A Randomized Controlled Trial of Antioxidant Supplementation for Pain Relief in Patients With Chronic Pancreatitis
Received 2 June 2008; accepted 18 September 2008. published online 26 September 2008.
Background & Aims
Oxidative stress has been implicated in the pathophysiology of chronic pancreatitis (CP). We evaluated the effects of antioxidant supplementation on pain relief, oxidative stress, and antioxidant status in patients with CP.
Methods
In a placebo-controlled double blind trial, consecutive patients with CP were randomized to groups that were given placebo or antioxidants for 6 months. The primary outcome measure was pain relief, and secondary outcome measures were analgesic requirements, hospitalization, and markers of oxidative stress (thiobarbituric acid-reactive substances [TBARS]) and antioxidant status (ferric-reducing ability of plasma [FRAP]).
Results
Patients (age 30.5 ± 10.5 years, 86 male, 35 alcoholic, and 92 with idiopathic CP) were assigned to the placebo (n = 56) or antioxidant groups (n = 71). After 6 months, the reduction in the number of painful days per month was significantly higher in the antioxidant group compared with the placebo group (7.4 ± 6.8 vs 3.2 ± 4, respectively; P < .001; 95% CI, 2.07, 6.23). The reduction in the number of analgesic tablets per month was also higher in the antioxidant group (10.5 ± 11.8 vs 4.4 ± 5.8 respectively; P = .001; 95% CI, 2.65, 9.65). Furthermore, 32% and 13% of patients became pain free in the antioxidant and placebo groups, respectively (P = .009). The reduction in the level of TBARS and increase in FRAP were significantly higher in the antioxidant group compared with the placebo group (TBARS: placebo 1.2 ± 2.7 vs antioxidant 3.5 ± 3.4 nmol/mL; P = .001; 95% CI 0.96, 3.55; FRAP: placebo −5.6 ± 154.9 vs antioxidant 97.8 ± 134.9 μMFe+2 liberated, P = .001, 95% CI 44.98, 161.7).
Conclusions
Antioxidant supplementation was effective in relieving pain and reducing levels of oxidative stress in patients with CP.
⁎Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India
‡Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India
Address requests for reprints to: Pramod Kumar Garg, MD, Associate Professor, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi 110029, India. fax: 91-11-26588663
The authors disclose the following: Supported by Indian Council of Medical Research, New Delhi, India, through an individual fellowship grant to Payal Bhardwaj under the guidance of Dr Anoop Saraya. Osper Pharmanautics provided the drug and placebo on a complimentary basis. The supporting sources had no role in study design, collection of data, interpretation of data, writing of the manuscript, or submission for publication.
ABSTRACT
A Randomized Controlled Trial of Antioxidant Supplementation for Pain Relief in Patients With Chronic Pancreatitis