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The University of Southampton
The RUTI trial

Aims and objectives

This research is part of a National Institute of Health Research (NIHR) funded project to investigate the possible contribution that Chinese herbal medicine (CHM) could make to the treatment of recurrent urinary tract infections (RUTIs). We are going to explore whether CHM helps to prevent RUTIs, whether it has any benefits in improving quality of life, and if there are any side effects from CHM treatment. We are also going to evaluate how people with RUTIs feel about taking CHM, and if it is a form of treatment that could be given by your GP, or if it needs to be administered by a trained CHM practitioner. In order to do this we are conducting a randomised controlled trial with two arms to test the effectiveness of two different types of CHM. The trial will last for 16 weeks. Details of the trial are below.

Image of medicinal capsules
herbal medicine capsules

In and around Southampton-Standardised herbal treatment

The first arm of the trial will use standardised herbal capsules and will take place in 8 GP practices in and around Southampton. If you belong to one of these practices and suffer from recurrent urinary tract infections, then you may be invited to take part in the trial. We will provide you with information about the trial and, if you are interested in finding out more, we will arrange a convenient time to talk to you on the phone. If you want to become a trial participant, and you meet the eligibility criteria for the trial, then you will be asked to sign a consent form to show that you understand what this commitment involves.

You will then be invited to attend an interview with the practice nurse, who will ask you a few questions to ensure you are eligible for the trial. You will then be asked to complete a couple of questionnaires which will provide us with information about your recurrent infections and how they affect your daily life. The practice nurse will also take a small sample of blood, so that we can check your liver and kidney function. This is something that we will do again after 4 weeks and at the end of the trial and it is a really important way of assessing the safety of the Chinese herbs. You will also be given a Symptom Diary to take away which we would like you to use to record your experiences during the trial. 

At the end of your initial consultation you will be provided with two types of herbal capsules. The first are to be used if you get an acute infection, and the second will be used to help prevent subsequent infections. They will be clearly labeled and you will be given instructions about how to take them. You will also be given a phone number and an email which you can contact if you have any concerns about any aspect of your treatment during the trial.

We would like you to see the practice nurse 4 weeks after starting your herbs so we can check everything is OK, and take another blood test to monitor your liver and kidney function. When you have completed 16 weeks of the herbs we will ask you to attend a final consultation with the practice nurse where we will collect your diary, ask you to complete a few more questionnaires, and take a final blood sample.

Image of pulse being taken
Consulting a CHM practitioner

NW London and Hove-Individualised treatment

The second arm of the trial will take place in two Complementary medicine centres located in Hove and North London. If you belong to GP practices in these areas you may be invited to take part in the trial. We will provide you with information about this arm of the trial and, as with the first arm, if you are interested in taking part we will arrange a convenient time to speak to you on the phone. If you want to proceed and are eligible to do so then we will ask you to sign a consent form and go through the same procedure outlined above. In this arm you will be interviewed by a Chinese herbal practitioner who will provide you with the outcomes for the trial. They will also take a small blood sample to test your liver and kidney function. This group will then be given an in depth diagnosis according to Chinese medicine. This involves asking some quite detailed questions about your general health and will also involve the practitioner looking at your tongue and feeling the pulse on your wrist. Although these might appear strange, they are important ways for practitioners of Chinese medicine to gather information about your state of health, which can then be used to work out the best treatment for you. 

In this 'individualised' arm of the trial the practitioner will write an acute and preventative formula for you to take. Instead of capsules you will be given a prescription of Chinese herbal granules that you make up into a strong tasting tea by adding hot water. The CHM practitioner will ask to see you after you have been taking the herbs for 2 weeks, and will then see you once a month for the 16 week duration of the trial. This is to allow the practitioner to adjust your formula if required. Women in this arm of the trial will also be given liver and kidney function tests at week 4 and at the end of the trial and asked to complete the same set of trial outcomes, including the symptom diaries.

Active and Placebo herbs

In both arms of the trial we will be using active herbs and placebo herbs. Placebo herbs mimic the appearance of real herbs but do not contain any active components to directly affect a urinary tract infection. By comparing women taking active and those taking placebo herbs we will be able to see if any benefits that may be experienced during the trial are the result of the herbs or due to other factors that can lead to a relief of symptoms such as the natural progression of the illness, or going to a practitioner for a new form of treatment.

Follow up period

After the trial we will ask all participants to carry on completing their symptom diaries for a further 6 months after stopping the herbs. In this way we will be able to see if there are any long-term benefits from the herbs. Some of the trial participants may also be asked if we could interview them for about an hour to find out more about their experience of taking part in the trial.

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