ObjectiveThe medicinal plants Rhodiola rosea L. (rhodiola, golden root) and Crocus sativus L. (saffron) have been shown separately to induce significant effects in depression. The objective of this study was to assess a fixed combination of rhodiola and saffron in mild–moderate depression.MethodsIn this observational study conducted with general practitioners (GPs), 45 adults (aged 18–85 years) suffering from mild or moderate depression (International Statistical Classification of Diseases and Related Health Problems 10th Revision definition) and reaching a score on the Hamilton Rating Scale for Depression of 8–18 were supplemented with a combination of rhodiola and saffron extracts (one tablet, 154 mg of rhodiola and 15 mg of saffron; recommended dose two tablets per day for 6 weeks).ResultsAfter 6 weeks (D42) of supplementation, Hamilton Rating Scale for Depression scores (primary outcome) decreased significantly by 58%±28.5% (from 13.6±2.3 at D0 to 5.6±3.8 at D42, P<0.0001; n=41). Score improvement was reported in 85.4% of patients. A significant drop in both Hospital Anxiety and Depression Scale anxiety and depression scores was also observed at D42, the decrease being significant from 2 weeks of supplementation. At the end of the study, both GPs and patients deemed there was a significant improvement in depression (Clinical Global Impression – improvement and Patient Global Impression of Change). Safety was excellent, and no serious adverse effects were recorded.ConclusionResults of this observational study performed in primary care suggest that the combination of rhodiola and saffron tested could be useful for the management of mild–moderate depression and improve depressive and anxiety symptoms. A double-blind placebo-controlled study is needed to confirm these results.
BackgroundFeverfew (Tanacetum parthenium L.), magnesium and coenzyme Q10 are frequently used for migraine prophylaxis. Supplementation with a fixed combination of these three agents (Antemig®, PiLeJe) was investigated in an observational study.MethodsAdult patients suffering from migraine according to the criteria of the International Headache Society were enrolled by general practitioners (≥2 migraine attacks during previous month; exclusion of chronic migraine and medication overuse) and after a one-month baseline phase, supplemented with one tablet of 100 mg feverfew, 100 mg coenzyme Q10 and 112.5 mg magnesium per day for 3 months.ResultsSupplementation significantly reduced the number of days with migraine headache during third month of supplementation compared to baseline phase (1.3 days ±1.5 versus 4.9 days ±2.6, p < 0.0001; n = 68 intention to treat; primary criterion). The decrease was progressive over the period of supplementation and significant from first month (1st month: −2.5 days ±3.1, p < 0.0001; 2nd month: −3 days ±2.8, p < 0.0001). The proportion of patients with a reduction of at least 50% in the number of days with migraine headache was 75% (51/68) after 3 months, with a progressive increase over the period of supplementation (63.2% [43/68] after 1 month and 70.6% [48/68] after 2 months). The proportion of patients with anxiety and depressive symptoms (Hospital Anxiety and Depression Scale) decreased between baseline phase and third month of supplementation from 61.9% (39/63 patients with information available) to 35% (21/60) for depression and from 52.4% (33/63) to 30% (18/60) for anxiety. An improvement of quality of life (Qualité de Vie et Migraine questionnaire) was also observed. The combination was well tolerated.ConclusionsResults suggest that the proprietary supplement containing feverfew, coenzyme Q10 and magnesium assessed could be beneficial and safe for the prevention of migraine in adult patients and merits further study.Trial registrationClinicalTrials.gov: NCT02901756, retrospectively registered on August 24, 2016.
Background: A probiotic mixture prevented epithelial barrier impairment in various experimental models. The objective was to evaluate its effects in patients suffering from IBS-D with confirmed leaky gut. Methods: IBS D patients with increased intestinal permeability measured by radionuclide tracers were enrolled in this pilot, open-label, prospective, interventional, single-center, Phase IV study. Patients received two capsules of a multistrain probiotic a day for 30 days and were evaluated by repeated intestinal permeability test, the Bristol Stool Scale, and patient-perceived quality of life and satisfaction. Results: Of the 30 enrolled patients (mean age: 42.1 [SD: 13.1] years; female: 60%), 27 completed the study (Full Analysis Set [FAS]), 18 had no major protocol violation (Per Protocol Set [PPS]). On D30, an improvement of intestinal permeability was observed in 81.5% of patients in FAS, normalization being observed in 37% of the participants (44% in PPS). Mean intestinal permeability was significantly decreased: baseline minus D30, 3.4 (95%CI: 1.7, 5.2); IBS-QOL Total score was significantly increased: D30 minus baseline, 8.0 (95%CI: 3.0, 12.9); stool consistency was significantly improved. On D15 and D30, 96.3% of patients claimed that their IBS symptoms had been satisfactory alleviated, and a significant improvement was reported for the following VAS-IBS items: Abdominal pain, Diarrhea, Impact of gastrointestinal problems in daily life. Compliance and tolerance were satisfactory. Conclusion: The multistrain probiotic tested may reduce intestinal permeability in a considerable proportion of patients and may improve abdominal pain, stool consistency, and quality of life. These results pave the way for larger, placebo-controlled clinical studies.
Purpose: This observational study evaluated a combination of boswellia, turmeric, and red algae extracts in patients with knee osteoarthritis (KOA). Given the growing interest in patientcentered care in osteoarthritis, effects were assessed by an arsenal of patient-reported outcome measures (PROMs): Patient Acceptable Symptom Scale (PASS), Minimal Clinically Important Improvement (MCII), Patient Global Impression of Change (PGIC), and Lequesne algofunctional index (LAFI). Patients also completed a list of 17 items on pain quality. Patients and Methods: Patients with painful unilateral or bilateral KOA had to take 1-4 capsules per day of a dietary supplement containing boswellia, turmeric, and red algae extracts for 90 days. Patients completed PROMs on Days 0 (baseline), 10, 20, 30, 60, and/or 90. Results: A total of 118 patients [female: 69.5%; age: 62.9 (9.5) years, mean (SD)] were included in the study and took at least one capsule. Mean (SD) follow-up duration was 100.7 (54.9) days. Pain relief was maximal on Day 90: 64.5% of patients were responders (positive PASS); 68.8% and 58.4% had MCII and PGIC scores indicating positive effect (score ≥3) or global improvement (score ≥5); 73.3% (versus 47.5% at baseline) were mildly/moderately disabled (LAFI score <8); 55.2% had meaningful decrease (−30%) in pain intensity (VAS), 35.1% (versus 59.2% at baseline) took analgesics as supplementary treatment. Median time to the first PASS change was 34 days. Pain intensity (VAS), as well as two pain characteristics (ie, "Stabbing pain" and "Widespread pain"), were independent factors associated with non-response on Day 30. Four clusters of responders were isolated according to pain characteristics, with one cluster exhibiting a higher responder rate. Conclusion:The results of this preliminary study suggest that the combination of boswellia, turmeric, and red algae extracts tested could improve KOA patients. Beyond these results, this study showed the importance of PROMs and specific pain qualitative descriptors for the accurate evaluation of dietary supplement approaches in painful conditions.
The potential benefits of Lactobacillus gasseri LA806 in IBS were previously identified in a comprehensive preclinical research program. The purpose of this multicenter study was to explore in real-life conditions changes in IBS symptoms and quality of life in patients receiving a 4-week supplementation with L. gasseri LA806. Altogether 119 patients meeting Rome IV criteria for IBS were included, of whom 118 received the supplement. The majority of patients (71.8% (95% CI 63.6−79.9%)) manifested a ≥30% decrease in abdominal pain at 4 weeks, the mean abdominal pain score diminishing by 54.2% (from 5.3 ± 2.2 to 2.2 ± 2.4, p < 0.0001). A statistically significant decrease in abdominal pain was seen as early as the first week. A decrease of ≥30% in both abdominal pain score and global IBS symptom score was attained in 61.5% of patients (95% CI 51.7−71.2%). The mean IBS‑SSS score fell by 152 ± 112 points (p = 0.001), with symptoms being attenuated in 85% of patients (CGI‑I). Supplementation led to a 10-fold decrease in the number of patients reporting severe IBS symptoms. The concomitant intake of antidiarrheals, antispasmodics and analgesics decreased and quality of life scores significantly improved. These preliminary results warrant confirmation by a randomized, placebo-controlled study that this study will allow a better design.
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