Randomized Pilot Trial Using External Yarrow Liver Compress Applications With Metastatic Cancer Patients Suffering From Fatigue: Evaluation of Sympathetic Modulation by Heart Rate Variability Analysis.

BACKGROUND: Liver compresses are commonly applied in complementary medicine during cancer treatment and are believed to have an energizing effect. We conducted a pilot study to investigate the influence of external application of yarrow liver compresses on the autonomous nervous system by analyzing the heart rate variability (HRV) in metastatic cancer patients undergoing radiation therapy and suffering from cancer-related fatigue (CRF). METHODS: A randomized pilot trial was undertaken with patients suffering from CRF receiving palliative radiation therapy for bone or brain metastasis over 2 weeks. CRF patients were randomized into an intervention group receiving yarrow liver compresses and a control group receiving no external application. HRV was analyzed at the beginning (T1) and end (T2) period of the study during daytime (d) and nighttime (n) in both groups and quantified using time-, frequency-, and nonlinear dynamics domains. RESULTS: A total of 39 patients were randomized between September 2017 and August 2019 and a total of 20 patients (10 per group) were available for analysis. For both groups, significant differences in HRV analyses were found in the comparison over the timeline between the first and second measurement (T1d→T2d) during daytime. Specifically, the intervention group showed decreased HRV and complexity of heart rate regulation, indicating increased sympathetic activity at time T2d, whereas the control group showed increased HRV and complexity of heart rate regulation, indicating increased vagal activity at time T2d. Furthermore, the observed HRV analyses showed almost no significant differences between the 2 groups in a direct comparison at the beginning and the end of the study (exception: T2d). CONCLUSIONS: Yarrow liver compresses led to increased sympathetic activity during daytime in the intervention group, whereas in the control group, which did not receive any external application, increased parasympathetic activity was observed.

External application of liver compresses to reduce fatigue in patients with metastatic cancer undergoing radiation therapy, a randomized clinical trial.

BACKGROUND: Liver compresses are frequently used in integrative medicine as supportive therapy during cancer treatment in order to reduce fatigue. We performed a pilot study to test whether the external application of yarrow liver compresses impacts fatigue in patients with metastatic cancer undergoing radiation therapy. METHODS: A randomized prospective pilot trial was performed including patients with brain metastasis or bone metastasis of solid tumors. Patients underwent either palliative radiation therapy (RT) of the metastatic lesions (control group) over two weeks or the same RT with additional external application of yarrow liver compresses once daily during RT. The primary objective was improvement on the general fatigue subscale of the multidimensional fatigue inventory (MFI-20) at the end of treatment, where a mean difference of two points is considered clinically relevant. Secondary objectives included psychological distress, quality of life and qualitative analysis with self-established visual analogue scales (VAS). Mean differences in general fatigue at the end of treatment compared to baseline were analyzed using the ANCOVA test. RESULTS: From 09/2017 to 08/2019 a total of 39 patients were randomized. Due to drop outs 24 patients (12 per group) were available for analysis. Patients in the intervention group received a mean number of 10.5 (range, 7-14) applications of yarrow liver compresses. The mean improvement at the end of therapy on the general fatigue subscale of the MFI-20 was 2 points in favor of the intervention group (p = 0.13), and all other MFI-20 subscales showed at least a trend towards improvement in favor of the intervention group. Likewise, psychological distress and VAS data was improved, the latter reaching statistical significance for the symptoms fatigue, tension and lack of drive. Major toxicities were not observed. CONCLUSIONS: External application of liver compresses appears to reduce fatigue within a clinical relevant range in patients with metastatic cancer undergoing radiation therapy. TRIAL REGISTRATION: ISRCTN, ICTRP DRKS00012999.