Methodological issues in the investigation of ginseng as an intervention for fatigue.
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.
Elam
Julie L
JL
Indiana University School of Nursing, Indianapolis, Ind 46202, USA. jlelam@iupui.edu
Carpenter
Janet S
JS
Shu
Xiao-Ou
XO
Boyapati
Sonia
S
Friedmann-Gilchrist
Janet
J
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
D028321:Plant Preparations