Herbal medicines as anxiolytics prior to third molar surgical extraction. A randomized controlled clinical trial

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ORIGINAL ARTICLE

Herbal medicines as anxiolytics prior to third molar surgical extraction. A randomized controlled clinical trial Rafael Soares da Cunha 1 & Klinger Souza Amorim 2 & Anne Caroline Gercina 2 & Allan Carlos Araújo de Oliveira 1 & Liciane dos Santos Menezes 1 & Francisco Carlos Groppo 2 & Liane Maciel Almeida Souza 1 Received: 23 April 2020 / Accepted: 21 July 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020

Abstract Objectives This study aimed to compare the effects of Passiflora incarnata, Erythrina mulungu, and midazolam in controlling anxiety in patients undergoing mandibular third molar extraction. Methods The volunteers underwent extraction of their third mandibular molars in a randomized, placebo-controlled, triple-blind, and parallel clinical trial. Passiflora incarnata (500 mg), Erythrina mulungu (500 mg), or midazolam (15 mg) was orally administered 60 min before the surgery. The anxiety level of participants was evaluated using questionnaires and measurements of physical parameters, including heart rate (HR), blood pressure (BP), and oxygen saturation (SpO2). Results A total of 200 volunteers were included in this clinical trial. Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO2 were observed among the protocols. Conclusions Passiflora incarnata showed a similar effect to midazolam but differed from placebo and mulungu, which were unable to control anxiety in this situation. Therefore, the results suggest that Passiflora configures an herbal medicine with an anxiolytic effect, adequate to use in third molar extractions. Clinical relevance The use of Passiflora incarnata may be an alternative to benzodiazepines for controlling anxiety in patients scheduled for oral surgery under local anesthesia. Trial registration ClinicalTrials.gov: ANSI-388.427 Keywords Passiflora incarnata . Midazolam . Erythrina mulungu . Anxiety . Third molar

Introduction Despite scientific and technological advances and the improvement of techniques in dentistry to achieve pain control, dental treatment is still a reason for anxiety [1]. Anxiety can manifest as agitated behavior and changes in physical parameters. Nevertheless, calm patients may also experience anxiety during dental procedures, causing delay or even

* Klinger Souza Amorim [email protected] Rafael Soares da Cunha [email protected] 1

Oral Surgery and Anesthesiology Area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Cidade Nova, Aracaju, Sergipe 49060-108, Brazil

2

Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, Av. Limeira, 901, Areião, Piracicaba, São Paulo 13414-903, Brazil

discontinuation of treatment, thereby compromising patients’ oral health and quality of life [2]. There are several pharmacological and nonpharmacological interventions for anxiety control. When non-pharmacological approaches are insufficient, sedation techniques can be used to decrease anxiety [