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

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.

Analysis of Outcome Indicators of Cancer-Related Fatigue Treated with Chinese Herbal Compounding

“…The interventions in the 70 RCT treatment groups included in this research were limited to herbal compounding alone, and the interventions in the control group included studies with symptomatic treatment at most as the control group 6 , 8 , 12 , 14–16 , 18–20 , 22 , 27 , 29 , 30 , 32–36 , 38 , 40 , 42 , 47 , 50 , 52 , 53 , 55 , 59 , 60 , 64 , 67–69 , 71 , 74 in 35 studies, chemotherapy alone as a control group 9 , 10 , 21 , 26 , 37 , 39 , 41 , 48 , 51 , 54 , 56 , 57 , 65 , 66 , 70 , 72 , 73 in 17 studies, placebo as a control group 23 , 24 , 44 , 62 in 4 studies, and the rest adopting symptomatic treatment + buzhongyiqi compound, 63 symptomatic treatment + compound zebrano capsules, 46 symptomatic treatment + guipiwan, 6 chemotherapy + detox tang, 11 chemotherapy + buzhongyiqi compound, 49 addy injection, 31 buzhongyiqi wan, 7 anti-tumor and potent formula, 45 modafinil capsule, 13 zhenqifuzheng capsule, 25 bozhi glycopeptide, 61 huangqi, 61 ...…”

“…From the 70 included studies, six fatigue scales were used in the herbal preparation for cancer fatigue of which 25 studies 6 , 14 , 16 , 18 , 20 , 26 , 29 , 32–34 , 37–40 , 44 , 46 , 50 , 51 , 54 , 55 , 57 , 64 , 65 , 71 , 72 used the piper fatigue scale (PFS) and 18 studies 6 , 14 , 16 , 18 , 20 , 26 , 29 , 32–34 , 37–40 , 44 , 46 , 50 , 51 , 54 , 55 , 57 , 64 , 65 , 71 , 72 took advantage of the PFS revised (PFS-R), 11 studies 4 , 9 , 13 , 17 , 23 , 31 , 42 , 45 , 49 , 61 , 73 using the cancer fatigue scale, and 8 studies 5 , 10 , 24 , 25 , 45 , 60 , 62 , 68 using the brief fatigue inventory, 3 studies 47 , 48 , 66 using the fatigue symptom inventory, and 2 studies ...…”

“…The interventions in the 70 RCT treatment groups included in this research were limited to herbal compounding alone, and the interventions in the control group included studies with symptomatic treatment at most as the control 6,8,12,[14][15][16][18][19][20]22,27,29,30,[32][33][34][35][36]38,40,42,47,50,52,53,55,59,60,64,[67][68][69]71,74 in 35 studies, chemotherapy alone as a control group 9,10,21,26,37,39,41,48,51,54,56,57,65,66,70,72,…”

Zhengyuan capsules for the treatment of chemotherapy-induced cancer-related fatigue in stage IIIB–IV unresectable NSCLC: study protocol for a randomized, multi-center, double-blind, placebo-controlled clinical trial

“…In China, patients prefer TCM to treat disease and relieve uncomfortable symptoms. Single herbs like Panax ginseng ( 33 ) and Panax quinquefolius ( 34 ), decoctions such as Bojungikki-Tang ( 35 ) and Sipjeondaebo-Tang ( 36 ), and proprietary formulations like the Shenfu injection ( 37 ) are proven to be effective for CRF with minimal side effects. Zhengyuan capsules invigorate Qi, the spleen, and kidneys, filling essence, softening firmness, and dispelling knots to improve symptoms of fatigue by enhancing post-chemotherapy hepatic glycogen levels and improving hematopoietic and immune function.…”

Effects of botanical drugs in the treatment of cancer-related fatigue in patients with gastric cancer: A meta-analysis and prediction of potential pharmacological mechanisms

“…In traditional Chinese medicine (TCM), fatigue is believed to be caused by the yin - yang disharmony and the deficiency of qi and blood in the human body ( Xiong et al, 2021 ). Botanical drugs have been used in treating fatigue for thousands of years and are still used in East Asia to treat various kinds of fatigue, including CRF, with good results ( Lee et al, 2021 ; Song et al, 2021 ; Zhang et al, 2021 ).…”