Eucarbon Ramadan Tips

Ramadan Champaign 2016
Created: Abbadi 05/16
Translated: Cosmoglott 06/16
Edited: Dr. Hübner 06/16

Does anyone wait until the pain has settled in?
Why wait?
Especially for patients for whom pain is always
there from day one

Ramadan
Influence on Irritable
Bowel Syndrome (IBS)
Gastrology
*Resident, **Professor *** Professor and head of department
(1) Department of hepato-gastroenterology and proctology, (2) Department of visceral surgery wing III University
Hospital Ibn Rochd. Casablanca

ASSUMPTION OF
RESPONSIBILITY FOR
IBS DURING THE
MONTH OF RAMADAN
IBS is to be treated on the
psychological level as well as
on the physiological level
because it concerns a
disorder
touching on interactions of
the brain and the digestive
system.
The fact of modifying one’s
diet and managing one’s
stress well can reduce the
symptoms in light or
moderate cases.
Whenever discomforts are
very unpleasant, the doctor
can prescribe drugs which
reduce the pain while acting
on the movements and the
contractions of the intestines.
the body to use one’s fat content
reserves properly.
That is not to say that there
should be an intense effort
provided, especially in the first
days of Ramadan where the body
is not adapted yet to the new
diet.
FOOD
Before undertaking treatment, it
is recommended to note over a
few weeks what one eats in order
to identify the food which starts
discomforts systematically and
to exclude them from the menu.
The advice of a nutritionist may
be of great help: they make it
possible to continue to eat in a
balanced way in spite of the fast.
affects from 10 to 20% of the
population of Western countries,
especially women.
INFLUENCE OF
RAMADAN ON IBS
The gravity, type and number of
symptoms vary greatly from one
person to another.
Certain individuals can present
several of the following symptoms:
•Constipation or diarrhea,
sometimes in alternation
•Abdominal pain and cramps
relieved by emission of gas or
stools;

Diary
Diet during Ramadan and functional digestive disorders
Diet during Ramadan and IBS
Let us define patient profiles together
Eucarbon: Why and How?
Practical training and cases
Diet during Ramadan and functional digestive disorders
Diet during Ramadan and IBS
Let us define patient profiles together
Eucarbon: Why and How?

Are there digestive diseases
whose incidence increases
during “Ramadan”?

Are there digestive diseases which increase dduring
Ramadan?
At the time of the Ramadan fast, the modification of
feeding after the iftar meal favours foods rich in lipids and glucids
which will directly act on the relaxation of the lower
sphincter of the esophagus accompanied by an increase
in the gastric secretion of acid at the origin of the pains at the
oesogastric level and by a deceleration of digestion.
Food changes in terms of quality and quantity
(significant and late consumption of food, just before
sleep) support the occurrence of RGO.

The appearance of dyspeptic symptoms relates to
poor feeding at the moment of breaking the fast
Frequent and excessive association with too fatty, too
sweet, too spicy food
Obstructed/isolated abdominal discomfort or
generally associated with warning signs such as
nausea or abdominal meteorism, dyspepsia
Are there digestive diseases which increase during the
Ramadan?

Dyspepsia
Intestinal functional disorders
Constipation
oGastro-œsophagal reflux
oGastroduodenal ulcer
Ramadan?

Constipation can cause disorders such as indigestion
with feeling of distension, but it can sometimes be more
serious with the appearance of hemorrhoids or anal
fissures.
Gastro-œsophagal reflux (RGO) is a disease which
affects the valve between the esophagus (conduit
which helps swallowing) and the stomach which
involves an inverse reflux of the contents of the
stomach into the esophagus.
Ramadan?

Intestinal Functional disorders
• Classification of ROME III:
– Irritable bowel syndrome (IBS)
– Functional diarrhea
– Functional constipation
– Functional distensions
– Non-specific intestinal functional disorders

Software house or SCI
• Dominated by pain or digestive discomfort
• Associated with disorders of transition:
constipation, diarrhea or alternation of the 2
• Capable of being associated with other
symptoms: urgency, feeling of incomplete
evacuation, mucus, dyschezia,

SCI
 The irritable bowel syndrome (IBS) is an intestinal
functional pathology frequent and incapacitating,
The irritable bowel syndrome, still called intestinal functional
disorder or functional colopathy or spasmodic colitis, is a frequent
affection which is defined by the coexistence of chronic
abdominal pains and of disorders of transition (cramps,
distensions and changes in the practices of evacuation, ranging
from a sudden attack of diarrhea to constipation) which is
heightened at the time of painful pushes

SCI
• Abdominal pains and cramps which may be intermittent or
take the shape of a continuous dull pain;
• constipation or diarrhea, or alternation of both;
• the urgent need go to stool;
• Feeling of incomplete evacuation
• flatulence (excess gas);
• Abdominal distension, changes in intestinal practices;
• presence of mucus in stools.

The SCI
The clinical diagnosis of irritable bowel syndrome (IBS), is
based on the criteria of Rome III
CRITERIA OF ROME III
Recurring pain or abdominal discomfort, present at least 3 days per month
over the last 3 months and associated with at least 2 of the following 3
characteristics:
•alleviated by defecation;
•onset associated with modification of the frequency of stools;
•onset associated with modification of the form (appearance)
of stools.
These criteria must be satisfied during the previous 3 months, but the
symptoms must have started 6 months earlier.

One distinguishes three sub-categories of this
syndrome according to the type of main symptoms:
syndrome with pain and diarrhea
syndrome with pain and constipation;
syndrome with pain, diarrhea
and constipation
SCI “software house”

Stricken persons may know periods of pushes,
intersected with more or less long phases of remission:
 Discomforts may appear each day, over a
week or a month
Then disappear or, last all one’s life.
Only a minority of patients present
serious conditions.
SCI “software house”

During the month of Ramadan, culinary and hygienic
practices change
These changes can affect the daily life of
patients suffering intestinal disorders
The SCI and the fast

practices change
Listed as being a
latent disease, IBS manifests itself
more and more clearly and may
even become very painful

practices change
It can also seriously obstruct
the professional and
social activities of those who suffer from it,
impoverish their quality of life and
involve anxiety and depression.

SUMMARY: The irritable bowel syndrome is regarded
more like a functional disorder than as a disease. It
concerns poor performance without apparent lesions at
the level of the intestine. As for the term “syndrome”, it
indicates a set of symptoms with a type of abdominal pains,
distensions and disorders of transition (constipation,
diarrhea). During the month of Ramadan, the change of
food and of lifestyle imposes on these patients a specific
medical monitoring in order to avoid aggravation of
digestive symptamology.

Influence of
Ramadan
on
irritable bowel
syndrome
Gastrology
Drs I. Baghad*, F Haddad **, R. Alaoui **, S. Nadir **, A. Cherkaoui ***, O. Loukili* (2), F Chihab *** (2)
* Resident, ** Professor *** Professor and head of department
(1) Department of Hepato-gastroenterology and proctology (2) Department of visceral surgery wing III
University Hospital Ibn Rochd. Casablanca
Drs I. Baghad*, F Haddad **, R. Alaoui **, S. Nadir **, A. Cherkaoui ***, O. Loukili* (2), F Chihab *** (2)Drs I. Baghad*, F Haddad **, R. Alaoui **, S. Nadir **, A. Cherkaoui ***, O. Loukili* (2), F Chihab *** (2)

The most frequent symptoms:
distension and flatulence
imperative need to go to stool;
feelings of incomplete evacuation of
stools;
rumblings
mucus in stools.;
These symptoms generally occur
after meals (iftar, shour.).
Other symptoms related to the fast

Other clinical signs sometimes present
Headaches
Heartburn;
Pelvic pain;
Nausea
Sleep disorders
These symptoms aggravate the clinical picture
and impair the quality of life of patients

Other influences of Ramadan on patient IBS
Seriousness, type and number of symptoms vary greatly
from one person to another
abdominal pains and cramps
often relieved by the emission of gas
or stools
constipation or diarrhea, sometimes in
alternation
Certain individuals may present several
of the following symptoms

Exercise N° 1
Crystallization
To form as a group
To prepare an intervention precisely summarizing
the data presented
Duration of preparation: 15 minutes

Exercise N° 2
Crystallization
To form as a group
To describe patient profiles for whom it would be
recommended to start preventive medication and
cover during the fasting period

Exercise N° 3
Crystallization
To form as a group
What are the benefits of Eucarbon compared to
its “competitors”

Exercise N° 4
Crystallization
To form as a group
To work out a specific sales leaflet for the
“Ramadan campaign” visit with the SPIN method

I am a private Gastro-
enterologist
What I think:
• Personally I remain favorable to
Eucarbon in curative TT
• I am not convinced as to the need
of preventive TTT
What I do:
• I prefer to prescribe
Eucarbon according to my
therapeutic practices
Define the doctor’s profile :
 skeptic,
 objection,
 indifferent
How to conduct the visit?
• ..........................
• ........
What I must say
• ..........................
• ........
Case N°1
What one asks of you:
• To prepare the general architecture of the visit
• To develop sales leaflets according to the
practical case
Medical representative
Hand In Hand
SPIN

enterologist
What I think:
• I no longer prescribe Eucarbon
• Currently we have other choices
What I do:
• I prefer to prescribe new
products often not known to
the patients
 skeptic,
 objection,
 indifferent
• ..........................
• ........
What I must say
• ..........................
• ........
Case N°2
practical case
Hand In Hand
SPIN

enterologist
What I think:
• I think it is not a bad idea to
consider preventive TTT
• But according to what protocol
and for how long?
What I do:
• I ask for clarification on your
part
 skeptic,
 objection,
 indifferent
• ..........................
• ........
What I must say
• ..........................
• ........
Case N°3
practical case
Hand In Hand
SPIN

enterologist
What I think:
• The patients whom we receive
over the course of the month of
Ramadan come with very
alarming clinical charts
• Eucarbon on its own is not
enough in this case
What I do:
• We choose other therapeutic
processes
 skeptic,
 objection,
 indifferent
• ..........................
• ........
What I must say
• ..........................
• ........
Case N°4
What one asks you:
practical case
Hand In Hand
SPIN

Treatment of patients
with Irritable Bowel Syndrome
(IBS) with
Eucarbon ® tablets
Dr. Wolf D. Hübner1, Dr. Ewald H. Moser2
1. Berolina Drug Development GmbH, Fontanestraße 84-90, D-15366 Neuenhagen
2. F. Trenka Chem.-pharm Fabrik GmbH, Goldeggasse 5, A-1040 Wien
Advances in Therapy September-October 2002; volume 19 (5)

Irritable Bowel Syndrome (IBS)
Repetitive benign chronic pathology
Complex pathology, with particularly difficult clinical and
therapeutic processing.
Characterized by:
• Recurrence of abdominal pain.
• Deterioration of intestinal function.
Frequency: 9 to 22% of general population.
(Carlson, 1998; Thompson and Gick, 1996)
Only about 5% consult a doctor.

High economic impact
Incapacity.
Professional and school absenteeism.
High medical cost.
69% to 85% of patients have been informed of their difficulties in
their daily activities (Chassany and col 1999)
Sub-group of IBS (similar frequencies)
Prevalence of constipation
Prevalence of diarrhea.
Prevalence of gas.
Prevalence of pain.
Alternation constipation - diarrhea.
Feeling of incomplete evacuation.

Criteria of diagnosis of IBS
(“ROME” Criteria)
1.Persistence and recurrence of one of the following symptoms for a 3
month minimal period: Abdominal pain and distrubances.
Which are reduced with defecation.
Associated with a change of frequency of defecation.
Associated with a change of consistency of stools.
2. Irregular defecation rhythm (variable) at least 25% of the time,
associated with two or more of the following symptoms:
 Deterioration of frequency of defecation.
Deterioration of form and consistency of stools (hard/lumpy stools or
soft/liquid stools),
Deterioration of defecation (effort and sense of urgency, or feeling of
incomplete evacuation),
Defecation of mucus.
 Flatulence and feeling of abdominal distension.

Clinical signs.
General feeling of abdominal pains (left lower quadrant)
Change of habits of defecation and the characteristics
(consistencies) of stools (soft stools, diameter of a pencil)
Abdominal distension
Usually these patients consult a few weeks even a few
months after the appearance of symptoms.

Eucarbon®
Intestinal adsorbent, soft laxative and regulator of intestinal
transition.
Product containing natural components of mineral and vegetable
origin: Vegetable coal, Senna leaves, Rhubarb roots, purified
Sulfur, Fennel and Mint essences.
Very extensive therapeutic experience: Eucarbon has been
marketed for nearly a century with the same ingredients.
Proven effectiveness, well tolerated and reliable, even for long-
term use.

STUDY
Multinational, multicentric, forward-looking study, as a randomized
double blind of phase III, with a parallel control group.
The two groups received tablets of identical size and appearance
during a 12 weeks study period.

Sites
35 centres in 4 countries
(Austria, Belgium, Israel and Morocco).

Causes of IBS
Stress (causes non-painful diarrhea, which regresses as of the
disappearance of the stress factor)
Depression, anxiety and other psychological phenomena
Intolerance of certain specific foods (lactose, gluten) unbalanced
feeding.
Sedentariness, lack of physical exercise…
Intestinal infections
Certain prolonged medicinal treatments.

Evaluation/Protocol
5 consultations on the whole are envisaged
Consultation 1: screening consultation.
Consultation 2: basic consultation.
3 monitoring consultations at 4th, 8th and 12th weeks after onset
of treatment.

Criteria for recruitment
For the choice of suitable patients:
7 to 14 days before the basic consultation (Screening)
Termination of all medications not authorized by the protocol.
Laboratory tests (test of occult blood in stools, routine
examinations such as blood count, serological and biochemical).
Diagnosis of IBS “by elimination”
Preliminary elimination of organic pathologies.
(irrigoscopy, colonoscopy/rectoscopy).

Consultations
At 4 week periodic intervals during treatment
Evaluation of the gravity of the patient symptoms using a
questionnaire (Francis Score slightly modified ).
The questionnaires must be completed by the patients.
Days of professional absenteeism and days of suffering caused by
IBS were evaluated after examination of the questionnaire and
discussions with patients.
Reactions to treatment were evaluated according to the Francis
Score at the end of the 12th week.

Laboratory tests
Before recruitment (before onset of treatment; consultation 2)
After 12 weeks of treatment (consultation 5).
Additional samples and examinations will remain at the discretion
of each doctor.

Undesirable effects
Reserved according to the usual criteria.
Evaluated with each consultation during the treatment.

Concurrent medications
All medications for IBS must be suspended at least 1 to 2 weeks
before the beginning of the study/ initial Point (consultation 2).
These medicines are not allowed during the study (except the
medication the object of the study).
Any other concurrent medication normally taken by the patient
must remain constant during the 12 weeks of the treatment.

Criteria for selection and
exclusion
Patients presenting symptoms in conformity with the Rome criteria
for IBS lasting at least 3 months and which satisfy all the criteria
for inclusion and exclusion.
All types of IBS may be included.
Exclusion of other organic intestinal pathologies in particular
malignant pathologies.

Products administered
Each patient receives Eucarbon or Vegetable Coal tablets.
Eucarbon® is a registered product of the Laboratories
F. Trenka GMBH, Vienna, Austria.
Eucarbon® tablets have the following ingredients:
• Carbo ligni (vegetable coal) pulverized, 180.00 Mg;
• Extract of Rhubarb, 25.00 Mg;
• Senna leaves, 105.00 Mg,
• Purified sulfur, 50 Mg and
• Essential oils of Mint and Fennel, 0,5mg.

• The Vegetable Coal tablets (Carbo ligni) have the same forms,
taste, and appearance of Eucarbon tablets.
The other components (extract of Rhubarb, Senna leaves, purified
Sulfur, Fennel and Mint essences) have been replaced by an inert
excipient.
• During the first 4 weeks: dosage is adapted according to the needs
of each patient from 1 to 8 tablets per day. (to be divided during or
after the meals.)
• dosage is adapted according to the symptoms of the patients, with
the possibility of increasing the amount in the evening to obtain a
more significant laxative effect.
•After the 4th week of treatment it is no longer permitted to change
the dosage which will have to remain unchanged until the end of the
study.

Division
The patients are divided into one of the two groups according to a
randomization method prepared by a computer program.
The treatment was administered in “double blind”.

Principal criterion of
evaluatation
The primary criterion of evaluation was the general well-being of
the patients measured according to an analog visual scale of 0-
100 mm, and is analyzed through corroborating statistics.
(Bilateral Test of Man Whitney, alpa = 0.05, beta = 0.10).

Secondary criteria of evaluation
Reduction in the degree of gravity of the IBS (first part
of “Francis score”), comparison of previous and
subsequent data, developments recorded throughout the
treatment.
Measurement using as criterion of validation a general
index of the gravity of the IBS (scale of measurement
slightly modified), (Francis and Al 1997).
 Other characteristics of the IBS (second part of
“Francis score”)

Individual record sheet of the patient on which is
evaluated daily:
_pain/malaises (frequency, intensity),
_flatulence/distension (frequency),
_ defecation (frequency, consistency),
_gas/flatulence/rumblings (daily details),
 Safety/tolerance (number of associated effects,
intercurrent malaises, medical interventions, side-
effects),
 number of patients who give up the study through
failure of treatment.

Characteristics of patients at the time
of their inclusion in the study
Eucarbon Carbo ligni
Total 131 131
 Women 91 85
Men 40 46
Median age (years) 42 42.5
(+ 11.2) (+ 11.6)
 Mean size (cm) 165.7 166.8
(+ 8.2) (+ 8.7)
Middleweight (kg) 68.8 69.9
(+ 12.8) (+ 13.1)
 Characteristic of pathology:
_Pain with palpation N = 89 N = 80
(68%) (61%)
_Tympanisme N = 89 N = 89
(68%) (68%)

Ethics
Each investigator requested the authorization of the responsible
Ethics committee.
In accordance with the requirements of international standards,
each patient, before giving his consent for participation in this
study, was duly informed by the investigator of all the details of
this study.
The patients were insured against all risks related to their
participation in this clinical trial.

Insurance.
All the patients who received Eucarbon® (145) or Vegetable Coal
(Carbo ligni) (139) and those who were retained at least for the
C2 consultation (and who received the treatment for the study)
were included for the insurance examinations.

Results
25 February, 2000: inclusion of the first patient.
28 December, 2001: final consultation of the last patient.
299 hospital out-patients satisfied the criteria for inclusion and
exclusion.
284 of them were treated with Eucarbon® or with Carbo ligni in 35
study centers divided between 4 countries.
262 patients presented comprehensive dossiers, ready to be
evaluated.
The 2 groups are comparable in all their characteristics.
The treatments were also divided:
131 patients were treated with Eucarbon® and
131 with Carbo ligni.

IBS Diagnosis
65 patients (Eucarbon® group)
72 patients (Carbo ligni group) before the initial point.

Concurrent pathologies
8 patients (Eucarbon® group)
30 patients (Carbo ligni group)

Patients and dosage
After 4 weeks of treatment, the number of patients for whom was
prescribed
• a daily amount from 1 to 3 tablets,
Group treated with Eucarbon 62  77
Group treated with Carbo ligni 74  72
• from 4 to 6 tablets or
• more than 6 tablets

For each patient only one possible change of dosage
during this study.
Eucarbon Carbo ligni
(N = 131) (N = 131)
 dosage from 1 to 3 t/d
_At the beginning of the study (C2) 62 74
_After 4 weeks of treatment (C3) 77 72
 dosage from 4 to 6 t/d
_After 4 weeks of treatment (C3) 45 49
dosage of more than 6 t/d
_After 4s weeks of treatment (C3) 4 6
 Completion of treatment(%) 95.1 94.3
Modification of the dosage administered between the consultations
C2 (departure from the study) and C3 (after 4 weeks of treatment)

Regression of pain and other
symptoms
Eucarbon® Group faster and more complete.
Also in this group tendency to use less tablets.
The differences in the Francis score are more striking in some
subgroups:
Patients having “stools with normal tendency” (C2)
Significant improvement of “general well-being” after treatment by
Eucarbon® (p=0,038, Wilcoxon test)
• Patients having “stools with tendency to hardness”
Improvement is more significant after treatment by Eucarbon®.

“General Well-being”
The improvement of “general well-being” (Analog Visual Scale) is
quite visible in the two groups treated.
The difference between the treatments is clearly favorable to the
group treated with Eucarbon® in all analyzed aspects.
Reduction in symptoms in the Eucarbon group of 62.5%
compared with 53.2% for the Carbo ligni group.

Complementary medications
Only 3 patients of the Eucarbon® group received new
medications for various gastro-intestinal symptoms.
9 patients with 19 new medications for the Carbo ligni group.
Other medicines were administered, equally in the two groups,
and this, for other than gastro-intestinal problems.
Notice.
During the study no medical intervention or new diagnosis was
raised.

Tolerance
Eucarbon and Carbo ligni were well tolerated.
Side-effects with a similar frequency in the two groups
(21% Eucarbon, 17% Carbo ligni).
For the greater part, light or moderate side-effects and gastro-
intestinal in nature. It was not clear to distinguish these side-effects
from symptoms in keeping with IBS.
Other undesirable effects were rare and on the whole without direct
causal relation with the treatment and this, in the opinion of the
investigators.
The investigators mentioned no serious or unusual undesirable
effect nor notable change of the “laboratory values” which might
have been causally linked to the treatment.

Termination of treatment
7 in the Eucarbon group.
5 in the Carbo ligni group.

Conclusion.
Eucarbon® is effective and reliable for the indication of IBS.
This is particularly important because IBS is a chronic pathology
which requires long treatment with medicines without side-
effects.

Eucarbon Ramadan Tips

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Eucarbon Ramadan Tips