Mehdi Pasalar1, Rasool Choopani2, Mahmoud Mosaddegh3, Mohammad Kamalinejad4, Abdolali Mohagheghzadeh5, Mohammad Reza Fattahi6, Ahmad Ghanizadeh7, Kamran Bagheri Lankarani8. 1. School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Tehran, Iran. Electronic address: Pasalar@sums.ac.ir. 2. School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Tehran, Iran. 3. Traditional Medicine and Materia Medica Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 4. Department of Pharmacognosy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 5. Department of Traditional Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. 6. Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. 7. Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences, Hafez Hospital, Shiraz, Iran. 8. Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Health Policy Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Abstract
BACKGROUND:Functional dyspepsia (FD) is a common gastrointestinal disease that is highly prevalent worldwide. Because of its heterogeneous pathophysiology, treatment options for FD can be difficult to choose; in this context, complementary and alternative medicine modalities have been suggested as promising options. AIM: To evaluate the efficacy of a traditional Persian medicine, jollab, in reducing patients' FD symptoms. METHODS: In a double-blind randomized clinical trial, 160 patients with a diagnosis of FD were enrolled and treated with eitherjollab or placebo (15ml, t.i.d., four weeks, orally). The outcomes reported were changes in symptom frequency and severity as recorded in patients' diaries and evaluated with the Short Form of the Leeds Dyspepsia Questionnaire (SF-LDQ), and physical examination. RESULTS: The response rate was higher in the treatment group (78%) than in the placebo group (31%) according to per-protocol sample analysis (P < .001). Symptoms of FD disappeared significantly more frequently, and the rate of concomitant synthetic drug consumption was significantly lower, in the jollab group compared to the placebo group at the end of the trial. Mean total symptom frequency and severity according to the SF-LDQ score was 1.55 ± 2.78 in the treatment group versus 5.61 ± 3.80 in the placebo group at the last follow-up time point (P < .001). A promising safety profile for jollab was observed throughout the trial. CONCLUSIONS: In patients with FD, jollab appeared to be more effective than the placebo. Complementary and alternative therapies such as the use of this traditional medicinal substance may be beneficial in relieving symptoms of dyspepsia [ACTRN12613000584730].
RCT Entities:
BACKGROUND:Functional dyspepsia (FD) is a common gastrointestinal disease that is highly prevalent worldwide. Because of its heterogeneous pathophysiology, treatment options for FD can be difficult to choose; in this context, complementary and alternative medicine modalities have been suggested as promising options. AIM: To evaluate the efficacy of a traditional Persian medicine, jollab, in reducing patients' FD symptoms. METHODS: In a double-blind randomized clinical trial, 160 patients with a diagnosis of FD were enrolled and treated with either jollab or placebo (15ml, t.i.d., four weeks, orally). The outcomes reported were changes in symptom frequency and severity as recorded in patients' diaries and evaluated with the Short Form of the Leeds Dyspepsia Questionnaire (SF-LDQ), and physical examination. RESULTS: The response rate was higher in the treatment group (78%) than in the placebo group (31%) according to per-protocol sample analysis (P < .001). Symptoms of FD disappeared significantly more frequently, and the rate of concomitant synthetic drug consumption was significantly lower, in the jollab group compared to the placebo group at the end of the trial. Mean total symptom frequency and severity according to the SF-LDQ score was 1.55 ± 2.78 in the treatment group versus 5.61 ± 3.80 in the placebo group at the last follow-up time point (P < .001). A promising safety profile for jollab was observed throughout the trial. CONCLUSIONS: In patients with FD, jollab appeared to be more effective than the placebo. Complementary and alternative therapies such as the use of this traditional medicinal substance may be beneficial in relieving symptoms of dyspepsia [ACTRN12613000584730].