BACKGROUND/AIM: Irritable bowel syndrome (IBS) is a frequent gastrointestinal disorder, with only limited evidence regarding self-management approaches. This study tested the efficacy of caraway oil poultices (CarO) for treating IBS. METHODS: This randomized controlled open-label cross-over trial included three treatment periods with hot CarO and hot olive oil poultice (OlivH) or nonheated poultices (OlivC) with olive oil as control interventions. Patients applied each intervention daily for 3 weeks. The primary outcome was symptom severity (IBS-SSS); secondary outcomes included responder rates (improvement ≥ 50 IBS-SSS), quality of life (EQ-5D, IBS-QOL), psychological distress (HADS), adequate relief, and safety. RESULTS:48 patients with IBS were included (40 females, 53.9 ± 14.4 years). A significant difference was found for symptom severity in favor of CarO compared to OlivC (difference -38.4, 95% CI -73.6, -3.1, p = 0.033), but not compared to OlivH (difference -24.3, 95% CI -56.5, 7.9, p = 0.139). Responder rates were highest for CarO compared to OlivH and OlivC (43.9, 20.0, 18.9%, respectively). Within the CarO, 51.8% reported adequate relief compared to 23.5% (OlivH) and 25.8% (OlivC). One adverse event (gastrointestinal infection) was reported during CarO. CONCLUSION: Hot caraway oil poultices appear effective and safe, although their effects may be a result of the heat application. Patients reported highest levels of subjective benefit from caraway oil poultices, making their use appropriate in the self-management of IBS.
RCT Entities:
BACKGROUND/AIM: Irritable bowel syndrome (IBS) is a frequent gastrointestinal disorder, with only limited evidence regarding self-management approaches. This study tested the efficacy of caraway oil poultices (CarO) for treating IBS. METHODS: This randomized controlled open-label cross-over trial included three treatment periods with hot CarO and hot olive oil poultice (OlivH) or nonheated poultices (OlivC) with olive oil as control interventions. Patients applied each intervention daily for 3 weeks. The primary outcome was symptom severity (IBS-SSS); secondary outcomes included responder rates (improvement ≥ 50 IBS-SSS), quality of life (EQ-5D, IBS-QOL), psychological distress (HADS), adequate relief, and safety. RESULTS: 48 patients with IBS were included (40 females, 53.9 ± 14.4 years). A significant difference was found for symptom severity in favor of CarO compared to OlivC (difference -38.4, 95% CI -73.6, -3.1, p = 0.033), but not compared to OlivH (difference -24.3, 95% CI -56.5, 7.9, p = 0.139). Responder rates were highest for CarO compared to OlivH and OlivC (43.9, 20.0, 18.9%, respectively). Within the CarO, 51.8% reported adequate relief compared to 23.5% (OlivH) and 25.8% (OlivC). One adverse event (gastrointestinal infection) was reported during CarO. CONCLUSION: Hot caraway oil poultices appear effective and safe, although their effects may be a result of the heat application. Patients reported highest levels of subjective benefit from caraway oil poultices, making their use appropriate in the self-management of IBS.