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Efficacy of Pregabalin and Antioxidants Combination in Reducing Pain in Chronic Pancreatitis: A Double Blind Randomized Trial

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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.

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Funding

Intramural research Grant received from Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER).

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Authors and Affiliations

  1. Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India

    Sathasivam Sureshkumar, Agrawal Omang, Amaranathan Anandhi, B. S. Rajesh, K. M. Abdulbasith, Chellappa Vijayakumar & Vikram Kate

  2. Department of PSM, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India

    Chinnakali Palanivel

  3. Department of Medical Gastroenterology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India

    Mohan Pazhanivel

Authors
  1. Sathasivam Sureshkumar
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  2. Agrawal Omang
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  3. Amaranathan Anandhi
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  4. B. S. Rajesh
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  5. K. M. Abdulbasith
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  6. Chellappa Vijayakumar
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  7. Chinnakali Palanivel
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  8. Mohan Pazhanivel
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  9. Vikram Kate
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Contributions

SS contributed to conceptualization, validation, supervision, and writing review and editing; AO contributed to data collection, formal analysis, investigation, and writing original draft; AA contributed to methodology, validation, and writing review and editing; BSR contributed to data collection, formal analysis, investigation, and writing original draft; KMA contributed to data collection and writing original draft; CV contributed to formal analysis, supervision, and writing review and editing; CP contributed to formal analysis, supervision, and writing review and editing; MP contributed to methodology, validation, and writing review and editing; and VK contributed to formal analysis, supervision, validation, and writing review and editing.

Corresponding author

Correspondence to Vikram Kate.

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The authors declare that they have no conflict of interest.

Ethical statement

Institute ethics committee approval obtained. Approval Number JIP/IEC/2016/1034.

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Informed consent was obtained from all the study participants.

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Sureshkumar, S., Omang, A., Anandhi, A. et al. Efficacy of Pregabalin and Antioxidants Combination in Reducing Pain in Chronic Pancreatitis: A Double Blind Randomized Trial. Dig Dis Sci 66, 4017–4025 (2021). https://doi.org/10.1007/s10620-020-06711-7

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  • DOI: https://doi.org/10.1007/s10620-020-06711-7

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