Evaluation of Treatment Response and Side Effects of Spinal-Z in Patients with Metastatic Gastroesophageal Adenocarcinoma: A Double-Blind Randomized Controlled Trial

Abstract

Background: Spinal-Z is a methanolic mixture of dried seed powder of Peganum harmala Linn. and leaf of Dracocephalum kotschyi Boiss. It is available as oral capsules and has been used to treat various cancers. The aim of this study was to evaluate the effects of Spinal-Z capsules (containing herbal extracts) on blood parameters and gastrointestinal symptoms of patients with metastatic gastric adenocarcinoma and to determine its potential side effects. Methods: A total of 76 patients were randomly assigned into 2 groups. The intervention group received 6 Spinal-Z capsules per day (2 after breakfast, 2 after lunch, and 2 after dinner). The control group received placebo capsules in the same manner. The patients were followed-up for 24 weeks. Results: The distribution of demographic and clinical characteristics was homogeneous in the intervention and control groups. Spinal-Z treatment had no significant effects on cardiovascular parameters, such as systolic blood pressure, diastolic blood pressure, or heart rate, compared to the control group. No significant changes were observed over time, although a significant reduction in fasting blood sugar was observed in the intervention group, compared to the controls. Based on the findings, treatment could significantly reduce dysphagia and stomachache in the follow-up, while it had no significant effects on symptoms, such as itching, nausea, or vomiting neither temporarily nor in the long run (follow-up; P > 0.05). Conclusions: Spinal-Z does not have any adverse effects on cardiovascular, renal, and hematopoietic systems or blood glucose level. On the other hand, it could improve gastrointestinal complications. Overall, Spinal-Z, as an accessible and affordable medication with very few side effects, may be a suitable option for treating complications in patients with metastatic gastroesophageal adenocarcinoma, as it can decrease fasting blood sugar and erythrocyte sedimentation rate.