OBJECTIVES/HYPOTHESIS: The need for class I and II studies on the efficacy of liberatory maneuvers in the treatment of lateral canal benign paroxysmal positional vertigo (LC-BPPV) motivated the present double-blind randomized trial on the short-term efficacy of the Gufoni liberatory maneuver (GLM). STUDY DESIGN: Double-blind randomized controlled trial. METHODS:Seventy-two patients with unilateral LC-BPPV were recruited for a multicentric study. Patients were randomly assigned to treatment by GLM (n = 37) or sham treatment (n = 35). Subjects were followed up twice (at 1 hour and 24 hours) with the supine roll test by blinded examiners. RESULTS: At 1- and 24-hour follow-up, 75.7% and 83.8% of patients, respectively, undergoing GLM had recovered from vertigo, compared to around 10% of patients undergoing the sham maneuver (P < 0.0001). CONCLUSION: To the best of our knowledge, this is the first class I study on the efficacy of the GLM in the treatment of LC-BPPV in both geotropic and apogeotropic forms. GLM proved highly effective compared to the sham maneuver (P < 0.0001). The present class I study of the efficacy of the GLM changes the level of recommendation of the method for treating LC-BPPV from level U to level B for the geotropic variant and from level B to level A for the apogeotropic variant of LC-BPPV.
RCT Entities:
OBJECTIVES/HYPOTHESIS: The need for class I and II studies on the efficacy of liberatory maneuvers in the treatment of lateral canal benign paroxysmal positional vertigo (LC-BPPV) motivated the present double-blind randomized trial on the short-term efficacy of the Gufoni liberatory maneuver (GLM). STUDY DESIGN: Double-blind randomized controlled trial. METHODS: Seventy-two patients with unilateral LC-BPPV were recruited for a multicentric study. Patients were randomly assigned to treatment by GLM (n = 37) or sham treatment (n = 35). Subjects were followed up twice (at 1 hour and 24 hours) with the supine roll test by blinded examiners. RESULTS: At 1- and 24-hour follow-up, 75.7% and 83.8% of patients, respectively, undergoing GLM had recovered from vertigo, compared to around 10% of patients undergoing the sham maneuver (P < 0.0001). CONCLUSION: To the best of our knowledge, this is the first class I study on the efficacy of the GLM in the treatment of LC-BPPV in both geotropic and apogeotropic forms. GLM proved highly effective compared to the sham maneuver (P < 0.0001). The present class I study of the efficacy of the GLM changes the level of recommendation of the method for treating LC-BPPV from level U to level B for the geotropic variant and from level B to level A for the apogeotropic variant of LC-BPPV.