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Efficacy of Pistacia lentiscus plant (Rumi Mastagi) in comparison to levosulpiride in patients with diabetic gastroparesis: A double-blind non-inferior randomised control trial study

Authors :
Ajaypal Singh
Ravi Kant
Rohit Raina
Vandana Dhingra
Rajeev Nema
Mukesh Chand Bairwa
Varsha Kanwar
Rifika l Sukhes Mukherjee
Anissa Atif Mirza
Mayank Agarwal
Source :
Indian Journal of Endocrinology and Metabolism, Vol 28, Iss 1, Pp 35-42 (2024)
Publication Year :
2024
Publisher :
Wolters Kluwer Medknow Publications, 2024.

Abstract

Introduction: Gastrointestinal neuropathies are frequently found in diabetic patients. The pathogenesis of diabetic gastroparesis (DG) is multifactorial. The usual treatment for DG includes dietary modifications, prokinetic and antiemetic agents. There is increasing demand for more effective medicines to treat DG. The current study was conducted on the Pistacia lentiscus stem extract to add to the armamentarium of DG treatment and to find the efficacy of P. lentiscus plant extract (mastic gum) in comparison to levosulpiride in DG for improvement in gastroparesis symptoms and gastric emptying scintigraphy (GES) in a single centric double-blind non-inferiority randomised control trial. Methods: Thirty-eight individuals were recruited and equally randomised into two study groups based on Gastroparesis Cardinal Symptom Index (GCSI) score and TC99 Radionuclide GES, mastic gum group and levosulpiride group. Both pre and post-intervention (8 weeks) GCSI scores were calculated, GES was performed to quantify the improvement in gastric emptying. Power analysis was performed using G*POWER software version 3.1.9.7 and data analysis using SPSS 23.0, variables measured in mean ± standard deviation (SD). Various statistical tests were used such as independent t-test, Chi-square test or Fisher's exact test, Wilcox Mann–Whitney test, analysis of variance (ANOVA) test, and posthoc pairwise tests. Results: The mastic gum is found effective in the improvement of 4 h gastric emptying percentage from the mean (SD) 76.60 (± 9.96) to mean (SD) 97.20 (2.17)% (P < 0.001). Mastic gum has the property of HbA1c reduction, which is more significant than that of levosulpiride (P = 0.044). Mastic gum also had significant Low density lipoprotein (LDL) (mg/dL) levels reduction, (P < 0.001), compared to levosupiride. An absolute increase was observed in haemoglobin (HB) level in mastic gum at a 2-month mean (SD) of 1.03 (0.77) (g/dL) (P-value

Details

Language :
English
ISSN :
22308210
Volume :
28
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Indian Journal of Endocrinology and Metabolism
Publication Type :
Academic Journal
Accession number :
edsdoj.1578bf8d2dd4475f8d6dab2c6994488e
Document Type :
article
Full Text :
https://doi.org/10.4103/ijem.ijem_84_23