A trial of sepia 200

1995 ◽  
Vol 84 (01) ◽  
pp. 14-20 ◽  
Author(s):  
A.V. Williamson ◽  
W.J. Crawford ◽  
B. Rennie ◽  
W.L. Mackie
Keyword(s):  
Reproductive Performance ◽  
Disease Risk ◽  
Controlled Trial ◽  
Mean Value ◽  
Post Treatment ◽  
Placebo Control ◽  
Control Groups ◽  
Placebo Controls ◽  
Group Data ◽  
The Difference

AbstractThe effect of Sepia 200c on the reproductive performance of Friesian cross dairy cows was assessed in a controlled trial from September 1989 until August 1990. Overall reproductive performance was monitored monthly and pregnancy diagnosis and cyclical status was determined. The cows were randomly allocated to 4 groups, untreated controls, placebo controls, Sepia-treated 24 to 48 hours postpartum and Sepia-teated day 14 postpartum.The trial was concluded in July 1990 when another treatment was employed to reduce declining herd reproductive status. Statistical analysis of the results was based on differences between the placebo control and the Sepia-treated, 24–48 hours postpartum, the pooled control groups and placebo control with Sepia day 14, and lastly the difference between the 2 Sepia-treated groups.The highest rates of periparturient disease occurred in the Sepia-treated groups, the highest single incidence rate of periparturient disease risk (cysts) found in the cows in the Sepia 24 to 48 hours postpartum group. Sepia day 14 produced the largest percentage of cows seen in first oestrus (45%), the largest number of observed heats (60%) in the cows without periparturient disease risk factors or recurrent traits and the lowest total mean value days to oestrus post-treatment.Sepia day 14 produced the largest percentage that held to first service, the lowest post-treatment period to first service, calving to conception interval, mean number of services and rectal examinations per conception, mean day calving interval and calving index. The results show that the effect of Sepia 200c administered to cows two weeks postpartum increased the numbers of cows observed in first oestrus, held to first service and lowered the calving to conception interval and calving index. The results of the Sepia day 14 postpartum group were also found to be compatible with the same group data reported in the previous study.

Auditory and Visual Executive Functions in Children and Response to Methylphenidate: A Randomized Controlled Trial

2017 ◽  
Vol 24 (2) ◽  
pp. 235-245
Author(s):  
Yaffa Hadar ◽  
Shraga Hocherman ◽  
Oren Lamm ◽  
Emanuel Tirosh
Keyword(s):  
Executive Functions ◽  
Visual Cues ◽  
Controlled Trial ◽  
Crossover Design ◽  
Control Groups ◽  
Children With Adhd ◽  
Randomized Controlled ◽  
The Difference ◽  
Visually Based ◽  
And Control

Objectives: The aim of the study was to assess auditory and visually based executive functions (EFs) and the effect of methylphenidate (MPH) in children with ADHD. Methods: Thirty-six boys between the ages of 8.3 and 9.7 years with ADHD and 36 matched controls were included. The study group was randomized into MPH and placebo for 7 days each in a crossover design. A Cued Choice Reaction Time (CCRT) test that included incongruent cuing was administered at baseline and following 1 and 2 weeks. Results: The difference between the study and control groups was more evident with visual cues and incongruent cuing. Increased gains by children with predominantly hyperactive–impulsive\combined (HI\C) type of ADHD were observed under MPH. Conclusions: The differences between children with ADHD and typical children are more pronounce under incongruent auditory cuing . The gains attributable to MPH are more specific to tasks involving auditory and visual EFs and in children with HI\C type ADHDs.

scholarly journals Evidence first, practice second in arthroscopic surgery: use of placebo surgery in randomised controlled trial

2019 ◽  
Vol 45 (12) ◽  
pp. 757-760
Author(s):  
Kazuha Kizaki ◽  
Lisa J Schwartz ◽  
Olufemi R Ayeni
Keyword(s):  
Controlled Trial ◽  
Arthroscopic Surgery ◽  
Pain Syndrome ◽  
Placebo Control ◽  
Placebo Controls ◽  
Study Results ◽  
Unnecessary Procedures ◽  
Randomised Controlled ◽  
Arthroscopic Subacromial Decompression ◽  
Based Medicine

The application of evidence-based medicine helps clinicians avoid unnecessary procedures and decreases unnecessary harm for future patients while sparing economic burdens. Randomised controlled trials (RCTs) most accurately produce best research evidence. In arthroscopic surgery, however, many procedures have been extensively used without supportive evidence verified with RCTs. In this paper, we introduce two procedures (arthroscopic partial menisectomy for degenerative knees and arthroscopic subacromial decompression for subacromial pain syndrome), where over 30 years of procedure usage has continued prior to garnering evidence for the inefficacy of the procedures. The situations are attributed to the fact that clinical trials in arthroscopic surgeries are challenging given the use of placebo controls. A placebo-control RCT can accurately answer research questions about efficacy and safety of surgical procedures; however, the majority of arthroscopic surgeries in practice have not been rigorously tested against placebo surgeries. This is because preparing surgical placebo controls, known as sham surgeries, are ethically controversial. Also considering that high-quality study results often do not change clinical practice due to insufficient knowledge translation, the benefits of such trials may be uncertain to society at large. Additionally, there are a lack of clear guidelines for conducting arthroscopic placebo surgeries in RCTs. We hope that this article helps drive discussion about appropriate use of placebo surgeries in RCTs to produce the best quality evidence in arthroscopic surgery.

Effectiveness of Mobile Phone-Based Support on Exclusive Breastfeeding and Infant Growth in Nigeria: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Daprim S Ogaji ◽  
Adaku O Arthur ◽  
Innocent George
Keyword(s):  
Randomized Controlled Trial ◽  
Mobile Phone ◽  
Usual Care ◽  
Exclusive Breastfeeding ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
The Difference ◽  
And Control

Abstract Background This study examined whether mobile phone-based support improve the rates, duration of exclusive breastfeeding (EBF) as well as infant growth patterns in Nigeria. Methods A 6-month prospective randomized controlled trial with 75 participants assigned to receive ‘usual care’ or ‘mobile phone-based support in addition to usual care’ EBF rates and duration as well as anthropometric measurements of infants before and after intervention were compared using proportions and mean differences. Results Attrition rates of 10.7% and 14.7% were observed in the intervention and control groups, respectively. Treatment groups were identical in all baseline characteristics and participants in the intervention group showed a slower rate of decline in the practice of EBF. The mean difference of 0.6 months (95% confidence interval: −0.22, 1.42) in EBF duration between intervention and control groups was not statistically significant (t = 1.45; p = 0.149). Similarly, the difference in the EBF rates at the 6th month for the intervention (55.2%) and control (46.8%) groups was not statistically significant (χ2 = 0.623; p = 0.430). Although the intervention group had significantly higher mean weight (p = 0.030) and length (p = 0.044) at the 6th month, the difference in the gain in weight and length of these infants over the period was only significant for the weight (p = 0.044). Although the incidence of adverse clinical nutritional status was more in the control group, these differences were not statistically significant. Conclusion Mobile phone-based intervention has positive effects on the rate and duration of EBF as well as the growth of young infants. Sustaining this simple and cheap technology will improve infant wellbeing especially in resource-constrained settings.

scholarly journals Placebo control in Covid-19 trials: A missed opportunity for international guidance

2021 ◽  
pp. 01-04
Author(s):  
Urban Wiesing ◽  
Hans-Jörg Ehni
Keyword(s):  
Biomedical Research ◽  
Ethical Dilemmas ◽  
Placebo Control ◽  
Vaccine Research ◽  
Ethical Conflict ◽  
Control Groups ◽  
Global Regulation ◽  
Placebo Controls ◽  
New System ◽  
Missed Opportunity

Vaccines preventing Covid-19 have been approved in several countries. Is it still ethically acceptable to use placebo controls during the development of other vaccine options? If two of the most influential international guidelines of biomedical research are consulted, the Declaration of Helsinki and the CIOMS-guidelines, the answer is “no”. We discuss the implications for ongoing vaccine research, and how placebo controls might be justified nevertheless. However, the ethical conflict remains highly problematic. We suggest that such ethical dilemmas should be avoided in the future by the introduction of a new system of global governance. Once vaccines are approved, a global regulation should oblige producers to provide the necessary amount of vaccine doses for the control groups of ongoing vaccine research.

scholarly journals Randomized trials of invasive cardiovascular interventions that include a placebo control: a systematic review and meta-analysis

2020 ◽  
Vol 41 (27) ◽  
pp. 2556-2569 ◽  
Author(s):  
Lucas Lauder ◽  
Bruno R da Costa ◽  
Sebastian Ewen ◽  
Sean S Scholz ◽  
William Wijns ◽  
...  
Keyword(s):  
Active Treatment ◽  
Treatment Effect ◽  
Meta Analysis ◽  
Additional Treatment ◽  
Placebo Control ◽  
Placebo Controls ◽  
The Difference ◽  
Mean Differences ◽  
Cardiovascular Interventions ◽  
Dichotomous Outcomes

Abstract Aims The difference in the benefit of invasive cardiovascular interventions compared with placebo controls has not been analysed systematically. Methods and results MEDLINE and Web of Science were searched through 29 March 2020. Randomized, placebo-controlled trials of invasive cardiovascular interventions (including catheter-based interventions and pacemaker-like devices) investigating predefined primary outcomes were included. Standardized mean differences (SMD) and odds ratios were calculated for continuous and dichotomous outcomes, respectively. Meta-regression analyses were performed to assess whether estimates of treatment effects were associated with methodological characteristics of trials. Thirty trials, including 4102 patients, were analysed. The overall risk of bias was judged to be low in only 43% of the trials. Ten trials (33%) demonstrated statistically significant superiority of invasive interventions over placebo controls for the respective predefined primary outcomes. In almost half of the 16 trials investigating continuous predefined primary outcomes, the SMD between the active and placebo procedure indicated a small (n = 4) to moderate (n = 3) treatment effect of active treatment over placebo. In contrast, one trial indicated a small treatment effect in favour of the placebo procedure. In the remaining trials, there was no relevant treatment effect of active treatment over placebo. In trials with a protocol-mandated stable and symmetrical use of co-interventions, the superiority of active procedures vs. invasive placebo procedures was significantly larger as compared with trials with frequent or unbalanced changes in co-interventions (P for interaction 0.027). Conclusions The additional treatment effect of invasive cardiovascular interventions compared with placebo controls was small in most trials.

Effects of Minimal Acupuncture in Children with Infantile Colic – a Prospective, Quasi-Randomised Single Blind Controlled Trial

2008 ◽  
Vol 26 (3) ◽  
pp. 171-182 ◽  
Author(s):  
Marianne Reinthal ◽  
Sven Andersson ◽  
Marianne Gustafsson ◽  
Kaety Plos ◽  
Iréne Lund ◽  
...  
Keyword(s):  
Side Effects ◽  
Rating Scale ◽  
Controlled Trial ◽  
Numeric Rating Scale ◽  
Post Treatment ◽  
Control Group ◽  
Seek Health Care ◽  
Parental Assessment ◽  
The Difference ◽  
Pre Treatment

Background Colic causes crying in 10–30% of infants and is one of the primary reasons parents seek health care. Treatments are generally not totally effective and some cause side effects. In this study we aimed to test the effect of light needling (minimal acupuncture) on crying. Methods Forty children (median six weeks of age) with excessive crying unresponsive to conventional therapies, were recruited from 21 Child Welfare Clinics within an area of western Sweden, and quasi-randomised to control or light needling treatment. Parents were unaware of which group their child was assigned to. Children were given light needling acupuncture on one point (LI4) on both hands for approximately 20 seconds on four occasions, or received the same care except needling. Parental assessment questionnaires were used pre- and post-treatment to assess crying intensity, frequency, duration of crying and pain related behaviour throughout the day in six hour periods. Results Light needling resulted in a significant reduction in the rated crying intensity (assessed by a numeric rating scale, 0 to 10). For example, during the morning time period 0600–1200 hours, the median (range) rated crying intensity changed from 6 (1 to 9) pre-treatment to 2 (0 to 5) post-treatment (P=0.002), in the light needling group. The corresponding ratings for the children in the control group was 6 (0 to 10) and 5 (0 to 10) respectively. The difference between the groups was significant (P=0.016). There were also significant differences between the groups for the afternoon (1200–1800 hours), and evening (1800–midnight) time periods. Pain related behaviour like facial expression, was also significantly less pronounced in the light needling group as compared to the control group post-treatment, (P=0.027). The parents rated the light needling as more effective in improving symptoms than the control group (P<0.001). Conclusion Four treatments with light needling on one point in the hand may alleviate crying and pain related behaviour without any noted side effects.

scholarly journals Effect of repetitive transcranial magnetic stimulation on patients with severe depression: a study protocol for systematic review and meta-analysis of randomised clinical trials

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050098
Author(s):  
Fang Han ◽  
Shuai Tao ◽  
Shanshan Liang ◽  
Danyang Li ◽  
Yutong Me ◽  
...  
Keyword(s):  
Systematic Review ◽  
Depressive Symptoms ◽  
Transcranial Magnetic Stimulation ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Trial ◽  
Severe Depression ◽  
Post Treatment ◽  
Cochrane Library ◽  
The Difference

IntroductionDepression is characterised by easy recurrence, high disability and high burden, and antidepressant therapy is the standard treatment. However, its treatment effect on patients with severe depressive disorder has been unsatisfactory. Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS), as a neurotherapy, can effectively mitigate the severity of depressive symptoms. Yet, more evidence is still required for TMS to treat severe depression. This study will be the first systematic review of the efficacy and tolerability of TMS for treating severe depression. We expect it to guide future clinical practice of TMS for the treatment of psychiatric disorders.Methods and analysisWe will search for the randomised controlled trial (RCT) involving rTMS for treating depression in eight electronic databases, including PubMed, Web of Science, EMBASE, the Cochrane Library and Wanfang Database, from publication up to September 2021. We will define Improvement in depressive symptoms, the difference between pretreatment (baseline) and post-treatment as the primary outcomes. The difference between pretreatment and post-treatment changes in resting state fMRI will be regarded as the secondary outcomes. Quality assessment of the included articles will be independently performed according to the Cochrane Risk of Bias tool.Ethics and disseminationEthical approval is not essential because there is no need to collect individual patient data. And this study will be published in a peer-reviewed journal.Trial registration numberCRD42020211460.

scholarly journals Effectiveness of cognitive–behavioural family intervention in reducing the burden of care in carers of patients with Alzheimer's disease

2000 ◽  
Vol 176 (6) ◽  
pp. 557-562 ◽  
Author(s):  
Alison Marriott ◽  
Catherine Donaldson ◽  
Nicholas Tarrier ◽  
Alistair Burns
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Positive Impact ◽  
Controlled Trial ◽  
Intervention Group ◽  
Family Intervention ◽  
Post Treatment ◽  
Burden Of Care ◽  
Control Groups

BackgroundThe majority of patients with Alzheimer's disease live outside institutions and there is considerable serious psychological morbidity among their carers.AimsTo evaluate whether family intervention reduces the subjective burden of care in carers of patients with Alzheimer's disease and produces clinical benefits in the patients.MethodA prospective single-blind randomised controlled trial with three-month follow-up in which the experimental group received family intervention and was compared with two control groups.ResultsThere were significant reductions in distress and depression in the intervention group compared with control groups at post-treatment and follow-up. There were significant reductions in behavioural disturbance at post-treatment and an increase in activities at three months in patients in the intervention group. Based on an improvement on the General Health Questionnaire resulting in a carer converting from a case to a non-case, the number to treat was three immediately post-treatment and two at follow-up.ConclusionsFamily intervention can have significant benefits in carers of patients with Alzheimer's disease and has a positive impact on patient behaviour.

scholarly journals Evaluation of the Stomatognathic System before and after Osteopathic Manipulative Treatment in 120 Healthy People by Using Surface Electromyography

2020 ◽  
Vol 17 (9) ◽  
pp. 3250 ◽  
Author(s):  
Andrea Manzotti ◽  
Chiara Viganoni ◽  
Dorina Lauritano ◽  
Silvia Bernasconi ◽  
Alice Paparo ◽  
...  
Keyword(s):  
Surface Electromyography ◽  
Muscular Activity ◽  
Placebo Treatment ◽  
Masticatory Muscles ◽  
Mean Value ◽  
Control Group ◽  
Placebo Control ◽  
Osteopathic Manipulative Treatment ◽  
Control Groups ◽  
Stomatognathic System

Objective: To investigate the action of osteopathic manipulative treatment on the muscular activity of the stomatognathic apparatus by using surface electromyography (sEMG). Material and Methods: Surface electromyography (sEMG) was performed on the masseter and anterior temporalis muscles of 120 subjects (73 F; 47 M), both at time T0 and T2. The sample was divided into three randomized groups of 40 subjects each: control, placebo, and osteopathic manipulative treatment (OMT). In the T1 interval between the two evaluations, the control group was not treated, the placebo group underwent a placebo treatment, and the OMT group underwent manipulative treatment. The mean value of each measurement and its coefficient of variation, between time T0 and T2, were calculated for both the intragroup (OMT, placebo, control) and the intergroup (OMT-placebo, OMT-control). Outcomes: In 40% of the subjects, statistically significant improvements were highlighted in the OMT. Whereas, the statistically significant results of the placebo and control groups were 7.5% and 17.5%, respectively, of which more than 75% moved away from the physiological range, showing a worsening of the muscular activity. This analysis showed statistically significant variations (p ≤ 0.05) in the OMT group compared to the placebo and the control groups. Conclusions: OMT determines variations of the activity of masticatory muscles.

Relationship between total plasma homocysteine and the risk of aneurysms – a meta-analysis

VASA ◽  
2020 ◽  
pp. 1-6
Author(s):  
Hanji Zhang ◽  
Dexin Yin ◽  
Yue Zhao ◽  
Yezhou Li ◽  
Dejiang Yao ◽  
...  
Keyword(s):  
Large Scale ◽  
Meta Analysis ◽  
Single Species ◽  
Total Plasma ◽  
Control Groups ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
The Difference ◽  
The Relationship ◽  
Healthy Participants

Summary: Our meta-analysis focused on the relationship between homocysteine (Hcy) level and the incidence of aneurysms and looked at the relationship between smoking, hypertension and aneurysms. A systematic literature search of Pubmed, Web of Science, and Embase databases (up to March 31, 2020) resulted in the identification of 19 studies, including 2,629 aneurysm patients and 6,497 healthy participants. Combined analysis of the included studies showed that number of smoking, hypertension and hyperhomocysteinemia (HHcy) in aneurysm patients was higher than that in the control groups, and the total plasma Hcy level in aneurysm patients was also higher. These findings suggest that smoking, hypertension and HHcy may be risk factors for the development and progression of aneurysms. Although the heterogeneity of meta-analysis was significant, it was found that the heterogeneity might come from the difference between race and disease species through subgroup analysis. Large-scale randomized controlled studies of single species and single disease species are needed in the future to supplement the accuracy of the results.

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