Efficacy of Pregabalin and Antioxidants Combination in Reducing Pain in Chronic Pancreatitis: A Double Blind Randomized
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ORIGINAL ARTICLE
Efficacy of Pregabalin and Antioxidants Combination in Reducing Pain in Chronic Pancreatitis: A Double Blind Randomized Trial Sathasivam Sureshkumar1 · Agrawal Omang1 · Amaranathan Anandhi1 · B. S. Rajesh1 · K. M. Abdulbasith1 · Chellappa Vijayakumar1 · Chinnakali Palanivel2 · Mohan Pazhanivel3 · Vikram Kate1 Received: 14 July 2020 / Accepted: 4 November 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Background In patients with chronic pancreatitis (CP), pain relief is a dilemma. Antioxidants with pregabalin therapy have been reported to be useful. Hence, this study was carried out to determine the efficacy of the combination of antioxidant and pregabalin therapy in reducing pain in patients with CP. Methods This was a prospective, double blind, superiority, and randomized trial in patients with CP. The treatment group received pregabalin with antioxidants therapy for 8 weeks, and a similar placebo was administered to the controls. Primary outcome was to determine the change in maximum pain intensity assessed by visual analog scale (VAS) and Izbicki pain score. Secondary outcomes were the number of painful days, opioid and non-opioid requirements, improvement in quality of life, number of hospital admission, and overall patient satisfaction. Results A total of 90 patients were randomized to 45 in each arm. Demographic profile and baseline pain score were comparable. Patients in treatment group when compared to placebo group had a significant reduction in pain intensity (VAS score 2 ± 0.8 vs. 1.3 ± 0.9; p = 0.007), non-opioid analgesic requirement in days (54.4±2.9 vs. 55.7±1.5; p = 0.014), and number of hospital admissions (0.2 ± 0.5 vs. 0.6 ± 0.7; p = 0.002), respectively. Significant proportion of patients was satisfied in the treatment group compared to placebo group (18% vs. 11%; p = 0.03). Conclusion The combination of pregabalin and antioxidant significantly reduces the pain, requirement of non-opioid analgesics, and the number of hospital admissions in patients with CP. It also significantly improves the overall patient satisfaction. Clinical Trials Register Number CTRI/2017/05/008492. Keywords Izbicki pain score · Non-opioid analgesic · VAS score · Pain relief · Quality of life
* Vikram Kate [email protected]
Chinnakali Palanivel [email protected]
Sathasivam Sureshkumar [email protected]
Mohan Pazhanivel [email protected]
Agrawal Omang [email protected]
1
Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India
2
Department of PSM, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India
3
Department of Medical Gastroenterology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006, India
Amaranathan Anandhi [email protected] B. S. Rajesh [email protected] K. M. Abdulbasith [email protected] Chellappa Vijayakumar vijaymmc01@gmail
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