One in forty people in the UK have gout, yet doctors do not know whether long-term use of urate-lowering drugs like allopurinol actually prevents the painful flares that define the condition. Current treatment for gout focuses on anti-inflammatory tablets that stop the pain of a flare but do nothing about the underlying cause—urate crystals lodged in the joints. Drugs such as allopurinol can dissolve those crystals by lowering uric acid in the blood, but no trial has tested whether a systematic, dose-adjusted approach reduces flare frequency over years rather than weeks. This trial will randomise 466 adults to either a goal-directed allopurinol protocol that gradually increases the dose until uric acid drops below a target level, or to usual GP care. Participants will be followed for four years, tracking the number and severity of flares, overall wellbeing, and NHS costs. If the protocol works, the results could change how the NHS treats gout. The team plans to take the evidence to NICE to develop a national guideline, potentially shifting gout management from reactive flare treatment to preventive crystal dissolution—a change that would affect hundreds of thousands of people and reduce the burden on primary care.
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Gout is a common form of arthritis that affects one in forty people in the UK. It results from high level of uric acid in the body which forms urate crystals inside the joints. From time to time, these crystals shake loose from their deposits and cause severe joint pain and swelling. These flares usually last for one to two weeks. Flares are treated with anti-inflammatory tablets such as ibuprofen. However, anti-inflammatory tablets do not dissolve the urate crystals. Other tablets such as allopurinol can lower the uric acid level to below a target level, and slowly dissolve the crystals. These are safe treatments that have been used for many years. However, whether their long-term use reduces the number of gout flares is unknown. We will carry out a study to find out if the long-term use of tablets such as allopurinol reduces the number of gout flares and improves wellbeing. We will also find out if this treatment is cost-effective for the NHS. Study process: General practitioners (GPs) will identify people who have gout and send them information and an invitation to join the study. People interested in taking part in the study will be asked to contact the research team. We need 466 adults with gout to take part in this study, and each person will be in the study for four years. People taking part in the study will receive either of the following two treatments by random allocation for the first two years: Group-A: allopurinol with gradual dose increase aimed at reducing blood uric acid to below target level, or Group-B: usual gout care from the GP including the option to start allopurinol depending on symptoms. People in Group-A will need an average of three to four visits in order to adjust the dose of allopurinol to reduce uric acid level sufficiently to allow the urate crystals to dissolve. In addition to the visits to increase the dose of allopurinol in Group-A, there will be three other visits for people taking part in the study. These visits will occur at study start, and annually for two years. Information on health and wellbeing, and medication use will be collected. The blood pressure, height, weight, kidney function and uric acid level will be measured at these visits. People taking part in the study will be requested to record details of each gout flare they experience while participating in the study. The main outcome of the study is the number and severity of gout flares within the first two years of treatment. This and the other information collected will be compared between the groups. The cost of treatment and overall wellbeing will be used to find out if this treatment is cost-effective for the NHS. After the first two years, participants will continue taking urate lowering treatment such as allopurinol as prescribed by their GP. They will be requested to continue to provide information about gout flares for a further two years. Information about other illnesses, hospital admissions and medications prescribed will be collected from their GP. The information collected will be compared between the groups. Patient and public involvement: This study was developed in partnership with people with gout. Two people with gout will be involved in managing this study as part of the research team. Study impact: The results of this study will be publicised to doctors, nurses, people with gout, the general public and to the UK government. If this study shows encouraging results, we will engage with the National Institute for Health and Care Excellence (NICE) to develop a new national guideline for the management of gout. We believe that such guidelines will improve the treatment of gout in the UK and worldwide.
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