OBJECTIVES: In this study, we assessed the effectiveness of physical counterpressure maneuvers (PCM) in daily life. BACKGROUND: There is presently no evidence-based therapy for vasovagal syncope. Current treatment consists of explanation and life-style advice. Physical counterpressure maneuvers have been shown to raise blood pressure and to control or abort vasovagal episodes in laboratory conditions. METHODS: We performed a multicenter, prospective, randomized clinical trial, which included 223 patients age 38.6 (+/-15.4) years with recurrent vasovagal syncope and recognizable prodromal symptoms. One hundred and seventeen patients were randomized to standardized conventional therapy alone, and 106 patients received conventional therapy plus training in PCM. RESULTS: The median yearly syncope burden during follow-up was significantly lower in the group trained in PCM than in the control group (p = 0.004). During a mean follow-up period of 14 months, overall 50.9% of the patients with conventional treatment and 31.6% of the patients trained in PCM experienced a syncopal recurrence (p = 0.005). Actuarial recurrence-free survival was better in the treatment group (log-rank p = 0.018), resulting in a relative risk reduction of 39% (95% confidence interval, 11% to 53%). No adverse events were reported. CONCLUSIONS:Physical counterpressure maneuvers are a risk-free, effective, and low-cost treatment method in patients with vasovagal syncope and recognizable prodromal symptoms, and should be advised as first-line treatment in patients presenting with vasovagal syncope with prodromal symptoms. (The PC-Trial; http://www.controlled-trials.com/isrctn/trial/45146526/0/45146526.html; ISRCTN45146526).
RCT Entities:
OBJECTIVES: In this study, we assessed the effectiveness of physical counterpressure maneuvers (PCM) in daily life. BACKGROUND: There is presently no evidence-based therapy for vasovagal syncope. Current treatment consists of explanation and life-style advice. Physical counterpressure maneuvers have been shown to raise blood pressure and to control or abort vasovagal episodes in laboratory conditions. METHODS: We performed a multicenter, prospective, randomized clinical trial, which included 223 patients age 38.6 (+/-15.4) years with recurrent vasovagal syncope and recognizable prodromal symptoms. One hundred and seventeen patients were randomized to standardized conventional therapy alone, and 106 patients received conventional therapy plus training in PCM. RESULTS: The median yearly syncope burden during follow-up was significantly lower in the group trained in PCM than in the control group (p = 0.004). During a mean follow-up period of 14 months, overall 50.9% of the patients with conventional treatment and 31.6% of the patients trained in PCM experienced a syncopal recurrence (p = 0.005). Actuarial recurrence-free survival was better in the treatment group (log-rank p = 0.018), resulting in a relative risk reduction of 39% (95% confidence interval, 11% to 53%). No adverse events were reported. CONCLUSIONS: Physical counterpressure maneuvers are a risk-free, effective, and low-cost treatment method in patients with vasovagal syncope and recognizable prodromal symptoms, and should be advised as first-line treatment in patients presenting with vasovagal syncope with prodromal symptoms. (The PC-Trial; http://www.controlled-trials.com/isrctn/trial/45146526/0/45146526.html; ISRCTN45146526).
Authors: Robert S Sheldon; Blair P Grubb; Brian Olshansky; Win-Kuang Shen; Hugh Calkins; Michele Brignole; Satish R Raj; Andrew D Krahn; Carlos A Morillo; Julian M Stewart; Richard Sutton; Paola Sandroni; Karen J Friday; Denise Tessariol Hachul; Mitchell I Cohen; Dennis H Lau; Kenneth A Mayuga; Jeffrey P Moak; Roopinder K Sandhu; Khalil Kanjwal Journal: Heart Rhythm Date: 2015-05-14 Impact factor: 6.343