Background

Intra-gastric balloon (IGB) therapy is an effective bariatric therapy, but only for the six months of the therapy. After the therapy, most of the patients in my previous clinical trial started to quickly regain their weight. Therefore after IGB therapy I have started an adjuvant therapy with the following medicines: SGLT2 inhibitor for patients with metabolic diseases and bofutsushousan (herbal medicine) for obese patients without any metabolic diseases. My aim is to maintain the weight loss effects of IGB therapy.

Methods

Twenty patients with BMI> 30 were classified into two groups. Nine patients (metabolic group) were complicated by diabetes mellitus and /or NAFLD (non–alcoholic fatty liver disease). Eleven patients were not complicated by any metabolic diseases (non-metabolic group). After 6 months of the IGB therapy, half of the patients belonging to the metabolic group took SGLT2, half of the non-metabolic group took bofutsushousan and the rest took a placebo. Every month, their body weights and the levels of HbA1c and ALT in their sera were examined. In addition, insulin resistance was determined by examining the serum insulin levels (IRI) of the metabolic group.

Results

1) The total body weight loss (TBWL) at the end of the IGB therapy (6 months) was 13.4%, which was almost maintained six months later by patients who took either SLGT2 (metabolic group 12.6%) or boufutushousan (non-metabolic group: 11.3%), but the patients who only underwent the IGB therapy, regained almost all of the weight they lost (TBWL 0.3%).2) The metabolic data of the metabolic group improved remarkably. HbA1cwas 7.4±0.4 before the clinical trial, 6.6±0.3 after 6 months of IGB therapy and 6.4±0.3 after six months of drug therapy. The IRI improved significantly from 21.4 before the trial to 5.3 after the drug therapy.The ALT level of the NASH patients was 143 before the trial and 38±5 at the end of the trial.

Conclusions

SLGT2 and boufutushousan were useful for maintaining the effects of the IGB therapy.