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- Aloe (Aloe vera)
- Safety
- Electrocardiographic Variables
- Blood Pressure
| Date:
06-30-2011 | HC#
031135-427
|
Re: Aloe Vera Exhibits No Electrocardiographic or Hemodynamic Effects in Study
Shah
SA, DiTullio P, Azadi M, Shapiro RJ, Eid TJ, Snyder JA. Effects of oral Aloe vera on electrocardiographic and
blood pressure measurements. Am J Health Syst
Pharm. 2010;67(22):1942-1946.
Aloe vera syn. A. barbadensis, the most commonly used
species of aloe, has been used topically and orally to treat several skin
conditions, constipation, diabetes, dyslipidemia, hypertension, and to prevent
cancer. In an evaluation of complementary and alternative medicine (CAM) use in
El Paso, Texas in 2000, 77% of residents reported using CAM, with aloe being the
second most popular herb used for medicinal properties.1 Despite
widespread use of oral aloe, its safety profile remains unknown, say the
authors. The objective of this double-blind, placebo-controlled, crossover
study conducted at David Grant USAF Medical Center at Travis Air Force Base,
California was to evaluate the electrocardiographic and hemodynamic effects of
oral aloe in healthy subjects.
For
the study, 16 young, healthy subjects (6 women and 10 men) were enrolled. None
had comorbid conditions or were taking any prescription, nonprescription, or
nutraceutical products. Their mean age was 25 ± 5 years.
On
day 1 of the study, the subjects were assigned randomly to receive either the
oral aloe solution (1200 mg ACTIValoe powder [Aloecorp; Lacey, Washington] in
120 mL of deionized water) or a placebo (citric acid in 120 mL of deionized
water). Eight subjects were in each group. On day 8, after a 7-day washout
period, the subjects received the treatment they did not receive on day 1.
The
subjects were instructed not to consume caffeinated products the evening before
and on each study day. Measurements were taken at the same time each day after
10-minute rest periods.
On
each study day, electrocardiographic variables and systolic and diastolic blood
pressures were evaluated at baseline and at 1, 3, 5, and 8 hours after
treatment.
For
both groups, the primary endpoint for electrocardiographic measurements was the
maximum post-treatment Q-Tc interval over 8 hours. For blood pressure
measurements, the primary endpoints were the maximum systolic and diastolic
blood pressures.
Adverse
events were evaluated at all post-treatment time points. One participant
reported an upset stomach 12 hours after placebo consumption; this was resolved
after an additional 12 hours. No other significant adverse effects were
reported.
The
authors report that no significant differences in electrocardiographic or blood
pressure measurements were seen. The maximum Q-Tc interval was 419 ± 17
milliseconds in the placebo group and 422 ± 17 milliseconds in the aloe group
(P=0.686). The maximum P-R interval was 166 ± 22 milliseconds in the placebo group and 169 ± 25 milliseconds in the aloe group (P=0.538). The maximum QRS
complex duration did not differ significantly between the groups.
The
maximum systolic blood pressure measurements in the placebo and aloe groups
were 120 ± 16 mm Hg and 120 ± 14 mm Hg, respectively (P=0.950). The maximum
diastolic blood pressure measurements in the placebo and aloe groups were 74 ±
10 mm Hg and 75 ± 9 mm Hg, respectively (P=0.478).
Among
the limitations of this study were the use of a single dose of aloe, the
unknown effect of consuming dosages >1200 mg per day, the absence of an
independent quality assessment of the product used, and the possibility that
some of the cardioactive constituents of aloe may not be absorbed after a
one-time dose, showing a lack of effect in this study.
The
authors explain that aloe consists of saccharides, vitamins, essential and
nonessential amino acids, inorganic compounds, enzymes, and other miscellaneous
agents, including low levels of anthraquinones. Anthraquinones are believed to
be responsible for aloe's laxative effects. "Arrhythmia induction, as a
result of laxative-driven electrolyte imbalance, cannot be ruled out as an
effect of oral aloe vera," say the authors. The manufacturer's evaluation
of this purified inner leaf product indicated that it contained ≤0.1 ppm
anthraquinones.
The
authors cite animal studies suggesting that aloe may induce cardiostimulant hemodynamic
values and exhibit hypotensive effects. This preliminary human study failed to
verify these effects after a single dose of twice the recommended daily dose.
The
authors conclude that, "A single dose of oral aloe vera had no effect on
electrocardiographic or blood pressure measurements in young healthy
volunteers."
―Shari
Henson
Reference
1Rivera JO, Ortiz M,
Lawson ME, Verma KM. Evaluation of the use of complementary and alternative
medicine in the largest United States-Mexico border city. Pharmacotherapy. 2002;22(2):256-264.
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