The RUTI trial is a multi-centred, 16 week, randomised, double-blind, feasibility study investigating the possible role of Chinese herbal medicine in the treatment of recurrent urinary tract infections (RUTIs).
But what exactly does that rather convoluted sentence mean?
This means that the RUTI trial will take place at a number of locations. Participants who take part will be invited from selected GP practices in and around Southampton, and from North West London, and Hove, East Sussex.
Women who chose to participate in the RUTI trial will be asked to take herbs over a 16 week period. During this time they will be prescribed herbs to treat acute urinary infections and herbs designed to prevent infections from occurring. It is the recurrent nature of this condition that causes so many problems and we need to give herbs over this sixteen week period to assess their long term impact on reducing the severity and frequency of these infections. After the trial finishes we will also be asking the women who participate to keep a record of any infections that occur in the subsequent six months. This will allow us to assess any lasting benefits from the herbs, after someone has stopped taking them.
All women taking part in the RUTI trial will be randomised to receive either active or placebo treatments. Active herbs will be prescribed either as capsules, or as granules which are made into a strong tasting drink by adding hot water. The placebo treatment will look and taste the same as the active herbs but will not contain any herbs. Although it may seem strange, many people who take placebo treatments can respond very positively and experience real changes in their health and well being. These are known as 'contextual effects' and one of the aims of the trial will be to assess the ways in which these effects might vary according to who is providing the treatments-a GP practice nurse, or a Chinese herbal practitioner.
Neither the health practitioner involved in the trial nor the participant taking the herbs will know which group they have been randomised to, so the trial is known as 'double blinded'. At the end of the trial the true allocation of all the participants is revealed so that we can analyse the effect of the real herbs versus the placebo herbs.
A feasibility study is a kind of trial that we do when relatively little is known about a treatment. Feasibility studies tend to be fairly small, and we are only recruiting 80 women for this trial. We will be investigating things like whether participants were able to take the herbs for the duration of the trial, how they found the taste of the herbs, and whether it was possible to provide these herbs via the NHS. Because the trial is small we will not be able to say definitively that Chinese herbs can benefit RUTIs, but we will have enough information to see if a larger trial is required and roughly how many people would needed for this trial. All these pieces of information are essential for future research into Chinese herbs for RUTIs, and other conditions that may benefit from a herbal approach.