OBJECTIVES: A prospective, randomized placebo-controlled study was designed to exclude a placebo response in transurethral microwave thermotherapy (TUMT). METHODS: During a sham procedure, the microwave applicator was installed in the urethra as in the real TUMT treatment and a complete procedure was simulated by the microwave delivery system (Prostatron). Any patient who entered this study had the option to request a second real TUMT treatment if, 3 months after the initial procedure, his condition had not improved. RESULTS: A total of 48 patients were available for evaluation at 3 months and 28 at 6 months. The TUMT group had an average decrease of 7.3 points (from 13.2 to 5.9) in the Madsen symptom score, an average increase in flowrate of 3.4 mL/s (9.6 to 13.0), and an increase in voiding percentage of 9.6% (81.7 to 91.3). All improvements were statistically significant. In the sham group, the average Madsen score decreased from 12.1 to 8.2 points, the average flowrate decreased from 9.7 to 9.5 mL/s, and the voiding percentage increased from 80.8% to 84.3%. Only the change in symptom score was significant. In both groups, observations at the 3-month follow-up were similar to those after 6 and 12 months. Patients who had TUMT after sham treatment showed similar significant changes in symptom score and peak flow as observed in the original TUMT group. Patients who did not respond favorably to a first TUMT did not experience improvement after a second TUMT. CONCLUSIONS: A placebo effect, although minimal, exists. This placebo response, however, accounts for little of the observed benefit of TUMT.
RCT Entities:
OBJECTIVES: A prospective, randomized placebo-controlled study was designed to exclude a placebo response in transurethral microwave thermotherapy (TUMT). METHODS: During a sham procedure, the microwave applicator was installed in the urethra as in the real TUMT treatment and a complete procedure was simulated by the microwave delivery system (Prostatron). Any patient who entered this study had the option to request a second real TUMT treatment if, 3 months after the initial procedure, his condition had not improved. RESULTS: A total of 48 patients were available for evaluation at 3 months and 28 at 6 months. The TUMT group had an average decrease of 7.3 points (from 13.2 to 5.9) in the Madsen symptom score, an average increase in flowrate of 3.4 mL/s (9.6 to 13.0), and an increase in voiding percentage of 9.6% (81.7 to 91.3). All improvements were statistically significant. In the sham group, the average Madsen score decreased from 12.1 to 8.2 points, the average flowrate decreased from 9.7 to 9.5 mL/s, and the voiding percentage increased from 80.8% to 84.3%. Only the change in symptom score was significant. In both groups, observations at the 3-month follow-up were similar to those after 6 and 12 months. Patients who had TUMT after sham treatment showed similar significant changes in symptom score and peak flow as observed in the original TUMT group. Patients who did not respond favorably to a first TUMT did not experience improvement after a second TUMT. CONCLUSIONS: A placebo effect, although minimal, exists. This placebo response, however, accounts for little of the observed benefit of TUMT.
Authors: Juan Va Franco; Luis Garegnani; Camila Micaela Escobar Liquitay; Michael Borofsky; Philipp Dahm Journal: Cochrane Database Syst Rev Date: 2021-06-28