Background: Bojungikki-tang (Bu-Zhong-Yi-Qi-Tang in Chinese or Hochu-ekki-to in Japanese) is a widely used herbal prescription in traditional medicine in China, Japan, and Korea. The aim of this study was to investigate the effectiveness of Bojungikki-tang for cancer-related fatigue. Methods: A total of 40 patients with cancer-related fatigue were randomized into an experimental or a waiting list control group. Patients in the experimental group were treated with Bojungikki-tang (TJ-41) and patients in the waiting list group remained without any intervention for 2 weeks. Results: The experimental group showed statistically significant improvements in fatigue level assessed by the Visual Analogue Scale of Global Fatigue (VAS-F) measuring the severity of fatigue (experimental vs control: -1.1 ± 2.1 vs 0.1 ± 0.9, P < .05) and results of Functional Assessment of Cancer Therapy—General (FACT-G), Functional Assessment of Cancer Therapy—Fatigue (FACT-F), and Trial Outcome Index—Fatigue (TOI-F) also showed significant improvements (FACT-G, 3.7 ± 9.9 vs -2.4 ± 9.5, P < .05; FACT-F,F, 8.0 ± 13.6 vs -2.2 ± 14.1, P < .05; TOI-F, 6.5 ± 9.2 vs -0.5 ± 10.9, P < .05). Conclusions: The results of this study indicate that Bojungikki-tang may have beneficial effects on cancer-related fatigue and quality of lives in cancer patients. More rigorous trials are needed to confirm the efficacy of Bojungikki-tang.

This study aims to evaluate the efficacy and effectiveness of a mindfulness-based stress reduction (MBSR) program in improving sleep in cancer survivors. Four electronic databases (Cochrane Library, EMBASE, PubMed, and PsycARTICLES) were searched for randomized controlled trials evaluating the effects of MBSR on the sleep of cancer survivors from their inception to May 2020. The primary outcome was sleep quality measured by validated questionnaires such as the Insomnia Severity Index and Pittsburgh Sleep Quality Index. The secondary outcomes were sleep parameters obtained from a sleep diary, polysomnography, and actigraphy. The included studies were critically appraised by the Cochrane risk of bias tool and meta-analyzed. Ten studies were included, and nine studies were analyzed quantitatively. MBSR significantly improved sleep quality compared to usual care (standardized mean difference -0.29, 95 % confidence interval -0.55 to -0.04, I2 = 58 %). However, there were no favorable results with sleep parameters. Compared to active controls, MBSR presented mixed results with sleep quality according to the outcomes and negative results with sleep parameters. This review suggests that MBSR helps cancer survivors improve sleep quality. Our results support the possibility of using MBSR for cancer survivors. However, its efficacy and effectiveness in improving sleep quality and sleep parameters are inconclusive because the number of included studies was few with inconsistent results. Further studies with high methodological quality are required to establish conclusive evidence about the efficacy and effectiveness of MBSR in improving sleep quality and sleep parameters in cancer survivors.

Background: Sleep disturbance is the second most bothersome symptom in patients with cancer, and it can significantly impair their quality of life. The aim of this study was to investigate the efficacy and safety of the traditional herbal medicine Gamiguibi-tang (GGBT) in patients with cancer-related sleep disturbance. Methods: We conducted a prospective, randomized, wait-list-controlled, open-label pilot clinical trial on cancer-related sleep disturbance. Patients with cancer experiencing poor sleep quality with a Pittsburgh Sleep Quality Index of at least 6 were randomly assigned to the GGBT and wait-list groups to receive GGBT and conventional care, respectively, for 2 weeks. The primary endpoint was the Insomnia Severity Index (ISI) score. Fatigue, depression, and cognitive impairment were assessed as the secondary endpoints by using the Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MoCA). Results: Thirty participants who met the eligibility criteria were enrolled. Sleep disturbance assessed using the ISI improved significantly more in the GGBT group than in the wait-list group (−5.5 ± 4.4 vs 0.1 ± 1.1, P < .001). Fatigue level determined using the BFI also improved significantly more in the GGBT group than in the wait-list group (−0.8 ± 0.8 vs 0.0 ± 0.3, P = .002). The BDI and MoCA scores showed no significant changes. Adverse events were reported in two patients in the GGBT group and consisted of mild dyspepsia and mild edema. Conclusion: GGBT may be a potential treatment option for cancer-related sleep disturbance. Further research is needed to investigate the efficacy and safety of GGBT.

Background. Moxibustion has been traditionally used to manage pain related to chronic diseases, including cancer. This study aims to investigate the efficacy and safety of moxibustion for relieving cancer pain in patients with metastatic cancer. Methods. A total of 16 patients were randomly divided into a true moxibustion (TM) group or a sham moxibustion (SM) group. In both groups, moxibustion was applied for 10 minutes, once daily for 7 consecutive days. In the SM group, the moxa cone was removed earlier than in the TM group, so as not to deliver heat stimulation completely into the skin. The changes of pain severity using the Brief Pain Inventory (BPI) and quality of life measured by the Functional Assessment of Cancer Therapy–General (FACT-G) were observed. A blinding credibility test was done to validate the sham moxibustion procedure. Results. The total BPI score significantly decreased in the TM group compared with the SM group (TM vs SM: −0.97 ± 1.05 vs 0.35 ± 0.60, P = .025). The 2 subsets of BPI, pain intensity score and pain interference score, also significantly decreased in the TM group (TM vs SM: intensity, −0.82 ± 0.93 vs 0.46 ± 0.87, P = .020; interference, −1.12 ± 1.31 vs 0.24 ± 0.61, P = .047). Even after adjusting for the values of opioid consumption, these results remained significant. FACT-G did not significantly improve in the TM group. The blinding to sham moxibustion was credible and no serious adverse events occurred. Conclusion. We suggest that moxibustion could be a safe and potential modality for cancer-related pain in patients with metastatic cancer. With the limitation of small sample size, a larger and long-term follow-up study is necessary to determine more definitely the efficacy of moxibustion.

Purpose: This study was performed to evaluate the efficacy and safety of clove-based herbal mouthwash in ameliorating radiation-induced oral mucositis in patients with head and neck cancer. Methods: Fourteen patients were prospectively enrolled in this study and randomized to either an experimental group or a control group. The patients of the experimental group swished their mouths with a clove-based herbal mouthwash during radiotherapy (RT), while the patients of the control group swished with clear water. The primary end point of this study was incidence of radiation-induced oral mucositis. The secondary end points were time to onset of radiation-induced oral mucositis, duration of radiation-induced oral mucositis, incidence of supplemental nutrition through feeding tube, maximum pain score, body weight loss, incidence of RT interruption, and duration of RT interruption. Results: The use of clove-based herbal mouthwash shortened the duration of grade ≥2 mucositis (24.3 days vs 37.1 days, P=0.044) and reduced body weight loss during RT (3.1% vs 7.4%, P=0.023) compared with clear water. The use of clove-based herbal mouthwash also reduced the incidence of grade 3 mucositis (28.6% vs 57.1%), supplemental nutrition (0% vs 28.6%), and RT interruption (14.3% vs 28.6%), and reduced the duration of grade 3 mucositis (5.1 days vs 17.7 days) and RT interruption (1 days vs 8.5 days). In addition, clove-based herbal mouthwash delayed the time to onset of mucositis (26.6 days vs 24.5 days) and reduced the maximum pain score (4.1 vs 4.9). However, these differences were not statistically significant. Conclusion: Although we could not find significant differences in some end points, this single-blind randomized study showed that a clove-based herbal mouthwash can have a potentially beneficial effect on minimizing or preventing radiation-induced oral mucositis in patients with head and neck cancer. To confirm the results of our study, well-designed randomized studies with large sample sizes will be required.

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 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. 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. 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.