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The steroid dexamethasone should not be prescribed for people with chronic subdural haematoma (a collection of blood in the space between the skull and the brain). New research found that people who received dexamethasone went on to have more disability and less independence than those who received dummy (placebo) treatment.

Chronic subdural haematoma is usually caused by minor head injury and is common in older people. Symptoms can include an ever-worsening headache, increasing confusion, difficulty walking and arm or leg weakness. It is usually treated with surgery to remove the blood, but it returns in 10-20% people.

If the haematoma is small or the symptoms are mild, some clinicians prescribe dexamethasone. Their aim is to avoid the need for surgery or repeat surgery. However, there is a lack of research to show whether taking dexamethasone has an impact on disability and how well people can manage their everyday activities.

In a new trial, dexamethasone was compared with placebo in people with chronic subdural haematoma. People who received dexamethasone did not have better outcomes (for instance more independence) than those who received placebo, it found.

The drug was linked to more adverse reactions, such as infections or a new diagnosis of diabetes or of psychosis. However, dexamethasone resulted in fewer repeated surgeries.

For more information about subdural haematoma visit the NHS website.

What’s the issue?

A chronic subdural haematoma is a collection of blood in the space between the skull and the brain. It is particularly common in older people and is usually caused by a minor head injury. It is also common in people taking drugs to prevent blood clots (anticoagulant and antiplatelet medicines). Subdural haematoma is becoming more common as the population ages.

The haematoma causes pressure on the brain. Symptoms can include an ever-worsening headache, increasing confusion, difficulty walking and arm or leg weakness. It is diagnosed using a brain scan.

Most people with a chronic subdural haematoma have surgery to remove it. However, the haematoma returns after surgery in 10 to 20% of people. Dexamethasone is sometimes given to avoid surgery if the haematoma is small and the symptoms mild. Alternatively, it is given alongside surgery to stop the haematoma from returning, and reduce the need for a second procedure.

However, there is little evidence to show that dexamethasone improves outcomes, such as people's independence. This study looked at the difference in patient outcomes between people receiving dexamethasone and others receiving placebo.

What’s new?

The study took part in 23 UK centres. Researchers analysed data on 680 people with an average age of 74 years; all had chronic subdural haematoma. Half the participants received a 2-week course of oral dexamethasone. The dose was reduced slowly over 2 weeks. The other participants received placebo. Most people (94%) in this study had surgery to remove their haematomas.

Participants completed a questionnaire (called the modified Rankin scale) when they entered the study, and then again 6 months later. The scale is commonly used in neurological disorders, including stroke, and it assesses how well people can cope with everyday activities. Scores run from 0 (no disability) through to 6 (death). A 'favourable' score is between 0 – 3 and means people have no more than moderate disability and can walk without help. A 'poor' score is 4+, and people cannot attend to their bodily needs without assistance.

The researchers compared the scores of patients who had been given dexamethasone with those on placebo. They found that, 6 months after treatment:

  • fewer people in the dexamethasone group had a favourable score than those receiving placebo (84% compared with 90%)
  • twice as many people in the dexamethasone group scored poorly than in the placebo group (17% compared with 8.6%)
  • more people in the dexamethasone group reported serious adverse reactions than those taking placebo (16% compared with 6%); these reactions included high blood sugar, new onset diabetes, infections, and gastrointestinal side effects.

One positive effect of dexamethasone was that fewer people taking it needed a repeat operation for haematoma than those on placebo (1.7% compared with 7.1%).

Only 38 people in this study did not have surgery to remove their haematomas. In this small group, people who took dexamethasone were less likely to have a favourable score at 6 months than those on placebo. All 16 people on placebo had a favourable score, compared with 18 out of 22 who received dexamethasone.

Why is this important?

Fewer people treated with dexamethasone in this study had favourable outcomes compared to people receiving dummy treatment. The researchers say that dexamethasone could be doing more harm than good. It was linked with more adverse reactions than dummy treatment. They recommend that clinicians stop prescribing dexamethasone to patients with subdural haematoma.

The numbers in this study were not large enough to say whether dexamethasone prevented the need for surgery. However, fewer people who took dexamethasone had repeat surgery, than those who took placebo.

What’s next?

The Society of British Neurological Surgeons is working with other specialist associations to issue new and updated guidance based on the study findings. The study found a clear signal of harm associated with dexamethasone.

The authors recommend that dexamethasone for chronic subdural haematoma should only be used as part of a research study. Further studies could explore different doses or length of treatment with dexamethasone. It is possible that this could reduce the number of adverse reactions.

The authors say that surgery for chronic subdural haematoma has a good safety profile. Most (90%) patients having surgery had a favourable outcome and almost two-thirds (65%) returned to their usual activities afterwards. They say research should focus on rehabilitation and integrated geriatric care to further improve people’s recovery.

The number of people with this condition is expected to continue rising. Well-designed studies are therefore needed, for example, to explore minimally invasive techniques carried out under local anaesthetic. The researchers say that studies should have outcomes relevant to patients and focus, for example, on their degree of disability.

You may be interested to read

This NIHR Alert is based on: Hutchinson P, and others. Trial of dexamethasone for chronic subdural haematoma. The New England Journal of Medicine 2020;383:2616-2627

A review of papers looking at dexamethasone in chronic subdural haematoma and highlighting the need for a well-controlled trial exploring the treatment: Berghauser Pont LME, and others.  The role of corticosteroids in the management of chronic subdural hematoma: a systematic review. European Journal of Neurology 2012;19:1397-1403

Funding: This research is supported by the NIHR Health Technology Assessment Programme.

Conflicts of Interest: One of the authors had shares in Marker Diagnostics.

Disclaimer: NIHR Alerts are not a substitute for professional medical advice. They provide information about research which is funded or supported by the NIHR. Please note that views expressed in NIHR Alerts are those of the author(s) and reviewer(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.


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Comments

Study authors

Surgery is the mainstay of treatment for patients with symptomatic chronic subdural haematoma. But dexamethasone has also been used since the 1970s as an adjunct to surgery or stand-alone therapy. The latter indication is mainly reserved for patients with mild symptoms. However, there has been a distinct lack of high-quality evidence from randomised trials.

This is the first multicentre randomised trial to evaluate a two-week tapering course of dexamethasone for patients with a symptomatic chronic subdural haematoma.

Our results are thought-provoking. Although dexamethasone reduced post-operative recurrence, it led to more unfavourable outcomes at 6 months. This is likely due to the higher rate of complications observed in patients treated with dexamethasone.

Peter Hutchinson, Professor of Neurosurgery, Addenbrooke’s Hospital & University of Cambridge 

The trial has undoubtedly shown that patients treated with dexamethasone fared worse than the placebo group. One caveat is that most enrolled patients were managed surgically. We can confidently say, therefore, that dexamethasone should not be used as an adjunct to surgery.

Only a small subgroup (38 patients) did not have surgery for their chronic subdural haematoma. We are less confident in stating that dexamethasone should not be used as a stand-alone therapy. However, another high-quality study from the Netherlands has similarly reported worse outcomes with dexamethasone.

While these results are disappointing in a way, they will help prevent harm to patients as we now have evidence against the use of dexamethasone for this indication.

Angelos Kolias, Consultant Neurosurgeon and Clinical Senior Lecturer, Addenbrooke’s Hospital & University of Cambridge 

Headway 

The potential lifelong consequences of a subdural haematoma cannot be underestimated. At Headway we see the devastating impact of brain injuries, such as those caused by subdural haematomas. These can include a range of physical, cognitive, emotional and behavioural effects, all of which can impact on domains of life such as employment, relationships and even self-identity.

The acute phase of care and initial treatment provided to patients can be crucial to their long-term prognosis. We therefore welcome any research that aims to clarify the role of medications such as dexamethasone in the treatment of brain injuries such as chronic subdural haematomas.

Further research in this area is needed to aid clinicians in their treatment of conditions such as subdural haematomas, among other types of acquired brain injury.

Headway – the brain injury association 

Royal College of Surgeons of England 

Before the COVID-19 pandemic, dexamethasone was mainly used by neurosurgeons – including for the treatment of patients with chronic subdural haematoma. Dexamethasone was often given to patients when surgery was considered too high risk. This was despite a lack of evidence for its benefit and the risk of side effects such as psychosis and high blood sugars.

In the dexamethasone group in this study, there were fewer favourable outcomes, more side effects and fewer repeat operations. In the placebo group, there were more favourable outcomes, fewer side effects and more repeat operations.

This excellent study clearly demonstrates the ongoing need to challenge existing treatments that have no evidence base and that may cause more harm than benefit. There is a duty on surgeons to undertake research that improves treatments and patient outcomes. This study shows that neurosurgeons should avoid using dexamethasone in patients who have had burr hole drainage (surgery) of their subdural haematoma. This recommendation should also be extended to those patients with chronic subdural haematoma who don’t undergo surgical drainage.

Michael Jenkinson, Sir John Fisher and Royal College of Surgeons of England Chair of Surgical Trials and Neurosurgery Surgical Specialty Lead 

Neurosurgeon

This important paper highlights the challenges and potential risks of using dexamethasone in people with chronic subdural haematoma. For a long time this drug has been used for these patients with a wide variety in practice amongst clinical teams. Some clinicians have favoured its use and others have been against it.

Other studies and meta-analyses have suggested that dexamethasone is effective and safe. The findings of this randomised controlled trial are more important in that light. Overall, this study indicates that dexamethasone should not be routinely used for subdural haematoma.

This study found significant risks associated with the use of dexamethasone in people with chronic subdural haematoma. There were fewer favourable outcomes and more adverse events. The finding that there were fewer repeat operations in the dexamethasone group is interesting (8.3% dexamethasone; 10.8% placebo). But the slight increase in re-operation rate for the placebo group did not appear to lead to harm for those patients.

It’s also worth noting that in patients treated conservatively without surgery, favourable outcome was 100% without dexamethasone (and 82% with dexamethasone).

As the margins are small between the groups, it might be interesting to see whether these results are restricted to UK patients. But overall, my interpretation of this study is that dexamethasone does not provide a robustly safe alternative to surgery and should not be routinely used in people with chronic subdural haematoma. This trial demonstrates the increase in risks with dexamethasone.

John Goodden, Consultant Neurosurgeon (Adult & Paediatric), Leeds Teaching Hospitals 

Member of the public

The findings indicate that using dexamethasone is less favourable than dummy, so clinicians/healthcare professionals should reconsider whether it is appropriate to prescribe dexamethasone to patients.

Replicated studies would increase the validity of these findings.

Rainbow Choi, Public Contributor, London 

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