4.7 Article

Effects of the traditional Chinese herb Astragalus membranaceus in patients with poststroke fatigue: A double-blind, randomized, controlled preliminary study

Journal

JOURNAL OF ETHNOPHARMACOLOGY
Volume 194, Issue -, Pages 954-962

Publisher

ELSEVIER IRELAND LTD
DOI: 10.1016/j.jep.2016.10.058

Keywords

Astragalus membranaceus; Clinical trial; Poststroke fatigue; EORTC QLQ-C30 scores; BFI scores; SF-36 scores

Funding

  1. Ministry of Health and Welfare Department of Chinese Medicine and Pharmacy [CCMP101-CT-202]
  2. Chinese Medicine Research Center, China Medical University (Ministry of Education, Aim for the Top University Plan)
  3. Taiwan Ministry of Health and Welfare Clinical Trial and Research Center of Excellence [MOHW105-TDU-B-212-133019]

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Background and purpose: Astragalus membranaceus (AM) is the first-choice herb for fatigue treatment in traditional Chinese medicine and the main herb used for stroke treatment in China and Taiwan. The purpose of this study was to evaluate the effect of AM on poststroke fatigue (PSF). Materials and methods: This study was designed as a double-blind, randomized, controlled preliminary study. Sixty-four patients with PSF were assigned to treatment group (TG; 31 patients), which received oral administration of AM (2.8 g three times per day) for 28 days, and a control group (CG; 33 patients), which received a placebo. The primary outcome measures were the changes in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Brief Fatigue Index (BFI) scores Results: A total of 61 patients (29 patients in the TG and 32 patients in the CG) completed the trial. The difference in BFI scores between Visit 2 and Visit 1 was -17.83 +/- 17.70 in the TG, which was greater than that in the CG (-8.03 +/- 9.95; p=0.01); additionally, the difference in BFI scores between Visit 3 and Visit 1 was -16.48 +/- 16.41 in the TG, which was also greater than that in the CG (-9.47 +/- 13.39; p=0.05). In the EORTC QLQ-C30, the difference in cognitive functioning scores between Visit 2 and Visit 1 was 14.37 +/- 13.89 in the TG, which was greater than that in the CG (3.65 +/- 19.74; p=0.02); additionally, the difference in these scores between Visit 3 and Visit 1 was 14.37 +/- 16.50 in the TG, which again was greater than that in the CG (6.25 +/- 19.74; p=0.04). The difference in social functioning scores between Visit 3 and Visit 1 was 9.77 +/- 15.12 in the TG, which was greater than that in the CG (-1.56 +/- 20.46; p=0.01). The difference in global quality of life (QOL) scores between Visit 2 and Visit 1 was 14.08 +/- 18.78 in the TG, which was also greater than that in the CG (1.56 +/- 18.14; p=0.003); moreover, the difference in these scores between Visit 3 and Visit 1 was 10.92 +/- 17.55 in the TG, and this was greater than that in the CG (1.82 +/- 15.8; p=0.05). Conclusion: AM can improve BFI scores; cognitive functioning, social functioning, and global QOL scores in the EORTC QLQ-C30. Our results suggest that physicians should pay close attention to the unmet medical needs of patients with PSF. AM is helpful for treating patients with PSF; however, additional studies with a larger sample and a longer period of investigation are required.

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