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Randomized Controlled Trial
. 2021 Jan-Dec:20:15347354211040830.
doi: 10.1177/15347354211040830.

Traditional Herbal Medicine, Sipjeondaebo-Tang, for Cancer-Related Fatigue: A Randomized, Placebo-Controlled, Preliminary Study

Jee Young Lee  1   2 , Eun Hye Kim  1 , Jee-Hyun Yoon  1 , Wankyu Eo  1 , Seong Woo Yoon  1
Affiliations
Randomized Controlled Trial

Traditional Herbal Medicine, Sipjeondaebo-Tang, for Cancer-Related Fatigue: A Randomized, Placebo-Controlled, Preliminary Study

Jee Young Lee et al. Integr Cancer Ther. 2021 Jan-Dec.

Abstract

Purpose: Sipjeondaebo-tang (SDT) is a widely used traditional herbal medicine for relieving fatigue. This randomized, placebo-controlled, preliminary study evaluated SDT for cancer-related fatigue, which is the most common symptom experienced by patients with cancer.

Patients and methods: Patients with a Brief Fatigue Inventory (BFI) score of at least 4 were randomly assigned in a double-blinded manner to receive SDT (3 g 3 times daily) or placebo orally for 3 weeks. The BFI was the primary outcome measure and secondary outcome measures included the Hospital Anxiety and Depression Scale (HADS), the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30), immunoregulatory tests, and safety.

Results: A total of 50 participants were randomly assigned and 48 patients completed the trial. Based on intention-to-treat analysis, fatigue, which was the primary outcome, was improved in both arms compared with the baseline, and was significantly better in the SDT group than in the placebo group at week 3 (3.56 ± 1.18 vs 4.63 ± 1.83, P = .019). Secondary outcomes, including anxiety, depression, and immunoregulatory tests, did not improve significantly in either group. However, quality of life measured using the EORTC QLQ-C30 improved in both arms compared with the baseline, and the global health subscale was significantly better in the SDT group than in the placebo group (P = .02). No significant toxicities were observed.

Conclusion: SDT may improve cancer-related fatigue and quality of life in patients with cancer. A further randomized clinical trial with large sample size is warranted.

Keywords: Sipjeondaebo-tang; brief fatigue inventory; cancer-related fatigue; cancer-related symptoms; traditional herbal medicine.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
CONSORT diagram. Abbreviations: SDT, Sipjeondaebo-tang; ITT, intention to treat.
Figure 2.
Figure 2.
Changes in brief fatigue inventory scores from baseline. Abbreviations: EOT, end of treatment; SDT, Sipjeondaebo-tang.
See this image and copyright information in PMC

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References

    1. Mock V, Atkinson A, Barsevick A, et al..; National Comprehensive Cancer Network. NCCN practice guidelines for cancer-related fatigue. Oncology. 2000;14:151-161. - PubMed
    1. Mock V. Fatigue management: evidence and guidelines for practice. Cancer. 2001;92:1699-1707. - PubMed
    1. Fulton C, Knowles G. Cancer fatigue. Eur J Cancer Care. 2000;9:167-171. - PubMed
    1. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: cancer-related fatigue. 2020. Accessed January 2, 2021. https://www.nccn.org/professionals/physician_gls/pdf/fatigue.pdf
    1. Kirshbaum M. Cancer-related fatigue: a review of nursing interventions. Br J Commun Nurs. 2010;15:214-NaN6, 218. - PubMed

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