Comparison of safety and efficacy of pantoprazole alone with pantoprazole plus amitriptyline in functional dyspepsia patients: a randomized control trial

Neelam Kumari; Atal Sood; Swatantara Gupta; Sushma Swaraj; Nitin Patiyal

doi:10.18203/2319-2003.ijbcp20250486

Authors

Neelam Kumari Department of Pharmacology, DRRPGMC, Kangra at Tanda, Kangra, Himachal Pradesh, India
Atal Sood Department of Pharmacology, DRRPGMC, Kangra at Tanda, Kangra, Himachal Pradesh, India
Swatantara Gupta Department of Hepatology and Gastroenterology, DRRPGMC, Kangra at Tanda, Kangra, Himachal Pradesh, India
Sushma Swaraj Department of Pharmacology, DRRPGMC, Kangra at Tanda, Kangra, Himachal Pradesh, India
Nitin Patiyal Department of Pharmacology, DRRPGMC, Kangra at Tanda, Kangra, Himachal Pradesh, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20250486

Keywords:

Amitriptyline, Glassgow dyspepsia severity score, Pantoprazole, Visual analog scale

Abstract

Background: The term functional dyspepsia refers to ulcer-like symptoms in patients who lack overt gastro duodenal ulceration. Functional dyspepsia can be subdivided into: postprandial distress syndrome (PDS), epigastric pain syndrome (EPS), and based on the presence of symptoms related to meals. It is defined as the presence of one or more of the following: postprandial fullness, early satiation, epigastric pain or burning, and no evidence of structural disease. Pantoprazole alone is compared with pantoprazole plus amitriptyline to relieve dyspepsia symptoms in functional dyspepsia patients.

Methods: The study was a randomized, prospective, open label, comparative interventional study. The study was conducted in the Department of Pharmacology and Department of Gastroenterology and Hepatology at Dr. R.P.G.M.C. Kangra at Tanda Himachal Pradesh, India which is 700 bedded multispecialty tertiary health care from August 2023 to May 2024 and follow -up was done for 4 weeks after initiation of treatment, to compare the safety and efficacy of pantoprazole with pantoprazole plus amitriptyline in functional dyspepsia patients.

Results: In our study compared to pantoprazole group, pantoprazole plus amitriptyline group has statistically significant reduction in all the 3 scores viz. Glasgow dyspepsia severity score (GDSS) (4.26±1.14 versus 3.3±1.37, p=0.002), short form leads dyspepsia questionnaire (SF-LDQ) (4 [3-5] versus 3 [2-4], p=0.005), and visual analogue pain score (VAS) (1 [1-2] versus 1 [0-1], p=0.0009).

Conclusions: The combination of pantoprazole and amitriptyline was more effective than pantoprazole alone in improving symptoms of functional dyspepsia, with no significant safety concerns.

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