Anna Ipsen Journal Article Summary #1 NTR 530-30-DI Practicum Professor Keri McComb Spring 2014

Aged garlic extract reduces blood pressure in hypertensives: a dose-trial response

Introduction Hypertension is defined as blood pressure >140/90mm Hg. Worldwide one in four adults have hypertension. Hypertension is caused by a variety of factors including smoking, overweight/obesity, lack of physical activity, high sodium diet, excessive alcohol consumption, stress, age, genetics, kidney disease, and thyroid disorders. Having high blood pressure puts a person at risk for heart failure. Today, 40% of cardiovascular deaths are secondary to hypertension. Many choose to take medications to manage their blood pressure. However, antihypertensive medications are not always effective, have multiple side effects, and can be costly. Therefore interest in alternative methods for managing blood pressure has increased. Past research has shown a variety of garlic supplements to have a lowering effect on blood pressure. Of these, aged garlic extract has had the highest success rate and thus was used for this trial. Methods This study took place in metropolitan Adelaide South Australia from March 2011 to August 2013. Eight hundred and forty adults from two general practices were invited to participate. Patients who were asked had have had uncontrolled hypertension (>135mm Hg systolic) for the past six months and be on an established plan of prescription antihypertensive medications for at least two months, without intentions of changing their regimen for the next 12 weeks. Exclusion criteria included having an illness with secondary hypertension, recent medical diagnosis or pregnancy, or already taking garlic supplements. It was predicted that 840 participants would need to be invited to detect a difference of 10mm Hg systolic blood pressure between each of the active treatment groups and placebo group with a 80% power and 95% confidence, account for 10% dropout or non attendance at one or more appointments, adjust for clustering, and a response rate of 15% to prove the study results significant. Of the 840 adults invited, 84 responded and were screened for the above criteria. They were then randomly allocated to one of four treatment groups. After randomization, five withdrew for personal reasons, changing the total number of participants to 79. Baseline characteristics were similar between the remaining participants; mean age was 70 + 12 years, 42 were male and 37 female, and all took two + one antihypertensive medications. For 12 weeks, group one took one capsule of garlic a day (240mg), group two took two capsules of garlic a day (480mg), group three was a placebo group (provided with capsules that matched in size, shape, odor, and packaging), and group four took four capsules of garlic a day (960mg). The primary outcome measure was systolic and diastolic blood pressure at four, eight, and 12 weeks compared to baseline blood pressure. Both tolerability and acceptability were

monitored by a questionnaire at week four, eight, and 12 appointments. Compliance was also monitored by calendar entries. Results A significant reduction in systolic blood pressure from baseline in the group taking two garlic tablets per day compared with the placebo group over the 12 weeks was found, although no change in diastolic blood pressure was noted. When analysis adjusted for five participants with poor compliance or a change in medication regimen, a significant difference in systolic blood pressure was still found, but at both eight and 12 weeks. Systolic blood pressure in group four was significant at eight weeks when compared to the placebo group. Group one systolic blood pressure dropped at 12 weeks, but was not significant when compared to the placebo group. Treatment with the garlic capsules did not affect all participants; covariate analysis by gender, age, BMI, smoking status, and number of antihypertensive medications was completed, but did not explain results. Diastolic blood pressure reduction was largest in group two, although was insignificant when compared to the placebo group. During the study, four participants changed their medication regime and five patients withdrew after four weeks. Three withdrawals were due to gastrointestinal complaints, one due to a broken arm, and one who no longer wished to participate. Participants in the garlic groups reported minor complaints in the first week including constipation, bloating, flatulence, reflux, garlic taste, difficulty swallowing capsules, dry mouth/cough. Most participants found taking the garlic capsules easy and acceptable, especially those taking fewer capsules per day. Participants reported willingness to continue taking garlic capsules after trial if effective, as well as pay the out-of-pocket cost of $0.30 per capsule. Blinding success of the study was measured by a questionnaire in which one third of participants guessed their treatment group correctly. Discussion This study showed that aged garlic extract has the potential to lower systolic blood pressure in patients with uncontrolled hypertension. A daily dose of two capsules (480mg) of aged garlic extract significantly lowered systolic blood pressure by -11.8 + 5.4mm Hg compared with a placebo group over 12 weeks. The daily dose of four capsules also lowered systolic blood pressure, but mean difference was -7.4 + 4.1 mm Hg at eight weeks when compared to the placebo group and was therefore only borderline significant. This difference when comparing group four and group two could be due to poorer compliance and lesser tolerability in group four. The gastrointestinal complaints that caused three participants to drop out could have been because genetics factors that can cause lower tolerance of sulphur-containing foods, inflammatory status, and/or levels of molybdenum and vitamin b12. The study had limited power due to a response rate of only 14% even before withdrawal was accounted for. Future recommendations include testing aged garlic extract as an alternative antihypertensive medication in other age groups, exploring underlying factors (genetic variations), completing the study with a larger sample size to compare the effect of taking both the garlic capsules and prescribed antihypertensive medications, as well as a longer study to investigate the prolonged effect of aged garlic extract on cardiovascular morbidity and mortality.

Works Cited Ried K, Frank OR, Stocks NP. Aged garlic extract reduces blood pressure in hypertensives: A dose-response trial. European Journal of Clinical Nutrition. 2013;67:64-70.