title: Efficacy and safety of honey based formulation of Nigella sativa seed oil in functional dyspepsia: A double blind randomized controlled clinical trial.
abstract: BACKGROUND
  A honey based formulation from Nigella sativa L. (N. sativa) has been used in Traditional Persian Medicine for upper gastrointestinal symptoms. Considering the traditional use of this formulation and its ingredients known pharmacologic effects, this study aimed to evaluate the efficacy and safety of N. sativa seed oil mixed with honey in treatment of patients with functional dyspepsia.
  
  
  METHODS
  Seventy patients diagnosed with functional dyspepsia according to ROME III criteria and confirmed by upper gastrointestinal endoscopy were selected to receive a traditional honey based formulation of N. sativa (5 ml N. sativa oil orally daily) or placebo for 8 weeks in a double-blind randomized placebo-controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 8 weeks of the intervention in terms of the Hong Kong index of dyspepsia severity, presence of Helicobacter pylori infection based on urease test, scores in different domains of short form (SF-36) health survey, and any observed adverse events.
  
  
  RESULTS
  The mean scores of Hong Kong index of dyspepsia severity sores and the rate of H. pylori infection were significantly lower in the N. sativa group comparing the placebo group after the intervention (P<0.001). No serious adverse event was reported.
  
  
  CONCLUSIONS
  This study showed that adjuvant supplementation of honey based formulation of N. sativa can cause significant symptomatic improvement of patients with functional dyspepsia whom received the standard anti-secretory therapy. The results should be investigated further in studies with longer duration and larger sample size.
authors.affiliation: Medicine Quran and hadith Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Reza
authors.initials: R
authors.lastname: Mohtashami
authors.affiliation: Medicinal Plants Research Center, Institute of Medicinal Plants, ACECR, Karaj, Iran.
authors.forename: Hasan Fallah
authors.initials: HF
authors.lastname: Huseini
authors.affiliation: Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Mojtaba
authors.initials: M
authors.lastname: Heydari
authors.affiliation: Gastroentrology and Liver diseases Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Mohsen
authors.initials: M
authors.lastname: Amini
authors.affiliation: Educational Administration Department, Kharazmi University, Tehran, Iran.
authors.forename: Zainab
authors.initials: Z
authors.lastname: Sadeqhi
authors.affiliation: Cellular and Molecular Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.
authors.forename: Habib
authors.initials: H
authors.lastname: Ghaznavi
authors.affiliation: Department of Pharmacology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran. Electronic address: Sa_mehrzadi@yahoo.com.
authors.forename: Saeed
authors.initials: S
authors.lastname: Mehrzadi
mesh_terms: D000328:Adult; D002626:Chemistry, Pharmaceutical; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy*; D005227:Fatty Acids / Q000032:analysis; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy; D006722:Honey; D006801:Humans; D008297:Male; D008875:Middle Aged; D031881:Nigella sativa; D010636:Phenols / Q000032:analysis; D008517:Phytotherapy; D010938:Plant Oils / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D011788:Quality of Life; D012639:Seeds; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005227:Fatty Acids; D010636:Phenols; D010938:Plant Oils
keywords: Functional dyspepsia; Honey; Nigella sativa; Traditional Persian Medicine