Effect of a Herbal Therapy on Clinical Symptoms of Acute Lower Uncomplicated Urinary Tract Infections in Women: Secondary Analysis from a Randomized Controlled Trial

Abstract

Background: Antibiotics are commonly used as first-line treatment for acute lower uncomplicated urinary tract infections (uUTIs). However, antimicrobial resistance is a growing global problem and efficacious nonantibiotic treatment options are urgently needed. Methods: A secondary analysis was conducted with data from a randomized, controlled, double-blind trial comparing a fixed combination of extracts of restharrow root, Java tea, and goldenrod herb (Aqualibra®) to placebo in 200 women with acute lower uUTI. Symptom scores reported in the original trial were reanalyzed and adjusted to the definitions of the Acute Cystitis Symptom Score (ACSS). Results: Based on a subgroup of patients with evaluable microbiologic data (n = 122), the decrease of the mean sum-score of three typical ACSS-adjusted symptoms showed significant superiority of the herbal preparation over placebo already after one day of treatment (p = 0.0086); on Day 7, the average difference was −1.9 score points (p < 0.0001). The superior efficacy of the herbal preparation on Day 1 was mainly driven by a difference in response rates of the symptom ‘dysuria’ (group difference: −29.4%, p = 0.0042). Furthermore, significantly fewer patients in the verum group required antibiotic therapy (15.3% vs. 49.2%, p = 0.0001). These results were confirmed in the intention-to-treat (ITT) population (n = 200). Conclusions: A fixed combination of extracts of restharrow root, Java tea, and goldenrod herb was superior to placebo regarding symptom relief and prevention of antibiotic use in women with lower uUTI. Trial registration: ClinicalTrials.gov: NCT04032574.

An integrative analysis to predict the Active Ingredients and explore Polypharmacological Mechanisms of Orthosiphon stamineus Benth. for human health

“…A few investigations also evaluated its neuroprotection in epilepsy, depression, and Alzheimer’s disease(Chung et al, 2020). However, most of these studies were at the pre-clinical phase; only three clinical trials of an herbal combination containing O. aristatus proved effective in treating hypertension, metabolic syndrome(Cicero et al, 2012), and urinary tract infections(Mainini et al, 2020; Vahlensieck et al, 2019). Based on the I-T-D network and DO analysis in our study, it seems to give an insight that O. aristatus was a versatile therapeutic agent.…”

“…As shown in Supplementary table S2, the average molecular weight of these ingredients was about 230.59, the median was 185.22, the maximum was 492.56, and the minimum was 100. 16. The prediction results of drug characteristics shown that of the 62 active ingredients, 77.42% had good water solubility, 96.77% had good intestinal absorption, and 74.19% can permeate the blood-brain barrier (BBB).…”

“…Plenty of pre-clinical experiments demonstrated that the various extracts of O. stamineus exerted pharmacological properties, including anti-proliferative(Doleckova et al, 2012; Ahamed et al, 2012), antioxidant(Awale et al, 2003; Hsu et al, 2010), analgesic(Chen et al, 2020), anti-inflammatory(Hsu et al, 2010; Yam et al, 2010), antimicrobial(Alshawsh et al, 2012; Ho et al, 2010), diuretic(Bode et al, 1991), among others. Recently, two rare clinical trials have been performed, and the results showed that the herbal combination with O. stamineus seems to be useful in the reduction of discomfort and prevention of antibiotic use in women with urinary tract infections(Mainini et al, 2020; Vahlensieck et al, 2019). Despite the fact that dozens of phytochemical studies investigated the natural compounds in O. stamineus from all over the world and hundreds of chemical compounds such as flavones, polyphenols, and terpenoids have been detected, very little is known about active substances, their targets, interactions, and specific molecular mechanisms.…”

Contribution of Symptomatic, Herbal Treatment Options to Antibiotic Stewardship and Microbiotic Health

“…For many common and recurring infections, such as urogenital infections [ 78 , 79 ] or infections of the upper and lower respiratory tract [ 80 , 81 ], effective and safe herbal treatment options are available. For instance, herbal treatment options for uncomplicated UTI include Centaurii herba , Levistici radix , and Rosmarini folium (Canephron ® , Bio-norica SE, Neumarkt in der Oberpfalz, Germany) [ 82 ], Tropaeoli herba and Armoraciae radix (Angocin ® , Repha GmbH, Langenhagen, Germany) [ 83 , 84 ], Ononidis radix, Orthosiphonis folium, and Solidaginis herba (Aqualibra ® , MEDICE Arzneimittel Pütter GmbH & Co. KG, Iserlohn, Germany) [ 85 ], Arctostaphylos uva-ursi (e.g., Cystinol ® , Schaper & Brümmer GmbH & Co. KG, Salzgitter, Germany) [ 86 ], and cranberry [ 87 ]. Likewise, for rhinosinusitis, various herbal medicinal products exist, such as Sambuci flos , Gentianae radix , Primulae flos , Rumicis herba , and Verbenae herba (Sinupret ® , Bionorica SE, Germany) [ 88 , 89 ], cineole (e.g., Soledum ® , Cassella-med GmbH & Co. KG, Köln, Germany) [ 90 ], myrtol (Gelomyrtol ® , G. Pohl-Boskamp GmbH & Co. KG, Hohenlockstedt, Germany) [ 91 ], and Pelargonium sidoides (Umckaloabo ® , Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany) [ 92 , 93 , 94 ].…”

Contribution of Symptomatic, Herbal Treatment Options to Antibiotic Stewardship and Microbiotic Health

“…For many common and recurring infections, such as urogenital infections [78,79] or infections of the upper and lower respiratory tract [80,81], effective and safe herbal treatment options are available. For instance, herbal treatment options for uncomplicated UTI include Centaurii herba, Levistici radix, and Rosmarini folium (Canephron ® ) [82], Tropaeoli herba and Armoraciae radix (Angocin ® ) [83,84], Ononidis radix, Orthosiphonis folium, and Solidaginis herba (Aqualibra ® ) [85], Arctostaphylos uva ursi (e.g., Cystinol ® ) [86], and cranberry [87]. Likewise, for rhinosinusitis various herbal medicinal products exist such as Sambuci flos, Gentianae radix, Primulae flos, Rumicis herba, and Verbenae herba (Sinupret ® ) [88,89], cineole (e.g., Soledum ® ) [90], myrtol (Gelomyrtol ® ) [91] and Pelargonium sidoides (Umckaloabo ® ) [92][93][94].…”