A Topical Treatment Optimization Programme (TTOP) improves clinical outcome for calcipotriol/betamethasone gel in psoriasis: results of a 64-week multinational randomized phase IV study in 1790 patients (PSO-TOP).

BACKGROUND: Around two-thirds of patients with psoriasis do not adhere to topical treatment. The Topical Treatment Optimization Programme (TTOP), a five-element tool, includes guidance for the conversation between dermatologists/nurses and patients, patient information material, telephone/e-mail helpdesks and treatment reminders. It has been developed by patients and dermatologists to help increase adherence to treatment in psoriasis. OBJECTIVES: To compare TTOP with standard of care ('non-TTOP') within a large European investigator-initiated study, PSO-TOP (clinicaltrials.gov NCT01587755). METHODS: Patients with mild-to-moderate psoriasis received calcipotriol/betamethasone dipropionate gel as standardized study medication and were randomized 1 : 1 to either TTOP or non-TTOP management. Study medication was applied once daily for 8 weeks followed by 'as needed' application for an additional 56 weeks. Response was defined as a Physician's Global Assessment (PGA) of 'clear' or 'almost clear'. RESULTS: In 1790 patients (full analysis set), response rates after 8 weeks (primary objective) were significantly higher for TTOP (36·3%) than for non-TTOP (31·3%, P = 0·0267). Better clinical outcome was accompanied by higher rates of patients feeling well informed about their skin condition, treatment and other factors related to adherence, but the Dermatology Life Quality Index was not statistically different. TTOP patients regarded the structured one-to-one conversations with their dermatologist/nurse as the most important element of TTOP. CONCLUSIONS: Patients randomized to the TTOP intervention had a better clinical response than patients receiving standard of care. Improved communication between the healthcare provider and patient might be an important element in increasing adherence to topical therapy in psoriasis.

Evaluation of adherence predictors for the treatment of moderate to severe psoriasis with biologics: the importance of physician-patient interaction and communication.

BACKGROUND: Treatment efficacy of biologic agents in moderate to severe psoriasis is regarded as high with patient adherence being higher than for traditional therapies. However, use of biologics is connected to high discontinuation rates. The current investigator-initiated study was conducted to improve the understanding of adherence. MATERIALS AND METHODS: The study was designed as non-interventional retrospective multicentre trial in Germany. Questionnaires were developed based on the adherence dimensions identified by the World Health Organization, WHO. Thirteen dermatologists and 246 patients participated in the study and replied to the questionnaires. Study data were analysed for potential predictors of adherence in an explorative manner. RESULTS: Based on the physician's assessment of the patients' individual adherence, subsets of adherent and non-adherent patients were discriminated. Two main drivers were identified on the patients' side that were positively connected to adherence: a lack of efficacy of the previous treatments and the knowledge of comorbidities associated with severe psoriasis. Furthermore, physician-patient communication seems to play a central role, as on the dermatologists' side, there was a strong association of adherence and positive personal interrelation between dermatologist and patient. CONCLUSION: The data reported here underline the importance of patient education and information delivery to optimize patient adherence and thereby treatment outcomes. Treating physicians should be aware that soft aspects of their interaction with the patient might influence treatment adherence.

FamilyPso - a new questionnaire to assess the impact of psoriasis on partners and family of patients.

BACKGROUND: Psoriasis is a lifelong disease for which there is no cure. It has been conclusively shown across all ethnicities that patients suffering from psoriasis have a significantly reduced health-related quality of life and a high disease burden. OBJECTIVE: Surprisingly little is known about the impact of a patient's psoriasis on partners or family members. METHODS: To address this issue a systematic literature search has been conducted and interviews with relatives of psoriasis patients living in the same household were performed. From this collected information, items were generated that were commonly mentioned to affect living and tested in a large group of relatives before the final item selection was done. RESULTS: A first set of 29 items was selected and tested in a study with 96 patient relatives. After adjustment and statistical analysis, the final FamilyPso questionnaire was condensed to 15 items to assess the burden of partners or family members living together with psoriasis patients. CONCLUSION: The FamilyPso enables physicians to achieve a better understanding of the impact of psoriasis as a lifelong chronic disease on partners and the family environment.

Efficacy of a fixed combination of calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicenter, randomized, controlled, prospective study.

BACKGROUND: Psoriasis is a common, chronic, inflammatory skin disease with the majority of individuals having limited disease, treated with topical medication. However, special attributes of topical treatments like galenic/cosmetic properties or an inconvenient treatment schedule may result in low preference for topical treatments. Hence, there is strong medical need for a topical medication, which is highly efficacious, easy-to-use and preferred by both physicians and patients. OBJECTIVE: Blinded interim analysis with the purpose to assess efficacy of (both from the physician's and patient's perspective) and the patients' preference with a highly efficacious and easy-to-use fixed combination of calcipotriol/betamethasone dipropionate topical gel after 8 weeks of once daily treatment in a large patient population. METHODS: In this phase IV, international, multicentre, randomized, controlled, prospective, parallel group study, adult patients with active, mild to moderate psoriasis despite previous topical psoriasis treatment, i.e. unsuccessful in the 8 weeks preceding study participation, are followed over 64 weeks. During the first 8 weeks the patients apply their medication once a day followed by a 56-weeks maintenance period according to SmPC. Blinded interim analysis of all patients included demographics, Physician's Global Assessment, the novel Patient's self Global Assessment (PsGA) and Patient Preference Questionnaire (PPQ). RESULTS: 1795 patients were analysed. At week 8, 36.5% of the physicians rated the patients' psoriasis as clear/almost clear. Similarly, based on the patients' self-assessment, 34.2% had a clear/almost clear score of PsGA in week 8. Analysis of the PPQ showed that the vast majority of the patients judged their 8-week treatment to be preferable compared with their previous treatments. CONCLUSION: Results of this blinded interim analysis indicate that the fixed combination of calcipotriol/betamethasone dipropionate gel is highly efficacious and preferred by the majority of analysed patients.

Non-adherence and measures to improve adherence in the topical treatment of psoriasis.

Psoriasis is a chronic, recurrent immune-mediated skin disease with a 2-3% prevalence in the Western population, which severely affects patients' quality of life and poses a considerable socioeconomic challenge. The majority of individuals have psoriasis in limited areas and topical products are the mainstay of therapy according to existing guidelines. It is known that medication adherence rates are lower for topical treatment than for systemic treatment. Poor medication adherence is a major multidimensional problem for patients with chronic disorders as it is associated with unfavourable treatment outcomes, increased risk for development of concomitant diseases and inefficient use of health resources. Despite four decades of adherence research and the large number of studies that have identified the importance of medication non-adherence, there are relatively few studies reporting and designing effective strategies to improve adherence. The aim of this article was to report and describe non-adherence in the topical treatment of psoriasis, the factors that might contribute to this phenomenon, and which interventions have so far been developed for the management of chronic conditions. This article proposes that given that the barriers to medication adherence are complex and varied, solutions to improve adherence and thus clinical outcomes must be multifaceted and must also provide the possibility to be tailored according to each patient's individual needs. Such an individualized and comprehensive adherence-enhancing intervention would probably enable the successful long-term management of this disabling chronic condition.

[Treatment of crow's feet with two different botulinum toxin type A preparations in split-face technique]. / Botulinumtoxin Typ A im Halbseitenvergleich. Wirksamkeit und Verträglichkeit bei der Behandlung von Krähenfüßen.

BACKGROUND: For the first time, the effectiveness of Xeomin®, and Dysport® in an dose-ratio of 1:3 treating crow's feet (FWS 2-3) was evaluated in a double-blind randomized pilot study. PATIENTS AND METHOD: Xeomin® (12 units) was compared to Dysport® (36 units) in an intra-individual split-face technique in 22 patients over a period of 4 months. According to the facial-wrinkle-scale (FWS) patients were rated as responders with an improvement of at least 1 point in FWS. RESULTS: One month after treatment significantly more than 80% of patients were rated as responders. The different products proved to be equivalent in response rate and effectiveness with no significant difference after 4 weeks and 4 months in statistical analysis. Surprisingly the decrease in FWS of crows' feet at rest was more pronounced. CONCLUSION: The different botulinum toxin type A formulations proved to be equivalent in effectiveness and tolerability in a dose ratio of 1:3 (Xeomin®: Dysport®) The more pronounced decrease of crow's feet at rest points out the importance of muscle insertion into the skin for the cosmetic result in the periorbital region.

[Does dilution have an impact on cosmetic results with BoNT/A? Complex-protein-free BoNT/A for treatment of glabella lines]. / Beeinflusst die Verdünnung das kosmetische Ergebnis von BoNT/A? Komplexproteinfreies BoNT/A zur Behandlung der Glabellafalte.

BACKGROUND: In this 2-armed, randomized study we investigated the efficacy and tolerability of complex-protein-free botulinum neurotoxin type A (BoNT/A), applied in two different dilution volumes for treatment of glabellar lines. PATIENTS AND METHODS: 40 patients with grade 2-3 glabellar lines (Facial Wrinkle Scale) received treatment with 25U BoNT/A (Xeomin). 100U of botulinum neurotoxin were diluted in 2.5 ml (group I) or 4 ml sodium chloride solution (group II). Responders showed an improvement in the wrinkle score (independent rater) of at least one point. RESULTS. Response rates two weeks after treatment were 100% / 89.5%, at 3 months 84.2% / 64.7% and at 4 months 53.3% / 61.5% (groups I / II respectively). There was no significant difference between the two dilutions. CONCLUSION: Complex-protein-free botulinum neurotoxin type A in both dilutions effectively reduced severity of glabellar lines. There was no statistically significant difference in efficacy between the two dilutions.

Treatment of therapy-refractive ulcera cruris of various origins with autologous keratinocytes in fibrin sealant.

BACKGROUND: Evaluation of the effects of cultivated, subconfluent, autologous keratinocytes in fibrin sealant (BioSeed-S) on the healing of therapy-refractive chronic wounds. PATIENTS AND METHODS: Open observational study in 60 patients with chronic leg ulcers and impaired wound healing of various origins. After whole-skin excision and cultivation of the autologous keratinocytes, the suspended cells were applied to the preconditioned wound in fibrin sealant. Wound epithelization and wound size were recorded at defined times. RESULTS: Fifty-two of the 60 participating patients could be evaluated. After 6 weeks, 29 ulcers (55.8%) were healed. The mean epithelization increased between the 8th and 42nd postoperative day from 23% to 62.5%. In 50.0% of the patients, global assessment of the wound showed a high degree of epithelization or healing after 42 days. In 32.6% of treated patients, improvement was observed, while no healing tendency was to be found in 17.4%. CONCLUSION: The present observational study indicates that the transplantation of autologous keratinocytes suspended in fibrin sealant could be of advantage in the treatment of refractive leg ulcers.

Development, validation and clinical use of the FLQA-I, a disease-specific quality of life questionnaire for patients with lymphedema.

BACKGROUND: It is known from clinical practice that lymphatic diseases can be associated with reductions of quality of life (QoL). Due to the lack of validated methods, only few studies however have systematically investigated the QoL in lymphedema. The aim of the study was 1) to develop a standardized QoL questionnaire specific for lymphedema and 2) to assess the QoL in these patients. PATIENTS AND METHODS: We developed and tested the FLQA-l, a novel QoL questionnaire developed specific for use in lymphedema on the basis of the previously validated FLQA vein questionnaire. The questionnaire consists of 92 items that refer to the following scales: Physical status, everyday life, social life, emotional well-being, treatment, satisfaction and profession/household. 392 patients with primary (n = 246) and secondary (n = 146) lymphedema were included in the validation study. RESULTS: The FLQA-l showed good internal consistency; Cronbach's alpha was higher than 0.75 in all scales. There were no floor and ceiling effects and satisfactory item selectivity. The test-retest reliability, sensitivity to change and convergent validity with other psychometric instruments were satisfactory. Clinically, patients with lymphedema showed markedly impaired QoL in all fields, compared to persons with early stage venous insufficiency, and comparable reductions of QoL, compared to patients with venous leg ulcer. CONCLUSION: These data indicate that the FLQA-l is a reliable and valid questionnaire for the assessment of QoL in lymphedema. Since the QoL is impaired in many patients with lymphedema, QoL evaluation may be helpful for clinical diagnostics as well as for outcome measurement of specific edema therapy.

[Therapeutic benefits in dermatological therapy. Evaluation of therapy from the physician's und patient's perspective in psoriasis and atopic dermatitis]. / Therapeutischer Nutzen in der dermatologischen Behandlung. Bewertung von Therapieerfolg aus Arzt- und Patientenperspektive bei Psoriasis und atopischer Dermatitis.

BACKGROUND: The patient's opinion has received only little consideration in current health-political discussions so far. This study examines the question of agreement between physicians and patients regarding their expectations of therapy and evaluation of its' usefulness. PATIENTS AND METHODS: 133 patients with psoriasis vulgaris (n=73) or atopic dermatitis (n=60) as well as medical personnel (n= 119) were assessed concerning the priority of therapy goals by means of a specially-designed questionnaire. RESULTS: There was overall agreement on the definition of therapy goals in the improvement of clinical symptoms and the importance of side effects between medical personnel and patients. Psychological distress and social improvements were clearly overrated by the medical staff, whereas the need for less therapeutic expenditure was clearly underestimated. CONCLUSIONS: The conventional evaluation of drugs and therapies covers the effectiveness and the side effects, topics about which patients and physicians are in general accordance. As far as further evaluation criteria are concerned, discussions should reflect the patient's opinion's, since it cannot be assumed that their perspective is adequately represented by physicians.

Psychosomatic liaison service in dermatology. Need for psychotherapeutic interventions and their realization.

BACKGROUND: Empirical investigations examining the psychosocial distress and need for care of dermatology patients are rare. Little is known about the use of psychotherapeutic interventions in routine care. OBJECTIVE: To evaluate the psychosocial distress of dermatological inpatients, the need for psychotherapeutic interventions and their realization in the framework of a psychosomatic liaison service. METHODS: 86 patients from one unit at the University Dermatology Clinic in Freiburg underwent psychodiagnostic interviews and completed self-rating instruments, elucidating mental disorders, psychosocial distress, coping methods, quality of life, treatment motivation and psychotherapeutic interventions. RESULTS: Using ICD-10 criteria, mental and behavioral disorders were diagnosed in 46%; most frequent were mood and anxiety disorders. Professional assessment indicated a need for psychotherapeutic treatment in 51%, while 28% of the patients wished for psychotherapy; actual intervention occurred in 38%. CONCLUSIONS: The need for psychotherapeutic treatment can only be handled within the framework of a liaison service in close collaboration with care givers.

[The validity of the Hornheide questionnaire for psychosocial support in skin tumor patients: a survey in an Austrian and German outpatient population with melanoma]. / Die Validität des Hornheider Fragebogens zur psychosozialen Unterstützung bei Tumorpatienten. Eine Untersuchung an zwei repräsentativen ambulanten Stichproben von Melanompatienten.

Tumour patients are subject to different degrees of psychosocial distress depending on the course of disease, personality variables and amount of social support available. Often patients do not spontaneously talk about their distress and attending physicians fail to detect it. Therefore, it is important that the presence of distress is ascertained by specific screening instruments so that appropriate supportive measures can be instituted. The Hornheide Questionnaire (HQ) employed for investigating the need for psychosocial support in the case of patients with skin tumours and with tumours in the head and neck region represents such a specific screening instrument. The present study investigates the validity of the HQ on the basis of two representative samples from two different University Clinics for treatment and follow-ups of melanoma patients. With the help of the HQ, 215 patients at the Dermatology Out-patient Unit of the University of Innsbruck and 223 patients at the University of Freiburg were investigated with regard to their subjective experience of distress. The external constructive validity criteria were established on the basis of the Freiburg Questionnaire of Disease-Coping, the questionnaire of social support and Beck's Depression Inventory. There were significant differences between individuals in the severity of distress in different age groups and in patients in different tumour stages. The internal consistency of the HQ and its subscales proved to be satisfactory demarcation from other psychosocial dimensions and an adequate correlation with similar dimensions (depression, depressive illness coping, social support, compliance). The HQ appears to be an economical and valid screening instrument for detecting the need for psychosocial support in melanoma patients in the out-patient follow-up stage.

The need for psychosocial support in parents with cochlear implanted children.

OBJECTIVE: The aim of the study was to assess the need of parents with Cochlear implanted children for psychosocial support, based on psychic symptoms reported by these parents and their motivation to make use of psychosocial interventions. METHODS: Fifty seven mothers and 46 fathers of 57 Cochlear implanted children were evaluated separately, employing validated questionnaires (Symptom Checklist-90-R and Questionnaire on Psychosocial Support). RESULTS: 26% of the mothers and 25% of the fathers showed severe psychic symptoms as reflected in the Symptom Checklist-90-R. Fifty nine percent of the mothers and 60% of the fathers were highly motivated to participate in psychosocial interventions--especially in the form of further information on their children's ailment and in parents' groups. CONCLUSIONS: The data presented suggest that there is a need for psychosocial support in 18% of the parents; 8% of the parents show high psychic stress, but low motivation. The rest of the parents are not in need of support; nevertheless, 42% of the parents are highly motivated in favor of psychosocial interventions.

[Psychological stress, knowledge and treatment expectation of parents with a child managed by cochlear implant]. / Psychische Belastung, Informiertheit und Behandlungserwartung von Eltern mit einem Cochlear Implant versorgten Kind.

UNLABELLED: ESTABLISHED KNOWLEDGE: It is known that parents of hard-of-hearing children suffer from an increase in psychosocial stress. SCIENTIFIC QUESTION: How does the psychosocial situation of parents with children who have cochlear implants change during rehabilitation? AIM OF STUDY: It was the aim of this study to demonstrate how parents evaluate retrospectively their own psychological well-being during the process of rehabilitation. METHODS AND RESULTS: We interviewed 87 parents by questionnaires which were mailed to them. Fifty-seven mothers and 46 fathers responded (59% return rate). Parents reported a significant increase in stress, as perceived by themselves, after the time of diagnosis. Of the parents, 25% continued to suffer from psychic stress during rehabilitation as could be demonstrated by the SCL-90-R questionnaire criteria. The expectations by parents were realistic prior to implantation but thereafter increased significantly with time. CONCLUSIONS: The psychological state of parents during the critical phase, after a diagnosis of deafness has been made for their child, has to be considered. Even after an initial phase of shock, parents seemed to be stressed to an extent that required therapeutic intervention.

Skin surgery under local anesthesia leads to stress-induced alterations of psychological, physical, and immune functions.

BACKGROUND: Although excision of nevi under local anesthesia is a frequent and harmless operation, it apparently causes increased stress in many patients. However, thus far no studies have focused on the question of whether there are measurable effects on psychological, physiological, and immunological parameters. OBJECTIVE: To assess the perioperative stress reactions of patients undergoing skin surgery under local anesthesia for nevocellular nevi. METHODS: Fifty consecutive patients with pigmented nevi were examined at five points of measurement: 1 week and 30 minutes before the operation, during the operation, 30 minutes and 1 week after the operation. Somatic parameters included blood pressure, pulse, respiratory rate, and the level of pain. Lymphocyte subpopulations, white blood cell count, and cortisol in saliva were determined. Anxiety and general psychological distress were evaluated with validated questionnaires. RESULTS: There was a significant increase in anxiety at the time of surgery. In parallel, the physiological parameters as well as the CD56+ lymphocytes changed significantly. Preoperation anxiety and intraoperation pain were significantly higher in women (P <.001), but did not depend on age. CONCLUSION: There appears to be an interaction between physiological and emotional components in the operative stress reaction under local anesthesia. In patients with skin cancer, the perioperative stress may lead to transient impairment of immune function.

[Effects of combined dermatological and behavioural medicine therapy in hospitalized patients with psoriasis and atopic dermatitis]. / Effekte kombinierter therapeutischer Massnahmen bei Patienten mit Psoriasis und atopischer Dermatitis.

The present study examined the effectiveness of combined dermatological and behavioural medicine therapy on the skin status and disease-specific stress of eighty-six patients with psoriasis and fifty-eight patients with atopic dermatitis who were hospitalized in the PsoriSol Clinic, Hersbruck, Germany. In addition to receiving instruction about their stain disease, the patients were offered, practice in relaxation techniques, social contacts and scratching control as well as individual psychological counselling. The clinical change was assessed by PASI and SCORAD, respectively. The Marburg questionnaire for coping with skin diseases (MHF) and a questionnaire for health-related control attributes (GKU-S) served as psychometric measures. Patients showed significant improvement in skin status and psychosocial parameters in pre-post comparison. Social fears, avoidance and helplessness were reduced by significant improvement of the emotional status in both groups. Patients with psoriasis also showed an increase in internal control attributes. Dermatological treatment combined with behavioural medicine therapy can be considered an effective method in patients with atopic dermatitis and psoriasis.

[Quality of life in skin diseases: methodological and practical comparison of different quality of life questionnaires in psoriasis and atopic dermatitis]. / Lebensqualität bei Haut- erkrankungen: Vergleich verschiedener Lebensqualitäts-Fragebögen bei Psoriasis und atopischer Dermatitis.

Aim of the present study was a comparison of four quality of life (QoL) questionnaires in 228 patients with psoriasis (PSO, n = 148) and atopic dermatitis (AD, n = 80) regarding feasibility, discriminant validity and sensitivity to change. Evaluating were performed before and after treatment in clinic. The following questionnaires were compared. 1) Freiburg Quality of Life Assessment for Dermatoses (FLQA-d), 2) Dermatology Life Quality Index (DLQI), 3) Chronic Skin Disease Questionnaire (CSDQ) and 4) questionnaire on everyday life (ALLTAG). All questionnaires were able to discriminate significant reductions of QoL in PSO and AD, as compared to controls. In parallel to the clinical improvement, all questionnaires showed QoL improvements as well, i.e. the questionnaires were sensitive to change. However, not all of the DLQI and ALLTAG scales were sensitive to change. Also, in some cases part of the scales of these questionnaires could not be calculated due to missing data. Otherwise, all questionnaires were valid and easy to handle. Thus, QoL of patients with PSO and AD can reliably be assessed by various questionnaires. Decisive for selection are the aim and the design of the study.

Sociodemographic profile and satisfaction with treatment of patients undergoing liposuction in tumescent local anesthesia.

OBJECTIVE: To assess patient satisfaction with liposuction in tumescent local anesthesia (TLA) and to define a patient profile regarding sociodemographic data. METHODS: Three hundred randomly selected patients were asked by mail to complete a standardized questionnaire on aesthetic dermatology and cosmetic surgery 3-25 months after liposuction. The 64 items addressed treatment satisfaction, treatment effects on body, social, and professional life as well as self-confidence, body feeling, and social contacts. RESULTS: One hundred fifty-nine (53.0%) of 300 patients returned complete questionnaires. Ninety-two percent of the patients were female and the mean age was 45.3 +/- 11.8 years. The mean body mass index (BMI) was 24.5 +/- 3.7, and 61.7% of the patients had a normal BMI. Satisfaction with the liposuction was high (about 85% mostly or completely satisfied). The procedure was regarded by most patients as a nonstressful event (>80%). About 40% reported positive effects on social life, about 91% on body feeling, 57% on attractiveness, and 20% on their profession. CONCLUSION: Liposuction in TLA is a satisfying and well-tolerated treatment for most patients.

[Psychological status and motivation for psychosocial intervention in patients with allergic disorders]. / Psychisches Befinden und Motivation zu psychosozialen Interventionen bei Patienten mit allergischen Erkrankungen.

The aim of this study was to compare the psychological stress of patients with different forms of immediate type hypersensitivity and urticaria. Moreover, the patients' motivation for different forms of psychological treatment was assessed and an indication for psychosocial support was defined. 228 consecutive inpatients with insect venom allergies (ins), food intolerance (food), drug hypersensitivities (dru) and urticaria (urt) were evaluated by validated questionnaires regarding psychological strain and motivation for psychosocial treatments. Patients with food intolerance and urticaria showed significantly elevated psychological stress and higher motivation for psychosocial support as compared to those with insect venom allergies and drug intolerance. Patient education was the favourite technique for the patients (food 78%, urt 57%, dru 24%, ins 17%), followed by relaxation treatment. The most important predictors for the motivation were the wish for self-responsibility, a feeling of helplessness and social limitations. If strong indication criteria are applied, psychosocial support is indicated in only small subgroups of each patient group. In spite of that, the management of allergic disease should consider the potential need for psychosocial support.

Psychosocial characterization of patients with atopic dermatitis in conventional versus alternative-medical therapy.

OBJECTIVE: Recording of psychosocial differences between patients with atopic dermatitis (AD) undergoing conventional versus alternative-medical treatment as indication of a center-related selection effect. STUDY DESIGN: In this prospective comparative study, inpatients of an alternative-medical clinic and of the University Dermatology Clinic Freiburg were given standardized questionnaires on psychosocial characteristics in the areas of disease-specific stress, social support, and coping with the disease. PATIENTS: Fifty-nine consecutive AD patients were recruited at the alternative-medical clinic and 79 AD patients at the University Dermatology Clinic. Fifty-five (93.2%) and 73 (92.4%) patients respectively returned completed questionnaires. RESULTS: The two treatment groups differed markedly from one another with respect to psychosocial parameters. Patients of the alternative-medical clinic showed greater disease-specific stress, lower social integration, and higher values in the coping scales 'depressive coping' and 'religious conviction and search for meaning'. Compared to patients with acne vulgaris, both patient groups were under significantly greater disease-specific stress. The factor 'social integration' was determined by logistical regression analysis to be the most important differentiation characteristic between the groups. CONCLUSIONS: Patients under alternative-medical treatment may show significant psychosocial differences in comparison with conventionally treated patients. In comparative studies between conventional and alternative-medical therapy centers, selection effects must be assumed and taken into account when evaluating the study.