Advances in Therapy

, Volume 22, Issue 6, pp 681–692 | Cite as

TopicalSymphytum herb concentrate cream against myalgia: A randomized controlled double-blind clinical study

  • Miroslav Kucera
  • Milos Barna
  • Ondrej Horácek
  • Jan Kálal
  • Alexander Kucera
  • Marie Hladíkova
Article

Abstract

The effectiveness and tolerability of the topicalSymphytum product Traumaplant® (Harras Pharma Curarina, München, Germany) (10% active ingredient of a 2.5:1 aqueous-ethanolic pressed concentrate of freshly harvested, cultivated comfrey herb [Symphytum uplandicum Nyman], corresponding to 25 g of fresh herb per 100 g of cream) in the treatment of patients with myalgia (n=104) were tested against a 1% reference product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n=111). The primary efficacy parameter in this double-blind, reference-controlled, randomized, multicenter study of 215 patients with pain in the lower and upper back was pain in motion, assessed with the aid of a visual analogue scale. Secondary efficacy parameters included pain at rest, pain on palpation, and functional impairment. With high concentrations of the treatment product, amelioration of pain on active motion (P > 5×10-9), pain at rest (P > .001), and pain on palpation (P=5×10-5) was significantly more pronounced than that attained with the reference product and was clinically highly relevant. A number needed to treat of 3.2 was calculated from the study results. Global efficacy was significantly better (P = 1 × 10-8) and onset of effects was faster (P = 4 × 10-7) with the high-concentration product. Tolerability of the highly concentrated study product was good to excellent in all patients. Study results confirm the known anti-inflammatory and analgesic effects of topicalSymphytum cream. As a new finding, applicability in certain forms of back pain can be concluded.

Keywords

comfrey Symphytum herb extract topical application double-blind study myalgia muscle pain back pain 

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Copyright information

© Springer Science and Business Media and LLC 2005

Authors and Affiliations

  • Miroslav Kucera
    • 1
  • Milos Barna
    • 1
  • Ondrej Horácek
    • 1
  • Jan Kálal
    • 1
  • Alexander Kucera
    • 2
  • Marie Hladíkova
    • 3
  1. 1.Department of Sports Medicine and Rehabilitation2nd Medical Faculty Charles University in PraguePragueCzech Republic
  2. 2.Department of Children’s SurgeryUK
  3. 3.Department of Medical Informatics2nd Medical Faculty Charles University in PraguePragueCzech Republic

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