Abstract

Objective: The purpose of this study was to investigate the efficacy and safety of spinal-Z, derived from Peganum harmala seeds and Dracocephalum Kotschyi Boiss leaves, in patients with esophageal and stomach adenocarcinoma, and squamous cell carcinoma of the esophagus. Methods: Sixty-one patients with malignancies of the upper gastrointestinal tract were randomly assigned to one of two groups (treatment or control) in a double-blind fashion. Six capsules of Spinal-Z were prescribed to the patients with the regimen of 600 mg/m2/day, and placebo to the control group, for six months. Results: There were no significant differences between the two groups with regard to age, sex, duration of cancer, type of cancer and family history of cancer. There were significant differences in abdominal pain, heartburn, constipation and vomiting between the two groups, following spinal-Z therapy. Evaluation of drug side effects showed no difference in cough or other respiratory symptoms, itching, headache or dizziness between the two groups, both before and after treatment. Conclusion: This study indicates that Spinal-Z is safe and efficacious in the management of patients with upper gastrointestinal tract cancers.