Batch 2011

EVIDENCE BASED NURSING

Musculoskeletal Disorder

Submitted by:

BSN111-Group 42

Submitted to:

Mr. Frederick Brigino RN, RM, MAN

EVIDENCE BASED NURSING

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CONTENTS
PAGE

1. CLINICAL QUESTION..................................................................................................................................1
2. CITATION.......................................................................................................................................................1
PROTEIN SUPPLEMENTS INCREASE SERUM INSULIN-LIKE GROWTH FACTOR-I LEVELS
AND ATTENUATE PROXIMAL FEMUR BONE LOSS IN PATIENTS WITH RECENT HIP
FRACTURE, A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL BY MARC-
ANDRE SCHIIRCH, MD ET. AL......................................................................................................................1
3. STUDY CHARACTERISTICS......................................................................................................................1
3A. PATIENTS:.......................................................................................................................................................1
3C. OUTCOMES MONITORED:....................................................................................................................................2
3D. DOES THE STUDY FOCUS ON A SIGNIFICANT PROBLEM IN CLINICAL PRACTICE?.............................................................2
4. METHODOLOGY DESIGN..........................................................................................................................3
4A. DESIGN:..........................................................................................................................................................3
4B. SETTING:.........................................................................................................................................................3
ORTHOPEDIC WARD OF GENEVA UNIVERSITY HOSPITAL...............................................................................................3
4C. DATA SOURCE.................................................................................................................................................3
4D. SUBJECT SELECTION..........................................................................................................................................3
Inclusion criteria...........................................................................................................................................3
Exclusion criteria...........................................................................................................................................3
5. RESULTS OF THE STUDY...........................................................................................................................4
6. AUTHOR’S CONCLUSION/RECOMMENDATIONS..............................................................................4
7. APPLICABILITY...........................................................................................................................................4
8. REVIEWER’S CONCLUSION/COMMENTARY......................................................................................5
1. Clinical Question

“The patients with recent hip fracture; Is Protein Supplements effective in

Increasing Serum Insulin-Like Growth Factor-I Levels and Attenuate Proximal
Femur Bone Loss in patients with recent hip fracture?

2. Citation

Protein Supplements Increase Serum Insulin-Like Growth Factor-I Levels

and Attenuate Proximal Femur Bone Loss in Patients with Recent Hip Fracture, A
Randomized, Double-Blind, Placebo-Controlled Trial by Marc-Andre Schiirch, MD
et. al

3. Study Characteristics

3a. Patients:
The study selected a total of 82 patients with mean age of 80.7 ± 7.4
years with recent osteoporotic hip fracture. They were recruited from the
orthopedic ward of Geneva University Hospital, the referral center that receives
94.6% of all patients with hip fracture from an area with a population of
approximately 400 000 persons.

3b. Intervention:
Using a random number table, the researchers assigned patients to
receive an oral protein supplement composed of 90% milk proteins or a placebo
made isocaloric by the addition of maltodextrins. Patients took the assigned
intervention five days a week for six months in addition to their regular diet.

All patients received one oral dose of vitamin D3, 200 000 IU (vitamine D3
B.O.N., Doms-Adrian, Courbevoie, France), to correct any possible vitamin D
deficiency. The daily protein supplement (Mer-itene, Sandoz Nutrition Ltd.,
Berne, Switzerland) provided 1050 kJ (250 kcal) of energy in the form of 20 g of
proteins, 3.1 g of lipids, and 35.7 g of carbohydrates (54.4 g in placebo). The
other constituents of the 65 g powder supplement were vitamin A (1000 IU),
vitamin Kx (30 /xg), vitamin C (20 mg), calcium (550 mg), magnesium (91 mg),
phosphorus (429 mg), and sodium (228 mg).

The supplement is designed to normalize but not overcom-pensate for

the insufficient dietary intake of protein of elderly persons with a recent fracture
of the proximal femur. Compliance was verified by weekly phone calls and by
counting the remaining nutritional supplement bags, which were forwarded
monthly by mail.

3c. Outcomes monitored:

During the 6-month intervention period, 9 patients who received protein
supplements and 7 controls dropped out because of nausea (4 patients and 4
controls), diarrhea (2 patients and 1 control), and refusal to pursue the trial (3
patients and 2 controls). Among patients who received protein supplements, 1
died of pulmonary embolism and 1 died of sepsis; 1 control died of myocardial
infarction. Thus, of the 41 persons enrolled in each group, 30 patients who
received protein supplements (73%) and 33 controls (80%) completed the
intervention. During post-treatment follow-up, 4 patients dropped out, 2
patients died, and 2 controls died.

During the 1-year study, dietary intake (excluding supplements) as

assessed by the mean of three frequency questionnaires at 6-month intervals
was 629 ± 58 mg/d in patients who received protein supplements and 679 ±41
mg/d in controls for calcium, 681 ± 46 mg/d in patients and 709 ± 35 mg/d in
controls for phosphorus, and 44.2 ± 3.8 g/d in patients and 46.4 ± 2.5 g/d in
controls for proteins (P > 0.2).

3d. Does the study focus on a significant problem in clinical practice?

I think that this study focuses on a significant problem in our clinical
practice because according to the authors, “Elderly persons who have
osteoporotic hip fracture are often undernourished, particularly with respect to
protein and Protein malnutrition may contribute to the occurrence and outcome
of hip fracture”. That is why it will be a big help to our elderly who are suffering

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from fractures if there will be people who will be willing to investigate whether
oral protein supplements will be beneficial to bone metabolism or not.

4. Methodology Design

4a. Design:
The study used a randomized, double-blind, placebo-controlled trial with
a 6-month post-treatment follow-up

4b. Setting:

Orthopedic ward of Geneva University Hospital

4c. Data source

Clinical and Biochemical data. Clinical data that includes patients
Activities of daily living which have been evaluated, Medical history, clinical
characteristics, anthropometric data, and performance status. Biochemical data
that includes patients’ protein-corrected plasma levels of calcium, phosphate,
creatinine, total proteins, albumin, and prealbumin.

4d. Subject Selection

Inclusion criteria

Age greater than 60 years with recent hip fracture (within 2

weeks) attributable to osteoporosis (that is, a fracture after a
minor trauma, such as a fall from standing height); and the ability
to give written, informed consent.

Exclusion criteria

Pathologic fracture; fracture caused by severe trauma;

history of contralateral hip fracture; severe mental impairment;
active metabolic bone disease; renal failure (plasma creatinine
concentration >200 jutmol/L); acute illness that could interfere
with the study protocol; severe malnutrition (serum albumin level
<15 g/L); consumption of drugs known to alter bone metabolism,

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 such as calcitonin, fluoride, sex hormones, corticosteroids, or
bisphosphonates; and life expectancy of less than 1 year.

5. Results of the study

Of 842 patients evaluated from April 1992 to February 1994, 82 were

recruited into the randomized, double-blind, placebo-controlled trial. This low
enrollment rate was due to patients' poor medical or cognitive conditions and
reluctance to give informed consent.

6. Author’s Conclusion/Recommendations

Protein repletion after hip fracture was associated with increased serum
levels of insulin-like growth factor-l, attenuation of proximal femur bone loss,
and shorter stay in rehabilitation hospitals.

7. Applicability

The Protein supplements effectiveness by Marc-Andre Schiirch, MD et. al

raises important questions about the effectiveness of a medication that provide
older people with hip fractures, a faster rate of recuperation. Previous studies
have shown that a 5-week course of protein supplements can reduce the
medical complication rate and duration of hospital stay in patients with recent
hip fracture, but this was based on relatively weak evidence primarily from
poorly designed cluster. These findings were independent of energy, calcium,
and vitamin D intake (17). Whether these observations were related to the
restoration of decreased IGF-I levels and whether bone may benefit from long-
term protein supplementation are not known. That is why the researchers
further investigated whether protein supplements in vitamin D-replete patients
with a recent hip fracture who were receiving calcium supplements could
increase circulating IGF-I levels and favorably influence bone mineral density,
and having concluded that Protein repletion after hip fracture was associated
with increased serum levels of insulin-like growth factor-l and attenuation of

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proximal femur bone loss, then this research is so applicable since it can shorter
the length of stay in rehabilitation hospitals.

8. Reviewer’s Conclusion/Commentary

Many studies have been conducted regarding medications and its effect
on bone density and faster recuperation of fractures. Most of these studies
indicate that protein supplementation does improve bone loss, but data on
prevention of fractures are less conclusive because of the relatively short study
periods. The trial by Marc-Andre Schiirch, MD et al had a long follow up and
confirmed the positive effect of protein supplementation on attenuation of
proximal femur bone loss in the elderly with recent fractures. However, because
of low compliance with study medications, some participants have failed to
complete the studies. Participants were age greater than 60 years with recent
hip fracture ranging within 2 weeks that is attributable to osteoporosis, a
fracture after a minor trauma, such as a fall from standing height. No
information was given about hip bone density, vitamin D supplementation, or
the presence of other conditions that might affect risk of fracture. The study
medication was a protein supplement, and so the findings may not be
applicable to other methods of supplementation. The study is important to
nurses working with elderly people in the community or in institutions, as well
as nurses working in orthopaedics or nutritional sciences. It reinforces the
importance of continued supplementation in terms of medication, applicable to
both man and woman, particularly in the Elderly or Old- Age period, because
the length of stay in the hospital due to fracture risk is likely to be reduced only
if patients continue with treatment. Because constipation as a side effect
appears to be related to adherence, nursing interventions should be designed to
promote healthy bowel habits and prevention of constipation.