Cheon Chunhoo, Yoo Jeong-Eun, Yoo Hwa-Seung, Cho Chong-Kwan, Kang Sohyeon, Kim Mia, Jang Bo-Hyoung, Shin Yong-Cheol, Ko Seong-Gyu
Department of Preventive Medicine, Korean Medical College, Kyung Hee University, Seoul, Republic of Korea.
Dunsan Korean Medicine Hospital of Daejeon University, Daejeon, Republic of Korea.
Evid Based Complement Alternat Med. 2017;2017:8780325. doi: 10.1155/2017/8780325. Epub 2017 Dec 26.
Anorexia occurs in about half of cancer patients and is associated with high mortality rate. However, safe and long-term use of anorexia treatment is still an unmet need.
The purpose of the present study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia.
A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests.
Anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group.
In the present study, [corrected] Sipjeondaebo-tang did not show a significant effect on anorexia [corrected]in patients with cancer. Further large-scale studies which compensate for the limitations of this study are needed to assess [corrected] the efficacy.
This trial is registered with ClinicalTrials.gov NCT02468141.
约半数癌症患者会出现厌食症状，且厌食与高死亡率相关。然而，安全且长期使用的厌食症治疗方法仍是未被满足的需求。
本研究旨在检验四君子汤（十全大补汤）治疗癌症相关性厌食症的可行性。
共有32名癌症厌食症参与者被随机分为四君子汤组或安慰剂组。参与者每日3次服用3克四君子汤或安慰剂，持续4周。主要结局指标为厌食/恶病质治疗功能评估（FAACT）中厌食/恶病质分量表的变化。次要结局指标包括厌食症的视觉模拟量表（VAS）、FAACT量表及实验室检查。
四君子汤治疗4周后，通过FAACT和VAS测量的厌食症及生活质量有所改善。然而，四君子汤组与安慰剂组的变化之间无显著差异。
在本研究中，四君子汤对癌症患者的厌食症未显示出显著疗效。需要进一步开展大规模研究以弥补本研究的局限性，从而评估其疗效。
本试验已在ClinicalTrials.gov注册，注册号为NCT02468141。
