Comparative Effectiveness of the Homeopathic Preparation Traumeel S in Third Molar Extraction Surgery: A Preliminary Triple-Blind Clinical Trial

Abstract

Background and Aim This preliminary study aimed to evaluate whether a homeopathic preparation (Traumeel S) might be a good option to control post-operative outcomes (pain, edema and trismus) associated with surgical removal of mandibular third molar teeth. The null hypothesis was that Traumeel S is not different from dexamethasone (gold standard) in controlling these post-operative inflammatory complications. Methods A randomized, “split-mouth”, triple-blind clinical trial was conducted. Seventeen healthy patients with a mean age of 20.94 ( ± 5.83) years had their lower asymptomatic bilateral third molars removed. Patients were randomized to receive Traumeel S or dexamethasone pre-operatively by injection into the masseter muscle; each patient acted as his/her own control. At 24, 48, 72 hours and 7 days after the surgery, the pain was evaluated according to a visual analog scale, edema through linear measurements of the face, and trismus through the maximum buccal opening. Wilcoxon statistics or paired t-test were used, and a significance level of 95% was adopted. Results For pain, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone after 24 hours, 72 hours, and 7 days. For edema, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone at all post-operative evaluations. For mouth opening, the results for Traumeel S were not different (p > 0.05) from those of dexamethasone at 72 hours and 7 days after third molar extraction. Conclusion With the exception of some early post-operative findings, the null hypothesis is not rejected. Traumeel S might be a good alternative approach to dexamethasone for controlling pain, edema and trismus after third molar removal.

Comparison of oral health-related quality of life after lower third molar extraction following preemptive administration of Traumeel S® vs dexamethasone

“…Research, Society andDevelopment, v. 11, n. 3, e20211326205, 2022 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v11i3.26205 Pain is one of the symptoms that most influence the QoL. In this way, following the results of this study, pain was higher in the Traumeel S ® group in the 48-hour follow-up (de Souza et al, 2021). This is explained by the half-life of dexamethasone, which is probably longer than the Traumeel S ® (de Souza et al, 2021;Al-Dajani, 2017;Troiano et al, 2018).…”

“…The descriptive analysis was the same reported in the previous published study by the same research group (de Souza et al, 2021). The similarity between the two groups can be proved by the results about surgery duration (p=0.19) and postoperative analgesic intake (p=0.15) (Table 1).…”

“…The previous published article resulted from this same research (de Souza et al, 2021), showed no statistically significant differences in rescue analgesic intake. However, as a result of the randomization, dexamethasone was administered mostly in the second surgery for each patient.…”

“…The Consolidated Standards of Reporting Trials (CONSORT) checklist for clinical trials was followed (Moher et al, 2010). This randomized clinical trial (RCT) is a branch of the same research already published, comparing Traumeel S ® vs dexamethasone on postoperative pain, edema, and trismus (de Souza et al, 2021), and was registered in (https://www.clinicaltrials.gov), NCT03567369. The present study shows the QoL results of this comparison.…”

“…Research, Society andDevelopment, v. 11, n. 3, e20211326205, 2022 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v11i3.26205 Traumeel S ® is a homeopathic formulation (Biologische Heilmittel Heel GmbH, Baden Baden, Germany) resulted from a mixture of 12 botanical substances and two minerals (Scientifics Bio-Logics-Heel). It has anti-inflammatory properties and has already shown a good performance on third molar surgeries (de Souza et al, 2021). However, no studies have searched whether homeopathic medications improve QoL after L3M surgeries.…”