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Take a look at a selection of our recent media coverage:

Mindfulness-based stress reduction equivalent to escitalopram for anxiety disorders

21st November 2022

Mindfulness-based stress reduction provides a non-inferior reduction in anxiety levels to treatment with the antidepressant escitalopram

The use of mindfulness-based stress reduction (MBSR) techniques decreases anxiety levels to a similar extent as treatment with the antidepressant escitalopram according to the findings of a randomised, controlled trial by US researchers.

Anxiety is a common mental health disorder, and it has been estimated that globally, in 2017 there were 284 million individuals affected by an anxiety disorder. Antidepressant drugs are effective for generalised anxiety disorders as highlighted in a 2019 network meta-analysis and which found that duloxetine and escitalopram showed better efficacy than other agents.

Alternatives to pharmacotherapy include mindfulness-based stress reduction and cognitive behavioural therapy, with a 2021 systematic review concluding that mindfulness-based interventions produced short-term anxiolytic effects. Whilst both pharmacological and non-pharmacological interventions appear to be effective, the relative efficacy of these interventions has not been directly compared. Consequently, for the present study, the US team undertook a randomised trial of MBSR versus escitalopram and which is currently approved for the management of social and generalised anxiety disorder.

The researchers enrolled adults aged 18 to 75 with a current diagnosis of generalised anxiety, social anxiety or panic disorder and randomised them 1:1 to either 8 weeks of MBSR or escitalopram 10 to 20 mg daily. The primary outcome was the change in anxiety levels as measured on the Clinical Global Impression of Severity Scale (CGI-S) which assesses symptoms on a 7-point scale, with higher scores indicative of more severe illness.

This was assessed at baseline and then after 4 and 8 weeks. The MBSR included a weekly 2.5-hour class, and a 45-minute daily home practice exercise and escitalopram was dosed at 10 mg daily but could be increased to 20 mg daily if tolerated. The researchers set a non-inferiority margin of -0.495 for the difference in CGI-S score between the two groups, i.e., if this were to be exceeded then one of the interventions would be deemed more effective.

Mindfullness-based stress reduction and change in anxiety score

A total of 276 participants with a mean age of 33 (75% female) were included and randomised to escitalopram (140) or MBSR and the mean baseline CGI-S scores were similar (4.44 vs 4.51).

After 8 weeks of therapy, the CGI-S scores reduced by 1.35 and 1.43 in the MBSR and escitalopram groups respectively. The difference -0.07 (95% CI -0.38 to 0.23, p = 0.65) was not significant and with the lower bound of the 95% confidence interval below the pre-defined margin for non-inferiority (i.e., -0.495) not reached, the two interventions were essentially not different.

The authors concluded that given how both interventions were non-inferior, the study provided evidence to support the use of mindfulness meditation as an evidence-based treatment option for patients with anxiety disorder.

Citation
Hoge EA et al. Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry 2022.

Research shows that over half of patients well enough to stop antidepressants have relapse

7th October 2021

Discontinuing antidepressants in patients feeling well enough to stop led to a higher rate of depression relapse compared with continued therapy.

Depression is a global problem thought to affect around 280 million people or 5% of adults. The causes of depression are multifactorial and can involve a complex interaction between social, psychological, and biological factors. Treatment can be achieved through cognitive behavioural therapy as well as the use of antidepressants.

However, among those prescribed antidepressants, once a patient feels better in themselves, should they stop treatment or continue? This was the question posed by a UK team of researchers who looked at primary care patients who considered that they were now well enough to stop antidepressant treatment.

The team recruited adults prescribed conventional doses of three commonly used antidepressants: citalopram, sertraline and fluoxetine. In addition, eligible patients were those who had reported at least two prior episodes of depression or who had been taking antidepressants for more than two years.

Patients were then randomised 1:1 to either maintenance of their current antidepressant (maintenance group) or tapering and discontinuing (discontinuation group). Treatments were provided in identical bottles so that patients were unaware of whether they were assigned to the maintenance or discontinuation arm. In the discontinuation arm, the dose of antidepressant drug was reduced over a two month period so that by the third month they were taking placebo.

The primary outcome was the first relapse of depression during a 52 week follow-up period. There were eight secondary outcomes including depressive symptoms using the Patient Health Questionnaire 9-item (PHQ-9), as well as measures of anxiety and quality of life.

Findings

A total of 478 patients with a mean age of 54 years (75% women) were enrolled and randomised to either maintenance (238) or discontinuation of therapy. By week 52, relapse had occurred in 39% of those in the maintenance group but more than half, 56%, in the discontinuation group (hazard ratio, HR = 2.06, 95% CI 1.56 – 2.70, p < 0.001). The secondary outcomes were all generally in the same direction.

The authors concluded that even though all patients believed that they were well enough to discontinue with their antidepressants, doing so resulted in a higher risk of depression relapse. In addition, quality of life and symptoms of depression and anxiety were all worse in those who stopped treatment.

Citation

Lewis G et al. Maintenance or Discontinuation of Antidepressants in Primary Care. N Eng J Med 2021.

Treatment-resistant depression trials show large placebo response

6th October 2021

In trials of treatment-resistant depression, researchers have identified a large and consistent placebo response to all modalities.

Treatment-resistant depression (TRD) can be defined as a major depressive disorder (MDD) in adults who failed to respond to at least two different antidepressant treatments in their current moderate-to-severe depressive episode. It is a common problem with a prevalence estimated from one analysis to affect 30.9% of patients.

Although the efficacy of an antidepressant in clinical trials is assessed by comparison against placebo, a common problem is the large and positive placebo response often observed. The magnitude of average placebo response in studies of major depression has been found to be 29.7%, but ranged between 12.5 and 51.8%.

Moreover, in an analysis of 252 antidepressant controlled trials with 26,324 patients assigned to placebo, a placebo response was seen in 35 to 40% of patients, although the analysis did not specifically examine treatment-resistant depression.

However, what remains uncertain, is the magnitude of the placebo response in patients with TRD who are exposed to a range of different modalities. This prompted a team from the Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada, to not only assess the size of the placebo response in patients with TRD, but to also identify relevant factors associated with the placebo response.

The team undertook a comprehensive literature search and included studies that were parallel-arm, double-blind and placebo-controlled, specifically recruiting patients with treatment-resistant depression. They set the primary outcome as the Hedges g value, which is a measure of the effect size, for the placebo response.

The value of Hedges g indicates the extent to which two groups differ, based on the size of the standard deviation, e.g., a value of 1 indicates that groups differ by one standard deviations, 2 denotes two standard deviations and so on. As a secondary outcome, the team used meta-regression to explore potential moderators of the placebo effect.

Findings

A total of 50 clinical trials with 3228 patients, with a mean age of 45.8 years (20.7% women), where included in the final analysis. The placebos included pills, liquids, parenteral injections and several sham procedures such as sham transcranial magnetic stimulation, transcranial direct current stimulation or invasive brain stimulation.

The pooled placebo effect size for all treatment modalities was large (Hedges g = 1.05, 95% CI 0.91 – 1.1) although this did vary with the type of placebo intervention. For example, with pill placebos, g = 1.14, parenteral placebo, g = 1.33. The pooled placebo response rate in all trials was 21.2% with a pooled remission rate of 13%.

In the TRD trials, meta-regression revealed that industry-sponsored trials, year of publication and studies with an open-label prospective phase before randomisation, all had a significantly higher placebo effect.

Discussing these findings, the authors felt that their results offered future researchers a benchmark for expected placebo responses in TRD trials. They concluded by calling for more consistent reporting of data, an agreement on the definition of TRD, and an assessment and reporting of participant’s expectations and experiences within a clinical trial.

Citation

Jones BDM et al. Magnitude of the Placebo Response Across Treatment Modalities Used for Treatment-Resistant Depression in Adults: A Systematic Review and Meta-analysis. JAMA Netw Open 2021.

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