Annegret Franke

A randomized controlled trial on the effectiveness of mild water-filtered near infrared whole-body hyperthermia as an adjunct to a standard multimodal rehabilitation in the treatment of fibromyalgia.

ObjectivesTo evaluate whether mild water-filtered near infrared whole-body hyperthermia (NI-WBH) produces an additional benefit when applied as an adjunct to a standard multimodal rehabilitation (MR) compared with MR only in patients with fibromyalgia (FM). MethodsOne hundred thirty-nine patients of a German inpatient rehabilitation hospital meeting the ACR 1990 criteria for FM were randomly allocated to NI-WBH (heating-up to 38.1 degrees C body core temperature followed by a 15 min heat retention period) and MR or MR only, twice a week over 3 weeks. Main outcome measures were affective and sensory pain assessed by a German version of the McGill Pain Questionnaire, measured at baseline, postintervention, 3 and 6 months postintervention and analyzed by intention to treat. ResultsRepeated measures analysis of covariance showed significant differences between groups for both primary outcome measures in favor of NI-WBH and MR compared with MR only (P<0.001 for affective pain, P=0.001 for sensory pain). Secondary analyses on pain intensity, FM-related quality of life and tender point assessment yielded similar results. Moderate effect sizes were observed for all outcome measures considered (range, 0.41 to 0.75). NI-WBH related side effects were observed in 14 of 69 participants (20%) but all disappeared in less than 30 minutes. DiscussionThe study indicates that NI-WBH is a worthwhile adjunct to MR in the treatment of FM.

Measurement of health-related quality of life in adult patients with birch pollen-associated food allergy.

The “Food Allergy Quality of Life Questionnaire – Adult Form” (FAQLQ‐AF) is the first freely available questionnaire for the assessment of health‐related quality of life (HRQL) in adults with food allergy (FA). We present validation data for the German version as well as data on HRQL in patients with birch pollen‐associated FA.

Evaluation of the efficacy of subcutaneous carbon dioxide insufflations for treating acute non specific neck pain in general practice: A sham controlled randomized trial

Background: Subcutaneous carbon dioxide insufflations are a safe and inexpensive treatment modality in complementary medicine and are used mainly in musculoskeletal pain and vascular conditions. However, no rigorous trial exists on their efficacy.

Construct Validity of the Questionnaire on Experience with Skin Complaints (Short Form)

Abstract. Introduction: Feelings of stigmatization can strongly influence quality of life in individuals with chronic skin diseases. The Short-Form of the Questionnaire on Experience with Skin Complaints (SF-QES) differentiates four factors of stigmatization: self-esteem and retreat, experienced refusal, concealment, and composure. The current study aimed to investigate the construct validity of the SF-QES. Method: The analysis was based on the complete SF-QES records of a clinical psoriasis trial, which yielded 1,005 records at baseline, 1,010 records at the end of therapy, and 885 and 827 records, respectively, at two follow-ups. Factor analyses and corresponding structural equation models (SEMs) using robust maximum likelihood estimation (RML) were applied. Additionally, the responsiveness of the scales to judgments of treatment success and two different interventions were compared. Results: The factor analyses provided results that widely agreed with the supposed four factors. SEM, however, showed mod...

The BASALIT multicenter trial: Gly m 4 quantification for consistency control of challenge meal batches and toward Gly m 4 threshold data.

Scope: The BASALIT clinical trial (EudraCT 2009‐011737‐27) investigated efficacy of birch allergen immunotherapy on lowest observed adverse effect levels after soy food challenge in patients with birch‐associated and Gly m 4 allergen mediated soy allergy. Thus, consistently stable Gly m 4 levels were required in standardized challenge meals. Methods and results: Soy meal included soy protein isolate (SPI, 88% total protein). A Gly m 4 specific ELISA was developed and validated. Six SPIs and 24 meal batches were analyzed for Gly m 4. (Repeated‐measures) analyses of variance were done to identify potential changes between batches and time intervals. Gly m 4 was below the ELISA detection limit (2 ng/mL) in placebo batches. With <20% mean coefficient of variation, Gly m 4 levels were consistent in 24 soy meal batches and within individual 12‐wk shelf‐life. Conclusion: The novel Gly m 4 specific ELISA proved consistency of challenge meal batches over a 56‐month study period. With an average of 178 μg/g Gly m 4 in SPI, Gly m 4 lowest observed adverse effect level can be calculated once clinical lowest observed adverse effect level data based on SPI are available. Hence, sensitivity of patients can be correlated to the relevant allergen content instead of total protein of the allergenic source.

Application of the German SF-36 in hospitals: overestimations in the psycho-social scales.

The well-known SF-36 is the most widely used generic instrument to quantify health-related quality of life (Ware 2000; Ware et al. 1993). Although it was originally developed for epidemiological research, it is increasingly applied in in-patient settings. However, results from in-patients who are requested to fi ll out the SF-36 at the end of their hospital stay show high non-response rates for the items of three scales (Zwingmann et al. 1998). Since some of the terms in the German SF-36 (Bullinger & Kirchberger 1998) such as “at home” or “at work” do not make sense in a hospital setting, this is hardly surprising. To eliminate this problem we developed a slightly modifi ed version of the SF-36. The psychometric evaluation of this modifi ed SF-36 yielded favorable results (Müller et al. 2001). However, we also observed a small but statistically signifi cant response shift bias yielding higher SF-36 scores in the hospital environment. It was not established whether this is unique to the original SF-36 or whether the modifi ed instrument version is equally sensitive to this response shift bias. The present paper examines this issue.

Messung der gesundheitsbezogenen Lebensqualität bei erwachsenen Patienten mit birkenpollenassoziierter Nahrungsmittelallergie.

: Der „Food Allergy Quality of Life Questionnaire – Adult Form“ (FAQLQ‐AF) ist der erste frei verfügbare Fragebogen zur Erfassung der gesundheitsbezogenen Lebensqualität (health‐related quality of life; HRQL) bei Erwachsenen mit Nahrungsmittelallergie (NMA). Wir präsentieren Daten zur Validierung der deutschsprachigen Version sowie zur HRQL bei Patienten mit birkenpollenassoziierter NMA.