Search results

Atomoxetine has been approved for the treatment of attention deficit/hyperactivity disorder in both adults and children. However, it is also being examined for several off-label uses in adults including mood disorders, eating disorders, cognitive dysfunction, and the treatment of addictions. Prior to such use it is important to examine the reported adverse events to see if this represents an appropriate level of risk. This is particularly important in the light of recent warnings from several regulatory bodies about an increase in blood pressure in a significant percentage of patients taking atomoxetine. To understand the risks a literature review was performed, and which identified the following potential problems. The first is that this drug should not be given in patients with known cardiovascular problems, and that all adult patients who receive atomoxetine should be monitored for changes in blood pressure throughout treatment. Secondly, there are several clinical situations in which atomoxetine should be closely monitored, or avoided, including patients who have a history or risk of narrow angle glaucoma, epileptic seizures, Tourette's syndrome, a history of urinary outflow obstruction, or who are pregnant or lactating. In conclusion, the current literature suggests that atomoxetine can be safely used off-label provided the above precautions are taken.

Today, coronavirus disease-19 (COVID-19) treatment is an evolving process, and synbiotic administration has been suggested as a new therapeutic strategy. This study aims to investigate the effect of synbiotic supplementation in COVID-19 patients.

In this placebo-controlled trial, 80 patients were randomized to receive oral synbiotic capsule (containing fructooligosaccharide and seven bacterial strains; Lactobacillus (L) casei, L. rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, L. acidophilus, Bifidobacterium longum, L. bulgaricus, each one 109 colony-forming units) or placebo for two months. Inflammatory markers (Interleukin-6 [IL-6], C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]) and white blood cell (WBC) count were evaluated at two timepoints (baseline, two months later). The measured variables were adjusted for confounders and analyzed by SPSS v21.0.

All 80 enrolled patients completed the study. The study adherence was good (approximately 70%). The mean changes for IL-6 were not significant (Δ = −0.6 ± 10.4 pg/mL vs Δ = +11.2 ± 50.3 pg/mL, p > 0.05). There were no significant improvements for CRP, ESR and WBC.

Administration of synbiotics for two months did not improve inflammatory markers in COVID-19 patients.

This paper aims to study the impact of combination Lactobacillus Rhamnosus Heriz I and Beta glucan on quality of life (QOL) in breast cancer (BC) patients receiving chemotherapy.

In all, 30 women with BC were enrolled in this randomized double-blind placebo-controlled clinical trial. Intervention group received either daily one capsule of L. rhamnosus strain Heriz I (2 × 10⁷ CFU) and two 10-mg capsules of soluble1–3,1–6,D-beta glucan and the placebo group receiving placebo, interval between two courses of chemotherapy. Health-related QOL was evaluated at baseline and end of the trial using the EORTC QOL Questionnaire version.3.0 (EORTC QLQ-C30).

The results showed that combination of L. rhamnosus Heriz I and Beta glucan supplementation in BC patients during chemotherapy improved functional scales score from 37.3 ± 12.1 to 39.8 ± 6.8 and this increase in comparison with placebo was significant after adjusting baseline value (p = 0.015). Changes in symptoms scores were not significant after intervention (p = 0.05) but the decreased score (66.1 ± 12.9 to 60.6 ± 9.4) was considerable clinically. As well as, changes in global health status/QOL score in intervention group in comparison with the placebo group was not significant (p = 0.93).

The findings suggest that combination of L. rhamnosus Heriz I and Beta glucan may be associated for improving functional scales and symptoms in patients with BC who underwent chemotherapy. To prove positive effect of supplements on other aspects of QOL, further studies are needed.

Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease which has become a public health concern, whose growing prevalence has been reported as around 33.9% in Iran. As oxidative stress plays a crucial role in the pathogenesis of NAFLD, antioxidant compounds such as quercetin could ameliorate the side effect of oxidative stress. The aim of the current study was to assess the effect of quercetin on lipid profile, liver enzymes and inflammatory indices in NAFLD patients.

In a randomized, double-blind, placebo-controlled trial conducted as a pilot study, 90 patients with NAFLD were supplemented with either a quercetin or a placebo capsule twice daily (500 mg) for 12 weeks. Both groups were advised to follow an energy-balanced diet with physical activity recommendations. Blood sample was obtained for laboratory parameters at baseline and the end of week 12.

At the end of the follow-up, quercetin group had significantly greater reduction in anthropometric parameters, cholesterol (−15 ± (−41, 0.00) in Q group versus −1± (−8, 2) in control group, p = 0.004), TG (−56.7 ± 22.7) in Q group versus −13.4 ± 27.7 in control group, p = 0.04), and tumor necrosis factor-α (TNF-α) (−49.5 ± (−99, 21) in Q group versus −5 ± (−21, 0.30) in the control group, p < 0.0001) compared to the control group. However, changes in fatty liver grade, liver enzymes, as well as high density lipoprotein-cholesterol and high-sensitivity C-reactive protein were not significantly different between the two groups.

To the best of the authors’ knowledge, this was the first study which assessed the effect of quercetin supplementation on liver enzymes, lipid profile and inflammatory indices of NAFLD patients as a double-blind placebo-controlled pilot study.

This study aims to test the effects of Celliant armbands on grip strength in subjects with chronic wrist and elbow pain. Celliant® is a functional textile fabric containing minerals that emit infrared radiation (IR) in response to body heat. IR-emitting fabrics have biological effects including the reduction of pain and inflammation and the stimulation of muscle function.

A randomized placebo-controlled trial recruited 80 subjects (40 per group) with a six-month history of chronic wrist or elbow pain (carpal tunnel syndrome, epicondylitis or arthritis) to wear an armband (real Celliant or placebo fabric) on the affected wrist or elbow for two weeks. Grip strength was measured by a dynamometer before and after the two-week study.

For the placebo group, the mean grip strength increased from 47.95 ± 25.14 (baseline) to 51.69 ± 27.35 (final), whereas for the Celliant group, it increased from 46.3 ± 22.02 to 54.1 ± 25.97. The mean per cent increase over the two weeks was +7.8% for placebo and +16.8% for Celliant (p = 0.0372). No adverse effects was observed.

Limitations include the wide variation in grip strength in the participants at baseline measurement, which meant that only the percentage increase between baseline and final measurements showed a significant difference. Moreover, no subjective measurements of pain or objective neurophysiology testes was done.

Celliant armbands are easy to wear and have not been shown to produce any adverse effects. Therefore, there appears to be no barrier to prevent widespread uptake.

IR-emitting textiles have been studied for their beneficial effects, both in patients diagnosed with various disorders and also in healthy volunteers for health and wellness purposes. Although there are many types of textile technology that might be used to produce IR-emitting fabrics, including coating of the fabric with a printed layer of ceramic material, incorporating discs of mineral into the garment, the authors feel that incorporating ceramic particles into the polymer fibers from which the fabric is woven is likely to be the most efficient way of achieving the goal.

Celliant armbands appear to be effective in painful upper limb inflammatory disorders, and further studies are warranted. The mechanism of action is not completely understood, but the hypothesis that the emitted IR radiation is absorbed by nanostructured intracellular water provides some theoretical justification.

Accumulating evidence highlights the importance of microbiota-directed intervention in neuropsychiatric disorders. This study aims to investigate the effects of probiotic supplements as an adjunct therapy in combination with Ritalin in children with attention-deficit hyperactivity disorder (ADHD).

Children with ADHD, aged 6–12 years, who had an intelligent quotient of ≥70 were enrolled in the study. Participants were randomly assigned to either the group that received probiotics or the group that received the placebo in addition to the weight-adjusted dose of Ritalin. Parents were asked to complete the revised Conners Parent Rating Scale–short version (CPRS–RS), and the psychiatrist completed the seven-point Clinical Global Impression–Severity (CGI–S) scale. Two study groups were compared in three time points, including T1 (before intervention), T2 (at the end of fourth week) and T3 (at the end of the eighth week).

A total of 38 participants completed the study. After eight weeks of intervention, the probiotic group had a significant improvement regarding CPRS–RS scores in T2 (9.4 unit, p = 0.014) and T3 (18.6 unit, p < 0.001), compared to placebo. In addition, children in the probiotic group had 0.7 unit lower CGI in T3 (p = 0.018) than the placebo group. A significant reduction of CGI scores was observed in each interval (T2 vs T1, T3 vs T2 and T3 vs T1; p < 0.05). This significant change in CGI score between intervals was also detected in the placebo group in T2 vs T1 (p = 0.002) and T3 vs T1 (p < 0.001). Mean CPRS scores of the groups were different in T2 and T3 (p = 0.011 and p < 0.001, respectively) and mean CGI scores of the two study groups were different in T3 (p = 0.018).

Eight weeks of supplementation with probiotics had a favorable effect on symptoms and severity of ADHD. Therefore, probiotics as an adjuvant treatment might have a promising efficacy regarding the management of ADHD.

Because of the importance of having enough sleep in life and health, this study aims to determine the effect of vitamin D supplementation on sleep quality and pregnancy symptoms (primary outcomes) and side effects (secondary outcome).

In this triple-blind randomized controlled clinical trial, 88 pregnant women with gestational age of 8–10 weeks and serum vitamin D concentration less than 30 ng/ml were allocated into vitamin D (n = 44) and control (n = 44) groups by blocked randomization method. The vitamin D group received a 4,000 IU vitamin D pill, and the control group received a placebo pill daily for 18 weeks. Independent t-, Mann–Whitney U and ANCOVA tests were used to analyze the data.

The post-intervention mean (SD: standard deviation) of total sleep quality score in the vitamin D and placebo group were 1.94 (2.1) and 4.62 (1.71), respectively. According to the Mann–Whitney U test, this difference between the two groups was statistically significant (p < 0.001). The mean (SD) of pregnancy symptoms in the vitamin D and placebo groups was 23.95 (16.07) and 26.62 (13.84), respectively, and there was no significant difference between the two groups based on ANCOVA test (p = 0.56). Considerable side effects were not observed in any groups.

This study was conducted due to the contradictory results of the effect of vitamin D on sleep quality and the high prevalence of sleep disorders and pregnancy symptoms.

Type 2 diabetes mellitus (T2DM) is a worldwide health problem. Blood pressure (BP) and inflammation are well-established risk factors for the cardiovascular complications of T2DM. Genistein is known to improve endothelial dysfunction. The purpose of this study is to investigate the effects of genistein supplementation on BP, high-sensitive C-reactive protein (hs-CRP) and homocysteine (Hcy) levels in postmenopausal women with T2DM.

This randomized, double-blind, placebo-controlled clinical trial is conducted on postmenopausal women with T2DM. A total of 54 subjects aged between 47 and 69 years are divided into two groups. Participants in the genistein group (n = 28) are given two genistein capsules (each capsule contained 54 mg genistein) and those in the placebo group (n = 26) received two placebo capsules (each capsule contained 54 mg maltodextrin) daily for 12 weeks. General characteristics, BP, hs-CRP and Hcy levels are measured at the baseline and at the end of the trial.

Genistein supplementation resulted in a significant reduction in systolic BP (SBP) (p < 0.001), diastolic BP (DBP) (p = 0.020), mean arterial pressure (MAP) (p < 0.001), serum levels of hs-CRP (p = 0.005) and Hcy (p = 0.001) in genistein group compared with placebo group at the end of the study. Significant decreases are also found in SBP by 5.4%, p < 0.001, DBP by 6.7%, p < 0.001, MAP by 6.2%, p < 0.001, serum levels of hs-CRP by 47.0%, p = 0.015 and Hcy by 18.4%, p < 0.001 in the genistein supplemented group. No significant changes are observed in terms of all post-intervention values in the placebo group.

Genistein administration improved BP, hs-CRP and Hcy levels in postmenopausal women with T2DM and may be useful in control of some CVD risk factors in these subjects.

The epigallocatechin gallate (EGCG) effect in diabetes has been investigated in animal studies, but results of clinical trials are inconsistent. Thus, this study aims to evaluate the effects of EGCG supplementation in patients with type 2 diabetes mellitus (T2DM).

A total of 50 patients with T2DM were recruited in a double-blind, randomized, placebo-controlled trial. The eligible participants were randomly allocated to EGCG (n = 25) and placebo (n = 25) groups. The EGCG group received two capsules of EGCG (each capsule contained 150 mg; Shari Made®, Iran) and placebo group was administered two capsules of placebo (starch) for eight weeks. A three-day 24-h dietary recall and anthropometric and laboratory measurements were carried out at the beginning and the end of the study.

At the end of the trial, weight and body mass index (BMI) were decreased significantly in both groups, but the reduction was not statistically significant between the two groups. Fasting blood sugar decreased significantly in EGCG group. No significant between-group and within-group differences were found in insulin, homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check index values. The high-sensitive C-reactive protein (hs-CRP) was significantly reduced in the EGCG group (4.13 ± 0.48-3.93 ± 0.50, p = 0.003) compared to baseline.

This study showed that consuming 300 mg/day of EGCG for eight weeks in patients with T2DM caused a significant decrease in fasting blood glucose, body weight, BMI and hs-CRP compared to baseline. Therefore, the EGCG supplementation may improve glycemic control, anthropometric and inflammation status in T2DM.

Metabolic syndrome contains metabolic disorders that have association with other chronic diseases. Melatonin is a bioactive compound which is found in plants and also produced in the body. The purpose of this paper is to assess the effect of melatonin supplement on metabolic syndrome components, also leptin and adiponectin blood concentrations in patients with metabolic syndrome.

A double blind, placebo-controlled, randomized clinical trial was conducted on 70 subjects with metabolic syndrome. Participants received 6 mg/day melatonin or placebo before bedtime for 12 weeks. At the beginning and end of treatment period, blood samples were collected and biochemical parameters were measured. In addition, blood pressure and anthropometric indices were examined before and after the supplementation. Independent sample t-test was used to compare changes in metabolic syndrome components between the two study groups.

Results showed a significant reduction in waist circumference (−1.54 vs −0.04 cm; p = 0.036), systolic blood pressure (−3.52 vs 0.79 mmHg; p = 0.020), diastolic blood pressure (−1.50 vs 1.73 mmHg; p = 0.014), serum leptin concentration (−2.54 vs 0.27ng/ml; p = 0.041) and an elevation in high-density lipoprotein cholesterol (2.19 vs −0.79 mg/dl; p = 0.038) in the melatonin group compared to the placebo.

If insulin concentration had been measured, it might have revealed better interpretation of melatonin effect on fasting blood glucose.

This study showed that melatonin as a nutritional supplement improved most metabolic syndrome components and concentration of leptin in the melatonin group compared to the placebo.