scholarly journals Effect of selenium on markers of risk of pre-eclampsia in UK pregnant women: a randomised, controlled pilot trial

2014 ◽  
Vol 112 (1) ◽  
pp. 99-111 ◽  
Author(s):  
Margaret P. Rayman ◽  
Elizabeth Searle ◽  
Lynne Kelly ◽  
Sigurd Johnsen ◽  
Katherine Bodman-Smith ◽  
...  
Keyword(s):  
Placebo Group ◽  
Pregnant Women ◽  
Whole Blood ◽  
Pilot Trial ◽  
Growth Factor Receptor ◽  
Treated Group ◽  
Angiogenic Factor ◽  
Secondary Outcome ◽  
Double Blind ◽  
Se Status

Pre-eclampsia is a serious hypertensive condition of pregnancy associated with high maternal and fetal morbidity and mortality. Se intake or status has been linked to the occurrence of pre-eclampsia by our own work and that of others. We hypothesised that a small increase in the Se intake of UK pregnant women of inadequate Se status would protect against the risk of pre-eclampsia, as assessed by biomarkers of pre-eclampsia. In a double-blind, placebo-controlled, pilot trial, we randomised 230 primiparous pregnant women to Se (60 μg/d, as Se-enriched yeast) or placebo treatment from 12 to 14 weeks of gestation until delivery. Whole-blood Se concentration was measured at baseline and 35 weeks, and plasma selenoprotein P (SEPP1) concentration at 35 weeks. The primary outcome measure of the present study was serum soluble vascular endothelial growth factor receptor-1 (sFlt-1), an anti-angiogenic factor linked with the risk of pre-eclampsia. Other serum/plasma components related to the risk of pre-eclampsia were also measured. Between 12 and 35 weeks, whole-blood Se concentration increased significantly in the Se-treated group but decreased significantly in the placebo group. At 35 weeks, significantly higher concentrations of whole-blood Se and plasma SEPP1 were observed in the Se-treated group than in the placebo group. In line with our hypothesis, the concentration of sFlt-1 was significantly lower at 35 weeks in the Se-treated group than in the placebo group in participants in the lowest quartile of Se status at baseline (P= 0·039). None of the secondary outcome measures was significantly affected by treatment. The present finding that Se supplementation has the potential to reduce the risk of pre-eclampsia in pregnant women of low Se status needs to be validated in an adequately powered trial.

scholarly journals Effect of Pumpkin Seed Oil on Hair Growth in Men with Androgenetic Alopecia: A Randomized, Double-Blind, Placebo-Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Young Hye Cho ◽  
Sang Yeoup Lee ◽  
Dong Wook Jeong ◽  
Eun Jung Choi ◽  
Yun Jin Kim ◽  
...  
Keyword(s):  
Placebo Group ◽  
Hair Growth ◽  
Seed Oil ◽  
Scalp Hair ◽  
Treated Group ◽  
Androgenetic Alopecia ◽  
Double Blind ◽  
Pumpkin Seed ◽  
Male Patients ◽  
Pumpkin Seed Oil

Pumpkin seed oil (PSO) has been shown to block the action of 5-alpha reductase and to have antiandrogenic effects on rats. This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of PSO for treatment of hair growth in male patients with mild to moderate androgenetic alopecia (AGA). 76 male patients with AGA received 400 mg of PSO per day or a placebo for 24 weeks. Change over time in scalp hair growth was evaluated by four outcomes: assessment of standardized clinical photographs by a blinded investigator; patient self-assessment scores; scalp hair thickness; and scalp hair counts. Reports of adverse events were collected throughout the study. After 24 weeks of treatment, self-rated improvement score and self-rated satisfaction scores in the PSO-treated group were higher than in the placebo group (P = 0.013, 0.003). The PSO-treated group had more hair after treatment than at baseline, compared to the placebo group (P<0.001). Mean hair count increases of 40% were observed in PSO-treated men at 24 weeks, whereas increases of 10% were observed in placebo-treated men (P<0.001). Adverse effects were not different in the two groups.

scholarly journals Effects of bright light therapy for depression during pregnancy: a randomised, double-blind controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038030
Author(s):  
Babette Bais ◽  
Astrid M Kamperman ◽  
Hilmar H Bijma ◽  
Witte JG Hoogendijk ◽  
Jan L Souman ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Pregnant Women ◽  
Rating Scale ◽  
Controlled Trial ◽  
Depression Scale ◽  
Bright Light ◽  
Light Therapy ◽  
Secondary Outcome ◽  
Bright Light Therapy ◽  
Double Blind

ObjectivesApproximately 11%–13% of pregnant women suffer from depression. Bright light therapy (BLT) is a promising treatment, combining direct availability, sufficient efficacy, low costs and high safety for both mother and child. Here, we examined the effects of BLT on depression during pregnancy.DesignRandomised, double-blind controlled trial.SettingPrimary and secondary care in The Netherlands, from November 2016 to March 2019.Participants67 pregnant women (12–32 weeks gestational age) with a DSM-5 diagnosis of depressive disorder (Diagnostic and Statistical Manual of Mental Disorders).InterventionsParticipants were randomly allocated to treatment with either BLT (9000 lux, 5000 K) or dim red light therapy (DRLT, 100 lux, 2700 K), which is considered placebo. For 6 weeks, both groups were treated daily at home for 30 min on awakening. Follow-up took place weekly during the intervention, after 6 weeks of therapy, 3 and 10 weeks after treatment and 2 months postpartum.Primary and secondary outcome measuresDepressive symptoms were measured primarily with the Structured Interview Guide for the Hamilton Depression Scale—Seasonal Affective Disorder. Secondary measures were the Hamilton Rating Scale for Depression and the Edinburgh Postnatal Depression Scale. Changes in rating scale scores of these questionnaires over time were analysed using generalised linear mixed models.ResultsMedian depression scores decreased by 40.6%–53.1% in the BLT group and by 50.9%–66.7% in the DRLT group. We found no statistically significant difference in symptom change scores between BLT and DRLT. Sensitivity and post-hoc analyses did not change our findings.ConclusionsDepressive symptoms of pregnant women with depression improved in both treatment arms. More research is necessary to determine whether these responses represent true treatment effects, non-specific treatment responses, placebo effects or a combination hereof.Trial registration numberNTR5476.

scholarly journals Effect of Photopheresis on Lymphocyte Population in Children with Newly Diagnosed Type 1 Diabetes

2004 ◽  
Vol 11 (5) ◽  
pp. 856-861 ◽  
Author(s):  
J. Ernerudh ◽  
J. Ludvigsson ◽  
G. Berlin ◽  
U. Samuelsson
Keyword(s):  
Type 1 Diabetes ◽  
Placebo Group ◽  
Lymphocyte Subsets ◽  
Randomized Study ◽  
Disease Process ◽  
Treated Group ◽  
Newly Diagnosed ◽  
Recent Infection ◽  
Double Blind

ABSTRACT In recent years photopheresis has been claimed to be an effective form of immunomodulation. It has also been shown to have an effect on the disease process at the onset of type 1 diabetes. In a double-blind, placebo-controlled randomized study, we analyzed if the effect of photopheresis in children with newly diagnosed diabetes is related to changes in the balance of lymhocyte populations. We also analyzed if lymphocyte subsets were related to recent infection, mild or aggressive disease manifestations, heredity, or gender. Nineteen children received active treatment with photopheresis, while 21 children received sham pheresis (placebo group). No influence of a history of previous infection, heredity, or certain clinical parameters on lymphocyte subsets was found. At the onset of type 1 diabetes, girls showed a higher proportion and a larger number of T cells (CD3+) and T-helper cells (CD4+) and a higher proportion of naïve CD4+CD45RA+ cells. In the placebo group, an increase in the number of subsets with the activated phenotype in both the CD4 (CD29+) and the CD8 (CD11a+) compartments was noted during the course of the study. These changes did not occur in the photopheresis group. No relation between lymphocyte subsets and clinical outcome was found 1 year after the treatment with photopheresis. In conclusion, we found no major effect of photopheresis on lymphocyte populations in a group of children with newly diagnosed type 1 diabetes. However, in the placebo group the proportions of activated CD4 and CD8 cells increased over time. Since these changes did not occur in the actively treated group, our findings suggest that photopheresis may have some suppressive effects.

scholarly journals The Clinical Interpretation of Platelet Survival with Cr51 Tagged Platelets

1977 ◽  
Author(s):  
J.J.C. Jonker ◽  
L.H.M. van Riel ◽  
W. Schopman ◽  
G.J.H. den Ottolander
Keyword(s):  
Placebo Group ◽  
Drug Effects ◽  
Treated Group ◽  
Correlation Factor ◽  
Control Group ◽  
Single Individual ◽  
Double Blind ◽  
Modified Method ◽  
Platelet Survival ◽  
Significant Difference

We obtained experience in 800 determinations of platelet survival time(PST) with a modified method according to Aster and Jandl . In 20 normal volunteers we obtained a mean T½ of 99 hours with a S.D. of 13.4 hours. The reproducibility of the method was obtained from two PST measurements with an interval of one week. The S.D. of replication was 13.4 percent. The reproducibility of PST over a long period of time (18-30 months) was determined from patients of the placebo group of a trialon patients with angina pectoris. Compared with the PST at entry in 72 patients the mean standard deviation in at least three determinations was 14.5%. Each single PST has a range of 90% reliability (T½ ± 2x S.D.) depending on the correlation factor between disappearance in comparison with time. Our mean correlation factor (R) is 0.92 with a range of 0.85-1.00). A single PST with a R of 0.92 has an S.D. of 15%, meaning that there is a significant difference between two PST determinations in a single individual when there is more than 30% difference. At entry 30% of angina patients has a shortened PST. After six months there was an increase of the PST in the Clofibrate treated group. After 18 months however there was also an increase in the placebo group. This means that no trial of drug effects on platelet survival can be accepted which are lacking a double blind setting and a control group.

Effectiveness of intrathecal ziconotide in malignant pain: A combined analysis of two controlled trials

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8552-8552
Author(s):  
A. W. Burton ◽  
B. Lemus ◽  
R. Fletcher ◽  
S. Chandler ◽  
T. Marmon
Keyword(s):  
Placebo Group ◽  
Calcium Influx ◽  
Pilot Trial ◽  
Controlled Trials ◽  
Dosing Regimen ◽  
Double Blind ◽  
Percent Improvement ◽  
Severe Chronic Pain ◽  
The Mean ◽  
Intent To Treat

8552 Background: Ziconotide is a nonopioid, N-type calcium channel blocker that inhibits neuronal calcium influx, thereby reducing neurotransmitter release at primary pain afferents. Clinical trials have shown ziconotide is useful in managing severe chronic pain, including nociceptive and neuropathic pain of malignant etiology. We reviewed the effectiveness of ziconotide using the Visual Analog Scale of Pain Intensity (VASPI: 100 mm=worst possible pain, 0 mm=no pain). Methods: Cancer patients from two double-blind, placebo-controlled trials (Studies 95–001 and 301) were analyzed. Study 95–001 used a fast titration scheme over 5 to 6 days, enrolling only patients with malignant pain due to cancer or AIDS. In Study 95–001, the initial dosing regimen was based on a pilot trial and was later modified due to the frequency of adverse events (AEs). The final slower titration, lower dosing regimen resulted in a reduced AE rate. Only patients from the final dosing regimen of Study 95–001 were included in this analysis. Study 301 used a slower titration scheme over 21 days, enrolling patients with malignant or nonmalignant pain. A two-sided, two-sample t-test was used to evaluate the null hypothesis that the mean percent change in VASPI score from baseline to end of titration for the ziconotide group was not significantly different from that of the placebo group (intent-to-treat population). Results: A total of 67 patients with malignant pain were treated in the trials; 51 (35 ziconotide, 16 placebo) had both baseline and end of titration VASPI scores. The ziconotide and placebo groups had similar mean baseline VASPI scores (75.5 and 75.8 mm, respectively). The mean percent improvement in VASPI score was 36.5% in the ziconotide group and 8.6% in the placebo group (p=0.0230). Conclusions: These results indicated that ziconotide was effective in relieving malignant pain. [Table: see text]

A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Individualized Homeopathic Medicines for Cutaneous Warts

Homeopathy ◽  
2021 ◽  
Author(s):  
Samit Dey ◽  
Shifa Hashmi ◽  
Sangita Saha ◽  
Mahakas Mandal ◽  
Abdur Rahaman Shaikh ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Pilot Trial ◽  
Attrition Rate ◽  
Effect Sizes ◽  
Secondary Outcome ◽  
Group Differences ◽  
Practice Research ◽  
Double Blind ◽  
Definitive Trial ◽  
Cutaneous Warts

Abstract Background Though frequently used in practice, research studies have shown inconclusive benefits of homeopathy in the treatment of warts. We aimed to assess the feasibility of a future definitive trial, with preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in treatment of cutaneous warts. Methods A double-blind, randomized, placebo-controlled trial (n = 60) was conducted at the dermatology outpatient department of D.N. De Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH (n = 30) or identical-looking placebo (n = 30). Primary outcome measures were numbers and sizes of the warts; secondary outcome was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample. Results Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater (all p < 0.05, Friedman tests) in IH than placebo. Inter-group differences were statistically non-significant (all p > 0.05, Mann-Whitney U tests) with small effect sizes—both in the primary outcomes (number of warts after 3 months: IH median [inter-quartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2]; p = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7]; p = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8]; p = 0.935). Thuja occidentalis (28.3%), Natrum muriaticum (10%) and Sulphur (8.3%) were the most frequently prescribed medicines. No harms, homeopathic aggravations, or serious adverse events were reported. Conclusion As regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted. Trial Registration CTRI/2019/10/021659; UTN: U1111–1241–7340

Bacillus clausii UBBC-07 reduces severity of diarrhoea in children under 5 years of age: a double blind placebo controlled study

2019 ◽  
Vol 10 (2) ◽  
pp. 149-154 ◽  
Author(s):  
M. Ratna Sudha ◽  
N. Jayanthi ◽  
D.C. Pandey ◽  
A.K. Verma
Keyword(s):  
Placebo Group ◽  
Acute Diarrhoea ◽  
Treated Group ◽  
Controlled Study ◽  
Duration Of Treatment ◽  
Double Blind ◽  
Safe Alternative ◽  
Multicentric Study ◽  
Oral Rehydration ◽  
Bacillus Clausii

Acute diarrhoea is one of the leading causes of mortality in infants and young children. Evidence suggests that probiotics can reduce diarrhoea duration. As the effects of probiotics are strain specific, the effect of Bacillus clausii UBBC-07, a safe probiotic strain in the treatment of acute diarrhoea in children was studied. The double blind, randomised, placebo-controlled, parallel group multicentric study was conducted at two outpatient facility sites in Lucknow, India. Children aged six months to five years suffering from acute diarrhoea, were randomly assigned to receive either probiotic (B. clausii UBBC-07) spore suspension or placebo suspension twice daily apart from oral rehydration solution (ORS). The duration of treatment was for five days with a follow -up until the 10th day. Outcomes evaluated were duration and frequency of diarrhoea, consistency of stool, fever and vomiting. The duration of diarrhoea was significantly shorter (P<0.05) in patients who received B. clausii suspension (75.66±13.23 h) than in placebo treated group (81.6±15.43 h). The average daily number of stools (frequency) was 8.67±3.42 at baseline in treatment group receiving B. clausii and 8.53±3.19 in placebo group. By day 4, there was a significant reduction (P<0.01) in frequency of stools in probiotic treated group (3.46±0.66) as compared to placebo group (4.57±1.59). Improvement in stool consistency was also observed in the probiotic treated group as compared to the placebo group. There was no effect on vomiting and duration of fever. B. clausii UBBC-07 significantly decreased the duration and frequency of diarrhoea as compared to placebo indicating effectiveness of strain in the treatment of acute diarrhoea in children and could be a safe alternative to antibiotics.

EFFECT OF ANTIAGGREGANT ON OCCLUSION OF SAPHENOUS GRAFT CORONARY BYPASS

1987 ◽  
Author(s):  
E Lavenne-Pardonge ◽  
C Col-De Beys ◽  
R Dion ◽  
R Ponlot ◽  
M Moriau
Keyword(s):  
Placebo Group ◽  
Coronary Bypass ◽  
Arterial Disease ◽  
Treated Group ◽  
Double Blind Study ◽  
Careful Study ◽  
Double Blind ◽  
Normal Limits ◽  
Group 2 ◽  
Long Acting

Double blind study on 49 patients, 24receiving aspirine-dipyri-damole, 25 a placebo. In both groups 20 patients were followed during one year. The two groupsdid not differ according to age, sex and number of coronary bypass. In all the patients, Calparin (3 x 5000 U/day) was injected subcutanously the day before andthe 7 days after surgery. In the first group dipyridamole (25 mg/ kg) was injected during the same period. The second group received a placebo IV injection. Thereafter long acting dipyridamole (400 mg/day) and aspirin (200 mg/day) were given orally in the first group, placebo in the second one. Cardiac follow-up included E.C.G. and thallium at maximum exercise. Coronarography was performed only incase of reappearence of chest pain. No difference was found between the two groups for the coagulation parameters duringthe whole year of study. Statistically significant differences between the two groups were found during the same period for β-thromboglobulin, fibrino-peptide A and the ratio Δ+ βTG/Δ+ FPA. Plateletactivity, elevated in the placebo group, was kept in normal limits in the treated group. During the two first months for the placebo and during the first month for the treated group the ratio Δ+ βTG/Δ+ FPA decreased in all patients showing the importance at this time of plasmatic hypercoagulability compared to platelet hyperactivity. During the 12 months of the study 5 thrombotic accidents (25 %) were noted in the placebo group (2 myocardial infarctions, 2 occlusions of bypass, 1 case of cerebral arterial disease) and 2 (10 % in the treated group) (1 postoperative death, 1 myocardial infarction) (NS ; p =0,21). Our results lead to two conclusions : 1) Platelet antiaggregants may influencethe permeability of saphenous .graft coronary bypass. A careful study of platelet acti-r vity with eventual change of the drug used may improve the late resultsof surgery. 2) Association of anticoagulant therapy (anti-vitamin K) during the two first months after surgery could also be useful.

scholarly journals Long-term supplementation with selenate and selenomethionine: Selenium and glutathione peroxidase (EC1.11.1.9) in blood components of New Zealand women

1993 ◽  
Vol 69 (2) ◽  
pp. 577-588 ◽  
Author(s):  
Christine D. Thomson ◽  
Marion F. Robinson ◽  
Judy A. Butler ◽  
Phllip D. Whanger
Keyword(s):  
New Zealand ◽  
Glutathione Peroxidase ◽  
Whole Blood ◽  
Plasma Proteins ◽  
Gel Filtration ◽  
Double Blind ◽  
Protein Pool ◽  
Gshpx Activity ◽  
Se Status

Thirty-three New Zealand women aged 18–23 years received daily for 32 weeks, 200 μg Se as Seenriched yeast (selenomethionine), or brewer's yeast mixed with selenate, or no added Se (placebo) in a double-blind trial. Se supplementation raised (P= 0.001), platelet glutathione peroxidase (EC1.11.1.9; GSHPx) activity, and also Se and GSHPx in whole blood, erythrocytes and plasma. Selenomethionine was more effective in raising blood Se concentrations than selenate, but both were equally effective in raising GSHPx activities in whole blood, erythrocytes and plasma, indicating a similar bioavailability for the two forms. These observations and those of gel filtration studies of erythrocytes and plasma proteins reported elsewhere (Butleret al.1991) are consistent with the incorporation of Se from selenomethionine into a general tissue protein pool while selenate is directly available for GSHPx synthesis, and explain the poorer correlation between Se and GSHPx in individuals with higher Se status. However, selenate raised platelet GSHPx activities to a greater extent than did selenomethionine suggesting some other effect of selenate on platelets which needs further investigation. A response of GSHPx activity in these New Zealand subjects indicates that their dietary Se intake is insufficient to meet recommended intakes based on the criterion of saturation of GSHPx activity, and could reflect a marginal Se status. The level of blood Se necessary for saturation of GSHPx of about 100 ng Se/ml whole blood confirms observations in earlier studies.

scholarly journals A randomized-controlled pilot study on the effects of naproxen for the treatment of bleeding and spotting among new Copper T 380A IUD users

2020 ◽  
Author(s):  
Emily M Godfrey ◽  
C. Holly A. Andrilla ◽  
Katherine Odem-Davis
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Treatment Cycle ◽  
Pilot Trial ◽  
Post Treatment ◽  
Menstrual Bleeding ◽  
Double Blind ◽  
Over The Counter ◽  
Prolonged Bleeding ◽  
Bleeding Episodes

Abstract Background: The most common reason women report discontinued use of the Copper T 380A (TCu380A) IUD is because of bleeding irregularities after method initiation. The objective of this study was to determine whether an over-the-counter NSAID, naproxen sodium, reduces the number of bleeding and spotting days and heavy or prolonged bleeding episodes among new users of the TCu380A IUD compared to placebo.Methods: In this double-blind pilot trial, we randomized 28 new TCu380A IUD users who reported menstrual cycle changes within 4-6 weeks after IUD placement to either naproxen 440 mg or placebo twice daily for 7 days for three consecutive 28-day cycles and one additional 28-day cycle without treatment. Participants completed a daily bleeding and other symptom diary, and monthly questionnaires. Results: Although not statistically significant, participants in the naproxen arm reported more mean number of spotting-only days during the three treatment cycles compared those in the placebo group (13.5 days (SE 5.1) vs.7.5 days (SE 1.7), respectively). Otherwise, the mean number of bleeding-only days during treatment and post-treatment and spotting-only post-treatment were similar between the groups. During each treatment cycle, fewer participants in the treatment group reported heavy bleeding compared to placebo group (30.7% fewer in cycle 2; 5.4% fewer in cycle 3). More women in the treatment group, however, reported prolonged menstrual bleeding of greater than 7 days for each cycle, although the percentage reporting prolonged bleeding decreased each consecutive treatment and post-treatment cycle (+27.5%, +19.8%, +9.1%, +4.5%, cycles 1-4 respectively). Other symptoms experienced by new TCu380A users did not differ between the study arms.Conclusions: Treatment with naproxen did not significantly reduce the number of bleeding or spotting days among new TCu380A users. Although not statistically different, proportionally fewer participants in the naproxen group reported moderate-heavy or heavy periods, but more reported prolonged menstrual bleeding compared to placebo. Participants tolerated oral naproxen use well.Trial registration: ClinicalTrials.gov: NCT02519231. Registered on August 10 2015.

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