|Date: 08-15-2016||HC# 011666-550|
Mohtashami R, Huseini HF, Heydari M, et al. Efficacy and safety of honey based formulation of Nigella sativaseed oil in functional dyspepsia: a double blind randomized controlled clinical trial. J Ethnopharmacol. December 4, 2015;175:147-152.
Black cumin (Nigella sativa, Ranunculaceae) seed oil has been used in traditional Persian medicine (TPM) for many ailments, and has been shown to have myriad bioactivities, as well as many bioactive compounds. It has been shown to have gastroprotective properties in animal models and antibacterial activity against clinicalHelicobacter pylori infections. Honey also is used to treat gastrointestinal diseases, and has demonstrated anti-H. pylori and anti-inflammatory activity. As documented in TPM manuscripts such as Avicenna's Canon of Medicine, honey formulations of black cumin oil have been used for over 1,000 years to treat gastrointestinal symptoms such as epigastric pain, flatulence, and postprandial fullness. Considering the traditional use and demonstrated pharmacological properties, this double-blind, randomized, placebo-controlled trial investigated the clinical efficacy of a combination of black cumin seed oil and honey on dyspepsia symptoms and H. pylori infections.
Cold-pressed black cumin seed oil (Barij Essence Company; Kashan, Iran) was mixed with honey (Asale-Khomein Company; Isfahan, Iran) and water in a ratio of 1:1:1. The placebo was mineral oil (Rose Polymer Company Ltd; Karaj, Iran) mixed with honey and water in the same ratio. To imbue comparable color and taste to the placebo, 0.1 ml of 1:1 chlorophyll and red chili pepper (Capsicum spp., Solanaceae) fruit extract was added per 100 ml of mineral oil. Total phenols, fatty acids, and volatile oil composition of black cumin seed oil were determined using high-performance liquid chromatography, gas-liquid chromatography (GC), and GC-mass spectrometry.
Patients with functional dyspepsia were recruited from the gastroenterology clinic of Baqiyatallah University of Medical Sciences; Tehran, Iran. Excluded were those with organic causes of dyspepsia, peptic ulcer disease, inflammatory bowel disease, or gastroesophageal reflux disease; those taking drugs for H. pylori; or those with any gastrointestinal surgery in the prior 3 months. Also, those with chronic or systemic diseases and those taking any routine medications, iron or calcium supplements, or antibiotics were excluded. Blood parameters were measured to screen patients, and 70 patients were ultimately included and randomly assigned to either the treatment (n=35) or placebo (n=35) group.
All patients received standard antisecretory therapy with famotidine. The primary endpoint was severity of dyspepsia symptoms, which were gauged at baseline and endpoint of the study using the Hong Kong index of dyspepsia. Secondary endpoints were quality of life (QoL), measured using the Short-Form Health Survey (SF-36), and degree of H. pylori infection based on the urease test. Observations or reports of any adverse effects were recorded. The study duration was 8 weeks, but dosage and administration information is not detailed in this article.
Two patients in the treatment group and 3 in the placebo group had limited adherence to the protocol but were included in the final (intent-to-treat) analysis. At baseline, demographic parameters were not significantly different between groups, but age, sex, and marital status were trending older, female, and married in the treatment group (P=0.07, 0.057, 0.08, respectively).
Although the Hong Kong index of dyspepsia scores significantly decreased in both groups after 8 weeks of treatment (P<0.001, treatment and P<0.006, placebo), the decreases in dyspepsia scores following 2 weeks (P=0.012), 4 weeks (P<0.001), and 8 weeks (P<0.001) were significantly greater in the treatment group compared to placebo. No significant differences in dyspepsia scores were seen between men and women, and no correlation was noted between scores and patient age.
At the end of the study, the rate of H. pylori infection was significantly decreased in the treatment group as compared with the placebo group (P<0.001). No correlations between rate of H. pylori infection and dyspepsia severity scores were observed. QoL scores were significantly greater in the treatment group than the placebo group in all domains (vitality, general health perception, physical functioning, physical role functioning, emotional role functioning, social role functioning, bodily pain, and mental health; P<0.05 for all). Adverse effects included nausea (group not specified), bloating (both groups), and burning sensation (treatment group).
In conclusion, the formulation of black cumin seed oil and honey was a safe and effective treatment of dyspepsia and H. pylori infection. Based on experimental evidence, potential mechanisms may include impacts on redox potential, inflammation, proton pumps, and acid secretion. Discussed limitations include the small sample size, short study duration, lack of post-study follow-up, absence of a positive control group, and lack of histopathological evaluation. The lack of dosage and drug delivery information is a serious deficit as it prevents reproduction of the trial. Larger studies of longer duration with rigorous, reproducible methodology are needed to confirm these findings.
—Amy C. Keller, PhD