A Randomized Controlled Study to Determine the Efficacy of Garlic Compounds in Patients with Hematological Malignancies at Risk for Chemotherapy-Related Febrile Neutropenia

Background. Patients receiving chemotherapy for hematological malignancies are at high risk for febrile neutropenia (FN). Garlic extracts (GEs) are natural food substances showing antimicrobial effects in vivo. Objectives. We explored whether adding GE may be efficacious in reducing the risk or severity of infections. Design. This was a placebo-controlled double-blind randomized study. Results. Of 95 patients randomized to receive GE or placebo following chemotherapy, a febrile episode was documented in 50% of patients receiving GE and 63.3% receiving placebo (P =.89). There was a higher risk of developing a third and fourth febrile episode in the GE group (P =.01). However, among those at a lower risk for FN, those receiving GE developed fewer FN episodes (P =.075), especially those with severe neutropenia (P =.05). Major adverse events were distributed equally, but nonadherence was more common in the GE than in the placebo group: 19.5% versus 4%, respectively (P =.05). Conclusions. GE was safe and did not reduce FN risk in the entire cohort, but yet appeared to exert a protective effect in the lower-risk subgroup. We do not recommend the use of GE for FN prevention in higher-risk patients. A larger-scale clinical trial for the lower-risk subgroup of patients is advocated. (This trial was registered at www.clinicaltrials.gov as NCT00247039.).