Phytomedicine : international journal of phytotherapy and phytopharmacology · 2025
Efficacy and safety of Roleca® juniper 100 mg in the treatment of functional dyspepsia: A randomized, double-blind, placebo-controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Albrecht Uwe, Madisch Ahmed, Stefenelli Ulrich, Schablauer Lukas, Felix Lisa, Lonnemann Niklas
Аннотация
BACKGROUND: Functional dyspepsia is a common gastrointestinal disorder characterized by upper abdominal symptoms such as bloating, fullness, and cramping. Herbal preparations containing Juniperus communis (e.g. juniper essential oil) have traditionally been used to treat such digestive complaints, but robust clinical trials testing their efficacy are currently limited.
PURPOSE: The aim of this study was to evaluate the efficacy and safety of Roleca® Juniper 100 mg in adults with functional dyspepsia. This is the first randomized, placebo-controlled trial to provide clinical evidence for a standardized juniper oil preparation in functional dyspepsia, thereby extending the therapeutic evidence base beyond traditional use.
STUDY DESIGN AND METHODS: In this randomized, double-blind, placebo-controlled prospective trial, 76 patients with dyspeptic symptoms were assigned to receive either Roleca® Juniper 100 mg (n = 39) or placebo (n = 37) once daily for 28 days. The primary outcome was the change from the baseline scores to those recorded on Day 28, compared to placebo. To this end, a composite symptom score comprising three patient-reported items: upper abdominal discomfort, pressure, and fullness, was recorded at Day 0 and Day 28. Secondary outcomes included physician and patient global assessments, quality of life scores (Nepean Dyspepsia Index), intensity and rate of occurrence of symptoms and adverse events. Outcome measures were recorded in a patient diary at Days 0, 14 and 28.
RESULTS: Treatment with Roleca® Juniper 100 mg over 4 weeks significantly reduced the composite symptom score from baseline (pdiff = 0.008), to a greater degree than placebo at Day 28 (p < 0.001). Physician- and patient-rated efficacy also improved at both Day 14 and Day 28 (both p ≤ 0.001). Quality of life scores increased, and the intensity and frequency of several individual dyspeptic symptoms were reduced. Adverse events were infrequent, mostly gastrointestinal, and comparable between groups. No serious adverse events occurred.
CONCLUSION: Roleca® Juniper 100 mg demonstrated statistically significant and clinically meaningful improvements in dyspeptic symptoms and quality of life compared to placebo, with a favorable safety profile. These findings support its use as a phytotherapeutic option in functional dyspepsia. This study is registered in the European Union Clinical Trials Register (EU CT No. 2023-504,750-35-01).
PURPOSE: The aim of this study was to evaluate the efficacy and safety of Roleca® Juniper 100 mg in adults with functional dyspepsia. This is the first randomized, placebo-controlled trial to provide clinical evidence for a standardized juniper oil preparation in functional dyspepsia, thereby extending the therapeutic evidence base beyond traditional use.
STUDY DESIGN AND METHODS: In this randomized, double-blind, placebo-controlled prospective trial, 76 patients with dyspeptic symptoms were assigned to receive either Roleca® Juniper 100 mg (n = 39) or placebo (n = 37) once daily for 28 days. The primary outcome was the change from the baseline scores to those recorded on Day 28, compared to placebo. To this end, a composite symptom score comprising three patient-reported items: upper abdominal discomfort, pressure, and fullness, was recorded at Day 0 and Day 28. Secondary outcomes included physician and patient global assessments, quality of life scores (Nepean Dyspepsia Index), intensity and rate of occurrence of symptoms and adverse events. Outcome measures were recorded in a patient diary at Days 0, 14 and 28.
RESULTS: Treatment with Roleca® Juniper 100 mg over 4 weeks significantly reduced the composite symptom score from baseline (pdiff = 0.008), to a greater degree than placebo at Day 28 (p < 0.001). Physician- and patient-rated efficacy also improved at both Day 14 and Day 28 (both p ≤ 0.001). Quality of life scores increased, and the intensity and frequency of several individual dyspeptic symptoms were reduced. Adverse events were infrequent, mostly gastrointestinal, and comparable between groups. No serious adverse events occurred.
CONCLUSION: Roleca® Juniper 100 mg demonstrated statistically significant and clinically meaningful improvements in dyspeptic symptoms and quality of life compared to placebo, with a favorable safety profile. These findings support its use as a phytotherapeutic option in functional dyspepsia. This study is registered in the European Union Clinical Trials Register (EU CT No. 2023-504,750-35-01).