RESUMO
Seyed Hamdollah Mosavat has made substantial contributions in conception, designing, acquisition of data and preformed clinical trial., Amin Moayedfard and Abbas Rahimi Jaberi had contribution in designing and preformed clinical trial. Zahra Sobhani and Maryam Mosaffa-Jahromi designed and prepared drugs of study. Aida Iraji has made drug biochemical assay. Seyed Hamdollah Mosavat had contribution in designing and revised the manuscript critically for important intellectual content and had contribution in designing and analyzing of data. Seyed Hamdollah Mosavat, Amin Moayedfard and Abbas Rahimi Jaberi had contribution in conception and designing and revised the manuscript critically for important intellectual content. All authors read and approved the final manuscript.
Assuntos
Analgésicos/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Pimpinella/química , Óleos de Plantas/uso terapêutico , Administração Cutânea , Adulto , Analgésicos/administração & dosagem , Analgésicos/isolamento & purificação , Método Duplo-Cego , Feminino , Humanos , Masculino , Medição da Dor , Projetos Piloto , Óleos de Plantas/administração & dosagem , Óleos de Plantas/isolamento & purificação , Resultado do TratamentoRESUMO
Depression is a prevalent disorder among patients suffering from irritable bowel syndrome. The current study was performed to evaluate the effect of a traditional Persian medicine product, anise oil, in removing the symptoms of mild to moderate depression in patients with irritable bowel syndrome. In a randomized double-blinded active and placebo controlled clinical trial, 120 participants with mild to moderate depression according to the Beck Depression Inventory-II total scores were categorized into 3 equal groups and received anise oil, Colpermin, and placebo. The results at the end of trial (week 4) and follow-up (week 6) demonstrated significant priority against active and placebo groups. Although the mechanism is unknown yet, anise oil could be a promising choice of treatment for depressed patients with irritable bowel syndrome.
Assuntos
Depressão/tratamento farmacológico , Depressão/etiologia , Síndrome do Intestino Irritável/complicações , Óleos Voláteis/uso terapêutico , Pimpinella , Óleos de Plantas/uso terapêutico , Adulto , Feminino , Humanos , Masculino , Medicina Arábica , Pessoa de Meia-Idade , Adulto JovemRESUMO
ETHNOPHARMACOLOGICAL RELEVANCE: Anise is a well-recognized plant in Traditional Persian Medicine (TPM) sources. Anise oil has been suggested for the treatment of bowel disorders in Persian medical textbooks. Based on TPM scholars, this ingredient has a favorable effect on gastrointestinal diseases. We did this trial to determine the efficacy and safety of enteric coated capsules of anise oil for clinical symptoms of irritable bowel syndrome (IBS). METHODS AND MATERIALS: This three-armed double-blind clinical trial was carried out from August 2014 to February 2015. 120 patients were divided into three groups by block randomization: AnisEncap, placebo and Colpermin®. Patients in each group received 3 similar capsules per day for 4 weeks. The primary outcome was measured as a visual analogue scale (VAS) score, and the secondary outcome was assessed with an IBS-quality of life questionnaire. Chi-squared tests were used for categorical variables and t-tests to compare continuous variables. RESULTS: There were no significant differences in demographic characteristics among the three groups. According to intention-to-treat sample analysis, 75% of patients in the treatment group, 35% in the placebo group and 52.5% in active control group were free from IBS symptoms (P<0.001). The effectiveness of AnisEncap in improving IBS symptoms (abdominal discomfort or pain, bloating, diarrhea, constipation severity, difficulty in defecation, gastroesophageal reflux, headache, tiredness, overall satisfaction and quality of life) was significantly greater than placebo or Colpermin® after the 4-week treatment period and the 2-week follow-up period (P<0.0001). The number needed to treat for enteric coated capsules of anise oil was 4, which indicated significantly superior efficacy compared to the other two groups (P<0.001). CONCLUSION: The effectiveness of AnisEncap was superior to that of placebo or Colpermin® in patients with IBS. Further studies are suggested to find the main mechanism of action of anise oil in this regard.