Characteristics, risk factors and treatment reality in livedoid vasculopathy - a multicentre analysis.

BACKGROUND: Livedoid vasculopathy (LV) is a rare cutaneous thrombotic disease. It is characterized by occlusion of dermal vessels resulting in livedo racemosa, ulceration and atrophie blanche. Clear guidelines for diagnosis and treatment are missing. OBJECTIVE: The purpose of this study was to better characterize epidemiology, clinical appearance and treatment reality of LV in a well-defined patient cohort. METHODS: The cohort was allocated within a prospective, multicentre, phase IIa trial that investigated the effect of rivaroxaban in LV. RESULTS: Analysis of 27 patients revealed that LV patients had an increased Body Mass Index (BMI; 11/27), hypertension (19/27) and increased levels of lipoprotein (a) (5/12) and homocysteine (10/12) in the blood. The female-to-male ratio was 2.1 : 1, and the median age was 53.0 years [interquartile range (IQR) 40.5-68]. Investigation of the clinical appearance found that 82% of patients had livedo racemosa, and the ankle region was most likely to be affected by ulceration (56-70%). The analysis of patient treatment history showed that heparin was most effective (12/17), while anti-inflammatory regimens were, although often used (17/24), not effective (0/17). CONCLUSION: We add clinical clues for a data supported diagnosis of LV, and we provide evidence that anticoagulants should be administered in monotherapy first line (EudraCT number 2012-000108-13-DE).

An international expert survey on acupuncture in randomized controlled trials for low back pain and a validation of the low back pain acupuncture score.

BACKGROUND: Acupuncture is a promising treatment approach in patients with chronic low back pain (cLBP) but little is known about the quality of acupuncture in randomized controlled trials (RCT) of acupuncture cLBP. - OBJECTIVE: To determine how international experts (IES) rate the quality of acupuncture in RCTs of cLBP; independent international validation of the Low Back Pain Acupuncture Score (LBPAS). METHODOLOGY: Fifteen experts from 9 different countries outside China were surveyed (IES). They were asked to read anonymized excerpts of 24 RCTs of cLBP and answer a three-item questionnaire on how the method of acupuncture conformed to 1) Chinese textbook standards, 2) the expert?s personally preferred style, and 3) how acupuncture is performed in the expert?s country. Likert scale rating, calculation of the mode for each answer, and Spearman?s rank correlation coefficient between all three answers and the LBPAS were calculated. RESULTS: On comparison with Chinese textbook standards (question 1), 6 RCTs received a good rating, 8 trials a fair and 10 trials a poor or very poor rating. 5 of the 6 trials rated good, received at least a good rating also in question 2 or 3. We found a high correlation of 0.85 (p<0.0001) between the IES and LBPAS ratings for question 1 and question 2, and a correlation of 0.66 (p<0.0001) for question 3. CONCLUSION: The international expert survey (IES) revealed that only 6 out of 24 (25%) RCTs of acupuncture for cLBP were rated "good" in respect to Chinese textbook acupuncture standards. There were only small differences in how the acupuncture quality was rated in comparison to Chinese textbook acupuncture, personally preferred and local styles of acupuncture. The rating showed a high correlation with the Low Back Pain Acupuncture Score LBPAS.

Designing an acupuncture study to meet evidence-based medical criteria: methodological considerations for logistic design and development of treatment interventions arising from the German randomized controlled acupuncture trial on chronic shoulder pain (GRASP).

The results from studies on potential treatment effects of acupuncture are often limited due to serious difficulties in methodology. Randomized controlled trials on acupuncture should test a widely accepted treatment strategy of verum and sham acupuncture. However, in clinical practice various patterns of acupuncture techniques are employed, and up to now no generally accepted guidelines on how to perform a reliable verum or sham treatment have been established. Another limitation is that in most studies the study populations are too small to obtain reliable data and to detect subtle differences between the unspecific needling of sham acupuncture and specific needling of verum acupuncture with sufficient statistical power. Moreover, only a multicenter trial in an outpatient setting would guarantee a naturalistic environment in which acupuncture is used in clinical practice. In the present report we discuss such methodological aspects in detail and summarize some practical considerations for planning an acupuncture trial that fulfills evidence-based medical criteria. The largest German study on the treatment effects of acupuncture in patients with chronic shoulder pain (recruited patients n = 452), might serve as an example for such a well-designed study. Before we could conduct our study, clear definitions and protocols for the verum and sham acupuncture treatments as well as adequate endpoints had to be developed. For this we used a combination of a comprehensive study of the literature and structured interviews with experienced physicians followed by an expert panel. A total of 41 physicians had to be trained to achieve a homogeneously high quality of acupuncture treatment. The latter represents a prerequisite for reproducibility, constituting a critical component of rigorous efficacy trials in scientific acupuncture research.