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Planta Med 2017; 83(18): 1384-1391
DOI: 10.1055/s-0043-112750
Biological and Pharmacological Activity
Original Papers
Georg Thieme Verlag KG Stuttgart · New York

A Rosa canina – Urtica dioica – Harpagophytum procumbens/zeyheri Combination Significantly Reduces Gonarthritis Symptoms in a Randomized, Placebo-Controlled Double-Blind Study

Margret Moré
1   Herbalist & Doc Gesundheitsgesellschaft mbH, Berlin, Germany
,
Joerg Gruenwald
1   Herbalist & Doc Gesundheitsgesellschaft mbH, Berlin, Germany
,
Ute Pohl
2   analyze & realize GmbH Berlin, Germany
,
Ralf Uebelhack
3   Charité, Berlin, Germany
› Author Affiliations
Further Information

Publication History

received 04 January 2017
revised 06 May 2017

accepted 27 May 2017

Publication Date:
14 June 2017 (online)

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Abstract

The special formulation MA212 (Rosaxan) is composed of rosehip (Rosa canina L.) puree/juice concentrate, nettle (Urtica dioica L.) leaf extract, and devilʼs claw (Harpagophytum procumbens DC. ex Meisn. or Harpagophytum zeyheri 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 (pU < 0.001; pt < 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 (pChi < 0.001) and patients (pChi < 0.001) rated MA212 superior to placebo. MA212 was well tolerated.

This study demonstrates excellent efficacy for MA212 in gonarthritis patients.

Key words

knee osteoarthritis - clinical trial - Rosa canina L. - Rosaceae - Urtica dioica L. - Urticaceae - Harpagophytum procumbens DC. ex Meisn./Harpagophytum zeyheri Decne. - Pedaliaceae - WOMAC

Supporting Information

    Fig. 1S (Supporting Information) shows HPLC chromatograms at 270 nm and 350 nm of the single MA212 ingredients (R. canina puree/juice concentrate, U. dioica leaf extract, H. procumbens/zeyheri root extract) and of Rosaxan; the positions of the marker compounds are indicated, and inlays show the UV spectra of the markers.

    Also, Table 1S (Supporting Information) shows characteristics of the ingredients of the special formulation MA212 (Rosaxan).

  • Supporting Information
 

  • References

  • 1 Herold G. Innere Medizin. Köln: Gerd Verlag; 2007: 614-615
    Search in Google Scholar
  • 2 Wirth CJ, Zichner L, Kohn D. Orthopädie und Orthopädische Chirurgie. Stuttgart: Thieme; 2005
    Search in Google Scholar
  • 3 National Institute of Arthritis and Mucosceletal and Skin Diseases. Handout on Health: Osteoarthritis. May 2016. Available at. http://www.niamsnihgov/Health_Info/Osteoarthritis/defaultasp Accessed June 10, 2017
    PubMed
  • 4 European Medicines Agency (EMA). Community Herbal Monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri DECNE, Radix. London: European Medicines Agency; 2008
    Search in Google Scholar
  • 5 Thorne Research, Inc.. Urtica dioica; Urtica urens (Nettle). 2007. Available at. http://www.altmedrev.com/publications/12/3/280.pdf Accessed June 10, 2017
    PubMed
  • 6 Engels G, Brinckmann J. Dog rose hip Rosa canina . HerbalGram 2016; 111: 8-19
    PubMedSearch in Google Scholar
  • 7 Engels G, Brinckmann J. Stinging Nettle Urtica dioica, U. urens. Family: Urticaceae. HerbalGram 2016; 110: 8-16
    PubMedSearch in Google Scholar
  • 8 Chrubasik C, Duke RK, Chrubasik S. The evidence for clinical efficacy of rose hip and seed: a systematic review. Phytother Res 2006; 20: 1-3
    CrossrefPubMedSearch in Google Scholar
  • 9 Christensen R, Bartels EM, Altman RD, Astrup A, Bliddal H. Does the hip powder of Rosa canina (rosehip) reduce pain in osteoarthritis patients? – A meta-analysis of randomized controlled trials. Osteoarthritis Cartilage 2008; 16: 965-972
    CrossrefPubMedSearch in Google Scholar
  • 10 Chrubasik JE, Roufogalis BD, Wagner H, Chrubasik SA. A comprehensive review on nettle effect and efficacy profiles, Part I: herba urticae. Phytomedicine 2007; 14: 423-435
    CrossrefPubMedSearch in Google Scholar
  • 11 Hager ROM. Hagers Handbuch der Drogen und Arzneistoffe. CD-ROM 2002.
    PubMed
  • 12 Jacquet A, Girodet PO, Pariente A, Forest K, Mallet L, Moore N. Phytalgic, a food supplement, vs. placebo in patients with osteoarthritis of the knee or hip: a randomised double-blind placebo-controlled clinical trial. Arthritis Res Ther 2009; 11: R192
    CrossrefPubMedSearch in Google Scholar
  • 13 [Anonymous] [General practice study with nettle extract. Arthrosis patient need fewer non-steroidal anti-inflammatory drugs]. MMW Fortschr Med 2002; 144: 52
    PubMedSearch in Google Scholar
  • 14 Mncwangi N, Chen W, Vermaak I, Viljoen AM, Gericke N. Devilʼs Claw – a review of the ethnobotany, phytochemistry and biological activity of Harpagophytum procumbens . J Ethnopharmacol 2012; 143: 755-771
    CrossrefPubMedSearch in Google Scholar
  • 15 Chrubasik S, Conradt C, Black A. The quality of clinical trials with Harpagophytum procumbens . Phytomedicine 2003; 10: 613-623
    CrossrefPubMedSearch in Google Scholar
  • 16 Gagnier JJ. Harpgophytum procumbens for osteoarthritis and low back pain: a systematic review. BMC Complement Altern Med 2004; 4: 13
    CrossrefPubMedSearch in Google Scholar
  • 17 Brendler T, Gruenwald J, Ulbricht C, Basch E. Devilʼs Claw (Harpagophytum procumbens DC): an evidence-based systematic review by the Natural Standard Research Collaboration. J Herb Pharmacother 2006; 6: 89-126
    PubMedSearch in Google Scholar
  • 18 Brien S, Lewith GT, McGregor G. Devilʼs Claw (Harpagophytum procumbens) as a treatment for osteoarthritis: a review of efficacy and safety. J Altern Complement Med 2006; 12: 981-993
    CrossrefPubMedSearch in Google Scholar
  • 19 Vlachojannis J, Roufogalis BD, Chrubasik S. Systematic review on the safety of Harpagophytum preparations for osteoarthritic and low back pain. Phytother Res 2008; 22: 149-152
    CrossrefPubMedSearch in Google Scholar
  • 20 Zhang W, Robertson J, Jones A, Dieppe P, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis 2008; 67: 1716-1723
    CrossrefPubMedSearch in Google Scholar
  • 21 European Food Safety Authority (EFSA). Scientific opinion on the substantiation of health claims related to vitamin D and normal function of the immune system and inflammatory response (ID 154, 159), maintenance of normal muscle function (ID 155) and maintenance of normal cardiovascular function (ID 159) pursuant to Article 13(1) of Regulation (EC) No 1924/20061. EFSA J 2010; 8: 1468
    PubMedSearch in Google Scholar
  • 22 Parker GB, Brotchie H, Graham RK. Vitamin D and depression. J Affect Disord 2017; 208: 56-61
    CrossrefPubMedSearch in Google Scholar
  • 23 Marstrand K, Campbell-Tofte J. The role of rose hip (Rosa canina L) powder in alleviating arthritis pain and inflammation – part II animal and human studies. Botanics 2016; 6: 59-73
    PubMedSearch in Google Scholar
  • 24 Winther K, Apel K, Thamsborg G. A powder made from seeds and shells of a rose-hip subspecies (Rosa canina) reduces symptoms of knee and hip osteoarthritis: a randomized, double-blind, placebo-controlled clinical trial. Scand J Rheumatol 2005; 34: 302-308
    CrossrefPubMedSearch in Google Scholar
  • 25 Schwager J, Richard N, Schoop R, Wolfram S. A novel rose hip preparation with enhanced anti-inflammatory and chondroprotective effects. Mediators Inflamm 2014; 2014: 105710
    PubMedSearch in Google Scholar
  • 26 Chrubasik JE, Roufogalis BD, Chrubasik S. Evidence of effectiveness of herbal antiinflammatory drugs in the treatment of painful osteoarthritis and chronic low back pain. Phytother Res 2007; 21: 675-683
    CrossrefPubMedSearch in Google Scholar
  • 27 Wenzig E, Widowitz U, Kunert O, Chrubasik S, Bucar F, Knauder E, Bauer R. Phytochemical composition and in vitro pharmacological activity of two rose hip (Rosa canina L.) preparations. Phytomedicine 2008; 15: 826-835
    CrossrefPubMedSearch in Google Scholar
  • 28 European Medicines Agency (EMA). Devilʼs claw root Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix. EMA/571858/2016; 2016. Available at. http://www.fitoterapia.net/archivos/201612/wc500217515.pdf?1 Accessed June 10, 2017
    PubMed
  • 29 Public Health England. Independent report – SACN vitamin D and health report. 2016. Available at: 2017. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/537616/SACN_Vitamin_D_and_Health_report.pdf Accessed June 10, 2017
    Search in Google Scholar
  • 30 World Medical Association (WMA). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013; 310: 2191-2194
    CrossrefPubMedSearch in Google Scholar
  • 31 Gandek B, Ware J, Aaronson N, Apolone G, Bjorner J, Brazier J, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. J Clin Epidemiol 1998; 51: 1171-1178
    CrossrefPubMedSearch in Google Scholar
  • 32 Rein E, Kharazmi A, Winther K. A herbal remedy, Hyben Vital (stand. powder of a subspecies of Rosa canina fruits), reduces pain and improves general wellbeing in patients with osteoarthritis – a double-blind, placebo-controlled, randomised trial. Phytomedicine 2004; 11: 383-391
    CrossrefPubMedSearch in Google Scholar
  • 33 Cohen M. Rosehip – an evidence based herbal medicine for inflammation and arthritis. Aust Fam Physician 2012; 41: 495-498
    PubMedSearch in Google Scholar