Abstract
Background:
This meta-analysis aimed to evaluate the efficacy and safety of sinus balloon catheter dilation (SBCD) versus functional endoscopic sinus surgery (FESS) in the treatment of chronic sinusitis (CRS).
Methods:
Four databases (PubMed, Embase, Web of Science, and Cochrane Library) were searched from the establishment of the databases to October 7, 2024, for randomized controlled trials comparing SBCD versus FESS in the treatment of CRS. Meta-analyses of Lund–Mackay score, sinonasal outcome test-20 score, complications, operating time and revision surgery were performed.
Results:
Totally 14 randomized controlled trials were included for meta-analysis. Compared with FESS, SBCD provided a significantly lower postoperative sinonasal outcome test-20 score (standard mean difference = ‐0.25, 95% confidence intervals [CI]: ‐0.42 to ‐0.07, P < .01, I2 = 94%) and lower operating time (odds ratio [OR] = ‐5.00, 95%CI: ‐8.08 to ‐1.91, P = .001, I2 = 50%), while significantly reduced the incidence of complications (OR = 0.14, 95%CI: 0.08 to 0.26, P < .01, I2 = 65%). There was no significant difference between 2 groups regarding Lund–Mackay score (standard mean difference = 0.14, 95% CI: ‐0.04 to 0.32, P = .12, I2 = 15%) and revision surgery between 2 groups (OR = 0.51, 95% CI: 0.12 to 2.21, P = .37, I2 = 0%).
Conclusions:
The results indicated that SBCD was an effective intervention for CRS, capable of substantially decreasing the occurrence of complications.
Keywords: balloon catheter dilation, chronic sinusitis, complication, endoscopic sinus surgery, Lund–Mackay score, meta-analysis
1. Introduction
Chronic sinusitis (CRS) is a prevalent form of chronic nasal irritation, which is an infection of the sinus mucous membranes, marked by sinus and extrasinus symptoms.[1] In contrast to acute sinusitis, CRS is not predominantly an infectious illness; instead, it is characterized by a persistent inflammatory process.[2] CRS denotes symptoms persisting beyond 12 weeks, encompassing nasal congestion, rhinorrhea, facial pain or pressure, and a diminished olfactory sense.[3] Recent data regarding the prevalence of CRS, according to the EPOS symptom-based definition, indicates a prevalence of 5.5% in Brazil, 8% in China, 11% in Europe and Korea, and 12% in the United States.[4]
For individuals who fulfill the diagnostic criteria for CRS, the recommended first-line treatment includes intranasal steroids, high-volume saline irrigation, or a combination of both.[2] Functional endoscopic sinus surgery (FESS) has emerged as a conventional approach for managing patients with CRS who have not responded to previous medicinal interventions, with favorable success rates documented.[5] FESS is based on the premise that CRS typically originates in the nasal cavity and disseminates through the ethmoidal prechambers to the frontal and maxillary sinuses, with infections in these latter sinuses generally being secondary in character.[6] The primary objective of surgery is to reestablish ventilation and drainage in the sinuses.[7] Numerous studies have indicated a high success rate for FESS in alleviating the symptoms of CRS.[8,9] Notwithstanding this success, some individuals encountered problems like adhesions, polyps, and mucocele development.[10]
The sinus balloon catheter dilation (SBCD) is an innovative technique for the minimally invasive endoscopic dilatation of obstructed sinuses. It is increasingly recognized as a minimally invasive enhancement to the sinus surgery.[11] The technology resembles catheter-based methods that have proven effective in other contexts, including coronary angioplasty and bile duct dilation.[12] The objective is to alleviate obstruction by expanding the sinus outflow through the dilation of the sinus ostia and the modification of the sinus outflow canal without excising tissue. This should reduce the duration of healing, the necessity for extensive postoperative debridements, and enhance the preservation of mucociliary function in these areas.[13]
However, there is still controversy regarding the effectiveness and safety of the SBCD for CRS. Given the growing use of SBCD, understanding its efficacy and safety profile is critical. Hence, we conducted this meta-analysis with the aim of providing clearer insights into the effectiveness and safety of SBCD versus FESS for CRS and informing clinical decision-making.
2. Materials and methods
2.1. Search strategy
The present meta-analysis was conducted in accordance with the 2020 standards of the Preferred Reporting Project for Systematic Review and Meta-Analysis. This meta-analysis has been officially recorded at PROSPERO under the registration number CRD42024617694. A comprehensive search was performed across 4 databases: PubMed, Embase, Web of Science, and the Cochrane Library, to discover literature published until October 7, 2024. The search strategy included a blend of MeSH and free-text terms in accordance with the PICOS principle. The search keyword was “Sinusitis” AND “Balloon” AND “Endoscopy.” Table S1, Supplemental Digital Content, https://links.lww.com/MD/P199 provided a comprehensive listing of the search results. Furthermore, we performed a comprehensive manual evaluation of the bibliographies of the identified articles, together with relevant reviews and meta-analyses, to identify any new randomized controlled trials (RCTs) that satisfied the inclusion criteria.
2.2. Inclusion and exclusion criteria
The criteria for inclusion were as follows: (1) patients diagnosed with CRS, with or without nasal polyposis and allergic rhinitis, who have not responded to drug therapy; (2) patients in the intervention group received SBCD; (3) patients in the control group received FESS; (4) at least one of the following outcomes was reported: Lund–Mackay score, sinonasal outcome test-20 (SNOT-20) score, complications, operating time and revision surgery; (5) study design: RCT.
The criteria for exclusion were as follows: (1) different types of articles, such as case reports, publications, letters, reviews, meta-analyses, editorials, animal studies, protocols, conferences, etc; (2) other diseases; (3) not relevant; (4) duplicate patient cohort; (5) the full text cannot be obtained; (6) data cannot be obtained.
2.3. Selection of studies
The literature selection process, which included the elimination of duplicate entries, was executed with EndNote (Version 20; Clarivate Analytics, Philadelphia). Two independent reviewers conducted the preliminary search. The redundant items were removed, and the titles and abstracts were evaluated to determine their relevance. Each study was subsequently classified as either included or omitted. We addressed the issue by achieving a consensus. If the parties could not reach an agreement, a third reviewer assumed the position of mediator.
2.4. Data extraction
Two independent reviewers extracted data. The extracted data included: (1) basic characteristics of studies included author, nationality, and year of publication; (2) baseline characteristics of the subjects included age, sample size, sinus, and postoperative follow-up time; (3) outcome indicators included SNOT-20 score, Lund–Mackay score, complications, operating time, and revision surgery.
The Lund–Mackay score method for the score varies from 0 to 24 and assigns points (0–2) based on involvement of 6 areas (Ostiomeatal Complex, Anterior Ethmoids, Posterior Ethmoids, Sphenoid Sinus, Frontal Sinus, and Maxillary Sinus) of the paranasal sinuses on both the left and right-hand sides, and for each location is assigned as 0 (not opacified), 1 (partially opacified), and 2 (completely opacified). The SNOT-20 scale contains 20 items covering nasal symptoms, social functioning, and emotional impact. Each item is rated on a scale of 0 to 3 according to the degree of distress the patient has experienced during the past 2 weeks: a score of 0 (none of distress), 1 (mild distress), 2 (moderate distress), and 3 (severe distress) and the final score of 20 items are summed, with total scores ranging from 0 to 60, with higher scores indicating a more severe effect of symptoms on quality of life. Complications included infection, scab formation, adhesion, scarring, bleeding, and anosmia.
2.5. Risk of bias assessment
Two reviewers independently assessed the risk of bias using the Cochrane Collaboration risk of bias assessment tool. This study evaluated 6 critical elements: randomization, allocation concealment, blinding methods, attrition rate, result reporting, and additional sources of bias. The quality evaluation outcomes classified each feature as low, ambiguous, or high risk. The quality assessment was performed by 2 reviewers, with any disparities addressed by conversation with a third senior author.
2.6. Statistical analysis
The statistical analysis was conducted with the Review Manager v5.3 software. The fixed-effects model integrated the odds ratio (OR) for binary outcomes and the standard mean difference (SMD) for continuous outcomes in its foundational framework. These measures are presented alongside their respective 95% confidence intervals (CI). In continuous data, the median and interquartile range are converted into the mean and standard deviation. Heterogeneity was assessed in all meta-analyses using the Cochrane Q P-value and the I2 statistic. Pooled data were analyzed using a fixed-effect model when heterogeneity was low or moderate (I2 < 50%), and a random-effect model when heterogeneity was large (I2 ≥ 50%). Statistical heterogeneity was evaluated using a standard chi-square test, with significance set at P < .05. The possible publishing bias was assessed through visual examination of the funnel plots.
3. Results
3.1. Search results
Figure 1 illustrated the procedure for selecting and integrating articles. A total of 530 records were acquired from 4 databases, and 3 additional articles were identified through the examination of the bibliographies of the aforementioned articles. Fourteen RCTs[14–27] were incorporated into the final meta-analysis, adhering to the predetermined inclusion and exclusion criteria.
Figure 1.
Flow chart of literature search.
3.2. Patient characteristics
This meta-analysis comprised 14 RCTs[14–27] published between 2011 and 2024, including of a total of 1060 patients diagnosed with CRS. Among them, 531 patients received SBCD and 529 patients received FESS. The registration ID, author, year, sinus, patient, age, postoperative follow-up time, and outcome indicators of the included RCTs are presented in Table 1, and the specific types of complications and the incidence data are presented in Table 2.
Table 1.
Patient characteristics of included studies and patients.
| Author, year | Country | Subgroups | Age (mean ± SD,y) | Number of patients | Follow-up | SNOT-20 (mean ± SD) | Lund-Mackay score(mean ± SD) | ||
|---|---|---|---|---|---|---|---|---|---|
| Pre-op | Post-op | Pre-op | Post-op | ||||||
| Bizaki, A. J. 2014[14] | Finland | SBCD | 39.2 ± 2.3 | 21 | 3 months | 43.57 ± 16.68 | 22.10 ± 15.03 | NA | NA |
| FESS | 40 ± 2.6 | 21 | 46.00 ± 16.82 | 25.05 ± 14.85 | NA | NA | |||
| Achar, P. 2012[15] | UK | SBCD | 38.92 ± 10.92 | 12 | 6 months | 63.67 ± 14.91 | 48.83 ± 15.17 | 7.92 ± 4.40 | NA |
| FESS | 41.33 ± 7.22 | 12 | 51.67 ± 17.71 | 29.66 ± 12.33 | 8.25 ± 3.91 | NA | |||
| Bikhazi, N. 2014[16] | U.S.A | SBCD | NA | 50 | 18 months | 2.54 ± 0.92 | 2.64 ± 0.95 | NA | NA |
| FESS | NA | 42 | 2.52 ± 0.79 | 2.62 ± 0.60 | NA | NA | |||
| Bizaki, A.J. 2016[17] | Finland | SBCD | 37.17 ± 1.8 | 30 | 6 months | 42.70 ± 17.53 | 25.31 ± 20.87 | NA | NA |
| FESS | 40.25 ± 2.1 | 30 | 45.62 ± 18.02 | 30.54 ± 17.53 | NA | NA | |||
| Cutler, J. 2013[18] | U.S.A | SBCD | 47.0 ± 14.6 | 50 | 6 months | 2.54 ± 0.91 | 1.67 ± 1.10 | NA | NA |
| FESS | 47.9 ± 14.5 | 42 | 2.54 ± 0.79 | 1.60 ± 0.96 | NA | NA | |||
| Guoquan F 2016[19] | China | SBCD | 32.2 ± 7.1 | 45 | 12 weeks | NA | NA | NA | NA |
| FESS | 32.1 ± 7.3 | 45 | NA | NA | NA | NA | |||
| Kutluhan, A. 2020[20] | Turkey | SBCD | 34.42 ± 5.89 | 61 | 12 months | NA | NA | 7.59 ± 2.7 | 4.5 ± 2.23 |
| FESS | 34.42 ± 5.89 | 61 | NA | NA | 7.56 ± 2.64 | 4 ± 1.96 | |||
| Lei C 2020[21] | China | SBCD | 44.55 ± 15.27 | 22 | 12 weeks | NA | NA | 1.94 ± 0.23 | 0.31 ± 0.47 |
| FESS | 41.48 ± 13.94 | 23 | NA | NA | 1.88 ± 0.33 | 0.30 ± 0.47 | |||
| Minni, A. 2018[22] | Italy | SBCD | NA | 69 | 12 months | 62.87 ± 8.22 | 24.29 ± 8.2 | 2.32 ± 0.85 | 0.57 ± 0.61 |
| FESS | NA | 79 | 66.41 ± 11.78 | 28.1 ± 8 | 2.39 ± 0.82 | 0.58 ± 0.63 | |||
| Panigrahi, U. K. 2024[23] | India | SBCD | 30.4 ± 6.35 | 50 | 12 months | NA | NA | NA | 5.01 ± 2.3 |
| FESS | 30.4 ± 6.35 | 50 | NA | NA | NA | 3.99 ± 2.01 | |||
| Tao Z 2015[24] | China | SBCD | 37 ± 8 | 30 | 12 months | 13.3 ± 4.6 | 3 months 6.6 ± 2.6 12 months 7.3 ± 2.1 |
NA | NA |
| FESS | 37 ± 8 | 30 | 12.9 ± 3.7 | 3 months 6.2 ± 2.7 12 months 6.7 ± 2.5 |
NA | NA | |||
| Marzetti 2014[25] | Italy | SBCD | NA | 35 | 6 months | 27.3 ± 0.8 | 5.3 ± 0.3 | NA | NA |
| FESS | NA | 40 | 28.6 ± 1.2 | 7.8 ± 0.6 | NA | NA | |||
| Plaza 2011[26] | Spain | SBCD | NA | 26 | 12 months | NA | NA | NA | NA |
| FESS | NA | 24 | NA | NA | NA | NA | |||
| Hathorn 2015[27] | Canada | SBCD | NA | 30 | 12 months | NA | NA | NA | 1.4 ± 2.1 |
| FESS | NA | 30 | NA | NA | NA | 1.6 ± 2.5 | |||
FESS = functional endoscopic sinus surgery, NA = not available, pre-op = preoperation, post-op = postoperation, SBCD = sinus balloon catheter dilation, SNOT-20 = sinonasal outcome test-20.
Table 2.
Subgroup analysis of specific complication.
| Complications | No. of studies |
Sample size | Incidence rate(%) | Heterogeneity | Overall effect size |
95% CI of overall effect |
P value | |||
|---|---|---|---|---|---|---|---|---|---|---|
| FESS | SBCD | FESS | SBCD | I2 (%) | P value | |||||
| Adhesion | 4 | 30 | 7 | 21.74 | 4.79 | 0 | <.0001 | OR = 0.17 | 0.07–0.40 | .42 |
| Scab | 3 | 24 | 6 | 25.81 | 5.94 | 65 | .0003 | OR = 0.19 | 0.08–0.47 | .06 |
| Infection | 2 | 5 | 9 | 9.80 | 17.65 | 0 | .23 | OR = 2.11 | 0.62–7.21 | .99 |
| Bleeding | 2 | 3 | 1 | 4.54 | 1.52 | 0 | .38 | OR = 0.42 | 0.06–2.91 | .43 |
| Scar formation | 1 | 2 | 1 | 4.76 | 2.00 | NA | NA | NA | NA | |
| Loss of smell | 1 | 4 | 1 | 19.05 | 4.76 | NA | NA | NA | NA | |
| The orbit was black and swollen | 1 | 1 | 0 | 2.22 | 0 | NA | NA | NA | NA | |
| The sinus ostium was closed | 1 | 3 | 1 | 6.67 | 2.22 | NA | NA | NA | NA | |
| Cerebrospinal fluid rhinorrhea | 1 | 3 | 1 | 6.67 | 2.22 | NA | NA | NA | NA | |
FESS = functional endoscopic sinus surgery, NA = not available, SBCD = sinus balloon catheter dilation.
3.3. Quality assessment
Figure 2 provided a concise overview of the results of the bias risk assessment. Fourteen trials produced sufficient randomized sequences, 5 trials explicitly implemented participant blindness, 12 trials provided complete outcome data, 2 trials did not selectively report, and 11 trials did not show any other bias.
Figure 2.
Risk of bias assessment for the RCTs. RCTs = randomized controlled trials.
3.4. Clinical outcomes
3.4.1. Postoperative Lund–Mackay score
Five RCTs reported postoperative Lund–Mackay scores.[20–23,27] There was no significant difference in terms of Lund–Mackay score between the 2 groups (SMD = 0.14, 95%CI: ‐0.04 to 0.32, P = .12, I2 = 15%) (Fig. 3).
Figure 3.
Forest plot of the meta-analysis for postoperative Lund–Mackay score.
3.4.2. Postoperative SNOT-20 score
Eight RCTs[14–18,22,24,25] reported postoperative SNOT-20 score. The results revealed that the postoperative SNOT-20 score in the SBCD group were significantly lower than that in the FESS group (SMD = ‐0.25, 95%CI: ‐0.42 to 0.07, P = .005, I2 = 94%) (Fig. 4).
Figure 4.
Forest plot of the meta-analysis for postoperative SNOT-20 score. SNOT-20 score = sinonasal outcome test-20 score.
Besides, a subgroup analysis was performed based on the evaluation time of SNOT-20 score. Two RCTs[14,24] reported postoperative SNOT-20 score at 3 months, 4 RCTs[15,17,18,25] reported postoperative SNOT-20 score at 6 months, and 2 studies[22,24] reported postoperative SNOT-20 score at 12 months. There was no significant difference between the 2 groups regarding postoperative SNOT-20 scores at 3 months (SMD = 0.01, 95%CI: ‐0.38 to 0.40, P = .97, I2 = 0%) (Fig. S1, Supplemental Digital Content, https://links.lww.com/MD/P200), postoperative SNOT-20 scores at 6 months (SMD = ‐0.83, 95%CI: ‐0.67 to 0.09, P = .55, I2 = 97%) (Fig. S2, Supplemental Digital Content, https://links.lww.com/MD/P201) or postoperative SNOT-20 score at 12 months (SMD = ‐0.26, 95%CI: ‐0.53 to 0.02, P = .07, I2 = 82%) (Fig. S3, Supplemental Digital Content, https://links.lww.com/MD/P202).
3.4.3. Postoperative complications
Four RCTs[14,17–19] reported postoperative complications. The results revealed that the incidence of complications in the SBCD group were significantly lower than that in the FESS group (OR = 0.14, 95%CI: 0.08 to 0.26, P < .00001, I2 = 65%) (Fig. 5).
Figure 5.
Forest plot of the meta-analysis for postoperative complications.
Besides, a subgroup analysis was performed based on the specific type of complications (Table 2). Four RCTs[14,17–19] reported postoperative adhesions, 3 RCTs[14,17,18] reported postoperative scabbing, 2 RCTs[14,17] reported postoperative infection, and 2 RCTs[14,19] reported postoperative bleeding. There were no significant difference between the 2 groups regarding postoperative infection (OR = 2.11, 95% CI: 0.62 to 7.21, P = .23, I2 = 0%) (Fig. S4, Supplemental Digital Content, https://links.lww.com/MD/P203) and postoperative bleeding (OR = 0.42, 95% CI: 0.06 to 2.91, P = .38, I2 = 0%) (Fig. S5, Supplemental Digital content, https://links.lww.com/MD/P204). However, the postoperative adhesions (OR = 0.17, 95%CI: 0.07 to 0.40, P < .0001, I2 = 0%) (Fig. S6, Supplemental Digital content, https://links.lww.com/MD/P205) and postoperative scabbing (OR = 0.19, 95% CI: 0.08 to 0.47, P = .0003, I2 = 65%) (Fig. S7, Supplemental Digital Content, https://links.lww.com/MD/P206) results revealed that the incidence in the SBCD group were significantly lower than that in the FESS group.
3.4.4. Revision surgery
Three RCTs[16,18,26] reported revision surgery. There was no significant difference in terms of revision surgery between 2 groups (OR = 0.51, 95%CI: 0.12 to 2.21, P = .37, I2 = 0%) (Fig. 6).
Figure 6.
Forest plot of the meta-analysis for postoperative renovation surgery.
3.4.5. Operating time
Two RCTs[25,27] reported operating time. The results revealed that the operating time in the SBCD group were significantly lower than that in the FESS group (OR = ‐5.00, 95%CI: ‐8.08 to ‐1.91, P = .001, I2 = 50%) (Fig. 7).
Figure 7.
Forest plot of the meta-analysis for operating time.
3.5. Publication bias
An evaluation of publication bias was conducted using funnel plots in relation to postoperative Lund–Mackay scores (Fig. S8, Supplemental Digital Content, https://links.lww.com/MD/P207), postoperative SNOT-20 score (Fig. S9, Supplemental Digital Content, https://links.lww.com/MD/P208), postoperative complication (Fig. S10, Supplemental Digital Content, https://links.lww.com/MD/P209), revision surgery (Fig. S11, Supplemental Digital Content, https://links.lww.com/MD/P210) and operating time (Fig. S12, Supplemental Digital Content, https://links.lww.com/MD/P211). The bilateral symmetric funnel plots did not reveal significant evidence of publication bias.
4. Discussion
4.1. General interpretation of the results
Although developments in FESS have improved safety compared to previous methods, considerable hazards persist associated with FESS in the management of patients with CRS.[28] SBCD is a minimally invasive, tissue-preserving endoscopic method that has recently garnered attention as a supplementary or alternative approach to FESS.[29] Nonetheless, the advisability of recommending SBCD remains contentious. This meta-analysis was conducted to compare the efficacy and safety of FESS versus SBCD in the treatment of patients with CRS. The findings indicated SBCD provided a significantly lower postoperative SNOT-20 score and lower operating time, while significantly reduced the incidence of complications. There was no significant difference between the 2 groups regarding Lund-Mackay score and revision surgery.
Regarding safety, the Lund–Mackay score and SNOT-20 score were used to compare the 2 procedures. The Lund–Mackay score was established in the mid-1980s as a straightforward assessment instrument to aid in treatment decision-making. This is a subjective assessment of illness severity in many facets of chronic sinusitis, correlating with other indicators of severity in chronic rhinosinusitis, the type of surgical intervention administered, and treatment results.[30] It has been utilized for numerous years to quantify inflammatory disorders prior to surgical intervention.[31] SNOT-20 score is a valid disease-specific health-related quality of life indicator for individuals with sinusitis. This could assist researchers in evaluating the severity and effects of sinusitis on health status and quality of life, as well as in measuring therapy response.[32] According to our results, SBCD provided a significantly lower postoperative SNOT-20 score and comparable Lund–Mackay score, which indicated that SBCD was an effective intervention for CRS. There are large differences in the operating procedures of FESS and SBCD. A standard FESS method entails the excision of the uncinate process, the formation of an enlarged maxillary antrostomy, an ethmoidectomy, and, in certain instances, a sphenoidotomy on each side. Further objectives of FESS may encompass the rectification of septal abnormalities, excision of significant concha bullosa deformities (enlarged middle turbinate with an air cell), and reestablishment of patency to the frontal sinus. Numerous studies have indicated a high success rate for FESS in alleviating the symptoms of CRS.[8,9] The SBCD is an innovative technique for the minimally invasive endoscopic dilatation of obstructed sinuses. In contrast, SBCD utilizes a flexible instrument (balloon catheter) that allows surgeons to endoscopically establish an opening in a patient’s obstructed or severely constricted sinus ostia and transitional areas, while optimizing tissue preservation and reducing iatrogenic mucosal damage.[33] Advocates of balloon dilatation contend that these instruments expand natural ostia, alleviate blockage, and reduce tissue stress when treating the frontal recess, maxillary sinus, and sphenoid sinus.[34]
Concerning safety, the majority of postoperative complications identified in the included RCTs were infection, scab formation, adhesion, scarring, bleeding, and anosmia.The findings indicated that SBCD significantly reduced the incidence of postoperative adhesion and scab compared with FESS. Compared with FESS, The SBCD causeed less damage to patients, and enhanced tissue preservation and minimized iatrogenic mucosal injury.[33] In addition, the mean operative duration, duration required to return to normal activities, and revision surgery were also significantly less in the SBCD group than in the FESS group. Achar.P. et al[15] found that the average duration to resume regular activities post-surgery was 2.2 days for the SBCD group and 5 days for the FESS group. Cutler.J. et al[18] reported that the mean duration to return to normal activities post-surgery was approximately 1.6 ± 1.1 days for the SBCD group, whereas the FESS group required 4.8 ± 6.2 days. Postoperative sinus infections is a key indicator of treatment success and long-term effectiveness, and our results indicated that there were no significant difference between the 2 groups regarding postoperative infection.
Operating time is important for evaluating the efficiency and feasibility of the intervention. The results revealed that the operating time in the SBCD group were significantly lower than that in the FESS group. Patient satisfaction and olfactory function directly impact the quality of life and treatment preference. Tao Z et al[24] reported that patient satisfaction in the SBCD group was significantly higher than that in the FESS group (97% vs 80%, P < .05). Patients who underwent SBCD exhibit greater pleasure, reduced cost load, and the procedure can be performed directly in the outpatient department without necessitating hospitalization. Guoquan F et al[19] reported that the proportion of patients with normal olfactory function in SBCD group was significantly higher than that in FESS group (55.6% vs 33.3%, P < .05). Besides, there was no significant difference in terms of revision surgery between the 2 groups. Postoperative narcotic use reflects pain levels and recovery, influencing patient comfort and opioid-related risks. Unfortunately, no studies included provided data about postoperative narcotic use.
4.2. Limitations of the evidence included in the review
First, the number of RCTs included was limited and the overall sample size was relatively small. This meta-analysis was limited by an incomplete reporting of the SD and mean difference between the pre- and post-intervention scores within each treatment group of BSD and FESS. Only 4 RCTs reported post-intervention Lund–Mackay score and 8 RCTs reported post-intervention SNOT-20 score. This might reduce statistical efficacy, increase the risk of class errors (false negatives) and limit the power of subgroup analysis. In addition, the RCTs included lacked adjustment for critical confounders such as baseline comorbidities, the presence of nasal polyps and prior sinus surgery history, potentially introducing variability into effect size estimates. Besides, the quality assessment revealed that a high proportion of RCTs included were of high risk of bias (e.g., unclear randomization procedures and lack of blinding), which might substantially compromise the internal validity of the pooled effect estimates and reduce the reliability of the conclusions.
4.3. Limitations of the review processes used
First, the literature search strategy might be flawed, potentially leading to literature omission. Second, though we had tried to contact corresponding authors, many missing critical data remained unavailable. Third, we failed to perform subgroup analyses because of the limitation of the original data (e.g., lack of stratified data on coexistence status of nasal polyps and severity of sinusitis), which prevented us to fully assess the effects of these confounders.
4.4. Implications of the results for practice, policy, and future research
According to our results, SBCD was had advantages over FESS in terms of postoperative SNOT-20 score, postoperative complications, operating time and revision surgery. The findings indicated that SBCD was an effective intervention for CRS, capable of substantially decreasing the occurrence of complications, and should be recommended clinically. More large-sample, multicenter RCTs should be carried out in the future with an emphasis on improving the following features, though, because of the constraints indicated above: (1) apply stratified randomization to control confounding factors including the severity of sinusitis and the coexisting status of nasal polyps; (2) standardize the collection and reporting of preoperative and postoperative standardized indicators.
In summary, the findings indicated that SBCD was effective and safe in the treatment of CRS. More well-design RCTs are needed to confirm our conclusion.
Author contributions
Conceptualization: Xiaotian Liang, Huaping Lan.
Data curation: Xiaotian Liang, Huaping Lan, Jiayong Wei.
Formal analysis: Xiaoman Liang, Weiming Liang, Jiayong Wei.
Funding acquisition: Weiming Liang.
Investigation: Xiaoman Liang, Mei Zhou.
Methodology: Xiaoman Liang, Mei Zhou, Jiayong Wei.
Resources: Mei Zhou, Weiming Liang.
Software: Jieru Quan, Weiming Liang.
Supervision: Jieru Quan.
Visualization: Jieru Quan.
Writing – original draft: Xiaotian Liang, Huaping Lan, Xiaoman Liang, Mei Zhou, Jieru Quan, Jiayong Wei.
Writing – review & editing: Weiming Liang, Jiayong Wei.
Supplementary Material
Abbreviations:
- CI
- confidence intervals
- CRS
- chronic sinusitis
- FESS
- functional endoscopic sinus surgery
- OR
- odds ratio
- RCTs
- randomized controlled trials
- SBCD
- sinus balloon catheter dilation
- SMD
- standard mean difference
- SNOT-20 score
- sinonasal outcome test-20 score
XL, HL, and XL contributed to this article equally.
The authors disclose the receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Key Laboratory Construction Project of Guangxi Health Commission (ZPZH2020007).
The ethical approval was not necessary, since this study was a meta-analysis and all data were obtained from published articles. This meta-analysis has been officially recorded at PROSPERO under the registration number CRD42024617694, https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024617694.
The authors have no conflicts of interest to disclose.
The datasets generated during and/or analyzed during the current study are publicly available.
Supplemental Digital Content is available for this article.
How to cite this article: Liang X, Lan H, Liang X, Zhou M, Quan J, Liang W, Wei J. Efficacy and safety of sinus balloon catheter dilation versus functional endoscopic sinus surgery in the treatment of chronic sinusitis: A meta-analysis. Medicine 2025;104:24(e42841).
Contributor Information
Xiaotian Liang, Email: weimingliang@gxust.edu.cn.
Huaping Lan, Email: 76701236@qq.com.
Xiaoman Liang, Email: weimingliang@gxust.edu.cn.
Mei Zhou, Email: 383541649@qq.com.
Jieru Quan, Email: 100001425@gxust.edu.cn.
Weiming Liang, Email: weimingliang@gxust.edu.cn.
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