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Effects of Aloe vera Cream
on Posthemorrhoidectomy Pain and Wound Healing:
Results of a Randomized, Blind, Placebo-Control Study
Fariborz Eshghi, M.D.,
1
Seyed Jalal Hosseinimehr, Ph.D.,
2
Nasrin Rahmani, M.D,
1
Mohammad Khademloo, M.D.,
1
Mohammad Sina Norozi, M.D.,
1
and Omolbanin Hojati, M.D.
1
Abstract
Objective: Aloe vera is an herbal medicine, which has wound healing effects in burn injury. This study assessed
the effects of Aloe vera cream in reducing postoperative pain, postdefection pain, and its promotion of wound
healing after open hemorrhoidectomy.
Design: A prospective, randomized, double-blind, placebo-controlled trial was conducted comparing the effects
of a cream containing Aloe vera versus a placebo cream on posthemorrhoidectomy pain. The study preparations
were applied by patients to the surgical site 3 times per day for 4 weeks after hemorrhoidectomy. Pain was
assessed with a visual analog scale immediately postoperatively and at hours 12, 24, and 48 after surgery and at
weeks 2 and 4. Wound healing was examined and evaluated at the end of 2 and 4 weeks. The use of analgesics
was recorded.
Results: Forty-nine (49) patients were randomly assigned to receive aloe (n¼24) or placebo (n¼25). Patients in
the topical aloe cream group had significantly less postoperative pain at hours 12, 24, and 48 hours and at 2
weeks. Aloe cream reduced the pain after defecation in 24 and 48 hours postsurgery ( p<0.001). Wound healing
at the end of the second postoperative week was significantly greater in the aloe group compared with the
placebo group ( p<0.001). Patients required fewer additional analgesics posthemorrhoidectomy ( p<0.001).
Conclusions: Application of Aloe vera cream on the surgical site is effective in reducing postoperative pain both
on resting and during defecation, healing time, and analgesic requirements in the patients compared with the
placebo group.
Introduction
Hemorrhoids are one of the most common chronic
anorectal diseases known. Hemorrhoids grade III and
IV require an operative hemorrhoidectomy to eliminate
hemorrhoidal symptoms.
1–3
Hemorrhoidectomy is associated
with significant pain in the postoperative period. Both open
and closed hemorrhoidectomy resulted in postoperative
pain.
4,5
Continuous internal anal spasm is considered a major
factor in the inducing of pain.
6,7
The patients mainly required
narcotic and nonnarcotic analgesics in the early period post-
hemorrhoidectomy for reducing pain.
6
With regard to the
effect of pain on discomfort of patients, several pharmaco-
logical agents were assessed for relieving pain in patients,
including diltiazem ointment,
8
lidocaine and prilocaine
creams,
9
sucralfate cream,
10
glyceryl trinitrite ointment,
11
and
ropivacaine.
12
Recently we showed that patients who applied
topical metronidazole had significantly lesser postoperative
pain than those in the placebo group up to day 14.
13
Some
studies have shown that reduced postoperative spasm of the
internal anal sphincter is effective in reducing pain associated
with sphincter spasm.
8,11
Patients applied topical glyceryl
trinitrite for reducing posthemorrhoidectomy pain and had
headaches.
11
Therefore, patients sought a safe topical drug
with natural origin and with less toxicity.
Aloe vera (family: Liliaceae) has been used in traditional
medicine for a long time. It is one of the most recognizable
herbs in the world and the medicinal part is the succulent
leaves. A topical skin gel provides wonderful healing
support for the skin. Aloe vera contains many important
nutrients for the body, including amino acids, B vitamins,
and other nutrients that support general health. It also has
1
Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.
2
Faculty of Pharmacy, Traditional and Complementary Medicine Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
Volume 16, Number 6, 2010, pp. 647–650
ªMary Ann Liebert, Inc.
DOI: 10.1089/acm.2009.0428
647
pharmacological properties including antioxidant, wound
healing, antibacterial, antifungal, and immunomodulating
effects.
14
Burn wound healing is one of the major indications
of Aloe vera gel use in several in animal and clinical studies.
15
Realizing the potential use of Aloe vera in wound healing,
we examined the effects of Aloe vera cream versus placebo in
reducing postoperative pain and pain on defection after open
hemorrhoidectomy.
Methods
This clinical trial was registered by Iranian Registry of
Clinical Trials as a code IRCT138711131627N1. After ob-
taining approval from the Ethical Committee at Mazandaran
University of Medical Sciences, this clinical trial was carried
out in Imam Hospital, Sari, Iran. This study was a random-
ized, double-blind, prospective, placebo-controlled trial
comparing aloe cream with placebo cream. All patients who
were enrolled this study had symptomatic III and IV degree
hemorrhoidal diseases and met criteria for surgical hemo-
rrhoidectomy. All patients underwent open hemorrhoi-
dectomy. Exclusion criteria were pregnancy, anal fissure,
and heart and liver diseases.
Preparation of aloe cream
Liquid white paraffin, sterile alcohol, cetyl alcohol, solid
white paraffin, and propylene paraben were mixed and he-
ated to the boiling point as the oil phase. Aloe vera powder
(Zarband, Phytopharmaceutical Company, Iran) mixed with
deionized water was added to a mixture of propylene glycol,
sodium lauryl sulfate, and methylparaben. The mixture was
heated as the aqueous phase. These two separate phases
were mixed continuously while being cooled. Thus, after
cooling, the uniform cream that was produced was placed in
an aluminum package similar to a placebo tube, weighing
50 g. The cream contained Aloe vera gel powder 0.5%. Placebo
creams were prepared according to similar protocol without
aloe powder. Our experimental research and formulations
were carried out under sterile conditions. The final creams
were tested for any probable contamination microbes, which
were not detected during the applications.
Patients and study procedure
In this study, 49 patients were randomized in two groups.
Patients had creams applied (aloe or placebo) immediately
after surgery and 12 hours after hemorrhoidectomy. This
treatment was continued on the surgery site 3 times a day up
to 28 days postoperatively. Study patients applied approxi-
mately 3 g of aloe cream to the wounds outside. Control
patients applied the same quantity of placebo cream in a
similar fashion. The initial application of cream was per-
formed as a part of the postoperative dressing. For blinding,
the aloe and placebo creams were coded and both the nurse
and patients were blinded as to which cream was used
during examination. Patients were discharged from the
hospital 24 hours after surgery. Patients were instructed to
apply the cream with the tip of the index finger to the
wounds three times daily. All patients were supplied with
analgesic drugs as needed. The patients were followed up
after discharge from the hospital. Postoperative pain was
evaluated by using a visual analog scale (VAS), which was
scored as 0 (no pain) to 10 (very severe pain). Pain score were
obtained immediately postoperatively and at 12 hours, 24
hours, and 48 hours after surgery and at days 14 and 28. Pain
on defecation was also recorded using the VAS. The patients
recorded their analgesic requirement. At the end of 2 and 4
weeks postoperatively, an expert surgeon examined the
healing of patients’ wounds. Wound healing was defined as
complete epithelial covering as observed by physical exam-
ination. Wounds were classified as grade I (severe and fresh
wound with inflammation), grade II (granulation tissue on
wound), and grade III (completed layer of epithelial covering
on wound).
Statistical analysis
Data were analyzed using the ttest and w
2
, as appropriate,
to compare patients’ demographics, pain score, wound
healing, and analgesic drug use. P<0.05 was considered a
significant difference. Statistical analysis performed using
SPSS software (version 12, SPSS Inc., Chicago, IL).
Results
Forty-nine (49) patients were randomly assigned to receive
aloe cream (n¼24) or placebo cream (n¼25) after hemor-
rhoidectomy. Both groups were predominately female (aloe
group 16 female; placebo group 14 female). The groups were
similar with respect to age, gender, and extent of preopera-
tive hemorrhoid diseases. The number of patients with III
and IV degrees of hemorrhoids was 10 and 14, 11 and 14 for
aloe and placebo groups, respectively. Pain scores immedi-
ately after hemorrhoidectomy were 9.29 0.81 and
9.24 0.66 in the aloe and placebo groups, respectively. The
VAS scores were not significantly different between the two
groups in the time immediately after hemorrhoidectomy.
Patients in the aloe group experienced significantly less pain
at 12, 24, and 48 hours and 2 weeks postsurgery ( p<0.001)
(Table 1). Patients who received aloe cream were found to
have significantly lower pain on defecation on 24 and 48
hours after hemorrhoidectomy ( p<0.001), but no significant
difference was observed at 2 and 4 weeks (Table 2).
Aloe cream significantly helped wound healing in patients
at 2 weeks postsurgery ( p<0.001) (Table 3), but no signifi-
cant difference was observed at the end of 4 weeks. All
wounds in the aloe group showed grade III wound healing
with epithelial covering, but wound healing was grades I
and II in the placebo group at 14 days (Table 3).
Table 1. Postoperative Pain Scores in Aloe vera
and Placebo Groups
Time
Aloe (n¼24)
mean SD
Placebo (n¼25)
mean SD p-value
Immediately
after surgery
9.29 0.81 9.24 0.66 0.807
12 hours 5.75 0.9 8 0.71 <0.001
24 hours 3.2 0.83 6.3 0.70 <0.001
48 hours 1.8 0.64 5.2 0.91 <0.001
Week 2 1.16 0.38 2.56 0.50 <0.001
Week 4 1 0.00 1.04 0.20 0.332
Pain scores ranged from 0 (no pain) to 10 (very severe pain).
SD, standard deviation.
648 ESHGHI ET AL.
The narcotic consumption in the aloe group was signifi-
cantly less compared with the placebo group at 12 hours after
hemorrhoidectomy ( p<0.001). At 12 hours postsurgery, the
percentages of patients who required narcotic analgesic drug
(tramadol injection) were 21% and 76% in the aloe and control
groups, respectively. No narcotic consumption was observed
at 24 hours after hemorrhoidectomy. Nonnarcotic analgesic
medications were significantly lower in the aloe group 2
weeks after hemorrhoidectomy (Table 4) ( p<0.001).
No mortality was encountered. No side-effects or allergic
reactions were observed in patients who received creams.
Discussion
This prospective, randomized study has demonstrated
that application of Aloe vera cream provided significant pain
relief through the 48 hours post open hemorrhoidectomy.
Aloe cream led to significant wound healing at 14 days
postsurgery. Compared with the placebo group, lower an-
algesic consumption in the aloe cream group confirms the
improved pain management following a hemorrhoidectomy.
Various factors believed to be responsible for the pain
after hemorrhoidectomy include spasm of the internal
sphincter, and inflammation and bacterial colonization of the
hemorrhoidectomy site.
14–16
Another reason for pain could
be the healing of wounds, which was extended up to the
anorectal ring.
10
There are several reports that pharmaco-
logical agents with different mechanisms contribute to re-
ducing pain, include antispasmodic effects such as glyceryl
trinitrate ointment,
11
calcium channel blocker ointment,
8
botulinum toxin injection,
7
antimicrobial effects such as
metronidazole ointment,
14,15
and diminishing tissue edema,
such as sucralfate cream.
10
Aloe vera preparations have many biological effects in-
cluding antidiabetic, immunomodulatory, antiinflammatory,
antioxidant, and wound-healing effects.
17
A recent review of
clinical trials investigating the effect of Aloe vera on burn
wounds found that Aloe vera significantly shortened the
wound healing time compared to control.
8
Aloe contains
various carbohydrate constituents. Polysaccharides, man-
nose, and acemannan were identified in the aloe prepara-
tion.
17
Polysaccharides are known to have an effective
property in skin wound repair.
17,18
Antiinflammation is the
first step in wound healing, and this effect of aloe prepara-
tions is believed to play a direct role in facilitating rapid
healing.
18
Wound healing involves biological processes such
as inflammation and granulation tissue formation. Collagen
is the major protein in the extracellular matrix and provides
strength and integrity to the dermis and other supporting
tissues.
19–21
Aloe vera enhances the production of collagen.
20
Glycoprotein fraction is the major component of aloe that is
involved in wound healing with cell proliferation and mi-
gration and promotes the growth of dermal fibroblasts.
22,23
The glycoprotein fraction of Aloe vera stimulated cell prolif-
eration, accelerated recovery of an artificial wound on the
monolayer of normal keratinocytes, and enhanced thicken-
ing of the epidermal covering. Another study found that Aloe
vera increased the collagen content of the granulation tissue
as well as the degree of cross-linkage. It is thought that the
enhanced collagen content promotes stimulation by aloe in
collagen synthesis or increases the proliferation of fibroblast
synthesis of collagen, or both.
24
In this study, aloe cream significantly improved the
wound healing posthemorrhoidectomy. Since inflammation
is one of the main causes of pain in patients in the early
postsurgery time,
25
the antiinflammatory effects of aloe
contribute to relief of postoperative pain in patients treated
with aloe cream. Aloe has an antimicrobial effect; this effect
is related to its constituents including anthraquinones and
aloe-emodin.
17,18
This antimicrobial effect could be contrib-
uting to the reduction of pain and promotion of wound
healing by Aloe vera. It was demonstrated that oral or topical
antimicrobial agents such as metronidazole significantly
decreased postoperative pain after open diathermy hemor-
rhoidectomy.
15,16
The beneficial role of topical Aloe vera may
be antimicrobial, antiinflammatory properties, and positive
effects on wound healing.
Conclusions
In this study, a topical cream containing Aloe vera as herbal
medicine decreased postoperative pain and pain on defeca-
tion and enhanced wound healing after hemorrhoidectomy
Table 2. Pain on Defecation in Aloe
and Placebo Groups
Time
Aloe (n¼24)
mean SD
Placebo (n¼25)
mean SD p-value
Immediately
after surgery
9.08 0.92 9.08 0.81 0.989
24 hours 5.45 0.72 7.72 0.84 <0.001
48 hours 2.91 0.83 4.16 0.85 <0.001
Week 2 1.29 0.46 1.48 0.51 0.183
Week 4 1 0.00 1.2 0.41 0.134
Pain scores ranged from 0 (no pain) to 10 (very severe pain).
SD, standard deviation.
Table 3. The Number of Patients with Grade
of Wounds in Aloe and Placebo Groups
at the End of Week 2Posthemorrhoidectomy
Grade of wounds Aloe (n¼24) Placebo (n¼25) p-value
Grade I 0 12 <0.001
Grade II 0 12 <0.001
Grade III 24 1 <0.001
Wounds were classified as grade I (severe and fresh wound with
inflammation), grade II (granulation tissue on wound), and grade III
(completed layer epithelial covering on wound).
Table 4. Posthemorrhoidectomy Nonnarcotic
Analgesic Consumption in Aloe and Placebo Groups
During 2Weeks After Discharge from Hospital
Number of
medications
Number of
patients aloe
group (n¼24)
Number of
patients placebo
group (n¼25) p-value
Without analgesic 9 2 <0.001
One tablet per day 12 3 <0.001
Two tablets per day 3 10 <0.001
Three tablets per day 0 10 <0.001
Medication was 500-mg acetaminophen tablet.
ALOE CREAM AND HEMORRHOIDECTOMY 649
when compared with a placebo cream. The use of postoper-
ative analgesic agents was significantly decreased in the aloe
group. There were no side-effects observed related to aloe
cream.
Acknowledgments
This work was supported by a grant from Mazandaran
University of Medical Sciences, Sari, Iran. This research was
the subject of a thesis by Mohammad Sina Norozi for an
M.D. degree in the Faculty of Medicine, Mazandaran Uni-
versity of Medical Sciences, Sari, Iran.
Disclosure Statement
No competing financial interests exist.
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Address correspondence to:
Seyed Jalal Hosseinimehr, Ph.D.
Faculty of Pharmacy
Traditional and Complementary
Medicine Research Center
Mazandaran University of Medical Sciences
Sari
Iran
E-mail: sjhosseinim@mazums.ac.ir
650 ESHGHI ET AL.
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