scholarly journals 0796 Dipyridamole for the Treatment of RLS: Preliminary Results of a Cross-Over, Placebo-Controlled, Double-Blind Trial

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A303-A303
Author(s):  
D Garcia-Borreguero ◽  
J Granizo ◽  
S Ferre
Keyword(s):  
Therapeutic Response ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Extracellular Adenosine ◽  
Preliminary Results ◽  
Dopaminergic Agents ◽  
Duration Of Illness ◽  
Adenosine A1 ◽  
Irls Score ◽  
The Mean

Abstract Introduction Recent animal models of restless legs syndrome (RLS) suggest that brain iron deficiency is associated with a hypoadenosinergic state, with downregulation of adenosine A1 receptors (A1R) in the striatum. Dipyridamole is a non-selective inhibitor of ENT1/ENT2 (the main reuptake mechanism of adenosine) and increases thereby extracellular adenosine. We hypothesized that treatment with dipyridamole would improve RLS symptoms more than placebo. Methods We performed a randomized, double-blind, placebo-controlled clinical trial on 15 previously untreated idiopathic RLS patients that underwent a two week treatment with either 300 mg dipyridamol or placebo (randomized for the order of treatments), following a cross-over design. Treatment started with a dose of 100 mg/day, followed by a forced up-titration to 200 mg on day 4, and to 300 mg on day 7. Severity was assessed at baseline, day 7 and day 14 of each treatment condition by means of the IRLS and CGI scales. The primary endpoint was therapeutic response (50% improvement in IRLS total score). Results Fifteen patients (nine women), never before treated with dopaminergic agents, completed both arms of the study. Mean age was 60,2 (±7,1), and the mean duration of illness was 6,03 (±3,1) yrs. IRLS score improved during treatment with dipyridamole from a mean (±S.D.) of 24,36 (±3,3) to 9,78 (±3,4), in contrast to a change from 23,9 (±3,8) to 16,6 (±3,7) under placebo (p< 0.05). Corresponding improvements on the CGI were 61,3% and 11,8% for dipyridamole and placebo, respectively. 7/ 15 patients improved by more than 50% during treatment with dipyridamole vs. 4/15 under placebo. Main side effects were abdominal cramps, diarrhea, dizziness, and flushing. Conclusion These preliminary results suggest that dipyridamole is an effective agent on RLS symptoms. It also provides evidence of hypoadenosinergic mechanisms playing a central role in RLS. Support No funding was provided for this investigation.

Professionally Applied Fluoride Gel in Low-caries 10.5-year-olds

2005 ◽  
Vol 84 (5) ◽  
pp. 418-421 ◽  
Author(s):  
G.J. Truin ◽  
M.A. van ’t Hof
Keyword(s):  
Relative Effect ◽  
Permanent Teeth ◽  
Caries Experience ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Tooth Surfaces ◽  
The Mean ◽  
Preventive Fraction ◽  
Pits And Fissures

The question has been raised whether low-caries children regularly using fluoride toothpaste will benefit from the professional application of additional fluoride gel. To investigate the caries-reducing effect of semi-annually-applied neutral 1% sodium fluoride gel, we carried out a double-blind randomized controlled clinical trial (n = 594) in a child population, initially aged 9.5–11.5 years, with baseline caries experience of D3MFS = 0 (decayed, missing, and filled tooth surfaces of permanent teeth). The mean number of tooth surfaces saved from caries development by fluoride gel application after 4 years was 0.2 D3MFS (SE = 0.17). The preventive fraction (PF) showed a mean relative effect of professionally applied fluoride gel of 18%. The cariostatic effect of the fluoride gel on pits and fissures would have been influenced by the sealant strategy in the study. Professionally applied fluoride gel showed no statistically significant effect on mean D3MFS score in low-caries 9.5- to 11.5-year-olds.

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background: There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods: In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results: Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34±17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p>0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion: According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

Efficacy of lettuce seed syrup on insomnia in patients with breast cancer: a pilot double blind randomized placebo controlled clinical trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Seyed Hamdollah Mosavat ◽  
Hamid Reza Mirzaei ◽  
Bahram Mofid ◽  
Reyhaneh Gharehgozlou ◽  
Mohammad Mahdi Parvizi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Sleep Quality ◽  
Sleep Disorders ◽  
Controlled Clinical Trial ◽  
Lettuce Seed ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Before And After ◽  
The Mean

Abstract Objectives Insomnia and sleep disorders are common and can be severe amongst patients with cancer, especially during chemotherapy. The aim of this study was to evaluate the efficacy of lettuce seed syrup in breast cancer patients who suffer from insomnia or disordered sleep. Methods This pilot study was a double-blinded randomized controlled clinical trial conducted in Shoha-e-Tajrish Hospital (Tehran, Iran) from September 2018 to June 2019. 50 adult patients with breast cancer with insomnia or sleep disorders were enrolled. Participants were randomly allocated to lettuce seed syrup (5 mL twice daily), or placebo syrup at the same dose for four weeks. The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate sleep quality before and after the intervention. Results Compared to placebo, the mean of the total PSQI score decreased significantly in participants who received lettuce seed syrup (p=0.014). In addition, there were statistically significant reductions in the mean scores of subject quality sleep (p=0.002), sleep duration (p=0.038), habitual sleep efficacy (p=0.029) and sleep disturbance (p=0.032) in patients who received lettuce seed syrup. Conclusions Lettuce seed syrup may improve self-reported sleep quality in participants with breast cancer. Larger trials are indicated in diverse samples of participants with caner to learn if these finds are generalizable.

scholarly journals Changes in the Diversity of Human Skin Microbiota to Cosmetic Serum Containing Prebiotics: Results from a Randomized Controlled Trial

2020 ◽  
Vol 10 (3) ◽  
pp. 91
Author(s):  
Ki-Bae Hong ◽  
Yang Hee Hong ◽  
Eun Young Jung ◽  
Kyungae Jo ◽  
Hyung Joo Suh
Keyword(s):  
Controlled Trial ◽  
Transepidermal Water Loss ◽  
Shannon Index ◽  
Water Holding Capacity ◽  
Controlled Clinical Trial ◽  
Skin Microbiota ◽  
Double Blind ◽  
Group Water ◽  
The Mean ◽  
Water Holding

Prebiotic treatment may rebalance the skin microbiota by regulating the growth of harmful and beneficial microorganisms. In this randomized, double-blind, placebo-controlled clinical trial (N = 60), we evaluated the effects of a cosmetic serum containing galacto-oligosaccharides (GOS) on the balance of the skin microbiota by measuring various skin parameters. The skin water-holding capacity between the control (ND) and experimental (NF) groups was significantly different after 8 weeks of serum treatment (p < 0.05). Similarly, changes in transepidermal water loss (TEWL) and the erythema index in the ND and NF groups were significantly different (p < 0.05). Furthermore, the wrinkle depth and Staphylococcus aureus population decreased in the NF group compared with those in the ND group (p < 0.05). The mean form factor, Shannon index, and Pediococcus population were significantly increased in the post-NF group compared with those in the post-ND group (p < 0.05). Finally, in the ND group, water-holding capacity was positively correlated with Enhydrobacter, whereas Enterobacteriaceae was negatively correlated with TEWL in the NF group. These results suggest that GOS inhibit the growth of harmful skin microbes and increase the population of beneficial microbes.

scholarly journals The Effectiveness of a 5% Retinoic Acid Peel Combined with Microdermabrasion for Facial Photoaging: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Gita Faghihi ◽  
Saghi Fatemi-Tabaei ◽  
Bahareh Abtahi-Naeini ◽  
Amir Hossein Siadat ◽  
Giti Sadeghian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Retinoic Acid ◽  
Adverse Effects ◽  
Treatment Initiation ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Photoaged Skin ◽  
The Mean

Background. Tretinoin has been shown to improve photoaged skin. This study was designed to evaluate the efficacy and tolerability of a 5% retinoic acid peel combined with microdermabrasion for facial photoaging. Materials and Methods. Forty-five patients, aged 35–70, affected by moderate-to-severe photodamage were enrolled in this trial. All patients received 3 sessions of full facial microdermabrasion and 3 sessions of either 5% retinoic acid peel or placebo after the microdermabrasion. Efficacy was measured using the Glogau scale. Patients were assessed at 2 weeks and 1, 2, and 6 months after treatment initiation. Results. The mean ± SD age of participants was 49.55±11.61 years, and the majorities (73.3%) were female. Between 1 month and 2 months, participants reported slight but statistically significant improvements for all parameters (P<0.001). In terms of adverse effects, there were statistically significant differences reported between the 5% retinoic acid peel groups and the control group (P<0.001). The majority of adverse effects reported in the study were described as mild and transient. Conclusion. This study demonstrated that 5% retinoic acid peel cream combined with microdermabrasion was safe and effective in the treatment of photoaging in the Iranian population. This trial is registered with IRCT2015121112782N8.

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background: There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods: In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results: Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34±17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p>0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion: According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background: There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods: In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results: Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34±17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p>0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion: According to results, six-month supplementation with synbiotic did not have a significant effect on the HEQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

scholarly journals Does Synbiotic Supplementation Affect the Quality of Life in Children with Cystic Fibrosis? A Pilot Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis.Results Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34 ± 17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after probiotic and placebo supplementation (p > 0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores.Conclusion According to results, six-month supplementation with synbiotic did not have a significant effect on the HEQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion.

The Effect of Coenzyme Q10 Supplementation on Pro-Inflammatory Factors and Adiponectin in Mildly Hypertensive Patients: A Randomized, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 85 (3-4) ◽  
pp. 156-164 ◽  
Author(s):  
Nasim Bagheri Nesami ◽  
Hassan Mozaffari-Khosravi ◽  
Azadeh Najarzadeh ◽  
Ebrahim Salehifar
Keyword(s):  
Coenzyme Q10 ◽  
Inflammatory Factors ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Hypertensive Patients ◽  
Double Blind Placebo ◽  
Tnf Α ◽  
The Mean ◽  
Hs Crp ◽  
Coenzyme Q10 Supplementation

Abstract. Introduction: There is considerable evidence that hypertension may increase the levels of cytokines via endothelial stimulation and may stimulate inflammatory reactions. The purpose of this study was to evaluate the effect of oral coenzyme Q10 supplementation on pro-inflammatory factors and adiponectin in mildly hypertensive patients. Methods: This 12-week randomized, double-blind, placebo-controlled clinical trial was carried out during 2012 - 2013 in Yazd. Sixty mildly hypertensive patients were randomly divided into two groups: placebo (PG, n = 30) and coenzyme Q10 (QG, n = 30). The QG was given 1 capsule containing 100 mg Q10 per day. The PG was given 1 capsule of the same size and color as the Q10 capsules, but it contained 100 mg of lactose. Plasma pro-inflammatory factors (IL6, IL2, and TNF-α), adiponectin, and hs-CRP were determined before and after the intervention. Results: The mean enhancement in adiponectin of QG was significantly higher than PG (from 21.1 ± 14.5 to 24.2 ± 15.5 ng/ml, P = 0.04). Significant declines in the median of IL6 (from 23 to 16 pg/ml, P = 0.001) and in the mean of hs-CRP were also observed in QG after intervention (from 3.53 ± 3.36 to 2.62 ± 2.51 mg/L, P = 0.03). In the two groups, no significant statistical changes were seen in the median of TNF-α and IL2. Conclusion: Daily supplementation of 100 mg coenzyme Q10 can be effective in decreasing some pro-inflammatory factors, such as IL6 and hs-CRP, and in increasing adiponectin.

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