Martens Camilla, Goplen Frederik Kragerud, Aasen Torbjørn, Gjestad Rolf, Nordfalk Karl Fredrik, Nordahl Stein Helge Glad
Norwegian National Advisory Unit on Vestibular Disorders, Department of Otorhinolaryngology & Head Neck Surgery Haukeland University Hospital Bergen Norway.
Department of Clinical Medicine University of Bergen Bergen Norway.
Laryngoscope Investig Otolaryngol. 2020 Jun 29;5(4):750-757. doi: 10.1002/lio2.420. eCollection 2020 Aug.
To compare the effect of a high-speed barbecue maneuver with the modified Lempert maneuver and sham in patients with benign paroxysmal positional vertigo (BPPV) of the horizontal canal.
Randomized sham-controlled, single blinded multicenter clinical trial in two university hospitals investigating consecutive patients with horizontal canal BPPV.Patients were randomly assigned to high-speed barbecue (HSB), modified Lempert maneuver (ML), or sham maneuver (SM). All treatments were performed in a biaxial rotational chair with weekly follow-up to a maximum of three treatment sessions. The final follow-up was 3 months after the last treatment.
Primary outcome: 2-week recovery rate per protocol. Secondary outcome: Cumulative recovery rate and Dizziness Handicap Inventory (DHI) scores after 3 months per protocol (HSB and ML) and intention to treat (all groups).Fifty-four patients were analyzed after 2 weeks (HSB = 17; ML = 20; SM = 17). Two-week recovery rate was 14/17 after HSB, 11/20 after ML, and 4/17 after SM, with significantly better recovery in HSB [OR 15.17, 95% CI (1.85, 124.63), = .001] using sham as base level. Recovery rate after 3 months was 15/17 after HSB and 15/19 after ML. Cumulative recovery rate showed no significant differences between the two treatment groups [95% CI (0.30, 13.14), = .46] in cure rate DHI [95% CI (-16.56, 15.02), = .92]. No unexpected adverse events were observed.
Velocity change in horizontal canal BPPV treatment gives a faster initial recovery. Rapid recovery could reduce the disease burden.
Clinicaltrials.gov. Identifier: NCT01905800.
1b.
比较高速烧烤手法与改良Lempert手法及假手法对水平半规管良性阵发性位置性眩晕(BPPV)患者的疗效。
在两家大学医院进行的随机、假对照、单盲多中心临床试验,研究连续的水平半规管BPPV患者。患者被随机分配至高速烧烤手法组(HSB)、改良Lempert手法组(ML)或假手法组(SM)。所有治疗均在双轴旋转椅上进行,每周随访一次,最多进行三次治疗。最后一次治疗后3个月进行最终随访。
主要结局:按方案计算的2周恢复率。次要结局:按方案计算(HSB和ML)及意向性分析(所有组)3个月后的累积恢复率和眩晕残障量表(DHI)评分。2周后分析了54例患者(HSB = 17例;ML = 20例;SM = 17例)。HSB组2周恢复率为14/17,ML组为11/20,SM组为4/17,以假手法组为对照,HSB组恢复情况明显更好[比值比15.17,95%可信区间(1.85,124.63),P = 0.001]。3个月后HSB组恢复率为15/17,ML组为15/19。两组治疗组的累积恢复率在治愈率方面无显著差异[95%可信区间(0.30,13.14),P = 0.46],DHI评分方面也无显著差异[95%可信区间(-16.56,15.02),P = 0.92]。未观察到意外不良事件。
水平半规管BPPV治疗中的速度变化可使初始恢复更快。快速恢复可减轻疾病负担。
Clinicaltrials.gov。标识符:NCT01905800。
1b。