Cost-Benefit of Combined Use of Acupuncture, Shiatsu and Lifestyle Adjustment for Treatment of Patients With Severe Angina

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COST-BENEFIT OF COMBINED USE OF ACUPUNCTURE, SHIATSU AND LIFESTYLE ADJUSTMENT FOR TREATMENT OF PATIENTS WITH SEVERE ANGINA PECTORIS.(*)

Abstract

Sixty-nine patients with severe angina pectoris were treated with acupuncture, Shiatsu and lifestyle adjustments, and were followed for 2 years. Forty-nine patients were candidates for coronary-artery bypass grafting (CABG), whereas bypass grafting was rejected in the remaining 20 patients. We compared our endpoint findings with those of a large prospective, randomized trial comparing CABG with percutaneous transluminal coronary angioplasty (PTCA). The incidence of death and myocardial infarction was 21% among the patients undergoing CABG, 15% among the patients undergoing PTCA and 7% among our patients. No significant difference was found concerning pain relief between the three groups. Invasive treatment was postponed in 61% of our patients due to clinical improvement, and the annual number of in-hospital days was reduced by 90%, bringing about an estimated economic saving of 12,000 US $ for each of our patients. Despite the fact that the men in the present study, had significantly less positive expectations towards the outcome of the treatment, when compared to the women, there was no significant difference concerning the effect. The study suggests that the combined treatment with acupuncture, Shiatsu and lifestyle adjustment may be highly cost effective for patients with advanced angina pectoris.

Key words: Acupuncture, Angina pectoris, Lifestyle, Shiatsu.

INTRODUCTION

The preferred treatment of advanced coronary artery disease today is bypass grafting which has an immediate success rate of 90% in stable and unstable angina pectoris ( 1). Similarly, balloon angioplasty is highly effective especially in patients with single-vessel coronary artery disease. Nevertheless, the combined immediate and late complication rates are about 28% for both procedures after 3 years. Moreover, subsequent revascularisation with either angioplasty or surgery may be needed in 52% and 9% after primary PTCA or CABG, respectively ( 2) and the procedures are very costly. In previous studies it has been shown that treatment with acupuncture can relieve angina, reduce the need for and-anginal medication and improve exercise performance ( 3, 4, 5). Similarly, changes in lifestyle have been found to reverse coronary artery disease ( 6). In the report presented here we have examined the combined effect of acupuncture, Shiatsu and lifestyle adjustments and have compared the results to those obtained after CABG and PTCA.

MATERIAL & METHODS

We treated 49 consecutive patients, who were candidates for bypass surgery or PTCA and 20 patients, in whom coronary bypass surgery was rejected. The characteristics of the patients are shown in Table 1. The patients received 12 acupuncture treatments within a four week period according to Traditional Chinese Theory ( 7). The needles were inserted with the patient in the supine position, and after obtaining needle sensation (or the arrival of "Qi"), the needles were left in place for 20 minutes. No electrical or mechanical stimulation was given. In addition, the patients were instructed to perform Shiatsu twice daily on the middle of the sternum at the level of 4th intercostal space: point Shanzhong (C.V. 17) and, if possible, by the spouse on the back between the shoulder blades 1,5 inch lateral to spinal process of the 4th and 5th thoracic vertebra Jueyinshu and Xinshu (U.B. 14

and 15) (Fig. 1).

Furthermore they were informed about adjustment of lifestyle and attitudes, stress coping techniques, daily relaxation exercise, daily physical exercise, and diets (rich in potatoes, vegetables, fruits, bread, nuts, fish, garlic, olive oil, moderate intake of red meat, and wine) ( 8).

After treatment, the patients were followed for a median of 24 months (range 2-108) until the occurrence of myocardial infarction, death, invasive therapy or the end of observation period (November 1(st), 1995). The follow-up data were based on hospital reports, supplemented by reports from the general practitioner and questionnaires. As there was no regular control group, the results were compared with recently published results of CABG and PTCA ( 2). The pre-treatment characteristics of the patients are shown in Table 1.

In order to be able to compare the outcome of acupuncture with the outcome of invasive treatment we used the same endpoints as King et al. ( 2); i.e. death, and/or myocardial infarction, and stroke within the initial hospitalization, plus death and/or myocardiai infarction during the observation period. As this paper has 3 years of observation, the published rates were reduced by 33% to make them comparable to our rates, which are based on a follow-up period of 24 months. Furthermore, the re-operation risk was calculated. A success was defined as performance according to New York Heart Association classification 0 - I after treatment and/or no need for and-anginal medication Association classification 0 - I after treatment and/or no need for and-anginal medication ( 2). Degree of disease and quality of life were evaluated by the patient using visual analog scales. When an invasive treatment was postponed, the decision was made exclusively by the patient, with a cardiologist as advisor.

The behavioral patterns and emotional states (anxiety and depression) of the patients were evaluated using Jenkins Activity Survey ( 9, 10) and Aaron Bech rating scale of mood disorders ( 11). These scales were used, as it has been shown that the presence of ischemic heart disease is associated with anxiety, depression and behavioral patterns characterized by impatience, excessive competitiveness, and hostility ( 12, 13).

The medical expenses were calculated from current cost in Denmark for the services of a general practitioner (20 US $ per visit), cardiologist (40 US $ per visit), in-hospital days (500 US $ a day), visit at hospitals on an out-patient basis (250 US $ per visit), PTCA ( 6,000 US $), CABG ( 15,000 US $), and expenses for pharmaceutical products (full retail price) during the 12 months prior to treatment and during the two 12 month periods after initiation of treatment.

Statistics

Evaluation between success rates for acupuncture and invasive treatments were analyzed by Fischer's exact test for non-paired data. The comparison of expectations between men and women were analyzed by rank-sum tests for non-paired data (Mann-Whitney). Intra-personal differences were evaluated by rank-sum tests for paired data (Wilcoxon). Five percent is used as the significance level.

RESULTS

The complication risk rate

Among the 69 patients receiving acupuncture and lifestyle adjustments, one myocardial infarction and four cardiac death occurred, giving a 24-month complication risk of 7%, compared to 21% and 15% for patients receiving CABG or PTCA, respectively (Table 2). For patients undergoing invasive treatment, there was an additional risk for repeated invasive procedures of 9% and 52%, respectively. Among the 49 candidates for CABG, in the present study, 30 patients (61%) postponed surgery due to improvement after treatment. No change in weight was observed among the acupuncture group (median change: 0 kilo; interquartile range : -2.5 - +0.5 kilo).

Success rate

There was no significant difference between the success rates in the three groups of patients (Table 3)

Measured on a visual analog scale, our patients reported a marked improvement in life quality (median improvement from 37 to 101 mm on a 115 mm analog scale (25% quartiles: 17-62 before treatment and 76-108 after treatment) (p<0.001), as well as in degree of disease (median improvement from 90 to 27 mm (25% quartiles: 78-103 before treatment and 12-44 after treatment) (p<0.001). Corresponding data do not exist in the study by King et al. ( 2).

Economy

Among the 69 acupuncture patients, the annual number of visits to the general practitioner was reduced from 223 to 109 (i.e. 49%) for the first year and to 83 visits (i.e. 37%) for the second year. The visits to the cardiologist were reduced from 30 annual visits to 40% and 33% respectively; the in-hospital days were reduced from 438 days to 21% and 7%, respectively; hospital visits on an out-patient basis were reduced from 242 visits to 40% and 13%, respectively; and the cost of pharmaceutical products was reduced from 50,000 US $ to 76% and 71%, respectively. (Fig. 2).

These reductions give an estimated saving of 225,000 US $ during the first year and 275,000 US $ during the second year. Thirty patients received no surgery. To calculate this saving, the distribution between CABG and PTCA performed in Denmark in 1993 was used (1700/400), leading to a 398,000 US $ saving. Nine percent of the CABG and 52% of the PTCA would be expected to be repeated within 24 months ( 2), adding a 50,000 US $ saving.

Expenses for acupuncture were 115,000 US $ the first year and 15,000 US $ the second year, a total of 130,000 US $. Consequently, the total saving for the acupuncture treatment may be estimated to be approximately 820,000 US $, or 12,000 US $ for each of the 69 patients.

Sixty percent of the patients received sick-payment due to their heart disease; approximately 18,000 US $ a year per patient. However, patients belonging to NYHA classification 0 - I are able to carry out their job. Before treatment 11% of the patients belonged to these classes, compared to 60% 2 years after treatment, suggesting a hypothetical annual saving of 600,000 US $ due to lack of need for sick-payment, or 9,000 US $ per patient.

Psychological aspects

Compared to the men, the women had a significantly greater expectation concerning the positive outcome of acupuncture and lifestyle adjustments (median difference was 30 mm on a 100 mm visual analog scale, 95% confidence limits 8 - 50) (p < 0.05), although no significant gender difference was found either in the severity of disease or in the effect of the treatment. Concerning the expectation for the effect of future treatment, no significant difference was found between men and women.

The results from the Jenkins Activity Survey and Beck questionnaire concerning the behavioral and psychological characteristics of the patients are shown in Table 4.

The patients with angina pectoris receiving pharmaceutical treatment had similar scores to the ones receiving acupuncture and lifestyle adjustment, both being significantly different from the group of healthy controls and patients without heart disease (p's < 0.05).

Compliance

Two years after initiation of the treatment with acupuncture and lifestyle adjustment, 92% of the patients were still using Shiatsu at home, 56% were using the relaxation procedure, 72% were exercising daily (80% had used the instructions) and 94% were eating healthy food at least inconsistently (60% had used the instructions).

DISCUSSION

The present study suggests that the combination of acupuncture, Shiatsu and lifestyle adjustments may decrease the risk of dying and/or of myocardial infarction in patients with severe angina pectoris more than coronary bypass surgery and PTCA. There are, however, some possible sources of error that need to be addressed. The variables used to estimate the efficacy of treatment, namely death and myocardial infarction, are not considered to be influenced systematically by researcher and/or patient bias. However, the presence of silent myocardial infarctions cannot be ruled out. In view of the severity of the disease among the present patients, this bias is considered to be small. In addition, it cannot be ruled out that patients who take the initiative to get better and who are willing to pay for the help of a specialist, may have a high degree of motivation that facilitates the positive outcome of any kind of treatment.

The present study showed, however, that the patients were not significantly different psychologically from a group of patients with similar disease who received pharmaceutical treatment on a cardiological out-patients basis. Furthermore, despite the observation that the men in the present study, when compared to the women, had significantly less positive expectations towards the outcome of the treatment, there was no significant difference between the two genders concerning the outcome of the treatment.

One may also question whether the groups are comparable concerning severity of disease. Angiographic examinations do not exist in the majority of our patients, whereas all of the patients of King et al. ( 2) had two- or three-vessel disease, suggestive of an increase in risk profile compared to our patients. However, the number of diseased vessels has been found not to influence the risk ( 15). Furthermore, 56% of our patients belong to groups of patients that were excluded from the study of King et al. ( 2) due to an increased risk. The open design does of course, make it possible for bias to occur in the present study. However, the observation period of 2 years would presumably eliminate the short-term fluctuations of the disease as well as any beneficial effect of the initial enthusiasm associated with the introduction of a new treatment modality to a group of patients with advanced chronic coronary disease. Among the patients of King et al. ( 2), 92% were excluded due to increased risk and, in similar studies, 96 and 97% of the patients were excluded prior to the study ( 15, 16). Thus, the results involving invasive treatment are not applicable to a large non-selected diverse population ( 17). In our study no patients were excluded.

Adjustments of lifestyle have been shown to reverse coronary atherosclerosis in a study carded out by Ornish and co-workers ( 6). Several aspects of the present lifestyle adjustment program have individually been found to reduce cardiac mortality: regular exercise for 20 minutes a day ( 18, 19, 20), a moderate consumption of wine ( 21, 22, 23, 24), a Mediterranean diet (25), and lowering of total serum cholesterol and/or an increase of the HDL/LDL cholesterol ratio (26). Several nutrients have been found to have these effects on cholesterol: olive oil (27), nuts (28), fish (29,30), vegetables rich in vitamin-E, Vitamin-C, Beta-caroten and flavanoides ( 21,31,32,33,34).

The patients of Ornish and co-workers ( 6) initially had an elevated body-mass index and the subsequent weight loss of ten kilos was correlated to the angiographic changes of the atherosclerotic lesions (35). The body-mass index of our patients was also elevated, but no change in weight was observed, suggesting that factors other than lifestyle adjustments contributed to the observed beneficial effect of treatment among our patients. One such factor could be acupuncture.

Although the exact mechanism is not fully understood, it seems likely that acupuncture brings about a decrease in sympathetic tone which relaxes the smooth muscle cells of the arterioles of the myocardium leading to a dilatation of the vessel and an increase in the blood supply (36,37). The systemic decrease in sympathetic tone induced by acupuncture may reduce the total peripheral resistance, and thereby lower the pumping demand of the myocardium (38,39). Furthermore, acupuncture may reduce total serum cholesterol and triglyceride ( 3, 8,36).

For some parts of the treatment only indirect indication of an effect on the end-points have been shown. Relaxation technique has been found to have a positive effect on the sympathetic tone of the cardiovascular system (40); love and care has been found to reduce atherosclerosis in rabbits on a high cholesterol diet (41), and human touch has been found to have a modulatory effect on the heart activity of unconscious patients after bypass surgery (42).

Although our results require confirmation in further, preferably randomized studies, they do suggest that this low cost and no risk treatment helps patients with severe angina pectoris.

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By Soren Ballegarrd; Solvejg Norrelund; Donald F. Smith and Skaering Sandager

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