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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.

Abstract

OBJECTIVE

The objective was to show the superiority of comfrey root extract ointment to placebo ointment in patients with acute upper or lower back pain.

DESIGN

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.

MAIN OUTCOME MEASURES

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.

RESULTS

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.

CONCLUSIONS

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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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    CRM Pharmaberatung GmbH, Rheinbach, Germany.

    , ,

    Source

    British journal of sports medicine 44:9 2010 Jul pg 637-41

    MeSH

    Acute Disease
    Adult
    Comfrey
    Double-Blind Method
    Female
    Humans
    Low Back Pain
    Male
    Middle Aged
    Ointments
    Phytotherapy
    Plant Extracts
    Plant Roots
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    19460762

    Citation

    Giannetti, B M., et al. "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." British Journal of Sports Medicine, vol. 44, no. 9, 2010, pp. 637-41.
    Giannetti BM, Staiger C, Bulitta M, et al. 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. 2010;44(9):637-41.
    Giannetti, B. M., Staiger, C., Bulitta, M., & Predel, H. G. (2010). 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. British Journal of Sports Medicine, 44(9), pp. 637-41. doi:10.1136/bjsm.2009.058677.
    Giannetti BM, et al. 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. 2010;44(9):637-41. PubMed PMID: 19460762.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - 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. AU - Giannetti,B M, AU - Staiger,C, AU - Bulitta,M, AU - Predel,H-G, Y1 - 2009/05/21/ PY - 2009/5/23/entrez PY - 2009/5/23/pubmed PY - 2011/7/2/medline SP - 637 EP - 41 JF - British journal of sports medicine JO - Br J Sports Med VL - 44 IS - 9 N2 - OBJECTIVE: The objective was to show the superiority of comfrey root extract ointment to placebo ointment in patients with acute upper or lower back pain. DESIGN: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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. SN - 1473-0480 UR - https://www.unboundmedicine.com/medline/citation/19460762/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_ L2 - http://bjsm.bmj.com/cgi/pmidlookup?view=long&pmid=19460762 DB - PRIME DP - Unbound Medicine ER -