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Aloe capensis
Cape Aloes 2014

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The Scientific Foundation for
Herbal Medicinal Products

ALOE CAPENSIS
Cape Aloes

2014
 ESCOP Monographs were first published in loose-leaf form progressively
from 1996 to 1999 as Fascicules 1-6, each of 10 monographs
© ESCOP 1996, 1997, 1999

Second Edition, completely revised and expanded

© ESCOP 2003

Second Edition, Supplement 2009

© ESCOP 2009

ONLINE SERIES
ISBN 978-1-901964-18-9
Aloe capensis - Cape Aloes

© ESCOP 2014

Published by the European Scientific Cooperative on Phytotherapy (ESCOP)

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Important Note: Medical knowledge is ever-changing. As new research and clinical experience
broaden our knowledge, changes in treatment may be required. In their efforts to provide information
on the efficacy and safety of herbal drugs and herbal preparations, presented as a substantial
overview together with summaries of relevant data, the authors of the material herein have consulted
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information contained herein is in every respect accurate or complete, and they are not responsible
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to use, to be certain that the information contained in this publication is accurate and that changes
have not been made in the recommended dose or in the contraindications for administration.

Edited by Simon Mills and Roberta Hutchins

Cover photographs by By Andrew Massyn (Own work) [Public domain],
via Wikimedia Commons (Aloe ferox) and Martin Willoughby
Cover and text design by Martin Willoughby
Typeset in Optima by Roberta Hutchins

Plant illustrated on the cover: Aloe ferox

 FOREWORD
It is a great pleasure for me to introduce the online era of ESCOP Monographs. Interest in herbal medicinal
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the high standard of the monographs.

Liselotte Krenn
Chair of the Board of ESCOP

PREFACE
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To accelerate the publication of new and revised monographs ESCOP has therefore decided to publish
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and convenient to all users of ESCOP Monographs.

As always, ESCOP is indebted to the many contributors involved in the preparation of monographs, as
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NOTES FOR THE READER

From 2011 new and revised ESCOP Monographs are published as an online series only. Earlier
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Second Edition Supplement 2009, but are not available online for copyright reasons.

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Abbreviations
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ABBREVIATIONS used in ESCOP monographs

AA arachidonic acid
ABTS 2,2’-azino-bis(3-ethylbenzthiazoline-6-sulphonic acid)
ACE angiotensin converting enzyme
ADP adenosine diphosphate
ALAT or ALT alanine aminotransferase (= SGPT or GPT)
ALP alkaline phosphatase
anti-IgE anti-immunoglobulin E
ASA acetylsalicylic acid
ASAT or AST aspartate aminotransferase (= SGOT or GOT)
ATP adenosine triphosphate
AUC area under the concentration-time curve
BMI body mass index
BPH benign prostatic hyperplasia
b.w. body weight
cAMP cyclic adenosine monophosphate
CI confidence interval
Cmax maximum concentration of a substance in serum
CNS central nervous system
CoA coenzyme A
COX cyclooxygenase
CSF colony stimulating factor
CVI chronic venous insufficiency
CYP cytochrome P450
d day
DER drug-to-extract ratio
DHT dihydrotestosterone
DNA deoxyribonucleic acid
DPPH diphenylpicrylhydrazyl
DSM Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association)
ECG electrocardiogram
ED50 effective dose in 50% of cases
EDTA ethylenediamine tetraacetate
EEG electroencephalogram
EMA European Medicines Agency
ENT ear, nose and throat
ER oestrogen receptor
ERE oestrogen-responsive element
FSH follicle-stimulating hormone
GABA gamma-aminobutyric acid
Gal galactose
GFR glomerular filtration rate
GGTP gamma-glutamyl transpeptidase
GOT glutamate oxalacetate transaminase (= SGOT)
GPT glutamate pyruvate transaminase (= SGPT)
GSH glutathione (reduced)
GSSG glutathione (oxidised)
HAMA Hamilton Anxiety Scale
12-HETE 12-hydroxy-5,8,10,14-eicosatetraenoic acid
HDL high density lipoprotein
HIV human immunodeficiency virus
HMPC Committee on Herbal Medicinal Products (of the EMA)
HPLC high-performance liquid chromatography
5-HT 5-hydroxytryptamine (= serotonin)
IC50 concentration leading to 50% inhibition
ICD-10 International Statistical Classification of Diseases and Related Health Problems, Tenth Revision
ICH The International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use
ICSD International Classification of Sleep Disorders
IFN interferon
IL interleukin
i.m. intramuscular
iNOS inducible nitric oxide synthase
INR International Normalized Ratio, a measure of blood coagulation (clotting) tendency
i.p. intraperitoneal
IPSS International Prostate Symptom Score
i.v. intravenous
kD kiloDalton
KM Index Kuppermann Menopausal Index
kPa kiloPascal
LC-MS liquid chromatography-mass spectrometry
LD50 the dose lethal to 50% of animals tested
LDH lactate dehydrogenase
LDL low density lipoprotein
LH luteinizing hormone
5-LOX 5-lipoxygenase
LPS lipopolysaccharide
LTB4 leukotriene B4
M molar (concentration)
MAO monoamine oxidase
MBC minimum bactericidal concentration
MDA malondialdehyde
MFC minimum fungicidal concentration
MIC minimum inhibitory concentration
Mr molecular
MRS Menopause Rating Scale
MRSA methicillin-resistant Staphylococcus aureus
MTD maximum tolerated dose
MTT 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide
MW molecular weight
NBT nitro blue tetrazolium
NF-kB necrosis factor kappa-B
NO nitric oxide
NOS nitric oxide synthase
n.s. not significant
NSAID non-steroidal anti-inflammatory drug
ovx ovariectomy or ovariectomized
ORAC oxygen radical absorbance capacity
PA pyrrolizidine alkaloid
PAF platelet activating factor
PCR polymerase chain reaction
PEG polyethylene glycol
PGE prostaglandin E
PHA phythaemagglutinin
p.o. per os
POMS profile of mood states
PVPP polyvinylpolypyrrolidone
RANKL receptor activator of nuclear factor kappa-B ligand
RNA ribonucleic acid
RT-PCR reverse transcription polymerase chain reaction
s.c. subcutaneous
SCI spinal cord injury
SERM selective oestrogen receptor modulator
SGOT or GOT serum glutamate oxalacetate transaminase (= ASAT or AST)
SGPT or GPT serum glutamate pyruvate transaminase (= ALAT or ALT)
SHBG sex hormone binding globulin
SOD superoxide dismutase
SSRI selective serotonin reuptake inhibitor
STAI state-trait anxiety inventory
t1/2 elimination half-life
TBARS thiobarbituric acid reactive substances
TGF-b transforming growth factor-beta
TNF tumour necrosis factor
TPA 12-O-tetradecanoylphorbol-13-acetate
URT upper respiratory tract
URTI upper respiratory tract infection
UTI urinary tract infection
VAS visual analogue scale
VLDL very low density lipoprotein
ALOE CAPENSIS 2014
Cape Aloes

DEFINITION

Cape aloes consists of the concentrated and dried juice of the leaves of various
species of Aloe, mainly Aloe ferox Miller and its hybrids. It contains not less
than 18.0 per cent of hydroxyanthracene derivatives, expressed as barbaloin
(C21H22O9; Mr 418.4) and calculated with reference to the dried drug.

The material complies with the monograph of the European Pharmacopoeia [EP].

CONSTITUENTS

The main active constituents are 13-27% barbaloin, which is a mixture of aloin
A (10S) and aloin B (10R), the aloe-emodin anthrone C-glycoside 5-hydroxyaloin
A (characteristic for Cape aloes) and the anthrone C- and O-glycosides
aloinosides A and B [Rauwald 1993a, 1993b]. Other constituents include
2-acetonyl-5-methylchromones (also known as aloeresins), small quantities of
1.8-dihydroxyanthraquinones (e.g. aloe-emodin), cinnamic acid and 1-methyl-
tetralin derivatives [Sigler 2007; Hiller 2009; Sticher 2010; Chen 2012].

CLINICAL PARTICULARS

Therapeutic indications
For short term use in cases of occasional constipation [Schilcher 1979; Sigler
2007; Hiller 2009].

Posology and method of administration

Dosage

The correct individual dosage is the smallest required to produce a comfortable

soft-formed motion.

Adults and children over 12 years: preparations equivalent to 10-30 mg of

hydroxyanthracene derivatives, calculated as barbaloin, to be taken once daily
at night [Sigler 2007; Hiller 2009].

Elderly: dose as for adults.

Not recommended for use in children under 12 years of age.

The pharmaceutical form must allow lower dosages.

Method of administration
For oral administration.

Duration of administration
Stimulant laxatives should not be used for periods of more than 2 weeks without
medical advice. If symptoms persist after intake of the preparation medical
advice should be sought [Tack 2011].

Contra-indications
Known hypersensitivity; intestinal obstruction and stenosis, atony, inflammatory
bowel diseases (e.g. Crohn's disease, ulcerative colitis), appendicitis; abdominal
pain of unknown origin; severe dehydration states with water and electrolyte
depletion [Schilcher 1979; Reynolds 1996; Hiller 2009; Pasricha 2011].

Special warnings and special precautions for use

As for all laxatives, aloes should not be given when any undiagnosed acute or
persistent abdominal symptoms are present.

1

Chronic use of anthraquinone laxatives may cause pigmentation
of the colon (pseudomelanosis coli) which is harmless and
reversible after drug discontinuation. Abuse, with diarrhoea
and consequent fluid and electrolyte losses, may cause
disturbance of the water and electrolyte balance (mainly
hypokalaemia). A symptom of hypokalaemia is an atonic colon
with impaired function (aggravation of constipation). In severe
cases hypokalaemia can result in cardiac and neuromuscular
dysfunction, especially if cardiac glycosides, diuretics or
corticosteroids are taken. Chronic use may result in albuminuria
and haematuria.
Long-term use of stimulant laxatives is not recommended. If
laxatives are needed every day the cause of the constipation
should be investigated. Use of stimulant laxatives for more than
2 weeks should be avoided and requires medical supervision. In
chronic constipation, stimulant laxatives are not an acceptable
alternative to a change in dietary habits, adequate fluid intake,
physical activities and training for normal bowel evacuation
[Schilcher 1979; Müller-Lissner 1993, 2005; Reynolds 1996;
Nusko 2000; Morales 2009; Sticher 2010; Keller 2011; Pasricha
2011].
Anthraquinone laxatives enhance circulation in the pelvic
region and thus are not recommended for patients suffering
from haemorrhoids [Frasch 2007; Sigler 2007; Hiller 2009;
Sticher 2010].
Not recommended for children under 12 years.
Interaction with other medicaments and other forms of
interaction
Hypokalaemia (resulting from long term laxative use) potentiates
the action of cardiac glycosides and interacts with antiarrhythmic
drugs and with drugs which induce reversion to sinus rhythm
(e.g. quinidine). Concomitant use with other drugs inducing
hypokalaemia (e.g. thiazide diuretics, adrenocorticosteroids
and liquorice root) may aggravate electrolyte imbalance [Sigler
2007].
Pregnancy and lactation
Pregnancy
Not to be taken by pregnant women as there is a greater risk
of abortion due to increased circulation in the pelvic region
and nervous stimulation of uterine muscles [Frasch 2007; Sigler
2007; Hiller 2009].
Lactation
Not to be taken during breastfeeding as small amounts of active
metabolites (rhein) may appear in breast milk [Faber 1988;
Sigler 2007; Hiller 2009].
Effects on ability to drive and use machines
None.
Undesirable effects
Abdominal spasms and pain, in particular in patients with
irritable colon; yellowish-brown or red (pH dependent)
discolouration of urine by metabolites, which is not clinically
significant [Ewe 1986; Tedesco 1986; Reynolds 1996; Pasricha
2011; Tack 2011].
Overdose
The major symptoms are griping and severe diarrhoea with
consequent losses of fluid and electrolytes, which should be
replaced [Pasricha 2011]. Treatment should be supportive with
generous amounts of fluid. Electrolytes, especially potassium,
should be monitored; this is particularly important in the elderly
and the young.   which pass directly into the large intestine without breakdown
ALOE CAPENSIS
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
1,8-dihydroxyanthracene derivatives possess a laxative effect
[Fairbairn 1965, 1970]. Aloins A and B, 5-hydroxyaloin A and
the aloinosides A and B are precursors which are not absorbed
in the upper gut. Studies in conventional and germ-free animals
have established that glycosidases from the intestinal flora are
responsible for the breakdown of glycosides. The ability to
metabolize various anthranoids varies greatly across species
depending upon the composition of intestinal flora [Dreessen
1988; de Witte 1993; Sigler 2007]. In humans, anthranoid glyco-
sides ingested orally pass into the colon unmodified. Human
intestinal flora is able to break down O-glycosides easily but
only to some extent C-glycosides of most anthranoids [Hattori
1988; Che 1991]. The main active metabolite is aloe-emodin-
9-anthrone, which acts specifically on the colon [Ishii 1990].
There are different mechanisms of action:
(i) reduced resorption of sodium and water and an influence
on the motility of the large intestine (inhibition of the Na+/K+
pump and of Cl- channels at the colonic membrane) resulting
in accelerated colonic transit [Ishii 1990; Hönig 1992; Rauwald
1992; Wanitschke 2003; Hiller 2009], and
(ii) an influence on secretion processes (stimulation of mucus
and chloride secretion) resulting in enhanced fluid secretion
[Ishii 1990, 1994a, 1994b; Wanitschke 2003].
(iii) direct and indirect stimulation of colonic neurons (indirect
stimulation by prostaglandins) resulting in enhanced motility
[Capasso 1983; Ishii 1990; Wintola 2010; Teuscher 2012].
Due to the time taken for transport to the colon and metabolism
into the active compounds defecation may take place after a delay
of 6-12 hours [Sigler 2007; Müller-Lissner 2009; Pasricha 2011].
Anti-tumour activity
Isolated aloe-emodin specifically inhibited the growth of
neuroectodermal tumor cell lines at ED50 of 1-13 µg in vitro.
However, no effect could be shown on other tumor cell lines or
by aloe-emodin glycosides, which was explained by a unique
drug uptake of aloe emodin in neuroectodermal tumour cells.
These results were confirmed by further experiments in rats
[Pecere 2000].
In two human hepatic cancer cell lines, Hep G2 and Hep 3B,
aloe-emodin inhibited cell proliferation by different mechanisms
[Kuo 2002]. Aloe-emodin was also shown to inhibit the growth
of Merkel carcinoma cells [Wassermann 2002]. In isolated rat
hepatocytes, a cytoprotective effect of aloes extract against
1.4-naphthoquinone-induced toxicity was demonstrated
[Norikura 2002; Chen 2012].
An ethanolic fraction of Cape aloes was reported to have anti-
tumour activity in vivo against Sarcoma 180 and Ehrlich ascites
cancer cells [Soeda 1969]. After a screening of 31different
plants, aloes extract showed strong growth inhibiting effects
on Ehrlich ascites tumor cells (EATC). From subsequent in
vitro studies with Cape aloes dichloromethane extract it was
concluded that constituents of aloes contribute synergistically
to this effect. Aloe-emodin has no growth-inhibiting effect on
EATC but enhanced the effect of the other constituents of the
extract [Kametani 2007].
Pharmacokinetic properties
Aloins A and B as well as hydroxyaloins A and B are C-glycosides
2

in the stomach or the jejunum. At their site of action, the
colon and rectum, they are metabolized by bacterial enzymes
into the active anthrone compounds. It has been shown that
Eubacterium sp. BAR isolated from human faeces is capable of
transforming aloin A into the active metabolite aloe-emodin-
9-anthrone. This bacterial strain is necessary to cause aloin
A-induced diarrhoea in the rat [Hattori 1988; Schulz 1993;
Morales 2009; Sticher 2010].
In a human pharmacokinetic study performed with Cape aloes
(equivalent to 16.4 mg of hydroxyanthracene derivatives)
administered orally for 7 days, aloe-emodin was detected as a
metabolite in the plasma only sporadically and with maximum
concentrations of less than 2 ng/ml. In the same study rhein
was detected in the plasma in concentrations ranging from
6-28 ng/ml (median cmax 13.5 ng/ml at median tmax 16 h) after
single dose administration. In 7-day administration there was
no evidence of accumulation of rhein [Schulz 1993].
Using an Ussing-type chamber with rat colonic mucosa as
the test system, isolated aloe-emodin anthrone significantly
increased the permeation of poorly the permeable compound
5(6)-carboxyfluorescein [Kai 2002]. Isolated rhein and danthrone
enhanced permeation of furosemide in a Caco-2 cell monolayer
test system [Laitinen 2007].
In vitro studies on various membrane models confirmed
membrane-related effects of barbaloin. Measurements of the
phospholipid/water partition coefficient of barbaloin, and
investigations on its influence on membrane thermotropic
behaviour, illustrated barbaloin’s high affinity for phospholipid
membranes. Barbaloin-induced leakage of intraliposomal
carboxyfluorescein and the antimicrobial effect of barbaloin-
containing liposomes were traced back to the membrane
interaction of this anthraquinone [Alves 2004].
In vitro absorption studies demonstrated that 5-14 % of aloin,
aloe-emodin and aloesin were absorbed directly from the gut
[Park 2009].
From another study it was concluded that free anthranoids
absorbed systemically in humans are partly excreted in the
urine as rhein or as conjugates [Vyth 1979].
Systemic metabolism of free anthranoids depends upon their ring
constituents [de Witte 1988; Sendelbach 1989]. In the case of
aloe-emodin, it has been shown in animal experiments that at
least 20-25% of an oral dose will be absorbed. The bioavailability
of aloe-emodin is much lower than the absorption, because
it is quickly oxidized to rhein and an unknown metabolite,
or conjugated. Maximum plasma values of aloe-emodin
were reached 1.5-3 hours after administration [Lang 1993].
Elimination of anthranoid metabolites occurs mainly via faeces,
but also renally as glucuronides and sulphates [Teuscher 2012].
Preclinical safety data
No specific toxicity was observed when aloes extract (up to 50
mg/kg daily for 12 weeks) and aloin A (up to 60 mg/kg daily for
20 weeks) were administered orally to mice [Siegers 1986, 1993].
Aloes fermentation products, which contain higher amounts
of aloin A and B and less glucans compared to unfermentated
aloe preparations, were administered orally to rats at doses of
1, 2 or 5 g/kg for single-dose toxicity tests, and at 0.5, 1 or 2
g/kg for repeated-dose toxicity tests. Treatment, even at high
dose levels, did not affect function of the autonomic nervous
system, general behavior, reaction, vigilance, mortality, body
weight, feed and water intake, nor in haematological and
histopathological parameters [Cho 2011].
ALOE CAPENSIS
There was no evidence of any embryolethal, teratogenic or
foetotoxic effects in rats after oral treatment with aloes extract
(up to 1000 mg/kg b.w./day) or aloin A (up to 200 mg/kg b.w./
day) [Bangel 1975].
Results from in vitro (gene mutation and chromosome
aberration) tests and in vivo (micronucleus test in mice bone
marrow cells) genotoxicity studies as well as human and animal
pharmacokinetic data indicate no genotoxic risk from Cape aloes
[Brown 1979, 1980; Morimoto 1982; Bootman 1987a, 1987b;
Marquardt 1987; Westendorf 1988, 1990, 1993; Wölfle 1990;
CCR 1992a, 1992b, 1992c; Heidemann 1993; Lang 1993].
In a 2-year study, male and female F344/N rats were exposed
to 280, 830 or 2500 ppm of emodin in the diet, corresponding
to an average daily dose of emodin of 110, 320 or 1000 mg/kg
b.w. in male rats and 120, 370 or 1100 mg/kg in female rats.
No evidence of carcinogenic activity of emodin was observed
in male rats. A marginal increase in the incidence of Zymbal’s
gland carcinoma occurred in female rats treated with the high
dosage but was interpreted as questionable [NIH 1999].
In a further 2-year study, on B6C3F1 mice, males were exposed
to 160, 312 or 625 ppm of emodin (corresponding to an average
daily dose of 15, 35 or 70 mg/kg b.w.) and females to 312,
625 or 1250 ppm of emodin (corresponding to an average
daily dose of 30, 60 or 120 mg/kg). There was no evidence
of carcinogenic activity in female mice. A low incidence of
renal tubule neoplasms in exposed males was not considered
relevant [NIH 1999].
Aloin fed to mice in the diet at a level of 100 mg/kg/day for 20
weeks did not promote dimethylhydrazine-induced colorectal
tumours [Siegers 1993].
The data from in vivo studies concerning the carcinogenic risk
of aloe in rats can be supported by studies on herbal stimulant
laxatives containing senna extract, another anthraquinone
containing plant with similar constituents. Senna preparations
showed no carcinogenic or genotoxic effect, and from studies
in rats no connection to tumours could be identified [Lydén-
Sokolowski 1993; Morales 2009].
Clinical safety data
In a case control study with retrospective and prospective
evaluation, no causal relationship between anthranoid laxative
use and colorectal cancer could be detected [Loew 1994a,
1994b].
In another prospective case control study involving 202 patients
with colorectal carcinomas, 114 patients with adenomas and
238 patients in the control group, no association between the
use of anthanoid laxatives and the development of colorectal
adenoma or carcinoma was shown [Nusko 2000].
A longer-term use of laxatives has been recommended in chronic
constipation [Andresen 2013].
 
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ALOE CAPENSIS
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5
 ALOE CAPENSIS

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6
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