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Jeff Creason (57), Ivan Ramirez Lopez (51), Janine Williams (50), Devin Burton (21), Lannis Joe Ward (36), and Kayla Smith (30) died in building collapse.

This phase I/II, open-label, noncontrolled study evaluated a TCM therapy, RSYRT decoction, to manage fatigue in Chinese cancer survivors with stable disease. As measured by a validated patient-reported symptom outcome instrument, the Chinese language version of the MDASI (MDASI-C), fatigue was significantly reduced after 6 weeks of TCM intervention. Given the excellent tolerability and safety of RSYRT and these promising fatigue-reduction results, the RSYRT decoction warrants further examination in a randomized trial, which would eliminate any placebo effect that may have resulted from the open-label approach in the current study.

Qualitative interviewing showed that two thirds of patients experienced satisfactory fatigue relief within 2 weeks of RSYRT administration and that most of the other patients experienced relief within 3 weeks. These results suggest that 2–3 weeks is a good study length for future trials seeking to detect effective fatigue reduction with a TCM decoction, such as RSYRT.

Originally found in Taiping Huimin Heji Ju Fang, a book with a 1000-year history of adoption in holistic health care, RSYRT consists of 12 herbs (Table 1). Animal studies and human studies have shown that most herbs in this decoction, and especially the anti-inflammatory compounds derived naturally from these herbal products, strengthen the immune system.

A recent study in patients with breast cancer demonstrated that cancer-related fatigue and its related symptoms were significantly associated with qi deficiency as assessed by TCM theory.qi and blood (which is the source of qi). All 33 patients in this study showed qi deficiency, according to bian zheng. In the decoction RSYRT, the main effects of dangshen (or ginseng, which has a similar effect), huangqi, baizhu, fuling, chenpi, and gancao are to replenish qi and invigorate the spleen. Shengdi, danggui, and baishao are used to nourish blood. Wuweizi and yuanzhi can calm the heart and tranquilize the spirit, which should alleviate the symptoms of insomnia and palpitations. Individualized medicine, presented in this study as a slightly altered dose or change in herbs, is one significant characteristic of TCM practice that takes into account individual differences in bian zheng (the subtypes shown in Table 3) and other symptoms. This study shows that small variations in the RSYRT decoction achieved an expected consistency in addressing the main characteristic of fatigue, qi deficiency. Using a relatively fixed TCM formula with a combination of herbs rather than a single herb is based on the TCM theory of the entire human system as an object in which symptoms are driven by maladjustments in the body.

TCM methods for managing chronic fatigue have been widely adopted for the treatment of cancer and other conditions in China and elsewhere.Astragalus mongholicus (huangqi)–based herbal medicine was associated with a trend (unconfirmed because of the quality of the study) of increased survival, tumor response, and performance status. Wisconsin ginseng (Panex quinquefolius) improved cancer-related fatigue in a phase III double-blind multicenter study, suggesting that a single herb can be used for effective fatigue management in certain patients.

Patients reported other symptoms besides fatigue, including disturbed sleep, dry mouth, drowsiness, and poor appetite, which is consistent with symptom research findings that moderate to severe fatigue often appears alongside other significant symptoms.

The quality and safety of Chinese herbal medicines have attracted increased global attention in recent years, given that a large population uses TCM products.Chinese Pharmacopoeia.

This study had several limitations. First, because of the lack of safety information based on phase I studies of this combination decoction, an open-label design was used for this study. The possibility of placebo effect and a resulting bias toward belief in effective symptom reduction can be significant in such a nonrandomized study. Second, this study deviated from the typical clinical-trial approach in that, although the usual dose of each herb (according to safety and effectiveness guidelines in the Chinese Pharmacopoeia) was given generally, doses were slightly adjusted individually per the outcomes of bian zheng, a TCM diagnostic method. As a result, a few herbs were added or deleted from the core 12-herb RSYRT formula for certain patients. This unusual practice rarely happens in classic phase I drug trials for dosage and tolerance discovery, but it is usual in TCM practice because of its nature as an individualized medicine. In any case, the fact that no toxicity was documented in this pilot study is consistent with years of clinical experience in which this formula has been used to treat chronic disease. Finally, it would have been beneficial to have more frequent assessment (such as weekly) during the trial and to have used the multisymptom MDASI-C to quantitatively measure incremental change in fatigue and other symptoms, rather than to rely on qualitative data collection. Even so, a pilot study to develop a MDASI-TCM module

In conclusion, good feasibility and no toxicity from RSYRT decoction were observed in 33 cancer survivors who had non–anemia-related fatigue that lasted for several months. Using a well-validated patient-reported symptom outcome measure and qualitative documentation, this study obtained a preliminary impression of positive fatigue reduction from this formula. The study suggests the need for additional randomized clinical study of RSYRT to confirm true evidence of symptom control in patients with fatigue.