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Psychosomatics 49:378-385, September-October 2008
doi: 10.1176/appi.psy.49.5.378
© 2008 Academy of Psychosomatic Medicine
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Efficacy of Functional Relaxation and Patient Education in the Treatment of Somatoform Heart Disorders: A Randomized, Controlled Clinical Investigation

Claas Lahmann, M.D., Thomas H. Loew, M.D., Karin Tritt, Ph.D., and Marius Nickel, M.D.

Received May 10, 2006; revised February 13, 2007; accepted February 21, 2007. From the Dept. of Psychosomatic Medicine, Technical University Munich, Germany (CL), the Center for Psychosomatic Medicine, University Hospital of Regensburg, Germany (CL, THL, KT), and the Inntalklinik, Clinic for Psychosomatic Medicine, Simbach am Inn, Germany (MN). Send correspondence and reprint requests to Claas Lahmann, M.D., Dept. of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technical University Munich, Langerstrasse 3, 81675 Munich, Germany. e-mail: lahmann{at}tum.de
© 2008 The Academy of Psychosomatic Medicine


  ABSTRACT

 
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 ABSTRACT
INTRODUCTION
 METHOD
 RESULTS
 DISCUSSION
 REFERENCES
 
BACKGROUND: Recurrent heart problems and, especially, chest pain in the absence of somatic heart disease is a common finding, although challenging to treat. OBJECTIVE: The authors assessed a body-oriented approach to the somatic fixation frequently seen in these patients. METHOD: They conducted a controlled study to assess the effect of functional relaxation in 22 patients with non-specific chest pain. The primary outcome measures were self-reported changes on the subscales Somatization and Anxiety of the Symptom Checklist of Derogatis, as well as the subscale Cardiovascular Complaints of the Giessen Inventory of Complaints. RESULTS: Significant improvements of the primary outcome measures were observed in patients treated with functional relaxation, whereas no significant improvements could be seen in the control group. CONCLUSION: Functional relaxation appears to be a safe and effective, non-pharmacological approach in the treatment of non-specific chest pain.


  INTRODUCTION

 
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 ABSTRACT
 INTRODUCTION
METHOD
 RESULTS
 DISCUSSION
 REFERENCES
 
Cardiologists frequently encounter patients with chest pain;1–3 however, in approximately 50%, no structural heart disease or other serious physical disorders are found.4 Although 2%–5% of all admissions to the Emergency Department are related to non-specific chest-pain (NSCP),5,6 the prevalence of NSCP in the community ranges from 23% to 33%.5,7

To some extent, NSCP results from over-investigation, non-indicated somatic pharmacotherapy, and other iatrogenic factors. NSCP is associated with considerable distress for patients8 and is often complicated by co-existing psychiatric disorders, such as depression or anxiety disorders.9 Also, a variety of etiological factors have been proposed, including coronary spasm, micro-vascular coronary artery disease,10 alcohol and cigarette use,11 hyperventilation,12 or esophageal dysmotility.13

Many patients with NSCP are reassured and discharged without a specific diagnosis or treatment,14 resulting in a moderate long-term prognosis of their functional disability. Treatment of NSCP patients is very challenging.15 Less than 50% of patients with NSCP benefit from the reassurance that heart disease does not exist; 75% continue to seek medical advice, and 50% consider themselves to be significantly disabled.16,17 Patients often continue to experience symptoms, and, as a result, they begin to restrict their daily activities and develop a help-seeking behavior, described as "doctor-shopping," based on the idea noted above that reassurance alone is almost never effective.18

A variety of pharmacological interventions, including beta receptor-blockers, nitrates, calcium channel-blockers, anxiolytics and antidepressants,19,20 and psychological interventions are used for the treatment of NSCP patients. Because of the etiological importance of dysfunctional cognitions in NSCP, cognitive/behavioral-oriented approaches are recommended as appropriate interventions;16,21,22 but psychodynamic approaches are also frequently applied in such patients.

Often, complex psychosomatic treatment approaches are accompanied by patient resistance, caused by their somatic interpretation of symptoms.23 In the present study, we focused on an approach called functional relaxation (FR), which includes psychosomatic education and a relaxation technique, both of which have proven to be effective in previous clinical trials, particularly in tension headache24 and asthmatic diseases modulated by psychosomatic influences.24–28

The aim of the present study was to investigate the efficacy of an intervention with 10 sessions of FR supplemented by a short patient-education session in the treatment of NSCP. Because of the high demand of NSCP patients for additional information regarding their medical condition, a 60-minute education session was added to the relaxation sessions.29


  METHOD

 
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 ABSTRACT
 INTRODUCTION
 METHOD
RESULTS
 DISCUSSION
 REFERENCES
 
The study was planned and performed in accordance with the Declaration of Helsinki and ethical laws pertaining to the medical profession. The trial design was approved by the Ethics Committee of the Regensburg Medical School, and written informed consent was obtained. The study was conducted independently of any institutional influence and was not funded.

Participants
The patients were recruited via inpatient screening of two cardiology departments and referrals from the Emergency Department of the University Hospital of Regensburg, Germany, as well as from local general practitioners in Regensburg. Inpatients were included after they had been discharged from the hospital. The screening criterion was a history of cardiac complaints with no evidence of somatic disease. Patients included in the study were over the age of 18 years who presented with NSCP. The diagnosis was confirmed by means of a structured interview. Reasons for exclusion of participants in the study included any underlying somatic disorders; any severe and disabling psychiatric disorder, such as schizophrenia or dementia; as well as patients undergoing psychotherapy and those current enrolled for retirement payment.

Of the 43 eligible patients, 40 agreed to take part in the study (Figure 1). The participants underwent a psychosomatic face-to-face interview and thorough cardiological diagnostic procedures, including a physical exam, blood work, an electrocardiogram (ECG), non-invasive blood pressure (NIBP) measurement, echocardiography, bicycle ergometry tests, and a long-term-ECG, either an ECG event-recorder or cardiac catheter examination, if indicated. A detailed medical history was also taken.


Figure 1
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FIGURE 1.  Flow Diagram of Trial Process


On the basis of the above-mentioned criteria, 22 patients (10 men, 12 women) were eligible to take part in the study. The required sample size was calculated for a Type I error of 5% (z1=1.96) and a power analysis of 80% (z2=0.842). The calculation was based on the mean value (m1: 65.2 and m2: 56.4) and standard deviation (s1: 7.4 and s2: 7.2) of the somatization subscale of the SCL–90, which were obtained from a small pilot study. The formula30 is n (per group) = [(z1 + z2)2 x (s12 + s22)] / (m1–m2)2. This resulted in a group size of n=11 patients. The participants were randomized in a 1:1 ratio either to the FR group or a control-group with enhanced medical care. Randomization was carried out confidentially, with allocation concealment implemented by the hospital’s administration department.

Assessment
The study was performed with the Symptom Checklist of Derogatis (SCL–90) and the Giessen Inventory of Complaints (GBB), which are both self-administered tests. The SCL–90 measures psychiatric symptoms by 90 possible physical and psychological symptoms during the previous 7-day period. The items were grouped into 9 subscales: Somatization, Obsessive-Compulsiveness, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism, and 3 global scales, of which the most important is the Global Symptom Index (GSI).

The conversion of the raw data to T-values, with sociodemographic factors taken into consideration, allows an orienting classification of the individual case. T-values starting at 60 are considered to be slightly elevated; at 65, obviously elevated; at 70, strongly elevated; and at 75, very strongly elevated. The internal consistency31 (Cronbach’s {alpha}) ranges between 0.75 and 0.87.

Subjective physical complaints were assessed by the Giessen Inventory of Complaints (Braehler and Scheer32). The 57 items are rated on a 5-point Likert scale, and 6 items each are summarized under 4 factor-analytically–derived scales: Exhaustion, Gastrointestinal, Musculoskeletal, and Cardiovascular Complaints, and an additional, Total-Complaints scale. The internal consistency (Cronbach’s {alpha}) ranges between 0.85 and 0.90.

The primary analysis is based on the Somatization and Anxiety subscales of the SCL–90 and the Cardiovascular Complaints subscale of the GBB; because of the exploratory nature of this trial, a post-hoc Bonferroni correction of level of significance, normally applied with multiple comparisons, was not carried out. The remaining subscales of the SCL–90 and the GBB were assessed as secondary endpoints.

Design and Procedure
All subjects were tested with SCL–90 and GBB 1 week before and after the 6-week treatment period. The study period in the functional relaxation (FR) group began with a 60-minute psychosomatic-education session, in which the development of NSCP was presented, as well as basic information relating to structure and function of the cardiovascular and autonomic nervous system. Throughout the course of the study, a total of 10 group-therapy sessions, 90 minutes each, were held during the 6-week treatment period. The structure of these FR sessions, in a group-therapy setting, was based on a manual from former investigations24,25,28 and on recommendations for a structured treatment with FR.33,34 The concept was adapted to the special features of NSCP patients, illustrated in Table 1.


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TABLE 1. Thematic Structure of Functional Relaxation (FR) Therapy



FR is a somato-psychotherapeutic intervention technique, commonly performed by German, Austrian, and Swiss psychosomatic therapists. It is used in the treatment of a variety of psychosomatic disorders. This technique uses positive stimulation of the autonomic nervous system35 and familiarization of patients with the processes of proprioception. Very subtle, hardly noticeable movements of small joints are executed during relaxed expiration, which is accompanied by focusing on and exploring the perceived differences of body sensations triggered by these movements. These movements, which are done on expiration, refer to the following four categories/fields: The relationship to the floor or a foundation is described as an "outer support," whereas the skeleton is considered to be the "inner support." Other focal points are the skin, as an "outer border" and the "interior rooms of the body," which refers to anatomical cavities such as the thorax or abdomen. In contrast to the exercise-based methods, such as progressive muscle relaxation, the resulting sensations are described either nonverbally, in thoughts, or explicitly, in the form of therapeutic interaction.33

Through the therapeutic approach on proprioceptive self-perception, basic motivational systems are rediscovered and further developed.36 For instance, early forms of bodily self-awareness, as they correspond to the core self, as described by Daniel Stern,37 can be re-experienced. It is generally assumed that a therapeutic modification of these perceptual modalities of perception favorably influence further development of bodily self-awareness and coherence of the self.

FR belongs to the psychodynamically-based and body-related psychotherapy methods, because it takes unconscious physical/psychological experiencing into account. In this study, FR was performed by a physiotherapist, certified in accordance with the Association of Functional Relaxation, with a physician as co-therapist. The patients in the control group were treated in an outpatient setting at the Cardiology Department of the University of Regensburg, receiving "enhanced medical care." This means that in addition to treatment-as-usual, they took part in two case-management counseling interviews. The goal of these interviews was to promote personal-care skills and shared decision-making. Patients assigned to "enhanced medical care" were informed of their diagnosis and were encouraged to pass this information on without restrictions to their general-practitioner in order to initiate primary-care or specialty treatment.

The case-management counseling interviews were carried out by a physician trained in psychosomatic medicine, in collaboration with the responsible cardiologist. Because of the difference between the study arms regarding the time spent with each patient, this design does not control for unspecific effects of this factor. The questionnaires were filled out by the patients independently and checked for completion.

Statistical Analysis
Since the data were not normally distributed, the Mann-Whitney U test was performed for a comparison of continuous variables. Standard deviations (SD), difference (DI) with 95% confidence intervals (95% CI), and probability (p) for reporting the treatment results30 according to the intent-to-treat principle were calculated. DI with 95% CI was calculated by a Hodges-Lehmann estimation, using the StatXact Statistical Software program, Version 6 (Cytel Software Corporation, Cambridge, MA, U.S.). The Hodges-Lehmann estimation for the calculation of shift parameters is a nonparametric alternative to the ANOVA with repeated measures and is the method of choice for small sample sizes. Other statistical analyses were performed with the SPSS Statistical Software Program, Version 12.0 (SPSS Inc., Chicago, IL, U.S.). Because of the exploratory approach, a post-hoc Bonferroni correction for level of significance (0.05/3 = 0.017) with multiple testing was not carried out in spite of the multiple testing with three primary end-points.


  RESULTS

 
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DISCUSSION
 REFERENCES
 
The patients’ sociodemographic data at the time of randomization are shown in Table 2.


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TABLE 2. Basic and Sociodemographic Data



The mean time of cardiovascular complaints was 69.7 (SD: 66.5) months in the treatment group and 48.5 (SD: 81.4) months in the control group, which was not significant. Also, the sociodemographic criteria of both groups were comparable, with no significant differences. Table 3 and Table 4 show the initial and final SCL–90 and GBB test results. No differences between the groups were found in the primary and secondary end-points at the beginning. The Somatization and Anxiety subscales of the SCL–90 showed distinctly increased scores, whereas the remaining subscales were within normal range in both groups. In the GBB, all subscales showed increased scores, with a peak in the Cardiovascular subscale. The final evaluation demonstrated that the FR group experienced a significantly greater change on the Somatization and Anxiety subscales of the SCL–90 and the Cardiovascular subscale of the GBB, defined as primary end-points. A statistically significant difference was also found in the GSI subscale of the SCL–90, which is a global marker for psychosomatic strain. Whereas, in the FR group, a trend toward improvement in all remaining subscales could be seen, the "enhanced medical care" group showed no improvement (Table 3 and Table 4); this trend did not reach statistical significance, however. No serious side effects were observed in the treatment group, nor did any subjects report difficulties with implementation of the body/psychotherapeutic techniques of FR.


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TABLE 3. SCL–90-R Initial and Final Evaluation (T-values)




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TABLE 4. Giessen Inventory of Complaints (GBB) at Initial and Final Evaluation (T-values)




  DISCUSSION

 
TOP
 ABSTRACT
 INTRODUCTION
 METHOD
 RESULTS
 DISCUSSION
REFERENCES
 
Analysis of the baseline data allowed comparison of the experimental and control groups. Treatment with FR supplemented by one session of patient-education resulted in a significantly greater rate of improvement on all primary end-points and the GSI subscale of the SCL–90 than treatment within enhanced medical care. Evaluation of the secondary end-points showed an improvement in the FR group, as compared with the control group. Even though there was no financial reward, all patients completed the 12 sessions of FR, which indicates a very good acceptance of a subgroup of somatoform patients. Although all patients fulfilled the criteria of NSCP, the focused subscale scores in the SCL–90 were only moderately increased at initial testing, whereas a higher symptom score was found on the Cardiovascular subscale of the GBB. All participating patients had high psychological strain, with great motivation to seek professional medical cure, which was emphasized by the fact that all patients were self-referrals.

Even if only a modestly elevated symptom intensity is registered in baseline measurement, a clear effect was observable nevertheless in the primary analysis, based on the SCL–90 subscales of Somatization and Anxiety and the Cardiovascular Complaints subscale of the GBB, in the sense of problem/treatment/outcome congruence. Furthermore, regarding the FR group, the once-moderately disturbed clients were not distinguishable from a meaningful and representative non-disturbed reference group31 after treatment, which indicates the clinical significance of the FR intervention according to the criteria of Jacobson and Truax.38 This clinically significant benefit was not observed in the control group.

Numerous studies deal with the treatment of somatoform disorders, but they are often lacking in methodological quality, use small sample sizes, or show deficits in their questionnaires. Therefore, we need to develop precise and evidence-based guidelines.39–41 In the field of psychodynamic or analytic psychotherapy, only a small number of high-quality studies have been published until now,42,43 most of the them dealing with cognitive-behavioral approaches, often in complex settings.4,15,29,44–47

In this study, a new therapeutic approach for the treatment of NSCP is presented, which takes the somatic orientation of patients into consideration. A functional relaxation technique was used, which combines a body- and symptom-centered approach, together with a psychodynamic- and analytically-oriented background. This treatment modality is therefore not only a relaxation, but also a psychotherapeutic technique. FR is a commonly-used method in psychosomatic medicine in German-speaking countries. It is easy to learn and has shown efficacy in other psychosomatic disorders.24,26,28,48 To supplement with the cognitive tradition, which has demonstrated its effectiveness in NSCP,4,16,29,44–47 we have chosen psychosomatic-education as a supplement of the FR therapy. This has resulted in a pronounced adaptation to patients’ clinical needs.

Study Limitations
The combined approach of psychosomatic-education and FR may lead to methodological limitations related to a possible confounding of the effects of the educational component and FR. This could have been avoided by an interim testing between the education session and the first relaxation session. However, repeated testing with the SCL–90 within 1 week is questionable because of the time-frame of the last 7 days focused by the SCL–90.31 From a clinical point of view, the effect of the one initial 60-minute education session versus the 10 following 90-minute sessions of FR therapy seems to be moderate. Also, it has to be taken into account that, despite a valid power analysis, the sample size was relatively small. Moreover, the very strict exclusion criteria may have resulted in an artificially homogeneous patient sample, since the comorbidity of psychiatric and somatoform disorders is reported to be high.49,50 This could also be responsible for the above-mentioned moderate severity of symptoms, and it is therefore only possible to generalize the results to a limited extent. The study demonstrated the beneficial effects of a combined treatment strategy; however, since the patients were not followed up, the long-term effects could not be determined. However, several studies have shown maintained improvement in long-term follow-up of treated somatoform disorders.51–53

We will need further research to prove such long-term effects and their reliability. Studies with larger patient groups, suffering from more severe symptoms, should confirm psychiatric comorbidity. Rudolf and Henningsen49,54 have shown that patients with somatoform disorders such as NSCP often also suffer from depressive and anxiety disorders.

In conclusion, FR appears to be a safe and effective approach in treating somatoform autonomic dysfunction of the heart and cardiovascular system.


  ACKNOWLEDGMENTS

 
We thank Joerg Marienhagen, M.D., for the biostatistical consultation, as well as Mike Cronan, M.A., and Mark Weidenbecher, M.D., for the linguistic revision.


  REFERENCES

 
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