Weight loss surgery is more effective than dieting to reduce brain pressure that can cause blindness in patients with a neurological condition, finds a study led by Birmingham Health Partners founder-members the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust (UHB).

Idiopathic Intracranial Hypertension (IIH) is a debilitating condition that raises pressure in the brain and can lead to chronic headaches and even permanent sight loss. The illness, which often leaves patients with a reduced quality of life, predominately affects women aged 25 to 36 and weight gain is a major risk factor of developing IIH and relapses of the disease.

Weight loss has been shown to be an effective treatment, with a reduction in body weight of between three to 15% inducing disease remission. However, maintaining weight loss is notoriously difficult, as most patients regain weight over a two to five year period.

In the first clinical trial of its kind, the research team set out to analyse whether bariatric surgery or a 12-month community weight management intervention (delivered through WW) would be the most effective for reducing brain pressure in women with IIH.

The trial, supported by the National Institute for Health Research (NIHR), involved 66 women with IIH with an average age of 32 years and a body mass index (BMI) of 35 or more. Half underwent bariatric surgery, while the other half took part in WW. Brain pressure was measured by lumbar puncture at the start and after 12 and 24 months.

The results, published today in JAMA Neurology, showed that bariatric surgery was significantly more effective than community weight management, with those having had surgery seeing an average intracranial pressure reduction of 25% after 12 months.

The results also showed that the surgery group lost on average 23Kg, as compared to losing 2kg in the WW group at 12 months. This difference was greater at 24 months with 24% more weight lost in the surgery group as compared to WW. This was because the bariatric surgery group continued to lose more weight over time (28Kg from the start of the study to 2 years), whilst the community weight management group had regained weight lost and, on average, were only 1kg lighter than at the start of the study.

Senior author Alex Sinclair, Professor of Neurology at the University of Birmingham and Neurology lead of the Idiopathic Intracranial Hypertension Service at UHB, said: “A link between weight and IIH has long been observed but, until now, there has been no robust evidence that weight loss can reduce brain pressure.

“We have shown that weight loss achieved through bariatric surgery is significantly more therapeutic than community weight loss management interventions both in the short and longer term to treat IIH brain pressure.

“Whilst we recognise that bariatric surgery may not be an appropriate approach for all patients with IIH and increased weight, it is important to now have the evidence that a surgical approach can lead to significant sustained disease remission.”

First author Dr Susan Mollan, Director of Ophthalmic Research at UHB, added: “We hope that as a consequence of this research, current NHS and NICE guidance can change to include bariatric surgery as a treatment for women with IIH and a BMI greater than 35 when appropriate and in line with the patient’s best interests and wishes.

“Weight stigma is a major barrier to patient care in IIH. We also hope this research will prompt discussion and education around weight management to ensure this sensitive topic is approached with care and dignity.”

Co-author James Mitchell, Lecturer in Neurology at the University of Birmingham, added: “Weight regain is often driven by biology rather than willpower, and obesity is a chronic relapsing disease that requires lifelong treatment. Therefore, it’s essential that patients are given appropriate support to achieve weight loss and further work is done to ensure they have good access to weight management services.”

A new clinical trial being led by two Birmingham Health Partners founder-members aims to identify the best surgical treatment option to prevent blindness in patients with a neurological condition.

Funded by almost £1.5 million from the National Institute for Health Research (NIHR), it is hoped the research will lead to changes in healthcare policy for the treatment of patients with Idiopathic intracranial hypertension (IIH).

Thus far, there is no known cause for the neurological condition, which increases intracranial pressure around the brain without the presence of tumour or disease. Common symptoms of IIH include debilitating headaches, visual loss, pulsatile tinnitus, and back and neck pain. If left untreated, the disorder can lead to blindness.

The condition is managed with weight loss and medication, however, in severe cases that present as an emergency with decreasing vision, surgery is needed to prevent blindness.

Currently two different types of surgeries – dural venous sinus stenting (stenting) and cerebrospinal fluid (CSF) shunting – are used to prevent blindness, however there have been no clinical trials to determine which is the best operation. The team will carry out a clinical trial involving up to 138 IIH patients with rapid vision deterioration to establish which of the surgical procedures is the best at saving vision; the safest with least complications; and the most cost effective.

The research, which has been developed in consultation with patient charity IIH UK, will be carried out by a team of BHP experts at the University of Birmingham, University Hospitals Birmingham (UHB), and at sites around the UK.

Alexandra Sinclair, Professor of Neurology at the University of Birmingham, Honorary Consultant Neurologist at UHB and Chief Investigator of the new research project, explained: “CFS shunting involves implanting a thin tube known as a shunt in the brain, which allows the excess cerebrospinal fluid flow to another part of the body, thus rapidly reducing brain pressure.

“However, within the first year of surgery many tubes become blocked or infected and stop working. This, and other complications, have a significant impact on patients’ lives and have important cost implications for the NHS.

“More recently, stenting has been used, which involves placing a small stent across a narrowing of certain blood vessels in the brain, which can improve blood flow and lower brain pressure.”

Philip White, Professor of Interventional and Diagnostic Neuroradiology at the University of Newcastle and Co-Investigator, added: “So far, studies have not provided high quality evidence to show that this procedure can prevent blindness when vision is rapidly declining. Additionally, we need to confirm procedural durability compared with the surgery, which may need to be repeated and establish its safety is at least comparable.”

Miss Susan Mollan, Director of Ophthalmic Research at UHB and Co-Investigator, added: “We hope that the results of our study will provide evidence that will influence NHS policy and will lead to improved care for IIH patients, ensuring they receive the best possible treatment to prevent them from losing their eyesight.”

Amanda Denton, IIH UK Trustee and Research Representative, said: “IIH UK is delighted that this important trial is being carried out. Identifying the best types of intervention is one of our members’ top ten research priorities. Many of our members have shunts and stents to prevent them losing their sight and research to find the most effective method with the least complications is vital to improve their quality of life.”

The trial, will see participants being allocated to CSF shunting or stenting, which will be decided at random by a computer. The main outcome of the trial to be evaluated will be preservation of vision. A number of key additional outcomes, including treatment-related complications, headache and patient reported quality of life, will also be assessed.

Dr Ben Wakerley, Consultant Neurologist at UHB and Co-Investigator, comments: “The impact of these interventions on headache and quality of life have been highlighted to be of key importance by patients.”

An economic evaluation will be performed, led by Professor Emma Frew, University of Birmingham Co-Investigator, to estimate the cost-effectiveness of shunting versus stenting. Participants will be asked to attend routine hospital check-up visits over a year. Their health would then be monitored through linked NHS database records for longer-term follow up at two years.

A clinical trial has shown that digoxin has the same effect on physical wellbeing as beta-blockers when used to treat patients with permanent atrial fibrillation and symptoms of heart failure.

Beta-blockers have long been the drug of choice for controlling rapid heart rates in patients with atrial fibrillation (AF), but a clinical trial led by Professor Dipak Kotecha of Birmingham Health Partners has shown that digoxin is just as effective, but with less adverse effects.

The ‘Rate Control Therapy Evaluation in Permanent Atrial Fibrillation’ (RATE-AF) trial was the first of its kind to compare the effectiveness of digoxin and beta-blockers to treat AF. Beta-blockers, such as bisoprolol, are one of the most common groups of drugs used in clinical practice to reduce heart rate and improve pump function. Digoxin primarily works to slowly improve the contraction of the heart but also has other broad range effects which at low-dose can potentially be helpful to counter the body’s response to AF and heart strain, and is usually only used when other treatments are unsuccessful.

The RATE-AF trial showed there was no difference in physical wellbeing between digoxin and beta-blockers and there was no difference in the effect on long-term heart rate between the two drugs. Importantly, digoxin at low dose was found to cause substantially and significantly less adverse effects than beta-blockers, lessened the impact of AF on the daily lives of patients by improving symptoms, and reduced a marker of heart strain, natriuretic peptide.

AF is caused by disorganised electrical impulses firing from different places in the top chambers of the heart and patients usually require medication to control an irregular heartbeat. Patients can also have a reduced quality of life, be admitted to hospital more frequently and have a higher chance of strokes and heart failure.  This trial, embedded in the NHS, involved 160 patients aged 60 or older. It has addressed a major evidence gap in the management of patients with permanent atrial fibrillation. The research team will plan a larger trial to see if digoxin can reduce hospital admissions in this patient group.

Chief Investigator Professor Kotecha said: “I hope that the results of this trial show the importance of randomised clinical trials to see how treatments actually work. On behalf of the research team and all the patients who designed and took part in the RATE-AF trial, we are delighted to show that digoxin is a drug that can be used to improve the lives of patients with AF.”

The trial was publicly funded by the National Institute for Health Research (NIHR). RATE-AF was coordinated by the Institute of Cardiovascular Sciences at BHP founder member the University of Birmingham, a Patient & Public Involvement Team and the Birmingham Clinical Trials Unit. Patients and staff involved in the trial were from BHP founder member University Hospitals Birmingham NHS Foundation Trust as well as Sandwell and West Birmingham Hospitals NHS Trust and local General Practitioners.