Hemorrhoids are a very common anorectal condition defined as the symptomatic
enlargement and distal displacement of the normal anal
cushions. Haemorrhoids, also called piles, are swollen veins in your anus
and lower rectum; similar to varicose veins. Hemorrhoids have a number of
causes, although often the cause is unknown. They may result from
straining during bowel movements or from the increased pressure on these
veins during pregnancy. Hemorrhoids may be located inside the rectum
(internal hemorrhoids), or they may develop under the skin around the anus
(external hemorrhoids). Worldwide, the overall prevalence of hemorrhoids
in the general population is estimated to be 4.4%. It is estimated that
more than 50% of the population over 50 years of age have experienced
hemorrhoid problems13. It is very difficult to live with symptoms and
complication of internal haemorrhoids. Anaemia due to per rectal bleeding
secondary to haemorrhoids is one of important reason for blood transfusion. Multiple
factors have been claimed to be the etiologies of
hemorrhoidal development, including constipation and prolonged straining.
The abnormal dilatation and distortion of the vascular channel, together
with destructive changes in the supporting connective tissue within the
anal cushion, is a paramount finding of hemorrhoidal disease.
Today’s lifestyle is
changed; most of the people are not perfect in their food habits. They
have bad food habits like irregular intake of food, eating of fried foods,
excessive use of chilies and spices in food, etc. which is causative
for haemorrhoids. Therapeutic treatment of hemorrhoids ranges from
dietary and lifestyle modification to radical surgery, depending on degree
and severity of symptoms. Those have their advantages and limitations.
Variety of topical treatments is available in market. The primary
objective of most topical treatment aims to control the symptoms rather
than to cure the disease. Thus, other therapeutic treatments could be subsequently
required. A number of topical preparations are available including creams
and suppositories. These topical medications can contain various
ingredients such as local anesthesia, corticosteroids, antibiotics and
anti-inflammatory drugs4.
No radical topical
treatment is not available. Hence radical non surgical treatment in form
of topical ointment is need of time. After review of literature it was
observed that such management of abhyantar Gudarsh is mentioned in ancient
ayurvedic Samhita. Acording to Sushruta management of Abhynatar Gudarsh is
of four types. Aushadhi Chikitsa, Ksharkarma, Agnikarma and Shastrakarma.
Amongst that Ksharkarma is more effective non invasive
method. Although effective but traditional Pratisaraniya Ksharkarma6 is
more complex and tedious process. So modification in it is requirement of
current era.
Kshar Ointment is
modification of Kshar Pratisaran. Previous study with Yava Kshar ointment
was done. Siktha taila is previously used as a base for Kshar ointment
preparation is proven safe and effective as a base.10 This showed encouraging
results. But Yava Kshar is difficult to prepare and also
expensive. Apamarga Kshar is used as Pratisaraniya Kshar at many places
and is very effective7,8,9,10. Hence Apamarga Kshar is used in current
study in place of Yava Kshar. Apamarga Kshar ointment which is an ointment
of Apamarga Kshar with base Siktha taila is modified technique for
Ksharkarma which will be used in current study.
Current Study is having
novelty in selection of drug, drug dose and animal study. It is Open
Labeled, Randomized Controlled Phase I/Phase II Clinical Study. Apamarga
Kshar ointment will be prepared and tested with animal study for its
effectiveness and its dermal safety. Animal Study will be carried out at Animal
House of genuine institute. Clinical study will be carried out in two
groups. Observation from both groups will be noted. Analyzed statistically
and Discussed with conclusion after study.
Research Question
Whether Apamarga Kshar
ointment is effective in Abhyantar Arsha Chikitsa to reduce per rectal
bleeding and size of internal haemorrhoids?
Hypothesis
Hypothesis of this PhD
thesis will be - Apamarga Kshar ointment applied locally at internal
haemorrhoids once a day for 28 days with laxative ‘Avipattikar Churna’
orally is effective in reducing per rectal bleeding and degree of internal
haemorrhoids.
H0 = Apamarga Kshar
ointment applied locally at internal haemorrhoids once a day for 28 days
with laxative ‘Avipattikar Churna’ orally is not effective in reducing per
rectal bleeding and degree of internal haemorrhoids.
HA = Apamarga Kshar
ointment applied locally at internal haemorrhoids once a day for 28 days
with laxative ‘Avipattikar Churna’ orally is effective in reducing
per rectal bleeding and degree of internal haemorrhoids.
Animal Study inference:
As
per histopathological studies and hematological parameters, the application
of Apamarga kshar ointment is effective in the management of
croton oil-induced internal hemorrhoids in Wistar rats. It is not having any
adverse effect on histopathology and in relation to hematological parameters.
Increase in some lipid profile tests shows that Apamarga kshar ointment
base was absorbed systemically but it did not have any negative changes on
liver function test and kidney function tests. Hence, Apamarga kshar ointment
can be used in humans for further clinical trials.
Observation and results
Sexwise distribution of patients
It was observed that male and female patients were equally
distributed in both group. A number of male patients was more than female
patients in both groups. There is no significant statistical difference. Male
patients were more than that of female patients. In previous studies, also it
was observed that male patients are more than that of female patients133.
However, in larger study it was found that males and females are equally
affected by haemorrhoids134.
Agewise distribution of patients
Maximum patients in both group was from the age group 31 to
45 years and then between 45-60 years. This disease is more common in
middle-aged people. In previous studies also it was mentioned that About 50% of
people would have hemorrhoids at some point in their lives by the age of 50,
and hemorrhoids affect 5% of the population on average at any given time.
Per rectal bleeding
It was observed that almost all patients were having either
moderated or severe per rectal bleeding. When the clinical trial started, both
groups were having equally distributed patients of per rectal bleeding.
Bleeding is most common and important symptom of hemorrhoids, which takes
patients to clinicians; hence, all patients were having per rectal bleeding
before treatment. Per rectal bleeding was reduced with high significance with
both treatments.
Apamarga kshar pratisaran is
a trusted and proven treatment in the management of internal hemorrhoids. It
reduces PR bleeding by inflammation, healing, and fibrosis of hemorrhoidal
cushion.
Apamarga kshar ointment is used daily after
defecation. It has all properties of Apamarga kshar,
which is useful in reducing per-rectal bleeding after localized application.
This action was supposed to be due to Apamarga kshar by
producing inflammation and fibrosis of hemorrhoidal tissue. Base sikth
taila is having lubricating properties, which help to lubricate and
heal of hemorrhoidal cushion and reduce friction and injury to haemorrhoidal
tissue while defecating and causing a reduction of per rectal bleeding.
Degree of Hemorrhoids
Patients with the degree of hemorrhoids grade II and grade
III were present in both groups. Both groups are having no statistical
difference in a baseline. Maximum patients were from grade II and grade III.
Many patients ignore symptoms in grade I and in Grade IV surgery is the choice
of treatment.135 Hence, for conservative treatment only grade
II and grade III patients were available and selected as inclusion criteria for
study.
With both treatments, change in the degree of hemorrhoids
was observed late i.e. after 28 days to 45 days. This change may be observed
due to the healing and fibrosis of hemorrhoidal tissue, which ultimately
reduces prolapsing mass. Long-term follow-ups and treatment may change the
degree of hemorrhoids in many patients. This needs further prolonged study.
Over all treatment was effective with high significance in reduction of
prolapse mass of hemorrhoids and degree of hemorrhoids.
Discharge per anal
It was observed that discharge per anal was mild in maximum
patients at the beginning of the study and difference in both group was not
significant. Hence, both groups were from the same population.
Discharge per anal is maximum and associated with patient
having 4th grade hemorrhoid. In the current study, the maximum
patient was from 2nd Grade and 3rd Grade. Hence
a maximum number of patients were with mild to nil discharge per anal. After
treatment in a group, reduction in per anal discharge was seen in both groups.
Overall treatment was effective in treatment of discharge per anal.
Final
Outcome:
Primary Outcome:
It was observed that all patients from both groups has
improvement in disease. Per rectal bleeding was totally stopped in 101 (92.66%)
and 102 (95.32%) patients in Apamarga kshar pratisaran and Apamarga kshar ointment
group respectively. Per rectal bleeding reduced to mild in 8 (7.32%) and 5
(4.67%) patients in Apamarga kshar pratisaran and Apamarga kshar ointment
group respectively. Discharge per anal totally stopped in 105 (96.33%) and 102
(95.32%) patients in Apamarga kshar pratisaran and Apamarga kshar ointment
group respectively
Discharge per anal was reduced to mild in 2 (2.75%) and 4
(3.74%) patients in Apamarga kshar pratisaran and Apamarga kshar ointment
group respectively. Change in degree of hemorrhoids observed in 32(25%) patients
treated with Apamarga kshar pratisaran and
26 (21%) patients treated with Apamarga kshar ointment.
All patients who underwent complete treatment have shown
improvement in both groups.
19 (15%) patients from Apamarga kshar ointment
group and 17 (13.49%) patients from Apamarga kshar pratisaran group
dropped out as they did not completed treatment protocol.
No complete cure in any patient of both groups was observed.
Secondary Outcome:
No
complication observed in any groups. Initially local irritation observed in
some patients who did not wipe anal region after treatment. However, it was
resolved after 2 to 3 days of taking care about wipe out excessive ointment at
anal region.
Conclusion
From results and statistical analysis, it was concluded that
Apamarga kshar ointment applied locally is
effective in reducing C reactive protein significantly as compared to active
control. It has histopathological changes indicating reduction in inflammation,
healing with fibrosis. It reduces recto anal coefficient after treatment as
compared to active control.
Application of Apamarga kshar ointment
is effective in management of croton oil induced internal hemorrhoids in Wistar
rats.
Apamarga kshar ointment was
absorbed in systemic circulation and showed minimal increase in serum
triglycerides, serum LDL and VLDL cholesterol. However, it did not have any
negative effect with respect to liver function test and Kidney function test of
Wistar rats. Hence, Apamarga kshar ointment is
safe and not having any acute toxic effect.
Primary Outcome : Apamarga kshar ointment
reduced per rectal bleeding from 3rd day and it was nil in
95.66% compared to Apamarga kshar pratisaran, in
which it was 92.06% patients after 28 days.
Apamarga kshar ointment was
effective in reduction of degree of internal hemorrhoids in few patients but it
did not reduced degree of haemorrhoids in all patients. Long-term treatment may
be effective in reduction of degree of internal hemorrhoids.
Apamarga kshar ointment was effective
in reduction of per anal discharge associated with internal hemorrhoids nil in
95.33% compared to Apamarga kshar pratisaran, in
which it was 96.33% patients after 28 days.
Secondary Outcome : No complications was
observed with treatment.
Hence, It is concluded that Apamarga kshar ointment
is effective in management of per rectal bleeding, reducing per anal discharge
due to internal hemorrhoids and degree of hemorrhoids up to some extent.
Thus, alternative hypothesis HA i.e. Local application of Apamarga
kshar ointment at internal haemorrhoids once a day for 28 days with
laxative ‘Avipattikar Churna’ orally is effective to reduce per
rectal bleeding and gradation of internal haemorrhoids is accepted
Difficulties in actual work :
Local application of Apamarga
kshar ointment is to be done by patient at home. Therefore, application
of ointment has possible error due to improper technique by patient, not
following proper treatment schedule and protocol by patient.
If some part of
ointment remains on normal skin then it can cause local irritation and
excoriation. Hence, patient must be advised to wipe out extra ointment, which
is present outside of anus.
Squeezing pressure by
patient can differ much time. Hence, quantity of ointment applied at
hemorrhoids differs and which can interfere with desired outcome.
Ointment base is sikth
taila, which is combination of Tila taila and beeswax it tends to
get harder in consistency during winter. This makes application of ointment
difficult as ointment come out of tubes difficultly and only after excessive
pressure. This problem was tackled by advising patient to keep ointment tube in
warm water before application. Further, by increasing proportion of Tila
taila in base sikth taila this problem can be solved.
Use of slit proctoscope
is sometimes painful. While removing proctoscope if slit proctoscope is not
having complete slit then hemorrhoid gets stuck in lower end of proctoscope and
it hurts patient.
If slit is complete
then obturator of proctoscope does not fix properly and again it may hurt patient
while insertion of proctoscope. Hence, procedure should be done very delicately
and with well-lubricated proctoscope only.
Apamarga kshar
pratisaran need one or two assistant while applying kshar. One
assistant is required for holding proctoscope and another for providing kshar,
Amla dravya and other instruments.
Application of Apamarga
kshar can be done with spatula. Loss of drug i.e. Apamarga kshar
is observed if pratisaran is done with the ear buds or cotton swabs.
Assessment of
per-rectal bleeding, discharge per anal and prolapsed of hemorrhoid during
defecation is totally dependent on patients response. It is not possible for
assessment actually by intervening doctor. This error can cause error in final
interpretation.
Suggestions
Long-term comparative animal
study i.e. for full duration of treatment is expected to be done for assessment
of local changes after long-term treatment.
Assessment of changes in
lipid profile of animals after long-term treatment and after seasation of
treatment for one month.
Study for longer
duration for assessment of complete reduction in degree of hemorrhoids.
Study for changes in
lipid profile of patient using Apamarga Kshar Ointment,