Motion Sifnos: A randomized, double-blind, placebo-controlled study demonstrating the effectiveness of tradipitant in the treatment of motion sickness

AbstractBackgroundNovel therapies are needed for the treatment of motion sickness given the inadequate relief, and bothersome and dangerous adverse effects of currently approved therapies. Neurokinin-1 (NK1) receptor antagonists have the potential to be effective in improving the symptoms of motion sickness, given the involvement of Substance P in nauseogenic and emetic pathways and the expression of NK1 receptors in the gastrointestinal system. Here, we evaluated the efficacy of tradipitant, a novel NK1 receptor antagonist, in preventing motion sickness in variable sea conditions.MethodsA total of 126 adults participated in the Motion Sifnos Study. Groups of participants were assigned to one of seven boat trips lasting approximately four hours on the Pacific Ocean. Participants were randomized 1:1 to tradipitant 170 mg or placebo and completed the Motion Sickness Severity Scale (MSSS) every 30 minutes, in addition to other assessments. Severity of motion sickness was assessed with the incidence of vomiting and the MSSS.ResultsParticipants on tradipitant had a significantly lower incidence of vomiting as compared to those on placebo across all boat trips (tradipitant=17.5%, placebo=39.7%, p=0.0039). For trips exposed to rough sea conditions, the difference in the incidence of vomiting between the groups was more dramatic (tradipitant=15.79%, placebo=72.22%, p=0.0009). Across these trips, motion sickness symptoms were significantly lower in the tradipitant group compared to the placebo group (tradipitant=3.19, placebo=4.57, p=0.0235).DiscussionTradipitant has the potential to be an effective therapy for the prevention of vomiting and treatment of nausea in people with motion sickness.

Download Full-text

A Combination of Lactoplantibacillus plantarum Strains CECT7527, CECT7528 and CECT7529 Plus Monacolin K Reduces Blood Cholesterol: Results from a Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽

10.3390/nu13041206 ◽

2021 ◽

Vol 13 (4) ◽

pp. 1206

Author(s):

Rafael Guerrero-Bonmatty ◽

Guadalupe Gil-Fernández ◽

Francisco José Rodríguez-Velasco ◽

Jordi Espadaler-Mazo

Keyword(s):

Intervention Group ◽

Study Groups ◽

Statin Treatment ◽

Blood Cholesterol ◽

Controlled Study ◽

Controlled Clinical Trial ◽

Red Yeast Rice ◽

Monacolin K ◽

Double Blind ◽

History Of

Background: Dietary supplements have been proposed to help manage blood cholesterol, including red yeast rice (RYR) extracts, plant sterols and stanols, beta-glucans, and some probiotics. This study was conducted to evaluate the efficacy of RYR (containing 10 mg of monacolin K) combined with 109 CFU of three Lactoplantibacillus plantarum strains (CECT7527, CECT7528, and CECT7529). Methods: A 12-week randomized, double-blinded, placebo-controlled clinical trial was conducted. In total, 39 adult patients were enrolled, having total cholesterol (TC) ≥200 mg/dL, and being statin-naïve or having recently stopped statin treatment because of intolerance. Active product or placebo were taken once daily, and subjects were evaluated at baseline, 6, and 12 weeks. Results: Study groups were comparable at baseline, except for history of recent hypercholesterolemia treatment (81% in active vs. 22% in placebo). Changes in LDL cholesterol and TC became significant compared to placebo (mean difference between groups and standard error of the mean = 23.6 ± 1.5 mg/dL, p = 0.023 and 31.4 ± 1.9 mg/dL, p = 0.011, respectively) upon adjusting for the baseline imbalance in hypercholesterolemia treatment. No adverse effects were noted during the study. Conclusion: This combination of 10 mg of monacolin K and L. plantarum strains was well tolerated and achieved a statistically significant greater reduction in LDL-C and TC in the intervention group compared to the placebo, once adjusting for recent history of hypercholesterolemia treatment.

Download Full-text

Evaluating the Effect of Intraoperative Dextrose 10% Administration on Reducing Postoperative Nausea and Vomiting after Laparoscopic Surgery

The Open Anesthesia Journal ◽

10.2174/2589645801913010078 ◽

2019 ◽

Vol 13 (1) ◽

pp. 78-85

Author(s):

Ashraf Nabil Saleh ◽

Dalia Fahmy Emam ◽

Mohamed Mohamed Kamal

Keyword(s):

Laparoscopic Cholecystectomy ◽

Postoperative Nausea ◽

Postoperative Nausea And Vomiting ◽

Study Groups ◽

Primary Objective ◽

Nausea And Vomiting ◽

Controlled Study ◽

Double Blind ◽

Female Patients ◽

Medication Consumption

Background: Although PONV is usually self-limiting or is treated without sequelae, the incidence of PONV could be as high as 70% to 80% in high-risk populations such as female sex, obese patients, age younger than 40 years, nonsmoker patients, history of PONV or motion sickness. Objectives: The study aimed to investigate whether dextrose 10% decreases the incidence of postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy Materials and Methods: This prospective, double-blind randomized placebo-controlled study comprised 130 ASA physical status I and II nonsmoker female patients, 20-40 years of age, scheduled for laparoscopic cholecystectomy at Ain Sham University – Assembled operating theater from August 2018 to October 2018. Patients were arbitrarily divided into two study groups of 65 patients each. Group LR received lactated Ringer’s solution and group D received 10% dextrose. The primary objective of this study was to compare the incidence of PONV in the study treatment groups. The secondary outcomes included measurement of antiemetic medication consumption as well as blood glucose changes between groups. Results: 50 from a total of 65 participants (76.9%) in Lactated Ringer (LR) group experienced nausea. On the other hand, 30 participants only (46.2%) in dextrose (D) group were nauseated. This dissimilarity was statistically highly significant (P= 0.0003). Conclusion: In this study, dextrose 10% administration resulted in improved postoperative emesis management as explained by the lower incidence of nausea and rescue antiemetic consumption.

Download Full-text

A randomized clinical efficacy study targeting mPGES1 or EP4 in dogs with spontaneous osteoarthritis

Science Translational Medicine ◽

10.1126/scitranslmed.aaw9993 ◽

2019 ◽

Vol 11 (516) ◽

pp. eaaw9993

Author(s):

Carol Robertson-Plouch ◽

John R. Stille ◽

Peng Liu ◽

Claire Smith ◽

Dorothy Brown ◽

...

Keyword(s):

Posterior Probability ◽

Brief Pain Inventory ◽

Repeated Measure ◽

Controlled Study ◽

Prostaglandin E ◽

Double Blind ◽

Mixed Effect ◽

Secondary Endpoints ◽

Efficacy Measures ◽

The Difference

Canine studies of spontaneous osteoarthritis (OA) pain add valuable data supporting drug treatment mechanisms that may translate to humans. A multicenter, randomized, double-blind, placebo- and active-controlled study was conducted in client-owned dogs with moderate OA pain to evaluate efficacy of LYA, an inhibitor of microsomal prostaglandin E synthase-1 (mPGES1), an EP4 antagonist (LYB), and carprofen, versus placebo. Of 255 dogs screened, 163 were randomized (placebo/LYA/LYB/carprofen: n = 43/39/42/39) and 158 completed treatment. Efficacy versus placebo was assessed using Bayesian mixed-effect model for repeated measure analyses of the Canine Brief Pain Inventory (CBPI) pain interference score (PIS; primary endpoint), pain severity score, and overall impression, as well as the Liverpool Osteoarthritis in Dogs (LOAD) mobility score. The posterior probability that the difference to placebo was <0 at week 2 was 80% for LYA and 54% for LYB for CBPI PIS (both <95% predefined threshold). For secondary endpoints, the posterior probability that the difference to placebo was <0 at week 2 ranged from 89 to 96% for LYA and from 56 to 89% for LYB. The posterior probabilities comparing carprofen to placebo groups were ≥90% for all efficacy endpoints. The proportion of dogs with one or more adverse event was not significantly different from placebo (32.6%) for LYA (35.9%) or carprofen (25.6%), but the rate for LYB (59.5%) was higher versus placebo (P = 0.017). LYA treatment demonstrated consistent improvement in all efficacy measures, suggesting that inhibition of mPGES1 may be an effective treatment for chronic pain associated with OA.

Download Full-text

Beta alanine supplementation effects on metabolic contribution and swimming performance

Journal of the International Society of Sports Nutrition ◽

10.1186/s12970-020-00365-6 ◽

2020 ◽

Vol 17 (1) ◽

Cited By ~ 1

Author(s):

Matheus Silva Norberto ◽

Ricardo Augusto Barbieri ◽

Danilo Rodrigues Bertucci ◽

Ronaldo Bucken Gobbi ◽

Eduardo Zapaterra Campos ◽

...

Keyword(s):

Repeated Measures ◽

Energy Demand ◽

Swimming Performance ◽

Controlled Study ◽

Double Blind ◽

Repeated Measures Anova ◽

Beta Alanine ◽

Before And After ◽

The Difference ◽

And Performance

Abstract Background Investigations of β-alanine supplementation shows effects on metabolic (aerobic and anaerobic) participation and performance on swimming by a possible blood acidosis buffering. Considering this background, the objective of the present study was to analyze the effects of β-alanine supplementation on metabolic contribution and performance during 400-m swim. Methods Thirteen competitive swimmers underwent a 6-week, double-blind placebo-controlled study, ingesting 4.8 g.day− 1 of β-alanine or placebo. Before and after the supplementation period, the total anaerobic contribution (TAn) and 30-s all-out tethered swimming effort (30TS) were assessed. Anaerobic alactic (AnAl) and lactic energy (AnLa) was assumed as the fast component of excess post-exercise oxygen consumption and net blood lactate accumulation during exercise (∆[La−]), respectively. Aerobic contribution (Aer) was determined by the difference between total energy demand and TAn. In addition to conventional statistical analysis (Repeated measures ANOVA; p > 0.05), a Bayesian repeated measures ANOVA was used to evidence the effect probability (BFincl). Results No differences and effects were found between groups, indicating no supplementation effects. Repeated measures ANOVA, with confirmation of effect, was indicate reduce in ∆Lactate (p: 0.001; BFincl: 25.02); absolute AnLa (p: 0.002; BFincl: 12.61), fatigue index (p > 0.001; BFincl: 63.25) and total anaerobic participation (p: 0.008; BFincl: 4.89). Conclusions Thus, the results demonstrated that all changes presented were evidenced as a result of exposure to the training period and β-alanine supplementation doesn’t affect metabolic contribution and performance during 400-m freestyle.

Download Full-text

Pc.6 Acupressure for Dental Nausea: A Preliminary Report of a Prospective Randomised Double Blind Clinical Trial, Part 1

Acupuncture in Medicine ◽

10.1136/aim.15.1.6 ◽

1997 ◽

Vol 15 (1) ◽

pp. 6-9 ◽

Cited By ~ 4

Author(s):

RAC Chate

Keyword(s):

First Trimester ◽

Small Sample ◽

Cytotoxic Agents ◽

Controlled Study ◽

Double Blind ◽

Double Blind Clinical Trial ◽

First Trimester Of Pregnancy ◽

The Difference ◽

Prior Application ◽

Randomised Controlled

Acupressure effectively reduces the amount of nausea experienced, both in the first trimester of pregnancy, and after either opiates or cytotoxic agents. The aim of this randomised, controlled study was to establish whether it could also reduce any sensation of nausea related to the taking of maxillary dental impressions. The sample comprised 8 males and 14 females, with a mean age of 14.64 years and whose self-registration of nausea following an impression was greater than 33% of a 100mm visual analogue. The test involved a second impression with prior application of pressure on either PC.6, the sixth point on the Chinese pericardial meridian, or a placebo point on the forearm of the patient's dominant limb. A random mental choice as to which point to press was made by each patient, and double blind conditions prevailed. After the withdrawal of the impression, another visual analogue was marked. Of the 9 patients who had used the placebo point during the test impression, there had been a mean reduction of 29% in the scale of nausea experienced. Of the 13 who had used the PC.6 acupressure point, the mean reduction was 30%. The difference was not significant. Three and a half minutes of acupressure on PC.6 did not reduce the sensation of nausea induced by tactile stimulation of the soft palate in this small sample of susceptible patients.

Download Full-text

Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study

Frontiers in Neurology ◽

10.3389/fneur.2020.563373 ◽

2020 ◽

Vol 11 ◽

Cited By ~ 1

Author(s):

Vasilios M. Polymeropoulos ◽

Mark É. Czeisler ◽

Mary M. Gibson ◽

Austin A. Anderson ◽

Jane Miglo ◽

...

Keyword(s):

Motion Sickness ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo

Download Full-text

Effect of Anodal-tDCS on Event-Related Potentials: A Controlled Study

BioMed Research International ◽

10.1155/2016/1584947 ◽

2016 ◽

Vol 2016 ◽

pp. 1-8 ◽

Cited By ~ 4

Author(s):

Ahmed Izzidien ◽

Sriharasha Ramaraju ◽

Mohammed Ali Roula ◽

Peter W. McCarthy

Keyword(s):

Parietal Lobe ◽

Event Related Potentials ◽

Controlled Study ◽

Oddball Paradigm ◽

Anodal Tdcs ◽

Neurologically Impaired ◽

Double Blind ◽

Significant Difference ◽

Related Potentials ◽

The Difference

We aim to measure the postintervention effects of A-tDCS (anodal-tDCS) on brain potentials commonly used in BCI applications, namely, Event-Related Desynchronization (ERD), Event-Related Synchronization (ERS), and P300. Ten subjects were given sham and 1.5 mA A-tDCS for 15 minutes on two separate experiments in a double-blind, randomized order. Postintervention EEG was recorded while subjects were asked to perform a spelling task based on the “oddball paradigm” while P300 power was measured. Additionally, ERD and ERS were measured while subjects performed mental motor imagery tasks. ANOVA results showed that the absolute P300 power exhibited a statistically significant difference between sham and A-tDCS when measured over channel Pz (p=0.0002). However, the difference in ERD and ERS power was found to be statistically insignificant, in controversion of the the mainstay of the litrature on the subject. The outcomes confirm the possible postintervention effect of tDCS on the P300 response. Heightening P300 response using A-tDCS may help improve the accuracy of P300 spellers for neurologically impaired subjects. Additionally, it may help the development of neurorehabilitation methods targeting the parietal lobe.

Download Full-text

Low Dose Perioperative Intravenous Tranexamic Acid in Patients Undergoing Total Knee Arthroplasty: A Double-Blind Randomized Placebo Controlled Clinical Trial

Journal of Blood Transfusion ◽

10.1155/2015/948304 ◽

2015 ◽

Vol 2015 ◽

pp. 1-5 ◽

Cited By ~ 3

Author(s):

Mahdi Motififard ◽

Mohammad Ali Tahririan ◽

Mehdi Saneie ◽

Sajad Badiei ◽

Amin Nemati

Keyword(s):

Tranexamic Acid ◽

Primary Outcome ◽

Low Dose ◽

Study Groups ◽

Controlled Clinical Trial ◽

Double Blind ◽

Significant Difference ◽

Duration Of Hospitalization ◽

Slow Infusion ◽

The Difference

Background and Objectives. The null hypothesis of this study was that TA has no effect on postsurgical bleeding in patients undergoing TKA. Methods. This study was a double-blind randomized trial. In the first group (T) patients received 500 mg of intravenous Tranexamic acid (TA) twice (once preoperatively and once 3 hours postoperatively) and in the second group (P) they received slow infusion of normal saline as placebo. The primary outcome of the study was the level of Hb 48 hours after surgery. Results. Hb levels 48 hours after surgery as the primary outcome were 10.92±0.97 and 10.23±0.98 (g/dL) in groups T and P, respectively, and the difference was statistically significant (P=0.001). Statistically significant differences were also observed in Hb levels 6 and 24 hours after surgery, the drain output 48 hours after surgery, and the number of units of packed cells transfused between study groups (P<0.05). There was no significant difference in duration of hospitalization between the study groups (P = n.s.). Conclusions. The low dose perioperative intravenous TA significantly reduces blood loss, requirement for blood transfusion, and drain output in patients undergoing TKA. However, duration of hospitalization did not change significantly.

Download Full-text

Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2015/201592 ◽

2015 ◽

Vol 2015 ◽

pp. 1-11 ◽

Cited By ~ 2

Author(s):

Tsuyoshi Miyaoka ◽

Motohide Furuya ◽

Jun Horiguchi ◽

Rei Wake ◽

Sadayuki Hashioka ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Controlled Study ◽

Efficacy And Safety ◽

Treatment Resistant ◽

Double Blind ◽

Double Blind Placebo ◽

Intention To Treat ◽

The Difference ◽

The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

Download Full-text

Salsalate in the Treatment of Rheumatoid Arthritis: A Double-Blind Clinical and Gastroscopic Trial versus Piroxicam. II – Endoscopic Evaluation

Journal of International Medical Research ◽

10.1177/030006058901700403 ◽

1989 ◽

Vol 17 (4) ◽

pp. 320-323 ◽

Cited By ~ 7

Author(s):

G. Bianchi Porro ◽

M. Petrillo ◽

S. Ardizzone

Keyword(s):

Rheumatoid Arthritis ◽

Controlled Study ◽

Gastric Lesions ◽

Endoscopic Evaluation ◽

Double Blind ◽

Treatment Groups ◽

End Of Treatment ◽

Dyspeptic Symptoms ◽

The Difference ◽

Equal Efficacy

A double-blind, double-dummy controlled study to compare the clinical efficacy and gastric tolerability of salsalate and piroxicam in the treatment of rheumatoid arthritis was performed. A total of 23 patients were treated with 1.5 g salsalate twice daily and 20 with 20 mg piroxicam (after the evening meal) for 4 weeks. Patients were submitted to gastroscopy at the start and end of treatment; only patients who presented a normal baseline gastroscopy were admitted to the trial. At the end of the planned treatment period, a statistically significant improvement of all clinical variables was observed in both treatment groups, the difference between the two drugs not being statistically significant. Five of 20 (25%) piroxicam treated patients and only 2/19 (11%) salsalate treated patients showed gastric lesions at final endoscopy. No relationship was found between dyspeptic symptoms and endoscopic lesions. The results show that salsalate and piroxicam have equal efficacy in relieving arthritic symptoms, but salsalate causes fewer gastric lesions.

Download Full-text