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

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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

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Acknowledgments

The corresponding author acknowledges the Department of Dentistry of the Federal University of Sergipe.

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Authors and Affiliations

  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

    Rafael Soares da Cunha, Allan Carlos Araújo de Oliveira, Liciane dos Santos Menezes & Liane Maciel Almeida Souza

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

    Klinger Souza Amorim, Anne Caroline Gercina & Francisco Carlos Groppo

Authors
  1. Rafael Soares da Cunha
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  2. Klinger Souza Amorim
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  3. Anne Caroline Gercina
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  4. Allan Carlos Araújo de Oliveira
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  5. Liciane dos Santos Menezes
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  6. Francisco Carlos Groppo
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  7. Liane Maciel Almeida Souza
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Rafael Soares da Cunha, Klinger de Souza Amorim, and Anne Caroline Gercina. The first draft of the manuscript was written by Rafael Soares da Cunha, Allan Carlos Araújo de Oliveira, and Liciane dos Santos Menezes. Conceptualization: Klinger de Souza Amorim and Liane Maciel de Almeida Souza. Methodology: Francisco Carlos Groppo and Liane Maciel de Almeida Souza. Formal analysis: Francisco Carlos Groppo. Investigation: Rafael Soares da Cunha. Writing—original draft preparation: Anne Caroline Gercina and Klinger de Souza Amorim. Writing—review and editing: Anne Caroline Gercina and Klinger de Souza Amorim. Supervision: Liane Maciel de Almeida Souza. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Klinger Souza Amorim.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This clinical trial was approved by the Sergipe Federal University Human Health Research Ethics Committee (CAAE: 19602613.1.0000.5546); additionally, it was submitted to ClinicalTrials.gov (ANSI-388.427).

Informed consent

Informed consent was obtained from all individual participants included in the study.

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da Cunha, R.S., Amorim, K.S., Gercina, A.C. et al. Herbal medicines as anxiolytics prior to third molar surgical extraction. A randomized controlled clinical trial. Clin Oral Invest 25, 1579–1586 (2021). https://doi.org/10.1007/s00784-020-03468-1

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  • DOI: https://doi.org/10.1007/s00784-020-03468-1

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