P100 Clinical Trial

Patients suffering from Ménière’s disease are particularly sensitive to negative pressure in the middle ear.

For example, attacks of vertigo can be triggered by a descent in an aircraft when ventilation of the middle ear can become critical.
Positive pressure pulse therapy has shown to have a beneficial effect on the sufferer by relieving the symptoms, and is now a true alternative in the treatment of Ménière’s disease.

A clinical trial was conducted by the Ear Institute, Queenswood, Pretoria, South Africa (Dr. Frits van der Laan) and Tinnitus Research and Balance Clinic, Melbourne, Australia (Ass. Prof. Burkhard Franz).

In this study two devices were compared that produced positive pressure pulses delivered to the inner ear via the external ear canal and after the insertion of a middle ear ventilation tube.

The aim was to investigate the effectiveness of positive pressure pulses delivered by the handheld manually operating device P100-For Ménière´s Disease and the electronic Meniett device.

25 patients took part in this study.

All patients that participated in this trial had a confirmed diagnosis of Ménière’s disease (AAO criteria) and had frequent attacks.

19 of these were seeking further treatment options for the relief of their symptoms as the insertion of a ventilation tube alone did not give enough relief.

A ventilation tube was either inserted in the office, or alternatively in the operating theatre.

Five days following the insertion of the ventilation tube a decision was made whether to proceed with the trial. Although some patients experienced an improvement of their symptoms, 19 were keen to proceed with the positive pressure pulse treatment.
Positive pressure treatment was either conducted with an expensive electronic device or a new manually operated alternative.
9 patients opted for the electronic device,10 opted for the manual device.

Fig.: Improvement of the symptoms vertigo, fullness in the ear and nausea were
statistically significant, and there was statistically no difference between
the electronic device and the manual device.

Symptoms before and after treatment with positive pressure pulses were recorded.

Statistical testing was performed using a nonparametric, Kruskall-Wallis single factor analysis of variance by rank.

Each symptom was considered separately, comparing the mean rank before and after treatment with either the manual device or the electronic device.

If a significant difference between means was detected, then post hoc, nonparametric multiple comparisons for unequal sample sizes were used to determine which mean ranks differed. In all cases a = 0,05.

Among the symptoms that improved significantly were vertigo, fullness in the ear and nausea (Fig.).

There was a slight difference between the two devices with the electronic device not quite performing as well as the manually operated device.

The differences, however, were not significant.

The difference might have been due to the convenience of the manual device, which was immediately available when needed and did not require the cumbersome setting up of the other device.

There was also a slight difference between the severities of symptoms in both groups which could have accounted for the differences, but these differences were not significant.

Several patients from the clinical trial refused to return the manually operated device after the clinical trial.

It has improved their life so much that they did not want to part with it.

Both the insertion of a middle ear ventilation tube and positive pressure pulse treatment address a disturbed relationship between the middle ear and the inner ear.

Our clinical trial confirms that positive pressure pulse therapy in Ménière’s disease is a true alternative to current treatment modalities.

The manually operated device is the preferred option for its convenience of use and its lower cost.

This trial was published in the ‘International Tinnitus Journal’, Vol. 11, No. 2, 146-149 (2005).

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