title: A Randomized Controlled Study to Determine the Efficacy of Garlic Compounds in Patients With Hematological Malignancies at Risk for Chemotherapy-Related Febrile Neutropenia.
abstract: 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.
  
  
  OBJECTIVE
  We explored whether adding GE may be efficacious in reducing the risk or severity of infections.
  
  
  METHODS
  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.).
authors.affiliation: Hadassah Medical Center, Jerusalem, Israel rmoshg@hadassah.org.il.
authors.forename: Moshe E
authors.initials: ME
authors.lastname: Gatt
authors.affiliation: Hadassah Medical Center, Jerusalem, Israel.
authors.forename: Jacob
authors.initials: J
authors.lastname: Strahilevitz
authors.affiliation: Hadassah Hebrew University Medical Center, Jerusalem, Israel.
authors.forename: Nir
authors.initials: N
authors.lastname: Sharon
authors.affiliation: Hadassah Medical Center, Jerusalem, Israel.
authors.forename: David
authors.initials: D
authors.lastname: Lavie
authors.affiliation: Hadassah Medical Center, Jerusalem, Israel.
authors.forename: Neta
authors.initials: N
authors.lastname: Goldschmidt
authors.affiliation: Hadassah Medical Center, Jerusalem, Israel.
authors.forename: Yossef
authors.initials: Y
authors.lastname: Kalish
authors.affiliation: Hadassah Medical Center, Jerusalem, Israel.
authors.forename: Alexander
authors.initials: A
authors.lastname: Gural
authors.affiliation: Hadassah Medical Center, Jerusalem, Israel Hadassah Hebrew University Medical Center, Jerusalem, Israel.
authors.forename: Ora B
authors.initials: OB
authors.lastname: Paltiel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D064147:Febrile Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D005260:Female; D005737:Garlic / Q000737:chemistry*; D019337:Hematologic Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012306:Risk; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents
keywords: chemotherapy; febrile; garlic; neutropenia; prevention