Methodological issues in the investigation of ginseng as an intervention for fatigue.

Elam JL, Carpenter JS, Shu XO, Boyapati S, Friedmann-Gilchrist J
Clin Nurse Spec. 2006 20 (4): 183-9

PMID: 16849930 · DOI:10.1097/00002800-200607000-00007

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.

PARTICIPANTS/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.

DISCUSSION - 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.

MeSH Terms (23)

Breast Neoplasms Contraindications Cross-Over Studies Double-Blind Method Drug Administration Schedule Drug Monitoring Equipment Failure Fatigue Feasibility Studies Female Health Services Needs and Demand Humans Killer Cells, Natural Middle Aged Panax Patient Selection Phytotherapy Pilot Projects Plant Preparations Research Design Sleep Wake Disorders Southeastern United States Treatment Outcome

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