Efficacy and safety of Sipjeondaebo-tang for cancer-related fatigue: A systematic review and meta-analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Approximately 52% of patients with cancer experience cancer-related fatigue (CRF), which negatively impacts both prognosis and quality of life (QoL). CRF is characterized by exhaustion, which is linked to cancer or treatment. Sipjeondaebo-tang (SDT) is an herbal medicine that is effective in alleviating fatigue and potentially easing CRF; however, there is currently insufficient clinical or scientific evidence to support the efficacy of SDT in managing CRF. AIM OF THE STUDY: We assessed the efficacy and safety of SDT for CRF by performing a systematic literature review and meta-analysis. MATERIALS AND METHODS: We collected randomized controlled trials (RCTs) on CRF by searching nine databases, including EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials, on November 30, 2023. Based on the predefined inclusion and exclusion criteria, two reviewers independently screened and selected the literature, followed by data extraction. We assessed the quality of the selected studies using version 2 of the Cochrane Collaboration Risk of Bias tool. Review Manager software was used for the data synthesis. A meta-analysis was conducted when two or more studies shared comparable interventions and outcome measures. For all other cases, a qualitative analysis was performed. The certainty of evidence for each result was assessed employing the Grading of Recommendations, Assessment, Development, and Evaluation method. RESULTS: This study contained eleven studies with a total of 754 participants. SDT significantly reduced CRF and improved QoL compared with the control group, both when used as an adjuvant therapy and as a monotherapy. Specifically, low-certainty evidence suggested that SDT, when used as an adjunctive therapy, could effectively reduce CRF, as indicated by a reduction in lack of strength (standardized mean difference = -1.28, 95% confidence interval (CI): -1.78 to -0.78, P < 0.00001). Additionally, moderate-certainty evidence indicated that SDT as an adjunctive therapy could improve QoL, as measured by Karnofsky Performance Status (mean difference = 4.67, 95% CI: 2.19 to 7.14, P = 0.0002). No serious adverse events occurred with SDT, whether it was used as an adjuvant therapy or as a monotherapy. CONCLUSIONS: This systematic review elucidated the safety and efficacy of SDT in managing CRF. Nevertheless, the low quality of the included studies highlights the need for carefully planned large-scale RCTs.