Abstract
Dear Editor,
The aim of my article was to describe the objectively measured therapeutic results in my clinical trial in which hyperacusis was treated, with a positive outcome. As the field is quite unexplored, some scientific references were referred to in which other positive promising treatment results had been reported in trials in which laser therapy and repetitive transcranial magnetic stimulation (rTMS) had been used for audiological treatment, mainly for disorders other than hyperacusis.
My reference to Teggi's article 1 was made because he had found a positive treatment effect on hyperacusis. The study was, however, conducted with very low laser doses and showed no effect on tinnitus; however, it did show an effect on hyperacusis.
The negative laser studies mentioned in the Letter to the Editor were not referred to in my article because those studies lack information about treatment method or dose levels, or they include very few treatment sessions or have very low doses per session: actually microscopic ones compared with the laser light doses used in my own clinical trial and many other positive studies. The results in studies using low portions of light indicate that small doses are not a successful treatment concept. I was not aiming to study tinnitus in my trial and my article was not an article comparing different studies using laser therapy for tinnitus. My clinical trial was clearly stated to be prospective, using fictitious groups for comparison, and only studying hyperacusis.
The statistics are not erroneous according to the programs used for calculation. These programs included χ2 test verifying significance, Student's t test verifying significance, variance, for statistical analysis and comparison between groups, standard deviation for statistical analysis and comparison between groups, average before and after therapy (including average improvement) for statistical analysis and comparison between groups, and median before and after therapy (including median improvement) for statistical analysis and comparison between groups.
The Letter points out that a study such as mine would be well suited for a placebo exposure. However, I was not allowed to conduct placebo-controlled studies in Sweden. An independent researcher is subject to Swedish laws and regulations, the Helsinki Protocol, and other circumstances, and is neither allowed nor able to in the absence of cooperating partners (university institutions) to conduct placebo-controlled trials.
No patients in my clinic were on a waiting list, as all patients included in the study started the treatment program instantly after being examined, tested, and verified to have hyperacusis. Therefore, I had no control group. Audiometric hyperacusis tests are almost never performed in official audiological clinics in Sweden, and therefore the patients in my study could not verify their hyperacusis history. In order to be able to make calculations of significance I had to compare my results with a fictitious groups, and I was actually advised to do so. The publisher accepted the structure of the article to be scientific enough to qualify for publication in a MEDLINE-indexed journal.
My method is not misleading for the readers. “The article is excellent and very transparent” is a statement made by a professor in otorhinolaryngology who himself is a researcher who has published many articles indexed in MEDLINE.
Erik Borg, a currently retired professor in audiology who 10 years ago was very skeptical regarding laser therapy for the treatment of tinnitus and other inner ear disorders, was, during the fall of 2011, interviewed by a Swedish branch magazine, Audio Nytt (Audio News), and there he stated that he suggested that researchers in audiology should interest themselves more in and look more closely at, laser therapy for inner ear disorders. 2 Today, Erik Borg has probably realized that laser therapy has healing effects on tissue and certainly seems to be a better treatment alternative for sensorineural inner ear disorders than methods (i.e., meditation and distraction therapy) in this field that at the moment are being targets for research in Sweden.
The Letter's author claims that there is a correlation between observations and organs within an individual. At the same time, he is referring to and basing his view upon correlation in his own study in which destruction of inner ear hair cells was conducted on pigs. However, his study was not based on any healing processes, but on the opposite: massive destruction. Everyone in the audiological field should know that an individual–pig or human or any other mammal–would most probably get injured in both ears when unprotected and exposed to loud sound.
Observing the individuals and the ears in my study displays a full correlation between improvement and any other similarity, for example, being a Caucasian. Among the observations, a little less correlation is found, but it was of course very high as the material displays positive effects on >90% of the observations studied. Because of this high rate of improvement, there is actually no specific knowledge to be gained by differentiating between individuals, organs, and/or observations.
Calculating the p values on a patient level brings these results: my findings compared with a placebo group where 40% would receive a positive treatment effect would be: p=2.15×10−17, based upon 60%: p=1.54×10−8 and upon 80%: p=5.32×10−4. The levels of significance are extremely high in comparison with any of these placebo groups, and the observations are measured through audiometry and are not subject to any subjective assessment. Imagining an improvement rate for as many as 80%, 60%, or even 40% of the patients in a placebo group is of course not realistic. In reality, the rate would be lower when using an objective measuring method, such as audiometry actually is. The average improvement per patient was 16.04 dB HL.
The significance values mentioned previously are easily calculated based on the information displayed in my original article.
The Letter claims that I have not stated any financial interests, but I have stated that I am running a private clinic where the study also was conducted. I even reminded the publisher about it when my information about financial interests was missing in the proof.