Dr. Douglas Berger Psychiatrist Tokyo’s response to THE QUIZ: Headaches: Page 2 of 2, Scientific American, March 30, 2017

http://www.psychiatrictimes.com/psychopharmacology/quiz-headaches/page/0/2

Dr. King, regarding acupuncture, perhaps you can comment on this article:

Research Casts Doubt on the Value of Acupuncture, Scientific studies show that the procedure is full of holes, Scientific American, August 2016

https://www.scientificamerican.com/article/research-casts-doubt-on-the-value-of-acupuncture/

The article makes these statements below, and it seems to me that because of the subjective nature of endpoints used in any clinical trial of pain or migraine treatment, whether acute or prophylactic treatment, that it seems a bit too early to make definitive conclusions about acupuncture worthy of a “True” or “False” in a quiz because there is no way to filter out bias of hope or expectation and/or researcher/treater bias effects on the subject even with masked raters as they only record the report of the patient:

1. effects of acupuncture are the same whether needles are placed along the meridians or at random locations around the body.

2. acupuncture studies are extremely difficult to double-blind—a methodological approach in which neither the researchers nor patients know who is receiving the treatment under investigation and who is receiving the placebo or sham.

3. researchers know which patients receive or do not receive real acupuncture, likely biasing the results.

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Douglas Berger Psychiatrist Tokyo’s Letter to the Editor of The New York Times, RE: “Tell it about You Mother ” by Casey Schwartz, June 24, 2015

FW: New York Times: Letter to the Editor RE: “Tell it about You Mother ” by Casey Schwartz, June 24, 2015

The article “Tell it about You Mother ” by Casey Schwartz, June 24, 2015, (http://www.nytimes.com/2015/06/28/magazine/tell-it-about-your-mother.html?_r=1) is a review of a study that suggests there is a link of psychoanalysis with specific brain changes. The article reports the fMRI images of one-patient which is neither a report of results nor analysis, and the one-patient data is a personal contact from the study authors to the NY Times article author, not a publication of the results (“Images from Andrew J. Gerber and Katherine R. Surrence/Columbia University”).

I could not find any results from this fMRI study on a literature search. I asked the authors of the original paper Gerber and Peterson for some data or analysis, and received no reply. One article I did find was a description of the of the study plan but no results are reported: Measuring Transference Phenomena with fMRI, Andrew J. Gerber and Bradley S. Peterson, Am Psychoanal Assoc. 2006; 54(4): 1319–1325 (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2367227/. This article noted that the study planned only 10 subjects and was not blinded to the therapist nor the subject as to the content of the procedures (so there was no blinded control group). The NY Times article had the term “Preliminary research” under the image, however, In spite of only presenting the data of one unblinded subject, and the data having no publication or analysis, the NYT article says “ goes on to state, “… indicates that brain regions involved in transference include the left and right insula”. The research article itself stated, “It is crucial that the paradigm be designed for optimal reliability and clinical relevance at this stage, before it is applied broadly to questions of development, psychopathology, and psychotherapeutic change.”

Changes in the brain are also seen in other activities. For example, this study, http://www.nature.com/neuro/journal/v12/n11/full/nn.2412.html, Nature Neuroscience 12, 1370 – 1371 (2009); 11 October 2009 | doi:10.1038/nn.2412, found an increase in white matter underlying the intraparietal sulcus following training of a complex visuo-motor skill. This study was not blinded and there was no placebo control group. Mindfulness meditation has also been found to alter regions of the brain associated with memory, awareness of self, and compassion, according to a brain imaging study: Psychiatry Research: Neuroimaging (Jan. 30, 2011). http://www.health.harvard.edu/mind-and-mood/mindfulness-meditation-practice-changes-the-brain. The subjects in this study were not blinded and there was no placebo control group.

The brain is clearly an organ that can modify itself to various stimuli, changes are not necessarily indicative of effects of a specific psychotherapy. There is data on only one subject presented, the study is not blinded, there is no comparison group, no blind placebo group, and no analysis of any cohort of data that can be found in the literature at this time. The NYT should look into whether there is any published data

and analysis of this data, and make an addendum to the Schwartz article of what is or isn’t published, the robustness of any study presented (i.e., number of subjects, blinding, placebo, comparison group, etc.), and revise any suggestions of effects of psychoanalysis on the brain in a new article written by a panel of clinical trial experts or as least by the Editors.

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Dr. Douglas Berger’s response to “Top Papers That Can Change Your Practice” by By, Sy Atezaz Saeed, MD, MS and Richard M. Bloch, PhD, Article Originally Published in the ‘Psychiatric Times’ on February 23, 2017

http://www.psychiatrictimes.com/psychopharmacology/top-papers-can-change-your-practice#comment-51647

Drs. Saeed and Bloch,

You quoted a paper on IPT as showing IPT to be more effective than placebo or waiting list and comparable to pharmacotherapies.

Did this paper, or any paper, ever study IPT with single-blinding (=subject blind) or double-blinding (and thus with blind placebo)? I think not as it is impossible to blind a psychotherapy study, using the term “placebo” in a psychotherapy study is misleading as it is not a blind placebo.

In addition, comparing IPT to medications that show efficacy vs blind placebo (thus the rigor in showing efficacy is higher than in unblinded studies) invalidates clinical trial logic because the methods to prove efficacy are very different in blinded medication studies vs psychotherapy studies. MDD is studied with subjective endpoints and an unblinded study can not filter bias from the expectation and hope of knowing the therapy one is given. Blind raters only record the unblinded report of the subjects.

Because MDD psychotherapy trials cannot be single- or double-blinded, nor can they have blind placebo, the rigor of these trials for psychotherapy in MDD is low so that it is premature to make claims of efficacy for IPT in MDD. These kinds of papers do not belong in a “Top Ten” list unless you want to include “papers with problems to be aware of” in the list.

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Douglas Berger Tokyo Psychiatrist repsonse to “Practical Tips for Managing the Agitated Patient: Avoiding Violence in the Clinical Setting”

Psychiatric Times

February 27, 2017 (originally published)

http://www.psychiatrictimes.com/special-reports/practical-tips-managing-agitated-patient-avoiding-violence-clinical-setting#comment-51644

Drs Lofchy and Fage write a nice article on violent patients. They rightly note that, “The risk of violence in psychiatric practice is a frightening aspect of our work”. The problem is that few of the many articles like this ever talk about what to do when a punch is on it way, you are getting pushed, or worse, getting strangled.

These articles are great-up to the point of attack assuming that the end-game is pushing a personal panic alarm. However, there needs to be a discussion of what we should do if things get out of hand, if there is no alarm and if security is not around the corner. Actual martial arts self-defense training, which also necessarily entails some offensive practice as part of defense, is the only thing to do next because by definition, all the processes, structures, and verbal de-escalations are not part of the equation at this point. My opinion is that kung fu would be the best training to have, but the best type could be subject to discussion and opinion.

Drs. Lofchy and Fage are right, there is a danger, and psychiatry needs to get over the “political correctness” of the assumption we should never discuss that we should learn how to physically defend, control, neutralize, or even attack back as a defense. Psychiatrists are too cerebral, once a week they need to get into a martial arts gym and train.

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Douglas Berger Tokoyo Psychiatrist Responds to “Bereavement, Grief, and Depression: Clinical Update and Implications” article orignally published on February 20, 2017 in “Psychiatric Times”

http://www.psychiatrictimes.com/cme/bereavement-grief-and-depression-clinical-update-and-implications#comment-51626

The logic of some key points of this article on complex bereavement (PCBD) has some serious problems, and I beg the senior author Dr. Bui of Harvard to reply.

In the “Persistent Complex Bereavement Disorder” section the authors state that PCBD, “has been shown to be distinct from mood, anxiety, and other trauma-related disorders despite some symptom overlap”.

Then later in that section they state that, “…risk factors for PCBD are similar to those for other bereavement-related conditions including MDD and PTSD, which suggests that all of these conditions share some common pathophysiologic processes.”

Two sections later under the “MDD” section they then say, “…recent studies have found no substantial differences between bereavement-related depressive syndromes and non-bereavement related depressive syndromes in terms of clinical characteristics and treatment response…”, and that, “The bereavement exclusion was dropped in DSM-5, and the death of a loved one no longer precludes the diagnosis of MDD…”.

They want to say that PCBD is distinct from MDD, but wait, they can have the same pathophysiology and the same clinical characteristics and treatment response (and we now can bill insurance companies for PCBD). This is strange medical science logic, unless billing has become part of medical science. 

Even if there are some clinical and epidemiologic data suggesting some difference between PCBD and MDD, distinguishing psychiatric disorders that have SUBJECTIVE parameters as the endpoints of a study is in no way robust enough to say, “…it has been shown..” by any stretch of the imagination in these constructs that have similar pathophysiology and the same clinical characteristics and treatment response to be “distinct”.

To begin with, there are really no biologic anchor points to clearly objectify any psychiatric disorder from another in a population of patients and certainly there is no way to prove what an individual’s diagnostic label should be much less in these conditions the authors themselves note to be extremely similar. Diagnostic labels in psychiatry are really only road signs for the doctor and patient to use as a working model for treatment. These authors need more modesty and clarity of the financial upside of making DSM diagnoses.

Ok, a person in complicated grief can yearn intensely for the deceased, feel confusion about themselves, and be unable to trust others. Is this so different from the many persons’ therapists see who are persistently depressed after any intimate breakup?

I recommend a review of this article in the PT

http://www.psychiatrictimes.com/articles/dsm5-and-medicalization-grief-two-perspectives

I think the logic presented by Allen Frances is the most lucid regarding avoiding over-medicalizing.

Next, the authors note that Complicated grief treatment (CGT) has “shown efficacy…across 3 randomized controlled trials”, all authored by Shear, however, none of these trials were single-blind (=subject blind), or double-blind (thus no blind placebo).

See the most recent trial here: https://www.ncbi.nlm.nih.gov/pubmed/27276373

This study had a “placebo”, but the term is misleading as a psychotherapy can not have a blind placebo group.

Do these Harvard authors wish to opine that a therapeutic modality in conditions with subjective endpoints can be show efficacy without a double-blind and blind placebo controlled study? Blind raters only record what unblinded subjects report.

Regarding disclosures, Dr. Bui has also worked with Dr. Shear, the author of the Complicated grief treatment trials noted in references 9-11 in the PT article on this study, and Director of the “Center for Complicated Grief”. The therapists of which bill clients for grief therapy and charge fees for workshops up to $600 per attendee (https://www.eventbrite.com/e/level-2-complicated-grief-treatment-tickets-30468955466), so there is some motivation to have CGT show efficacy in a “clinical trial”.

Bui and Shear coauthors on:

THE STRUCTURED CLINICAL INTERVIEW FOR COMPLICATED GRIEF: RELIABILITY, VALIDITY, AND EXPLORATORY FACTOR ANALYSIS

http://onlinelibrary.wiley.com/doi/10.1002/da.22385/abstract

In this article, while Bui notes “Although diagnostic criteria for CG have yet to be adequately validated, the SCI-CG may facilitate this process.” He then says, “The SCI-CG can now be used as a validated instrument in research and clinical practice.”

This means we can validate an instrument for a diagnosis where the diagnostic criteria are not validated?

This article requires rethinking, rewriting, and re-disclosing.

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Dr. Douglas Berger Tokyo Psychiatrist’s letter to Dr. de Leon RE: Nonvalidated Pharmacogenetic Tests, Part I: Confessions of an Embarrassed Psychiatry Professor: Page 3 of 3

Referenced article originally published October 26, 2016 in the Psychiatric Times:
 
Dr. de Leon
 
It is refreshing to read about a seasoned clinician backtracking on mistaken prior conclusions. I would opine to go further in limiting the need or utility of these tests.
 
For example, you want to do CYP2D6 and 2C19 before giving a tricyclic. What is the risk of giving someone 10mg BID of nortriptyline and increasing by 10mg BID every 2 weeks up to 40mg BID watching how the patient reacts vs the risk of delaying treatment and cost of the test? Poor metabolizers may easily tolerate titration to 20mg or 30mg BID and have a response after 6-8 weeks stopping the dose there anyway. If a rare patient will have trouble after a few 10mg BID doses they can just stop the medication. EVERY patient regardless of metabolic profile requires careful and slow titration of a tricyclic and should be advised to pause their drug dosing and contact their Dr if they have trouble. I really don’t see the risk-benefit ratio falling on the side of doing a costly test.
 
For CYP2C, Asians have a 3-4x increase number of poor metabolizers. Here in Japan, CYP is not tested, its start low and go slow with most every psychiatric drug. There seems to be little problem with this method as long as there is close follow up. Again, EVERY patient should be followed closely.
 
You also want to do HLA testing before giving CBZ to Asians, I assume to decrease the risk of SJS. The best approach is not to give CBZ to Asians, not do a test. Why not use oxcarbazepine if you need to? There are plenty of other drugs to use, even for seizure disorder treatment, then again your article was on “genetic tests in psychiatry” not neurology. CBZ isn’t used much in psychiatry in Japan nowadays. HLA testing isn’t done here either, though LFT and WBC should be tested a week into CBZ therapy regardless of HLA type.
 
Ok, maybe there is an exceptional case where we want to do a test, but it should be a rare case and tests are no substitute for careful and knowledgeable clinical monitoring. I vote that these tests stay in the research lab for pharmacology research, and in pharmaceutical company labs during drug development, not in clinical psychiatry.
 
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