Extrait

Background and study aims In the UK urinary tract infections (UTIs) are the most common infection that women come to the GP surgery with. About 40-50% of women experience this at least once in their lifetime. This accounts for between 1-3% of all consultations in general practice. Repeated urinary tract infections (RUTIs) are commonly defined as three episodes of UTI in the last 12 months or two episodes in the last 6 months. Between 20-30% of women who have had one episode of UTI will have a recurrent UTI, and around 25% of these will develop subsequent recurrent episodes. RUTIs can affect the quality of life, and have a high impact on healthcare costs as a result of outpatient visits, diagnostic tests and prescriptions. Whilst antibiotics are effective as a preventative treatment for RUTIs there is increasing concern about microbial resistance to these drugs and side effects of long-term use. Also, between 50-60% of women will become re-infected within 3 months after stopping antibiotics so they are not getting to the root of the problem. Chinese herbal medicine (CHM) has a long history of treating the symptoms of UTIs. In recent years there has been some encouraging research in China looking at the effect of CHM given either on its own or together with antibiotics to help prevent RUTIs. Unfortunately the methodology of most of these studies is poor and we need to conduct a more rigorous clinical study to assess the effect of CHM in preventing RUTIs. This study is the first stage of this process and will assess the feasibility of delivering CHM through GP surgeries to a group of women suffering from 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 whether it is a form of treatment that could be given by GPs or whether it needs to be given by a trained CHM practitioner. Who can participate? Women aged between 18-65 with three or more RUTIs in the previous 12 months. What does the study involve? Patients will be randomly allocated to one of four groups: 1. Active standardised CHM treatment delivered via GPs 2. Placebo standardised CHM treatment delivered via GPs 3. Active individualised treatment delivered via CHM practitioners 4. Placebo individualised treatment delivered via CHM practitioners Standardised CHM treatment will be delivered as herbal capsules via GP practice nurses and will involve the use of fixed herbal formulae for severe episodes and for preventative treatment. These formulae will be developed through expert consultation. They will comprise of three herbs in each formula. A matching placebo (dummy) herbal capsule will be prepared and tested prior to the study. Individualised treatment will be administered by experienced practitioners of CHM and will be delivered as concentrated herbal granules that will be dissolved in hot water and drunk. Treatment will be based on the patient-specific diagnosis made by the practitioner and will vary between patients and over time. What are the possible benefits and risks of participating? The treatment may reduce the frequency and severity of participants’ RUTIs. However, this is something that has not been proven and it is the aim of this research to explore whether CHM can help in these circumstances. In CHM the herbs can cause some digestive upset like temporary nausea or loose bowels. However, these usually only lasts for 2-3 days and generally the herbs are well tolerated. In very rare instances the herbs can cause abnormal liver or kidney function. Blood tests will be conducted at the beginning of the study, after 4 weeks of taking the herbs and again at the end of the trial to measure liver and kidney function and to ensure that the participant can tolerate the Chinese herbs. Where is the study run from? Standardized herbal remedies administered by practice nurses will take place in Hampshire and Dorset. We anticipate that up to eight GP practices will be involved. Individualized herbs administered by CHM practitioners will take place in two complementary medicine clinics. One will be in North London and the other will be in Hove, UK. Trial participants will still require to be referred by their GPs before they can take part in this group of the study. When is the study starting and how long is it expected to run for? The study will run from January to December 2015. Who is funding the study? The National Institute of Health Research (NIHR) (UK). Who is the main contact? Dr Andrew Flower [email protected]

Critère d'inclusion

• Topic: Primary Care; Subtopic: Infectious diseases and microbiology, Primary care; Disease: All Diseases

Liens

• ictrp
• isrctn