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Ameliorating effect of antioxidants and pregabalin combination in pain recurrence after ductal clearance in chronic pancreatitis: Results of a randomized, double blind, placebo-controlled trial.
J Gastroenterol Hepatol 2016; 31(9):1654-62JG

Abstract

BACKGROUND AND AIM

The aim of this study was to evaluate the effect of antioxidant-pregabalin combination on pain recurrence in patients with chronic calcific pancreatitis.

METHODS

In this randomized, double-blind, placebo-controlled trial, chronic calcific pancreatitis patients with pain recurrence following pancreatic ductal clearance of stones received either antioxidant-pregabalin combination or matching placebo for 2 months followed by open-label antioxidants for the next 4 months in both groups. Compliance, daily pain, and adverse events were recorded weekly and at the end of study by a coordinator blinded to treatment status. Primary outcome was pain improvement (visual analog scale and Izbicki score); secondary outcomes were as follows: complete pain resolution, painful days, and adverse events. Number needed-to-treat was calculated.

RESULTS

We randomized 42 and 45 patients (mean age 29.3 years) to treatment and placebo arms, respectively. Baseline characteristics, including pain scores, were similar for both groups. No patients received high-potency narcotic. At 2 months, a significant improvement in the treatment arm was observed in percent reduction of visual analog scale (-50 [-80.0; -32.1] vs -29.5 [-64.5; 0]; P = 0.01), Izbicki score (14.5 [0; 21.3] vs 30.0 [11.8; 41.3]; P = 0.001), complete pain resolution (20 [47.6%] vs 12 [26.7%]; P = 0.04), and number of painful days (10.0 [2.0; 16.0] vs 18.0 [7.0; 34.0]; P = 0.01). Needed-to-treat was 4.8. Pain reduction persisted at 6 months in the original treatment group (20.0 [15.0; 28.0] vs 36.0 [20.0; 50.0]; P = 0.006). A total of 33 patients in the treatment arm experienced mild to moderate self-limiting nausea/vomiting and drowsiness, respectively and did not require any change in study protocol.

CONCLUSION

Antioxidant-pregabalin combination results in significant relief in pain recurrence after ductal clearance in narcotic naïve patients with chronic calcific pancreatitis.

Authors+Show Affiliations

Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India. rup_talukdar@yahoo.com. Wellcome-DBT Laboratory, Asian Healthcare Foundation, Hyderabad, India. rup_talukdar@yahoo.com.Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.Surgical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.Surgical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.Biostatistics, Asian Institute of Gastroenterology, Hyderabad, India.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26945817

Citation

Talukdar, Rupjyoti, et al. "Ameliorating Effect of Antioxidants and Pregabalin Combination in Pain Recurrence After Ductal Clearance in Chronic Pancreatitis: Results of a Randomized, Double Blind, Placebo-controlled Trial." Journal of Gastroenterology and Hepatology, vol. 31, no. 9, 2016, pp. 1654-62.
Talukdar R, Lakhtakia S, Nageshwar Reddy D, et al. Ameliorating effect of antioxidants and pregabalin combination in pain recurrence after ductal clearance in chronic pancreatitis: Results of a randomized, double blind, placebo-controlled trial. J Gastroenterol Hepatol. 2016;31(9):1654-62.
Talukdar, R., Lakhtakia, S., Nageshwar Reddy, D., Rao, G. V., Pradeep, R., Banerjee, R., ... Murthy, H. V. (2016). Ameliorating effect of antioxidants and pregabalin combination in pain recurrence after ductal clearance in chronic pancreatitis: Results of a randomized, double blind, placebo-controlled trial. Journal of Gastroenterology and Hepatology, 31(9), pp. 1654-62. doi:10.1111/jgh.13332.
Talukdar R, et al. Ameliorating Effect of Antioxidants and Pregabalin Combination in Pain Recurrence After Ductal Clearance in Chronic Pancreatitis: Results of a Randomized, Double Blind, Placebo-controlled Trial. J Gastroenterol Hepatol. 2016;31(9):1654-62. PubMed PMID: 26945817.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ameliorating effect of antioxidants and pregabalin combination in pain recurrence after ductal clearance in chronic pancreatitis: Results of a randomized, double blind, placebo-controlled trial. AU - Talukdar,Rupjyoti, AU - Lakhtakia,Sundeep, AU - Nageshwar Reddy,D, AU - Rao,G Venkat, AU - Pradeep,Rebala, AU - Banerjee,Rupa, AU - Gupta,Rajesh, AU - Ramchandani,Mohan, AU - Tandan,Manu, AU - Murthy,H Vivekananda, PY - 2015/12/29/received PY - 2016/02/14/revised PY - 2016/02/20/accepted PY - 2016/3/7/entrez PY - 2016/3/8/pubmed PY - 2019/3/21/medline KW - antioxidants KW - endotherapy KW - pain KW - pregabalin KW - surgery SP - 1654 EP - 62 JF - Journal of gastroenterology and hepatology JO - J. Gastroenterol. Hepatol. VL - 31 IS - 9 N2 - BACKGROUND AND AIM: The aim of this study was to evaluate the effect of antioxidant-pregabalin combination on pain recurrence in patients with chronic calcific pancreatitis. METHODS: In this randomized, double-blind, placebo-controlled trial, chronic calcific pancreatitis patients with pain recurrence following pancreatic ductal clearance of stones received either antioxidant-pregabalin combination or matching placebo for 2 months followed by open-label antioxidants for the next 4 months in both groups. Compliance, daily pain, and adverse events were recorded weekly and at the end of study by a coordinator blinded to treatment status. Primary outcome was pain improvement (visual analog scale and Izbicki score); secondary outcomes were as follows: complete pain resolution, painful days, and adverse events. Number needed-to-treat was calculated. RESULTS: We randomized 42 and 45 patients (mean age 29.3 years) to treatment and placebo arms, respectively. Baseline characteristics, including pain scores, were similar for both groups. No patients received high-potency narcotic. At 2 months, a significant improvement in the treatment arm was observed in percent reduction of visual analog scale (-50 [-80.0; -32.1] vs -29.5 [-64.5; 0]; P = 0.01), Izbicki score (14.5 [0; 21.3] vs 30.0 [11.8; 41.3]; P = 0.001), complete pain resolution (20 [47.6%] vs 12 [26.7%]; P = 0.04), and number of painful days (10.0 [2.0; 16.0] vs 18.0 [7.0; 34.0]; P = 0.01). Needed-to-treat was 4.8. Pain reduction persisted at 6 months in the original treatment group (20.0 [15.0; 28.0] vs 36.0 [20.0; 50.0]; P = 0.006). A total of 33 patients in the treatment arm experienced mild to moderate self-limiting nausea/vomiting and drowsiness, respectively and did not require any change in study protocol. CONCLUSION: Antioxidant-pregabalin combination results in significant relief in pain recurrence after ductal clearance in narcotic naïve patients with chronic calcific pancreatitis. SN - 1440-1746 UR - https://www.unboundmedicine.com/medline/citation/26945817/Ameliorating_effect_of_antioxidants_and_pregabalin_combination_in_pain_recurrence_after_ductal_clearance_in_chronic_pancreatitis:_Results_of_a_randomized_double_blind_placebo_controlled_trial_ L2 - https://doi.org/10.1111/jgh.13332 DB - PRIME DP - Unbound Medicine ER -