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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.
Br J Sports Med 2010; 44(9):637-41BJ

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.

Authors+Show Affiliations

CRM Pharmaberatung GmbH, Rheinbach, Germany.No affiliation info availableNo affiliation info availableNo affiliation info available

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 -