On 2015 Dec 05, David Keller commented:

Patient-oriented result: response rate to magnetic stimulation was the same as to placebo

This study of repetitive transcranial magnetic stimulation (rTMS) was designed to test the hypothesis that rTMS would result in a "statistically significantly greater percentage of responders to treatment in an active rTMS group compared with a placebo rTMS group" [1]. A relatively new metric called the Tinnitus Functional Index (TFI) was used to measure response to treatment. The TFI rated 18 of the 32 subjects actively treated with rTMS as responders to treatment (56%), while only 7 of the 32 subjects treated with sham therapy were rated as responders (22%). These two rates differed significantly, which was pre-specified in the Objectives section as defining a successful outcome.

However, 7 of the 18 treated subjects rated as "responders to therapy" using the TFI scale nevertheless believed they had received sham therapy, implying that they did not perceive any treatment benefit beyond the placebo effect. When a subject states that his treatments seemed like sham therapy, providing only placebo-strength benefit, this is important information. Since it is a direct expression of the subject's assessment of the efficacy of rTMS therapy, it has more validity than a contrived metric like the TFI, from a patient-oriented perspective.

The data in e-Table 12 indicate that, of the 32 subjects who received active rTMS treatments, only 11 correctly guessed they had received active therapy at the end of the last treatment, which implies that only 11 out of 32 actively-treated subjects (about 34%) noted perceptible improvement in their tinnitus symptoms. Coincidentally, 11 of the 32 placebo-treated subjects (also 34%) guessed that they had received active rTMS therapy, which equals the placebo effect. Thus, active rTMS treatments had the same response rate as sham therapy, equal to the placebo effect of 34%.

Conclusion: rTMS is no more effective than placebo for treating tinnitus, when assessed by subjects after a full course of treatments, based on their perception of whether they received active or sham therapy. The advantage of this assessment is that it eliminates uncertainty about the accuracy and clinical relevance of the TFI metric, because the assessment of treatment benefit came directly from the subjects themselves.

Reference

1: Folmer RL, Theodoroff SM, Casiana L, Shi Y, Griest S, Vachhani J. Repetitive Transcranial Magnetic Stimulation Treatment for Chronic Tinnitus: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Aug;141(8):716-22. doi: 10.1001/jamaoto.2015.1219. PubMed PMID: 26181507.

On 2015 Nov 29, David Keller commented:

38% of the reported "responders to therapy" thought they had been randomized to placebo & reply by author

At the end of this study, only 11 of the 32 subjects who received active treatment for tinnitus guessed that they had received active treatment. The remaining 21 subjects who were actively treated guessed that they had received placebo (sham treatments).

18 of the 32 actively treated subjects were rated as "responders" to therapy by Folmer et al. Thus, 7 of the actively treated subjects, who were rated as "responders" to therapy, thought they had received sham treatments. Bottom line: 7 of the 18 tinnitus sufferers (38%) who were reported to be "responders to therapy" actually did not perceive any benefit.

Tinnitus is a subjective phenomenon. I contend that, by definition, a responder to tinnitus therapy cannot believe that he received sham therapy. If a subject thinks he was treated with sham therapy, he did not perceive any benefit, and he cannot be a reported to be a "responder to therapy". This is the essence of my criticism of this study, and it has not been addressed.

Addendum (12/4/2015): Yesterday, in reply to the above comment, Dr. Folmer issued the following statement (start of quotation):

In our study, participants were categorized as "responders" or “non-responders” to TMS treatment based solely on the change in their TFI score from baseline to post-TMS assessment – this is stated in the article.

The definition of "responders" or “non-responders” we used had nothing to do with

1. Whether or not study participants “perceived” any benefit if that was based on anything else but their TFI score
   

2. Study participants’ guesses that they received active or placebo rTMS  
   

These are separate issues. You can debate, discuss or disagree with them, but they remain separate issues and definitions as specified in the article.

--Robert L. Folmer, Ph.D. (end of quotation)

On 2015 Nov 29, David Keller commented:

38% of the reported "responders to therapy" thought they had been randomized to placebo & reply by author

At the end of this study, only 11 of the 32 subjects who received active treatment for tinnitus guessed that they had received active treatment. The remaining 21 subjects who were actively treated guessed that they had received placebo (sham treatments).

18 of the 32 actively treated subjects were rated as "responders" to therapy by Folmer et al. Thus, 7 of the actively treated subjects, who were rated as "responders" to therapy, thought they had received sham treatments. Bottom line: 7 of the 18 tinnitus sufferers (38%) who were reported to be "responders to therapy" actually did not perceive any benefit.

Tinnitus is a subjective phenomenon. I contend that, by definition, a responder to tinnitus therapy cannot believe that he received sham therapy. If a subject thinks he was treated with sham therapy, he did not perceive any benefit, and he cannot be a reported to be a "responder to therapy". This is the essence of my criticism of this study, and it has not been addressed.

Addendum (12/4/2015): Yesterday, in reply to the above comment, Dr. Folmer issued the following statement (start of quotation):

In our study, participants were categorized as "responders" or “non-responders” to TMS treatment based solely on the change in their TFI score from baseline to post-TMS assessment – this is stated in the article.

The definition of "responders" or “non-responders” we used had nothing to do with

1. Whether or not study participants “perceived” any benefit if that was based on anything else but their TFI score
   

2. Study participants’ guesses that they received active or placebo rTMS  
   

These are separate issues. You can debate, discuss or disagree with them, but they remain separate issues and definitions as specified in the article.

--Robert L. Folmer, Ph.D. (end of quotation)

On 2015 Dec 05, David Keller commented:

Patient-oriented result: response rate to magnetic stimulation was the same as to placebo

This study of repetitive transcranial magnetic stimulation (rTMS) was designed to test the hypothesis that rTMS would result in a "statistically significantly greater percentage of responders to treatment in an active rTMS group compared with a placebo rTMS group" [1]. A relatively new metric called the Tinnitus Functional Index (TFI) was used to measure response to treatment. The TFI rated 18 of the 32 subjects actively treated with rTMS as responders to treatment (56%), while only 7 of the 32 subjects treated with sham therapy were rated as responders (22%). These two rates differed significantly, which was pre-specified in the Objectives section as defining a successful outcome.

However, 7 of the 18 treated subjects rated as "responders to therapy" using the TFI scale nevertheless believed they had received sham therapy, implying that they did not perceive any treatment benefit beyond the placebo effect. When a subject states that his treatments seemed like sham therapy, providing only placebo-strength benefit, this is important information. Since it is a direct expression of the subject's assessment of the efficacy of rTMS therapy, it has more validity than a contrived metric like the TFI, from a patient-oriented perspective.

The data in e-Table 12 indicate that, of the 32 subjects who received active rTMS treatments, only 11 correctly guessed they had received active therapy at the end of the last treatment, which implies that only 11 out of 32 actively-treated subjects (about 34%) noted perceptible improvement in their tinnitus symptoms. Coincidentally, 11 of the 32 placebo-treated subjects (also 34%) guessed that they had received active rTMS therapy, which equals the placebo effect. Thus, active rTMS treatments had the same response rate as sham therapy, equal to the placebo effect of 34%.

Conclusion: rTMS is no more effective than placebo for treating tinnitus, when assessed by subjects after a full course of treatments, based on their perception of whether they received active or sham therapy. The advantage of this assessment is that it eliminates uncertainty about the accuracy and clinical relevance of the TFI metric, because the assessment of treatment benefit came directly from the subjects themselves.

Reference

1: Folmer RL, Theodoroff SM, Casiana L, Shi Y, Griest S, Vachhani J. Repetitive Transcranial Magnetic Stimulation Treatment for Chronic Tinnitus: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Aug;141(8):716-22. doi: 10.1001/jamaoto.2015.1219. PubMed PMID: 26181507.