scholarly journals The GH-2004 project: the response of IGF1 and type III pro-collagen to the administration of exogenous GH in non-Caucasian amateur athletes

2010 ◽  
Vol 163 (1) ◽  
pp. 45-54 ◽  
Author(s):  
Richard I G Holt ◽  
Ioulietta Erotokritou-Mulligan ◽  
Cathy McHugh ◽  
E Eryl Bassett ◽  
Christiaan Bartlett ◽  
...  

ContextThe GH-2000 team proposed a method based on IGF1 and type III pro-collagen (P-III-P) to detect exogenously administered GH. As previous studies involved predominantly white European athletes, it is important to assess whether the response of these markers to recombinant human GH (rhGH) differs with ethnicity.ObjectiveTo examine the response of serum IGF1 and P-III-P and GH-2000 score to rhGH in non-Caucasian amateur athletes.DesignDouble-blind placebo-controlled rhGH administration study.SettingWellcome Trust Clinical Research Facility, Southampton General Hospital.SubjectsThe study included 31 male and 14 female amateur athletes of different ethnicities.InterventionThe subjects were assigned to treatment with placebo or 0.1 IU/kg per day (low dose) or 0.2 IU/kg per day (high dose) rhGH for 28 days. Blood was collected weekly during treatment and on days 35, 42 and 84 during the washout period. Serum IGF1 and P-III-P were measured, and GH-2000 score was calculated.ResultsIGF1, P-III-P and GH-2000 score rose in response to both low- and high-dose GH in both men and women. When compared with the Caucasian volunteers of the previous GH-2000 study, mean baseline and placebo-treated P-III-P and GH-2000 score were lower in GH-2004 men and women. Post-GH, however, peak IGF1 or P-III-P did not differ between studies but the peak GH-2000 score was lower in GH-2004 men. There was no difference between studies in the maximal change in IGF1, P-III-P and GH-2000 score in response to GH in either gender.ConclusionsThese data do not support a significant ethnic effect on the peak or maximal response to rhGH.

1981 ◽  
Vol 26 (6) ◽  
pp. 395-401 ◽  
Author(s):  
D. Garfinkel Barry ◽  
D. Webster Christopher ◽  
Leon Sloman

Six children with the diagnosis of Attention Deficit Disorder were treated as day hospital patients, using different stimulant medication. They were studied in a double-blind crossover experiment in which they received caffeine in low dose or in a high dose. Methylphenidate was added to both dosages, as well as administered alone. Results indicated that caffeine in low dosage when added to methylphenidate was superior to all other treatment conditions. Caffeine in low dosage could not be differentiated from 10 mg of methylphenidate. High dosage caffeine was not different from placebo or no-drug conditions. This study offers evidence to support a curvilinear pattern of dose-response for caffeine, in attenuating the behavioural manifestations of this syndrome.


Hypertension ◽  
2020 ◽  
Vol 76 (3) ◽  
pp. 724-731
Author(s):  
Lucy Norcliffe-Kaufmann ◽  
Jose-Alberto Palma ◽  
Jose Martinez ◽  
Horacio Kaufmann

Afferent lesions of the arterial baroreflex occur in familial dysautonomia. This leads to excessive blood pressure variability with falls and frequent surges that damage the organs. These hypertensive surges are the result of excess peripheral catecholamine release and have no adequate treatment. Carbidopa is a selective DOPA-decarboxylase inhibitor that suppresses catecholamines production outside the brain. To learn whether carbidopa can inhibit catecholamine-induced hypertensive surges in patients with severe afferent baroreflex failure, we conducted a double-blind randomized crossover trial in which patients with familial dysautonomia received high dose carbidopa (600 mg/day), low-dose carbidopa (300 mg/day), or matching placebo in 3 4-week treatment periods. Among the 22 patients enrolled (13 females/8 males), the median age was 26 (range, 12–59 years). At enrollment, patients had hypertensive peaks to 164/116 (range, 144/92 to 213/150 mm Hg). Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075). The 2 co-primary end points of the trial were met. The SD of systolic BP variability was reduced at both carbidopa doses (low dose: 17±4; high dose: 18±5 mm Hg) compared with placebo (23±7 mm Hg; P =0.0013), and there was a significant reduction in the systolic BP peaks on active treatment ( P =0.0015). High- and low-dose carbidopa were similarly effective and well tolerated. This study provides class Ib evidence that carbidopa can reduce blood pressure variability in patients with congenital afferent baroreflex failure. Similar beneficial effects are observed in patients with acquired baroreflex lesions.


2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Sanjib Kumar Sharma ◽  
Emilie Alirol ◽  
Anup Ghimire ◽  
Suman Shrestha ◽  
Rupesh Jha ◽  
...  

Diagnosing and treating acute severe and recurrent antivenom-related anaphylaxis (ARA) is challenging and reported experience is limited. Herein, we describe our experience of severe ARA in patients with neurotoxic snakebite envenoming in Nepal. Patients were enrolled in a randomised, double-blind trial of high vs. low dose antivenom, given by intravenous (IV) push, followed by infusion. Training in ARA management emphasised stopping antivenom and giving intramuscular (IM) adrenaline, IV hydrocortisone, and IV chlorphenamine at the first sign/s of ARA. Later, IV adrenaline infusion (IVAI) was introduced for patients with antecedent ARA requiring additional antivenom infusions. Preantivenom subcutaneous adrenaline (SCAd) was introduced in the second study year (2012). Of 155 envenomed patients who received ≥ 1 antivenom dose, 13 (8.4%), three children (aged 5−11 years) and 10 adults (18−52 years), developed clinical features consistent with severe ARA, including six with overlapping signs of severe envenoming. Four and nine patients received low and high dose antivenom, respectively, and six had received SCAd. Principal signs of severe ARA were dyspnoea alone (n=5 patients), dyspnoea with wheezing (n=3), hypotension (n=3), shock (n=3), restlessness (n=3), respiratory/cardiorespiratory arrest (n=7), and early (n=1) and late laryngeal oedema (n=1); rash was associated with severe ARA in 10 patients. Four patients were given IVAI. Of the 8 (5.1%) deaths, three occurred in transit to hospital. Severe ARA was common and recurrent and had overlapping signs with severe neurotoxic envenoming. Optimising the management of ARA at different healthy system levels needs more research. This trial is registered withNCT01284855.


2020 ◽  
pp. 108705472090908 ◽  
Author(s):  
Gianpiera Ceresoli-Borroni ◽  
Azmi Nasser ◽  
Toyin Adewole ◽  
Tesfaye Liranso ◽  
Jiahong Xu ◽  
...  

Objective: To evaluate efficacy and safety of SPN-810 (extended-release molindone) in a Phase-2b, randomized, double-blind, placebo-controlled, dose-ranging study of children (6–12 years) with ADHD and persistent impulsive aggression (IA). Method: After lead-in, children were randomized to (a) placebo ( N = 31); (b) low-dose ( N = 29, 12/18 mg/day); (c) medium-dose ( N = 30, 24/36 mg/day); and (4) high-dose ( N = 31, 36/54 mg/day) groups. Treatment included ~2.5-week titration, 3-week maintenance, and 1-week tapering/conversion, alongside existing monotherapy (stimulants/nonstimulants) and behavioral therapy. The primary endpoint was change in Retrospective-Modified Overt Aggression Scale (R-MOAS) score at end of study, with safety monitored. Results: A total of 95 (78.5%) children completed the study. Aggression (R-MOAS) improved with low and medium doses (low dose: p = .031; medium dose: p = .024; high dose: p = .740). The most common adverse events were headache (10.0%), sedation (8.9%), and increased appetite (7.8%). Conclusion: These results suggest SPN-810 may be effective in reducing residual IA behaviors in children with ADHD. Research is still needed to support the benefit–risk profile of SPN-810 in pediatric populations.


1998 ◽  
Vol 88 (1) ◽  
pp. 72-75 ◽  
Author(s):  
William M. Splinter ◽  
Elliot J. Rhine

Background Ondansetron and dexamethasone have been observed to decrease the incidence of vomiting by children after general anesthesia. This study compared the effect of high-dose (150 microg/kg) ondansetron with low-dose (50 microg/kg) ondansetron plus 150 microg/kg dexamethasone on the incidence of vomiting after strabismus in children. Methods This study had a double-blind, blocked, stratified, randomized design. With parental consent and Hospital Ethics Committee approval, healthy children aged 2-14 yr who were undergoing elective strabismus surgery were studied. Anesthesia was induced intravenously with propofol or by inhalation with halothane and nitrous oxide. Patients in the high-dose group were given placebo plus 150 microg/kg (maximum dose, 8 mg) of ondansetron intravenously, whereas patients in the low-dose group were given 150 microg/kg dexamethasone (maximum dose, 8 mg) and 50 microg/kg ondansetron intravenously in a double-blind manner. Anesthesia was maintained with halothane and nitrous oxide. All incidences of vomiting occurring as long as 24 h after anesthesia were recorded. Results Three of the 200 patients enrolled in the study were excluded from data analysis. The groups were similar with respect to demographic data and potential confounding variables. Patients vomited from 0-12 times. The low-dose ondansetron plus dexamethasone group had a lower incidence of vomiting, 9% (95% CI = 4-17%) versus 28% (95% CI = 20-38%; P < 0.001). Only 1% of the patients in the low-dose ondansetron plus dexamethasone group vomited while in the hospital. Conclusions Low-dose ondansetron plus dexamethasone is an effective prophylactic antiemetic combination for children undergoing strabismus surgery.


2008 ◽  
Vol 74 (2) ◽  
pp. 160-167 ◽  
Author(s):  
Turkay Kirdak ◽  
Aysun Yilmazlar ◽  
Sinan Cavun ◽  
Ilker Ercan ◽  
Tuncay Yilmazlar

Preoperative single, high-dose methylprednisolone administration improves postoperative outcomes after colonic surgery. Several randomized studies, including major surgeries, assessed various high-dose steroid regimens; however, evidence about the effect of administration of lower doses on postoperative outcomes in colorectal surgery is not available. The aim of the present study is to determine whether the administration of a single, low dose of dexamethasone before surgery would confer an outcome advantage after colorectal surgery. Thirty patients undergoing colorectal surgery were included in this randomized, double-blind study. Patients received 8 mg dexamethasone or serum physiologic preoperatively. Levels of Interleukin-6 and C-reactive protein, pain scores, postoperative nausea and vomiting, mobilization, complications, hospital stay, and readmissions were compared. Age, sex, indications, and operations were similar in both groups ( P > 0.05). C-reactive protein and Interleukin-6 levels increased significantly postoperatively in each group ( P < 0.05), but there were no differences between groups when compared ( P > 0.05). There were also no significant differences between pain scores, bowel functions, mobilization, hospital stay, complication rates, and readmission rates between the two groups ( P > 0.05). Preoperative 8 mg dexamethasone administration has no significant effect on reducing postoperative inflammatory response and also does not improve outcomes of colorectal surgery.


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