CRITICAL APPRAISALEBM HARM II

KELOMPOK A13SPECIAL 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

ARE THE RESULTS OF THIS HARM STUDY VALID ?

EBM Harm Worksheet - Validity

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.

ARE THE VALID RESULTS OF THIS HARM STUDY IMPORTANT ?

EBM Harm Worksheet - Importance

Adverse Outcome

Totals

Present (Case) Absent (Control)

Exposed to The Treatment

Yes (Cohort) 19 9 28

No (Cohort) 26 8 34

45 17 62

Adverse Outcome

Totals

Present (Case) Absent (Control)

Exposed to The Treatment

Yes (Cohort) 18 9 27

No (Cohort) 26 8 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

SHOULD THESE VALID, POTENTIALLY IMPORTANT RESULTS CHANGE THE TREATMENT OF YOUR PATIENT?

EBM HARM WORKSHEET - APPLICABILITY

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 patient’s risks of the adverse event ?

NNH = 10

What are our patient’s 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!