Efficacy and Safety of a Novel Herbal Medicine in the Treatment of Irritable Bowel Syndrome: A Randomized Double-Blinded Clinical Trial

Abstract

Background. The unresponsiveness to conventional pharmacological treatments and their side effects have led patients with irritable bowel syndrome (IBS) to use complementary and alternative medicine such as herbal remedies. Beside, Zataria multiflora Boiss (ZM), Trachyspermum ammi L. (TA), and Anethum graveolens L. (AG) are being used as an antiseptic, carminative, and antispasmodic in traditional medicine. This trial investigated the efficacy and safety of a combination of ZM, AG, and TA essential oils in the treatment of IBS. Method. The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in the control arm received three tablets of 10 mg hyoscine butylbromide daily for two weeks, and the intervention arm was daily treated with two 250 mg softgel capsules containing 180 mg of essential oils of ZM, AG, and TA for two weeks. Primary outcomes were the response rates based on the IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR), and IBS Global Assessment Improvement (IBS-GAI) at the end and two weeks after the end of the intervention. Secondary outcomes were the improvement rates in IBS-SSS scores, improving the quality of life, safety, and tolerability. Results. The posttreatment improvement percentage based on IBS-AR, IBS-GAI, and IBS-SSS scales was 83.9%, 75%, and 87% in the intervention group and 37.9%, 27.5%, and 34.4% in the control group, respectively (P<0.001). Also, the improvement of the quality of life in the herbal medicine arm was significantly more than that in the control arm (P<0.001). Conclusions. According to the results, the herbal medicine investigated in this study can be considered an appropriate alternative treatment for IBS.

Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical Trial

“…Exclusion criteria included the participants' lack of consent to continue the study; taking antibiotics or nonsteroid anti-inflammatory drugs two weeks before the study; gastroesophageal reflux disease (heartburn, acid regurgitation); drug or alcohol abuse; the presence of gastroesophageal malignancy, chronic digestive diseases, and peptic ulcer disease based on history, physical examination, laboratory tests (e.g., white blood cell count, C reactive protein (CRP) or erythrocyte sedimentation rate (ESR)), and upper endoscopy; liver and kidney dysfunction based on laboratory tests; planned or current pregnancy; the history of a severe allergic reaction to medicinal plants; the history of upper gastrointestinal tract surgery; and serious illnesses like heart failure, diabetes and epilepsy, and previous or current significant psychiatric comorbidity [ 19 – 24 ]. Participants were not allowed to receive PPIs, H 2 -receptor antagonists, antacids, mucosal protectants, prokinetics, antidepressant drugs, anticholinergic agents, and cholinergic agents one week of study commencement or during the study.…”

“…The essential oils and sunflower oil were produced in Barij Essence Pharmaceutical Company (Kashan, Iran). The method of determining the safe dosage and preparation of herbal soft-gel capsule is as detailed in our previous investigation [ 24 ].…”

“…The gas chromatography-mass spectrometry (GC-MS) analyses of essential oils were performed on an HP 5890 GC system coupled to a Quadrupole Mass Detector. The analysis method has been described in detail in previous studies [ 24 , 26 , 27 ].…”

“…Patients were asked to keep their medication until the end of the study. To consumption, more than 80%, 60-80%, and less than 60% of prescribed medications were considered full, good, and poor compliance rates, respectively [ 24 , 33 ].…”

“…Based on these findings, the sample size was estimated to be 32 cases in each group. Statistical analysis method by using the statistical package of social sciences (SPSS) version 17 has been described in our previous investigation in detail [ 24 ].…”