The prevailing attitude “There’s a pill for that” comes from effective marketing!
The prevailing attitude “There’s a pill for that” comes from effective marketing!
The bispectral index monitor (BIS) illustrates
many of the principles of medical
reversal. Although rare, anesthesia awareness
(or intraoperative awareness) is debilitating
and is associated with post traumatic stress disorder
and anxiety.74 The BIS monitor was
developed to ensure that patients were
receiving adequate anesthesia by using a single
electroencephalographic lead to calculate a
the monitor’s use increased. By
July 2007, half of all operating rooms in the
United States had a BIS monitor.77 Then in
2008, a large, randomized trial comparing the
BIS monitor with a standardized sedation monitoring
strategy found no benefit for the device on
anesthesia awareness.78 Many reversals have
similar narratives
These reversals include arthroscopic surgery
for knee osteoarthritis,40 vertebroplasty for
osteoporotic fractures,17 endovascular repair
of infrarenal abdominal aortic aneurysms,43
stenting in patients with stable coronary artery
disease,1 amnioinfusion for women with meconium
staining,44 C-reactive protein testing,45
screening men with the prostate specific antigen
test,46 and routine revascularization or stress
testing before surgery
Antimicrobial treatment in
diabetic women with
asymptomatic bacteriuria
(Harding et al,48 2002)
In contrast to European societies, several groups49,50 in the United States recommended screening and treating
for asymptomatic bacteriuria in women with diabetes. This randomized trial found that although this practice
leads to more antibiotic use, it did not reduce complications or improve the time to symptomatic infection
Conventional adjuvant
chemotherapy with or
without high-dose
chemotherapy and
autologous stem-cell
transplantation in high-risk
breast cancer (Tallman
et al,51 2003)
Multiple studies have claimed that high-dose chemotherapy with stem cell transplantation improves disease-free
survival at 3 years to 65%-70%, an improvement of 20%-30% beyond standard adjuvant chemotherapy.52,53
High-dose chemotherapy and autologous stem cell transplantation became a common, costly, and
controversial practice for more than a decade. This trial randomized patients with primary breast cancer with
involvement of at least 10 ipsilateral axillary lymph nodes to standard adjuvant chemotherapy vs adjuvant
chemotherapy followed by high-dose chemotherapy and stem cell transplant. The study arm was found to
reduce risk of relapse, but no improvement in survival was found
Control of exposure to mite
allergen and allergen impermeable
bed covers for
adults with asthma
(Woodcock et al,54 2003)
The cost of impermeable bed covers is in the millions of dollars annually, whereas the cost of all preventive
interventions for asthma and allergic rhinitis is in the billions.55 US56 and European57 guidelines recommend
these covers be used among many patients with asthma. This double-blind, randomized, placebo-controlled
trial of >1100 patients found no benefit on any clinical or physiologic outcome for this practice
Methylprednisolone,
valacyclovir, or the
combination for vestibular
neuritis (Strupp et al,58
2004)
The cause of vestibular neuritis is presumed to be a viral infection,59 and yet it is unknown whether
corticosteroids, an antiviral medication, or a combination of both have any benefit in treating this disease. At
the time of this publication, physicians prescribed either or both. A prospective, randomized, double-blind, 2-by-2
factorial trial was performed assessing whether placebo, methylprednisolone, valacyclovir, or a combination of the 2
would improve symptoms. Only the corticosteroids, and not the antiviral, improved the recovery of patients with
vestibular neuritis
Mild intraoperative
hypothermia during surgery
for intracranial aneurysm
(Todd et al,60 2005)
Hypothermia was found to be helpful as a neurosurgical adjunct in 1955, especially for ischemic and traumatic insults.
At the time of this publication, the practice was used in nearly 50% of aneurysm surgeries.61 This large randomized
study, the Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST), found no improvement in neurologic
outcomes with hypothermia, while noting an increase in bacterial infections with the intervention
Optimal medical therapy with
or without PCI for stable
coronary disease (Boden
et al,35 2007)
Although treatment guidelines recommended an initial approach of intensive medical therapy, reduction of risk
factors, and lifestyle modification (optimal medical therapy) for patients with stable coronary artery disease,
percutaneous coronary intervention (PCI) was still a common initial treatment strategy for patients with stable
coronary artery disease at the time this study was performed.62,63 The authors found that PCI added to optimal
medical therapy did not reduce the risk of death, myocardial infarction, or other major cardiovascular events
In vitro fertilization with
preimplantation genetic
screening (Mastenbroek
et al,64 2007)
Because low pregnancy rates in women of advanced maternal age undergoing in vitro fertilization (IVF) may result
from chromosomal abnormalities, the use of preimplanation genetic screening had become increasingly more
common at the time of this study.65-67 However, this multicenter, double-blind randomized controlled trial
comparing IVF with and without preimplantation genetic screening found that screening significantly reduced
rates of ongoing pregnancies and live births after IVF in women of advanced maternal age
Effects of intensive glucose
lowering in type 2 diabetes
(Action to Control
Cardiovascular Risk in
Diabetes Study Group
et al,68 2008)
A target hemoglobin A1c of 7.0% or less as recommended for most patients with diabetes.69 The Action to Control
Cardiovascular Risk in Diabetes (ACCORD) trial found that target of <7 .0="" 3.5="" for="" increased="" p="" sustained="" years="">
mortality and did not significantly reduce major cardiovascular events compared with a more permissive goal
Revascularization versus
medical therapy for renal artery
stenosis (ASTRAL
Investigators et al,70 2009)
Renal artery stenosis is associated with hypertension and kidney disease, but it is unclear if the relationship is
causal. Despite this uncertainty, data from studies in the United States indicate that revascularization is
performed in 16% of patients with newly diagnosed atherosclerotic renovascular disease and hypertension.71
This large randomized trial of revascularization with medical management vs medical management alone found
substantial risks but no evidence of benefit from revascularization in this population
Gentamicin-collagen sponge
for infection prophylaxis in
colorectal surgery (Bennett-
Guerrero et al,72 2010)
The gentamicin-collagen sponge has been approved for use in numerous countries and used in millions of patients
worldwide since 1985. A single-center, randomized trial found a 70% decrease in surgical site infection with
implantation of the sponge.73 However, this large, multicenter, phase 3 trial found that the gentamicin-collagen
sponge paradoxically resulted in significantly more surgical site infections, was associated with more visits to the
emergency department or surgical office, and more frequently precipitated subsequent hospitalization for the
infection
evidence for vitamin E’s cardiovascular benefits from 1993 (refuted in 2005).
Also looked at articles citing evidence for b-carotene in cancer from 1981 (refuted in 1994-1996)
Also looked at articles citing evidence for estrogen in Alzheimer’s disease from 1996 (refuted 2004)
Table 1. Number (Percentage) of Reversal, Reaffirmation, and Inconclusive Articles by Year
|
Year
|
Reversal
|
Reaffirmation
|
Inconclusive
|
|
2001 (n=48)
|
14 (29.2)
|
20
|
14
|
|
2002 (n=26)
|
12 (46.2)
|
9
|
5
|
|
2003 (n=31)
|
12 (38.7)
|
12
|
7
|
|
2004 (n=33)
|
12 (36.4)
|
15
|
6
|
|
2005 (n=41)
|
19 (46.3)
|
14
|
8
|
|
2006 (n=20)
|
12 (60.0)
|
5
|
3
|
|
2007 (n=54)
|
18 (33.3)
|
17
|
19
|
|
2008 (n=32)
|
15 (46.9)
|
13
|
4
|
|
2009 (n=35)
|
16 (45.7)
|
16
|
3
|
|
2010 (n=43)
|
16 (37.2)
|
17
|
10
|
|
Total (N=363)
|
146 (40.2)
|
138 (38.0)
|
79 (21.7)
|
The prevailing attitude “There’s a pill for that” comes from effective marketing!
