comfrey and Acute-Disease

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.

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

A previously published study comparing the efficacy of comfrey extract to a commercial diclofenac (CAS 78213-16-8) preparation in the treatment of unilateral ankle sprains is critically re-evaluated. The study was designed to show non-inferiority of the comfrey extract. The data were re-evaluated for superiority according to CPMP guidelines. The study was an observer-blind, randomised, multi-centre clinical trial with two independent treatment groups "comfrey extract" and "diclofenac gel" (parallel group design) and included a total of 164 patients (82 in the comfrey group and 82 in the diclofenac group, intention-to-treat (ITT) analysis). Key variables were the area under the curve (AUC) from Visits 1 to 2 of the difference of the tenderness values contra-lateral minus injured side (primary variable), pain assessment (Visual Analogue Scale, VAS) at rest and on movement by patient, swelling (figure-of-eight method) and ankle movement (neutral zero method). On average (mean difference comfrey extract minus diclofenac), the AUC was +61.1 h x N/cm2 greater for patients treated with comfrey extract compared to diclofenac treated patients (95% confidence interval: 19.08; 103.09 h x N/cm2). The difference between the two treatment groups was statistically significant (analysis of variance with factors "study drug", "centre", and "drug x centre interaction"). Safety was excellent in both treatment groups. The re-evaluation of the data showed superiority of the plant based ointment over the diclofenac gel in the treatment of distortions. It is encouraging and impressive to realize that a natural product seems to be an effective and safe alternative to the standard topical treatment with diclofenac.

Topics: Acute Disease; Administration, Topical; Adult; Anti-Inflammatory Agents, Non-Steroidal; Area Under Curve; Comfrey; Diclofenac; Edema; Female; Humans; Male; Manometry; Ointments; Pain; Pain Measurement; Phytotherapy; Plant Extracts; Single-Blind Method; Sprains and Strains