Article

Efficacy and safety of comfrey root extract ointment in the treatment of acute upper or lower back pain: results of a double-blind, randomised, placebo controlled, multicentre trial. Br J Sports Med

CRM Pharmaberatung GmbH, Rheinbach, Germany.
British Journal of Sports Medicine (Impact Factor: 5.03). 06/2009; 44(9):637-41. DOI: 10.1136/bjsm.2009.058677
Source: PubMed

ABSTRACT

The objective was to show the superiority of comfrey root extract ointment to placebo ointment in patients with acute upper or lower back pain.
The study was conducted as a double-blind, multicentre, randomised clinical trial with parallel group design over a period of 5 days (SD 1). The patients (n = 120, mean age 36.9 years) were treated with verum or placebo ointment three times a day, 4 g ointment per application. The trial included four visits.
The primary efficacy variable was the area under the curve (AUC) of the visual analogue scale (VAS) on active standardised movement values at visits 1 to 4. The secondary efficacy variables were back pain at rest using assessment by the patient on VAS, pressure algometry (pain-time curve; AUC over 5 days), global assessment of efficacy by the patient and the investigator, consumption of analgesic medication and functional impairment measured using the Oswestry disability index.
There was a significant treatment difference between comfrey extract and placebo regarding the primary variable. In the course of the trial the pain intensity on active standardised movement decreased on average (median) approximately 95.2% in the verum group and 37.8% in the placebo group.
The results of this clinical trial were clear-cut and consistent across all primary and secondary efficacy variables. Comfrey root extract showed a remarkably potent and clinically relevant effect in reducing acute back pain. For the first time a fast-acting effect of the ointment (1 h) was also witnessed.

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    • "This trial design was discussed and agreed in a scientific advisory procedure with the relevant German national authority, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Parties agreed to conduct this trial as a sibling study of the above mentioned back pain trial with comfrey root extract (Giannetti et al., 2010) and to use the most similar design possible. The full concept and the results that can be taken from both trials in combination will be subject to a seperate publication under preparation. "
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    ABSTRACT: This randomised, multicentre, double-blind, three-arm, placebo-controlled trial compared a topical combination of 35% comfrey root extract plus 1.2% methyl nicotinate versus a single preparation of methyl nicotinate or placebo cream for relief of acute upper or low back pain. 379 patients were randomly assigned to three groups (combination, n = 163; methyl nicotinate, n = 164; placebo, n = 52). They applied a 12 cm layer of cream three times daily for 5 days. The primary efficacy variable was the area under the curve (AUC) of the visual analogue scale (VAS) on active standardised movement values at visits 1 to 4. Secondary measures included back pain at rest, pressure algometry, consumption of analgesic medication, functional impairment measured with Oswestry Disability Index, and global assessment of response. The AUC of the VAS on active standardised movement was markedly smaller in the combination treatment group than in the methyl nicotinate and in the placebo group (ANOVA: p < 0.0001). The combination demonstrated superiority to the two other treatment arms, while methyl nicotinate displayed a considerable effect as well. Copyright © 2012 John Wiley & Sons, Ltd.
    Full-text · Article · Jun 2013 · Phytotherapy Research
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    • "A double-blind, placebo-controlled, multi-centre, randomised clinical trial with parallel group design was conducted over a period of 5 days [11]. Total 120 patients with acute upper or lower back pain used either a verum cream containing comfrey root fluid extract (1:2, 35.0 g, extraction solvent ethanol 60 % (v/v), less than 0.35 ppm of pyrrolizidine alkaloids) or a corresponding placebo. "
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    ABSTRACT: Comfrey (Symphytum officinale L.) has been used over many centuries as a medicinal plant. In particular, the use of the root has a longstanding tradition. Today, several randomised controlled trials have demonstrated the efficacy and safety. Comfrey root extract has been used for the topical treatment of painful muscle and joint complaints. It is clinically proven to relieve pain, inflammation and swelling of muscles and joints in the case of degenerative arthritis, acute myalgia in the back, sprains, contusions and strains after sports injuries and accidents, also in children aged 3 years and older. This paper provides information on clinical trials, non-interventional studies and further literature published on comfrey root till date.
    Full-text · Article · Dec 2012 · Wiener Medizinische Wochenschrift
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    • "A double-blind, placebo-controlled, multicentre, randomized clinical trial with parallel group design was conducted over a period of 5 days (Giannetti et al., 2010). One-hundred and twenty patients with acute upper or lower back pain were treated three times a day, 4 g per application. "
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    ABSTRACT: Comfrey has a centuries-old tradition as a medicinal plant. Today, multiple randomized controlled trials have demonstrated the efficacy and safety of comfrey preparations for the topical treatment of pain, inflammation and swelling of muscles and joints in degenerative arthritis, acute myalgia in the back, sprains, contusions and strains after sports injuries and accidents, also in children aged 3 or 4 and over. This paper provides information on clinical trials and non-interventional studies published on comfrey to date and further literature, substantiating the fact that topical comfrey preparations are a valuable therapy option for the treatment of painful muscle and joint complaints. Copyright © 2012 John Wiley & Sons, Ltd.
    Full-text · Article · Apr 2012 · Phytotherapy Research
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