BACKGROUND & AIMS: Ablation of gastric inlet patches (GIP) in the cervical esophagus by argon plasma coagulation (APC) can alleviate chronic globus sensations in the throat. We investigated the efficacy of this therapy in a randomized, controlled multicenter trial. METHODS:Patients with chronic globus sensations and GIP were randomly assigned 1:1 to groups that were treated with APC or a sham procedure (controls). Patients and their referring physicians were blinded to therapy. All patients completed a standardized questionnaire about symptoms before and 3 months after the procedure. Thereafter, control patients were eligible for cross-over therapy. Long-term efficacy was assessed in all patients >or=6 months after APC. RESULTS:Improvement of symptoms was reported in 9 (82%) of 11 patients who received APC, compared with 0 (0%) of 10 patients in the control group (P = .002). Nine (90%) of 10 patients treated with APC had per protocol healing, compared with 0 (0%) of 9 controls (P < .001). Scores for symptom/globus assessment significantly improved in patients in the APC group, whereas patients in the control group did not perceive any symptom relief. Eight of the 10 patients who started in the control group crossed over to the APC group. Long-term efficacy (after a median follow-up of 17 months) was documented in 13 (76%) of 17 treated patients. CONCLUSIONS: Ablation of gastric inlet patches appears to be an effective therapy for alleviation of associated globus sensations. This new treatment modality might change the paradigm for treatment of these patients.
RCT Entities:
BACKGROUND & AIMS: Ablation of gastric inlet patches (GIP) in the cervical esophagus by argon plasma coagulation (APC) can alleviate chronic globus sensations in the throat. We investigated the efficacy of this therapy in a randomized, controlled multicenter trial. METHODS:Patients with chronic globus sensations and GIP were randomly assigned 1:1 to groups that were treated with APC or a sham procedure (controls). Patients and their referring physicians were blinded to therapy. All patients completed a standardized questionnaire about symptoms before and 3 months after the procedure. Thereafter, control patients were eligible for cross-over therapy. Long-term efficacy was assessed in all patients >or=6 months after APC. RESULTS: Improvement of symptoms was reported in 9 (82%) of 11 patients who received APC, compared with 0 (0%) of 10 patients in the control group (P = .002). Nine (90%) of 10 patients treated with APC had per protocol healing, compared with 0 (0%) of 9 controls (P < .001). Scores for symptom/globus assessment significantly improved in patients in the APC group, whereas patients in the control group did not perceive any symptom relief. Eight of the 10 patients who started in the control group crossed over to the APC group. Long-term efficacy (after a median follow-up of 17 months) was documented in 13 (76%) of 17 treated patients. CONCLUSIONS: Ablation of gastric inlet patches appears to be an effective therapy for alleviation of associated globus sensations. This new treatment modality might change the paradigm for treatment of these patients.