Background: Depression is a serious and burdensome disorder in modern societies, with lifetime prevalence of about 16%. Disturbed immune responses in the gut and immune-privileged sites including the central nervous system might occur subsequent to dysbiosis of gut microbiome. In this study we aimed at assessing the efficacy of 6 weeks synbiotic supplementation in the treatment of moderate depression in a double-blind, placebo-controlled, multi-center, and randomized trial. Methods: A total of 40 adult outpatients, who met the diagnostic and statistical manual of mental disorders fifth edition for moderate depression, were recruited based on the structured interview for DSMV. Recruited patients had a Hamilton rating scale for depression (HAM-D) score of 17 to 23 at baseline. All patients received fluoxetine (20 mg/d) for 4 weeks. Then, either a synbiotic capsule (plus fluoxetine) or placebo (plus fluoxetine) was added to the therapy for 6 weeks. Results: The mean age of the participants in the synbiotic treated group was 34.45 years and it was 35.50 years in the placebo group. Following the adjustment of ANCOVA models for gender, age, and BMI at baseline, there was a greater reduction in HAM-D score in synbiotic treated patients (Mean ± SD = -19.25 ± 1.71) compared to placebo taking group (Mean ± SD = -17.75 ± 2.05; P = 0.024). At the end of the 10th week of the intervention and after applying ANCOVA adjusted for the mentioned variables as well as baseline HAM-D score, it was found that the synbiotic group had a significantly decreased HAM-D score compared to the placebo (3.65 vs. 4.80, P = 0.013). Conclusions: The results of the current study revealed the efficacy of synbiotic as an adjuvant therapy in moderate depression. Keywords: Fluoxetine; Hamilton Rating Scale for Depression (HAM-D); Moderate Depression; Prebiotic; Synbiotic

The current study was designed to assess the effect of supplementation with a 14-strain probiotic mixture on episodic and chronic migraine characteristics. Forty episodic and 39 chronic migraine patients who completed this randomized double-blind controlled trial received two capsules of multispecies probiotic or placebo. The migraine severity was assessed by visual analog scale (VAS). The number of abortive drugs consumed, migraine days, frequency and duration of attacks were recorded on paper-based headache diaries. Serum tumor necrosis factor alpha (TNF-α) and C- reactive protein (CRP) levels were measured at baseline and the end of the intervention. After a 10-week intervention, among episodic migraineurs the mean frequency of migraine attacks significantly reduced in the probiotic group compare to the placebo group (mean change: −2.64 vs. 0.06; respectively, p < 0.001). A significant reduction was also evident in the migraine severity (mean decrease: −2.14 in the probiotic group and 0.11 in the placebo group; p < 0.001). Episodic migraineurs who received the probiotic also showed significant reduction in abortive drug usage per week (mean change: −0.72; p < 0.001) compare to baseline, while there was no significant changes within the placebo group. In chronic migraine patients, after an 8-week intervention, the mean frequency of migraine attacks significantly reduced in the probiotic compared to the placebo group (mean change: −9.67 vs. −0.22; p ≤ 0.001). In contrast to the placebo, probiotic supplementation significantly decreased the severity (mean changes: −2.69; p ≤ 0.001), duration (mean changes: −0.59; p ≤ 0.034) of attacks and the number of abortive drugs taken per day (mean changes: −1.02; p < 0.001), in chronic migraine patients. We failed to detect any significant differences in the serum levels of inflammatory markers at the end of the study either in chronic or in episodic migraineurs. The results of this study showed that the 14-strain probiotic mixture could be an effective and beneficial supplement to improve migraine headache in both chronic and episodic migraineurs. Further research is required to confirm our observations.

Objective: To assess the efficacy and safety of cinnarizine for the prophylaxis of migraine associated vertigo in the vestibular migraine and migraine with brainstem aura. Background: Vestibular migraine and migraine with brainstem aura are two principal clinical syndromes that frequently are associated with vertigo. Since cinnarizine is a well-tolerated calcium channel blocker which has acceptable effect on both vertigo and migraine headache, we carried out this study to evaluate the efficacy and safety of this medication in vestibular migraine and also migraine with brainstem aura associated with vertigo. Methods: This was a retrospective, single-center, open-label, investigation of the effects of cinnarizine on vestibular migraine and migraine with associated with vertigo. We assessed the change in monthly frequency of vertigo and also frequency, duration and intensity of migraine attacks after one, two and three months of cinnarizine administration. Results: The mean frequency of vertigo and also the mean frequency, duration and intensity of migraine headaches per month were reduced significantly after three months of cinnarizine therapy (all p < 0.001). Conclusion: This study suggests that cinnarizine is safe and effective in reducing both headache and vertigo aspects of “migraine plus vertigo” among the patients who suffer from either vestibular migraine or migraine with brainstem aura associated with vertigo.