scholarly journals Neurological Development and Iron Supplementation in Healthy Late-Preterm Neonates: A Randomized Double-Blind Controlled Trial

2021 ◽  
Author(s):  
Rita Luciano ◽  
Domenico Marco Romeo ◽  
Giuseppina Mancini ◽  
Serena Sivo ◽  
Carolina Dolci ◽  
...  
Keyword(s):  
Placebo Group ◽  
Iron Supplementation ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Neurological Development ◽  
Double Blind ◽  
Neurological Outcomes ◽  
Increased Risk ◽  
The Mean

Abstract ObjectiveLate-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelaeand iron deficiency. Aim of the study is to assess the positive effect of iron supplementation on neurological development in healthy LPT.DesignWe designed a perspective, randomized placebo-controlled double-blind trial. The newborns were randomized in two groups: thirty-three patients received martial prophylaxis, thirty-three placebo. Every patient was assessed using the Griffith Mental Development Scales (GMDS)-II edition at 12 months of post-conceptional age.SettingThe study was performed at the Neonatology Unit of Fondazione Policlinico Gemelli IRCCS.PatientsSixty-six healthy LPT infants born between 340⁄7 and 366⁄7 weeks of Gestational Age were enrolled in the study.InterventionsOne group received martial prophylaxis from the third week of life to six months of post-conceptional age (2 mg/kg/day of iron pidolate), the other received placebo.Main outcome measuresFifty-two of the enrolled infants were assessed using the GMDS at 12-month of post-conceptional age. Statistical analysis of the mean scores of the Griffith subscales was performed.ResultsThere was a difference in the mean Developmental Quotient (DQ) (p<0.01) between the two groups: Iron Group mean DQ 121.45+10.53 vs Placebo Group mean DQ 113.25+9.70. Moreover, mean scores of the Griffith subscales A, B and D showed significant differences between the two Groups (scale A p<0.05, scale B p<0.02, scale D p<0.01 respectively).ConclusionsOur data show that newborns who received iron supplementation during the first six months of life achieved significantly better neurological outcomes at GMDS than Placebo group.

scholarly journals Neurological development and iron supplementation in healthy late-preterm neonates: a randomized double-blind controlled trial

2021 ◽  
Author(s):  
R. Luciano ◽  
D. M. Romeo ◽  
G. Mancini ◽  
S. Sivo ◽  
C. Dolci ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Preterm Infants ◽  
Iron Supplementation ◽  
Late Preterm ◽  
Double Blind ◽  
Late Preterm Infants ◽  
Neurological Outcomes ◽  
Increased Risk ◽  
The Mean

AbstractLate-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelae and iron deficiency. The aim of the study is to assess the positive effect of iron supplementation on psychomotor development in healthy LPT. We designed a randomized placebo-controlled double-blind trial dividing the newborns into two groups. Every patient was assessed using the Griffiths Mental Development Scales (GMDS)-II edition at 12-month post-conceptional age. The study was performed at the Neonatology Unit of our Hospital, in Italy. Sixty-six healthy LPT infants born between 340⁄7 and 366⁄7 weeks of gestational age were enrolled in the study. One group received martial prophylaxis from the third week of life to 6 months of post-conceptional age (2 mg/kg/day of iron pidolate), the other received placebo. Fifty-two of the enrolled infants were assessed using the GMDS at 12-month of post-conceptional age. Statistical analysis of the mean scores of the Griffiths subscales was performed. There was a difference in the mean developmental quotient (DQ) (p < 0.01) between the two groups: iron group mean DQ 121.45 ± 10.53 vs placebo group mean DQ 113.25 ± 9.70. Moreover, mean scores of the Griffiths subscales A, B, and D showed significant differences between the two groups (scale A p < 0.05, scale B p < 0.02, scale D p < 0.01, respectively).Conclusions: We recommend that all LPT neonates receive iron supplementation during the first 6 months of life in order to improve their 1-year neurodevelopmental quotient. What is Known:• Late-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelae and also for iron deficiency.• Iron deficiency is an independent risk factor for adverse neurological outcomes. What is New:• Healthy late-preterm who received iron supplementation during the first 6 months of life achieved better neurological outcomes at 12-month post-conceptional age than LPT who received placebo.• Our study strongly supports the need for the implementation of martial prophylaxis in LPT neonates.

A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder

2011 ◽  
Vol 41 (10) ◽  
pp. 2159-2166 ◽  
Author(s):  
Y. Panahi ◽  
B. Rezazadeh Moghaddam ◽  
A. Sahebkar ◽  
M. Abbasi Nazari ◽  
F. Beiraghdar ◽  
...  
Keyword(s):  
Placebo Group ◽  
Post Traumatic Stress Disorder ◽  
Traumatic Stress ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Post Traumatic Stress ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Traumatic ◽  
The Mean

BackgroundUnlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.MethodSeventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.ResultsOn both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.ConclusionsThe results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.

scholarly journals A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

2021 ◽  
Author(s):  
Victor Ifeanyichukwu Modekwe ◽  
Jideofor Okechukwu Ugwu ◽  
Okechukwu Hyginus Ekwunife ◽  
Andrew Nwankwo Osuigwe ◽  
Jideofor Chukwuma Orakwe ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Categorical Variables ◽  
Paediatric Surgery ◽  
Peripheral Oxygen Saturation ◽  
Double Blind ◽  
Oral Ketamine ◽  
The Mean ◽  
Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

Increased risk of acquisition and transmission of ESBL-producing Enterobacteriaceae in malnourished children exposed to amoxicillin

2019 ◽  
Vol 75 (3) ◽  
pp. 709-717 ◽  
Author(s):  
Naouale Maataoui ◽  
Céline Langendorf ◽  
Fatou Berthe ◽  
Jumamurat R Bayjanov ◽  
Willem van Schaik ◽  
...  
Keyword(s):  
Placebo Group ◽  
Severe Acute Malnutrition ◽  
Controlled Trial ◽  
Acute Malnutrition ◽  
Double Blind ◽  
Adjusted Risk ◽  
Malnourished Children ◽  
Nutritional Recovery ◽  
Adjusted Risk Ratio ◽  
Increased Risk

Abstract Objectives Routine amoxicillin for children with uncomplicated severe acute malnutrition raises concerns of increasing antibiotic resistance. We performed an ancillary study nested within a double-blind, placebo-controlled trial in Niger testing the role of routine 7 day amoxicillin therapy in nutritional recovery of children 6 to 59 months of age with uncomplicated severe acute malnutrition. Methods We screened 472 children for rectal carriage of ESBL-producing Enterobacteriaceae (ESBL-E) as well as their household siblings under 5 years old, at baseline and Week 1 (W1) and Week 4 (W4) after start of therapy, and characterized strains by WGS. ClinicalTrials.gov: NCT01613547. Results Carriage in index children at baseline was similar in the amoxicillin and the placebo groups (33.8% versus 27.9%, P = 0.17). However, acquisition of ESBL-E in index children at W1 was higher in the amoxicillin group than in the placebo group (53.7% versus 32.2%, adjusted risk ratio = 2.29, P = 0.001). Among 209 index and sibling households possibly exposed to ESBL-E transmission, 16 (7.7%) had paired strains differing by ≤10 SNPs, suggesting a high probability of transmission. This was more frequent in households from the amoxicillin group than from the placebo group [11.5% (12/104) versus 3.8% (4/105), P = 0.04]. Conclusions Among children exposed to amoxicillin, ESBL-E colonization was more frequent and the risk of transmission to siblings higher. Routine amoxicillin should be carefully balanced with the risks associated with ESBL-E colonization.

scholarly journals The Effect of a Transdermal Scopolamine Patch on Postoperative Nausea and Vomiting after Retromastoid Craniectomy with Microvascular Decompression: A Preliminary Single Center, Double-Blind, Randomized Controlled Trial

2020 ◽  
Vol 9 (1) ◽  
pp. 156 ◽  
Author(s):  
Hyun Hee Lee ◽  
Hyun-Mi Kim ◽  
Ji Eun Lee ◽  
Young-Tae Jeon ◽  
Sanghon Park ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Placebo Group ◽  
Microvascular Decompression ◽  
Postoperative Nausea ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Mean

Background: We performed this prospective double-blind randomized controlled trial to identify the effect of a preoperative prophylactic transdermal scopolamine (TDS) patch on postoperative nausea and vomiting (PONV) after retromastoid craniectomy with microvascular decompression (RMC-MVD). Methods: We recruited 38 patients undergoing RMC-MVD and randomized them into two groups: the TDS group (n = 19, application of the TDS patch) and placebo group (n = 19, application of a sham patch). Nausea (as a self-reported 100-mm visual analog scale (VAS) score; range, 0 (no nausea) to 10 (worst nausea)), vomiting, and the use of antiemetics were the primary endpoints. Results: There was no significant difference in terms of the incidence of PONV (73.7% in the TDS group and 78.9% in the placebo group; p = 1.00) between the groups. However, the mean nausea VAS score was significantly different at arrival to the general ward (0.93 ± 1.71 in the TDS group vs. 2.52 ± 2.85 in the placebo group; p = 0.046), and throughout the study period (0.03 ± 0.07 in the TDS group vs. 0.44 ± 0.71 in the placebo group; p = 0.029). Rescue antiemetics were more frequently used in the placebo group than in the TDS group (9 (47.4%) vs. 2 (10.5%), respectively; p = 0.029). The mean number of antiemetics used throughout the study period was significantly higher in the placebo group than in the TDS group (1.37 ± 2.19 vs. 0.16 ± 0.50, respectively; p = 0.029). Conclusions: The preoperative prophylactic use of a TDS patch was safe and effective in the management of PONV after RMC-MVD in terms of the severity of PONV and the use of rescue antiemetics.

The effect of nadolol on heart rate in hyperthyroidism. A controlled trial

1987 ◽  
Vol 114 (1) ◽  
pp. 102-106
Author(s):  
J. H. Lazarus ◽  
J. C. Kingswood ◽  
R. John
Keyword(s):  
Heart Rate ◽  
Placebo Group ◽  
Controlled Trial ◽  
Circadian Variation ◽  
Maximum Heart Rate ◽  
Double Blind ◽  
Early Management ◽  
The Mean ◽  
To Receive ◽  
Hyperthyroid Patients

Abstract. Twenty hyperthyroid patients were randomly assigned in a double-blind fashion to receive either nadolol 80 mg/day or placebo for 2 weeks; all patients then took carbimazole as well from 2–6 weeks. Twenty-four hour Holter ECG recordings at 0, 2 and 6 weeks showed that nadolol reduced the mean maximum heart rate by 19.9% (P < 0.0005) at 2 weeks and by 30.3% (P < 0.0005) at 6 weeks compared to 5.2% (ns) and 18.3% (P < 0.0005) in patients taking placebo. There was no alteration of the normal circadian variation of heart rate by nadolol. The minimum heart rate before therapy was significantly correlated with FT4 (r = 0.52) and with FT3 (r = 0.44). The percentage of time per hour during which the heart rate was greater than 100 was reduced by 79% at week 2 by nadolol compared to 22% in the placebo group. At the 6 week point the placebo group still had a tachycardia (mean maximum heart rate 101.6 beats/min ± 15.2 sd) compared to the nadolol group (80.4 ± 7.7). Nadolol did not cause excessive bradycardia. It is effective in the early management of hyperthyroidism and should be given for at least the first 4–6 weeks.

Efficacy of andrographolide in not active Progressive Multiple Sclerosis: A prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial

2020 ◽  
Author(s):  
Ethel Ciampi ◽  
Reinaldo Uribe-San-Martin ◽  
Claudia Carcamo ◽  
Juan Pablo Cruz ◽  
Ana Reyes ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Placebo Group ◽  
Controlled Trial ◽  
Mean Difference ◽  
Relative Reduction ◽  
Disability Progression ◽  
Double Blind ◽  
The Mean ◽  
Anti Inflammatory

Abstract Background: Multiple sclerosis (MS) is a chronic immune mediated disease and the progressive phase appears to have significant neurodegenerative mechanisms. The classification of the course of progressive MS (PMS) has been re-organized into categories of active vs. not active inflammatory disease and the presence vs. absence of gradual disease progression. Clinical trial experience to date in PMS with anti-inflammatory medications has shown limited effect. Andrographolide is a new class of anti-inflammatory agent, that has been proposed as a potential drug for autoimmune disorders, including MS. In the present trial, we perform an exploratory pilot study on the efficacy and safety of andrographolide (AP) compared to placebo in not active PMS. Methods: A pilot clinical trial using 140mg oral AP or placebo twice daily for 24 months in patients with not active primary or secondary progressive MS was conducted. The primary efficacy endpoint was the mean percentage brain volume change (mPBVC). Secondary efficacy endpoints included 3-month confirmed disability progression (3-CDP) and mean EDSS change. Results: Forty-four patients were randomized: 23 were assigned to the AP group, and 21 were assigned to the placebo group. The median baseline EDSS of both groups was 6.0. Annualized mPBVC was -0.679% for the AP group and -1.069% for the placebo group (mean difference: -0.39; 95% CI [-0.836-0.055], p=0.08, relative reduction: 36.5%). In the AP group, 30% had 3-CDP compared to 41% in the placebo group (HR: 0.596; 95% CI [0.200 – 1.777], p=0.06). The mean EDSS change was -0.025 in the AP group and +0.352 in the placebo group (mean difference: 0.63, p=0.042). Adverse events related to AP were mild rash and dysgeusia. Conclusions: AP was well tolerated and showed a potential effect in reducing brain atrophy and disability progression, that need to be further evaluated in a larger clinical trial. Trial registration: ClinicalTrials.gov NCT02273635

The favourable effects of long-term selenium supplementation on regression of cervical tissues and metabolic profiles of patients with cervical intraepithelial neoplasia: a randomised, double-blind, placebo-controlled trial

2015 ◽  
Vol 114 (12) ◽  
pp. 2039-2045 ◽  
Author(s):  
Maryam Karamali ◽  
Sepideh Nourgostar ◽  
Ashraf Zamani ◽  
Zahra Vahedpoor ◽  
Zatollah Asemi
Keyword(s):  
Placebo Group ◽  
Cervical Intraepithelial Neoplasia ◽  
Serum Insulin ◽  
Controlled Trial ◽  
Intraepithelial Neoplasia ◽  
Metabolic Profiles ◽  
Model Assessment ◽  
Double Blind ◽  
Double Blind Placebo

AbstractThis study was conducted to assess the effects of long-term Se administration on the regression and metabolic status of patients with cervical intraepithelial neoplasia grade 1 (CIN1). This randomised, double-blind, placebo-controlled trial was carried out among fifty-eight women diagnosed with CIN1. To diagnose CIN1, we used specific diagnostic procedures of biopsy, pathological diagnosis and colposcopy. Patients were randomly assigned to two groups to receive 200 μg Se supplements as Se yeast (n 28) or placebo (n 28) daily for 6 months. After 6 months of taking Se supplements, a greater percentage of women in the Se group had regressed CIN1 (88·0 v. 56·0 %; P=0·01) compared with those in the placebo group. Long-term Se supplementation, compared with the placebo, resulted in significant decreases in fasting plasma glucose levels (−0·37 (sd 0·32) v. +0·07 (sd 0·63) mmol/l; P=0·002), serum insulin levels (−28·8 (sd 31·2) v. +13·2 (sd 40·2) pmol/l; P<0·001), homeostatic model assessment of insulin resistance values (−1·3 (se 1·3) v. +0·5 (se 1·4); P<0·001) and a significant elevation in quantitative insulin sensitivity check index (+0·03 (sd 0·03) v. −0·01 (sd 0·01); P<0·001). In addition, patients who received Se supplements had significantly decreased serum TAG (−0·14 (sd 0·55) v. +0·15 (sd 0·38) mmol/l; P=0·02) and increased HDL-cholesterol levels (+0·13 (sd 0·21) v. −0·01 (sd 0·15) mmol/l; P=0·003). In addition, compared with the placebo group, there were significant rises in plasma total antioxidant capacity (+186·1 (sd 274·6) v. +42·8 (sd 180·4) mmol/l; P=0·02) and GSH levels (+65·0 (sd 359·8) v. −294·2 (sd 581·8) μmol/l; P=0·007) and a significant decrease in malondialdehyde levels (−1·5 (sd 2·1) v. +0·1 (sd 1·4) μmol/l; P=0·001) among those who took Se supplements. Overall, taking Se supplements among patients with CIN1 led to its regression and had beneficial effects on their metabolic profiles.

scholarly journals Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-9 ◽  
Author(s):  
Chunhoo Cheon ◽  
Jeong-Eun Yoo ◽  
Hwa-Seung Yoo ◽  
Chong-Kwan Cho ◽  
Sohyeon Kang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Large Scale ◽  
Controlled Trial ◽  
Unmet Need ◽  
Double Blind ◽  
Patients With Cancer ◽  
Significant Difference ◽  
Cancer Anorexia

Background. Anorexia occurs in about half of cancer patients and is associated with high mortality rate. However, safe and long-term use of anorexia treatment is still an unmet need. Objective. The purpose of the present study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. Methods. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests. Results. Anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group. Conclusions. Sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy. Trial Registration. This trial is registered with ClinicalTrials.gov NCT02468141.

The effects of a multispecies probiotic supplement on inflammatory markers and episodic and chronic migraine characteristics: A randomized double-blind controlled trial

Cephalalgia ◽  
2019 ◽  
Vol 39 (7) ◽  
pp. 841-853 ◽  
Author(s):  
Fahimeh Martami ◽  
Mansoureh Togha ◽  
Maryam Seifishahpar ◽  
Zeinab Ghorbani ◽  
Hossein Ansari ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chronic Migraine ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Double Blind ◽  
Necrosis Factor Alpha ◽  
Probiotic Group ◽  
Mean Frequency ◽  
The Mean ◽  
Episodic Migraineurs

Background The current study was designed to assess the effect of supplementation with a 14-strain probiotic mixture on episodic and chronic migraine characteristics. Methods 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. Results 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. Discussion 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.

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