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

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.

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Use of a placebo in clinical trials

European Psychiatry ◽

10.1016/s0924-9338(98)80031-x ◽

1998 ◽

Vol 13 (5) ◽

pp. 254-263 ◽

Cited By ~ 2

Author(s):

G Emilien ◽

JM Maloteaux ◽

A Seghers ◽

G Charles

Keyword(s):

Clinical Trials ◽

Placebo Response ◽

Drug Efficacy ◽

Placebo Treatment ◽

High Response Rate ◽

Experimental Methodology ◽

Necessary Condition ◽

Control Group ◽

Placebo Control ◽

Experimental Drug

SummaryThe use of a placebo control group in the evaluation of a new product is today considered by most as a necessary condition of experimental drug research. Placebo response is an essential consideration in all clinical trials. If not properly controlled, incorrect and dangerous conclusion may be inferred for a product efficacy and safety profile. However, the inclusion of a placebo group in clinical trials in neuropsychiatric research raises several ethical and scientific questions. Whereas in certain indications, such as suicidal patients and severe and psychotic depression, the use of a placebo is generally not accepted, it is difficult to assess drug efficacy. This article discusses the concept of placebo in clinical trials, the occurrence of adverse events after placebo treatment and the high response rate of placebo in neuropsychiatric clinical research. The experimental methodology to adequately control all the factors involved is also analysed and discussed.

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The Effect of Ant Plant on the Increase of CD4 Count in PLHIV in the Papua Province

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2021.7782 ◽

2021 ◽

Vol 9 (A) ◽

pp. 1231-1239

Author(s):

Arwam Hermanus Markus Zeth ◽

Nouvy Helda Warouw ◽

Paula Krisanty

Keyword(s):

Viral Load ◽

Experimental Design ◽

Intervention Group ◽

Placebo Treatment ◽

Daily Basis ◽

Cd4 Count ◽

Control Group ◽

Control Groups ◽

Randomized Control ◽

And Control

The ant plant (Myrmecodia pendans), an epiphyte of Hydnophytinae (Rubiceae), has long been used for traditional medication. This research aimed to examine the effect of ant plant on the increase of CD4 count in PLHIV in Papua Province and to identify the effect of ant plan supplementation on the increase of CD4 in PLHIV. The research used true experimental design with modified randomized control group pretest-posttest design. The pretest was performed by conducting a preliminary count of CD4 in both the intervention and control groups, to which ART has been administered. The intervention group was supplemented with the ant plant on a daily basis, while the control group was given a placebo treatment with tea. Based on the results, it can be concluded that PLHIV given ant plant supplementation may have a higher increase in their CD4 count after receiving an intervention for one month than those who only received ART. Further research is needed to investigate the effect of the ant plant on the viral load in PLHIV.

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Early COVID-19 Therapy with Azithromycin Plus Nitazoxanide, Ivermectin or Hydroxychloroquine in Outpatient Settings Significantly Reduced Symptoms Compared to Known Outcomes in Untreated Patients.

10.21203/rs.3.rs-100994/v1 ◽

2020 ◽

Author(s):

Flavio A. Cadegiani ◽

Andy Goren ◽

Carlos G. Wambier ◽

John McCoy

Keyword(s):

Safety Profile ◽

Randomized Clinical Trials ◽

Clinical Symptoms ◽

Early Stage ◽

Control Group ◽

Placebo Control ◽

Control Groups ◽

Persistent Symptoms ◽

Number Of Patients ◽

Outpatient Settings

Abstract Background: While there was a lack of pharmacological interventions proven to be effective in early, outpatient settings for COVID-19, in a prospective, open-label observational study (pre-AndroCoV Trial) the use of nitazoxanide, ivermectin and hydroxychloroquine demonstrated similar effects, and apparent improvement of outcomes compared to untreated patients. The unexpected apparent positive results led to ethical questions on the employment of further full placebo-control studies in early stage COVID-19. The objective of the present study was to elucidate whether the conduction of a full placebo-control RCT was still ethically viable, through a comparative analysis with two control-groups.Materials and methods: Active group (AG) consisted of mild-to-moderate early stage COVID-19 patients enrolled in the Pre AndroCoV-Trial, treated with nitazoxanide ivermectin, or hydroxychloroquine in selected cases, in association with azithromycin. Vitamin D, vitamin C, zinc, glucocorticoids and anticoagulants, when clinically recommended. Control Group 1 (CG1) consisted of a retrospectively obtained group of untreated patients from the same population as those from the Pre-AndroCoV Trial, and Control Group 2 (CG2) resulted from a precise prediction of clinical outcomes, based on a thorough and structured review of articles indexed in PubMed and MEDLINE and statements by official government agencies and specific medical societies. For both CGs, patients were matched for proportion between sex, age, obesity and other comorbidities. Results: Compared to CG1 and CG2, AG showed a reduction of 31.5 to 36.5% in viral shedding (p < 0.0001), 70 to 85% and 70 to 73% in duration of COVID-19 clinical symptoms when including and not including anosmia and ageusia, respectively ((p < 0.0001 for both), and 100% in respiratory complications through the parameters of the Brescia COVID-19 Respiratory Scale (p < 0.0001). For every 1,000 confirmed cases for COVID-19, a minimum of 140 patients were prevented from hospitalization (p < 0.0001), 50 from mechanical ventilation, and five deaths, when comparing to age-, sex- and comorbidity-matched non-treated patients with similar initial disease severity at the moment of diagnosis.Conclusion: Apparent benefits of the combination between early detection and early pharmacological approaches for COVID-19 demonstrated to be consistent when when compared to different control groups of untreated patients. The potential benefits could allow a large number of patients prevented from hospitalizations, deaths and persistent symptoms after COVID-19 remission. The potential impact on COVID-19 disease course and numbers of negative outcomes and the well-established safety profile of the drugs proposed by the Pre-AndroCoV Trial led to ethical questions regarding the conduction of further placebo control randomized clinical trials (RCTs) for early COVID-19. Early pharmacological approaches including azithromycin in combination with any of the options between nitazoxanide, ivermectin or optionally hydroxychloroquine should be considered for those diagnosed with COVID-19 presenting less than seven days of symptoms. Of the three drugs, we opted for nitazoxanide, due to more extensive demonstration of in vitro and in vivoantiviral activity, proven efficacy against other viruses in humans, and steadier safety profile.

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Letter to the Editor

PEDIATRICS ◽

10.1542/peds.93.5.871 ◽

1994 ◽

Vol 93 (5) ◽

pp. 871-871

Author(s):

Mary C. Theroux ◽

David West

Keyword(s):

Heart Rate ◽

Placebo Group ◽

Multiple Comparisons ◽

Control Group ◽

Placebo Control ◽

Maximum Heart Rate ◽

Control Groups ◽

Placebo Control Group ◽

Objective Outcome ◽

Mean Heart Rate

We thank Drs Lopez and Urbansky for their comments. Their observation that the placebo group may have sufficiently biased the combined placebo/control group to account for the significant findings noted is reasonable, despite no significant differences being found between the placebo group and the control group. Analysis of variance among the three groups was carried out for the objective outcome variables. Differences in mean heart rate changes and maximum heart rate changes remained significant, and differences between study versus control groups and study versus placebo groups were both found to be significant, accounting for multiple comparisons.

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Treatment effect of selexipag on time to disease progression when initiated early in pulmonary arterial hypertension (PAH) patients: GRIPHON and TRITON pooled analysis

European Heart Journal ◽

10.1093/eurheartj/ehab724.1964 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

G J Coghlan ◽

S Gaine ◽

R N Channick ◽

K M Chin ◽

C Du Roure ◽

...

Keyword(s):

Disease Progression ◽

Oral Therapy ◽

Group Versus ◽

Pooled Analysis ◽

Control Group ◽

Placebo Control ◽

Control Groups ◽

Risk Of Disease ◽

And Control ◽

The Impact

Abstract Background In PAH clinical practice, drugs targeting the prostacyclin pathway, including the oral prostacyclin receptor agonist selexipag, are often initiated years after diagnosis. The GRIPHON (NCT01106014) and TRITON (NCT02558231) randomised controlled trials examined the impact of selexipag on disease progression, primary and secondary endpoints, respectively. In GRIPHON, selexipag significantly reduced the risk of disease progression (composite primary endpoint) in a PAH population (N=1156) with a mean time from diagnosis of 2.4 years, as part of an oral triple, double or monotherapy regimen versus placebo. In TRITON, a potential signal for reduced risk of disease progression was observed with initial triple oral therapy (selexipag, macitentan, tadalafil) versus initial double oral therapy (placebo, macitentan, tadalafil) in a population of 247 newly diagnosed, treatment naïve patients. Purpose To investigate the impact of initiating selexipag within 6 months of diagnosis on disease progression in a large PAH population. Methods We selected patients from GRIPHON and TRITON diagnosed within 6 months of randomization and compared those on active therapy with selexipag (selexipag group) versus those on control therapy with placebo (control group). Disease progression endpoints were defined as in the GRIPHON and TRITON studies, respectively. Hazard ratios (HR) and 95% CI for time to first disease progression event up to end of double-blind treatment (selexipag/placebo) + 7 days were estimated using a Cox regression model which included treatment as a factor, and baseline prognostic factors and study as covariates. Results Overall, 649 patients met the criteria (diagnosis ≤6 months) for these analyses: 329 in the selexipag group (207 from GRIPHON and 122 from TRITON) and 320 in the control group (197 from GRIPHON and 123 from TRITON). Patient characteristics at baseline and treatment regimens were balanced between the treatment groups. With respect to treatment regimen, selexipag/placebo was given as part of triple therapy in 44%, double therapy in 32% and monotherapy in 24% of patients. The median (range) exposure to study treatment was 510 (4–1280) and 409 (3–1318) days in the selexipag and control groups, respectively. There were 67 (20%) and 116 (36%) patients who experienced a disease progression event in the selexipag and control groups, respectively. Selexipag reduced the risk of disease progression (first event) by 52% compared to control (HR 0.48 [95% CI 0.35, 0.66]) (Figure). Conclusions This post-hoc pooled analysis of GRIPHON and TRITON patients diagnosed within 6 months suggests that targeting the prostacylin pathway with selexipag within a short time after diagnosis may reduce the risk of disease progression in a broad PAH population. FUNDunding Acknowledgement Type of funding sources: Other. Main funding source(s): Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson

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Efficacy of a novel topical combination of esafoxolaner, eprinomectin and praziquantel against Echinococcus multilocularis infections in cats

Parasite ◽

10.1051/parasite/2021025 ◽

2021 ◽

Vol 28 ◽

pp. 29

Author(s):

Joe Prullage ◽

Dwight Bowman ◽

Michael Ulrich ◽

Eric Tielemans

Keyword(s):

Echinococcus Multilocularis ◽

Experimental Studies ◽

The United States ◽

Treated Group ◽

Control Group ◽

Placebo Control ◽

The Novel ◽

Control Groups ◽

Geometric Means ◽

Placebo Control Group

NexGard® Combo, a novel topical endectoparasiticide formulation for cats combining esafoxolaner, eprinomectin and praziquantel, for the treatment of internal and external parasite infestations, including arthropods, nematodes and cestodes, was tested for efficacy against induced infections of Echinococcus multilocularis in cats, in two experimental studies. The two studies were performed in the United States with the same E. multilocularis isolate sourced locally. In each study, 20 cats were inoculated intra-gastrically with ~30,000 E. multilocularis protoscoleces three weeks before treatment, then ten cats were randomly allocated to a placebo control group or to the novel formulation treated group. Inoculated cats were treated topically once at the minimum recommended dose of the novel formulation, or with an identical volume of placebo. One week after treatment, cats were humanely euthanized for parasite recovery and count. The efficacy calculation was based on comparison of number of scoleces found in the control group and the novel formulation group. In the two control groups, E. multilocularis scoleces were found in five (range: 30–1025) and eight (range 2–345) cats, the geometric means inclusive of the ten cats per group were 8.9 and 28.8, respectively. In the two novel formulation-treated groups, none of the cats harbored any E. multilocularis scoleces, demonstrating 100% efficacy.

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Evaluation of a neuromotor ability of the tongue in patients at the developmental age using a stereognostic examination

Forum Ortodontyczne ◽

10.5604/01.3001.0010.8770 ◽

2017 ◽

Vol 13 (4) ◽

pp. 267-282

Author(s):

Sandra Osiewacz ◽

Adrian Strzecki ◽

Joanna Szczepańska ◽

Elżbieta Pawłowska

Keyword(s):

Speech Therapy ◽

Visual Assessment ◽

Control Group ◽

Differential Analysis ◽

Control Groups ◽

Stomatognathic System ◽

Developmental Age ◽

Tongue Dysfunction ◽

And Control ◽

Oral Perception

Normal development of physiological functions affects normal maturation of the whole stomatognathic system and articulation. A persistent infantile swallowing pattern is listed as one of factors responsible for malocclusions and speech problems. “Stereognosis” originates from neurology and indicates an ability to recognise objects only by touch. Aim. The aim of the paper was to compare a neuromotor ability of the tongue in patients with a persistent infantile swallowing pattern compared to patients with a mature swallowing pattern. Material and methods. The study included 620 patients aged between 4 and 13 years. All subjects were diagnosed for swallowing dysfunctions with a spatula for speech therapy and a visual assessment when they were swallowing saliva, and then divided into 3 groups: study group (children with malocclusions and tongue dysfunctions) – 290 patients; comparator group (children with malocclusions and without tongue dysfunctions) – 240 patients; control group (children without malocclusions or tongue dysfunctions) – 90 patients. Stereognostic tests were performed according to Koczorowski methods and included recognition of geometrical shapes of silicone moulders using one’s tongue and without vision. Results. A differential analysis was performed and the following factors were included: age, sex and malocclusion. There were statistically significant differences between individual groups namely the study and comparator groups, study and control groups, and between the comparator and control groups. Results obtained indicate that a tongue dysfunction is a factor impairing sensory and motor correlation in patients at the developmental age. Conclusions. Patients with malocclusions complicated by tongue dysfunctions have impaired stereognostic sensation in the oral cavity. Impaired oral perception in patients at the developmental age with an abnormal position and functions of the tongue requires interdisciplinary specialist orthodontic treatment and speech therapy. (Osiewacz S, Strzecki A, Szczepańska J, Pawłowska E. Evaluation of a neuromotor ability of the tongue in patients at the developmental age using a stereognostic examination. Orthod Forum 2017; 13: 267-82).

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MULTICHANNEL s-EMG SYSTEM OF MASTICATORY MUSCLES: DESIGN AND CLINICAL APPLICATION IN DIAGNOSIS OF DYSFUNCTION IN STOMATOGNATHIC SYSTEM

Biomedical Engineering Applications Basis and Communications ◽

10.4015/s1016237215500088 ◽

2015 ◽

Vol 27 (01) ◽

pp. 1550008 ◽

Cited By ~ 1

Author(s):

Hong Kang ◽

Wei Wang ◽

Xin Li ◽

Hongliang Du ◽

Lan Li ◽

...

Keyword(s):

Masticatory Muscles ◽

Acquisition System ◽

Control Group ◽

Signal Acquisition ◽

Graphical Interface ◽

School Students ◽

Time Frequency ◽

Stomatognathic System ◽

System A ◽

Emg Signal

To develop a more convenient electromyography (EMG) signal acquisition system for masticatory muscles (MMs) will have implication for the diagnosis of disease of stomatological system and functional reconstruction in dentistry. This study attempted to design a multi-channel MM surface electromyography (s-EMG) signal acquisition system which has high common mode rejection ratio (CMRR) and preamplifier system. In this system, a USB graphical interface technology on windows operating system was specifically designed and s-EMG data were analyzed by a combination of time domain, frequency domain, time-frequency, several spectral analysis, wavelets and other special algorithms under multi-parameter. Then the EMG data from some patients with stomatological dysfunction in temporomandibular joint (TMJ) clinic and a control group from dental school students were acquired and analyzed. The data indicate that the s-EMG signal acquisition system which has been built is simple and useful in aiding diagnosis and treatment evaluation of temporomandibular disorders.

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A trial of sepia 200

British Homeopathic Journal ◽

10.1016/s0007-0785(05)80713-6 ◽

1995 ◽

Vol 84 (01) ◽

pp. 14-20 ◽

Cited By ~ 4

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.

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PROGNOSTIC INDICES OF PATHOLOGICAL TOOTH WEAR DEVELOPMENT

Wiadomości Lekarskie ◽

10.36740/wlek202007107 ◽

2020 ◽

Vol 73 (7) ◽

pp. 1345-1349

Author(s):

Svetlana A. Pavlenko ◽

Elena V. Pavlenkova ◽

Irina. M. Tkachenko ◽

Alla I. Sidorova ◽

Dmytro M. Korol

Keyword(s):

Research Group ◽

Treatment Plan ◽

Nervous Activity ◽

Young Patients ◽

Muscular Activity ◽

Tooth Wear ◽

Masticatory Muscles ◽

Control Group ◽

Research Groups ◽

Muscle System

The aim: To study possibilities of prognosis of pathological wear of tooth hard tissues development depending on the functional activity of masticatory muscles. Materials and methods: In order to achieve the goal of the study, a survey of patients at the age of 19 to 69 years was conducted for precision of number of persons who have increased tooth wear. During the examination of all patients, three groups were selected: control and two researched ones. Patients in the control group (30 patients between the age of 18 and 60 years old) had an intact dentition without any visible sign of increased tooth wear. The researched groups included 25 patients aged from 18 to 60 years old. The second research group included patients who had increased tooth wear of I-III level. The children of the patients of the II group with or without any sign of increased tooth wear were referred to the third research group. Results: The method of electromyography was performed for the study of peculiarities of the muscular activity of the maxillofacial area of the patients of the control and research groups. In our opinion, all manifestations of increased tooth wear are related to changes in the muscle system, the motor apparatus and the nervous activity of an organism. Conclusions: The study of direct muscular apparatus and related bone system may predict the possibility of developing of an increased tooth wear of young patients in the future and prevent its development, as well as to justify the application of a prevention and treatment plan of the studied pathology.

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