302 EUROPEAN JOURNAL OF MEDICAL RESEARCH July 26, 2007 Eur J Med Res (2007) 12: 302-310 © I. Holzapfel Publishers 2007 ANTHROPOSOPHIC VS. CONVENTIONAL THERAPY FOR CHRONIC LOW BACK PAIN: A PROSPECTIVE COMPARATIVE STUDY H. J. Hamre1, C. M. Witt2, A. Glockmann1, K. Wegscheider3, R. Ziegler4, S. N. Willich2, H. Kiene1 1Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany 2Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany 3Institute for Statistics and Econometrics, University of Hamburg 4Society for Cancer Research, Arlesheim, Switzerland Abstract INTRODUCTION Objective: To compare anthroposophic treatment (eu- rythmy, rhythmical massage or art therapy; coun- Two-thirds of adults experience low back pain (LBP) selling, anthroposophic medication) and conventional at some point in life [1]. In several studies LBP was treatment for low back pain (LBP) under routine con- the second most common symptom for which patients ditions. saw a physician [2]. LBP causes considerable morbidity Methods: 62 consecutive outpatients from 38 medical and impairs quality of life; in a survey of German practices in Germany, consulting an anthroposophic adults, 23% suffered current back pain with high pain (A-) or conventional (C-) physician with LBP of ≥ 6 intensity or severe functional impairment [3]. weeks duration participated in a prospective non-ran- 85% of LBP cases are non-specific, i. e. without a domised comparative study. Main outcomes were diagnosable patho-anatomical condition [2;4]. In pri- Hanover Functional Ability Questionnaire (HFAQ), mary care, non-specific LBP is usually treated with LBP Rating Scale Pain Score (LBPRS), Symptom medication (paracetamol, non-steroid anti-inflamma- Score, and SF-36 after 6 and 12 months. tory drugs (NSAID), muscle relaxants, opioid anal- Results: At baseline, LBP duration was > 6 months in gesics, antidepressants), physiotherapy, and spinal ma- 85% (29/34) of A-patients and 54% (15/28) of C-pa- nipulation [5-7]. Long-term use of medication is not tients (p = 0.004). Unadjusted analysis showed signifi- proven effective and poses risks for serious, some- cant improvements in both groups of HFAQ, LBPRS, times fatal adverse effects (NSAID), toxicity (paraceta- Symptom Score, SF-36 Physical Component Summary, mol), and dependency (muscle relaxants and opioids) and three SF-36 scales (Physical Function, Pain, Vitali- [8-11]. In refractory LBP, intensive multidisciplinary ty), and improvements in A-patients of three further rehabilitation programs may be helpful [12] but re- SF-36 scales (Role Physical, General Health, Mental quire high patient motivation and compliance. Under Health). After adjustment for age, gender, LBP dura- real-world conditions, primary care treatment of tion, and education, improvements were still signifi- chronic LBP is associated with modest [13] or no im- cant in both groups for Symptom Score (p = 0.030), provement [5]. SF-36 Physical Component Summary (p = 0.004), and Anthroposophic medicine (AM) was founded in the three SF-36-scales (Physical Function, p = 0.025; Role 1920s by Rudolf Steiner and Ita Wegman [14]. AM Physical, p = 0.014; Pain, p = 0.003), and in A-patients aims to stimulate patients’ salutogenetic, self-healing for SF-36-Vitality (p = 0.032). Compared to C-pa- capacities [15] and is practiced in 67 countries world- tients, A-patients had significantly more pronounced wide [16]. AM therapy for LBP is provided by physi- improvements of three SF-36 scales (Mental Health: cians (counselling, AM medication) and non-medical p = 0.045; General Health: p = 0.006; Vitality: p = therapists (eurythmy therapy, rhythmical massage ther- 0.005); other improvements did not differ significantly apy, embrocation, and art therapy) [17-19]. Eurythmy between the two groups. therapy (Greek “harmonious rhythm”) is an active ex- Conclusion: Compared to conventional therapy, an- ercise therapy, involving cognitive, emotional, and vo- throposophic therapy for chronic LBP was associated litional elements [20]. During eurythmy therapy ses- with at least comparable improvements. sions patients are instructed to perform specific move- Key words: anthroposophy, comparative study, drug ments with the hands, the feet or the whole body. Eu- therapy, eurythmy therapy, intervertebral disk displace- rythmy movements are related to the sounds of vowels ment, low back pain, physical therapy, rhythmical mas- and consonants, to music intervals or to soul gestures, sage therapy e. g. sympathy-antipathy. Between therapy sessions pa- Abbreviations: A-: Anthroposophic, AM: Anthropo- tients practice eurythmy movements daily [21]. Rhyth- sophic Medicine, C-: Conventional, HFAQ: Hanover mical massage therapy was developed from Swedish Functional Ability Questionnaire, LBPRS: Low Back massage by Ita Wegman, physician and physiotherapist Pain Rating Scale Pain Score, MCS (PCS): SF-36 Men- [22], and is practiced by physiotherapists with 1 1/2 -3 tal (Physical) Component Summary Measure years specialised training. In rhythmical massage thera- July 26, 2007 EUROPEAN JOURNAL OF MEDICAL RESEARCH 303 py, traditional massage techniques (effleurage, petris- activity-related questions (e. g. “Can you bend down sage, friction, tapotement, vibration) are supplemented to pick up a paper from the floor?”) which are an- by gentle lifting and rhythmically undulating, stroking swered on three-point Likert scales (“Can do with- movements, where the quality of grip and emphasis of out difficulty” / “Can do, but with some difficulty” movement are altered to promote specific effects [15]. / “Either unable to do, or only with help”) [30]. To date AM therapy for LBP has been evaluated in The HFAQ score ranges from 0 (minimal function) three observational studies, conducted in specialised to 100 (optimal function, no limitation). A score of settings [23-25]. Here we present a study conducted in ≤ 70 points indicates a clinically significant func- primary care. tional limitation; a difference of ≥ 12 points be- tween or within groups is considered clinically rele- MATERIAL, METHODS AND STATISTICS vant. The WHO lists the HFAQ among the three most relevant disease-specific instruments for DESIGN AND OBJECTIVE spinal disorders [4]. • Low Back Pain Rating Scale Pain Score (LBPRS): This is a prospective one-year, non-randomised com- The LBPRS [31] consists of three back pain and parative study. The study was initiated by a health in- three leg pain items: current pain, worst pain and surance company as part of a research program on the average pain during the last seven days (0 “no pain” effectiveness and costs of complementary therapies in to 10 “unbearable pain”). The LBPRS ranges from chronic disease (Modellvorhaben Naturheilverfahren 0 (6 x “no pain”) to 100 (6 x “unbearable pain”). [26-28]). • Symptom Score: numerical rating scale [32] from 0 The objective was to compare clinical outcomes, („not present“) to 10 („worst possible“), patients’ therapies provided, health service use, adverse reac- assessment of one to six most relevant symptoms tions, and satisfaction in outpatients seeing either AM present at baseline. or conventional physicians for subacute or chronic • Quality of life: SF-36 Physical (PCS) and Mental LBP and treated under routine clinical conditions. (MCS) Component Summary Measures, eight scales [33]. SETTING, PARTICIPANTS, AND THERAPY Primary outcomes were HFAQ and LBPRS. Clinical Anthroposophic (A-) physicians certified by the Physi- outcomes were documented after 0, 6, and 12 months. cians’ Association for Anthroposophical Medicine in LBPRS and Symptom Score were not documented in Germany and conventional (C-) physicians not using A-patients enrolled before 1 Jan 1999. AM or other complementary therapies were invited to participate. A-physicians were recruited from all parts OTHER OUTCOMES of Germany, C-physicians from Berlin only. The par- ticipating physicians enrolled consecutive outpatients • Therapy and health service use in the pre-study year fulfilling eligibility criteria: (documented at study enrolment) and follow-up year (documented after six and 12 months): inpa- Inclusion criteria: (1) Age 17-75 years, (2) LBP at least tient hospital and rehabilitation treatment, back-re- six weeks duration, (3) starting LBP therapy for the lated physician visits (visits to general practitioners, first time with the study physician: internists, orthopaedic surgeons, neurologists or • A-group: AM therapy provided by A-physician or psychiatrists), paraclinical investigations, use of referral to AM therapist (art, eurythmy or rhythmi- back-related drugs (Anatomical Therapeutic Chemi- cal massage); cal Classification Index M01 Anti-inflammatory and • C-group: any non-AM therapy provided by C-physi- antirheumatic products, M02 Topical products for cian or referral to any non-AM therapy for LBP. joint and muscular pain, M03 Muscle relaxants, N01 Analgesics, N06A Antidepressants; additional docu- Exclusion criteria: Previous back surgery, congenital mentation after three months), back surgery, phys- spinal malformation, spinal infectious or malignant iotherapy, Heilpraktiker (non-medical practitioner) disease, ankylosing spondylitis, Behcet's Syndrome, visits, sick leave. Reiter's Syndrome, osteoporosis with vertebral frac- • Patient rating of therapy outcome, patient satisfac- ture, spinal stenosis, spondylolysis, spondylolisthesis, tion with therapy after six and 12 months. fibromyalgia. • Adverse drug or therapy reactions reported