title: Methodological issues in the investigation of ginseng as an intervention for fatigue.
abstract: BACKGROUND
  Although literature suggests that fatigue is commonly reported by women during and after breast cancer treatment, treatment options are limited. Although ginseng is widely used in Asian countries as a tonic to increase energy, its efficacy for treating cancer-related fatigue has not been carefully studied. We conducted a pilot study to evaluate the feasibility of a larger clinical trial to investigate the efficacy of ginseng for treating breast cancer-related fatigue.
  
  
  METHODS
  Breast cancer survivors seeking treatment for fatigue were recruited to participate in an 8-week randomized, double-blind, placebo-controlled trial.
  
  
  RESULTS
  A variety of practical problems were encountered in the study, including large numbers of survivors with conditions that were possible contraindications to ginseng use, inability to achieve blinding for the intervention because of strong odor from the ginseng, and measurement device failure.
  
  
  CONCLUSIONS
  Evaluating ginseng for breast cancer treatment-related fatigue is a great challenge, particularly if a blinded randomized design is desired. This article provides insight into issues related to investigating complementary therapies and the importance of pilot studies for identifying methodological problems.
authors.affiliation: Indiana University School of Nursing, Indianapolis, Ind 46202, USA. jlelam@iupui.edu
authors.forename: Julie L
authors.initials: JL
authors.lastname: Elam
authors.forename: Janet S
authors.initials: JS
authors.lastname: Carpenter
authors.forename: Xiao-Ou
authors.initials: XO
authors.lastname: Shu
authors.forename: Sonia
authors.initials: S
authors.lastname: Boyapati
authors.forename: Janet
authors.initials: J
authors.lastname: Friedmann-Gilchrist
mesh_terms: D001943:Breast Neoplasms / Q000150:complications / Q000628:therapy; D000075202:Contraindications; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000295:instrumentation / Q000379:methods; D004868:Equipment Failure; D005221:Fatigue / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D006301:Health Services Needs and Demand; D006801:Humans; D007694:Killer Cells, Natural / Q000187:drug effects / Q000276:immunology; D008875:Middle Aged; D005894:Panax / Q000276:immunology; D018579:Patient Selection; D008517:Phytotherapy / Q000379:methods*; D010865:Pilot Projects; D028321:Plant Preparations / Q000276:immunology / Q000627:therapeutic use*; D012107:Research Design; D012893:Sleep Wake Disorders / Q000188:drug therapy / Q000209:etiology; D015144:Southeastern United States; D016896:Treatment Outcome
chemical_list: D028321:Plant Preparations