Supplementary Therapy with Herbal Extract (Spinal-Z): Squamous Cell Carcinoma of Esophagus and Adenocarcinoma of Esophagus and Stomach Yunes Panahi 1*, Alireza Saadat 2 1 Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, IR Iran. 2 Department of Hematology & Oncology, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Tehran, IR Iran. Supplementary Therapy with Herbal Extract (Spinal-Z): Squamous Cell Carcinoma of Esophagus and Adenocarcinoma of Esophagus and Stomach Yunes Panahi 1*, Alireza Saadat 2 1 Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, IR Iran. 2 Department of Hematology & Oncology, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Tehran, IR Iran. Background and Aims Esophageal cancer is the fourth most common tumor in developing countries, although the incidence of adenocarcinoma has increased enormously over the last decades. The roles of radiotherapy and chemotherapy in the management of esophageal cancer remain unclear, with diverse side effects. Present study evaluated the effect of supplementary treatment with Spinal-Z, a herbal extract mainly obtained from Peganum harmala, on Squamous cell carcinoma and adenocarcinoma. Peganum harmala Linn (commonly known as Syrian Rue) has long been used in traditional Iranian medicines as well as in more conventional treatments to fight various types of cancer for many years. Digestive cancer sites include the colon and rectum, esophagus and stomach, liver and pancreas. Digestive system cancers are the most common cancers worldwide, with three million new cases and more than two million deaths reported worldwide each year. Methods In a randomized, double blinded, clinical trial from Feb-2009 to Mar Forty four patients with adenocarcinoma or squamous cell carcinoma were entered to one of case or control groups. Case group received Spinal-Z (600mg/m2/day; 6 capsules/day; purchased from Daru Pakhsh Co, Iran) for six months, in addition to the standard treatments. In control group, patients received six months of treatment with placebo (similar to the Spinal-Z in appearance, without effect) and standard treatments. Dysphagia, Abdominal pain, Indigestion and Anorexia (as the signs of disease) were evaluated every 3 month during study. Adverse effects were checked every month. Results Nine of 44 patients were excluded (4 because of adverse effects and 5 by their own decision). Twenty one of 35 patients had adenocarcinoma and 14 had esophagus squamous cell carcinoma. Before treatment there were no significant differences between groups in grade of Dysphagia (p=0.24), Abdominal pain (p=0.11), Indigestion (p=0.3) and Anorexia (p=0.47). At the end of study there was significant difference between groups in abdominal pain (p=0.03) and indigestion (p=0.05), both with less incidence in Spinal-Z group. Spinal-Z was successful in decreasing the Anorexia (p=0.042), Indigestion (p=0.021) and Abdominal pain (p=0.033), while the effect of placebo treatment was significant only in the case of Anorexia (p=0.046). The most common adverse effects in both groups were vomiting and nausea (15 patients) with no significant difference between groups (p=0.87). Conclusions The results suggest that administration of spinal-Z along with standard treatments in squamous cell carcinoma and adenocarcinoma can increase the efficacy of treatment by decreasing the signs of disease and making the treatments tolerable for patients. Conclusions References El Gendy et al. Harmaline and harmalol inhibit the carcinogen-activating enzyme CYP1A1 via transcriptional and posttranslational mechanisms. Food Chem Toxicol. (2011) References Figure 2 Figure 3 Figure 4 Acknowledgements Daru Pakhsh Co. for providing Spinal Z. Patients, their families and staff members of Baqiyatallah Hospital for their cooperation. Acknowledgements