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Dr. Nagler

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In July 2019, a paper appeared in JAMA entitled “Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial.” The study concluded that the results of TRT were no better than SoC (Standard of Care). The population being studied was a military population, and the SoC in that population consisted of some general patient-centered counseling that contained elements of cognitive behavioral therapy. The SoC also included instructions in sound enrichment, taking advantage of environmental sound rather than using wearable devices like in TRT.

So here is the problem. In any study, regardless of where it might be published, the conclusion is only as good as the data and methodology. And if you read this particular study all the way through, you will find that there is a rather lengthy section under the heading “Limitations.” Among the limitations, which appear nowhere in the abstract, is the fact that none of the clinicians involved had experience administering TRT prior to the study, and most of them treated “only a few participants during the trial.” That sounded just a bit nebulous to me – so I contacted one of the lead investigators for clarification. Turns out that the clinicians administering TRT took a two-day course (one that also included material other than TRT), read some sort of manual, and then typically treated a total of three or four participants during the entire trial.

Now I am not lobbying for or against TRT here. But what I am very definitely saying is that there is a huge learning curve when it comes to becoming a TRT clinician. It is virtually impossible to develop any reasonable level of proficiency in TRT counseling and in the fitting of TRT devices by merely taking a two-day course and reading a manual. Yet that was the sum total of the preparation the clinicians in the study had in treating their three or four participants. If you ask any knowledgeable and experienced TRT clinician in practice today, that clinician will likely tell you that it took twenty patients or so (along with a lot of coaching) before he or she was any good at it.

Other limitations enumerated in the full study included the fact that there were more missed follow-up visits in the TRT group than in the SoC group and that the wearable devices in the TRT group were not working properly early on in the study.

Taking these limitations into account, it seems to me that what the study actually showed quite nicely was that TRT in the hands of an ill-prepared and inexperienced clinician can be expected to yield results no better than SoC, especially if participants miss some of their follow-up TRT appointments and if their TRT devices are not dependable.

The much-heralded July 2019 study in question does not prove that TRT is no more effective than SoC. What it does prove is that a flawed study will yield a flawed conclusion. And it reinforces the words of the Nobel Prize winning British economist, Ronald Coase, who said: "If you torture the data long enough, it will confess to anything."

Stephen M. Nagler, M.D.


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