CRITICAL APPRAISAL

EBM HARM II
KELOMPOK A13
SPECIAL SENSES SYSTEM
2012

Influence of Obesity on Bone Mineral

Density in Post-Menopausal Asthma
Patients Undergoing Treatment with
Inhaled Corticosteroids
Bureu Yanik, Aylin Ayrim, Duygu Ozol, Asli
Koktener, Derya Gokmen

ABSTRACT
Objectives
The etiology of osteoporosis in asthma is complex as
various factors contribute to its pathogenesis. The
purpose of our study was to investigate the effects of
obesity and inhaled steroids, as well as the severity and
duration of asthma, on osteoporosis in postmenopausal
asthma patients as compared to healthy controls.

Methods
A total of 46 patients with asthma and 60 healthy female
controls, all postmenopausal, were enrolled in our study.
Bone mineral density was assessed at the lumbar spine
and hip using a Lunar DPX-L Densitometer.

ABSTRACT
Results
Bone mineral density (BMD) scores were comparable
between the asthmatic and control groups, with average
scores of 0.95 0.29 and 0.88 0.14g/cm2,
respectively. Likewise, osteoporosis was diagnosed in a
similar percentage of patients in the asthmatic (39,1%)
and control (43,3%) groups. Bone fracture was identified
in four patients with asthma (8,6%) and in six patients
from the control group (10%). There was no difference
between the two groups with respect to age or years
since menopause. Although asthma patients were more
likely to be overweight and presented higher BMD scores
on average than the control subjects, these differences
were not statistically significant.

ABSTRACT
Conclusion
There is a slight positive protective effect of high BMI against
osteoporosis in asthma patients, but this effect is overcome by
time and menopause status. Therefore, the protective effect of
obesity against osteoporosis in asthma patients seems to not
be significant.

EBM HARM WORKSHEET

Validity Importance Applicability

EBM Harm Worksheet - Validity

ARE THE RESULTS OF THIS

HARM STUDY VALID ?

Was there clearly defined

groups of patients, similar in all
important ways other than
exposure to the treatment or
other cause?

Yes.

Were treatments/exposures
and clinical outcomes
measured in the same ways in
both groups ? (Was the
assessment of outcomes either
objective or blinded to
exposure ?
Yes.

Was follow-up of patients

sufficiently long and complete?

Yes.

DO THE RESULTS SATISFY SOME

DIAGNOSTIC TESTS FOR CAUSATION?

Is it clear that the exposure

preceded the onset of the
outcome ?

No.

DO THE RESULTS SATISFY SOME

DIAGNOSTIC TESTS FOR CAUSATION?

Is there a dose-response
gradient ?

Yes.

DO THE RESULTS SATISFY SOME

DIAGNOSTIC TESTS FOR CAUSATION?

Is there positive evidence from

a dechallenge-rechallenge
study ?

No.

DO THE RESULTS SATISFY SOME

DIAGNOSTIC TESTS FOR CAUSATION?

Is the association consistent

from study to study?

Yes.

DO THE RESULTS SATISFY SOME

DIAGNOSTIC TESTS FOR CAUSATION?

Does the association make

biological sense?

No.

EBM Harm Worksheet - Importance

ARE THE VALID RESULTS

OF THIS HARM STUDY
IMPORTANT ?

Adverse Outcome

Exposed to
The
Treatment

Totals

Present
(Case)

Absent
(Control)

Yes
(Cohort)

19

28

No
(Cohort)

26

34

45

17

62

Adverse Outcome

Exposed to
The
Treatment

Totals

Present
(Case)

Absent
(Control)

Yes
(Cohort)

18

27

No
(Cohort)

26

34

44

17

61

What is the magnitude of the

association between the
exposure and outcome ?

Osteopenia : RR = 0,88 ; NNH

= - 1 orang
Osteoporosis : RR = 0,86 ; NNH
= - 10 orang

How precise is the estimate of

the treatment effect ?

95% CI

EBM HARM WORKSHEET - APPLICABILITY

SHOULD THESE VALID, POTENTIALLY

IMPORTANT RESULTS CHANGE THE
TREATMENT OF YOUR PATIENT?

Do these results apply to our

patients ?
Yes/No.
Is our patient so different from
those in the study that its
results cannot apply ?
No.

What are our patients risks of

the adverse event ?

NNH = 10

What are our patients

preferences concerns and
expectations from this
treatment ?

Due to aesthetic and cosmetic

reasons.

What alternative treatments are

available ?

Replaced the drugs with other

drugs.

THANK YOU!