|Date: 02-15-2017||HC# 081666-562|
Re: Adjuvant Curcumin Treatment Improves Peptic Ulcer Symptoms
Peptic ulcers (PU) are commonly characterized by the symptoms of upper abdominal pain, abdominal fullness, gastroesophageal reflux, and nausea. The bacteria Helicobacter pylori is the main cause of PU. Standard therapy for PU includes antibiotics and proton pump inhibitors to reduce stomach acid. Curcumin, a compound found in turmeric (Curcuma longa, Zingiberaceae) rhizome, has antibacterial, anti-inflammatory, and wound-healing properties, and experimental evidence suggests it may be effective in treating H. pylori infection. This randomized, placebo-controlled, double-blind trial investigated the efficacy of curcumin as an adjuvant to standard treatment for PU.
Patients were recruited from Baqiyatallah Hospital in Tehran, Iran (study dates not reported). Those with ulcers in the presence of H. pylori infection were included. Those taking drugs for H. pylori infection or corticosteroids, who had chronic disease or cancer, or who could not adhere to the study protocol were excluded. The urea breath test (UBT) was used to detect H. pylori infection. All included patients received standard H. pylori eradication triple therapy with clarithromycin, amoxicillin, and pantoprazole. Patients were randomly assigned to take 1 capsule daily of either 500 mg curcumin (Curcumin C3 Complex®; provided by Sami Labs Ltd.; Bangalore, India) or placebo for 4 weeks. The 500-mg curcumin capsule contained a patented ratio of curcumin, demethoxycurcumin, and bisdemethoxycurcumin, "determined using HPLC [high-performance liquid chromatography]," and 5 mg of piperine to improve bioavailability. The identical placebo capsules (provided by Sami Labs Ltd.) contained microcrystalline cellulose and 5 mg piperine.
The Hong Kong dyspepsia index (HKDI) questionnaire was administered at baseline and endpoint. The HKDI assesses the severity of 12 symptoms of dyspepsia including bloating, pain, and vomiting, with a scale ranging from 1 (no symptoms) to 5 (incapacitating symptoms). Those with scores ≥ 16 were considered to be dyspeptic.
From the 68 patients enrolled, 30 in each group completed the study, with 8 patients (3 in the curcumin group and 5 in the placebo group) failing to finish. Reasons given were loss to follow up or lack of attendance at the final study visit. There were no significant differences between groups in anthropometric indices or total HKDI scores at baseline.
At the end of the study, the results of the UBT indicated both groups had equal eradication of H. pylori. Data and P value were not presented. Compared to placebo, those in the curcumin group had significantly greater improvements in total HKDI score (P<0.001), upper abdominal dull ache (P=0.002), stomach pain prior to meals (P=0.004), and belching (P=0.028). At the end of the study, 27.6% of those in the curcumin group had an HKDI total score of <16 (no dyspepsia) as compared to only 6.7% of those in the placebo group (P=0.042). The 6 adverse events reported were diarrhea (1 patient in each group), headache (2 patients in the curcumin group and 1 in the placebo group), and vertigo (1 patient in the placebo group).
The authors conclude that curcumin used as an adjuvant to standard treatment for PU significantly improves symptoms of dyspepsia but does not impact the rate of clearance of H. pylori infection. They point out that the long-term efficacy of adjuvant curcumin in the treatment of PU, especially with respect to the prevention of new H. pylori infections, needs to be evaluated. Limitations of the study include the small sample size, subjective symptom evaluations, and the lack of a direct assessment of H. pylori infection.
One of the authors (M. Majeed) serves as CEO of Sabinsa Corporation and Sami Labs Ltd.—Amy C. Keller, PhD