MATERIALS AND METHODS: Retrospective single-center analysis of adults completing IGB treatment. Weight, glycated hemoglobin (HbA1c), fasting glucose, lipid profile and blood pressure were recorded before and at the end of treatment; weight was also recorded 12 months after placement. The primary outcome was percentage total weight loss (%TWL) at end of treatment. Between-device differences were adjusted for baseline value, age, sex, diabetes and dyslipidemia and by propensity weighting, and metabolic comparisons were corrected for multiple testing.
RESULTS: Of 357 patients treated, 239 were analyzed (133 swallowable, 106 adjustable; 76.6% women); attrition before analysis was far higher in the adjustable group (48.5% vs. 11.9%). Both devices reduced weight, HbA1c and atherogenic lipids and raised high-density lipoprotein cholesterol. At end of treatment the adjustable balloon achieved greater %TWL (10.2 ± 4.2% over ≈ 12 months vs. 8.9 ± 4.0% over ≈ 4 months; adjusted difference 1.27%, 95% CI 0.20 to 2.34). At 12 months, swallowable-group %TWL had fallen to 6.6 ± 7.1% and the difference widened to 3.6% (95% CI 2.2 to 5.1). No between-device difference in metabolic change survived correction for multiple testing. A tipping-point analysis showed the end-of-treatment difference to be fragile to the observed attrition, whereas the 12-month difference was not.
CONCLUSION: Both IGBs produced meaningful weight loss and metabolic improvement, but comparison between them is strongly time-dependent: the swallowable balloon's short-term advantage per month of dwell was not maintained at 12 months. Incomplete adjustable-group follow-up means the device comparison should be read as an upper bound. Metabolic improvement was similar between devices and not proportional to weight loss.
METHODS: A total of 486 consecutive patients with overweight or obesity who underwent swallowable IGB insertion were included in this prospective data collection.
RESULTS: Out of 486 patients, 404 patients (83%) had complete data at the end of 4 and 12 months. Patients included in the study had a starting mean body mass index of 35.3 ± 7.2 kg/m2 which decreased to 31.5 ± 5.7 kg/m2 (p
Materials and Methods: Our study consisted of IGB patients diagnosed between 2010 March and 2016 December who had been followed-up for at least one year. Structured questionnaires and medical records were reviewed to analyse demographic characteristics, lifestyle patterns, blood tests, and imaging studies. We categorized the cases into two groups based on the response to conservative treatment and the need for surgical intervention.
Results: The most common initial chief symptoms were buttock pains in 24 patients (37.5%). Physical examinations showed the tenderness of ischial tuberosity area in 59 (92.2%) patients, but no specific findings were confirmed in 5 patients (7.8%). 51 patients (79.7%) responded well to the conservative management, 11 patients (17.2%) needed injection, and 2 patients (3.1%) had surgical treatment performed due to continuous recurrence. There was no difference in demographic and blood lab data between the two groups. However, the incidence of inflammatory diseases (response group: 10.3% vs non-response group: 66.7%, p=0.004) was significantly different between the two groups.
Conclusion: The diagnosis of IGB can be missed due to variations in clinical symptoms, and cautions should be exercised in patients with inflammatory diseases as conservative treatment is less effective in them, leading to chronic progression of IGB.