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

  • 2020-09-19
  • Clinical oral investigations 25(3)
    • Rafael Soares da Cunha
    • Klinger Souza Amorim
    • Anne Caroline Gercina
    • Allan Carlos Araújo de Oliveira
    • Liciane Dos Santos Menezes
    • Francisco Carlos Groppo
    • Liane Maciel Almeida Souza

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 200
Population
200 volunteers undergoing mandibular third molar extraction
Methods
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
Blinding
Triple-blind
Duration
60 min before the surgery (single dose, no intervention duration beyond that)
  • Large Human Trial

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.

Research Insights

  • Passion Flower→Improved Oxygen Saturation

    Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO2 were observed among the protocols.

    Effect
    Neutral
    Effect size
    Small
    Dose
    500 mg
  • Passion Flower→Reduced Anxiety

    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.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    500 mg
  • Passion Flower→Reduced Blood Pressure

    Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO2 were observed among the protocols.

    Effect
    Neutral
    Effect size
    Small
    Dose
    500 mg
  • Passion Flower→Reduced Heart Rate

    Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO2 were observed among the protocols.

    Effect
    Neutral
    Effect size
    Small
    Dose
    500 mg
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