CME
Evidence-Based Practice
Answering clinical questions with the best sources
WHAT’S INSIDE
HELP DESK
3
4
n
n
n
5
n
VOLUME 10
NUMBER 6
JUNE 2007
IN THE NEWS
3
When should patients with Kawasaki
disease be screened for coronary artery
aneurysms?
What anxiolytics are safe for use
in breastfeeding women?
he Paradise trial, a randomized controlled trial (RCT) evaluating
the use of tympanostomy tubes for chronic middle ear effusion that
T
started in 1991, has ended. Data that became available during the 16-
What is the best way to treat
pyogenic granuloma?
What are the main benefits and risks
of testosterone patches for postmenopausal
women with hypoactive sexual desire
disorder?
T O P I C S I N M AT E R N I T Y C A R E
8
Misoprostol for prevention and treatment
of postpartum hemorrhage
B E H AV I O R A L H E A LT H M AT T E R S
9
Which measures are effective for diagnosing
and monitoring treatment progress of social
anxiety disorder in primary care?
DRUG PROFILE
Long-term trial on tympanostomy
tubes completed
10
Paliperidone ER (Invega®) for treatment
of schizophrenia
year trial improved our understanding of the natural history of middle ear effusions in infants and children. Journal articles published
during the past few years with data from this trial have changed the
treatment recommendations for young children who have otitis media
with effusion, placing the emphasis on medical management rather
than on tympanostomy tube placement.
Paradise trial
Investigators enrolled 6,350 singleton infants between 2 and 61 days
of age in the Paradise trial. Additional enrollment requirements
included a birth weight of more than 2,270 g and the absence of
health problems during the immediate postpartum period. They
excluded infants from households with limited English fluency and
those from potentially chaotic home environments (ie, foster care,
extremely ill mother, or mother younger than 18 years). Every month
from enrollment to age 3 years, the participating children had an evaluation for middle ear effusions using pneumatic otoscopy supplemented with tympanometry as needed.
Children diagnosed with a unilateral or bilateral middle ear effusion that persisted for 8 continuous weeks received audiometric testing, with repeat testing every 4 weeks until the effusion cleared.
Investigators used brain stem responses from children younger than 6
months and pure tone audiometry in older children. The definition of
effusion included acute otitis media, otitis media with effusion, and
draining ear tubes; children who met the diagnosis of effusion were
treated with antibiotics. Children were eligible for randomization if
they developed an antibiotic-refractory effusion that persisted 90 days
if bilateral, or 135 days if unilateral between 2 months and 3 years of
age. Children with intermittent effusions were also included if the
Evidence-Based Practice / Vol. 10, No. 6
1
IN THE NEWS
effusions were present a percentage of the time that
met established guidelines. Most effusions were associated with mild to moderate hearing loss (<40 dB).
Using blinded allocation and stratification by
study site, children were randomized to 2 groups. In
the immediate intervention group, tympanostomy
tubes were inserted as soon as practical. In the delayed
intervention group, children were followed for another 6 months for bilateral effusions and 9 months for
unilateral effusion; tubes were then placed if the effusions persisted. Tubes were left in place for both
groups until they extruded naturally. Children in
both groups underwent developmental testing at 3,
4, and 6 years of age, and then again at a convenient
time between 9 and 12 years of age. The investigators
performed age-appropriate developmental testing
during an interval of documented normal hearing.
Results
The trial results were published in 4 papers.1–4 Of
the 6,350 children enrolled, 429 were ultimately
randomized. About 40% of those randomized
developed their effusions during the first year of life,
47% during the second year, and 12% during the
third year. The investigators conducted developmental testing in 402 children at 3 years of age, in
395 children at 6 years, and in 391 children
between 9 and 12 years. Children in the early treatment group had significantly fewer days with middle-ear effusion than children in the delayed treatment group; this effect lasted for 2 years. However,
no significant differences were noted in outcomes
between the groups on any developmental scale
used by the investigators throughout the study period, including tests of speech and vocabulary skills
during early phases of the study and tests of reading
skills, social skills, and academic achievement during the final phase.
Changing treatment recommendations
Interim reports using Paradise trial data have influenced systematic reviews and major guidelines. A
Cochrane review5 published in 2005 evaluating the
efficacy of ventilation tubes included several of the
earlier Paradise papers. The Cochrane review’s
authors sought all high-quality RCTs evaluating
the effect of ear tubes on hearing, duration of effusion, and development of language, cognition, or
behavior. They identified 581 abstracts on the topic
and included 21 of the studies in a meta-analysis.
They found that children treated with tympanostomy tubes spent 32% less time with effusions
during the first year of follow-up compared to children without tympanostomy tubes (95% confidence
interval [CI], 17%–48%). The review also found
that tympanostomy tubes resulted in improved
hearing levels (9 dB at 6 months; 95% CI, 4–14 dB;
and 6 dB at 12 months; 95% CI, 3–9 dB). However,
in otherwise healthy children with long-standing
middle ear effusions and hearing loss, the early
insertion of tubes had no effect on language development or cognition. Also, ears treated with tympanostomy tubes had an additional risk of scarring
at 1 year (risk difference for control group=0.33;
95% CI, 0.21–0.45; number needed to harm=3).
The Paradise trial results have also influenced
guidelines for the diagnosis and management of
middle ear effusions. The American Academy of
Pediatrics guidelines from 1994 were based primarily on retrospective studies that linked middle ear
effusions with subsequent developmental impairment.6 At that time, the experts recommended a
much more aggressive treatment of chronic middle
ear effusions than is currently recommended. After
publication of the 1994 guidelines, surgical treatment of chronic ear effusions became the norm and
the placement of tympanostomy tubes became the
second most frequent surgical procedure preformed
in the United States (after circumcision).7
Summary
Revised ear effusion guidelines incorporating the
Paradise trial results were published in 2004 by the
American Academy of Pediatrics, The American
Academy of Family Physicians, and the American
Academy of Otolaryngology.8 Under the current
recommendations, children with ear effusions that
last more than 3 months should still undergo hearing evaluations. But in otherwise normal children,
experts recommend that a child’s hearing should be
monitored at 3- to 6-month intervals until the effusion resolves, language delay is suspected, or a hearing loss of 40 dB or greater is documented. They
advise tympanostomy tube placement only in children with chronic ear effusions and a language delay
EBP
or a significant hearing loss.
Jon O. Neher, MD
University of Washington
continued on page 6
2
Evidence-Based Practice / June 2007
Help Desk
CONCISE ANSWERS TO PHYSICIANS’ CLINICAL QUESTIONS
When should patients with Kawasaki disease be
screened for coronary artery aneurysms?
associated with the development of coronary artery
abnormality (odds ratio [OR] 4.1; 95% CI,
1.2–14.3; P=.03).2
A retrospective cohort study revealed all 50
patients with normal findings on ultrasound at 2
weeks to 2 months from onset of illness had normal
findings upon follow-up study (mean follow-up 12.5
months).3 This finding was duplicated by a larger,
multi-institutional retrospective study, in which
none of 217 patients with a normal study at 1 to 2
months, regardless of initial finding, had coronary
abnormalities at follow-up of more than 5 months.4
The American Heart Association (AHA) recommends screening all typical (complete) cases of
Kawasaki disease at the time of diagnosis, at 2
weeks and 6 to 8 weeks after onset of disease. For
atypical (incomplete) presentation, echocardiography should be included as part of diagnostic study
if evidence of systemic inflammation is present (Creactive protein ≥3.0 mg/dL and/or erythrocyte
sedimentation rate ≥40 mm/hr). The AHA also
recommends echocardiography in any infant
younger than 6 months with unexplained fever of
7 days or more without any of the principal clinical features of Kawasaki disease, if signs of inflammation are present.5 Echocardiography beyond 8
weeks is optional, if findings at the 6- to 8-week
follow-up are normal.
Evidence-Based Answer
Screening for coronary artery aneurysms with
echocardiography is recommended for all patients
with typical (complete) cases of Kawasaki disease
at the time of diagnosis, and at 2 weeks and 6 to 8
weeks after onset of disease. Echocardiography
beyond 8 weeks is optional if prior findings are
normal. For patients with atypical (incomplete)
presentations, echocardiography should be included at the time of diagnosis if evidence of systemic
inflammation is found. (SOR C, based on expert
opinion.)
Kawasaki disease is a self-limited illness with coronary artery aneurysm developing in 20% to 25%
of cases. In addition to fever, the principal clinical
features of Kawasaki disease include:
• Changes in extremities (indurated edema,
erythema, desquamation)
• Polymorphous exanthema
• Bilateral bulbar conjunctival injection without exudates
• Changes in lips and oral cavity (“strawberry
tongue,” mucositis, cracked red lips)
• Cervical lymphadenopathy
Complete disease is defined as fever for at least 5
days and at least 4 of the above features. Incomplete
disease is defined as fever for at least 5 days associated with 2 or 3 of the above features.
A retrospective chart review of 100 children
treated for Kawasaki disease revealed patients with
incomplete presentation had significantly longer
time to treatment compared with patients with
complete disease (median 10 vs 7 days, respectively; P=.001). An initial echocardiogram performed
within 72 hours of treatment demonstrated coronary artery aneurysm in 37% versus 12% (P=.009)
of patients with incomplete compared with complete disease.1
Various studies identify duration of fever as a
strong predictor for development of coronary
artery aneurysm. A recent cohort study of 285
cases of complete and incomplete Kawasaki disease
found 19 (6.7%) with coronary artery abnormality.
Fever for more than 8 days was significantly
Tak Hirata, MD
C. Randall Clinch, DO, MS
Family Residency Program
Wake Forest University School of Medicine
1.
Baer AZ, Rubin LG, Shapiro CA, et al. Prevalence of coronary artery lesions
on the initial echocardiogram in Kawasaki syndrome. Arch Pediatr Adolesc
Med 2006; 160:686–690. [LOE 2b]
2.
Kim TY, Choi WS, Woo CW, et al. Predictive risk factors for coronary artery
abnormalities in Kawasaki disease. Eur J Pediatr 2007; 166:421–425. [LOE
2b]
3.
Scott JS, Ettedgui, JA, Neches WH. Cost-effective use of echocardiography
in children with Kawasaki disease. Pediatrics 1999; 104(5):E57–E59. [LOE
2b]
4.
McMorrow Tuohy AM, Tani LY, Cetta F, et al. How many echocardiograms are
necessary for follow-up evaluation of patients with Kawasaki disease? Am J
Cardiol 2001; 88:328–330. [LOE 2b]
5.
American Heart Association. Diagnosis, treatment, and long-term management of Kawasaki disease: a statement for health professionals from the
Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease,
Council on Cardiovascular Disease in the Young. Pediatrics 2004;
114:1708–1733. [LOE 5]
continued
We invite your questions and feedback.
Email us at [email protected].
Evidence-Based Practice / Vol. 10, No. 6
3
Help Desk
CONTINUED
What anxiolytics are safe for use in
breastfeeding women?
zodone are rated as “infant risk has been demonstrated” or “infant risk cannot be ruled out.”2
The American Academy of Pediatrics committee on drugs currently classifies all SSRIs and benzodiazepines as drugs whose effects are unknown
but may be of concern during lactation.1
In its 2002 Model List of Essential Drugs, the
World Health Organization classified clomipramine
as compatible with breastfeeding and the use of
oxazepam, clonazepam, lorazepam, or diazepam as
compatible with breastfeeding in single doses only.3
Long-term use of benzodiazepines can result in
hypotonia and lethargy in the breastfed infant.
Evidence-Based Answer
Evidence exists to support the safe use of selective
serotonin reuptake inhibitors (SSRIs) for the treatment of anxiety disorders in lactating women.
Paroxetine may be the best tolerated. (SOR B,
based on a meta-analysis of primarily low-quality
studies.) Clomipramine and select benzodiazepines
in single doses may also be reasonable. (SOR C,
based on expert opinion.)
A 2005 meta-analysis identified 36 studies and
case reports on breastfeeding women taking
SSRIs.1 A total of 267 infants were described. All
SSRIs studied were found to be excreted in breast
milk to varying degrees. A small number of
reversible pediatric adverse effects were reported
for all SSRIs studied except paroxetine (Table). All
of the studies were of small sample size. Only 1
study provided follow-up data to 12 months of age
and no studies provided follow-up data on possible
adverse effects beyond 12 months of age.
Additionally, some but not all of the infants studied were also exposed to maternal SSRIs in utero.
No data were reported on escitalopram.
A review of the Micro Medex web site by individual drug names reveals a Thomson Lactation
Rating of “infant risk is minimal” for sertraline
and paroxetine. All other SSRIs, benzodiazepines,
bupropion, buspirone, clomipramine, and tra-
TABLE
Summary of studies and case reports
on SSRIs during breastfeeding1
Drug
N (infants)
Adverse effects reported
Citalopram
23
1 case of disturbed sleep
Fluoxetine
69
1 case of irritability,
2 cases of colic,
2 cases of withdrawal symptoms,
1 possible case of seizure-like activity
Fluvoxamine
12
1 case of icterus
Paroxetine
77
None
Sertraline
76
1 case of disturbed sleep
SSRIs=selective serotonin reuptake inhibitors.
4
Evidence-Based Practice / June 2007
Sarah Cole, DO
St. John’s Mercy Family Medicine
St. Louis, Missouri
1.
Hallberg P, Sjoblom V. The use of selective serotonin reuptake inhibitors
during pregnancy and breast-feeding: a review and clinical aspects. J Clin
Psychopharmacol 2005; 25:59–73. [LOE 1b]
2.
Available at: http://www.thomsonhc.com/home/dispatch [restricted access].
MICROMEDEX Healthcare Series. Greenwood Village, Colo: Thomson
Healthcare. [LOE 2b]
3.
World Health Organization. Breastfeeding and Maternal Medication:
Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs.
Geneva, Switzerland: WHO; 2002. Available at: http://www.who.int/childadolescent-health/New_Publications/NUTRITION/BF_Maternal_Medication.pdf.
Accessed April 30, 2007. [LOE 5]
What is the best way to treat
pyogenic granuloma?
Evidence-Based Answer
For pyogenic granuloma, both cryotherapy and
combination therapy with curettage and electrodesiccation resolve 100% of small lesions.
Curettage/electrodesiccation requires fewer treatments. (SOR B, based on a single small randomized controlled trial.) Surgical excision, laser
therapy, silver nitrate, and other sclerosing agents
may also be beneficial. (SOR B, based on cohort
studies.)
Pyogenic granuloma is a common, benign,
acquired, proliferative vascular lesion. Possible
treatments include excision, curettage, cryotherapy, sclerotherapy, cauterization, radiotherapy, or
use of lasers.
In a nonblinded randomized trial, 89 patients
clinically diagnosed with pyogenic granuloma of
less than 15 mm in diameter received either
curettage with electrodesiccation or cryotherapy
Help Desk
with liquid nitrogen.1 Fifteen percent of patients
were lost to follow-up (6 in the curettage/electrodesiccation group and 7 in the cryotherapy
group). Treatment resulted in complete disappearance of the lesion in 100% of patients in both
groups.
Resolution was obtained within 2 treatments
in the curettage/desiccation group and within 3
treatments in the cryotherapy group (P<.001).
Patient satisfaction with the result was reported by
94% of the curettage/desiccation group and 88%
of the cryotherapy group (P=.30). The cosmetic
result, as determined by blinded clinicians, was
acceptable in all patients in the curettage/desiccation group and 90% of patients in the cryotherapy
group (P=.12). A noted disadvantage of cryotherapy is the inability to obtain a biopsy specimen.
One retrospective analysis of 178 pediatric
cases of pyogenic granuloma found a 0% recurrence rate when lesions were treated by surgical
excision, compared with a 43% recurrence rate of
lesions treated by cautery alone or with shave
(intradermal) excision followed by cautery. This
difference was called “significant” by Chi-square,
but the P value was not given.2
No other randomized or controlled trials were
found. One small observational study found that
laser therapy resolved pyogenic granuloma in 16 of
18 patients.3 Another small study found that treatment with a sclerosing agent, monoethanolamine
oleate solution, resulted in resolution of pyogenic
granuloma in 9 of 9 patients.4 A third noncontrolled study found that silver nitrate resolved
85% of 13 lesions treated.5 More rigorous research
of these treatment approaches is required.
Kristin K. Andreen, MD
Fort Collins Family Medicine Residency
Fort Collins, Colo
1.
Ghodsi SZ, Raziei M, Taheri A, Karami M, Mansoori P, Farnaghi F.
Comparison of cryotherapy and curettage for the treatment of pyogenic granuloma: a randomized trial. Br J Dermatol 2006; 154:671–675. [LOE 1b]
2.
Patrice SJ, Wiss K, Mulliken JB. Pyogenic granuloma (lobular capillary
hemangioma): a clinicopathologic study of 178 cases. Pediatr Dermatol
1991; 8:267–276. [LOE 4]
3.
Gonzalez S, Vibhagool C, Falo LD Jr, Momtaz KT, Grevelink J, Gonzalez E.
Treatment of pyogenic granuloma with a 585 nm pulsed dye laser. J Am
Acad Dermatol 1996; 35:428–431. [LOE 4]
4.
Matsumoto K, Nakanishi H, Seike T, Koizumi Y, Mihara K, Kubo Y. Treatment
of pyogenic granuloma with a sclerosing agent. Dermatol Surg 2001;
27:521–523. [LOE 4]
5.
Quitkin HM, Rosenwasser MP, Strauch RJ. The efficacy of silver nitrate cauterization for pyogenic granuloma of the hand. J Hand Surg [Am] 2003;
28:435–438. [LOE 4]
What are the main benefits and risks of
testosterone patches for postmenopausal women
with hypoactive sexual desire disorder?
Evidence-Based Answer
Compared to placebo, a 300-µg/day testosterone
patch can increase a postmenopausal woman’s sexual desire and increase the frequency of sexually
satisfying sexual episodes. Commonly reported
risks of testosterone patch use include application
site reactions, acne, and hirsutism/facial hair. (SOR
A, based on RCTs.) Long-term (>6 months) risks
are unknown. While most data have been collected from surgically postmenopausal women, naturally menopausal women also appear to benefit.
(SOR B, based on a single RCT.)
All 4 studies described here were 24-week, randomized, multicenter, double-blind, placebo-controlled, parallel-group clinical trials using 300 µg
per day transdermal testosterone patches with similar outcome measures and were funded in part by
the patch manufacturer.1–4 One study was conducted in naturally postmenopausal women1; the other
3 studies included only surgically postmenopausal
women.2–4
In a trial of 549 naturally postmenopausal
women, individuals in the testosterone group experienced a 48% increase in desire scores and a 73%
increase in number of sexually satisfying experiences
per 4 weeks from baseline compared with 20% and
19% increases, respectively, for the placebo group
(number needed to treat [NNT] for desire=4,
P=.0001; NNT for experiences=2, P<.0001).1 The
Personal Distress Scale showed a 52% decrease in
women in the testosterone group compared with a
28% decrease in the placebo group (NNT=4,
P=.0001). Arousal increased 55% and number of
orgasms increased 60% for testosterone users compared with 29% and 21%, respectively, for placebo
(NNT for arousal=4, P≤.01; NNT for orgasm=3,
P≤.001). Application site reactions, facial hair
growth, and acne affected 26.4%, 10.5%, and
6.5%, respectively, of testosterone users.
In a study that included 562 surgically postmenopausal women, desire scores improved 64%
from baseline values for the testosterone group but
only 29% for placebo (NNT=3, P=.0006); the
testosterone group experienced a 74% increase in
continued on page 7
Evidence-Based Practice / Vol. 10, No. 6
5
EVIDENCE-BASED PRACTICE
IN THE NEWS
CONTINUED FROM PAGE 2
Editor-in-Chief
Jon O. Neher, MD
University of Washington
Section Editors
REFERENCES
1.
Paradise JL, Feldman HM, Campbell TF, et al. Tympanostomy tubes and developmental outcomes at 9 to 11 years of age. N Engl J Med 2007; 356:248–261. [LOE 1b]
2.
Paradise JL, Campbell TF, Dollaghan CA, et al. Developmental outcomes after early or delayed
insertion of tympanostomy tubes. N Engl J Med 2005; 353:576–586. [LOE 1b]
3.
Paradise JL, Dollaghan CA, Campbell, TF, et al. Otitis media and tympanostomy tube insertion
during the first three years of life: developmental outcomes at the age of four years. Pediatrics
2003; 112:265–277. [LOE 1b]
4.
Paradise JL, Feldman HM, Campbell TF, et al. Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years.
N Engl J Med 2001; 344:1179–1187. [LOE 1b]
Drug Profile
Rex Force, PharmD
Idaho State University
Maternity Care
Lee Dresang, MD
University of Wisconsin
Pharmacy HDAs
Connie Kraus, PharmD, BCPS
University of Wisconsin
Behavioral Health Matters
Vanessa Rollins, PhD
University of Colorado
Lous J, Burton MJ, Felding JU, Ovesen T, Rovers MM, Williamson I. Grommets (ventilation
tubes) for hearing loss associated with otitis media with effusion in children. Cochrane
Database Syst Rev 2005; (1):CD001801. [LOE 1a]
5.
6.
American Academy of Pediatrics The Otitis Media Guideline Panel. Managing otitis media with
effusion in children. Pediatrics 1994; 94:766–773.
7.
Berman S. The end of an era in otitis research. N Engl J Med 2007; 356:300–302.
8.
American Academy of Family Physicians; American Academy of Otolaryngology-Head and
Neck Surgery; American Academy of Pediatrics Subcommittee on Otitis Media With Effusion.
Otitis media with effusion. Pediatrics 2004; 113:1412–1429.
Patient Education
Janet Hale, RN
Rockbridge Baths, VA
Dana Abbey, MLS
University of Colorado
Executive Editor
Bernard Ewigman, MD, MSPH
University of Chicago
Consulting Editor
Sarah Lovinger, MD
Chicago, IL
Behavioral Health Matters
Medical Copy Editor
Melissa L. Bogen, ELS
Chester, NY
CONTINUED FROM PAGE 9
Layout and Design
Robert Thatcher
Englewood, NJ
Mini-SPIN
The 3 SPIN items that best differentiated individuals with
social anxiety disorder from control groups were termed the
Mini-SPIN. In a sample of managed care patients and using a
cutoff score of 6 on these items, sensitivity was 89% and specificity 90% (LR+ 8.9; LR– 0.1), yielding a PPV of 53% and
NPV of 98%. Therefore, the Mini-SPIN may be an effective
screening tool, particularly good at ruling out the diagnosis.
However, the Mini-SPIN is not sensitive enough to reliably
make the diagnosis or track treatment progress.1
Social anxiety disorder responds to cognitive behavioral
therapy and pharmacological interventions.3 Accurate diagnosis and patient education about the nature and treatability of symptoms are important first steps in initiating a
EBP
treatment plan.
Vanessa Rollins, PhD
Rose Family Medicine Residency
Denver, Colo
REFERENCES
1.
Connor KM, Kobak KA, Churchill LE, Katzelnick D, Davidson JR. Mini-SPIN: a brief screening assessment for generalized social anxiety disorder. Depress Anxiety 2001; 14:137–140.
[LOE 1b]
Project Manager
Jonathan W. Crowell
Columbia, MO
[email protected]
Statement of Purpose
Evidence-Based Practice (EBP) addresses the most important
patient care questions asked by practicing family physicians, using
the best sources of evidence in a brief, clinically useful format.
Newsletter Topics
Transforming Practice: Research evidence on diagnostic testing or
treatment periodically accumulates to a “tipping point” that warrants a change in practice. Each month the editors select one topic
for which a substantial change in clinical practice seems justified.
Alternates monthly with News Alert.
News Alert: A discussion of current issues that affect family medicine today. Alternates monthly with Transforming Practice.
Help Desk: EBP authors search the highest quality sources for best
evidence (PrimeEvidence and the TRIPS database) in a concise,
clinically useful format. If definitive answers are not available from
these sources, the editors turn to high-quality, well-referenced
sources. Other resources are used at the editors’ discretion.
Topics in Maternity Care: To keep readers current with trends and
new evidence regarding obstetrics and maternity care
Behavioral Health Matters/Evidence in Nutrition: Two features which
alternate monthly, and present the most current evidence relating to
their respective disciplines.
2.
Katzelnick DJ, Kobak KA, DeLeire T, et al. Impact of generalized social anxiety disorder in
managed care. Am J Psychiatry 2001; 158:1999–2007. [LOE 2b]
3.
Bruce TJ, Saeed SA. Social anxiety disorder: a common, underrecognized mental disorder. Am
Fam Physician 1999; 60:2311–2322. [LOE 2c]
4.
Heimberg RG, Horner KJ, Juster HR, et al. Psychometric properties of the Liebowitz Social
Anxiety Scale. Psychol Med 1999; 29:199–212. [LOE 1b]
Drug Profile: Pharmaceutical information is promoted directly to
consumers as well as physicians, and is readily available on the
Internet and in other mass media. In each issue of EBP, the editors
objectively review the advantages and disadvantages of a featured
medication based on scientific evidence.
5.
Connor KM, Davidson JRT, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry 2000;
176:379–386. [LOE 2b]
Patient Education: An evidence-based patient summary of a Clinical
Inquiry, provided as a tear-out page to be copied and distributed to
your patients.
6
Evidence-Based Practice / June 2007
Help Desk
CONTINUED FROM PAGE 5
the frequency of satisfying sexual activities per 4
weeks compared to 33% for placebo (NNT=2,
P=.0003).2 Personal distress scores for testosterone
users were 54% lower at study completion versus
32% lower for placebo (NNT=5, P=.0006).
Arousal, number of orgasms, and sexual self-image
also improved for testosterone users compared with
placebo (data not shown). Testosterone users experienced application site reactions (31.1%), unwanted
hair (5.7%), and acne (6%).
Another trial enrolled 533 surgically postmenopausal women.3 Sexual desire increased 49%
compared to baseline for the testosterone group, and
the number of satisfying sexual episodes per 4 weeks
increased 51% from baseline. Personal distress
scores decreased 68% in the testosterone group
compared to baseline. Arousal, orgasm, and sexual
concerns also improved (74%, 35%, and 65%,
respectively) for the testosterone group compared to
baseline. Participants experienced application site
reactions (29.7%), facial hair (9%), and acne (7.5%).
Testosterone patches were also evaluated in
another trial; surgically postmenopausal women
were allocated to 1 of 3 testosterone doses.4 Results
for the 110 participants in the 300-µg testosterone
per day group include a 67% increase in sexual
desire score and a 79% improvement in total satisfying sexual episodes per week as compared to 48%
and 43% improvements, respectively, for the placebo group (NNT for desire=5, P=.05; NNT for
episodes=3, P=.049). Sexual arousal was also
improved in the testosterone group. Application
site reactions (27%), hirsutism (5%), and acne
EBP
(18%) affected testosterone users.
Kasey Johnson, PharmD candidate
Denise L. Walbrandt Pigarelli, PharmD, BC-ADM
University of Wisconsin School of Pharmacy, Madison
REFERENCES
1.
Shifren JL, Davis SR, Moreau M, et al. Testosterone patch for the treatment of
hypoactive sexual desire disorder in naturally menopausal women: results from
the INTIMATE NMI Study. Menopause 2006; 13:770–779. [LOE 1b]
2.
Simon J, Braunstein G, Nachtigall L, et al. Testosterone patch increases sexual activity and desire in surgically menopausal women with hypoactive sexual
desire disorder. J Clin Endocrinol Metab 2005; 90:5226–5233. [LOE 1b]
3.
Buster JE, Kinsberg SA, Aguirre O, et al. Testosterone patch for low sexual
desire in surgically menopausal women: a randomized trial. Obstet Gynecol
2005; 105:944–952. [LOE 1b]
4.
Braunstein GD, Sundwall DA, Katz M, et al. Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically
menopausal women. Arch Intern Med 2005; 165:1582–1589. [LOE 1b]
CME CREDIT
This activity has been planned and implemented in accordance with the
Essential Areas and policies of the Accreditation Council for Continuing
Medical Education through the joint sponsorship of Michigan State
University College of Human Medicine and the Family Physicians
Inquiries Network (FPIN). The Michigan State University College of
Human Medicine is accredited by the ACCME to provide continuing
medical education for physicians.
It is estimated that this educational activity will require 3 hours to
complete.
Credit Designation statement
Michigan State University, College of Human Medicine, designates this
educational activity for a maximum of three (3) hours in Category 1 credit toward the AMA Physician’s Recognition Award. Each physician should
claim only those hours of credit that he/she actually spent in the activity.
The learning objectives of the Evidence-Based Practice newsletter are to
become knowledgeable about evidence-based solutions to commonly
encountered clinical problems, to understand how ground-breaking
research is changing the practice of family medicine, and to become conversant with balanced appraisals of drugs that are currently being marketed to physicians and/or consumers.
The editors of this educational material may review studies that discuss
commercial products or devices as well as the unapproved/investigative
use of commercial products/devices. The editors of this educational
material report that they do not have significant relationships that create, or may be perceived as creating, a conflict relating to this educational material.
Statements and opinions expressed in abstracts and communications herein are those of the author(s) and not necessarily those of the Publisher. The
Publisher of this newsletter does not guarantee warrant, or endorse any
methods, product, instructions, procedures, techniques, or ideas mentioned in the newsletter. The Publisher and Editors disclaim any liability,
loss or risk, personal or otherwise, which may arise, directly or indirectly,
from any use or operation of any methods, products, instructions, procedures, techniques, or ideas contained in the material herein.
Evidence-Based Practice (ISSN 1095-4120) is published monthly by
the Family Physicians Inquiries Network, Inc., 409 W. Vandiver Drive,
Bldg 4, Suite 202, Columbia, MO 65202. Telephone: 573-256-2066,
Fax: 573-256-2078. E-mail: [email protected]. Subscription rates for 2007:
U.S. Individual $149, CME upgrade $75 annually; U.S. Institutions
$159; International Individual $179; International Institutions $209.
Back issues: U.S. $17; International $19. Third Class postage paid at
Columbia, MO 65202. The GST number for Canadian subscribers is
124002536. Postmaster: Send address changes to FPIN, Inc., 409 W.
Vandiver Drive, Bldg 4, Suite 202, Columbia, MO 65202; Attn:
Jonathan W. Crowell. Copyright © 2007 by Family Physicians Inquiries
Network, Inc.
Evidence-Based Practice / Vol. 10, No. 6
7
TOPICS IN MATERNITY CARE
Misoprostol for prevention and treatment
of postpartum hemorrhage
Postpartum hemorrhage (PPH) is defined as a blood
loss of more than 500 mL after a vaginal delivery. In
the United States, PPH is the third leading cause of
maternal mortality and is directly responsible for
approximately one-sixth of maternal deaths.1
Misoprostol is an attractive option for the prevention and treatment of PPH because it is inexpensive,
is not dosed intravenously, and does not require cold
storage. Evidence to date on its efficacy is varied due
to the many different protocols studied. More
research is needed to clarify the optimal dosing regimen, most effective route for administration, and
timing of dose.
It is already established that active management
of the third stage of labor with uterotonics after
delivery of the anterior shoulder and gentle traction
on the cord results in a statistically significant
decrease in PPH and time until delivery of the placenta.2 In this role, misoprostol appears to be less
effective than oxytocin at preventing PPH; however, analysis of the literature is complicated by differing oxytocin dosing regimens.3 Seven trials with a
total of 22,746 women comparing oral misoprostol
(600 µg) with injectable uterotonics yielded a higher rate of blood loss (≥1,000 mL) with misoprostol
(3.6% vs 2.7%; relative risk [RR]=1.34; 95% confidence interval [CI], 1.16–1.55).3 Misoprostol also
had more side effects, mainly shivering and elevated
body temperature.3 However, when misoprostol was
compared with placebo, women in the misoprostol
group were less likely to have blood loss of ≥500 mL
(adjusted odds ratio, 0.30; 95% CI, 0.16–0.56),
making misoprostol a reasonable choice when
injectable uterotonics are not available or cannot be
properly used.4
Most studies of misoprostol to treat established
hemorrhaging have been performed in Gambia and
in South Africa. A meta-analysis of randomized controlled trials comparing rectal misoprostol (600and 1,000-µg doses) with placebo showed a reduction in blood loss ≥500 mL in the treatment group
(2 trials, 397 women; RR=0.57; 95% CI,
8
Evidence-Based Practice / June 2007
0.34–0.96), but no decrease in the need for additional uterotonics (2 trials, 398 women; RR=0.98;
95% CI, 0.78–1.24), blood transfusion (2 trials,
394 women; RR=1.33, 95% CI, 0.81–2.18), evacuation of retained products (1 trial, 238 women;
RR=5.17; 95% CI, 0.25–107), or hysterectomy (2
trials, 398 women; RR=1.24; 95% CI,
0.04–40.78).5 This meta-analysis did not have
enough power to assess the effect on maternal mortality. Misoprostol was associated with maternal
fever (2 trials, 392 women; RR=6.40; 95% CI,
1.71–23.96) and shivering (2 trials, 394 women;
RR=2.31; 95% CI, 1.68–3.18). The use of 800 µg
rectal misoprostol was demonstrated in 1 randomized trial of 64 women to be superior to
oxytocin/ergotamine in subjective cessation of
bleeding within 20 minutes, as well as reduction in
the number of women requiring additional uterotonics (RR=0.18; 95% CI, 0.04–0.76).5 Although
misoprostol can be administered rectally, vaginally,
or orally, oral and vaginal routes may not be feasible
when a woman is unconscious or bleeding heavily.
At this time, not enough research is available to
recommend changing the current practice in the
United States of treating PPH with a combination
of oxytocin and ergotamine to treating alone with
EBP
misoprostol.
Jill Mallory, MD, Family Medicine Resident
Lee Dresang, MD
University of Wisconsin Department of Family Medicine, Madison
REFERENCES
1.
Poggi S. Postpartum hemorrhage—the abnormal puerperium. In: Friedman S,
McQuaid K, Grendell J, eds. Current Diagnosis & Treatment Obstetrics &
Gynecology. 10th ed. Columbus, Ohio: McGraw Hill; 2007:31.
2.
Gulmezoglu AM, Forna F, Villar J, Hofmeyr GJ. Prostaglandins for prevention
of postpartum haemorrhage. Cochrane Database Syst Rev 2004;
(1):CD000494. [LOE 1a]
3.
Prata N, Hamza S, Gypson R, Nada K, Vahidnia F, Potts M. Misoprostol and
the active management of the third stage of labor. Int J Gynaecol Obstet 2006;
94:149–155. [LOE 1b]
4.
Prendiville WJ, Elbourne D, McDonald S. Active versus expectant management
in the third stage of labour. Cochrane Database Syst Rev 2000;
(3):CD000007. [LOE 1a]
5.
Mousa HA, Alfirevic Z. Treatment for primary postpartum hemorrhage.
Cochrane Database Syst Rev 2007; (1):CD003249. [LOE 1a]
Behavioral Health Matters
Which measures are effective for diagnosing and monitoring
treatment progress of social anxiety disorder in primary care?
Summary
The Social Phobia Inventory (SPIN) is a brief selfreport measure effective for diagnosing and assessing treatment progress of social anxiety disorder in
adults. The 3-item Mini-SPIN is suitable only in
screening for social anxiety (SOR B, based on
exploratory cohort studies).
TABLE
The Social Phobia Inventory (SPIN)5
1. I am afraid of people in authority
2. I am bothered by blushing
3. Parties and social events scare me
4. I avoid talking to people I don’t know
The Evidence
Social anxiety disorder is the third most common
psychiatric disorder, with a lifetime prevalence
rate of 13%, or up to 14% in primary care settings. Social anxiety, also known as social phobia,
is associated with higher rates of psychiatric
comorbidities such as substance abuse, depression,
and panic disorder. The disorder is also associated
with significantly more outpatient medical visits,
lower employment wages, less educational and
work attainment, poorer health-related quality of
life, and increased suicide attempts.1,2
Social anxiety disorder is underdiagnosed and
treated, possibly because symptoms are trivialized
as shyness by medical caregivers and patients, or
treatment is misdirected toward individual symptoms or comorbidities.3 Diagnostic measures of
social anxiety suitable for primary care should be
brief, yet sensitive enough for diagnosis and tracking treatment progress.
Liebowitz Social Anxiety Scale (LSAS) and
Brief Social Phobia Scale (BSPS)
Validated clinician-administered measures include
the 24-item Liebowitz Social Anxiety Scale (LSAS)
and the 18-item Brief Social Phobia Scale (BSPS).
Both measures are commonly used in studies of
pharmacotherapy for social anxiety.4 However,
patient self-report measures may have an advantage by saving providers time and effort, and may
also address socially anxious patients’ reluctance to
describe their fears face-to-face.3
Social Phobia Inventory (SPIN)
The Social Phobia Inventory (SPIN) consists of 17
items assessing symptoms of fear, avoidance, and
physiological discomfort (Table).5 The measure
5. Being criticized scares me
6. Fear of embarrassment causes me to avoid doing things or
speaking to people*
7. Sweating in front of people causes me distress
8. I avoid going to parties
9. I avoid activities in which I am the center of attention*
10. Talking to strangers scares me a lot
11. I avoid having to give speeches
12. I would do anything to avoid being criticized
13. Heart palpitations bother me when I’m around people
14. I am afraid of doing things when people might be watching
15. Being embarrassed or looking stupid is among my worst fears*
16. I avoid speaking to anyone in authority
17. Trembling or shaking in front of others is distressing to me
Respondents report how much they were bothered by symptoms during the past week.
0=not at all, 1=a little bit, 2=somewhat, 3=very much, 4=extremely. Cutoff score = 19.
*Mini-SPIN items (#s 6, 9, and 15). Mini-SPIN cutoff score = 6.
was validated with 238 social phobia clinical trial
subjects, 47 psychiatric outpatients without a
diagnosis of social phobia, and 68 nonpsychiatric
volunteers. A cutoff score of 19 yielded 73% sensitivity and 84% specificity (positive likelihood
ratio [LR+] 4.6; negative likelihood ratio [LR–]
0.3). The corresponding positive predictive value
(PPV) and negative predictive value (NPV) was
81% and 77%, respectively. The SPIN was also
sensitive to treatment effects in that the mean total
score for the group treated with fluvoxamine was
significantly lower than that for the placebo
group.5 The validation sample consisted of adults
who were predominately Caucasian, so additional
research is needed to determine if the measure is
also valid with children, adolescents, and other
ethnic groups.
continued on page 6
Evidence-Based Practice / Vol. 10, No. 6
9
DRUG PROFILE
Paliperidone ER (Invega®) for treatment of schizophrenia
The Bottom Line
Paliperidone extended release (Invega®), the most recent second-generation antipsychotic (SGA) to receive
approval from the US Food and Drug Administration, is also known as 9-hydroxy-risperidone and is the active
metabolite of risperidone (Risperdal®). Paliperidone ER tablets utilize a patented osmotic push drug delivery system to deliver the medication at a controlled rate over a 24-hour period.1 Current data show that paliperidone
ER is similar to risperidone in terms of safety and efficacy, but may have some advantages due to its metabolism
and extended-release formulation.
Key Points
• Paliperidone ER is the active metabolite of risperidone
• Risperidone is set to go off patent at the end of 2007
• Paliperidone is currently priced comparably to risperidone to facilitate switching, but risperidone will
most likely be less expensive when it goes generic
• Paliperidone appears to be comparable to risperidone in terms of safety and efficacy
• Paliperidone may be advantageous for patients with hepatic impairment, complex drug regimens, or for
individuals who require once-daily dosing
The Pitch
At the end of 2007, Janssen’s blockbuster
antipsychotic risperidone is set to go off patent.
Consequently, Janssen has released paliperidone
ER. Paliperidone has been priced in a way that
makes it a viable alternative to risperidone from
a cost standpoint. However, as risperidone
becomes generically available, it will likely
become a less expensive option than paliperidone. Promotional information emphasizes the
advantages associated with the unique extendedrelease delivery system of paliperidone and its
lack of hepatic metabolism.2
Proposed advantages of the osmotic delivery
system and the associated steady plasma drug levels
include:
• Once-daily dosing
• No initial dose titration
• Increased tolerability
Proposed advantages of paliperidone over
risperidone are primarily linked to its lack of significant hepatic metabolism leading to:
10
Evidence-Based Practice / June 2007
• Fewer drug–drug interactions
• Less variability in metabolism from 1 patient
to the next
• No dose adjustment or avoidance in hepatically impaired patients
Context
Antipsychotics are currently the foundation for the
treatment of schizophrenia.3 Their mechanism of
action is unclear, although their effects are thought
to be exerted through their ability to block D2
dopamine receptors and 5-HT2a serotonin receptors.
SGAs are often favored clinically over the first-generation antipsychotics (FGAs) due to their decreased
propensity to cause extrapyramidal side effects
(EPS) and tardive dyskinesia. However, comparative
studies between SGAs and FGAs are limited. A
government-funded study involving 1,493 patients
suggests that SGAs are not more efficacious than
FGAs, with the exception of olanzapine and clozapine.4 Also, while SGAs are associated with a lower
incidence of movement disorders, these disorders
still may occur with their use, particularly at high
DRUG PROFILE
TABLE
Comparison of safety, efficacy, and cost of risperidone and paliperidone ER
(not head to head)
Risperidone7,8
Dose
EPS (%)
Placebo
2 mg/day
6 mg/day
10 mg/day
16 mg/day
13
13
16
20
31
Weight gain* (% of patients)
Clinical response (%)†8
No specific dose-related data:
Overall incidence 18% in risperidone vs 9% in placebo
22
Cost ($)/month‡
35
57
40
51
266
496
928
1,324
Paliperidone ER1,2
Dose
Placebo
3 mg/day
6 mg/day
9 mg/day
12 mg/day
11
12.6
10.2
25.2
26.0
Weight gain* (% of patients)
5
7
6
9
9
Clinical response (%)
30
NA
56
51
61
379
379
541
920§
EPS (%)
†2
Cost (%)/month
‡
* Weight gain defined as >7% increase from baseline weight.
† All information with the exception of clinical response is a result of pooled data. Clinical response is defined as a 20% reduction in total PANSS score from baseline for risperidone
(P<.05 for 6, 10, and 16 mg vs placebo) and a ≥30% reduction in PANSS total score with paliperidone (P<.001 for all groups compared with placebo).
‡ Drug cost obtained from walgreens.com on February 26, 2007.
§ 12-mg tablet not available, must use 9- and 3-mg tab.
EPS=extrapyramidal side effects; NA=not available; PANSS=Positive and Negative Symptoms of Schizophrenia.
doses. Other major side effects that can limit the use
of SGAs include weight gain, hyperprolactinemia,
orthostasis, and metabolic disturbances, such as diabetes and dyslipidemia.3
The Data
Paliperidone ER has been studied in more than
1,600 acutely schizophrenic individuals at doses
ranging from 3 to 15 mg. In these studies, paliperidone ER was found to be superior to placebo for the
reduction of total Positive and Negative Symptoms
of Schizophrenia (PANSS) scores.2,5,6 Clinical
response rates, which were defined as the percentage
of individuals with a PANSS reduction of more than
30% from baseline, were also found to be superior
to placebo.2 At doses lower than 9 mg/day, paliperidone was well tolerated. However, at doses of more
than 9 mg/day, substantial increases in the incidence of EPS and weight gain were observed
(Table).
While no head-to-head comparison trials
between risperidone and paliperidone ER have been
performed, the results from the current paliperidone
ER studies appear to be consistent with results
observed in the early risperidone studies with
respect to response rates and dose-related EPS.
Paliperidone ER also appears to be comparable to
risperidone with regard to prolactin elevation.1
Paliperidone ER is the first SGA that does not
undergo any significant hepatic metabolism.9 This
fact could be advantageous for the treatment of
patients with impaired liver function as well as individuals with complex drug regimens. The lack of
hepatic metabolism may also eliminate some of the
between-patient dose–response variability observed
with risperidone.
Overall, paliperidone ER appears to be comparable to risperidone in terms of efficacy and adverse
effects, including serum prolactin elevation and
dose-related EPS. As a result, a decision to use
paliperidone ER over risperidone should not be
made based on safety or efficacy. The possible advantages of paliperidone ER are its once-daily dosing
regimen and its ability to be initiated at therapeutic doses. The lack of hepatic metabolism of
paliperidone ER also makes it an attractive option
for individuals with hepatic impairment or those
with complex drug regimens, although the agent
Evidence-Based Practice / Vol. 10, No. 6
11
DRUG PROFILE
CONTINUED
has yet to be extensively studied in these populations. While cost may not currently be an issue
when choosing between these 2 agents, the generic
availability of risperidone in the near future should
EBP
be considered.
Dan Telford, PharmD candidate
Tracy K. Pettinger, PharmD
Kelli Christensen, MD
Idaho State University
REFERENCES
1.
2.
Invega™ (paliperidone) extended release tablets [prescribing information].
Titusville, NJ: Janssen LP; December 2006. Available at: http://
www.invega.com/active/janus/en_US/assets/common/company/pi/invega.pdf.
Accessed February 26, 2007.
Kane J, Canas F, Kramer M, et al. Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial. Schizophr
Res 2007; 90:147–161. [LOE 1b]
3.
American Psychiatric Association. Practice Guideline for the Treatment of
Patients With Schizophrenia. 2nd ed. Arlington, Va: American Psychiatric
Association; 2004. [LOE 1a]
4.
Lieberman JA, Stroup TS, McEvoy JP, et al; for the Clinical Antipsychotic Trials
of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005;
353:1209–1223. [LOE 1b]
5.
Davidson M, Emsley R, Kramer M, et al. Efficacy, safety and effect on functioning of paliperidone extended-release tablets in the treatment of acute
schizophrenia: an international 6-week placebo-controlled study [abstract].
Schizophr Res 2006; 81(suppl 1):43. [LOE 1b]
6.
Marder SR, Kramer M, Ford L, et al. Efficacy and tolerability of two fixed
dosages of paliperidone extended-release tablets in the treatment of acute
schizophrenia: a 6-week placebo-controlled study [abstract]. Schizophr Res
2006; 81(suppl 1):56. [LOE 1b]
7.
Risperdal® (risperidone) [prescribing information]. Titusville, NJ: Janssen LP;
Revised December 2006. Available at: http://www.risperdal.com/active/janus/
en_US/assets/common/company/pi/risperdal.pdf. Accessed February 26, 2007.
8.
Marder SR, Meibach RC. Risperidone in the treatment of schizophrenia. Am J
Psychiatry 1994; 151:825–835. [LOE 1b]
9.
Conley RR, Kelly DL. Drug-drug interactions associated with second-generation
antipsychotics: considerations for clinicians and patients. Psychopharmacol
Bull 2007; 40(1):77–97. [LOE 5]
CORRECTIONS
Evidence-Based Practice
For the April 2007 EBP, Behavioral Health Matters article entitled, “Are psychosocial interventions effective in the treatment
of infertility?” (page 9), the first author’s name was misspelled
and his degree was incorrect. His name should have been listed as “Brant Odland, DO.”
Family Physicians Inquiries Network, Inc.
409 West Vandiver Drive
Building 4, Suite 202
Columbia, MO 65202
In the May 2007 EBP, In The News article entitled, “AHRQ
report targets arthritis medication safety,” a 95% confidence
interval for lumiracoxib was reported incorrectly on page 3. The
corrected sentence follows: Therapy with lumiracoxib was associated with fewer upper GI complications than the other NSAIDs (HR
0.34; 95% CI, 0.22–0.52; P<.0001, NNT with lumiracoxib for 1
less GI event 167).
PRESORTED
STANDARD
U.S. POSTAGE
PAID
LINCOLN, NE
PERMIT # 365
Copy for your patients
CLINICAL INQUIRIES: PATIENT EDUCATION
Information you can trust. Information you can use.
Patient Handout
Based on the Clinical Inquiries® by the Family Physicians Inquiries Network:
What is the best treatment for plantar fasciitis?
Journal of Family Practice, September 2003, Vol. 52, No. 9
What Is the Best Treatment for a
Common Type of Heel Pain?
Do you have sharp pain in your heel when you step out of bed, or aching pain in the heel after exercising, getting up
from a sitting position, or standing on tiptoe? Your pain may be caused by an irritation of the tissue on the bottom of
your foot. The tissue that connects your heel to your toes is called the plantar fascia. The heel pain you may be experiencing is called plantar fasciitis (PLAN-tur fas-e-I-tis). The tenderness usually develops gradually but can come on
suddenly and last for months. Normally the pain occurs in 1 foot at a time and can be very frustrating.
What causes plantar fasciitis? Often it is a case of overuse. Runners and joggers sometimes develop heel pain.
Wearing shoes with thin soles, no arch support, or high heels can also irritate the plantar fascia tissue. In addition,
people with some types of arthritis and individuals with diabetes may be at increased risk for this type of irritation.
What can be done for heel pain? Limiting activities that aggravate the condition may reduce the pain. You can try
changing the type of exercise you do, switching shoes, resting your foot, or gently stretching the foot. If resting the
foot is not helping after a few weeks or the pain is getting worse, it is time to talk to your doctor.
Your doctor will examine your foot to check for tenderness and rule out other causes of heel pain such as arthritis or
tendonitis. He or she may order an x-ray or MRI to look for a cyst causing the pain. In the past, little pieces of extra
bone sticking out from the heel bone (called spurs) were thought to cause the pain, but removing bone spurs does not
relieve the pain and the surgery is rarely done today.
The latest research shows that mechanical treatment such as a rigid arch support, taping, or a night splint and a good
dose of patience are the most effective means of treatment. Doctors may inject medication into the irritated area or have
you take an anti-inflammatory drug such as ibuprofen. If the pain is not resolved after 6 months, a form of treatment
called shock wave therapy may be tried to relieve the pain. Surgery to release the tissue from the heel is performed only
for the worst cases and when no other treatment has given relief. A side effect of the surgery is that it also weakens the
arch of your foot.
Sharp heel pain can make daily activities difficult. If this is happening to you, seek medical advice. With time and
conservative treatment, you will be back kicking up your heels.
For more information
Heal Injuries and Disorders (MedlinePlus)
http://www.nlm.nih.gov/medlineplus/heelinjuriesanddisorders.html
Heel Pain (American Podiatric Medical Association)
http://www.apma.org/s_apma/doc.asp?CID=371&DID=9408
Plantar Fasciitis (Mayo Clinic Fitness)
http://www.mayoclinic.com/health/plantar-fasciitis/DS00508
JUNE 2007
Evidence-Based Practice
CME
CONTINUING MEDICAL EDUCATION TEST
JUNE 2007
For each question, please mark the single best answer by checking the appropriate box.
1. Which of the following agents has the most evidence to support its
safe use for treating anxiety in breastfeeding women?
o a. Paroxetine
o b. Clomipramine
o c. Buspirone
o d. Lorazepam
2. Which of the following treatments has been found to completely
resolve pyogenic granulomas in 2 treatments or less?
o a. Curettage and electrodesiccation
o b. Cryotherapy with liquid nitrogen
o c. Sclerotherapy
o d. Laser therapy
3. What is the most common short-term side effect of testosterone
patch therapy in postmenopausal women?
o a. Application site irritation
o b. Impaired orgasmic response
o c. Acne
o d. Hirsutism
4. Which of the following statements about
postpartum hemorrhage (PPH) is true?
o a. Misoprostol is superior to oxytocin in the
prevention of PPH
o b. Treatment of PPH with misoprostol results in
decreased maternal mortality
o c. Misoprostol is inexpensive and does not require
cold storage
o d. Oral misoprostol is associated with shivering
and a reduction in body temperature
5. Which of the following statements is true about
social anxiety disorder?
o a. It is associated with higher rates of substance abuse
and depression
o b. Lifetime prevalence is about 13%
o c. Symptoms can be effectively assessed
with the Social Phobia Inventory (SPIN)
o d. All of the above
6. The results of the Paradise trial on tympanostomy tubes
for middle ear effusions are applicable to infants
and children with effusions and
o a. Cleft palate
o b. A hearing loss of <40 dB
o c. Chaotic home situations
o d. A history of birth asphyxia
7. What feature of incomplete Kawasaki disease would
indicate need for echocardiography to screen for
coronary artery abnormalities?
o a. White blood cell count <10,000/mm3
o b. Signs of systemic inflammation
o c. Presence of cough
o d. Platelets <300,000/mm3
8. Which of the following statements is true regarding paliperidone
extended release for treatment of schizophrenia?
o a. It is associated with a lower incidence of
hyperprolactinemia than risperidone
o b. It causes fewer drug–drug interactions than risperidone
o c. It is not associated with significant dose-related
extrapyramidal side effects
o d. It should not be used in patients with hepatic impairment
This test must be received by March 31, 2008 to be accepted for credit
Answer key: 1. a; 2. a; 3. a; 4. c; 5. d; 6. b; 7. b; 8. b
Affix proper postage to this mailer to subscribe, renew your subscription, or submit your CME test
Printed Name (include MD, DO, etc.)
Last 4 digits of SS #
Address
State
City
Phone:
E-mail (for internal admin. use only):
Zip
Please detach, fold, seal and affix proper postage to this mailer with the return address facing out, and return it today to subscribe,
renew, or to receive your CME credit.
• $224 CME subscription includes processing fee for three (3) hours of ACCME Category 1 CME credit with
each issue, for up to a maximum total of 36 hours annually.
• $15 processing for each test, for subscriptions without CME upgrade.
Payment enclosed for $
o MasterCard
Charge my
Card #
Signature
o
Visa
o American Express
Card 3 Digit Verification #
Exp