The anti-inflammatory effect of Arnica montana 6cH was evaluated using acute and chronic inflammation models. In the acute, model, carrageenin-induced rat paw oedema, the group treated with Arnica montana 6cH showed 30% inhibition compared to control (P<0.05). Treatment with Arnica 6cH, 30 min prior to carrageenin, did not produce any inhibition of the inflammatory process. In the chronic model, Nystatin-induced oedema, the group treated 3 days previously with Arnica montana 6cH had reduced inflammation 6 h after the inflammatory agent was applied (P<0.05). When treatment was given 6 h after Nystatin treatment, there was no significant inhibitory effect. In a model based on histamine-induced increase of vascular permeability, pretreatment with Arnica montana 6cH blocked the action of histamine in increasing vascular permeability.

OBJECTIVES:To design a model for performing reproducible, objective analyses of skin color changes and to apply this model to evaluate the efficacy of homeopathic Arnica montana as an antiecchymotic agent when taken perioperatively.

METHODS:Twenty-nine patients undergoing rhytidectomy at a tertiary care center were treated perioperatively with either homeopathic A. montana or placebo in a double-blind fashion. Postoperative photographs were analyzed using a novel computer model for color changes, and subjective assessments of postoperative ecchymosis were obtained.

RESULTS:No subjective differences were noted between the treatment group and the control group, either by the patients or by the professional staff. No objective difference in the degree of color change was found. Patients receiving homeopathic A. montana were found to have a smaller area of ecchymosis on postoperative days 1, 5, 7, and 10. These differences were statistically significant (P<.05) only on postoperative days 1 (P<.005) and 7 (P<.001).

CONCLUSIONS:This computer model provides an efficient, objective, and reproducible means with which to assess perioperative color changes, both in terms of area and degree. Patients taking perioperative homeopathic A. montana exhibited less ecchymosis, and that difference was statistically significant (P<.05) on 2 of the 4 postoperative data points evaluated.

INTRODUCTION: In homeopathy ARNICA is widely used as a woundhealing medication and for the treatment of hematomas. OBJECTIVE: In this pilot study the efficacy and safety of ARNICA D12 in patients following varicose vein surgery were investigated. DESIGN: Prospective, randomized, double-blind, placebo-controlled pilot trial according to ICH GCP guidelines. SETTING: The study was conducted by a surgeon at the Angiosurgical Clinic, Berlin- Buch. INTERVENTION: After randomized allocation, 60 patients received either ARNICA D12 or placebo. Start of medication occurred the evening before operation with 5 globules. On the operation day one preoperative and hourly postoperative dosages after awakening were given. On days 2-14 of the study 5 globules 3 times a day were given. OUTCOME CRITERIA: Surface (in cm(2) and using a three-point verbal rating scale) and intensity of hematomas induced by operation, complications of wound healing, and intensity of pain (five-point verbal rating scale) as well as efficacy and safety of the study medication were assessed. RESULTS: Hematoma surface was reduced (from day 7 to day 14) under ARNICA by 75.5% and under placebo by 71.5% (p = 0.4726). The comparison of hematoma surface (small, medium, large) using the verbal rating scale yielded a value of p = 0.1260. Pain score decreased by 1.0 +/- 2.2 points under ARNICA and 0.3 +/- 0.8 points under placebo (p = 0.1977). Remission or improvement of pain was observed in 43.3% of patients in the ARNICA group and in 27.6% of patients in the placebo group. Tolerability was rated as very good in all cases. CONCLUSION: The results of this pilot study showed a trend towards a beneficial effect of ARNICA D12 with regard to reduction of hematoma and pain during the postoperative course. For a statistically significant proof of efficacy of ARNICA D12 in patients following varicose vein surgery a larger sample size is necessary. Copyright 2003 S. Karger GmbH, Freiburg

OBJECTIVE: This study was undertaken to answer the question: "Is Arnica D4 as efficacious as diclofenac in relation to symptoms and wound healing after foot surgery?" METHODS: In this randomized double-blinded, parallel-group study (GCP-standard), the efficacy of Arnica D4 10 pillules (taken orally, 3 times per day) and diclofenac sodium, 50 mg (taken orally, 3 times per day) were investigated for equivalence in 88 patients 4 days after hallux valgus surgery. Outcome parameters were (1) postoperative irritation, (2) patient mobility, (3) rated pain, and (4) use of analgesics. The hierarchic equivalence test based on one-sided Wilcoxon-Mann-Whitney-U confidence intervals (CIs) was used. Equivalence was perceived, when the lower margin of the 95% CI was>0.36 corresponding to a range of equivalence of 1/2 standard deviation. RESULTS: Arnica D4 and diclofenac were equivalent for wound irritation (lower margin of the 95% CI on day 4: 0.4729 for rubor; 0.3674 for swelling; 0.4106 for calor) and patient mobility (0.4726). A descriptive analysis showed the superiority of Arnica D4 with respect to patient mobility (p = 0.045). With respect to pain, Arnica D4 was inferior to diclofenac (lower margin of the 95% CI 0.026). No significant differences were found regarding the use of additional analgesics during the 4 postoperative days (Dipidolor, Janssen-Cilag, Neuss, Germany; p = 0.54; Tramal, Grünenthal, Aachen, Germany; p = 0.1; and Novalgin, AVENTIS-Pharma, Bad Soden, Germany; p = 0.1). Arnica D4 was significantly better tolerated than diclofenac (p = 0.049). Nine (9) patients (20.45%) of the diclofenac group and 2 (4.5%) of the Arnica D4 group reported intolerance. There was no disturbance in wound healing in any of the patients. Arnica D4 is 60% cheaper than diclofenac. CONCLUSIONS: After foot operations, Arnica D4 can be used instead of diclofenac to reduce wound irritation.

OBJECTIVE:To evaluate the efficacy of Homeopathic Arnica in reducing the morbidity following tonsillectomy.

METHODS:Randomised double blind, placebo controlled trial at a tertiary referral centre. 190 patients over the age of 18 undergoing tonsillectomy were randomised into intervention and control groups receiving either Arnica 30c or identical placebo, 2 tablets 6 times in the first post-operative day and then 2 tablets twice a day for the next 7 days. The primary outcome measure was the change in pain scores (visual analogue scale) recorded by the patient on a questionnaire over 14 days post-operatively; Secondary outcome measures were: analgesia consumption, visits to the GP or hospital, antibiotic usage, the day on which their swallowing returned to normal and the day on which they returned to work.

RESULTS:111 (58.4%) completed questionnaires were available for analysis. The Arnica group had a significantly larger drop in pain score from day 1 to day 14 (28.3) compared to the placebo group (23.8) with p<0.05. The two groups did not differ significantly on analgesic consumption or any of the other secondary outcome measures (number of post-operative visits to GP, use of antibiotics and secondary haemorrhage readmissions).

CONCLUSION:The results of this trial suggest that Arnica montana given after tonsillectomy provides a small, but statistically significant, decrease in pain scores compared to placebo.

The effects of Arnica montana 6cH on the individual modulation of acute inflammation kinetics in rats were evaluated. Adult male Wistar rats were inoculated with 1% carrageenan into the footpad and treated with Arnica montana 6cH, dexamethasone (4.0 mg/kg; positive control) or 5% hydroalcoholic solution (negative control), per os, each 15 minutes, between 30 and 180 minutes after the irritant inoculation. Histopathological and immunohistochemistry procedures were done in order to get a panel of inflammatory positive cells for CD3 (T lymphocytes), CD45RA (B lymphocytes), CD18 (beta 2 integrin), CD163 (ED2 protein), CD54 (ICAM-1), and MAC 387 (monocytes and macrophages). The statistical treatment of data included a posteriori classification of animals from each group (N = 20) in two subgroups presenting spontaneous precocious or late oedema. Animals that presented precocious oedema were less responsible to Arnica montana 6cH in relation to hemodynamic changes. Instead, rats that exhibited late oedema presented less intense oedema (P = .01), lower percentage of mast cell degranulation (P = .0001), and increase in lymphatic vessels diameter (P = .05). The data suggest an individually qualitative adjustment of inflammatory vascular events by Arnica montana 6cH.

CONTEXT:Arnica is commonly used by the public as a treatment for bruising and swelling.

OBJECTIVE:To assess whether Arnica administration affects recovery from hand surgery.

DESIGN:Double-blind, randomized comparison of Arnica administration versus placebo.

SETTING:Specialist hand surgery unit at the Queen Victoria NHS Trust.

PARTICIPANTS:Thirty-seven patients undergoing bilateral endoscopic carpal-tunnel release between June 1998 and January 2000.

INTERVENTION:Homeopathic Arnica tablets and herbal Arnica ointment compared to placebos.

MAIN OUTCOME MEASURES:Grip strength, wrist circumference, and perceived pain measured 1 and 2 weeks after surgery.

RESULTS:No difference in grip strength or wrist circumference was found between the 2 groups. However, there was a significant reduction in pain experienced after 2 weeks in the Arnica-treated group (P<.03).

CONCLUSIONS:The role of homeopathic and herbal agents for recovery after surgery merits further investigation.