2. بسم ا الرحمن الرحيم
)وكلوا واشربوا ول تسرفوا
(انه ل يحب المسرفين
eat and drink: but waste not by excess, for
Allah loveth not the wasters
3.
4. INTRODUCTION
• Asthma is one of the most common chronic
inflammatory conditions that affect children.
• The prevalence of asthma and allergic diseases
has increased dramatically over the past few
decades .
• cause of airway inflammation is multifactorial
and involves many of cell types and
inflammatory mediators.
5. INTRODUCTION
• Despite many therapeutic advances asthma
continues to result in significant childhood
morbidity .
• There has been a considerable interest in the
potential therapeutic and protective value of
dietary supplementation to decrease incidence
of asthma.
6. omega-3 fatty acids
• omega-3 fatty acids are incorporated into
cellular membranes of all tissues.
7. Vitamin C
• Vitamin C is an antioxidant free-radical
scavenger present in intracellular and extracellular lung fluids.
8. Zinc
• Zn is an important element in
the preservation of immune
resistance and plays an
important role in DNA and
protein synthesis also as a
cofactor .
9.
10. Objectives
• The aim of this work is to investigate the
beneficial role of omega-3 fatty acids,
vitamin C and Zn diet supplementation in
asthmatic children either as a single
supplement or in combination.
11. METHODOLOGY
• 76 children between 7 and 10 years of age
(suspected of having moderate persistent bronchial
asthma and attending the Asthma Clinic of Paediatric
Department.
• children were randomly allocated using computergenerated list of random numbers from March 2007
to November 2007.
• Twelve of them were excluded due to failure to trace
them, and four were excluded due to the intake of
anti- leukotrienes.
12. METHODOLOGY
• Exclusion criteria
1. Any chronic diseases other than asthma and
rhinitis.
2. Intake of antileukotrienes during the study.
3. Children taking polyunsaturated fatty acid (PUFA)
or antioxidants supplements above the levels
recommended for adequate intake, or regularly
consumed more than one fish meal per week.
4. Manifestations of vitamin C or Zn deficiency.
13. METHODOLOGY
• randomized, double blind, placebo-selfcontrolled crossover trial over 38 week.
• All children 76 entered the study on their
normal diet (phase 1).
• after which all the children entered five
different therapeutic phases, each of 6-week
duration in a random sequence.
• observers, subjects and families being
blinded to which treatment was being given
at which time.
14. METHODOLOGY
• Every therapeutic phase is followed
by a 2-week washout period.
• Each child got each treatment phase,
one after the other in random order.
• By the end of the study, all children
had been exposed to the five
treatment phases (including the
placebo).
16. PHASES:
• In the placebo phase:(normal diet plus three placebo
identical appearing capsules containing lactose).
• In the omega 3 phase :( normal diet plus one capsule per
day containing 1000 mg of a triglyceridic oil and two placebo
capsules containing lactose).
• In Zn phase, ( normal diet plus daily one capsule containing
15 mg Zn and two placebo capsules) .
• In vitamin C phase:normal diet plus daily one capsule
containing 200 mg ascorbic acid and two placebo capsules)
• in the combined treatment phase: normal diet supplemented
daily with one capsule containing triglyceridic oil one capsule
17. PHASES
Pre- treatment phase
Normal diet
3 placebo
placebo phase
Normal diet
2 placebo
Omega 3
omega 3 phase
Normal diet
2 placebo
Zn
Zn phase
Normal diet
2 placebo
vitamin C
vitamin C phase
vitamin C
combined
treatment phase
Normal diet
Omega 3
Zn
phase 6
18. Triple assessment
• The primary end point of this trial was improvement of
the lung function.
• triple assessment as follow:
1. Subjective: by childhood asthma control test (C-ACT).
2. Physiological: by pulmonary function test.
3. Inflammation by:
(i) sputum differential cell count,esinophil
percentage.
(ii) sputum inflammatory mediators.
21. RESULTS
Childhood asthma control test:
• There was no statistical difference between
the pretreatment phase and placebo as
regard to C-ACT (p = 0.2 and 95% CI of 0.06
[−0.25, 0.38]).
• while there was a significant improvement of
the score in all four treatment phases when
compared to the pre-treatment and placebo
phases (p < 0.001)..
• It increased from (16.5 ± 1.66) to (22.1 ±
2.02) in the phase where the patients were
supplied omega3, Zn and vitamin C all
together (p < 0.001).
22. RESULTS
Pulmonary function tests:
• The FEV1 showed no significant difference between
pretreatment and placebo phases (p = 0.08 95% CI of
7.1[−0.13, 14.3])
• Both FEV1 and FEV1/FVC ratio showed statistically
significant improvement in all four treatment phases
when compared to the pre-treatment and placebo
phases (p< 0.001).
• They also showed statistically significant improvement
in phase 6 with the use of the three substances than
other mono-therapy phases (p < 0.001)
23. RESULTS
Sputum analysis:
1-Cellular element:
• The total sputum WBC showed no significant
difference between pre-treatment and placebo
phases (p = 0.7)
•
while there was a significant decrease of the count
in all four treatment phases.
• It also significantly decrease in phase 6 than any of
the other three treatment phases with mono
supplementation (p < 0.001)
24. RESULTS
2-Inflammatory mediators:
• All the inflammatory mediators showed no significant
difference between pre-treatment and placebo phase (p >
0.05;).
•
Sputum LTE4-C4 and LT1B showed a significant reduction in
all four treatment phases when compared to the pretreatment
phase .
•
It also showed significant decrease in phase 6 than in the
other three mono supplementation phases (p < 0.001).
27. PICO
• Population: children between 7 and
10 years of age (suspected of having
moderate persistent bronchial
asthma .
• Intervention: omega-3 fatty acids,
vitamin C and Zn
• Control: placebo.
• Out come: improvement of the lung
function.
28. Relevance
1. Does the study address a common problem in your
practice?
2. Does the study address an important outcome to you
or to your patient? (DOE vs. POEM).
3. Assuming that the study conclusion is true
would it lead to a change in your practice?
29. Validity
1. Was the assignment of patients to
treatment randomized?
Yes
2- Was the assignment concealed?
Yes
30. Validity
3- Were patients analyzed in the groups to which they
were randomized (intention to treat analysis)?
N/A
• Was follow-up complete& long enough?
,
• Sensitivity analysis (WCS)
31. Validity
3. Were the groups similar at the start of the trial?
Baseline prognostic factors (demographics, comorditity, disease severity, other known
confounders) balanced?
N/A
4. Were patients, their clinicians, and study personnel
'blind' to treatment?
32. Validity
5. Aside from the experimental intervention,
were the groups treated equally?
• Co-intervention?
• Contamination?
• Compliance?
36. Applicability
1.
Can you do the Intervention exactly as it is
described in the paper
we can’t till
2. Is your Patient is similar to the population of the
study?
3. Are the likely treatment benefits worth the potential
harms and costs?
we can’t till
37. CONCLUSION
• Children with moderately persistent bronchial asthma may get
benefit from their diet supplementation with omega-3 fatty
acids, Zn and vitamin C.
•
This study showed that their asthma control test, pulmonary
function tests and pulmonary inflammatory markers showed
significant statistically improvement with these diet
supplementation.
•
Further studies of different age groups, and different degrees
of asthma severity are needed.
41. Spirometry
• (meaning the measuring of
breath) is one of the
Pulmonary Function Tests
(PFTs), measuring lung
function, specifically the
measurement of the amount
(volume) and/or speed (flow)
• Spirometry is an important
tool used in assessing
conditions such as asthma,
pulmonary fibrosis, cystic
fibrosis, and COPD.
42. • Forced Vital capacity (FVC)
• Total amount of air that can be blown out after
a maximal deep breath, as fast as you can.
• Forced Expired Volume in One second
(FEV1)
• The amount of air that can be blown in the first
second in the FVC maneuvere.
43. Crossover study
• A crossover trial also referred to as a crossover
study is a clinical trial in which patients are given
all of the medications to be studied, or one
medication and a placebo in random order.
• These studies are generally done on patients with
chronic diseases to control their symptoms.
• A crossover study has the advantage over a simple
double-blind study that the variability between
patients is minimized because each patient
crossing over in effect serves as their own control.
44. Crossover study
• One disadvantage is that long term effects
cannot be tracked with this approach.
• Another disadvantage is that curative
therapies cannot be tested after one another or
before a placebo.
• the issue of order effects, because it is possible
that the order in which treatments are
administered may affect the outcome. An
example might be a drug with many adverse
effects given first, making patients taking a
second, less harmful medicine, more sensitive
to any adverse effect.
