Background

Subjective discomforts in a preclinical range are often due to imbalanced autonomic nervous system activity, which is a focus of craniosacral therapy. 

Objective

The aim of this work was to determine any changes in heart rate variability (HRV) in a study on craniosacral therapy. 

Design, Setting, Participants and Interventions

This is a quasi-experimental (controlled) study with cross-over design. In a private practice, measurements were performed on 31 patients with subjective discomforts before and after a control and an intervention period. HRV was determined using a device that requires a measuring time of 140 s and electrode contact only with the fingertips. 

Main Primary Outcome Measures

HRV change under the influence of a defined one-time intervention (test intervention) with craniosacral therapy versus control (defined rest period). 

Results

Standard deviation of all RR-intervals (ms) and total power of RR-interval variability in the frequency range (ms2) were together interpreted as an indicator of test subjects’ autonomic nervous activity and as a measure of their ability to cope with demands on their health. Neither of these parameters increased during the control period (P>0.05), whereas during the test intervention period there was an increase in both (P<0.05, P<0.01). Nevertheless, interactions between treatment and the increase were statistically not significant (P>0.05). No changes were observed in the low frequency/high frequency ratio (sympathetic-vagal balance) in the course of the control or the test intervention period (P>0.05). 

Conclusion

Craniosacral treatment had a favourable effect on autonomic nervous activity. This in itself is an interesting result, but further research will be needed to distinguish specific effects of craniosacral therapy technique from less specific therapist-client interaction effects.

Background

Traditional Chinese medicine (TCM) is considered an important complementary therapy with beneficial effects for cancer patients. Elderly patients with non-small-cell lung cancer (NSCLC) are a complex patient group with increasing co-morbidity and shrinking physiological reserve, and may derive substantial benefit from the supportive aspects of TCM. Researchers from Shanghai Longhua Hospital found that qi and yin deficiency is a common syndrome in patients with stage III or IV lung cancer. This project was designed to study the combination of single-agent chemotherapy with TCM methods of benefiting qi and yin in elderly patients with advanced NSCLC.

Methods and design

This is a double-blind controlled, multi-center, and prospective study with randomly selected participants from elderly NSCLC patients in China. Seventy-six patients who meet the inclusion criteria will be allocated into two groups, which will receive treatments of 3-week single-agent chemotherapy with TCM or placebo for four cycles. Progression-free survival (PFS) is the primary end point, and the secondary end points are overall survival, objective response rate, time-to-progression, and quality of life (EORTC QLQ-LC43, and TCM syndrome score). Meanwhile, other end points such as toxicity, side effects and safety of the treatments will be assessed.

Discussion

Results from this study may provide evidence on the effectiveness, and parameters for the usage of single-agent chemotherapy combined with or without TCM on PFS of elderly patients with NSCLC.

Trial Registration

ClinicalTrials.gov. (Identifier: NCT01780181).