Abstract
Abstract
Background:
Dyspnea is a common symptom in end-stage lung cancer patients and is only infrequently controlled. Currently, the use of complimentary therapies using traditional Chinese medicine (TCM), including auricular application of Vaccaria segetalis (a small seed), is understudied. Acupressure using auricular Vaccaria segetalis application has been reported as effective in reducing dyspnea when applied to a specific area of the ear associated with lung function in the TCM paradigm.
Objective:
The purpose of this feasibility study was to evaluate the effects of standardized auricular acupressure therapy using Vaccaria segetalis on dyspnea intensity and distress and oxygen saturation in end-stage lung cancer patients.
Methods:
The experimental design was three conditions with eight measurement points in time. Patients were randomly assigned to one of three treatment conditions: (1) Standard Care (SC); (2) SC with Vaccaria segetalis taped to random auricular locations (placebo); and (3) SC with Vaccaria segetalis taped to the auricular location deemed specific to lung function in TCM. Subjects were 11 hospice patients with advanced lung cancer and dyspnea. Dyspnea intensity and distress were measured by the Cancer Dyspnea Scale (CDS) and oxygen saturation was measured by pulse oximeter at eight time points.
Results:
Non-parametric statistical analyses suggest the presence of acupressure effects with medium to large effects and significant effect for dyspnea effort.
Conclusions:
This pilot information suggests the need for further study of auricular acupressure using Vaccaria segetalis in the dyspneic advanced lung cancer population.
Introduction
F
Background
Given the widespread nature of poorly controlled dyspnea in the lung cancer population, the examination of complimentary alternative interventions as adjuncts to traditional interventions is an appropriate area of study. Alternative therapies from traditional Chinese medicine (TCM) include acupressure on specific auricle locations deemed in the TCM paradigm to be associated with corresponding somatic locations. 2 This study utilized the TCM technique of placing a small Vaccaria segetalis seed with an adhesive tape on the auricle location associated with lung function. The use of acupressure/acupuncture in the auricular location associated in TCM with lung function has been shown effective in alleviating respiratory symptoms in other patient populations.3,4
Objective
The purpose of this feasibility study was to evaluate the effects of standardized auricular acupressure therapy using Vaccaria segetalis on dyspnea intensity and distress and oxygen saturation in end-stage lung cancer patients.
The hypothesis was that the use of auricular acupuncture seed adhesive on appropriate points plus Standard Care (SC) would be more effective in (1) reducing dyspnea and (2) increasing oxygen saturation.
Definitions
Dyspnea
For the purposes of this study, the definition of dyspnea established by the American Thoracic Society 5 was used: “a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity.” Implicit in this definition is the underlying assumption that dyspnea is a subjective symptom that is perceived by the person experiencing it. 5
Auricular acupressure
Auricular acupressure consists of applying pressure to specific locations on the ear. For the purposes of this study, the specific intervention of auricular acupressure consisted of placing a small seed (Vaccaria segetalis) with an adhesive material (non-allergenic tape) that allows the seed to be held in place over the appropriate acupressure point on both ears. The method of using Vaccaria segetalis is based on TCM practices, which postulate that the auricle represents a micro-system representing the entire body. 2 By applying pressure to specific locations on the auricle, distressing symptoms affecting various body locations can be attenuated. Prior researchers 6 have documented the successful use of auricular acupressure/acupuncture in decreasing a variety of distressing symptoms, including dyspnea. 3 Although the exact physiological mechanisms underlying its effects remain currently unknown, the use of this technique in a small feasibility study is an appropriate first step in establishing documentation regarding this alternative method of dyspnea control.
Design
The experimental design was three conditions with eight measurement points in time. Patients were randomly assigned to one of three treatment conditions: (1) SC; (2) SC with Vaccaria segetalis taped to auricular locations not specific to lung function (placebo); and (3) SC with Vaccaria segetalis taped to the auricular location specific to lung function. Neither the investigator nor the participants applied any additional stimulation.
Setting/Subjects
A total sample of 11 subjects with a primary diagnosis of lung cancer were drawn from a large hospice and palliative care center in Southern California, with four (36.4%) subjects in an Inpatient Care Center (ICC) and seven (63.6%) in a home care (HC) setting. Prior to study initiation, Institutional Review Board (IRB) approval was obtained. The subjects gave written, informed consent and were enrolled and randomly assigned among three conditions: two in the Control group, five in the Placebo group, and four in the Experimental group.
Measurements
Dyspnea
The Cancer Dyspnea Scale (CDS) 7 was used to measure dyspnea. This 12-item scale assesses three dimensions of dyspnea (sense of effort, sense of anxiety, and sense of discomfort) using a 5-point Likert scale for responding to each item from “not at all” to “very much.” The CDS was deemed appropriate for use in this study because its average time required for completion was 140 seconds, 7 requiring minimal subject burden for participants completing the scale.
Oxygen saturation levels
Level of oxygen saturation was measured by a standard fingertip pulse oximeter (Welch Allyn SureTemp® Pulse Oximeter; Welch-Allyn, Skaneateles Falls, NY). Pulse oximeters are well established, reliable, and valid medical instruments.8,9
Procedure
Following written, informed consent, subjects were enrolled in the study and randomly assigned among three conditions: the Control group (SC), the Placebo group (SC plus acupressure placebo = SC + AP), and the Experimental group (SC plus acupressure experiment = SC + AE).
On Day 1, once in the morning (about 9 AM ±1.5 hours) and once in the evening (about 6 PM ±1.5 hours), baseline data were collected. Participants completed the CDS 7 and had oxygen saturation assessed. Data collection was conducted for all participants twice a day (morning and evening) for the next 3 days (Day 2, Day 3, Day 4). On the morning of Day 2 and prior to data collection, the treatment intervention began. A licensed acupuncturist applied the acupressure intervention. The experimental acupressure intervention consisted of placing Vaccaria segetalis seeds obtained from the Heilo company with a non-allergenic adhesive tape that allowed the seed to be held in place over the lung acupressure point on both ears. The placebo acupressure condition consisted of the use of the identical seed and adhesive tape placed on an alternative site of the ears not associated with the lung. Day 3 and Day 4 involved the morning and evening data collection on all participants. At the end of data collection on Day 4, the acupressure intervention was removed and all subjects were thanked for their participation.
Results
Data analysis
This feasibility study enrolled only 11 subjects, thus excluding the assumption of normality. Nevertheless, statistical analyses were carried out to identify any trending patterns present as a basis for planning future research in this area. A 3 (condition) by 8 (time) mixed design analysis of variance (ANOVA) with time as the repeated measure was used for testing the two hypotheses predicting change in dyspnea and oxygen saturation as a function of assigned experimental conditions (Control, Placebo, Experimental).
Although no significant relationship was identified for oxygen saturation level as a function of assigned experimental conditions, statistical analyses suggest the presence of a significant effect of acupressure treatment on dyspnea effort. For the CDS subscale of Dyspnea Effort, the effects were of reasonable sizes for both the time main effect and the condition by interaction effect (large with Eta sub-rho 2 = 0.21 and medium with Eta sub-rho 2 = 0.17, respectively.) Importantly, the tests for the form of the changes were significant with large effects for both the main effect of time (F(1,8) = 11.63, p < 0.01; Eta sub-rho 2 = 0.59) and the condition by time interaction (F(2,8) = 4.69, p < 0.05, Eta sub-rho 2 = 0.54). It appears that the experimental condition changes over time, more steeply, whereas the other conditions are flatter over time as well as becoming worse and better at different time points. Because of concerns regarding the use of such parametric statistics as ANOVA with a small sample size, these data were re-run using the non-parametric statistic Friedman two-way ANOVA by ranks. 10 The nature of the Friedman is such that the three conditions could not be simultaneously run. Hence, the Friedman was run once for each of the three conditions. The only condition that resulted in a statistically significant change over time was the auricular acupressure experimental condition, with Chi 2 df=7 = 7.0, p = 0.43. Thus, these non-parametric results support those generated by the parametric test.
Conclusions
In general, auricular acupressure appears to be a feasible intervention for dyspnea in hospice patients with a primary lung cancer diagnosis. The intervention was well tolerated by participants and did not result in any skin irritation or other negative outcomes. Thus, the end-stage lung cancer population, although certainly fragile, is an appropriate focus for intervention studies designed to reduce dyspnea, given that subject burden is minimized as much as possible.
The experimental effects of primary interest in this study were those of treatment condition by time interactions with the expectation that the interactions would be linear in form. In general, estimation of these effect sizes yielded medium to large effects with the larger effects assuming linear shapes. For the dependent variable of Dyspnea Effort, this interaction was statistically significant and linear with the effects of actual auricular acupressure being greater than those of either the Control or the Placebo acupressure conditions. Thus, it can be posited from this result that future studies of the use of auricular acupressure with Vaccaria segetalis for dyspnea are indicated in a larger and more diverse patient population. Future investigations could benefit from standardizing the location of the placebo site in a more rigorous manner. Although this study represents a preliminary investigation, the data suggest the use of auricular acupressure by skilled personnel is a feasible and potentially useful therapeutic approach in end-stage lung cancer patients.
Footnotes
Author Disclosure Statement
No competing financial interests exist.