comfrey and Edema

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

In a controlled, double blind, randomized multicentre study, the efficacy and safety of the topical comfrey product Traumaplant (10% active ingredient of a 2.5:1 aqueous ethanolic pressed juice of freshly harvested, cultivated comfrey herb (Symphytum x uplandicum NYMAN), corresponding to 25 g of fresh herb per 100 g of cream; n = 104) was tested against a 1% product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n = 99) in 203 patients with acute ankle distortion. With the high concentration, decrease of the scores for pain on active motion, pain at rest and functional impairment was highly significant and clinically relevant on days T3-4 as well as T7 (p < 0.001). Amelioration of swellings as compared to reference was also significant on day 3-4 (p < 0.01). Efficacy was judged good to excellent in 85.6% of cases with verum and in 65.7% of cases with reference on day 3-4. Overall tolerability was excellent.

Topics: Administration, Topical; Adolescent; Adult; Ankle Injuries; Comfrey; Double-Blind Method; Edema; Female; Humans; Joint Dislocations; Male; Middle Aged; Phytotherapy; Plant Extracts; Treatment Outcome

To assess the effect of Symphytum 5CH on the postoperative pain and swelling after placement of a titanium dental implant.. Data on pain and swelling following pure titanium implants were reviewed. Patients were treated postoperatively with ketoprofen only or ketoprofen and Symphytum 5CH, according to the treating dentist's usual practice. Demographics and baseline characteristics were recorded and compared. Pain and swelling were compared between the two treatment groups using the Wilcoxon rank sum test and ordinal logistic regression, estimating odds ratios and confidence intervals.. 100 implants in 57 patients (28 males, 29 females) were treated with ketoprofen alone; 100 implants in 60 patients (14 males, 46 females) with ketoprofen and Symphytum. The group treated with ketoprofen and Symphytum appeared to have a better response in terms of both pain and swelling. Ordinal logistic regression: pain 0.23, 95% CI 0.13-0.41; swelling 0.24, 95% CI 0.13-0.44. Correction for demographics and implant characteristics greatly widened the confidence intervals so that the results were no longer statistically significant (pain: OR = 0.15, 95% CI 0.07-34.56; swelling OR = 0.18, 95% CI 0.07-46.78).. Adding Symphytum 5CH to conventional analgesia may reduce pain and swelling after minor dental implant surgery. No firm conclusion can be drawn since the results are confounded by baseline differences, principally gender. Further, randomized, studies should be conducted.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Comfrey; Confidence Intervals; Dental Implants; Drug Therapy, Combination; Edema; Facial Pain; Female; Homeopathy; Humans; Ketoprofen; Logistic Models; Male; Middle Aged; Odds Ratio; Pain Measurement; Pain, Postoperative; Plant Extracts; Treatment Outcome