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.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
Briel R. Die Anwendung vonSymphytum officinale, einer natürlichen Cholin-Allantoin-Kombination, in der Gynäkologie.Med Klin (München). 1953;48:676–678.
Hess H. Wirkung einerSymphytum-Salbe bei Sportverletzungen des Kniegelenks.Dtsch Z Sportmed. 1991;42:156–162.
Klein F. Der antiphlogistische Umschlag mitSymphytum officinale.Hippokrates. 1952;23:550–552.
Koll R, Buhr M, Dieter R, et al. Wirksamkeit und Verträglichkeit von Beinwellwurzelextrakt (Extr. rad.Symphyti) bei Sprunggelenksdistorsionen. Ergebnisse einer multizentrischen, randomisierten, Placebo-kontrollierten Doppelblindstudie.Z Phytother. 2000;21:127–134.
Koll R, Klingenburg S. Therapeutische Eigenschaften und Verträglichkeit topischer Beinwellzubereitungen.Fortschr Med Orig. 2002;120:1–9.
Kucera M, Kalal J, Polesna Z. Effects ofSymphytum ointment on muscular symptoms and functional locomotor disturbances.Adv Ther. 2000;17:204–210.
Kucera M, Barna M, Horacek O, Kovarikova J, Kucera A. Efficacy and safety of topically appliedSymphytum herb extract cream in the treatment of ankle distortion: results of a randomized controlled clinical double blind study.Wiener Med Wschr. 2004;154:498–507.
Majewska M. [Therapy of chronic skin ulcerations withSymphytum products.]Pol Tyg Lek (Wars). 1955;10:333–335.
Mayer G. Die Lokalbehandlung der akuten lateralen Distorsion des oberen Sprunggelenkes mit einer Symphytum-Wirkstoffkomplexsalbe.Acta Ther. 1991;17:89–100.
Mayer G. Die Lokalbehandlung von Kontusionen und Distorsionen des Kniegelenkes mit einer Symphytum-Wirkstoffkomplex-Salbe.Erfahrungsheilkunde. 1992;41:888–891.
Mayer G. Die Lokalbehandlung des akuten Supraspinatus-Sehnensyndroms mit einerSymphytum- Wirkstoffkomplex-Salbe.Acta Ther. 1993;44:121–124.
Niedner R. Beeinflussung der Epithelialisierung durch einen Wirkstoffkomplex ausSymphytum.Acta Ther. 1989;15:289–297.
Schmidtke-Schrezenmeier G, Reck R, Gerster G. Behandlung der nichtaktivierten Gonarthose-Besserung durch ein Phytotherapeutikum.Therapiewoche. 1992;42:1322–1326.
Ziolkowski Z, Orszulak J, Wojtanowska H. [Aqueous extract ofSymphytum officinale in the treatment of some skin diseases in infants.]Pediatr Pol. 1957;32:1353–1360.
German Commission E. Monographie:Symphyti herba/folium (Beinwellkraut/-blätter).Bundesanz. No. 138; July 27, 1990.
Huskisson EC. Measurement of pain.Lancet. 1974;2:1127–1131.
Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain?Acad Emerg Med. 1998;5:1086–1090.
Eberle E, Ottillinger B. Clinically relevant change and clinically relevant difference in knee osteoarthritis.Osteoarthritis Cartilage. 1999;7:502–503.
Ehrlich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis.J Rheumatol. 2000;27:2635–2641.
Reiter S. Topische nichtsteroidale Antirheumatika: Aspekte zur Planung und Auswertung klinischer Studien und Ergebnis-Bewertung im Zulassungsverfahren.Bundegesundheitsbl Gesundheitsforsch Gesundheitsschutz. 2000;43:950–959.
Moore RA, Tramèr MR, Carroll D, Wiffen PJ, McQuay HJ. Quantitative systematic review of topically applied non-steroidal anti-inflammatory drugs.BMJ. 1998;316:333–338.
Wells GA, Tugwell P, Kraag GR, Baker PR, Groh J, Redelmeier DA. Minimum important difference between patients with rheumatoid arthritis: the patient’s perspective.J Rheumatol. 1993;20:557–560.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Kucera, M., Barna, M., Horácek, O. et al. TopicalSymphytum herb concentrate cream against myalgia: A randomized controlled double-blind clinical study. Adv Therapy 22, 681–692 (2005). https://doi.org/10.1007/BF02849961
Issue Date:
DOI: https://doi.org/10.1007/BF02849961