Frequency of reporting of adverse events in RCTs of psychotherapy vs psychopharmacotherapy (Vaughan)

[Tom Kindlon]

Free full text: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4346151/

Frequency of reporting of adverse events in randomized controlled trials of psychotherapy vs. psychopharmacotherapy.

Compr Psychiatry. 2014 May;55(4):849-55. doi: 10.1016/j.comppsych.2014.01.001. Epub 2014 Jan 23.

Vaughan B1, Goldstein MH2, Alikakos M2, Cohen LJ2, Serby MJ2.

Author information

Abstract

BACKGROUND:

Psychopharmacology and psychotherapy are the two main therapies in mental health.

It is common practice to consider adverse events (AEs) of medications, but it's not clear this occurs with psychotherapy.

AIM:

This study investigates the frequency with which reports of AEs occur in clinical trials using either psychopharmacology alone, psychotherapy alone, or combined approaches.

METHODS:

Forty-five articles of randomized trials published in high-impact journals were chosen from a Medline search, and separated into three groups of 15 articles: pharmacotherapy alone (M), psychotherapy alone (T) and combined studies that looked at the effect of both a psychotherapeutic (CT) and psychopharmacologic (CM) intervention.

Criteria for what defines an AE were established and the papers were rated for mentions of AEs in papers as a whole and by each section.

RESULTS:

The χ(2)-analysis of AE mentions showed significant differences between the four study conditions in terms of each paper as a whole (χ(2):10.1,p<0.018), and by section.

Medication (M+CM) and psychotherapy papers (T+CT) were then combined into two groups to compare the odds that one was more likely to mention AEs than the other.

Bivariate logistic regression yielded statistically significant odds ratios ranging from 9.33 to 20.99, with medications being far more likely to mention AEs.

CONCLUSION:

We believe the difference in reports of AEs mirrors the attitudes researchers and providers.

It's critical to consider, and standardize the definition of, AEs in psychotherapy, and imperative to identify and address potential AEs in psychotherapy research.

 

[Tom Kindlon]

I read the full text. Not that existing as papers go: they simply counted whether adverse events where mentioned in different sections of a paper and also in the whole paper.

 

[Tom Kindlon]

I looked at the issue in relation to some therapies for ME/CFS in my open access paper:

http://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx

Bulletin of the IACFS/ME. 2011;19(2): 59-111.

Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapyin Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

ABSTRACT

Across different medical fields, authors have placed a greater emphasis on the reporting of efficacy measures than harms in randomised controlled trials (RCTs), particularly of nonpharmacologic interventions.

To rectify this situation, the Consolidated Standards of Reporting Trials (CONSORT) group and other researchers have issued guidance to improve the reporting of harms.

Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT) based on increasing activity levels are often recommended for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

However, exercise-related physiological abnormalities have been documented in recent studies and high rates of adverse reactions to exercise have been recorded in a number of patient surveys.

Fifty-one percent of survey respondents (range 28-82%, n=4338, 8 surveys) reported that GET worsened their health while 20% of respondents (range 7-38%, n=1808, 5 surveys) reported similar results for CBT.

Using the CONSORT guidelines as a starting point, this paper identifies problems with the reporting of harms in previous RCTs and suggests potential strategies for improvement in the future.

Issues involving the heterogeneity of subjects and interventions, tracking of adverse events, trial participants’ compliance to therapies, and measurement of harms using patient-oriented and objective outcome measures are discussed.

The recently published PACE (Pacing, graded activity, and cognitive behaviour therapy: a randomised evaluation) trial which explicitly aimed to assess “safety”, as well as effectiveness, is also analysed in detail.

Healthcare professionals, researchers and patients need high quality data on harms to appropriately assess the risks versus benefits of CBT and GET.

 

[Tom Kindlon]

Some extracts for what they're worth:

Barlow has recently noted the lack of attention to this issue within the psychotherapy community, concluding that “it is time to focus attention in a more systematic manner on those unfortunate cases where harm might occur or benefit is conspicuously absent [2].” One article emerging from the STAR*D report noted an increase in suicidality after the initiation of cognitive therapy [3]. The authors state in their discussion they “thought it noteworthy that although the U.S. Food and Drug Administration warns of the emergence of suicidal ideation as a hazard following initiation of antidepressant medication, several cases of suicidal ideation occurred as serious adverse events following the initiation of cognitive therapy in our study [3].”

To our knowledge, this is the first paper to systematically compare the consideration and reporting of adverse outcomes in psychotherapy and psychopharmacology research.

 

[Tom Kindlon]

By comparison, in psychotherapy it is likely that “a significant number of practitioners may either underestimate the occurrence of negative treatment effects or not realize that they can occur [4].”

Some of the adverse events that were explicitly noted included high density exposure therapy being dangerous for those with coronary heart disease, and too difficult for depressed patients [6]; increased suicidality with cognitive behavioral therapy [3]; increased anxiety from applied relaxation therapy [7] and exposure treatment [8,9]; and dropouts due to issues with the format of group therapy [10] and problems in the therapeutic relationship [11].

 

[Tom Kindlon]

Whatever the case, psychotherapy research should examine negative outcomes, and attempt to clarify which reactions result from treatment and why they do so [12,13]. Psychotherapy will be a safer and more effective treatment modality when adverse outcomes are acknowledged, studied, and ultimately explained to patients.

 

[Tom Kindlon]

Other research has focused on identifying and defining negative consequences of “potentially harmful therapies” (PHTs), such as “Scared Straight,” recovered traumatic memories, and boot-camp interventions [15]. Additional adverse events observed in context of psychotherapy include onset of panic symptoms as a paradoxical effect of relaxation, deterioration during grief counseling in normal bereavement, and increased drug consumption associated with drug prevention programs [15].

 

[Tom Kindlon]

In conclusion, our findings suggest that at present the monitoring of AEs in psychotherapy research falls behind that of psychopharmacology research. We suggest that this stems from the lack of a consensual definition of AEs in psychotherapy. Continued research is therefore needed to identify, define, and standardize potential AEs of psychotherapy. Ultimately, a reliable and valid definition should be incorporated into routine practice and clinical training to enhance safety and efficacy in the provision of psychotherapy.

 

[JaimeS]

Very interesting, @Tom - weird how this hasn't been studied much. I think it's fascinating. While I'd like to think that no one could be so illogical as to assume that good therapy has potent curative effects, but poor therapy is harmless, this seems to be the case. Sometimes I find natural practitioners are the same: they believe their remedies are potent, but 'natural' and 'gentle' and therefore incapable of causing harm.

Neither of these suppositions is logical of course... but asking logic of people seems to be too much to ask.

-J