Effect of topical Arnica montana cream on postoperative oedema and ecchymosis after septorhinoplasty: a prospective, randomised, split-face, blinded trial

Introduction

Rhinoplasty is one of the most commonly performed aesthetic and reconstructive facial procedures worldwide. Technical refinements in rhinoplasty have arguably enhanced precision and outcomes, though postoperative oedema and ecchymosis remain frequent and distressing sequelae. These changes may delay return to work and social activity, reduce satisfaction during the recovery period and adversely affect patient perception of the surgical result (1-3).

A range of interventions have been proposed in the literature to reduce postoperative oedema and ecchymosis including systemic corticosteroids, local cold compression, and antifibrinolytic agents such as tranexamic acid (1,4). These approaches have produced variable results and none of these have been universally adopted into standard postoperative care (1,5). Complementary topical therapies such as Arnica montana preparations might safely accelerate resolution of bruising and inflammation, and are often appealing to patients due to their natural derivation and availability (6-8).

Arnica montana is a perennial herb of the family Asteraceae and has been used to treat soft-tissue trauma, bruising and inflammation (8). Its principal active constituents are sesquiterpene lactones such as helenalin and have been shown in preclinical experiments to inhibit nuclear-factor-κB signalling and modulate immune-cell activation (9,10). Arnica montana is available in both oral and topical formulations and clinical evidence for its postoperative use remains inconsistent. Small studies have reported reductions in periorbital ecchymosis after rhinoplasty or blepharoplasty using Arnica montana cream (Arnica cream), while other randomised trials found no significant difference compared with placebo (6,7,11,12).

Assessment of postoperative oedema and ecchymosis is complicated by inter-individual variability in tissue response, skin tone, and surgical technique. Split-face, within-subject designs minimise these confounding factors by allowing each patient to serve as their own control, thereby enhancing the precision of comparison in small samples (13-15).

The primary objective of this pilot study was to evaluate the efficacy of topical Arnica cream in reducing postoperative oedema and ecchymosis in patients undergoing open septorhinoplasty with lateral osteotomies. To minimise inter-individual variability we adopted a prospective, blinded, randomised split-face design in which each patient applied Arnica cream to one hemiface for 10 days postoperatively with the contralateral hemiface serving as an untreated control. Periorbital oedema and ecchymosis were assessed at postoperative days (PODs) 4 and 7 using a validated ordinal scale supplemented by objective CIELAB-based colourimetric analysis (3).

By generating preliminary data on the potential benefits of topical Arnica cream in rhinoplasty recovery, this study aimed to inform postoperative management strategies and establish a foundation for larger, multicentre clinical trials.

Methods

Study design

A prospective, blinded, randomised split-face trial was performed, evaluating the effect of topical Arnica cream on postoperative periorbital ecchymosis and oedema following open septorhinoplasty. Each participant served as their own control, with Arnica cream applied to one hemiface and no treatment applied to the contralateral side. The study is reported according to the CONSORT reporting guidelines (available at https://www.theajo.com/article/view/10.21037/ajo-2025-1-97/rc).

Participants

Patients were recruited between August 2022 and November 2023 from the Otolaryngology Outpatient Department at the Royal Brisbane and Women’s Hospital (RBWH), Brisbane, Australia. Eligible patients undergoing septorhinoplasty were identified from a prospective surgical waiting list database and invited to participate during pre-operative appointments. Patients received no financial compensation for participation. Exclusion criteria included: coagulopathy or anticoagulant use; systemic disease affecting oedema or wound healing; pregnancy or breastfeeding; hypersensitivity to Arnica cream or excipients; inability to comply with specified treatment instructions or photographic documentation, and insufficient English proficiency for consent and instructions. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Royal Brisbane and Women’s Hospital Research Governance Office (No. HREC/2021/QRBW/80888) and informed consent was taken from all individual participants.

Intervention

Participants applied 1 g or two fingertips of Arnica cream 20 mg/g (Arnica cream, Martin & Pleasance, city, country) cream twice daily to the assigned hemiface excluding the columella incision for 10 days postoperatively. Side allocation (left vs. right) was predetermined using a computer-generated sequence to balance distribution. Patients were instructed to avoid cross-application and to adhere to standard postoperative care which included analgesia, oral antibiotics, a topical antibiotic cream to the columella incision and review at day 7 for removal of splint and sutures. Participants were instructed to take self-portraits daily in the morning with a smart phone camera under the same lighting conditions for the designated days. Demographic data was collected including Fitzpatrick skin type scale (16).

Outcome measures

Subjective assessments

Two blinded assessors independently graded each hemiface using a previously validated ordinal scale. Any discrepancies were resolved by averaging the two raters’ scores. Ratings were recorded on POD 1, POD 4, and POD 7 for the following parameters (Table 1) (4):

• EX—extent of ecchymosis;
• EC intensity—ecchymosis colour intensity;
• O—oedema.

Objective colour analysis

Standardised clinical and patient-captured photographs underwent blinded analysis using CIELAB colour space performed on Adobe Photoshop. LAB values were extracted from three predefined periorbital regions (medial periorbital 1 cm, medial periorbital 3 mm, and medial canthal 3 mm) of each hemiface to allow for lighting normalization and reproducibility. ΔE was calculated to quantify colour difference between hemifaces. Lower ΔE values indicate reduced inter-side contrast.

Statistical analysis

This pilot study aimed to include 20 participants over a 12-month period. The sample size of was based on the absence of prior literature using Arnica cream in a split faced trial and on the feasibility of cases managed at the surgical unit. To assess the reliability between the two blinded observers, weighted Cohen’s Kappa was calculated. Reliability was interpreted as follows: 0.21–0.40 (fair), 0.41–0.60 (moderate), 0.61–0.80 (substantial), and >0.81 (almost perfect). Given the ordinal non-normal nature of the scoring system, data were analyzed using non-parametric statistics. Continuous variables are presented as medians with interquartile ranges (IQR). To compare the skin appearance scores between the Arnica cream-treated and untreated hemifaces at each postoperative time point (PODs 1, 4, and 7), a Wilcoxon signed-rank test was employed. This test determined whether there were statistically significant differences in the distribution of scores between the paired sides. All statistical analyses were performed using SPSS Statistics v31. A two-tailed P value of <0.05 was considered statistically significant for all tests.

Results

Thirty-seven patients undergoing open septorhinoplasty with bilateral osteotomies were enrolled with the intent of forming a 20-patient cohort. Fifteen patients completed adequate applications and recordings for comparison. Among the excluded patients, twelve failed to complete adequate applications, seven did not complete recordings, and three applied the cream to both sides of the face rather than one hemiface. Arnica cream was applied to the right hemiface in nine patients (60%) and the left in six patients (40%). All participants completed the 10-day application period without protocol deviation, one patient did not complete photodocumentation to day 7. Demographic characteristics are summarised in Table 2.

Image availability and analysis windows

Daily postoperative self-portraits were obtained for most patients from PODs 1 to 8, supplemented by standardised clinical photographs at scheduled follow-up. Variability in lighting and angle within early and late images limited inclusion in quantitative analyses. Therefore, evaluations were restricted to POD 4 and POD 7, representing the early and intermediate postoperative intervals, respectively. Complete day 1 (POD 1) and day 4 (POD 4) subjective scores were available for all 15 participants, and day 7 scores were available for 14 participants across all subjective parameters. For colourimetric analysis, bilateral image sets suitable for LAB extraction were available for 15 participants at POD 4 and 14 at POD 7.

Subjective assessment of periorbital ecchymosis and oedema

Periorbital bruising and swelling were assessed using an ordinal scale that captured ecchymosis extent (EX), EC intensity, and oedema (O). At POD 4, the Arnica cream-treated side demonstrated significantly lower EX scores than the untreated side [median 2.5 (IQR, 2–3.25) vs. 3 (IQR, 2.75–3.5)]. The median difference was −0.5 (95% CI: −0.36, −0.9) with a large effect size (r=0.58; P=0.001). A similar pattern was observed for EC intensity [median 1.5 (IQR, 1–2) vs. 2 (IQR, 1.75–2.25)]. The median difference was −0.5 (95% CI: −0.1, −0.83) with a medium effect size (r=0.46; P=0.011). Oedema scores were also modestly lower on the treated side [1 (IQR, 0.75–1.75) vs. 1 (IQR, 1–1.75)]; this did not yield a median difference (95% CI: −0.1, −0.5) with a medium effect size (r=0.45, P=0.013). These findings indicate small but statistically significant reductions in bruising severity and swelling during the early postoperative period.

At POD 7, residual bruising and oedema were reduced on both sides compared with POD 4. EX, EC, and O scores remained numerically lower on the Arnica cream-treated hemiface [EX: 1 (IQR, 0.75–2) vs. 2 (IQR, 1.75–2.5); median difference −1 (IQR, −0.56, −1.29); EC: 1 (IQR, 0.5–1) vs. 1.5 (IQR, 1–1.5); median difference −0.5 (IQR, −0.1, −0.83); O: 0.5 (IQR, 0–0.75) vs. 1 (IQR, 0.5–1); median difference −0.5 (IQR, −0.15, −0.63)], these median differences did reach statistical significance (EX: large effect size (r=0.56, P=0.003); EC: medium effect size (r=0.46, P=0.014); O: large effect size (r=0.8, P=0.003). A inter-rater reliability analysis was performed with a Cohen’s Kappa score which showed near perfect reliability (0.824) (Table 3).

Objective colourimetric assessment (CIELAB ΔE)

To quantify visible asymmetry in periorbital discoloration, LAB values were extracted from three predefined periorbital regions on each hemiface, and ΔE values were calculated. POD 1 baseline images recorded mean ΔE between treated and control sides which had the lowest asymmetry score 8.24±5.1. At POD 4, the mean ΔE between treated and control sides was 10.54±5.2 (n=15). By POD 7, ΔE had decreased to 9.324±4.44 (n=14), indicating progressive resolution of ecchymosis and reduced inter-side contrast. In both participants with paired observations, ΔE decreased from POD 4 to POD 7, aligning with the direction of change observed in subjective ratings (Table 4).

Representative examples

Figure 1 illustrates representative clinical photographs. At POD 4, reduced periorbital ecchymosis is visible on the left sided Arnica cream-treated hemiface when compared with the control. By POD 7, visible bruising had largely started resolving on both sides. These examples support the direction of change demonstrated by the objective and subjective assessments.

Figure 1 Representative days 1, 4, 7 postoperative photographs with Arnica cream treatment to left hemiface. This image is published with the patient’s consent. Photography completed via smart phone in the morning with similar lighting conditions.

Safety

No adverse reactions related to topical Arnica cream were observed. No patient discontinued treatment due to irritation, hypersensitivity, or other complications.

Discussion

This split-face, within-subject randomised controlled study examined the effect of topical Arnica cream on postoperative periorbital ecchymosis and oedema following septorhinoplasty. Our principal finding was that the Arnica cream-treated hemiface demonstrated small but statistically significant reductions EX, EC, and oedema at POD 4 and POD 7 compared with the untreated side. These early differences were consistent across all three subjective measures and supported by a parallel trend in objective colourimetric analysis.

The magnitude of improvement at POD 4 was modest, with median inter-side reductions of approximately 0.5 points across rating domains (Subjective measures of 0–5, 0–4, 0–3). Although numerically small, these differences occurred within the context of an ordinal scale with a limited scoring range and may still be perceptible to patients during the early postoperative period, a time when bruising is most visually prominent and psychosocial impact is greatest. Similar early reductions have been reported in small trials of oral or topical Arnica cream in rhinoplasty and blepharoplasty (5,6,11), though findings across the literature remain mixed. Differences in Arnica cream formulation, dosing, application frequency, surgical technique, and timing of assessment may help explain inconsistencies across studies. Patient factors of age, gender and skin tone could also impact on the ability to complete and compare subjective scoring between individuals. The split-face design allowed direct comparison of treatment and control while controlling these factors.

Objective colourimetric analysis, used here to mitigate subjectivity inherent in ordinal scales, demonstrated initially lower ΔE values, that increased in value with variation between sides and then had reducing values by POD 7. The alignment with subjective scores suggests Arnica cream may contribute to accelerated early resolution of bruising. The concordance between subjective ratings and ΔE measurements strengthens confidence in the direction of the observed early effect. CIELAB analysis is increasingly recognised as a sensitive and reproducible tool for quantifying postoperative ecchymosis, and future studies incorporating automated colour segmentation may improve robustness of objective findings.

By POD 7, residual bruising and swelling were minimal in all participants, and differences between sides were less but still significantly detected. This is consistent with expected postoperative recovery patterns in contemporary rhinoplasty and suggests that any treatment effect of Arnica cream is most relevant during the early inflammatory phase. Whether such early improvements translate to higher patient satisfaction or faster return to social activity remains unclear, as this study did not assess patient-reported outcomes.

The strengths of this study include its prospective split-face design, which controls for inter-individual variability in tissue response, skin characteristics, and surgical technique. Randomised side allocation and blinded outcome assessment further minimise bias. Objective colourimetric analysis provides an additional level of methodological rigor.

Several limitations should be acknowledged. Subjective ratings were available for all patients at POD 4 through POD 7 data, and subsequent later data was incomplete due to lack of patient collection, limiting the power. The considerable number of exclusions from enrolment may introduce an element of selection bias. Our single-centre cohort limits generalisability, and the absence of a placebo cream prevents assessment of potential tactile or cooling effects of application. The lack of blinding for the patients introduces performance bias for patient expectancy and protective behaviour towards the treatment side. Also split face is limited by the ability of the postoperative swelling and bruising to be asymmetrical, including POD 1 was implemented to analyse this. The ability to assess EX and colour may be influenced by skin type. In this trial, most participants had Fitzpatrick skin types I or II, which may limit generalizability to darker skin tones. Finally, as a pilot study, the sample size was not powered to detect small clinical differences; therefore, findings should be interpreted with these limitations in mind.

Despite these limitations, the consistency of early postoperative improvements across subjective and objective measures suggests that topical Arnica cream may offer a modest benefit in reducing bruising and swelling in the days immediately following septorhinoplasty. Given the minimal risk profile and low cost of topical Arnica cream, these preliminary findings support further evaluation in a more powered, placebo-controlled and multi-centre trial; incorporating patient-reported outcomes and more robust imaging protocols. Based on these pilot results, 32 participants would be required in future studies to demonstrate treatment effect with 80% power at two-sided alpha of 0.05.

Conclusions

This pilot split-face study demonstrated that topical Arnica cream was associated with small but statistically significant reductions in early postoperative periorbital ecchymosis and oedema following open Septorhinoplasty. These improvements were most evident during the early postoperative period (POD 4) and were supported by parallel trends in objective colourimetric analysis. This effect persisted at POD 7, with detectable differences between the treated and control sides despite overall resolution of bruising and swelling. Although the magnitude of improvement was modest, the consistency across subjective and objective measures suggests a potential early benefit of topical Arnica cream following septorhinoplasty and other facial plastic surgical procedures. Given its favourable safety profile and low cost, further evaluation in larger, placebo-controlled, multicentre studies, including patient-reported outcomes and standardised imaging, is warranted to clarify the clinical relevance of these preliminary findings.

Acknowledgments

The authors would like to thank all patients who contributed their time and effort during the trial.

Footnote

Reporting Checklist: The authors have completed the CONSORT reporting checklist. Available at https://www.theajo.com/article/view/10.21037/ajo-2025-1-97/rc

Trial Protocol: Available at https://www.theajo.com/article/view/10.21037/ajo-2025-1-97/tp

Data Sharing Statement: Available at https://www.theajo.com/article/view/10.21037/ajo-2025-1-97/dss

Peer Review File: Available at https://www.theajo.com/article/view/10.21037/ajo-2025-1-97/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://www.theajo.com/article/view/10.21037/ajo-2025-1-97/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Royal Brisbane and Women’s Hospital Research Governance Office (No. HREC/2021/QRBW/80888) and informed consent was taken from all individual participants.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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