scholarly journals Pharmacodynamics Must Inform Statistics: An Example from a Cocaine Dependence Pharmacotherapy Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-7
Author(s):  
Theresa M. Winhusen ◽  
Daniel F. Lewis ◽  
Eugene C. Somoza ◽  
Paul Horn
Keyword(s):  
Blood Pressure ◽  
Statistical Model ◽  
Statistical Models ◽  
Statistical Approach ◽  
Antihypertensive Effect ◽  
Controlled Trial ◽  
Cocaine Dependence ◽  
Double Blind ◽  
Blood Pressure Data ◽  
Antihypertensive Properties

Background. There is no FDA-approved medication for cocaine dependence or consensus on the statistical approach for analyzing data from cocaine dependence pharmacotherapy trials. The goal of this paper is to illustrate the importance of understanding medication’s pharmacodynamics when specifying the statistical model to test its efficacy. Method. Data from a double-blind placebo controlled trial of reserpine for cocaine dependence are analyzed. Since the antihypertensive properties of reserpine are well established, blood pressure data are utilized to evaluate the ability of two statistical models, one that does not take the pharmacodynamics of reserpine into account and one that does, to detect reserpine’s antihypertensive effect. Results. The statistical model specified without regard to reserpine’s pharmacodynamics failed to find a significant medication effect for either systolic (P=0.49) or diastolic (P=0.59) blood pressure. Contrariwise, the model based on the pharmacodynamics of reserpine found a significant effect for both systolic (P=0.002) and diastolic (P=0.004) blood pressure. Conclusions. If the pharmacodynamics of a study medication are not considered when specifying statistical models, then erroneous conclusions may be reached. This trial is registered with NCT00033033.

Can Placebo Therapy Influence Arterial Blood Pressure?

1981 ◽  
Vol 61 (s7) ◽  
pp. 487s-490s ◽  
Author(s):  
B. A. Gould ◽  
S. Mann ◽  
A. B. Davies ◽  
D. G. Altman ◽  
E. B. Raftery
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Antihypertensive Effect ◽  
No Reduction ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Clinic Blood Pressure ◽  
Double Blind ◽  
Arterial Blood ◽  
Minimal Reduction

1. With standard sphygmomanometric techniques used in conjunction with continuous intra-arterial monitoring the antihypertensive effect of placebo was examined in a group of patients participating in a controlled clinical trial. 2. Twelve of the 20 patients entered completed all stages of a randomized double-blind controlled trial of placebo and indoramin. Clinic blood pressure in patients receiving placebo showed reductions which were highly significant (P < 0.001). Simultaneous intra-arterial monitoring showed no reduction of the blood pressure over the 24 h studied. 3. The clinic pressures showed minimal reduction of blood pressure in response to indoramin therapy whereas intra-arterial pressures showed a significant fall (P < 0.01). 4. The response of the blood pressure to placebo appears to be an artifact of the indirect sphygmomanometric method and its use as a control in this study led to under-estimation of the efficacy of indoramin.

scholarly journals The effect of Sang-qi Granules on blood pressure and endothelial dysfunction in stageI or II hypertension: study protocol for a randomized double-blind double-simulation controlled trial

2019 ◽  
Author(s):  
Haoyue Shi ◽  
Deshuang Yang ◽  
Jiajun Qiao ◽  
Rui Sun ◽  
Ruihan Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Endothelial Dysfunction ◽  
Vascular Function ◽  
Short Form ◽  
Controlled Trial ◽  
Ankle Brachial Index ◽  
Vascular Endothelial ◽  
Double Blind ◽  
Endothelial Cell Function ◽  
Self Rating

Abstract Background Hypertension is an important worldwide public health challenge because of its high prevalence and concomitant risks of cardiovascular disease. It induces half of the coronary heart disease and approximately two-thirds of the cerebrovascular disease burdens. Vascular endothelial dysfunction plays important roles in the pathophysiology of essential hypertension. Sang-qi Granules (SQG), a Chinese herbal formula, is used to treat I or II hypertension. Several animal experimental studies have shown that SQG can lower blood pressure and myocardial fibrosis by suppressing inflammatory responses. However, there is no standard clinical trial to confirm this and whether SQG can improve endothelial cell function is unknown.Methods In this randomized, double-blind, double-simulation controlled trial, 300 patients with stage I or II hypertension will be recruited and randomly allocated in a 1:1:1 ratio to group A(treatment with SQG and placebo of Cozaar), group B (treatment with Cozaar and placebo of SQG), and group C (treatment with SQG and Cozaar). SQG (or its placebo) will be administrated twice a day at the doze of 10g each time, and 50mg Cozaar(or its placebo) will be administrated once in the morning. The primary endpoint is the drug efficiency of the each three groups. The secondary endpoints are the change of average systolic and diastolic blood pressure during the day and the night, the change of blood pressure drop rate at night, target organ damage assessment (heart rate variability, ankle-brachial index and pulse wave velocity), symptoms improvement assessment (hypertension symptom scale, TCM syndrome integral scale, Pittsburgh sleep quality index scale, Self-Rating Anxiety Scale, Self-Rating Depression Scale and the Short Form-36 Health Survey), blood lipids, serum indicators of vascular function (changes in serum ET-1, TXA2, NO, PGI2 values) and safety indicators.Discussion This study will provide clinical evidence for the efficacy and safety of SQG in the treatment of hypertension. Meanwhile, the possible mechanism of SQG for lowering blood pressure will be further explored by observing the protective effect of SQG on vascular endothelial function, as well as its effect on related clinical symptoms, risk factors and target organs of hypertension.

scholarly journals Effects of 12-Week Supplementation of a Polyherbal Formulation in Old Adults with Prehypertension/Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-15 ◽  
Author(s):  
Tian Shen ◽  
Guoqiang Xing ◽  
Jingfen Zhu ◽  
Yong Cai ◽  
Shuxian Zhang ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Placebo Group ◽  
Controlled Trial ◽  
Adult Population ◽  
Chest Tightness ◽  
Double Blind ◽  
Old Adults ◽  
Severity Scores ◽  
Rapid Heart Rate

Background. Uncontrolled blood pressure is the leading cause of mortality and disability due to associated cerebral and cardiovascular diseases and kidney failure. More than one-third of the old adult population have hypertension or prehypertension and many of their blood pressure are poorly controlled. Objective. We hypothesized that plant extracts-based antioxidants may benefit those with prehypertension/hypertension. Method. One hundred age- and gender-matched healthy older adults were randomly assigned to receive HyperBalance capsules (n=50) or placebo (n=50) at Tang-Qiao Community Health Service Center, Shanghai. Blood pressure and severity scores of hypertension treatment-related symptoms (dizziness, headache, ringing/buzzing in ears, rapid heart rate, and chest tightness) were evaluated before and after the 12-week intervention. Results. Ninety-eight people completed the study, with 2 dropouts in the placebo group before the end of the study. Forty-one subjects (82%) of the HyperBalance group and 40 subjects (83.3%) of the placebo group had prehypertension (systolic blood pressures (SBP) between 130-139 and diastolic blood pressure (DBP) between 85-89mmHg), and 9 subjects (18%) in the HyperBalance group and 8 subjects (16.7%) in the placebo group had hypertension (≥140/90mmHg) before the intervention. HyperBalance significantly (P<0.01) reduced SBP from 136.18±4.38 to 124.14±3.96 mmHg and reduced DBP from 82.45±2.91 to 80.24±2.41mmHg, respectively, and reversed all 9 hypertension people to normotension or prehypertension state, whereas the placebo moderately reduced SBP from 135.79±4.22 to 132.35±4.656mmHg and reduced DBP from 82.90±3.07 to 82.27±3.01mmHg. All symptom severity scores became significantly lower in the HyperBalance group than in the placebo group after HyperBalance intervention: dizziness (0.82±0.44; vs 2.02±0.64, P<0.01); headache (0.46±0.50; vs 1.81±0.61, P<0.01); ringing/buzzing in ears (0.44±0.50; vs 1.04±0.29, P<0.01); and rapid heart rate and chest tightness (0.30±0.46; vs 0.92±0.28, P<0.01). Conclusion. Polyherbal supplementation such as HyperBalance could benefit old adults with prehypertension/hypertension and improve treatment-related symptoms. Further studies are needed to validate the current findings.

scholarly journals A Randomized, Double-Blind, Placebo-Controlled, Trial of Lamotrigine Therapy in Bipolar Disorder, Depressed or Mixed Phase and Cocaine Dependence

2012 ◽  
Vol 37 (11) ◽  
pp. 2347-2354 ◽  
Author(s):  
E Sherwood Brown ◽  
Prabha Sunderajan ◽  
Lisa T Hu ◽  
Sharon M Sowell ◽  
Thomas J Carmody
Keyword(s):  
Bipolar Disorder ◽  
Controlled Trial ◽  
Cocaine Dependence ◽  
Mixed Phase ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals A food-based dietary strategy lowers blood pressure in a low socio-economic setting: a randomised study in South Africa

2008 ◽  
Vol 11 (12) ◽  
pp. 1397-1406 ◽  
Author(s):  
Karen E Charlton ◽  
Krisela Steyn ◽  
Naomi S Levitt ◽  
Nasheeta Peer ◽  
Deborah Jonathan ◽  
...  
Keyword(s):  
Blood Pressure ◽  
South African ◽  
Controlled Trial ◽  
Control Diet ◽  
Diet Group ◽  
Post Intervention ◽  
Intervention Effect ◽  
Double Blind ◽  
Cation Content ◽  
The Impact

AbstractObjectiveTo assess the impact of a food-based intervention on blood pressure (BP) in free-living South African men and women aged 50–75 years, with drug-treated mild-to-moderate hypertension.MethodsA double-blind controlled trial was undertaken in eighty drug-treated mild-to-moderate hypertensive subjects randomised to an intervention (n40) or control (n40) arm. The intervention was 8-week provision of six food items with a modified cation content (salt replacement (SOLO™), bread, margarine, stock cubes, soup mix and a flavour enhancer) and 500 ml of maas (fermented milk)/d. The control diet provided the same quantities of the targeted foods but of standard commercial composition and 500 ml/d of artificially sweetened cooldrink.FindingsThe intervention effect estimated as the contrast of the within-diet group changes in BP from baseline to post-intervention was a significant reduction of 6·2 mmHg (95 % CI 0·9, 11·4) for systolic BP. The largest intervention effect in 24 h BP was for wake systolic BP with a reduction of 5·1 mmHg (95 % CI 0·4, 9·9). For wake diastolic BP the reduction was 2·7 mmHg (95 % CI −0·2, 5·6).ConclusionsModification of the cation content of a limited number of commonly consumed foods lowers BP by a clinically significant magnitude in treated South African hypertensive patients of low socio-economic status. The magnitude of BP reduction provides motivation for a public health strategy that could be adopted through lobbying of the food industry by consumer and health agencies.

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