1 Introduction
The auditory intervention technique Psychofonie has been used by medical professionals in Switzerland, Germany, and Austria to treat thousands of patients in the last 15 years. The new therapy was initially recommended only as a solution of last resort. Nevertheless, it has brought about improvements in the majority of cases with lasting relief for several functional disorders. Early studies previously documented the effectiveness of Psychofonie. The open pilot study [1] on 128 cases reported a reduction in frequency and intensity in migraines and a reduction in the intake of pharmaceuticals after four weeks. Because of promising results, further investigations were recommended to evaluate the long-term effect of Psychofonie since the response from placebos only lasts for short periods. Thereafter, a Swiss hospital studied the efficacy of Psychofonie on migraines for one year in 46 cases.[2] They measured a pronounced effect after patients listened to the sound pattern three times each day for three months. Based on a professional survey, patients experienced even more relief after 6, 9, and 12 months of application, and they reduced the consumption of pain medications accordingly. Three migraine centers in Salzburg, Erlangen, and Berlin contributed to a third study that included a control group in a randomized double-blind setting published in 2002 in [3]. The study compared Psychofonies derived from individual electroencephalograms (EEGs) against placebo Psychofonies derived from averaged third-party EEGs without any individual content. Despite indistinguishable sound patterns, the effect was significantly better in the treatment group. Since this study was conducted during a 12-week treatment period only and since [2] there was evidence for much better results after one year, we carried out the present pilot survey that summarized the long-term experience of many patients. We sent out a simple one-page selfexplanatory questionnaire[9] to a randomized address base of the Swiss clientele asking them to answer immediately, truthfully, and without medical professional assistance or bias that would prevent objective consideration. This is the weakness and strength of this study. Each patient filled in the questionnaire uninfluenced and only once. In this way, the reports documented patients who were at different points in the course of and aftermath of the treatment. Together a picture emerged of how the patients thought that Psychofonie affected various pain and suffering, after treatment periods of 1 to 144 months, although there is no means and no need to distinguish between self-healing and specific effects that may be too limited to explain a complex regulation therapy such as Psychofonie.
2 What is Psychofonie?
To produce the individualized Psychofonie Audio CD, a 17-minute-long, four-channel resting state EEG is recorded during a patient’s pain-free period. Artifacts are visually removed in this one-time collected data in a central laboratory, and after a frequency-analytical procedure, it is transformed into a four-channel audio sequence. Based on the rhythm and frequency fluctuations of the brain waves (excluding the alpha waves), musical notes are computed and copied to audio CD in the form of a midi sound sequence. The patient listens to the CD for 12 minutes, 3 times a day, for several weeks. The rhythmic sounds serve as instrumental conditioning in an open neurofeedback loop involving an area in the midbrain that is interconnected with the central auditory pathway.[4] EEG rhythms are partially induced via thalamo-cortical loops from the vegetative and pain-modulating brain nuclei.[5] These waves are then FFT-filtered through the Psychofonie method and transformed into hard-to-remember and inharmonious sequences of sound and rhythm. Efficiency builds slowly but strongly as patients continue their therapy over several weeks.[6]
3 Motivation and Background
The collective experiences with Psychofonie ascertained by 24 Swiss clinics over the course of ten years were the motivation for this study. The Psychofonie method became increasingly known. Physicians who included Psychofonie in their therapy plans reported relatively high compliance in long-term use among patients who had Psychofonie CDs generated from their EEGs. A second EEG recording was needed only in rare cases in which the effect could not be refreshed using the original recording. Current research had previously focused only on short time spans. The goal of this study is to follow many patients, both those who have completed treatment and those that are currently undergoing the Psychofonie method at the time of this study. In this way, data involving patients that have experience with Psychofonie for as little as one month or as long as ten years can be collected and analyzed.
Psychofonie is a standardized method, as clinics and physicians in private practice were responsible only for the recording of the EEGs. All audio material was edited by a single laboratory in Switzerland using the same method each time.[7] Thus, the long-term data are readily comparable.
Psychofonie encompasses aspects of several known therapy models, such as music therapy, neurofeedback, and hypnosis.[8] This study is designed to elaborate on Psychofonie’s effectiveness, as defined below. Patient self-report in various criteria of pain, complaints, and duration of relief provided data for in-depth analysis of Psychofonie.
The following questions were posed and tested:
- Did the Psychofonie method result in a significant decrease in patient complaints over the course of the self-treatment?
- Was the expectation of sustained, or even increased, improvement after the end of the treatment fulfilled?
- How long were the Psychofonie treatments?
- How did patient rankings in the various specific criteria described in section 4.2 change during the observation periods?
- Were there any correlations between criteria?
- Was the efficiency of the Psychofonie method significantly affected when paired with concurrent medicinal treatment? Did a considerable number of Psychofonie listeners succeed in reducing their medication dosage?
4 Method
All data in this study were obtained through the use of a voluntary and anonymous questionnaire.[9] It was sent by surface mail one time only and concurrently to a random sample of patients of Psychofonie treatment without any preferences.
4.1 Questions of Personal Nature
Information concerning year of birth, gender, start date of therapy (month and year), frequency of Psychofonie use, and end date of therapy were collected. Out of 163 respondents, three quarters were female. Most participants were Swiss German. Age distribution, among those reporting their age, ranged between 7 and 75 years, and is depicted in figure 1. The questionnaire requested personal motives and judgments from the participants where they could clarify important experiences or provide background information, but, in particular, this background information is beyond the scope of this study. Further inquiries or clarifications beyond the questionnaire results were not pursued.
4.2 Questions Regarding Effectiveness
Overall condition, physical health, mental condition, social contacts, and prescription medications were assessed at the beginning of therapy, the end of therapy (if applicable), and at the time of the questionnaire. These data were collected on a scale with 5 stages ranging from very bad to very good. Participant responses were independent of influence by medical personnel, assuring legitimate and reliable personal responses, since, in many cases, patient rankings took place after therapy was completed.
Desirable outcomes for which Psychofonie is typically indicated were identified for measurement in the study. These outcomes include pain reduction, diminished tinnitus, decreased prescription medication, and an improvement in sleep, relaxation, attentiveness, and work performance.
5 Results
5.1 The Evolution of Effectiveness Over Time
The general evolution of the effectiveness was computed as the sum of the differences in all criteria from section 4.2 before and after treatment (improvement score). Improvement scores and treatment duration were computed from the questionnaire data of 108 patients, though, in 40 cases, treatment dates were missing so only improvement scores were calculated in those cases. Improvement scores and treatment duration, divided into time sections, are depicted as box plots in figure 2. As seen in this figure, the typical patient began to see improvement after about four months of Psychofonie treatment. Thereafter, the effect continued, and even increased, in the group of long-term listeners (with 4 to 10 years of treatment). In the rare event that subjects did not experience desirable outcomes, a negative score was calculated. According to the Mann-Whitney Test (statistically significant for p<0.05), improvement between the groups from 1 to 3 and 4 to 122 months is with p=0.002 statistically highly significant.
In cases in which treatment had already ended at the time of this survey, the data not only included the period of treatment but also the period of time since Psychofonie therapy had ended. On average, the time span that had passed since therapy had ended was about 3 years (35±30 months), and therapy duration had continued for about 2 years (24±24 months). The hypothesis was that the long-term benefits of Psychofonie, after ending treatment, would not diminish. Figure 3 demonstrates that, in all four symptom criteria, there is lasting improvement even years after treatment has ended. According to the Wilcoxon Signed-Rank Test (statistically significant for p<0.025 with Bonferroni-Correction), improvements throughout the treatment and after the treatment are significant, except one bar # (p=0.038).
5.2 Patient Improvement
Using the improvement score data, patient improvement was analyzed (figure 4). Four out of 108 subjects (4%) experienced a minor worsening of symptoms during Psychofonie treatment. Seven patients (6%) experienced no change. Ninety-seven participants (90%) reported symptom improvement after the treatment, 55 (51%) of those with remarkable improvement scores of ten or more.
5.3 The Specific Effectiveness
Figure 5 provides an overview of the distribution of the seven desirable outcomes mentioned above. The number of participants who made statements concerning the improvement in each outcome criterion was counted.
Figure 6 illustrates, based on the sum of improvement scores in each criterion, the ranking of the effect that Psychofonie and spontaneous recovery had on the seven specific criteria. Of course, the two factors cannot be separated in this study.
5.3.1 Correlation Between the Use of Medication and Pain Reduction
The use of analgesics is a common but controversial practice in the treatment of headaches. Frequent use of pain killers against tension-type headache may lead to the development of medication-overuse headaches. But, in patients involved in the study, 46 could reduce the use of medicine to treat episodic headaches and migraines, and 34 were able to decrease reliance on medication intended for longterm use. Decreased reliance on medication was, by far, the most often mentioned reason for Psychofonie treatment. This was experienced by 48 patients.
As was to be expected, there was a strong correlation between medication reduction and pain relief, as depicted in figure 7. Each point corresponds to one of the 52 patients who stated that they had experienced improvements in the two criteria. Kendall’s Tau is a rank correlation coefficient especially designed for ordinal data and hence appropriate in this situation. Kendall’s Tau beta gives a correlation coefficient of 0.47, with p=0.0001 the paired effects are highly correlated.
5.3.2 Correlation Between Attentiveness and Work Performance
Fifty-five participants reported an improvement in both attentiveness and work performance. The strong correlation is depicted in figure 8. The two axes (terms) are nearly interchangeable. With Kendall’s Tau bet...