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Placebo effect in surgery for Ménière's disease. A double-blind, placebo-controlled study on endolymphatic sac shunt
Abstract:
To investigate the placebo effect in surgery for Ménière's disease, a double-blind controlled study was undertaken, comparing effects of a regular endolymphatic shunt with those of regular mastoidectomy. Thirty patients with typical Ménière's diseases, selected because of unsuccessful medical treatment, participated. Patients completed daily dizziness questionnaires three months before and 12 months after surgery, with registration of nausea, vomiting, vertigo, tinnitus, hearing impairment, and pressure in the ears. Patients were operated on at two universities, and the patients operated on at one underwent controlled study each month at the other. At termination of the trial, both investigators and patients gave their opinions of the efficacy of the operations. Minor differences were seen between active and placebo groups, but the greatest difference in symptoms was found when preoperative and postoperative scores were compared: both groups improved significantly
Insights
This study on Ménière's disease surgery found that both regular endolymphatic shunt and mastoidectomy procedures significantly improved patient symptoms, suggesting a notable placebo effect in surgical interventions.
Area of Science:
- Otolaryngology
- Neurosurgery
- Clinical Trials
Background:
- Ménière's disease is a disorder of the inner ear.
- Surgical interventions are considered for medically refractory cases.
- The placebo effect in surgical treatments requires further investigation.
Purpose of the Study:
- To evaluate the placebo effect in Ménière's disease surgery.
- To compare the efficacy of endolymphatic shunt versus mastoidectomy.
- To assess symptom changes in patients undergoing these surgical procedures.
Main Methods:
- A double-blind, controlled study involving 30 patients with Ménière's disease.
- Comparison between regular endolymphatic shunt and regular mastoidectomy.
- Daily symptom questionnaires (dizziness, nausea, vomiting, tinnitus, hearing, ear pressure) recorded pre- and post-surgery for 12 months.
Main Results:
- Both surgical groups showed significant improvement in symptoms from pre- to post-operative scores.
- Minor differences were observed between the active (shunt) and placebo (mastoidectomy) groups.
- The overall improvement suggests a substantial placebo effect in Ménière's disease surgery.
Conclusions:
- Surgical interventions for Ménière's disease demonstrate a significant placebo effect.
- Both endolymphatic shunt and mastoidectomy yield considerable symptom relief.
- Further research is warranted to delineate the specific contributions of surgical technique versus placebo response.