Can you take uva ursi with antibiotics

For the primary analyses, descriptive statistics will be obtained for the randomisation groups to characterise recruited patients and assess baseline comparability. For the primary outcome, analysis of covariance will be used to analyse symptom-severity data with imputation of missing data. Logistic regression will be used to analyse the dichotomous outcomes antibiotic use, re-consultation in 1 month with UTI and re-consultation with UTI from notes review in the next 12 months.

Negative binomial regression will be used to analyse duration of moderately bad symptoms. All analyses will be adjusted for the factorial design and, if necessary, for potential confounding variables, e. We will explore the effect of the interventions on symptoms in the frequency and unwell clusters. The Data Monitoring Committee will review safety and efficacy data at least annually.

The main analysis will be carried out when all patients have completed the study. A statistical analysis plan will be written before the data are analysed. The ATAFUTI study is the first double-blind, placebo-controlled, factorial randomised trial to investigate a traditional herbal medicinal product as an alternative treatment for UTIs in women, with the aim of reducing symptoms and reducing antibiotic consumption in primary care. It will provide clinical evidence on the efficacy and safety of using ibuprofen and a traditional herbal medicine uva-ursi, either singularly or in combination for the relief of the distressing symptoms of UTI in women, one of the most common reasons for antibiotic prescription.

The diary format has been previously validated and shown to be sensitive to change for other acute infections [ 22 , 24 ]. By using this method it will allow the impact of the intervention on symptom severity and on the duration of symptoms to be investigated.

The finding will be disseminated by publication and presentation at conferences. Summary findings will be provided to participating practices. Recruitment commenced in August and is due to complete by October Nick Francis and Dr. Julie Whitehouse. Details are available from the CTU. The project is sponsored by the University of Southampton.

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR School of Primary Care. See Additional file MM was responsible for the research question. CE and JT are the qualitative researchers on the trial and had responsibility for data collection, analysis and reporting. TM, AG and LS are the trial statisticians and contributed to the writing of the study protocol and statistical analysis plan. MR is the data manager. FW and CS are the trial managers and contributed to the design of the trial and writing of the study protocol.

GG is the director of the SCTU, and contributed to the study management, analysis and development of the protocol. All authors have provided comments on the drafts of this paper and have approved the final version. No professional writers were used. All ethical bodies involved in the recruiting and participating centres are listed in an additional file see Additional file Informed written consent will be obtained from all participants. Neither individual patient data nor identifiable information which could compromise the confidentiality of the study participants will be included.

Informed written consent will be obtained for publication of the study. The authors declare that they have no competing interests. There are no limitations on access to the data set for the investigators. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material. Jeanne Trill, Email: ku. Catherine Simpson, Email: ku. Frances Webley, Email: ku. Mike Radford, Email: ku. Louise Stanton, Email: ku. Tom Maishman, Email: ku. Angeliki Galanopoulou, Email: ku. Andrew Flower, Email: ku. Caroline Eyles, Email: ku. Merlin Willcox, Email: ku.

Alastair Hay, Email: ku. Gareth Griffiths, Email: ku. Paul Little, Email: ku. George Lewith, Email: ku. Michael Moore, Email: ku. National Center for Biotechnology Information , U. Journal List Trials v. Published online Sep 8. Author information Article notes Copyright and License information Disclaimer.

Corresponding author. Received Oct 25; Accepted Aug This article has been cited by other articles in PMC. DOC kb. PDF kb. Additional file 6: Participant diary. Additional file Trial amendments. Abstract Background Women with acute uncomplicated urine infection are usually treated with antibiotics. Secondary outcomes include antibiotic use and symptom duration. Discussion The outcomes from this trial have the potential to modify the current approach to the management of acute urinary symptoms with less dependence on the use of antibiotics.

Electronic supplementary material The online version of this article doi Herbal product Herbal products for the relief of urinary symptoms are widely available over-the-counter OTC with a traditional-use licence, although they have never been subjected to rigorous efficacy studies.

Recruitment and randomisation Eligible participants will be identified and approached in primary care centres Fig. Open in a separate window.

Assessment and follow-up Participants will be required to maintain a daily symptom diary used in previous studies of UTI [ 20 , 21 ], grading severity of their presenting and subsequent UTI symptom s.

Primary outcome: Symptom severity on days 2—4 using validated diary data [ 2 , 15 , 22 ]. Secondary outcomes: Use of antibiotics Individual data from each of the four groups for primary outcome and use of antibiotics Duration of moderately bad symptoms Duration of symptoms until little or no problem Total symptom burden derived from diary data Re-consultation in 1 month with UTI from notes review Re-consultation in 3 months with UTI from notes review Exploratory analysis: Differential effects on primary outcome depending on culture results Adverse events will be recorded as detailed below under safety considerations.

Participants are also free to withdraw at any time without giving a reason. In particular, all medical encounters related to the following medical areas or symptoms will be recorded in the Adverse Events Form: Abdominal symptoms: any events relating to abdominal discomfort or other symptoms Urine infection: any events relating to UTI Medication: any events relating to study medication The practitioners providing care for the patient are advised to record any event for which there is uncertainty as to whether it is study-related or not, and to discuss with the local principal investigator PI or chief investigator CI.

Test tube studies show that uva ursi may inhibit the growth of Staphylococcus saprophyticus and E. However, in another small randomized study on 57 women who had recurring UTIs, those who took a uva ursi extract with dandelion root a diuretic had fewer UTIs over the course of a year than those who received a placebo 3 , 9.

This suggests that uva ursi may be more effective if you take it at the first sign of an infection. Furthermore, the hydroquinone in uva ursi also seems most effective against bacteria if your urine is alkaline, with a pH over 7 3 , 9.

Normally, urine has a pH of 4. A diet low in animal proteins and higher in plants tend to create more alkaline urine. Taking sodium or potassium citrate may also alkalize your urine and make uva ursi more effective. That said, you should ask your healthcare practitioner before taking uva ursi or sodium or potassium citrate 3 , 9. When choosing uva ursi or any herbal supplement , look for those made with organic ingredients from companies that follow the current good manufacturing practices set by the Food and Drug Administration.

Most evidence for uva ursi comes from studies done in a lab rather than on humans. If you have a UTI, it may or may not clear it up. If you want to try it, look for a whole plant extract that provides — mg of arbutin in a daily dose. Side effects are uncommon, but they might include nausea , vomiting, shortness of breath, or tinnitus ringing in your ears 2.

You should also limit its use to fewer than 2 weeks at a time 3 , The main safety concern is with hydroquinone, the chemical that comes from arbutin. There is some concern that long-term exposure to hydroquinone can cause cancer 3 , 4 , Furthermore, if you delay antibiotic treatment for a UTI, the infection might worsen and affect your kidneys. You might find uva ursi or its active compound, arbutin, in multi-ingredient dietary supplements promoted for weight loss or wellness, although no studies support this use 2 , Thus, arbutin and hydroquinone are common ingredients in skin cream products because they may promote skin lightening and help eliminate brown spots and freckles You can also find its active compounds, arbutin and hydroquinone, in skin creams because they may work as skin lightening agents.

As UTI may resolve spontaneously, a third group with observation only could generate further data on the effects of a watch and wait treatment strategy. However, this might also lead to a less participation rate. Patients in this study will receive an active substance irrespective of which group they are randomized to.

Uncomplicated UTIs have a good prognosis and usually do not require follow-up consultations. To follow this pragmatic approach and to influence the course of the symptoms as little as possible, only one final visit at day 28 without a GP contact is planned in this study.

Return visits are possible at any time if symptoms persist or reoccur. Study-related changes of usual GP procedures are minimized in order to optimize external validity. Nevertheless, GPs can decide whether further diagnostic procedures or an alteration of the initial treatment strategy is necessary in patients with i. Therefore, additional procedures i. No trial-related invasive procedures are planned. A urine culture will be performed at inclusion so that specific antibiotic therapy can be initiated if necessary in case of persistent or recurrent symptoms.

We estimate that adverse drug events will occur less frequently with UU than with antibiotic therapy and we do not expect complicated disease courses, since UTI is a benign condition. Besides, in both groups the treatment courses are very short. Although only few data exist, the risk of pyelonephritis after non-antibiotic treatment of UTI is mentioned frequently [ 3 , 29 ].

In ICUTI comparing ibuprofen versus fosfomycin for uncomplicated UTI, only 5 of patients treated with ibuprofen were suspected to have a pyelonephritis [ 10 ].

We expect that some patients will require antibiotic treatment after failure of non-antibiotic treatment, but this will be predominated by the benefits of patients with symptom resolution without antibiotics. Eventually, the rate of relapses might increase — this will be assessed within the trial.

In a follow-up study, we will assess the number of patients with recurrent UTI or pyelonephritis after 3 months. A confirmation of the trial hypothesis could lead to a revision of the recommended treatment for uncomplicated UTI. Using UU as a first line treatment option may be proven as effective in resolution of UTI symptoms and reduction of antibiotic use. It may also provide favorable effect on resistance rates.

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Epub Jun Download references. The authors thank all GPs and practice staff for participating in this study. The funder had no role in the trial design and will have no influence on data collection, analysis, or reporting. You can also search for this author in PubMed Google Scholar.

All authors substantially contributed to the implementation of the study and have given relevant intellectual input. TF and KW made substantial contributions to the statistical analysis.