Chinese herbal medicine in the treatment of women with recurrent urinary tract infections
| ISRCTN | ISRCTN95402719 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95402719 |
| Clinical Trials Information System (CTIS) | 2013-004657-24 |
| Protocol serial number | 17290 |
| Sponsor | University of Southampton (UK) |
| Funder | National Institute of Health Research (NIHR) (UK); Grant Codes: NIHR-PDF-2011-04-027 |
- Submission date
- 23/10/2014
- Registration date
- 23/10/2014
- Last edited
- 06/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Andrew.Flower@soton.ac.uk
Contact information
Scientific
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| Phone | +44 23 8059 5000 |
|---|---|
| Andrew.Flower@soton.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised, double-blind, placebo-controlled, feasibility study exploring the role of Chinese herbal medicine in the treatment of women with recurrent urinary tract infections |
| Study acronym | CHM for RUTIs |
| Study objectives | This trial is a feasibility study to provide preliminary information on: 1. The effect size of individualised, standardised and placebo Chinese herbal treatments in reducing the frequency and severity of recurrent UTIs 2. On the feasibility of administering CHM via GP practices and via non-NHS CHM practitioners and using the therapeutic environment in eliciting contextual treatment effects in the delivery of CHM |
| Ethics approval(s) | Surrey Borders NRES; 17/10/2014; ref: 14/LO/1425 |
| Health condition(s) or problem(s) studied | Topic: Primary Care; Subtopic: Infectious diseases and microbiology, Primary care; Disease: All Diseases |
| Intervention | During the trial herbal medicines will be administered either as standardised capsules or as individualised herbal granules to be dissolved in hot water to make a herbal drink. Standardised herbs will be administered as 0.4 g capsules (four pills taken twice a day [b.d.] for preventative treatment and four pills taken four times a day [q.d.] in the event of an acute infection). The individualised arm of the trial will follow the routine practice of CHM, which involves qualified practitioners. Follow Up Length: 6 month(s); Study Entry : Registration and One or More Randomisations |
| Intervention type | Other |
| Primary outcome measure(s) |
Current outcome measures as of 09/01/2019: |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 80 |
| Total final enrolment | 61 |
| Key inclusion criteria | Women will be eligible for the trial if they are aged over 18 and under 65 years of age and have reported three or more uncomplicated recurrent lower UTIs in the previous 12 months where at least one episode has been documented as bacterial UTI. |
| Key exclusion criteria | Women will be excluded from the trial if they: 1. Have symptoms of complicated UTIs such as acute pyelonephritis 2. Have known hepatic or renal disease 3. Are pregnant or breastfeeding 4. Have diabetes 5. Are taking drugs which may interact with Chinese herbal medicine: cardiac glycosides (Digoxin), warfarin and lithium 6. Have psychosis, dementia or terminal illness that may prevent completion of symptom diaries. 7. Have commenced a new treatment (conventional or CAM) for RUTIs in the previous 6 months. 8. During the trial women will be excluded if they develop significantly raised liver (ALT > 90 U/l) or renal function tests (GFR < 90 mL/mm/1.73m2). 9. Any women who also become pregnant during the trial will also be advised to stop taking the CHM and to inform a member of the study team for further advice. If pregnancy is confirmed, the participant will be asked to withdraw from the intervention in the study and asked for their consent to remain for safety monitoring purposes. |
| Date of first enrolment | 05/01/2015 |
| Date of final enrolment | 30/12/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SO16 5ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | Planned publication in a high-impact peer reviewed journal |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/10/2019 | 06/03/2020 | Yes | No |
| Basic results | 07/01/2019 | 09/01/2019 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN95402719_BasicResults_07Jan19.pdf
- Uploaded 09/01/2019
Editorial Notes
06/03/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
10/01/2019: The intention to publish date was changed from 01/01/2019 to 01/09/2019.
09/01/2019: The basic results of this trial have been uploaded as an additional file.
15/12/2016: The publication and dissemination plan and IPD sharing plan have been added.
08/12/2016: The overall trial end date has been updated from 30/12/2015 to 30/12/2017.
