Evaluating Ma-ol-asal Syrup for Chemotherapy-induced Fatigue in Gastrointestinal Cancer Patients: A Randomized Double-blinded Placebo-controlled Clinical Trial :.

Abstract

Background: Chemotherapy-induced fatigue (CIF) is a common and debilitating side effect in cancer patients, particularly those with gastrointestinal cancers. This study explores the potential of Ma-ol-asal, a traditional Persian herbal syrup, as a holistic, supportive approach to alleviate CIF's physical and psychological burdens.

Materials and methods: This randomized, double-blind, placebo-controlled trial involved 120 gastrointestinal cancer patients with fatigue, randomly assigned to receive 10 mL of Ma-ol-asal (compound honey syrup) or placebo thrice daily for four weeks. Fatigue was assessed with validated scales at baseline and post-intervention once, with data analyzed to evaluate efficacy.

Results: After withdrawals, 42 patients per group remained. No significant demographic or lab differences were observed. Both groups had comparable scores post-treatment across all measures, with no significant differences. Adverse events, mainly nausea, vomiting, and abdominal pain, were similar. Perception of benefit varied between groups.

Conclusion: Our study shows Ma-ol-asal syrup isn't superior to placebo for chemotherapy-induced fatigue, highlighting significant placebo effects. This emphasizes the need to understand harnessing placebo responses to improve symptom management safely.