Moré Margret, Gruenwald Joerg, Pohl Ute, Uebelhack Ralf
Herbalist & Doc Gesundheitsgesellschaft mbH, Berlin, Germany.
analyze & realize GmbH Berlin, Germany.
Planta Med. 2017 Dec;83(18):1384-1391. doi: 10.1055/s-0043-112750. Epub 2017 Jun 14.
The special formulation MA212 (Rosaxan) is composed of rosehip ( L.) puree/juice concentrate, nettle ( L.) leaf extract, and devil's claw ( DC. ex Meisn. or Decne.) root extract and also supplies vitamin D. It is a food for special medical purposes ([EU] No 609/2013) for the dietary management of pain in patients with gonarthritis.This 12-week randomized, placebo-controlled double-blind parallel-design study aimed to investigate the efficacy and safety of MA212 versus placebo in patients with gonarthritis.A 3D-HPLC-fingerprint (3-dimensional high pressure liquid chromatography fingerprint) of MA212 demonstrated the presence of its herbal ingredients. Ninety-two randomized patients consumed 40 mL of MA212 (n = 46) or placebo (n = 44) daily. The Western Ontario and McMaster Universities Arthritis Index (WOMAC), quality-of-life scores at 0, 6, and 12 weeks, and analgesic consumption were documented. Statistically, the initial WOMAC subscores/scores did not differ between groups. During the study, their means significantly improved in both groups. The mean pre-post change of the WOMAC pain score (primary endpoint) was 29.87 in the MA212 group and 10.23 in the placebo group. The group difference demonstrated a significant superiority in favor of MA212 (p < 0.001; p < 0.001). Group comparisons of all WOMAC subscores/scores at 6 and 12 weeks reached same significances. Compared to placebo, both physical and mental quality of life significantly improved with MA212. There was a trend towards reduced analgesics consumption with MA212, compared to placebo. In the final efficacy evaluation, physicians (p < 0.001) and patients (p < 0.001) rated MA212 superior to placebo. MA212 was well tolerated.This study demonstrates excellent efficacy for MA212 in gonarthritis patients.
特殊配方MA212(Rosaxan)由玫瑰果(蔷薇属)果泥/浓缩汁、荨麻(荨麻属)叶提取物和魔鬼爪(哈氏破布木或 刺续断)根提取物组成,还含有维生素D。它是一种特殊医学用途食品([欧盟]第609/2013号),用于膝关节炎患者疼痛的饮食管理。这项为期12周的随机、安慰剂对照双盲平行设计研究旨在调查MA212与安慰剂相比对膝关节炎患者的疗效和安全性。MA212的三维高效液相色谱指纹图谱证明了其草药成分的存在。92名随机分组的患者每天服用40毫升MA212(n = 46)或安慰剂(n = 44)。记录了西安大略和麦克马斯特大学关节炎指数(WOMAC)、0、6和12周时的生活质量评分以及镇痛药的使用情况。在统计学上,两组的初始WOMAC子评分/评分没有差异。在研究期间,两组的均值均有显著改善。MA212组WOMAC疼痛评分(主要终点)的前后平均变化为29.87,安慰剂组为10.23。组间差异显示MA212具有显著优势(p < 0.001;p < 0.001)。6周和12周时所有WOMAC子评分/评分的组间比较均达到相同的显著性。与安慰剂相比,MA212使身体和心理生活质量均显著改善。与安慰剂相比,MA212有减少镇痛药使用的趋势。在最终疗效评估中,医生(p < 0.001)和患者(p < 0.001)均评定MA212优于安慰剂。MA212耐受性良好。这项研究证明MA212对膝关节炎患者具有出色的疗效。