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Introduction:
Efficacy and safety of herbal treatment was compared with modern medicine
treatment in patients of fissure-in-ano.
Methods: Fifty patients of anal fissure attending the surgery OPD randomly
received the study (25) medication (Herbal ointment and Herbal oral
powder) or control (25) medication (lignocaine jelly application and
oral liquid paraffin) after obtaining written informed consent. Clinical
evaluation done by proctoscopy and PR (per rectal) examination for constipation,
pruritus, bleeding per rectal (PR), discharge and anal spasm for a period
of 4 weeks. Pain was evaluated on Visual Analogue Scale (VAS). Effect
on renal and hepatic functions was evaluated by laboratory investigations.
Results: Twenty three patients from study group and 21 from control
group completed the study. Pain scores significantly reduced on days
7, 14 and 28 with both the treatments (p < 0.05) and the reduction
was similar in both groups (p > 0.05). Improvement in constipation,
bleeding and anal spasm was comparable in the two groups. Healing was
better in the control group at the end of study. Hepatic and renal functions
were unaltered in all patients.
Conclusion: Herbal ointment and Herbal powder provided significant symptomatic
improvement in patients of fissure-in-ano which is comparable to the
standard therapy. |
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| INTRODUCTION |
Anal
fissure is a common problem that causes substantial morbidity in people
who are otherwise healthy. The incidence of anal fissure is similar
in men and women.1,2 Spasm of the anal sphincter has been noted in association
with anal fissure,3,4 and for many years treatment has been focused
on alleviating hypertonia of the sphincter. The most common treatment
for chronic anal fissure has been lateral internal sphincterotomy which
is simple and effective, but the fundamental drawback of surgery is
its potential to cause minor but sometimes permanent alterations in
the control of gas, mucus, and occasionally, stool.1-3,5-7 Pharmacological
sphincterotomy with injection of botulinum toxin8 and application of
nitroglycerin ointment, calcium channel blockers and phosphodiesterase
inhibitors have been used to eliminate the need for surgery and avoid
the risk of permanent injury to the internal anal sphincter, but have
shown to be inconsistent in promoting healing of fissure.9-14
A reduction in the anal spasm by use of local anaesthetics or smooth
muscle relaxants and preventing constipation with emollients allows
the fissure to heal.
erbal ointment is a proprietory herbal preparation containing ingredients
having anti-inflammatory15-19 anti-microbial,20 immuno-modulatory,21,22
emollient and analgesic activity.
Herbal powder is a proprietory herbal preparation having laxative action.
It is useful as a demulcent in inflammatory19 and irritable affections.
Herbal ointment is advocated as an adjuvant therapy with Herbal powder
in patients of ano-rectal disorders.
Hence, the present study was planned to study the efficacy of herbal
ointment as local application along with herbal powder orally in comparison
with local application of Lignocaine jelly along with liquid paraffin
emulsion orally. |
| |
| METHODS |
Aim
To compare the efficacy and safety of herbal treatment versus modern
medicine treatment in patients of fissure-in-ano.
Study Population
A total of 50 patients attending the surgical outpatient department
of the tertiary health care institute, who were diagnosed as fissure-in-ano
were enrolled during April 2002 to August 2002 after obtaining informed
written consent. Patients with haemorrhoids, diabetes, ischaemic heart
disease (IHD), congestive cardiac failure (CCF), irritable bowel syndrome
(IBS), chronic inflammatory bowel disease (CIBD), carcinoma colon, hepatic
and renal disorders and those who had undergone anal surgical procedures
in the past were excluded.
Study Design
This was a single blind, comparative, randomized study. The treating
physician was unaware of the randomization code. The study protocol
was approved by the Institutional Ethics Committee.
Interventions
All patients were screened by clinical evaluation, proctoscopy and laboratory
investigations. Eligible patients were randomly assigned as per the
computer generated randomization chart to one of the following two groups.
Study group
HERBAL OINTMENT contains Yashtimadhu (Glycyrrhiza glabra) 3 gms which
has anti-inflammatory and immunomodulatory activity, Haridra (Curcuma
longa) 2 gms having anti-inflammatory, antioxidant and immunomodulatory
activity, Lajjawati (Mimosa pudica) 2 gms having antimicrobial activity,
Rudhra sal (Symplocus racemosa) 2 gms, Babul sal (Acacia arabica) 3
gms having antimicrobial and hypoglycemic activity, Peepal sal (Ficus
religiosa) 2 gms having antibacterial activity, Wat sal (Ficus bengalensis)
2 gms having antibacterial, antioxidant and antidiabetic activity, Udumber
sal (Ficus glomerata) 2 gms having hypolipidaemic activity, Til oil
(Sessamum indicum) 15 ml having antiproliferative and antioxidant activity,
Madhu (Honey) 10 ml having wound healing properties, Chandan oil (Santalum
album) 0.1 ml and Ointment base upto 100 gms.
HERBAL POWDER contains Isapgol (Plantago Isapgula), Sannay (Cassia angustifolia),
Madhurika (Foeniculum vulgare) and Yashtimadhu (Glycyrrhiza glabra)
which are having laxative activities.
Study group received Herbal ointment applied twice daily locally and
Herbal powder 10 grams daily orally.
Control group
LAXATIVE EMULSION contains (each 15 ml) Liquid paraffin 3.75 ml and
Milk of magnesia 11.25 ml.
LIGNOCAINE JELLY 2 % is a local anaesthetic.
Control group received lignocaine jelly 2% applied twice daily locally
and laxative emulsion oral administration 10 ml daily. |
|
Follow-Up
and Assessment |
Patients
were followed up on days 7, 14 and 28 or in event of any adverse effect
related to the medication, aggravation of symptoms or excess bleeding.
Pain assessment was done on a 0-100 VAS. Assessment was done by clinical
examination, proctoscopy and history at enrolment and on days 7, 14
and 28 for bleeding, ulcer healing, pruritus, anal spasm and constipation.
|
|
Statistical
Analysis |
Symptomatic improvement was defined as persistence of fissure without
symptoms. Ulcer healing in the two groups was analyzed by Chi-square
test for statistical significance. Improvement in pain scores was analyzed
by ‘t’-test for significance between the two groups. |
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|
RESULTS |
Forty
four patients completed the study (23 study and 21 control) and 6 patients
were lost to follow up (4 study and 2 control). Two groups were similar
with regards to demographic data and symptom scores at enrolment (Table
1).
 
Pain scores improved significantly in both the treatment groups on days
7, 14 and 28, the difference being statistically significant (p <
0.05, paired ‘t’-test) (Fig. 1). Reduction in pain score
from baseline values on days 7, 14 and 28 was found to be similar in
the two treatment groups (Table 2), there being no statistically significant
difference between the two treatment groups (p > 0.05, unpaired ‘t’-test).
17 (73.91%) patients in study group and 14 (66.66%) patients in control
group reported adequate pain control (p > 0.05 by Chi-Square test).
22 (95.62%) patients in the study and 19 (90.47%) in the control group
reported constipation on enrolment. At the end of the study, only 1
(4.34%) patient in study and 3 (14.28%) in control had constipation.
The incidence of constipation reduced in both groups (Fig. 2).
4 (17.39%) patients in study and 2 (9.52%) in control group had pruritus
at enrolment whereas 3 (14.28%) patients from the study and 2 (9.52%)
from the control reported anal pruritus after starting the study treatment.
On enrolment 16 (69.56%) patients in study and 17 (80.95%) in control
group had severe anal spasm. Number of patients having anal spasm reduced
to 4 (17.39%) in the study group and no patient had anal spasm in the
control group at the end of the study period.
5 (21.73%) patients in the study group and 10 (47.61 %) in the control
group had healed fissures at the end of the study, the difference between
the two treatment groups being statistically significant (p < 0.05
Chi-Square test).
Symptomatic improvement was seen in 13 (56.52%) patients in study group
and 10 (47.61%) patients in control group.
All the laboratory parameters remained unaltered during the study period
in both the treatment groups.
Nine patients in study group and 8 in the control group had per rectal
bleeding on enrolment. On day 28, there was no bleeding in 7 out of
8 patients in the study group; one patient reported bleeding during
treatment period, whereas in the control group anal bleeding stopped
in 5 out of 8 patients and one patient had increased bleeding.
One patient in each of the two groups reported burning sensation in
the anal region after starting the treatment. One patient in the study
group had prolapsed piles and was referred for surgery on day 14. No
other complications or side effects were reported in any of the patients.
|
| |
| DISCUSSION |
Anal dilatation
and sphincterotomy under general or local anaesthesia is the preferred
management of anal fissure, but surgery is associated with a number
of complications, most common being incontinence, which in 8 to 30
percent of patients is permanent.12,23 Recently, chronic fissures
have been successfully treated with topical nitroglycerin ointment,
injection of botulinum toxin, calcium channel blockers and phosphodiesterase
inhibitors.9-14,24
Our study compared the use of lignocaine jelly local application along
with use of a laxative versus herbal study medication which consisted
of Herbal ointment for local application and Herbal powder orally
as a laxative. Present study shows significant improvement in symptoms
of anal fissure with the study treatment and this improvement is comparable
to the control treatment.
Herbal ointment contains various ingredients which have shown to have
anti-inflammatory15-19 anti-microbial,20 immunomodulatory,21,22 emollient
and analgesic activity. Anal fissure is associated with local inflammation,
which leads to pain and anal spasm. Extracts of Curcumin, Glycirrhaza
and Ficus species have potent anti-inflammatory activity16,18,19 which
helps in reducing the inflammation thus reducing anal spasm. Reducing
anal spasm has shown to improve the healing rate in previous studies.9,10,24
Honey is known to have emollient and wound healing properties and
has shown to promote healing of infected venous leg ulcers.25
Herbal powder contains Isapgol (Plantago Isapgula) as a main ingredient
which is a potent laxative, which prevents straining at stools thus
reducing pain and anal spasm.
Reduction in anal spasm was better in the control group in the present
study, which may be attributed to the local anaesthetic in the control
group. Ulcer healing was found to be better in the control group.
In summary, we found Herbal ointment and Herbal powder to provide
adequate symptomatic relief, which was comparable to the standard
pharmacological therapy for anal fissure. Further large-scale multi-centric
studies should be conducted to evaluate the efficacy and safety of
these preparations in patients of anal fissure.
|
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| ACKNOWLEDGEMENT |
We
kindly acknowledge VAIPANI HERBAL, Nagpur for supplying the study medication.
We also acknowledge the efforts of Mr. Dashrathe, In-charge, drug store
for his assistance in the work. |
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