Background: 4–10% of the general population and 20% of primary care patients have what are called “non-specific, functional, and somatoform bodily complaints.” These often take a chronic course, markedly impair the sufferers’ quality of life, and give rise to high costs. They can be made worse by inappropriate behavior on the physician’s part.
Methods: The new S3 guideline was formulated by representatives of 29 medical and psychological specialty societies and one patient representative. They analyzed more than 4000 publications retrieved by a systematic literature search and held two online Delphi rounds and three consensus conferences.
Results: Because of the breadth of the topic, the available evidence varied in quality depending on the particular subject addressed and was often only of moderate quality. A strong consensus was reached on most subjects. In the new guideline, it is recommended that physicians should establish a therapeutic alliance with the patient, adopt a symptom/coping-oriented attitude, and avoid stigmatizing comments. A biopsychosocial diagnostic evaluation, combined with sensitive discussion of signs of psychosocial stress, enables the early recognition of problems of this type, as well as of comorbid conditions, while lowering the risk of iatrogenic somatization. For mild, uncomplicated courses, the establishment of a biopsychosocial explanatory model and physical/social activation are recommended. More severe, complicated courses call for collaborative, coordinated management, including regular appointments (as opposed to ad-hoc appointments whenever the patient feels worse), graded activation, and psychotherapy; the latter may involve cognitive behavioral therapy or a psychodynamic-interpersonal or hypnotherapeutic/imaginative approach. The comprehensive treatment plan may be multimodal, potentially including body-oriented/non-verbal therapies, relaxation training, and time-limited pharmacotherapy.
Conclusion: A thorough, simultaneous biopsychosocial diagnostic assessment enables the early recognition of non-specific, functional, and somatoform bodily complaints. The appropriate treatment depends on the severity of the condition. Effective treatment requires the patient’s active cooperation and the collaboration of all treating health professionals under the overall management of the patient’s primary-care physician.
When the S2e guideline “Somatoform disorders” (1) expired, the German College of Psychosomatic Medicine (DKPM, Deutsches Kollegium für Psychosomatische Medizin) and the German Society of Psychosomatic Medicine and Medical Psychotherapy (DGPM, Deutsche Gesellschaft für Psychosomatische Medizin und Ärztliche Psychotherapie) determined to rework it comprehensively in an interdisciplinary way for the new edition. Under the coordination of these bodies, from 2008 to 2012, representatives of 28 medical and psychological specialist societies, the German Association for the Support of Self Help Groups (patient representative), and the Association of Scientific Medical Societies in Germany (AWMF, Arbeitsgemeinschaft medizinischer Fachgesellschaften) (eBox 1) developed the new S3 guideline “Management of patients with non-specific, functional, and somatoform bodily complaints” (NFS), of which the present article is the official short version (2–4).
The guideline group included members from all areas of care and was balanced in terms of gender and seniority. At the inaugural meeting, key questions on all clinically relevant themes were formulated and divided up between nine working groups. Building on the 2002 S2e guideline, a seven-member steering group (eBox 1) carried out a systematic literature search of publications dating from 1 January 2000 to 1 January 2009 (for search terms see eBox 2), which was added to and brought up to date by the working groups up to May 2011 (3). After assessment of inclusion and exclusion criteria (eBox 3) and the quality and relevance of the studies (e1) (eTable 1), 761 publications were included for the guideline (Figure 1). The working groups analyzed the literature, evaluated the evidence levels (ELs) (e2) (eTable 2), and developed 148 recommendations, statements, and source texts. For the most important forms of therapy, examples of numbers needed to treat (NNTs) were calculated as a statistical measure of efficacy (Table 1). The guideline was modified in two online Delphi procedures and three consensus conferences, and finalized by consensus, in most cases strong consensus (e3) (eTable 3). The corresponding recommendation grades (RGs) were based on the evidence levels, but could be raised or lowered during the consensus procedure (e4) (eFigure). Recommendations regarded by the guideline group as representing a standard despite a lack of evidence were marked as “clinical consensus points” (CCPs) (e5). The guideline version passed by consensus was posted on the Internet in February 2012 for 4 weeks for public comment. It was reviewed by three external experts (eBox 1), approved by the participating medical societies and associations, and adopted by the AWMF on 15 April 2012 (register no. 051–001). It is valid for 5 years.
Terms and objectives
The plethora of terminology (e6) is a hindrance to care and to research (e7). With the aim of achieving an interdisciplinary perspective, the triple term “non-specific, functional, and somatoform bodily complaints” takes up the parallel classification of functional somatic syndromes (FSS) (somatic medicine) and somatoform disorders (psychosocial medicine), and complements the general medical perspective of non-specific bodily complaints (eBox 4). The guideline is concerned with what these disorders of adults have in common (5, 6, e8, e9). Its aim is to provide practical, interdisciplinary recommendations for all levels of care, to promote a biopsychosocial understanding of health and illness, to optimize early diagnosis, prevention, and treatment, to improve the quality of life and ability to function of those affected, and to reduce undertreatment and erroneous treatment.
Characterization of the disorder
The main symptoms of NFS are pain in various locations, impaired organ functions (gastrointestinal, cardiovascular, respiratory, urogenital), including autonomic complaints, and exhaustion/fatigue (7). These are often accompanied by illness anxiety. If this anxiety dominates, a hypochondriac disorder is present (e10).
Multifactorial disorder model
Current etiopathogenetic models assume complex interactions between psychosocial factors, biological factors, iatrogenic factors or factors related to the medical system, and sociocultural factors, which can lead to neurobiological changes, and act together in disposition, triggering and maintenance of the complaints (7, 8, e11). A health system that focuses more on repair and care than on self-responsibility and prevention, and provides counterproductive financial incentives to illness-related behavior and technical measures rather than to healthy behavior, achievement through talking to the patient, and the avoidance of unnecessary treatment, has the effect of maintaining complaints (7, e11–e13). The iatrogenic chronification factors to be avoided (e14–e21) (CCP) are shown in Box 1.
Epidemiology, co-morbidity, and health care utilization behavior
NFS affect 4% to 10% of the population (2, 4, e22) and 20% of primary care patients (9, 10) (EL 1b), and are reported more frequently by women in all age groups (♀:♂ = 1.5–3:1) (e23, e24) (EL 2b). In specialized settings, such as specialist somatic medical outpatient units or practices, a percentage up to 50% may be assumed (2, 4, e25). In the general population, 10% of those affected with an FSS also fulfill the criteria of one or more other FSSs; in clinical populations this overlap may be as much as 50% (e8, e9, e26) (EL 2a). In both clinical and population-based samples, NFS show a co-morbidity that increases with the severity of the NFS, including depressive, anxiety (11, e27, e28), and post-traumatic stress disorders (e29) as well as addiction disorders (medications, alcohol) (e30, e31). In severe cases (full-blown somatization disorder F45.0) there are often co-morbid personality disorders (e32, e33) (EL 2a). A majority show high, dysfunctional use of the health care system, especially in cases of psychological co-morbidity (9, e34) (EL 2b). The result is high direct (multiple diagnoses, overdiagnosis, inappropriate treatment) and indirect health costs (loss of productivity, long-term inability to work, early retirement) (13, e35). Also in older patients, NFS parts of the complaints should be considered, even if the differential diagnosis is more complex and uncertain because of multimorbidity and multimedication. (14, e36) (EL 2a, RG B).
Course and prognosis
Life expectancy for patients with NFS is presumably normal (e37, e38), but quality of life is more impaired than with somatic diseases (e39) (EL 2b). Suicide risk, especially among those in chronic pain, is greater than in the general population (e40, e41). In patients with fibromyalgia, the standardized mortality ratio for suicide was between 3.3 (95% confidence interval [95% CI] 2.2–5.1) (Danish retrospective cohort study, n = 1269 women [e38]) and 10.5 (95% CI 4.5–20.7) (US retrospective case control study, n = 8186 [e37]).
Irrespective of clinical setting, a less severe course with improvement of functioning and quality of life is seen in 50% to 75% of those affected, and a more severe course (usually marked functional/somatoform disorders, with deterioration of functioning and quality of life is seen in 10% to 30% (15) (EL 1b).
Principles and preconditions of diagnosis and treatment
Attitude and physician–patient relationship
Since the physician–patient relationship is often felt to be difficult on both sides (e42–e45), building up a sound working alliance on a partnership basis is of central importance (7, e46–e48). An active, supportive and biopsychosocial attitude (“as well/as attitude”) is recommended, focusing on symptoms and on coping with them. It is characterized by situational consistency; that is the right balance between reticence and authenticity (“I'm not going to say everything that would be authentic, but what I do say should be authentic”) (e52) (RB B).
First, the physician should allow the patient to describe the complaints spontaneously and explicitly (“accepting the complaint”) (e53) (EL 4, EG B), signaling attention, interest, and acceptance in both verbal and nonverbal ways (“active listening”) (EL 4, EG B). Psychosocial themes should be handled casually and indirectly rather than by confronting them, e.g., by accompanying the patient's report switching to and fro between hinting at psychosocial stressors and returning to the complaints description (“tangential conversation”) (e51). Clues to psychosocial problems and needs shall be picked up empathetically and spoken of as meaningful (e54) (EL 1b, RG A). In constructing the contextual interdependencies, phrases from the vernacular can help (“Is something making you heavy hearted?”) (EL 5, RG 0). The patient should be offered to make a joint decision together with the physician once enough information has been given (“shared decision making”) (e55) (EL 2b, RG A).
Simultaneous biopsychosocial diagnostic assessment
For early diagnosis of NFS, stepped simultaneous diagnostic assessment of both somatic and psychosocial conditioning factors should be carried out. If necessary further medical and/or psychotherapeutic specialists should be consulted (e56–e58) (EL 1b, RG A) (Figure 2). For patients with a chronic course, the first thing is to take stock of the results of previous diagnostic and therapeutic procedures (EL 5, RG 0). Waiting for the exclusion of somatic disease despite the presence of psychosocial stressors is contraindicated.
Biopsychosocial history taking
First, the bodily complaints should be recorded precisely (nature, location, number, frequency, duration, intensity) (e53) (EL 3b, RG B). Because accompanying complaints are often not reported spontaneously, history taking should be extended beyond the main symptoms, e.g., by systematic questioning about the different organ systems (2, 4) (EL 2b, RG A). The number of symptoms is an important predictor of the presence of NFS and of an unfavorable course (15) (EL 1b). For all bodily complaints, everyday functioning and psychological state should be assessed even at the first consultation (e59) (EL 2b, RG B). The patient’s subjective theory of the illness and illness/health behavior should be explored, including, if there are cues about psychosocial stressors or functional impairment, the context of the complaints (family, social network, work, biographical stressors, and resources) (CCP).
Somatic diagnostic investigations
Basic organic diagnostic investigation including physical examination is always necessary. Depending on the pattern of symptoms, specialist diagnostic procedures may also be required (e58) (EL 5, RG B). In the absence of “red flags” and so long as any dangerous illness appears unlikely, a “watchful waiting” approach is recommended, which will not increase the patient’s anxiety (e60) (EL 1b, RG B). Any tests should be discussed with the patient before and after they are carried out in a “de-catastrophizing” way (“normal results expected”) and the reasons for doing them clearly explained (transparency) (e61). A reasonable endpoint for the somatic diagnostic pathway should be agreed and adhered to (EL 1b, RG A).
Characteristics of more severe cases (“yellow flags”) and red flags for more severe, complicated courses including suicidality should be repeatedly evaluated (7, e62, e63) (EL 2b, RG B). Some protective factors (“green flags”) presumably have a favorable effect on the prognosis (e64) (EL 4) and should be recorded and supported (RG B) (Table 2).
Basic treatment in primary care and specialist somatic medicine
The basis of treatment should be “Basic Psychosomatic Care” (CCP). Both complaints and findings should be explained clearly and reassuringly, and psychophysiological relationships should be explained (psychoeducation: e.g., vicious circles of resting, somatosensory amplification etc.) (17, e66) (EL 2a). This should connect with the patient’s subjective theory of the illness, so that a biospychosocial explanatory model can be built up (RG B). The physician should offer a positive description of the complaints (e.g., “non-specific,” “functional,” “bodily distress,” with a corresponding diagnosis if appropriate), but should not belittle (“There’s nothing wrong with you,”) or use stigmatizing terms (“hysteria”) (e66, e67) (EL 2b, RG B). Important elements are reassuring the patient that dangerous disease is unlikely (17, e56, e60) (EL 2b, RGA) and no unnecessary steps should be taken (“first, do no harm”, “quaternary prevention”) (e68) (EL 5, RG B), and furthermore long-term support with physical and social activation (7, e69, e70) (EL 2b). Medication (e.g., symptomatic medication for patients with irritable bowel syndrome, pain alleviation, treatment of psychological co-morbidity) should be discussed with the aim of alleviating symptoms within the framework of an overall treatment plan, carefully weighing the risks and benefits, and for a limited period (4) (CCP). Physicians should not be too quick to certify patients as unable to work, and should weigh the advantages (rest, relief from stress) against the disadvantages (avoidance, increased weakness due to rest, loss of participatory activity) early on (e83) (EL 4–5). Short-term sick notes (7 days, patient to attend again, another 7 days if appropriate) may be considered, in order to support spontaneous improvement of symptoms and promote the therapeutic relationship and/or adherence to treatment (RG B). Psychotherapy may be considered, e.g., if the patient wants to discuss psychosocial stressors or when the bodily complaints are incidental findings in, for example, a patient with depression (CCP).
Additional steps in severe courses
Even in severe courses, care at the primary level and specialist somatic medical level is at the center of management. Within the framework of a clear treatment plan, there should be a stronger structuring of the framework and content of treatment (e71) (EL 2a, RG B). Essential elements are regular appointments that are time-limited and are not complaint-led (e48, e71) (EL 2b) along with treatment of comorbid disorders in accordance with guidelines (RG B). Specific, realistic therapy goals should be developed with the patient (18, e72) (EL 2b, RG A), in the process of which the importance of self-responsibility and collaboration should be conveyed (EL 4). Physical activation (especially aerobic exercise [endurance training] and strength training of low to moderate intensity) should be carried out in stages, with slowly increasing work alternating with rest (7, e73–e76) (EL 2b, RG A) (Table 2) and should be accompanied by sustained encouragement. Similarly, the patient should be encouraged towards social activation (7, e69, e70). Some body-centered or nonverbal therapy elements and relaxation techniques (e.g., biofeedback, progressive muscle relaxation, autogenic training, tai chi, qi-gong, yoga, Feldenkrais, mindfulness training, meditation, writing as therapy, music therapy) may be recommended as additional elements within an overall treatment plan, but not as monotherapies (e77–e79) (EL 2a). In severe cases where pain predominates, low-dose, short-term antidepressant treatment should be given (7, 19, e80–e82) (EL 1a, RG A) (Table 1). In severe courses where pain does not dominate, treatment with antidepressants according to guidelines should be given only where there is relevant psychological co-morbidity (e5) (EL 2a, RG B). Referrals, especially psychosocial referrals, should be well organized and carefully discussed both before and after they take place (CCP).
Requesting a specialist psychosocial assessment will reduce health service utilization (20) (EL 1a, RG A). A consultation/care recommendation letter provided to the primary care physician (information about the patient’s illness and specific recommendations for treatment including assessment wether inpatient or day clinic treatment is indicated [Box 3]), which may if necessary be repeated, leads to improvement in the level of functioning and saves costs when used as an additional measure, but not on its own (21, 22) (EL 1a, RG A).
In severe courses, psychotherapeutic interventions should be disorder-/ or symptom-oriented-focused, context-related (co-morbidity, social situation, ability to work), and resource-oriented (CCP). Wider evidence is available for various NFS – with low to moderate effect sizes – especially for cognitive behavioral therapy (22–24, e80, e81, e84, e85) (EL 1a), and also for psychodynamic (interpersonal) (7, 25, e81, e86) (EL 1b) and hypnotherapeutic/imaginative approaches (e81, e85, e87, e88) (EL 1a, RG A) (Table 1). Follow-up studies showing positive effects are available for psychotherapy and physical activation, but not for medications (e74, e75, e81, e89).
Particularly severe courses: multimodal treatment, if necessary on an inpatient/day clinic basis
In particularly severe and chronic cases, multimodal treatment should already be initiated at the primary care and specialist somatic medical level (Box 2). Multimodal treatment has been shown to be effective especially for chronic pain syndrome (e90) (EL 1b, CCP). It should be assessed wether inpatient/day clinic treatment at a facility offering multimodal therapy at a clinic offering multimodal therapy is indicated, including when there are few or no options for treatment on an outpatient basis (Box 3) (e91, e92) (CCP).
Rehabilitation should also follow a multimodal approach (e93). The main goals are improvement in ability to function and to work, and to prevent (further) chronification. The sociomedical baseline situation (e.g. duration of inability to work) appears essential for success (e94) (CCP). In suitable facilities (e.g., day clinics with the appropriate range of indications/treatments), rehabilitation measures should be done at first on an outpatient basis, in close collaboration between primary care physician/somatic medical specialist and psychotherapist, and only after that on an inpatient or partly inpatient basis.
Reassessment after 3 months at the latest
To prevent cases become dangerous or chronic when this could have been prevented, complaints, diagnostic categorization, and the severity of illness and the outcome of treatment should be reassessed after 3 months at the latest (e56, e95) (EL 2b, RG B). If appropriate, and in agreement with the patient and collaborating physicians and therapists, both somatic and psychosocial diagnostic investigations and treatment should be adjusted. Basic medical diagnostic investigations including physical examination should be regularly repeated, especially where complaints persist. In this way, changes in symptoms will be recognized, organic disease will be identified, the patient will be given a feeling of being looked after and taken seriously, and unnecessary tests will be avoided (EL 5, RG B). After 6 months, if treatment on an outpatient basis fails, treatment on an inpatient or day clinic basis should be considered (Box 3).
In the S3 guideline “Management of patients with non-specific, functional, and somatoform bodily complaints,” a broad group of medical and psychological societies together with a patient representative have for the first time achieved an evidence-based consensus on terminology and care of these patients that is interdisciplinary and bridges the borders of health care sectors as well as psychosocial and somatic disciplines. The innovations are summarized in Box 4. To date, randomized controlled studies, reviews, and meta-analyses are available on only a few aspects (Figure 1), so that in places the present guideline has to rely on weaker evidence or clinical consensus. Overall, a very strong need is evident for fundamental research as well as research in treatment and health services. Guideline texts and practice materials may be downloaded from the AWMF website (www.awmf.org/ leitlinien/detail/ll/051–001.html) and from the project website (www.funktionell.net). An important complement to this guideline is the Evidence-Based Guideline on Psychotherapy of Somatoform Disorders and Associated Syndromes by the Group for Clinical Psychology and Psychotherapy of the German Society of Psychology (24). This is primarily aimed at psychotherapists as an aid to choosing effective psychotherapeutic interventions.
The authors are grateful to the AWMF, and to all colleagues, professional societies, and patient representatives (eBox 1) who contributed to the development of this guideline. Special thanks are due to Dipl.-Psych. Heribert Sattel as a member of the steering and editorial group.
Conflict of interest statement
P. Henningsen has received lecture fees from Lilly.
W. Häuser has been on an advisory board of Daiichi Sankyo, has had conference and travel expenses reimbursed by the Falk Foundation and Eli Lilly, and has received non-product-related lecture fees from the Falk Foundation and from Janssen-Cilag.
R. Schaefert, C. Hausteiner-Wiehle, M. Herrmann und J. Ronel declare that no conflict of interest exists according to the guidelines of the International Committee of Medical Journal Editors.
Manuscript received on 2 August 2012, revised version accepted on 19 September 2012.
Translated from the original German by Kersti Wagstaff, MA.
Dr. med. Rainer Schaefert
Klinik für Allgemeine Innere Medizin und Psychosomatik
Thibautstr. 2, 69115 Heidelberg, Germany
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