The effect of synbiotic supplementation on hypothyroidism: A randomized double-blind placebo controlled clinical trial.

OBJECTIVE: We hypothesize that synbiotic supplementation could modulate the intestinal microbiota and subsequently, improve the condition of hypothyroid patients. METHODS: Fifty-six adult hypothyroid patients were recruited to this double-blind, placebo-controlled, randomized clinical trial. The intervention was 10 weeks of synbiotic (500 mg of 109 CFU/g probiotics plus fructo-oligosaccharide, n = 28) compared to placebo (lactose, magnesium stearate, talc, and silicon dioxide, n = 28). Randomization and allocation to trial groups were carried out using random number sequences drawn from https://sealedenvelope.com/. Primary outcomes were serum thyroid stimulating hormone (TSH) and free thyroxine (FT4), and secondary outcomes were depression, quality of life, and blood pressure (BP). P-values< 0.05 were considered statistically significant. RESULTS: Analysis on 51 patients who completed the trial showed that TSH and depression (p> 0.05) did not change significantly, while serum FT4 significantly increased in both groups (p = 0.03 and p = 0.02 in symbiotic and placebo respectively). A significant decrease in systolic BP occurred only in the synbiotic group (p = 0.05). Significant improvements occurred regarding different domains and areas of quality of life in the crude and adjusted analysis, including perceived mental health (p = 0.02), bodily pain (p = 0.02), general health perception (p = 0.002), and wellbeing (p = 0.002), which were significantly higher in the synbiotic group. CONCLUSIONS: Ten-week supplementation with synbiotic had no favorable effect on depression and TSH, but it improved blood pressure and quality of life in patients with hypothyroidism. More trials are needed to support or reject these findings. TRIAL REGISTRATION: IRCT20210926052583N1, Iranian Registry of Clinical Trials (IRCT), registered October 1st, 2021.

Efficacy of a multispecies probiotic as adjunctive therapy in generalized anxiety disorder: a double blind, randomized, placebo-controlled trial.

ABSTRACT Objectives: Studies have shown that probiotics may decrease anxiety symptoms, but to our knowledge so far no trial has investigated the effects of probiotics in generalized anxiety disorder (GAD). The aim of the present study was to determine the effects of probiotics as adjunctive therapy on anxiety severity and quality of life (QOL) in patients with GAD. Methods: Forty-eight drug-free patients with a diagnosis of GAD based on DSM-V criteria were randomly assigned to two groups to receive daily either one capsule of probiotics or placebo in addition to 25 mg sertraline for 8 weeks. Probiotic capsules contained 18*109 CFU Bifidobacterium longom, Bifidobacterium bifidum, Bifidobacterium lactis and Lactobacillus acidophilus bacteria. Results: Intention to treat analysis was performed in 39 Patients who completed at least 4 weeks of the intervention. After 8 weeks, the score of Hamilton Rating Scale for anxiety (HAM-A) decreased more in the probiotics + sertraline (PS) group (p = 0.003). Although the reduction of Beck Anxiety Inventory (BAI) was also more in the PS group, it was not significantly different from that of the sertraline alone(S) group. Moreover, despite the greater reduction of State-Anxiety Inventory score in the PS group, the score of Trait-Anxiety Inventory was not statistically different between the two groups at week 8. With regard to QOL, there was no significant difference between the two groups in the change of the score of QOL domains. Conclusions: Probiotics + sertraline combination was superior to sertraline alone in decreasing anxiety symptoms after 8 weeks in patients with GAD, although it did not affect QOL.