Monday, November 17, 2014

Cochrane review finds CBT not effective for medically unexplained symptoms

When a physician fails to find a cause for physical symptoms (medically unexplained physical symptoms, or MUPS), the patient is usually given a diagnosis of 'somatoform disorder,' or "it's all in your head."

Somatoform disorder is a relic of Freudian psychology, whose disciples believed that underlying emotional distress could manifest itself in physical symptoms. While it is true that some forms of emotional trauma can produce a release of adrenal hormones, which will in turn raise blood pressure, increase heart rate, and cause other transient physiological symptoms, the idea that emotional distress can cause significant long-term physiological consequences (e.g. gallbladder disease, cancer, etc.) is completely unfounded.

Although there is no scientific basis for somatofom disorder, it has become widely accepted as a diagnosis because it is easier to relegate patients to the dustbin of "it's all in your head" than to devote the necessary time and effort to figure out what might actually be wrong with them. In a medical system in which physicians only have 10 minutes (at most) to spend with a patient, and in which doctors are discouraged from taking their patients' complaints seriously, but instead rely on the results of a few simple tests, the diagnosis of somatoform disorder is a convenient means of disposing of "difficult" patients.

The diagnosis also saves money. National health care systems and insurance companies are especially concerned with costly medical outlays for chronic illnesses, which are becoming increasingly common. They are likely to embrace the idea that MUPS can be treated with comparatively inexpensive therapy, rather than pursue a line of treatment that may involve extensive testing and expensive treatments.

ME/CFS falls into the category of MUPS, and as a consequence many patients with the disease are consigned to psychological therapy. While there has been a great deal of resistance on the part of patients and specialists to the idea that psychological interventions are a legitimate treatment for ME/CFS (treatment being defined as something that can affect the actual course of a disease, rather than provide solace), there has not yet been a careful, unbiased evaluation of therapy in MUPS.

This systematic review found that compared with usual care (which is in most cases minimal) patients with MUPS did slightly better with psychological interventions. However, when compared with enhanced, or specialized, care CBT was not more effective. This finding would seem to be obvious. For example, for patients with heart disease, seeing a cardiologist would clearly be more efficacious than receiving CBT. However, because the "it's all in your head" diagnosis has become so popular, the report could only conclude that CBT was not more effective than enhanced care. This is, in essence, a negative conclusion, but it is still valid as a critique of CBT employed instead of specialized care.

To their credit, the authors pointed out that the studies they evaluated did not include any patients who were unwilling to receive CBT, thereby skewing the results. (If studies only include patients who are positively disposed to receiving CBT, outcomes will be more favorable.) They also pointed out that while no harms were reported, the studies did not include harms as part of their outcome measures. (Absence of evidence is not evidence of absence.) They also noted a high drop-out rate, and the fact that the studies were unblinded. When combined, all of these factors can only lead to the conclusion that evidence in support of CBT and other psychological interventions for treating ME/CFS is weak by anybody's standards.


Non-pharmacological interventions for somatoform disorders and medically unexplained physical symptoms (MUPS) in adults

By N. Van Dessel et al.

BACKGROUND: Medically unexplained physical symptoms (MUPS) are physical symptoms for which no adequate medical explanation can be found after proper examination. The presence of MUPS is the key feature of conditions known as 'somatoform disorders'. Various psychological and physical therapies have been developed to treat somatoform disorders and MUPS. Although there are several reviews on non-pharmacological interventions for somatoform disorders and MUPS, a complete overview of the whole spectrum is missing.

OBJECTIVES: To assess the effects of non-pharmacological interventions for somatoform disorders (specifically somatisation disorder, undifferentiated somatoform disorder, somatoform disorders unspecified, somatoform autonomic dysfunction, pain disorder, and alternative somatoform diagnoses proposed in the literature) and MUPS in adults, in comparison with treatment as usual, waiting list controls, attention placebo, psychological placebo, enhanced or structured care, and other psychological or physical therapies.

SEARCH METHODS: We searched the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) to November 2013. This register includes relevant randomised controlled trials (RCTs) from The Cochrane Library, EMBASE, MEDLINE, and PsycINFO. We ran an additional search on the Cochrane Central Register of Controlled Trials and a cited reference search on the Web of Science. We also searched grey literature, conference proceedings, international trial registers, and relevant systematic reviews.

SELECTION CRITERIA: We included RCTs and cluster randomised controlled trials which involved adults primarily diagnosed with a somatoform disorder or an alternative diagnostic concept of MUPS, who were assigned to a non-pharmacological intervention compared with usual care, waiting list controls, attention or psychological placebo, enhanced care, or another psychological or physical therapy intervention, alone or in combination.

DATA COLLECTION AND ANALYSIS: Four review authors, working in pairs, conducted data extraction and assessment of risk of bias. We resolved disagreements through discussion or consultation with another review author. We pooled data from studies addressing the same comparison using standardised mean differences (SMD) or risk ratios (RR) and a random-effects model. Primary outcomes were severity of somatic symptoms and acceptability of treatment.

MAIN RESULTS: We included 21 studies with 2658 randomised participants. All studies assessed the effectiveness of some form of psychological therapy. We found no studies that included physical therapy.Fourteen studies evaluated forms of cognitive behavioural therapy (CBT); the remainder evaluated behaviour therapies, third-wave CBT (mindfulness), psychodynamic therapies, and integrative therapy. Fifteen included studies compared the studied psychological therapy with usual care or a waiting list. Five studies compared the intervention to enhanced or structured care. Only one study compared cognitive behavioural therapy with behaviour therapy.Across the 21 studies, the mean number of sessions ranged from one to 13, over a period of one day to nine months. Duration of follow-up varied between two weeks and 24 months. Participants were recruited from various healthcare settings and the open population. Duration of symptoms, reported by nine studies, was at least several years, suggesting most participants had chronic symptoms at baseline.

Due to the nature of the intervention, lack of blinding of participants, therapists, and outcome assessors resulted in a high risk of bias on these items for most studies. Eleven studies (52% of studies) reported a loss to follow-up of more than 20%. For other items, most studies were at low risk of bias. Adverse events were seldom reported. For all studies comparing some form of psychological therapy with usual care or a waiting list that could be included in the meta-analysis, the psychological therapy resulted in less severe symptoms at end of treatment (SMD -0.34; 95% confidence interval (CI) -0.53 to -0.16; 10 studies, 1081 analysed participants). This effect was considered small to medium; heterogeneity was moderate and overall quality of the evidence was low. Compared with usual care, psychological therapies resulted in a 7% higher proportion of drop-outs during treatment (RR acceptability 0.93; 95% CI 0.88 to 0.99; 14 studies, 1644 participants; moderate-quality evidence). Removing one outlier study reduced the difference to 5%.

Results for the subgroup of studies comparing CBT with usual care were similar to those in the whole group. Five studies (624 analysed participants) assessed symptom severity comparing some psychological therapy with enhanced care, and found no clear evidence of a difference at end of treatment (pooled SMD -0.19; 95% CI -0.43 to 0.04; considerable heterogeneity; low-quality evidence). Five studies (679 participants) showed that psychological therapies were somewhat less acceptable in terms of drop-outs than enhanced care (RR 0.93; 95% CI 0.87 to 1.00; moderate-quality evidence).

AUTHORS' CONCLUSIONS: When all psychological therapies included this review were combined they were superior to usual care or waiting list in terms of reduction of symptom severity, but effect sizes were small. As a single treatment, only CBT has been adequately studied to allow tentative conclusions for practice to be drawn. Compared with usual care or waiting list conditions, CBT reduced somatic symptoms, with a small effect and substantial differences in effects between CBT studies. The effects were durable within and after one year of follow-up.

Compared with enhanced or structured care, psychological therapies generally were not more effective for most of the outcomes. Compared with enhanced care, CBT was not more effective. The overall quality of evidence contributing to this review was rated low to moderate.The intervention groups reported no major harms. However, as most studies did not describe adverse events as an explicit outcome measure, this result has to be interpreted with caution.An important issue was that all studies in this review included participants who were willing to receive psychological treatment. In daily practice, there is also a substantial proportion of participants not willing to accept psychological treatments for somatoform disorders or MUPS. It is unclear how large this group is and how this influences the relevance of CBT in clinical practice.The number of studies investigating various treatment modalities (other than CBT) needs to be increased; this is especially relevant for studies concerning physical therapies. Future studies should include participants from a variety of age groups; they should also make efforts to blind outcome assessors and to conduct follow-up assessments until at least one year after the end of treatment.

: Van Dessel N, Den Boeft M, van der Wouden JC, Kleinstäuber M, Leone SS, Terluin B, Numans ME, van der Horst HE, van Marwijk H. Cochrane Database Syst Rev. 2014 Nov 1;11:CD011142. [Epub ahead of print]

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