
The Effect of Four-Herb Extract on Kidney Stone Expulsion in Patients Undergoing Extracorporeal Shockwave Lithotripsy: A Randomized Controlled Trial
Seyedeh Ghazal Mirhosseini 1 ℗, Amirhossein Rahavian 2 ©, Reza Zadali 3
Abstract
Introduction: Kidney stone expulsion following Extracorporeal Shockwave Lithotripsy (ESWL) remains a significant clinical challenge, often complicated by undesirable side effects of current pharmacotherapies. Recognizing the potential of natural remedies, this study investigated a novel Four-Herb Extract a blend of individually recognized lithotriptic herbs aiming to enhance stone clearance in patients post-ESWL. Methods and Materials: This randomized, double-blind, placebo-controlled crossover trial enrolled 62 adult patients with kidney stones (1-2 cm, Hounsfield Unit 1000) undergoing ESWL. Participants were randomized to receive either the Four-Herb Extract syrup (nettle, Tribulus terrestris, horsetail, and celery) or a placebo (10 cc, three times daily), in addition to standard care. Stone expulsion status (complete, incomplete, or no passage) and residual stone size were assessed via ultrasound imaging 40 days post-ESWL. Baseline patient characteristics were recorded, and adverse events were closely monitored throughout the study. All data were analyzed using SPSS 21, with statistical significance set at P0.05. Results: All 62 patients completed the 40-day study. Baseline characteristics, including stone size, Hounsfield Unit, gender distribution, history of ESWL, and stone location, were comparable between groups (P0.05 for all). Complete stone expulsion was significantly higher with Four-Herb Extract (61.3%) versus placebo (22.6%, P=0.008). Conversely, 77.4% of placebo recipients experienced incomplete or no passage compared to 38.7% of extract recipients. Logistic regression analysis for the overall population showed that only stone location in the pelvis was significantly associated with complete stone expulsion (OR=0.046; 95% CI=0.002-0.857; P=0.039). Two mild, transient adverse events were reported in the extract group, with no severe complications or withdrawals. Conclusion and Discussion: This study found the Four-Herb Extract significantly increased complete kidney stone expulsion after ESWL, demonstrating its potential as an effective and safe adjunctive therapy. These promising results, however, warrant further large-scale investigation.
Keywords: Kidney stone expulsion- Extracorporeal shockwave lithotripsy- Herbal medicine- Four-Herb Extract