Real-world safety and effectiveness of Pistacia lentiscus (mastic gum) in patients with diabetic gastroparesis: 24-week interim analysis postintervention

Abstract

INTRODUCTION: Gastrointestinal neuropathies are frequently found in diabetic patients. AIM: The aim of this study was to find out the safety, adverse reactions, and long-term effectiveness of Pistacia lentiscus plant extract (mastic gum) in diabetic gastroparesis (DG) with respect to sustainable improvement in gastroparesis symptoms (Gastrointestinal Cardinal Symptom Index [GCSI] score) by observational follow-up study of a single-centric double-blind noninferiority randomized control trial. MATERIALS AND METHODS: Thirty-eight individuals were recruited and equally randomized in two study groups based on GCSI score and TC99 radionuclide gastric emptying scintigraphy (GES), i.e. the mastic gum group and the levosulpiride group. After 24 weeks, the GCSI score was recalculated in both the groups, and patients were evaluated for the safety, adverse reactions, and long-term effectiveness of mastic gum and the standard drug levosulpiride. RESULTS: In the extended study, mean GCSI score changes at 24 weeks were statistically significant (P < 0.001) (t-test) between the two groups. In the mastic gum arm, the change in mean GCSI score at 24 weeks was statistically nonsignificant mean ± (standard deviation [SD]) 16.7± (3.81) compared to the GCSI score at 2-month postintervention mean (SD) 16.35± (2.27) (intragroup P = 0.89) (repeated measures ANOVA). It strongly indicates that mastic gum provided a sustainable improvement in DG symptoms in comparison to levosulpiride, with excellent subjective well-being postintervention, without any obvious significant adverse effects. CONCLUSION: Six-month (24-week) interim analysis of patients suggests that mastic gum gives a sustainable improvement in DG symptoms without any obvious adverse effects as compared to levosulpiride.