	Overall incidence
Control group	48	2 (4.17)	0 (0.00)	2 (4.17)
Observation group	64	1 (1.56)	4 (6.25)	5 (7.81)
χ2		0.714	3.111	0.622
P value		0.398	0.078	0.430

DISCUSSION

The association between obesity and OME has gradually attracted clinical attention in recent years[21]. Obese patients are prone to eustachian tube dysfunction and poor middle ear drainage due to factors such as fat accumulation around the eustachian tube, chronic low-grade inflammation and mucosal edema, which can induce or aggravate OME[22,23]. LSG is an effective weight loss method that can improve obesity-related metabolic disorders, but the process of middle ear effusion resolution in the early postoperative period is still relatively slow. Montelukast, as a leukotriene receptor antagonist, has anti-inflammatory and mucosal edema-reducing effects, and theoretically can work with LSG to promote the recovery of OME. This study is the first to explore the application effect of LSG combined with montelukast in obese patients with OME. The results show that the combined treatment regimen can significantly promote the absorption of middle ear effusion, improve hearing and eustachian tube function, and improve postoperative quality of life while ensuring the weight loss effect, and has good safety.

Regarding bariatric outcomes, the %TWL and %EWL did not differ significantly between the two groups at 1.6 months follow-ups (P > 0.05), suggesting montelukast neither enhanced nor compromised post-LSG weight reduction. This result is in line with expectations, because the main target of montelukast is leukotriene receptors, and it exerts its effect through anti-inflammatory mechanisms, without directly participating in energy metabolism or appetite regulation[24,25]. LSG achieves weight loss by limiting gastric capacity, and its effect depends mainly on the surgery itself and postoperative dietary compliance, rather than the intervention of adjuvant drugs[11]. Therefore, the result that the weight loss efficiency of the two groups is basically the same further confirms that combined drug therapy can focus on improving ear complications without affecting the core weight loss effect.

With respect to otologic outcomes, complete resolution of middle ear effusion occurred substantially earlier in the montelukast-supplemented cohort compared to standard care alone (28.39 ± 6.51 days vs 42.10 ± 8.32 days, P < 0.001). This accelerated clearance likely reflects the pharmacologic antagonism of leukotriene receptors, which attenuates inflammatory cascades within the middle ear mucosa, reduces mucosal edema, and ultimately restores eustachian tube patency[26]. Audiometric assessment at the 1-month postoperative interval revealed significantly diminished air-bone conduction gaps in the intervention group relative to controls (18.92 ± 4.65 dB vs 22.04 ± 4.57 dB, P = 0.001), suggesting more effective rehabilitation of conductive hearing deficits in this obese OME population. Of particular clinical relevance, ETDQ-7 scores-capturing patient-reported Eustachian tube dysfunction-were also significantly lower in the observation arm at the same timepoint (2.63 ± 0.97 vs 3.75 ± 1.16, P < 0.001). This subjective improvement further substantiates montelukast's beneficial impact on tubal aeration mechanics. These findings align coherently with existing literature demonstrating that leukotriene receptor antagonists ameliorate eustachian tube mucosal inflammation, thereby facilitating middle ear ventilation and promoting effluent drainage[27].

A critical consideration arising from our findings is the potential paradoxical effect of rapid weight loss on eustachian tube function. Recent literature has raised concerns that significant weight reduction following bariatric surgery might induce patulous eustachian tube (PET)[11,12], characterized by symptoms such as autophony, which can mimic the resolution of OME. This “weight loss paradox” challenges the interpretation of our primary outcome: Could the shortened effusion resolution time represent a phenotypic shift to PET rather than genuine therapeutic success? We argue this is unlikely for several reasons. First, the symptomatic profiles differ substantially-PET presents with autophony, while OME is characterized by hypoacusis and dull fullness. Our intervention group demonstrated significant improvements in both air-bone gap (an objective measure of conductive hearing loss) and ETDQ-7 scores, with no reports of autophony. Second, the rapid effusion clearance is more plausibly explained by montelukast’s direct anti-inflammatory action on the middle ear mucosa[26,27]. Nevertheless, to definitively distinguish between OME resolution and PET onset, future prospective studies should incorporate objective Eustachian tube function measures such as tubomanometry.

Postoperative SF-36 scores improved significantly in both arms at 1.3 months, with the montelukast cohort demonstrating superior outcomes (P < 0.01). This enhancement likely stems from: (1) Prompt effusion clearance and auditory recovery alleviating otologic symptoms; (2) Restored eustachian tube patency preventing recurrent discomfort; and (3) Metabolic benefits from bariatric surgery itself[28,29]. The intervention advantage persisted through 3 months, suggesting brief montelukast exposure (1 month) may yield sustained middle ear improvements.

Regarding safety, the overall incidence of adverse events was comparable between groups (7.81% vs 4.17%, P > 0.05), with no serious events documented. Mild gastrointestinal discomfort and headache in the observation group were consistent with montelukast’s known safety profile and resolved without intervention. However, the potential for neuropsychiatric events (NEs) warrants nuanced discussion. While no NEs were observed in our study, this finding should be interpreted cautiously, as the current literature remains controversial. Tunca et al[30] reported increased parent-reported NEs in children following montelukast treatment, whereas Wintzell et al[31] found no increased risk compared to long-acting beta-agonists. These conflicting results highlight the influence of study design and population on safety outcomes. Our retrospective design, with reliance on medical records, is prone to underreporting of subjective symptoms like NEs. Furthermore, our one-month follow-up is insufficient to capture all potential adverse reactions. Therefore, while our data support short-term safety, they cannot definitively rule out NE risk. Future prospective, long-term studies with active monitoring for neuropsychiatric symptoms are essential to fully establish the safety profile of this combined approach.

This investigation presents several methodological constraints. Primarily, its retrospective design inherently carries susceptibility to selection bias. Despite demonstrable baseline equilibrium and comparability between cohorts, and our use of consecutive inclusion to minimize bias, definitive validation through prospective randomized controlled trials remains essential. Second, although outcome assessors were blinded to group allocation to ensure objectivity, the sample size is relatively limited and the data originate from a single center; therefore, extrapolation of the conclusions should be approached with caution. Third, the follow-up period is relatively short, and the long-term effects of montelukast on middle ear condition and the relapse rate after drug withdrawal require further observation. Fourth, as a subjective rating scale, the ETDQ-7 may be subject to individual differences; future studies could combine it with objective examination methods such as eustachian tube manometry for comprehensive evaluation. Fifth, the one-month duration of montelukast therapy, while sufficient to demonstrate early efficacy, may not represent the optimal treatment course, and further research is needed to determine the ideal duration of adjunctive pharmacotherapy.

CONCLUSION

In conclusion, the combination of LSG and montelukast in obese patients with OME significantly promotes middle ear effusion absorption, improves hearing and eustachian tube function, and enhances postoperative quality of life while ensuring effective weight loss, all with a favorable short-term safety profile. This combined treatment regimen provides a safe and effective comprehensive intervention strategy for obese patients with OME and warrants broader clinical application. Future prospective, multicenter studies with larger sample sizes and extended long-term follow-up are warranted to further validate its efficacy, establish long-term benefits, and definitively address the ongoing controversies regarding neuropsychiatric safety and the potential for disease phenotype transition.