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International Journal of Preventive... 2021A low level of vitamin B6 may theoretically cause symptoms of depression.
BACKGROUND
A low level of vitamin B6 may theoretically cause symptoms of depression.
AIMS
To investigate the effect of vitamin B6 on the prevention of postpartum depression (PPD) among mothers at risk for PPD.
METHODS
This single-blind, placebo-controlled clinical trial was conducted on 81 pregnant women who were at risk of PPD from February to July 2016 at six selected health centers in Isfahan, Iran. A simple random sampling method was adopted. Forty cases and 41 controls received 80 mg vitamin B6 and placebo, respectively from the 28 week until the end of pregnancy. The risk of PPD was assessed as the main inclusion criteria using a structured clinical interview using hospital anxiety-depressive scale (HADS), social support appraisals scale (SS-A), and Holmes and Rahe life change and stress evaluation questionnaire (HRLCSEQ). The Edinburgh postpartum depression scale (EPDS) was used to assess the rate of depression prior to and 1.5 months after the intervention (end of pregnancy). Data were analyzed using SPSS 20 and statistical tests (Chi-square, independent -test, Mann-Whitney's, and Exact Fisher Test).
RESULTS
Forty-three subjects were assigned to each group and the final analysis comprised 81 subjects (40 in the case and 41 in the control groups), the mean age of the case and control groups being 5.8 ± 29.6 and 4.6 ± 28.2, respectively. The mean depression score was 10.4 ± 1.4 in the case and 9.3 ± 4.2 in control groups ( = 0.34) before and 4.2 ± 2.7 in the case and 10.4 ± 3.4 in control groups ( < 0.001) after intervention.
CONCLUSIONS
Vitamin B6 has a positive effect on reducing postpartum depression scores among mothers at risk for PPD. These may be clinically useful for preventing PPD in high-risk women.
PubMed: 34912512
DOI: 10.4103/ijpvm.IJPVM_240_19 -
Virology Journal Oct 2023The live-attenuated Rift Valley Fever Smithburn (SB) vaccine is one of the oldest products widely used in ruminants for control of RVF infections. Vaccinations with RVF...
BACKGROUND
The live-attenuated Rift Valley Fever Smithburn (SB) vaccine is one of the oldest products widely used in ruminants for control of RVF infections. Vaccinations with RVF Smithburn result in residual pathogenic effect and is limited for use in non-pregnant animals. Commercially available RVFV inactivated vaccines are considered safer options to control the disease. These products are prepared from virulent RVFV isolates and present occupational safety concerns. This research study evaluates the ability of an inactivated SB vaccine strain to elicit neutralising antibody response in sheep.
METHODS
The RVF Smithburn vaccine was inactivated with binary ethylenimine at 37 °C. Inactivated RVFV cultures were adjuvanted with Montande™ Gel-01 and aluminium hydroxide (Al (OH)) gel for immunogenicity and safety determination in sheep. The commercial RVF inactivated vaccine and a placebo were included as positive and negative control groups, respectively.
RESULTS
Inactivated RVFV vaccine formulations were safe with all animals showing no clinical signs of RVFV infection and temperature reactions following prime-boost injections. The aluminium hydroxide formulated vaccine induced an immune response as early as 14 days post primary vaccination with neutralising antibody titre of 1:20 and a peak antibody titre of 1:83 was reached on day 56. A similar trend was observed in the animal group vaccinated with the commercial inactivated RVF vaccine obtaining the highest antibody titre of 1:128 on day 56. The neutralizing antibody levels remained within a threshold for the duration of the study. Merino sheep vaccinated with Montanide™ Gel-01-Smithburn were characterised with overall lower immune response when compared to aluminium hydroxide vaccine emulsions.
CONCLUSIONS
These finding suggests that the inactivated RVF Smithburn vaccine strain adjuvanted with aluminium-hydroxide can be used an alternative to the products prepared from virulent RVFV isolates for protection of ruminants against the disease. The vaccine can further be evaluated for safety in pregnant ewes.
Topics: Animals; Female; Aluminum Hydroxide; Antibodies, Neutralizing; Antibodies, Viral; Rift Valley Fever; Rift Valley fever virus; Ruminants; Sheep; Sheep Diseases; Vaccines, Attenuated; Vaccines, Inactivated; Viral Vaccines
PubMed: 37789354
DOI: 10.1186/s12985-023-02180-2 -
Brazilian Journal of Otorhinolaryngology 2020Tranexamic acid is a hemostatic agent, which inhibits fibrin degradation, which may be beneficial in controlling bleeding during surgery. (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Tranexamic acid is a hemostatic agent, which inhibits fibrin degradation, which may be beneficial in controlling bleeding during surgery.
OBJECTIVES
The purpose of this study was to provide a meta-analysis and review of the effects of tranexamic acid on hemorrhage and surgical fields and side effects on patients during endoscopic sinus surgery.
METHODS
Two authors independently searched six databases (Medline, Scopus, Embase, Web of Science, Google Scholar and Cochrane library) from the start of article collection until July 2018. Postoperative complications such as intraoperative bleeding, operative time, hypotension, nausea, vomiting, and coagulation profile were included in the analysis of tranexamic acid (Treatment Group) and placebo (Control Group) during the operation.
RESULTS
The amount of blood loss during surgery was statistically lower in the treatment group compared to the placebo group, and the surgical field quality was statistically higher in the treatment group than in the placebo group. On the other hand, there was no significant difference in operation time, hemodynamics, or coagulation profile between groups. In addition, tranexamic acid had no significant effect on vomiting and thrombosis compared to the Control Group.
CONCLUSION
This meta-analysis has shown that topical administration of tranexamic acid can reduce the amount of bleeding during surgery and improve the overall quality of the surgery. Hemodynamic instability during surgery, vomiting after surgery, or abnormal clotting profile were not reported. Additional studies are needed to confirm the results of this study because there are fewer studies.
Topics: Administration, Topical; Anesthesia, General; Antifibrinolytic Agents; Blood Loss, Surgical; Endoscopy; Epistaxis; Humans; Intraoperative Complications; Nasal Surgical Procedures; Randomized Controlled Trials as Topic; Tranexamic Acid
PubMed: 31653606
DOI: 10.1016/j.bjorl.2019.08.006 -
The Cochrane Database of Systematic... Apr 2020Ascaris lumbricoides is a common infection, and mainly affects children living in low-income areas. Water and sanitation improvement, health education, and drug... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Ascaris lumbricoides is a common infection, and mainly affects children living in low-income areas. Water and sanitation improvement, health education, and drug treatment may help break the cycle of transmission, and effective drugs will reduce morbidity.
OBJECTIVES
To compare the efficacy and safety of anthelmintic drugs (albendazole, mebendazole, ivermectin) for treating people with Ascaris infection.
SEARCH METHODS
We searched the Cochrane Infectious Disease Group Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, three other databases, and reference lists of included studies, without language restrictions, up to 4 July 2019.
SELECTION CRITERIA
Randomized controlled trials (RCT) that compared albendazole, mebendazole, and ivermectin in children and adults with confirmed Ascaris infection.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion, assessed risk of bias, and extracted data from the included trials. A third review author checked the quality of data extraction. We used the Cochrane 'Risk of bias' assessment tool to determine the risk of bias in included trials. We used risk ratios (RRs) with 95% confidence intervals (CIs) to compare dichotomous outcomes in treatment and control groups. We used the fixed-effect model for studies with low heterogeneity and the random-effects model for studies with moderate to high heterogeneity. We assessed the certainty of the evidence using the GRADE approach. We used the control rate average to provide illustrative cure rates in the comparison groups.
MAIN RESULTS
We included 30 parallel-group RCTs, which enrolled 6442 participants from 17 countries across Africa, Asia, Central America and the Caribbean, and South America. Participants were from 28 days to 82 years of age, recruited from school, communities, and health facilities. Twenty studies were funded or co-funded by manufacturers, while 10 studies were independent of manufacturer funding. Twenty-two trials had a high risk of bias for one or two domains (blinding, incomplete outcome data, selective reporting). Single dose of albendazole (four trials), mebendazole (three trials) or ivermectin (one trial) was compared to placebo. Parasitological cure at 14 to 60 days was high in all the studies (illustrative cure of 93.0% in the anthelmintic group and 16.1% in the placebo group; RR 6.29, 95% CI 3.91 to 10.12; 8 trials, 1578 participants; moderate-certainty evidence). Single dose of albendazole is as effective as multiple doses of albendazole (illustrative cure of 93.2% with single dose, 94.3% with multiple doses; RR 0.98, 95% CI 0.92 to 1.05; 3 trials, 307 participants; high-certainty evidence); or as single dose of mebendazole (illustrative cure of 98.0% with albendazole, 96.9% with mebendazole; RR 1.01, 95% CI 1.00 to 1.02; 6 trials, 2131 participants; high-certainty evidence). Studies did not detect a difference between a single dose of albendazole and a single dose of ivermectin (cure rates of 87.8% with albendazole, 90.2% with ivermectin; RR 0.99, 95% CI 0.91 to 1.08; 3 trials, 519 participants; moderate-certainty evidence). Across all the studies, failure after single dose of albendazole ranged from 0.0% to 30.3%, mebendazole from 0.0% to 22.2%, and ivermectin from 0.0% to 21.6%. The egg reduction rate (ERR) measured up to 60 days after the treatment was high in all treated groups, regardless of the anthelmintic used (range 96% to 100%). It was not possible to evaluate parasitological cure by classes of infection intensity. No included trials reported complication or serious adverse events. Other adverse events were apparently similar among the compared anthelmintic groups (moderate- to low-certainty evidence). The most commonly reported other adverse events were nausea, vomiting, abdominal pain, diarrhoea, headache, and fever.
AUTHORS' CONCLUSIONS
Single-dose of albendazole, mebendazole, and ivermectin all appeared effective against Ascaris lumbricoides infection, yielding high parasitological cure and large reductions in eggs excreted, with no differences detected between them. The drugs appear to be safe to treat children and adults with confirmed Ascaris infection. There is little to choose between drugs and regimens in terms of cure or adverse events.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Albendazole; Animals; Anthelmintics; Ascariasis; Ascaris lumbricoides; Child; Child, Preschool; Humans; Infant; Ivermectin; Mebendazole; Middle Aged; Parasite Egg Count; Placebos; Randomized Controlled Trials as Topic; Young Adult
PubMed: 32289194
DOI: 10.1002/14651858.CD010599.pub2 -
Scientific Reports Dec 2022Little is known about the impact of control group therapy on clinical benefit scales such as American Society of Clinical Oncology Value Framework (ASCO-VF), European...
Little is known about the impact of control group therapy on clinical benefit scales such as American Society of Clinical Oncology Value Framework (ASCO-VF), European Society for Medical Oncology Magnitude Clinical Benefit Scale (ESMO-MCBS), National Comprehensive Cancer Network (NCCN) Evidence Blocks and ASCO Cancer Research Committee (ASCO-CRC). We searched Drugs@FDA to identify cancer drugs approved between January 2012 and December 2021 based on randomized trials (RCTs). Definition of substantial clinical benefit was based on recommendations for each scale. Associations between characteristics of control group therapy and clinical benefit were explored using logistic regression. RCTs with a control group of active treatment plus placebo were associated with significantly lower odds of substantial benefit with ESMO-MCBS (OR 0.27, P = 0.003) and ASCO-VF (OR 0.30, P = 0.008) but not with NCCN Evidence Blocks or ASCO-CRC. This effect was attenuated and lost statistical significance without adjustment for quality of life (QoL) and/or toxicity (ESMO-MCBS OR 0.50, P = 0.17; ASCO-VF OR 0.49, P = 0.11). Clinical benefit scales can be sensitive to control group therapy. RCTs with substantial overlap between experimental and control therapy showed lower magnitude of clinical benefit using ESMO-MCBS and ASCO-VF scales; possibly due to differences in the weighting of QoL and toxicity between different frameworks.
Topics: Humans; Neoplasms; Control Groups; Antineoplastic Agents; Medical Oncology; Quality of Life
PubMed: 36494465
DOI: 10.1038/s41598-022-25983-9 -
Frontiers in Immunology 2021This study aimed to develop a placebo response model for pharmaceutical clinical trials of primary Sjogren's syndrome,and to quantitatively analyze the distribution and... (Meta-Analysis)
Meta-Analysis
This study aimed to develop a placebo response model for pharmaceutical clinical trials of primary Sjogren's syndrome,and to quantitatively analyze the distribution and related factors influencing the placebo response to further optimize the design of clinical trials and evaluate the results of single-arm clinical trials. Public databases, including PubMed, Embase, and Cochrane Library were searched for reports on randomized placebo-controlled trials for Sjögren's syndrome which used the change from baseline in ESSDAI score as the primary outcome. The model-based meta-analysis method was used to evaluate the time course and the related influencing factors of the placebo response for ESSDAI in such clinical trials. A virtual placebo control group was constructed based on the final placebo response model to determine the treatment efficacy of belimumab and cyclosporine A for primary Sjögren's syndrome in a single-arm study. A total of 12 studies involving 450 subjects were included in the analysis. The established model described the time-course characteristics of the changes in ESSDAI score from the baseline in the 48 weeks placebo group. We found that the onset time of placebo response was approximately 12 weeks, and its efficacy plateaued at 48 weeks. The baseline ESSDAI score had a significant effect on the maximum value of the placebo response; the maximum value of the placebo response decreased by 0.552 for every 1 score rise in the baseline ESSDAI score. The efficacy of belimumab and cyclosporine A in the single-arm trial was comparable to that of the placebo response at the same baseline; no significant therapeutic advantage was observed. The placebo response model established in this study could provide a basis for designing clinical trials for primary Sjogren's syndrome in the future. It may also provide a reliable external efficacy control standard for single-arm clinical trials.
Topics: Datasets as Topic; Humans; Immunosuppressive Agents; Models, Biological; Monte Carlo Method; Placebo Effect; Placebos; Randomized Controlled Trials as Topic; Research Design; Severity of Illness Index; Sjogren's Syndrome; Treatment Outcome
PubMed: 34868062
DOI: 10.3389/fimmu.2021.783246 -
Pain Jul 2024Previous research has indicated that an open-label placebo can reduce pain in both healthy participants and patients with chronic pain. Because nondeceptive placebos... (Randomized Controlled Trial)
Randomized Controlled Trial
Previous research has indicated that an open-label placebo can reduce pain in both healthy participants and patients with chronic pain. Because nondeceptive placebos seem to be an effective and more ethical alternative to deceptive placebos, optimizing this kind of treatment is essential. Observational learning was previously shown to induce the deceptive placebo effect; therefore, this study aimed to verify its effectiveness in fortifying the open-label placebo effect. Healthy volunteers (N = 117) were randomly assigned to 4 groups: open-label placebo with observational learning (OLP + OBL), open-label placebo (OLP), deceptive placebo with observational learning (OBL), or control group. Participants underwent baseline and testing measurements, during which they self-reported pain induced by heat stimulation. Between assessments, placebo cream was openly administered in the OLP and OLP + OBL groups. The OLP + OBL group next watched a model experiencing hypoalgesia after cream application. In the OBL group, participants received placebo cream with no information about its effect, and then they watched the model. The placebo effect was successfully evoked in all experimental groups (OLP + OBL, OLP, and OBL), which confirms the effectiveness of both open-label and deceptive placebo interventions for pain reduction. However, the hypoalgesic effect was of similar magnitude in the OLP and OLP + OBL groups, which indicates that observation did not contribute to the effect. The results showed that reinforcing the open-label placebo by observational learning may be redundant, but more research is needed to confirm these findings.
Topics: Humans; Male; Female; Placebo Effect; Adult; Young Adult; Pain Measurement; Pain Threshold; Learning; Adolescent; Pain; Placebos
PubMed: 38227574
DOI: 10.1097/j.pain.0000000000003161 -
Nature Communications Mar 2021The brain systems underlying placebo analgesia are insufficiently understood. Here we performed a systematic, participant-level meta-analysis of experimental functional... (Meta-Analysis)
Meta-Analysis
The brain systems underlying placebo analgesia are insufficiently understood. Here we performed a systematic, participant-level meta-analysis of experimental functional neuroimaging studies of evoked pain under stimulus-intensity-matched placebo and control conditions, encompassing 603 healthy participants from 20 (out of 28 eligible) studies. We find that placebo vs. control treatments induce small, widespread reductions in pain-related activity, particularly in regions belonging to ventral attention (including mid-insula) and somatomotor networks (including posterior insula). Behavioral placebo analgesia correlates with reduced pain-related activity in these networks and the thalamus, habenula, mid-cingulate, and supplementary motor area. Placebo-associated activity increases occur mainly in frontoparietal regions, with high between-study heterogeneity. We conclude that placebo treatments affect pain-related activity in multiple brain areas, which may reflect changes in nociception and/or other affective and decision-making processes surrounding pain. Between-study heterogeneity suggests that placebo analgesia is a multi-faceted phenomenon involving multiple cerebral mechanisms that differ across studies.
Topics: Adult; Analgesia; Behavior; Brain; Female; Humans; Image Enhancement; Magnetic Resonance Imaging; Male; Nervous System; Pain; Placebos
PubMed: 33654105
DOI: 10.1038/s41467-021-21179-3 -
Deutsches Arzteblatt International Nov 2021Total thyroidectomy is the most common surgical treatment of thyroid diseases, and postoperative hypocalcemia is its most common complication. Hypocalcemia prolongs the... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Total thyroidectomy is the most common surgical treatment of thyroid diseases, and postoperative hypocalcemia is its most common complication. Hypocalcemia prolongs the patient's hospital stay and impairs his or her quality of life. Although a low vitamin D level is a recognized risk factor, the utility of preoperative vitamin D administration to prevent postoperative hypocalcemia is unclear. In this trial, therefore, we studied the effect of giving vitamin D before total thyroidectomy.
METHODS
In a multicenter, randomized, minimally interventional trial (registration number: DRKS 00005615), patients about to undergo total thyroidectomy were randomized either to an intervention group that received 0.5 μg of calcitriol per os twice daily for three days up to the day immediately before surgery, or to a control group that did not (no placebo was given). The primary endpoint was the absence of hypocalcemia (serum calcium <2.1 mmol/L) in the postoperative course.
RESULTS
Of the 287 patients recruited in six hospitals over the period 23 July 2014 to 20 March 2017, 246 were included in the final analysis. The intervention and control groups did not differ significantly with respect to the rate of postoperative hypocalcemia (29.2% and 33.6%, respectively; p = 0.546, power 8.8%). The duration of postoperative hypocalcemia was, however, shorter in the intervention group (3.5 vs. 7 days; p = 0.016, power 68%). The rates of hypocalcemia in the individual trial locations varied widely, ranging from 13.9% to 71.4%.
CONCLUSION
Short-term administration of calcitriol did not affect the rate of occurrence of hypocalcemia after thyroidectomy, but did shorten its duration. The rate of postoperative hypocalcemia varied widely across hospitals, probably because of differences in surgical technique.
Topics: Calcitriol; Calcium; Female; Humans; Hypocalcemia; Male; Postoperative Complications; Quality of Life; Thyroidectomy
PubMed: 34702443
DOI: 10.3238/arztebl.m2021.0351 -
Human Vaccines & Immunotherapeutics Jul 2021Rotavirus infections, prevalent in human populations, are caused mostly by group A viruses. Immunization against rotaviruses in infancy is currently the most effective... (Randomized Controlled Trial)
Randomized Controlled Trial
Rotavirus infections, prevalent in human populations, are caused mostly by group A viruses. Immunization against rotaviruses in infancy is currently the most effective and economical strategy to prevent rotavirus infection. This study evaluated the safety of a novel hexavalent rotavirus vaccine and analyzed its dose and immunogenicity. This randomized, double-blinded, placebo-controlled phase I clinical trial enrolled healthy adults, toddlers, and infants in Zhengding County, Hebei Province, northern China. 40 adults and 40 children were assigned in a 2:1:1 ratio to receive one vaccine dose, placebo 1, and placebo 2, respectively. 120 6-12 week old infants were assigned equivalently into 3 groups. The infants in each group were assigned in a 2:1:1 ratio to receive three doses of vaccine, placebo 1, and placebo 2, at a 28-day interval. Adverse events (AEs) until 28 days after each dose and serious adverse events (SAEs) until 6 months after the third dose were reported. Virus shedding until 14 days after each dose in infants was tested. Geometric mean concentrations (GMCs) and seroconversion rates were measured for anti-rotavirus IgA by using an enzyme-linked immunosorbent assay (ELISA). The solicited and unsolicited AE frequencies and laboratory indexes were similar among the treatment groups. No vaccine-related SAEs were reported. The average percentage of rotavirus vaccine shedding in the infant vaccine groups was 5.00%. The post-3rd dose anti-rotavirus IgA antibody geometric mean concentrations (GMC) and seroconversion rate were higher in the vaccine groups than in the placebo groups. The novel oral hexavalent rotavirus vaccine was generally well-tolerated in all adults, toddlers and infants, and the vaccine was immunogenic in infants.
Topics: Adult; Antibodies, Viral; China; Double-Blind Method; Humans; Immunogenicity, Vaccine; Infant; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; Vaccines, Attenuated; Vaccines, Combined
PubMed: 33545015
DOI: 10.1080/21645515.2020.1861874