What Is the Effect on a Bp Reading if the Cuff Size Is Too Small?
Integr Blood Press Command. 2016; 9: ix–21.
The effect of aged garlic extract on blood pressure level and other cardiovascular risk factors in uncontrolled hypertensives: the AGE at Heart trial
Karin Ried
1National Plant of Integrative Medicine, Melbourne, Australia
twoKinesthesia of Health Scientific discipline and Medicine, Bond University, Gold Coast, Commonwealth of australia
3Department of General Exercise, University of Adelaide, Adelaide, Australia
Nikolaj Travica
1National Institute of Integrative Medicine, Melbourne, Australia
Avni Sali
iNational Institute of Integrative Medicine, Melbourne, Australia
Abstract
Groundwork
Hypertension affects 30% of adults worldwide. Garlic supplements have shown promise in the treatment of uncontrolled hypertension, and the mechanism of action is biologically plausible. Our trial is the commencement to appraise the effect of aged garlic excerpt on central claret pressure and arterial stiffness, regarded as important adventure factors for cardiovascular morbidity.
Subjects and methods
A total of 88 general practice patients and community members with uncontrolled hypertension completed a double-blind randomized placebo-controlled trial of 12 weeks investigating the event of daily intake of anile garlic excerpt (1.2 thou containing one.2 mg Due south-allylcysteine) or placebo on blood pressure, and secondary outcome measures of central-hemodynamics and other cardiovascular markers, including cholesterol, homocysteine, platelet office, and inflammatory markers.
Results
Mean blood pressure level was significantly reduced past 5.0±2.1 mmHg (P=0.016) systolic, and in responders by 11.5±1.ix mmHg systolic and 6.3±ane.1 mmHg diastolic compared to placebo (P<0.001). Central hemodynamic-measures tended to improve in the garlic group more than in the placebo group, including primal blood force per unit area, fundamental pulse pressure level, hateful arterial pressure, augmentation pressure, pulse-wave velocity, and arterial stiffness. While changes in other cardiovascular markers did not attain significance due to small numbers in subgroups with elevated levels, trends in beneficial effects of garlic on the inflammatory markers TNFα, total cholesterol, low-density lipid cholesterol, and apolipoproteins were observed. Aged garlic extract was highly tolerable and acceptable, and did not increase the risk of bleeding in patients on claret-thinning medication.
Determination
Our trial suggests that aged garlic extract is effective in reducing peripheral and central blood pressure level in a large proportion of patients with uncontrolled hypertension, and has the potential to improve arterial stiffness, inflammation, and other cardiovascular markers in patients with elevated levels. Aged garlic excerpt was highly tolerable with a loftier safety contour every bit a stand-alone or adjunctive antihypertensive treatment.
Keywords: hypertension, primal blood pressure, arterial stiffness, cardiovascular risk factors, aged garlic excerpt
Introduction
Hypertension affects 1 billion (one in iv) adults worldwide, and attributes to nigh forty% of cardiovascular-related deaths.ane–three Standard antihypertensive medication is not always effective, leaving about 24% (3 one thousand thousand) of the developed population uncontrolled hypertensive.4 Garlic supplements have been associated with a blood pressure (BP)-lowering result of clinical significance in hypertensive patients.5–8 The machinery of action is biologically plausible, whereby garlic'south BP-lowering effect involves the hydrogen sulfide- and nitric oxide-signaling pathways.nine Garlic in the course of Kyolic aged garlic excerpt is especially constructive and tolerable with a loftier prophylactic profile, and standardized by dosage of the agile ingredient Due south-allylcysteine (SAC).vi,x
While previous research has shown anile garlic extract to reduce peripheral BP,5–8 this study is the showtime to assess the effect of aged garlic excerpt on key hemodynamic measures, including primal BP, key pulse pressure, pulse-wave velocity (PWV), and arterial stiffness.
Central hemodynamic measures and arterial stiffness are regarded as more than important predictors or risk factors than peripheral BP for cardiovascular disease.xi Furthermore, arterial stiffness, an indicator of the loss of flexibility or hardening of the arteries, increases with age through loss of intact elastin and collagen fibers in the arterial wall, leading to atherosclerosis and contributing to increased BP.12 However, arterial stiffness is one of many other chance factors contributing to hypertension.
Here, we describe the event and tolerability of aged garlic extract equally an adjunct treatment on peripheral (office/clinical) BP, central hemodynamic measures, and cardiovascular markers in patients with uncontrolled hypertension.
Subjects and methods
Trial design and methods
This report was approved past the Human being Research Ideals Committee at National Institute of Integrative Medicine, and the trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12613000747729). Participants provided informed written consent.
Adults with uncontrolled hypertension (systolic BP [SBP] ≥140 mmHg and/or diastolic BP [DBP] ≥90 mmHg) were sought to participate in the double-blind randomized placebo-controlled parallel 12-week trial investigating the upshot of aged garlic extract on BP and other cardiovascular markers/parameters. We recruited through seven general practices in metropolitan Melbourne, Australia, every bit well equally by distribution locally of flyers, postcards, advertizement in the local newspaper, our found's website, and social media. We included patients with a mean SBP ≥138 mmHg or mean DBP ≥85 mmHg nether clinical trial weather who had been either on an established program of prescription antihypertensive medication for at least 2 months or did not have any BP medication and their doctor did not programme to change their BP-medication regime during the trial. We excluded patients with unstable or serious atmospheric condition, including dementia, final illness, secondary hypertension, or pregnancy. Patients were besides excluded if they were not able to give informed consent or were taking daily supplements containing aged garlic extract.
Resource allotment and treatment
Consenting eligible patients were randomly allocated to the garlic or placebo group using a calculator-generated permuted random-number table provided by an contained consulting statistician. Patients were assigned either 2 capsules daily of Kyolic aged garlic extract (Reserve formula; Wakunaga of America Co Ltd, Mission Viejo, CA, United states of america)thirteen containing 1.ii g of aged garlic excerpt powder and 1.2 mg SAC) or to two placebo capsules daily for 12 weeks.
Kyolic aged garlic extract powder is manufactured from organically grown garlic bulbs that have undergone a 20-month natural aging process at room temperature. During the aging process, volatile sulfur components found in raw garlic, such as allicin, are chemically converted into stable and standardizable components, including the main active component SAC.13,14
Placebo capsules were matched in advent to the active capsules, and packaged in identical containers past independent staff not involved in the trial. Activated carbon sachets were added to each container to disguise whatsoever odor.
Patients, investigators, and research assistants were blinded to treatment resource allotment. Blinding success of patients was assessed at the cease of the trial by questionnaire. Patients were instructed to take the trial capsules in the evening with food. Patients were reminded to have their usual prescription medication as instructed by their doctor. Compliance was assessed by daily entries in calendars provided. Baseline demographics, practise, and stress levels were assessed at the offset appointment by questionnaire.
Assessments
Blood pressure monitoring
Clinical blood pressure level
Primary outcome measures were SBP and DBP at 4, 8, and 12 weeks compared with baseline. BP was measured by a trained research assistant using two independent devices: 1) a calibrated and validated digital sphygmomanometer (HEM-907; Omron Corporation, Kyoto, Japan), and two) an oscillometric ambulatory BP monitor (Mobil-O-Graph; IEM GmbH, Stolberg, Germany), with appropriately sized brachial cuffs.
The displays of the BP monitors were positioned away from the patient to assure blinding to the BP readings. BP measurements were taken with the patient in a seated position with the arm supported at middle level, after 5 minutes' rest, and afterwards abstinence from food, caffeinated beverages, and smoking for a minimum of two hours prior to BP measurement at approximately the same fourth dimension and day of the week. BP taken with the digital sphygmomanometer was recorded as three serial measurements at intervals of 30 seconds on both artillery. Subsequently, BP was recorded with the Mobil-O-Graph device in one case on both artillery, starting with the same arm as before. The hateful of the BP measured with both devices on both arms was used in the analysis. If a BP reading deviated past more than than 10 mmHg from the average reading, the BP reading on that arm was repeated.
Cardinal blood pressure, arterial stiffness
With the Mobil-O-Graph device, we also assessed fundamental hemodynamic measures, including central BP, PWV, pulse pressure, and arterial stiffness at baseline and 4, eight, and 12 weeks. The Mobil-O-Graph uses brachial oscillometric BP waves for a noninvasive estimation of central BP, past taking a 10-second snapshot of the radial arterial pressure level moving ridge and calculating the ascending aortic force per unit area wave with the ARCSolver algorithm, which in turn provides central BP, aortic augmentation index, ejection elapsing, and subendocardial viability ratio.15 The Mobil-O-Graph has been validated for automated BP monitoring against invasive recordings using benchmark solid-state force per unit area sensor-tipped catheters (Millar Instruments, Houston, TX, United states of america) and against a validated Usa Food and Drug Assistants-approved noninvasive system (SphygmoCor; AtCor Medical Inc., Sydney, Commonwealth of australia).16,17
Aortic PWV is considered the gilt standard in the assessment of arterial stiffness,eleven and tin can be measured not-invasively by brachial oscillometry or radial tonometry using the Mobil-O-Graph monitor.18 Measures of arterial stiffness, including augmentation pressure, augmentation alphabetize, and PWV, are strongly correlated with historic period and sex.nineteen,20
Cardiovascular biomarkers
Fasted blood samples were taken by a research nurse at baseline and at 12 weeks to assess cardiovascular biomarkers, including serum cholesterol and triglycerides, lipoproteins, homocysteine, platelet part, and the inflammatory markers of ultrasensitive CRP, TNFα, and IL-1β. Platelet function was measured by clotting time on epinephrine/collagen and adenosine diphosphate/collagen using the PFA-100 platelet-role analyzer (Siemens AG, Munich, Germany), indicating platelet adhesion, activation, and aggregation. Principally, results indicate the longer the closure time the thinner the blood, and the shorter the closure fourth dimension the thicker or stickier the claret. Liver and kidney part and glucose levels were besides assessed past standard pathology assays.
Tolerability and acceptability
The tolerability of trial supplements was monitored throughout the trial by questionnaire at the 4-weekly appointments, and long-term acceptability was assessed at 12 weeks using our previously developed questionnaire.five,6 Patients were followed up by phone to assess reasons for withdrawal.
Sample size
A sample size of 100 patients was calculated based on the following assumptions: 1) to detect a difference of 10 mmHg SBP (standard divergence 10) or 6.5 mmHg DBP (standard departure 10) in BP modify betwixt the active treatment (n=50) and command groups (northward=50) with a power of ≥fourscore% and 95% conviction; and two) to account for 20% dropout or nonattendance at all appointments. Based on the experience of our previous trials,5,vi bold a response rate of 15% and 50% of patients meeting eligibility criteria under trial weather condition, we aimed to invite 1,630 patients from 7 general practices.
Statistical analysis
Analyses were performed using IBM SPSS version 22. Statistical significance was set at P<0.05. Descriptive analysis was carried out for baseline characteristics. Differences between the groups were assessed by χ 2 test or Fisher's exact test for binominal variables, Isle of man–Whitney U test for ordinal variables, and one-way analysis of variance with Bonferroni adjustment for continuous variables. Potential confounding variables were included in the analysis using analysis of covariance (ANCOVA), eg, age and sexual practice relevant for some key hemodynamic measures, and any baseline variables significantly different between groups. Principal consequence measures were clinical and central BP, and secondary issue measures were other hemodynamic measures and cardiovascular markers.
Repeated-mensurate ANCOVA was used to assess the mean differences between groups for variables with multiple time points at 4, 8, and 12 weeks compared to baseline, including SBP and DBP and other fundamental hemodynamic measures. Primary assay was conducted with all participants following the protocol, excluding data points owing to BP-medication alter and participant noncompliance of less than 50%.
Exploratory subgroup analysis using ANCOVA adjusted for baseline differences was performed past response to treatment for the master consequence measure – BP. We defined responders to garlic treatment equally mean reduction past more than 3% in SBP (≥5 mmHg) or DBP (≥3 mmHg) over time compared to baseline, which is clinically and statistically meaningful and similar to definitions past others.21
Exploratory subgroup analysis of secondary outcome measures using ANCOVA adjusted for age and sex was done past baseline levels (elevated versus normal) of selected cardinal hemodynamic measures (eg, PWV, augmentation force per unit area, and augmentation index), and selected cardiovascular blood markers (total cholesterol, low-density lipoprotein [LDL], apolipoprotein A/B (ApoA/B), homocysteine, and platelet-function markers).
Results
Participants
The trial was conducted in Melbourne, Commonwealth of australia betwixt September 2013 and August 2014. Two-thirds of the patients with uncontrolled hypertension on medical tape were recruited from vii metropolitan general practices with the support of 11 doctors. A third of the patients were recruited past letterbox driblet of flyers, postcard displays at local pharmacies, advertising in the local paper, and through our plant's website and social media. Of the ane,170 invitations sent through general practices, 13% responded. A total of 185 patients were screened for eligibility, and 104 patients (56%) were enrolled in the trial and randomly allocated to the garlic or the placebo group. Nine patients withdrew after their baseline cess, due to personal reasons unrelated to the trial (Figure 1). After assessment of brachial BP and central hemodynamic measures using the digital sphygmomanometer and the ambulatory BP monitor (Mobil-O-Graph), eligible enrolled patients were asked to return to the dispensary within the adjacent few days for a fasted blood sample. On the twenty-four hour period of the baseline claret-sample test, patients were provided with a calendar month's supply of the trial medication and a agenda, until the adjacent engagement in four weeks' time.
Trial flowchart.
Abridgement: BP, claret force per unit area.
Baseline characteristics were not significantly dissimilar betwixt groups, including BP medication and other prescription medication (eg, blood-thinning medication, lipid-lowering medication, hormone-replacement therapy), as well as physical activities and stress levels (Table ane).
Tabular array 1
Baseline characteristics
| Demographics | All (due north=88) | Placebo (due north=38) | Garlic (due north=50) | Garlic subgroup responders (n=29) | Garlic subgroup nonresponders (northward=21) |
|---|---|---|---|---|---|
| | |||||
| Mean ± SD | |||||
| Age | |||||
| Years | 62.3±11.iii | 61.5±13.0 | 63.three±9.nine | 63.2±11.seven | 63.4±8.2 |
| BMI | |||||
| kg/m2 | 27.7±four.9 | 28.3±4.nine | 27.three±iv.9 | 26.7±5.0 | 28.1±4.8 |
| Vigorous exercise | |||||
| Days/week | 1.4±2.0 | i.1±i.v | 1.6±2.3 | one.1±1.5 | one.3±2.1 |
| Moderate exercise | |||||
| Days/week | 3.6±2.4 | 3.5±2.4 | 3.half dozen±two.4 | three.5±ii.4 | 3.five±2.5 |
| Stress score (Cohen) | |||||
| Range 0–40 points | 10.1±half-dozen.half dozen | 12.0±vi.5 | 13.nine±half-dozen.half-dozen | 13.8±6.5 | 13.ix±half dozen.7 |
| Other stressors | |||||
| Range 0–4 | 0.4±0.viii | 0.4±0.6 | 0.5±0.nine | 0.five±0.9 | 0.5±0.9 |
| north (%) | |||||
| Sexual activity | |||||
| Male/female person | 47/41 (53/47) | 19/nineteen (50/50) | 28/22 (56/44) | 17/12 (59/41) | 10/11 (48/52) |
| Electric current smoker | 4 (5) | iii (8) | i (2) | 1 (3) | 0 |
| Family history of CVD | 56 (64) | 26 (68) | 30 (60) | 17 (59) | 13 (62) |
| Heart assail | 20 (23) | 10 (26) | nine (xviii) | four (14) | five (23) |
| Stroke | xiii (15) | v (13) | 7 (fourteen) | 4 (xiv) | 3 (14) |
| CAD, bypass | 13 (fifteen) | three (eight) | 10 (20) | 5 (17) | 5 (23) |
| Hypertension | thirteen (15) | 8 (21) | v (10) | 3 (ten) | 2 (10) |
| BP medication | |||||
| Yes | 63 (72) | 26 (68) | 37 (74) | 23 (79) | 14 (66) |
| BP medications, n | |||||
| 0 | 25 (28) | 12 (32) | 13 (26) | half dozen (21) | 7 (33) |
| i | 35 (40) | 12 (32) | 23 (46) | 15 (52) | 8 (38) |
| 2 | 21 (24) | 11 (29) | 10 (20) | 5 (17) | five (24) |
| 3 | 6 (7) | ii (5) | 4 (8) | 3 (x) | 1 (v) |
| iv | ane (1) | 1 (3) | 0 | 0 | 0 |
| BP-medication type | |||||
| ACEI | 25 (28) | eleven (29) | 14 (28) | 10 (34) | 4 (19) |
| A2RA | 34 (39) | 15 (40) | xix (38) | 12 (41) | 7 (33) |
| CCB | 22 (25) | 10 (26) | 12 (24) | 7 (24) | 5 (24) |
| BB | 8 (nine) | 4 (eleven) | 4 (8) | 10 (34) | 2 (9) |
| D | 14 (16) | 7 (18) | 7 (fourteen) | iii (x) | four (19) |
| Other medication | |||||
| Yes | 41 (47) | 23 (60) | 18 (36) | 9 (31) | 9 (39) |
| Claret-thinning medication | 22 (25) | 10 (20) | 12 (32) | 6 (21) | 4 (19) |
| Lipid (statin) | 15 (17) | vii (18) | 8 (16) | 2 (7) | 6 (29) |
| Diabetes | 6 (7) | one (2) | 5 (x) | ii (7) | 3 (xiv) |
| Depression/SSRI | 7 (8) | 2 (5) | 5 (10) | 2 (7) | iii (14) |
| Reflux/PPI | seven (eight) | 4 (11) | three (half dozen) | 1 (11) | ii (10) |
| Thyroid | 3 (iii) | 3 (viii) | 0 | 0 | 0 |
| HRT (% female) | three (3) | 2 (11) | 1 (2) | 0 | ane (9) |
Of the 95 participants who completed the trial, seven were excluded due to significant protocol departure known to influence chief outcome measures, including BP-medication change during the trial (n=4) and low compliance (<fifty%, n=3), resulting in 88 participants for full analysis.
A total of fifty participants were allocated to the garlic group, and 38 participants to the placebo group, with a hateful age of 62±12 years and almost even distribution of sexes. The average body mass index in the trial participants was slightly overweight with a hateful of 27.7±5 kg/chiliadtwo. Participants exercised moderately an boilerplate of 3.5 days a week (eg, 30 minutes of brisk walking, dancing, gardening, or housework) and one.five days vigorously (30 minutes of running, fast cycling, fast pond, heavy shoveling, or carrying heavy loads). The average stress levels of participants assessed by the Cohen Stress score22 were comparable to the population boilerplate in a similar age-group.
Family history of cardiovascular events was reported past ii-thirds of the participants, including myocardial infarction by nigh 25% and stroke by 15% (Table 1). Three-quarters of participants were taking standard BP medication, with the majority taking one to two different types, with angiotensin 2-receptor antagonists and angiotensin-converting enzyme inhibitors the most often prescribed, followed by calcium-aqueduct blockers, diuretics, and β-blockers. Almost one-half of the participants took other prescription medication, including claret thinners (25%) and lipid-lowering drugs (17%), and a few took medication for diabetes, depression, reflux, thyroid problems, or hormone-replacement therapy (Table 1).
Blood pressure and central hemodynamic measures
Analysis of all participants (n=88) revealed a meaning reduction in SBP from baseline in the garlic group compared with placebo over 12 weeks (mean divergence in SBP ± standard error =−5.0±2.one mmHg, P=0.016), but not for DBP (mean difference in DBP ± standard mistake =−one.nine±1.2, P=0.12; Table 2 and Figure ii).
Effect of anile garlic excerpt on claret pressure.
Notes: Mean alter in SBP (A) and DBP (B) over 12 weeks in the placebo and garlic groups, and responder (SBP change ≥five mmHg, DBP change ≥iii mmHg) and nonresponder subgroups.
Abbreviations: SBP, systolic blood pressure; DBP, diastolic BP.
Tabular array two
Blood pressure level and central hemodynamic measures
| Measures | Grouping | due north | Baseline | Baseline divergence | 12 weeks | Alter | Mean deviation betwixt groups (garlic vs placebo) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Office BP | Variable | Details | Hateful | SD | P-value | Mean | SD | Mean | SD | Hateful difference | SE | P-value | ||
| SBP | mmHg | Placebo | 38 | 142 | 9.4 | 140.three | 18.ii | −2.ix | 7.9 | |||||
| Garlic | 50 | 148.vii | xv.3 | 0.02 | 141.7 | 15.iii | −8 | 10.half-dozen | −5 | 2.i | 0.02 | |||
| SBP >138 mmHg | 68% high at baseline | Placebo | 26 | 146.4 | 7.5 | 141.4 | 9.four | −four.9 | 7 | |||||
| 76% high at baseline | Garlic | 38 | 153.8 | xiii.8 | 0.02 | 143.8 | 12.1 | −x | 10.8 | −five.1 | 2.4 | 0.04 | ||
| SBP <138 mmHg | Placebo | 12 | 132.4 | 4.5 | 133.8 | seven.7 | one.four | eight.i | ||||||
| Garlic | 12 | 132.4 | 4.2 | NS | 130.9 | 7.ane | −1.v | six.6 | −2.nine | 3 | 0.34 | |||
| SBP placebo | Placebo | 38 | 142 | nine.4 | 139.1 | 9.5 | −2.9 | 7.nine | ||||||
| SBP responders | 58% >v mm change | Garlic | 29 | 153.2 | fifteen.iv | 0.001 | 138.eight | 11.4 | −14.4 | 8.8 | −eleven.five | 1.9 | <0.001 | |
| SBP nonresponders | Garlic | 21 | 142.3 | 12.nine | NS | 143.3 | 13.iii | 1 | 4.5 | 3.ix | two.1 | 0.18 | ||
| DBP | Placebo | 38 | 87.eight | nine.1 | 86 | nine | −1.8 | v | ||||||
| Garlic | 50 | 89.ix | 11.7 | NS | 86.1 | 11.3 | −3.7 | five.nine | −1.9 | one.ii | 0.12 | |||
| DBP >85 mmHg | 63% high at baseline | Placebo | 24 | 92.ix | 6.vi | 91.3 | 9.4 | −ii.iii | five.7 | |||||
| 64% high at baseline | Garlic | 32 | 96.2 | 9 | NS | 92.4 | 9.9 | −4.4 | six.ii | −2.ane | 0.xix | |||
| DBP <85 mmHg | Placebo | 14 | 79.1 | 5.ane | 78.5 | 7.5 | −i | 3.5 | ||||||
| Garlic | xviii | 78.5 | five.7 | NS | 76.vii | seven.7 | −two.3 | 5 | −1.3 | i.6 | 0.twoscore | |||
| DBP placebo | Placebo | 38 | 87.viii | 9.one | 86 | 9 | −1.8 | 5 | ||||||
| DBP responders | fifty% >3 mm change | Garlic | 25 | 93.2 | 11.4 | NS | 85.1 | 10.9 | −1.8 | 3.8 | −6.iii | 1.1 | <0.001 | |
| DBP nonresponders | Garlic | 25 | 86.5 | 11.one | NS | 88.four | 12.seven | 0.eight | 4 | ii.5 | 1.1 | 0.08 | ||
| MAP | mmHg | Placebo | 38 | 112.vii | 10.6 | 110.4 | 8.8 | −2.3 | vii.2 | |||||
| Garlic | 49 | 117.8 | 12.1 | 0.045 | 112.four | 9.8 | −five.4 | ix.3 | −3.1 | 1.8 | 0.1 | |||
| HR | L/min | Placebo | 38 | 70.4 | 9.six | 70 | 8.v | −0.5 | six | |||||
| Garlic | 48 | 68.vii | 11.2 | NS | 67.nine | 10.seven | −0.vii | half-dozen.half-dozen | −0.2 | i.4 | 0.9 | |||
| PP | mmHg | Placebo | 38 | 51 | 9.3 | 49.8 | ix.2 | −1.3 | ix.5 | |||||
| Garlic | 49 | 54.two | fourteen.vii | NS | fifty.2 | 10.1 | −four | 9.7 | −two.seven | 2.one | 0.2 | |||
| Central BP | cSBP | mmHg | Placebo | 38 | 129.iii | 9.3 | 126.8 | ix.ix | −2.4 | 7.eight | ||||
| Garlic | 48 | 134.8 | 14.2 | 0.04 | 128.5 | 10.3 | −6.2 | 9.vii | −3.viii | 1.nine | 0.05 | |||
| cDBP | mmHg | Placebo | 38 | xc.8 | 9.7 | 88.vi | 8.8 | −2.two | 6.iii | |||||
| Garlic | 48 | 95.1 | 12.3 | 0.08 | ninety.4 | x.vii | −4.7 | eight | −2.six | i.6 | 0.11 | |||
| cPP | mmHg | Placebo | 38 | 38.4 | 7.3 | 37.8 | 7.7 | −0.v | 6.4 | |||||
| Garlic | 49 | twoscore.vi | 11.eight | NS | 37.5 | viii | −3.2 | 7.4 | −two.7 | 1.5 | 0.08 | |||
| Cardiac output | L/min | Placebo | 38 | 5.3 | 0.half-dozen | 5 | 0.5 | −0.3 | 0.5 | |||||
| Garlic | 49 | 5.ane | 0.7 | NS | 5.1 | 0.7 | −0.1 | 0.5 | 0.2 | 0.1 | 0.17 | |||
| TVR | due south · mmHg/mL | Placebo | 38 | 1.3 | 0.17 | 1.33 | 0.15 | 0.04 | 0.13 | |||||
| Garlic | 49 | ane.41 | 0.21 | NS | i.39 | 0.15 | −0.03 | 0.17 | −0.07 | 0.03 | 0.06 | |||
| Cardiac index | L/min × L/grand2 | Placebo | 38 | 2.71 | 0.29 | 2.58 | 0.33 | −0.thirteen | 0.25 | |||||
| Garlic | 49 | ii.65 | 0.45 | NS | 2.57 | 0.35 | −0.06 | 0.32 | 0.07 | 0.06 | 0.28 | |||
| Arterial stiffness | ||||||||||||||
| AP | mmHg | Placebo | 38 | x.i | 6.5 | 10.8 | 6.half dozen | 0.76 | 5 | |||||
| Garlic | 49 | 13.two | eight.nine | 0.07 | 11.vi | 4.ix | −1 | 5.6 | −1.9 | 1.ii | 0.12 | |||
| High AP* | mmHg | Placebo | xiv | xv.4 | vi.9 | 14.4 | eight | −i | 5.3 | |||||
| Garlic | 23 | 20.6 | 7.5 | NS | fifteen.2 | iii | −four.6 | 5.1 | –3.5 | 1.8 | 0.06 | |||
| High AP, male | mmHg | Placebo | two | ten | 2.8 | 7.5 | 0 | 0.three | 3.3 | |||||
| Garlic | 7 | 23.1 | ten.v | NS | 15 | 7.i | −vi.3 | four.2 | −6.6 | 2.7 | 0.04 | |||
| Loftier AP, female | mmHg | Placebo | eleven | 17.5 | 6.2 | 19.five | eleven.5 | −i.4 | v.8 | |||||
| Garlic | 14 | 19 | 4.half dozen | NS | 18.four | six.4 | −3.7 | 5.4 | −ii.3 | two.3 | 0.32 | |||
| Low AP | mmHg | Placebo | 24 | half dozen.nine | 3.5 | 8.7 | 4.vi | 1.8 | 4.6 | |||||
| Garlic | 26 | six.half-dozen | 2.viii | NS | viii.5 | iv.one | 1.8 | iv.ii | −0.03 | 1.3 | 0.98 | |||
| RM | % | Placebo | 38 | 65.1 | vi.half dozen | 64.iii | five.8 | −0.82 | 5.2 | |||||
| Garlic | 49 | 63.6 | 8.ii | NS | 64.iii | 5.7 | 0.67 | 6.5 | −one.5 | 1.3 | 0.25 | |||
| AI | % | Placebo | 35 | 21.7 | 11.6 | 21.8 | 10 | 0.82 | 9.8 | |||||
| Garlic | 48 | 24 | 13.8 | NS | 24.2 | eleven.one | −0.15 | 9.4 | −0.97 | 3.1 | NS | |||
| AI high* | % | Placebo | 12 | 31.8 | 7.ii | 26.4 | 8.3 | −5 | x.five | |||||
| Garlic | 22 | 36.2 | 7.7 | NS | 31.iii | 8.nine | −4.6 | 7.9 | ane.5 | 3.4 | 0.66 | |||
| AI low | % | Placebo | 23 | sixteen.iv | ix.vii | 19.3 | 10.1 | iv.3 | 7.6 | |||||
| Garlic | 25 | 13.viii | eight.3 | NS | 18.1 | 9 | iii.half-dozen | 9.1 | −0.5 | 2.five | 0.85 | |||
| PWV | chiliad/due south | Placebo | 38 | nine.iii | one.8 | nine.ii | 1.viii | −0.071 | 0.33 | |||||
| Garlic | 49 | 9.8 | 1.9 | NS | 9.five | 1.6 | −0.28 | 0.58 | −0.xvi | 0.11 | 0.xiii | |||
| PWV high# | g/s | Placebo | 25 | 9.half-dozen | 1.9 | ix.five | 2 | −0.15 | 0.35 | |||||
| Garlic | 31 | 10.two | 2.2 | NS | 9.7 | 1.9 | −0.49 | 0.62 | −0.33 | 0.14 | 0.02 | |||
| PWV normal | g/south | Placebo | 13 | viii.5 | 1.ii | 8.6 | 1.two | 0.08 | 0.25 | |||||
| Garlic | eighteen | 9 | 0.eight | NS | 9.1 | 0.9 | 0.07 | 0.29 | 0.01 | 0.1 | 0.89 | |||
Nearly two-thirds of participants presented with high SBP or DBP at baseline, with about one-half of the participants having essential hypertension (SBP ≥140 and DBP ≥90). Subgroup analysis of participants with high SBP/DBP at baseline did not change results appreciably (Tabular array two).
However, closer evaluation of participants in the garlic group revealed that a proportion of participants (l%–60%) responded to treatment over fourth dimension. Nosotros divers responders to garlic treatment equally hateful reduction past more than than 3% in SBP (≥v mmHg) or DBP (≥3 mmHg) over time compared to baseline, which is clinically and statistically meaningful and similar to definitions past others,21 while mean BP, assessed by repeated-measure out ANCOVA, did non modify appreciably for nonresponders. Subgroup analysis of responders revealed an boilerplate reduction of 11.5±1.9 mmHg SBP and half-dozen.3±1.1 DBP compared to placebo (P<0.001; Table two and Effigy 2).
A number of primal hemodynamic measures tended to better more than in the garlic group compared to placebo, including primal SBP (mean deviation =−iii.eight±1.9 mmHg, P=0.05), key pulse pressure (hateful difference =−2.vii±ane.5 mmHg, P=0.08), total vascular resistance (hateful difference =−0.07±0.03 s · mmHg/mL, P=0.06), hateful arterial pressure level (hateful difference =−3.1±one.eight mmHg, P=0.09), augmentation pressure if high at baseline (mean difference =−3.5±i.8 mmHg, P=0.06), and PWV if high at baseline (hateful difference =−0.33±0.fourteen m/s, P=0.02) (Tabular array 2). Trends were confirmed in ANCOVA analysis including historic period and sex equally covariates.
Claret tests
None of the blood markers tested changed significantly over time; however, lipid levels, including total cholesterol and LDL, tended to better slightly more in the garlic group (Tabular array three). Subgroup analysis by lipid-lowering medication (eg, statins) intake did not alter results appreciably. ApoA levels were highly correlated with loftier density lipoprotein (HDL) levels (Pearson r=0.588, P<0.001), and ApoB levels were highly correlated with LDL levels (Pearson r=0.767, P<0.001), as expected. Reduction of ApoB when above the reference range was greater in the garlic group compared to placebo, admitting not statistically significant due to small sample size (mean difference =−29.one±46.3 mg/dL, P=0.three [n=12]). The average homocysteine level within participants in both groups was higher than the reference range (hateful 14.2±3.half-dozen μmol/50), indicating potential underlying vitamin B12 or folate deficiencies.
Table 3
Cardiovascular markers by claret test
| Claret tests | Reference range | Units | Group | north | Baseline | Baseline deviation | 12 weeks | Change from baseline | Change divergence | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hateful | SD | P-value | Mean | SD | Hateful | SD | P-value | |||||
| Lipids | ||||||||||||
| TG | mmol/L | Placebo | 38 | 1.vi | 0.9 | NS | 1.5 | one | −0.07 | 0.66 | 0.07 | |
| Garlic | fifty | 1.2 | 0.half-dozen | i.three | 0.8 | 0.15 | 0.45 | |||||
| TC | <five.5 | mmol/L | Placebo | 38 | v.3 | one | NS | 5.3 | 1.3 | 0.003 | 0.84 | NS |
| Garlic | l | 5.v | 1.3 | 5.5 | i.two | −0.01 | 0.75 | |||||
| TC subgroups | High | Placebo | 17 | six.i | 0.6 | NS | 5.9 | 1.5 | −0.sixteen | 1.i | NS | |
| Garlic | 23 | 6.half-dozen | i | 6.3 | 0.9 | −0.27 | 0.79 | |||||
| Normal | Placebo | 21 | 4.6 | 0.6 | NS | iv.7 | 0.7 | 0.xiii | 0.54 | NS | ||
| Garlic | 27 | 4.6 | 0.7 | 4.eight | 0.9 | 0.21 | 0.64 | |||||
| LDL | <3.4 | mmol/Fifty | Placebo | 37 | iii.1 | 0.ix | NS | 3.1 | one | −0.028 | 0.52 | NS |
| Garlic | fifty | 0.viii | 1.1 | three.2 | 0.9 | −0.12 | 0.seven | |||||
| LDL subgroups | Loftier | Placebo | 13 | iv | 0.6 | 3.viii | 1.two | −0.ii | 0.76 | NS | ||
| Garlic | xviii | 4.4 | ane | NS | 4 | 0.half dozen | −0.46 | 0.91 | ||||
| Normal | Placebo | 24 | 2.6 | 0.vi | 2.vii | 0.6 | 0.061 | 0.29 | NS | |||
| Garlic | 32 | 2.7 | 0.6 | NS | 276 | 0.seven | 0.069 | 0.46 | ||||
| HDL | 0.9–ii.two | mmol/L | Placebo | 38 | 1.5 | 0.6 | NS | 1.four | 0.5 | −0.068 | 0.39 | NS |
| Garlic | l | 1.seven | 0.6 | i.7 | 0.6 | −0.02 | 0.27 | |||||
| TC/HDL | Placebo | 38 | 3.ix | 1.2 | NS | three.9 | 1.one | −0.0026 | 0.48 | NS | ||
| Garlic | 50 | 3.5 | one.one | three.5 | 1 | −0.0034 | 0.47 | |||||
| ApoA | 105–185 | mg/dL | Placebo | 38 | 170.1 | 34.8 | 0.06 | 169.2 | 33.4 | −0.92 | 21 | NS |
| Garlic | 50 | 184.nine | 38 | 187.7 | 41.five | two.78 | 28.27 | |||||
| ApoA subgroups | High | Placebo | 8 | 219 | 34 | NS | 209.8 | 35.four | −9.25 | 27.28 | NS | |
| Garlic | 24 | 217 | 23.1 | 210.7 | 29.2 | −half dozen.25 | 23.81 | |||||
| Normal | Placebo | thirty | 157.1 | 20.nine | NS | 158.4 | 23.3 | i.3 | xviii.94 | NS | ||
| Garlic | 25 | 154.9 | 21.5 | 164.vii | 40 | ix.76 | 29.69 | |||||
| ApoB | 55–125 | mg/dL | Placebo | 38 | 101.v | 25.five | NS | 101.2 | 31 | −0.26 | sixteen.38 | NS |
| Garlic | l | 102 | 32.5 | 100.7 | 30.8 | −i.34 | 28.4 | |||||
| ApoB subgroups | High | Placebo | 5 | 146.2 | 23.9 | NS | 148.two | 51.1 | two | 32.57 | NS | |
| Garlic | 7 | 160.9 | 32.ii | 129.7 | 57.4 | −31.fourteen | 64.34 | |||||
| Normal | Placebo | 32 | 96.ane | sixteen.4 | NS | 94.9 | nineteen.4 | −i.15 | 13.11 | NS | ||
| Garlic | 42 | 92.iv | twenty.6 | 95.5 | 21.8 | 3.xiv | 13.17 | |||||
| Homocysteine | 3.7–13.nine | μmol/Fifty | Placebo | 37 | 14.1 | 3.iv | NS | 13.5 | iv.three | −0.67 | four.xix | NS |
| Garlic | 50 | 14.ii | iii.7 | 14.ix | 4.five | 0.67 | three.88 | |||||
| Homocysteine subgroups | High | Placebo | 17 | 17 | 2.8 | NS | 15 | v.4 | −ane.97 | v.34 | NS | |
| Garlic | 26 | 17 | 2.half dozen | 16.9 | four.vi | −0.12 | 4.15 | |||||
| Normal | Placebo | 20 | 11.8 | one.three | NS | 12.2 | 2.6 | 0.43 | 2.55 | NS | ||
| Garlic | 24 | eleven.2 | i.7 | 12.eight | 3.two | 1.57 | iii.44 | |||||
| Platelet role | ||||||||||||
| Epi/Coll | 120–150 | south | Placebo | 35 | 143.3 | 45.viii | NS | 142.7 | 55.4 | −0.52 | 37.7 | NS |
| Garlic | 46 | 142.iii | 47.two | 138.6 | 54.five | –three.67 | 45.2 | |||||
| Epi subgroups | Thick nether 120 | Placebo | 12 | 101.seven | fifteen.7 | NS | 110.1 | 25.6 | eight.42 | 21.63 | NS | |
| Garlic | 18 | 102.5 | 10.4 | 107.9 | 32.vii | 5.4 | 32.ix | |||||
| Thin over 150 | Placebo | xiii | 188.8 | twoscore.four | NS | 178.eight | 73 | −x | 56.7 | NS | ||
| Garlic | 16 | 193.four | 41.ix | 180 | 61.ix | –13.34 | 63.5 | |||||
| ADP/Coll | 85–110 | south | Placebo | 34 | 95.4 | 21.6 | NS | 95.ix | 26.1 | 0.47 | 17.25 | NS |
| Garlic | 41 | 92.8 | 21 | 89.half-dozen | xvi.3 | −3.12 | 14.2 | |||||
| Thick under 85 | Placebo | 12 | 75.4 | v.9 | NS | 79.6 | 12.4 | 4.17 | 10.9 | NS | ||
| Garlic | 17 | 77.four | 4.six | 84.4 | 12.one | vii.06 | 11.i | |||||
| Sparse over 110 | Placebo | 6 | 132 | 15.1 | NS | 125.7 | 41.four | −6.33 | 26.8 | NS | ||
| Garlic | 5 | 137.4 | 25 | 117 | 19.3 | −20.4 | 10 | |||||
| Inflammatory markers | ||||||||||||
| CRP | mg/L | Placebo | 38 | iii.two | four.half dozen | NS | 4 | iv.six | 0.8 | three.7 | NS | |
| Garlic | l | 2.7 | 3.7 | three.ane | iv.2 | 0.4 | iii.8 | |||||
| TNFα | fg/mL | Placebo | 27 | 245.half dozen | 269.v | NS | 448.7 | 550.8 | 203.one | 475.9 | 0.05 | |
| Garlic | 31 | 238.9 | 310.6 | 227.viii | 196.6 | −xi.1 | 358.6 | |||||
| IL-1β | fg/mL | Placebo | 27 | 145.6 | 89.2 | NS | 139.8 | 104.two | −5.8 | 96.0 | NS | |
| Garlic | 31 | 211.7 | 439.0 | 114.3 | 48.3 | −97.4 | 433.6 | |||||
Platelet-role analyses indicated a daily trial dosage of aged garlic extract to be safety, equally platelet-aggregation times did not further increase in participants with slow platelet adhesion/aggression at baseline, ofttimes due to blood-thinning medication (eg, warfarin, aspirin). In contrast, platelet office tended to modify more toward normal levels in the garlic group with loftier closure times (thin blood) at baseline for both agonists compared to the placebo group (Table 3).
The inflammatory marking TNFα was reduced in the garlic group compared to placebo with borderline significance (P=0.05), while changes in IL-1β were not significant, but greater reduction was observed in the garlic group (Table iii). Subgroup analyses excluding patients with loftier inflammatory markers due to astute infection did not change results appreciably (data not shown). Neither glucose levels nor kidney-function and liver-role exam variables inverse noticeably over time within or betwixt groups (Tabular array 4).
Table 4
Kidney- and liver-function test results
| Claret tests | Reference range | Unit of measurement | Group | n | Baseline | Baseline difference | 12 weeks | Change from baseline | Change difference | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hateful | SD | P-value | Mean | SD | Mean | SD | P-value | |||||
| Kidney function | ||||||||||||
| Na | mmol/L | Placebo | 38 | 139.8 | 2.seven | NS | 139.8 | 2.two | 0.one | 1.9 | NS | |
| Garlic | 49 | 140.1 | 2.3 | 139.9 | 2.three | −0.2 | two.3 | |||||
| K | mmol/L | Placebo | 38 | 4.46 | 0.53 | NS | 4.3 | 0.4 | −0.one | 0.6 | NS | |
| Garlic | 49 | 4.55 | 0.47 | four.four | 0.4 | −0.1 | 0.5 | |||||
| Cl | mmol/50 | Placebo | 38 | 103.1 | iii.4 | NS | 103.3 | 2.nine | 0.3 | 2.8 | NS | |
| Garlic | 49 | 103.5 | 2.nine | 103.three | ii.half-dozen | −0.ane | 2.5 | |||||
| Bicarbonate | mmol/L | Placebo | 38 | 28.3 | 2.8 | NS | 30.1 | two.2 | 1.eight | 3.ane | 0.03 | |
| Garlic | 49 | 29.one | 2.6 | 29.5 | 2.4 | 0.3 | two.9 | |||||
| Urea | mmol/L | Placebo | 38 | vi.ane | 1.eight | NS | 6.2 | 1.half dozen | 0.ane | ane.5 | NS | |
| Garlic | 49 | 5.8 | 1.4 | 5.7 | one.4 | 0.one | 1.iv | |||||
| eGFR | mL/min | Placebo | 38 | 86.2 | ix.4 | NS | 84.9 | 9.six | −i.ii | 5.i | 0.06 | |
| Garlic | 8 | 85.6 | 9.five | 86.four | 9.3 | 0.9 | four.viii | |||||
| Creatinine | μmol/Fifty | Placebo | 38 | 69.7 | xviii.5 | NS | 70.63 | 17.34 | 1 | 7.8 | 0.05 | |
| Garlic | 49 | 69.8 | fifteen.four | 67.eighteen | xvi.42 | −2.8 | ix.1 | |||||
| Ca | mmol/50 | Placebo | 38 | 2.3 | 0.1 | NS | ii.33 | 0.096 | −0.01 | 0.one | NS | |
| Garlic | 50 | ii.3 | 0.1 | 2.33 | 0.07 | −0.0012 | 0.i | |||||
| CorCa | mmol/Fifty | Placebo | 36 | 2.3 | 0.1 | NS | 2.23 | 0.07 | −0.02 | 0.1 | NS | |
| Garlic | 50 | 2.3 | 0.1 | 2.24 | 0.07 | −0.004 | 0.i | |||||
| Phosphate | mmol/L | Placebo | 38 | 1.06 | 0.2 | NS | ane.02 | 0.2 | −0.four | 0.two | NS | |
| Garlic | 50 | 1.04 | 0.2 | 1.05 | 0.one | 0.01 | 0.two | |||||
| Urate | mmol/L | Placebo | 38 | 0.37 | 0.ane | NS | 0.36 | 0.096 | −0.01 | 0.06 | ||
| Garlic | 50 | 0.35 | 0.1 | 0.36 | 0.09 | −0.01 | 0.06 | NS | ||||
| Liver office | ||||||||||||
| Bilirubin | μmol/50 | Placebo | 38 | 11.4 | 4.seven | NS | 12 | iv.22 | 0.6 | 3.5 | NS | |
| Garlic | fifty | 11.4 | iv.v | eleven.7 | 4.4 | 0.iii | 3.4 | |||||
| ALT | U/L | Placebo | 38 | xxx.5 | 14.1 | 0.12 | thirty.8 | 14.5 | 0.3 | ten.ane | NS | |
| Garlic | l | 25.vii | 13.8 | 25.5 | 14.ane | −0.3 | 6.i | |||||
| AST | U/L | Placebo | 38 | 26.2 | half dozen.8 | NS | 28.3 | ten.7 | 2.1 | 7.7 | 0.03 | |
| Garlic | 50 | 26.5 | 8.1 | 25.5 | 7.iii | −one | five.7 | |||||
| ALP | U/50 | Placebo | 38 | 67.four | 14.4 | 0.005 | 71.ii | 18.1 | 3.8 | 10.9 | NS | |
| Garlic | 50 | 78.6 | 22 | 80.1 | 24.4 | 1.five | ten.8 | |||||
| GGT | U/Fifty | Placebo | 38 | 39.2 | 58 | 0.5 | 42.9 | 90.ane | 3.8 | 35.5 | NS | |
| Garlic | 50 | 32.7 | 30.iii | 34.viii | 34.8 | 2.one | 12.ii | |||||
| Total protein | thousand/L | Placebo | 38 | 72.half-dozen | iv.one | NS | 73 | iv.3 | 0.3 | 3.viii | NS | |
| Garlic | l | 72.7 | five.1 | 73 | 3.7 | 0.iii | 5.1 | |||||
| Albumin | yard/L | Placebo | 38 | 44.3 | 3.3 | NS | 45 | iii.5 | 0.7 | 2.7 | NS | |
| Garlic | 50 | 44.2 | 2.9 | 44.4 | 2.v | 0.2 | 3.ane | |||||
| Globulin | g/L | Placebo | 38 | 28.3 | 3 | NS | 28 | 3.3 | −0.3 | two.one | NS | |
| Garlic | 50 | 28.5 | 3.4 | 28.five | 3.1 | 0.1 | two.5 | |||||
| Glucose | mmol/L | Placebo | 38 | 5.4 | 1.1 | 5.3 | 1 | −0.1 | 0.5 | 0.xix | ||
| Garlic | 49 | 5.3 | 1.ii | NS | 5.v | i.7 | 0.two | i.1 | ||||
Tolerability, acceptability, and blinding
Compliance of included participants was high in both groups (96.6%±5.6%). About twoscore% of participants in both groups reported minor side furnishings, including reflux (8%), burping (5%), bloating (3%), and also improved digestion (vii%) (P>0.05; Table five). Few participants found side effects bothersome, and usually experienced these simply in the kickoff week of the trial. All but 4 participants found information technology easy (95%) and acceptable (100%) to take ii trial capsules a day for 12 weeks, and about lxxx% stated they would be willing to go along taking the capsules if they helped with BP control (Table v). Blinding success was assessed at the cease of the trial past questionnaire. While more participants in the garlic group (42%) than in the placebo group (21%) guessed their allocation correctly, a larger proportion in both groups were unsure or incorrect (garlic 58%, placebo 79%; P=0.023; Table v).
Table 5
Tolerability, acceptability, and blinding
| Tolerability | All (n=88) | Garlic (due north=50) | Placebo (n=38) |
|---|---|---|---|
| northward (%) | n (%) | n (%) | |
| Side furnishings | |||
| Total | 28 (32) | eighteen (36) | 10 (26) |
| Reflux | seven (8) | 5 (10) | two (5) |
| Improved digestion | half-dozen (vii) | 5 (10) | ane (2) |
| Garlic taste | 3 (3) | 3 (6) | 0 |
| Hot flushes | 4 (five) | 3 (vi) | one (2) |
| Burping | 4 (5) | two (4) | 2 (5) |
| Bloating | 3 (three) | one (2) | 2 (v) |
| Flatulence | 3 (3) | i (2) | 2 (5) |
| Lightheaded | ane (1) | 1 (ii) | 0 (0) |
| Nosebleed | 1 (1) | one (2) | 0 |
| Diarrhea | ii (2) | one (2) | 1 (2) |
| Indigestion | 2 (two) | 1 (2) | 1 (2) |
| Difficulty swallowing capsules | two (2) | 1 (2) | 1 (2) |
| Nausea | i (i) | 0 | 1 (ii) |
| Dry mouth | i (1) | 0 | i (ii) |
| Acceptability | |||
| Easy taking capsules | |||
| Easy | 84 (95) | 48 (96) | 36 (95) |
| Adequate | |||
| Acceptable | 88 (100) | 50 (100) | 38 (100) |
| Willing to continue | |||
| Agree | 74 (84) | 44 (88) | thirty (79) |
| Unsure | 11 (13) | 4 (8) | 7 (xviii) |
| Disagree | 3 (3) | ii (4) | one (3) |
| Willing to spend (AU$0.3/capsule) | |||
| Agree | 70 (80) | 42 (84) | 28 (76) |
| Unsure | fourteen (xvi) | 7 (xiv) | 7 (19) |
| Disagree | 3 (iii) | 1 (ii) | 2 (five) |
| Blinding | |||
| Right | 29 (33) | 21 (42) | 8 (21) |
| Unsure | 46 (52) | 22 (44) | 24 (63) |
| Incorrect | xiii (15) | 7 (14) | six (16) |
Discussion
Our trial suggests that aged garlic extract is superior to placebo in lowering BP in patients with uncontrolled hypertension. A dosage of two capsules daily containing i.2 g of anile garlic excerpt and ane.2 mg of SAC significantly lowered SBP by 5 mmHg compared with placebo over 12 weeks (P=0.016), and was highly tolerated. BP changes were observed just in a proportion of participants, whereby 50%–58% responded to treatment by a reduction in SBP of more than five mmHg (58%) or a reduction in DBP of more than than 3 mmHg (50%). Subgroup analysis of responders revealed a significant average reduction of eleven mmHg SBP and half dozen mmHg DBP compared to placebo (P<0.001).
Interindividual differences in BP response to garlic treatment are biologically plausible9 and in line with our previous research, whereby SBP was reduced significantly in about 70% of participants.vi Average BP reduction of responders in this trial is also consequent with meta-analyses of the effect of garlic on BP in hypertensives by 9–10 mmHg SBP and by 4–8 mmHg DBP (P<0.001).8,23
Garlic-derived polysulfides tin influence BP via the nitric oxide- and hydrogen sulfide-signaling pathways.ix Several dietary and genetic factors influence the efficiency of these pathways, including vitamin B6, vitamin B12, and folate levels or genetic polymorphisms, eg, the transsulfuration gene CBS, and hence back up or ameliorate the BP response to garlic intake.nine
In our study, responders and nonresponders did not differ past historic period, sex activity, torso mass index, or BP-medication intake. Therefore, we speculate that the variability in BP response to garlic in this study may be linked to underlying vitamin B6, vitamin B12 or folate deficiency, or genetic polymorphisms.
Variation in vitamin B12 levels prevalent in centre-aged populations is supported by the relatively high mean homocysteine levels found in our study sample, and the lack of effect of garlic on homocysteine levels, in line with the literature linking low vitamin B12 levels and high homocysteine levels with hypertension and cardiovascular affliction.24
Secondary outcome measures, including primal hemodynamics, such as central SBP, central pulse pressure, hateful arterial pressure, total vascular resistance, arterial stiffness, and PWV, were positively influenced past anile garlic extract. Fundamental hemodynamic measures are regarded as more than important predictors than peripheral BP for cardiovascular disease.eleven Our findings are in line with a previous trial showing a beneficial issue of aged garlic excerpt plus coenzyme Q10 on PWV and endothelial function,25 and provide new evidence that aged garlic excerpt has the potential to reduce fundamental BP and arterial stiffness in individuals with uncontrolled hypertension.
While we did not notice significant differences in other cardiovascular markers, favorable effects observed in the inflammatory marker TNFα, too as total cholesterol, LDL cholesterol, and correlated ApoA and ApoB levels, were in line with previous research, whereby garlic was found to reduce the proinflammatory markers IL-1β and TNFα, subsequent activation of nuclear factor NFκB, and levels of oxidative LDL in vitro.26,27 Furthermore, a previous meta-analysis of 39 trials suggested garlic was effective in reducing total cholesterol and LDL cholesterol by 10% in individuals with slightly elevated levels.28
Platelet-part testing provided evidence that Kyolic anile garlic excerpt was safe, even if taken in addition to blood-thinning medication, which is in line with previous research,x and in dissimilarity to raw garlic intake.29 In our sample, Kyolic aged garlic extract tended to normalize platelet office.
While our written report was adequately powered and adjusted for confounding factors for the primary outcome measures – SBP and DBP – assuasive likewise for exploration by subgroups of responders/nonresponders, our report has a few limitations. The dropout rate in the placebo group (22%) was college than in the garlic group (9%), which may have led to some biased results. Assessments of the consequence of anile garlic extract on nearly secondary outcome measures, including arterial stiffness measures and cardiovascular blood markers, were limited by the smaller sample size in subgroups of participants with elevated levels of these markers at baseline. Intake of prescription medication, including medicines for BP, lipid-lowering agents, or hormone-replacement therapy were not matched between the groups, and numbers were likewise small-scale in each category to undertake subgroup analyses. Yet, differences between the groups were not statistically significant, and did non alter results appreciably when incorporated in the analyses equally covariates.
Further larger studies are needed to appraise the full potential of anile garlic extract on arterial stiffness measures, including PWV and augmentation force per unit area, too equally on cardiovascular biomarkers, such as inflammatory markers, lipids, and platelet function. Additionally, futurity research should exam the hypothesis that individuals' responsiveness to aged garlic excerpt intake may be dependent on underlying dietary and genetic factors, such every bit vitamin B6, vitamin B12, folate levels, and CBS gene polymorphisms.
Acknowledgments
Nosotros thank all patients, general practices, doctors, and staff for their participation in the trial. We are grateful to the research nurse Adela Cretoiu, who was instrumental in liaising with practices and patients. This trial was supported by a grant from Wakunaga of America Co Ltd, who supplied trial capsules and provided funding for costs of tests and research aid. Wakunaga of America was not involved in written report design, information collection, analysis, or grooming of the manuscript.
Footnotes
Writer contributions
KR and Every bit conceptualized the study, and KR acquired funding and oversaw data collection by NT. KR and NT undertook data analysis. All authors contributed toward drafting and critically revising the paper and concord to be accountable for all aspects of the work.
Disclosure
The authors report no conflicts of interest in this piece of work.
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