Ending Medical Reversal
Page 26
68 A trial of contraceptive methods in women with systemic lupus erythematosus
12/15/05
Oral contraceptives are often withheld from patients with lupus for fear that they might worsen the disease. Studies 68 and 69 showed that the use of oral contraceptives does not increase the incidence of lupus flares.
69 Combined oral contraceptives in women with systemic lupus erythematosus
12/15/05
See study 68.
70 The risk associated with aprotinin in cardiac surgery
1/26/06
This trial showed that a drug used for patients having surgery for myocardial infarction was associated with increased risk of renal failure, myocardial infarction or heart failure, and stroke.
71 Clozapine alone versus clozapine and risperidone with refractory schizophrenia
2/2/06
Often patients with schizophrenia are given multiple drugs to control symptoms. This study showed that the combination of two commonly used drugs was no better than one.
72 Saw palmetto for benign prostatic hyperplasia
2/9/06
Although saw palmetto is used by more than 2 million men in the United States for the symptoms of prostate enlargement, this study showed no benefit in multiple outcomes.
73 Calcium plus vitamin D supplementation and the risk of fractures
2/16/06
As discussed in chapter 6, this study suggested the commonly used calcium with vitamin D supplementation does not reduce hip fracture and increases the risk of kidney stones.
74 Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis
2/23/06
Also discussed in chapter 6, this study showed that glucosamine and chondroitin sulfate, alone or in combination, did not reduce pain in patients with osteoarthritis of the knee.
75 Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome
4/20/06
This study overturned the practice of using steroids to treat patients with acute respiratory distress syndrome, a common complication of critically ill patients.
. 76 Pulmonary-artery versus central venous catheter to guide treatment of acute lung injury
5/25/06
Similar to study 27, this study called into question the utility of the pulmonary artery catheter.
77 A controlled trial of homocysteine lowering and cognitive performance
6/29/06
Because observational studies suggested that people with low levels of plasma homocysteine retain better cognitive function, some clinicians have prescribed the vitamins folate, B12, and B6. This double-blind, placebo-controlled, randomized clinical trial showed that this intervention is not beneficial.
78 Effectiveness of atypical antipsychotic drugs in patients with Alzheimer’s disease
10/12/06
This important study demonstrated the high incidence of adverse effects caused by medications commonly used to treat psychosis, aggression, and agitation in patients with Alzheimer’s disease.
79 DHEA in elderly women and DHEA or testosterone in elderly men
10/19/06
DHEA and testosterone are widely promoted as supplements. In this placebo-controlled, randomized, double-blind study, men were randomized to placebo, testosterone, or DHEA. Women received either DHEA or placebo. Neither DHEA nor low-dose testosterone were shown to have beneficial effects on body composition, physical performance, insulin sensitivity, or quality of life.
80 Correction of anemia with epoetin alfa in chronic kidney disease
11/16/06
Patients with kidney disease often develop an anemia that can be effectively treated with erythropoiesis-stimulating agents. How aggressively this anemia should be treated was unclear, and both guidelines and practice tended toward more aggressive therapy. This trial showed that less aggressive therapy was equally effective.
81 Coronary intervention for persistent occlusion after myocardial infarction
12/7/06
Patients with persistent total occlusion of a coronary artery after treatment for a myocardial infarction were often treated with stenting. This trial showed that this intervention was no better than optimal medical therapy alone (and might actually be associated with a higher likelihood of recurrent myocardial infarctions).
82 Tympanostomy tubes and developmental outcomes at 9 to 11 years of age
1/18/07
Further follow-up from a study showing no benefit of inserting ear tubes in children with middle-ear infections. (See studies 6 and 63.)
83 Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden
3/8/07
This study reversed the use of a certain type of stent in a subset of patients with narrowed coronary arteries.
84 Influence of computer-aided detection on performance of screening mammography
4/5/07
This is an unsettled and highly controversial topic. This study suggested that the adoption of computer-aided detection systems to analyze digitized mammograms was actually associated with reduced accuracy of interpretation.
85 Optimal medical therapy with or without PCI for stable coronary disease
4/12/07
The COURAGE trial, reversing the use of stents for stable coronary-artery disease, is discussed throughout this book.
86 Effectiveness of adjunctive antidepressant treatment for bipolar depression
4/26/07
Although the FDA had not approved standard antidepressants for treatment of bipolar depression, many physicians used them in addition to the more accepted medications. This randomized controlled trial showed that the use of a standard antidepressant as an adjunctive treatment was not associated with better outcomes.
87 Randomized comparison of strategies for reducing treatment in mild persistent asthma
5/17/07
This trial showed that one way of reducing asthma therapy, from an inhaled steroid to montelukast, was ineffective.
88 Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
6/14/07
The Avandia controversy was well covered in the press (and discussed briefly in chapter 3). Rosiglitazone was introduced in 1999 and was approved in type 2 diabetes mellitus because of its ability to reduce blood glucose and HbA1c (surrogate outcomes). This meta-analysis found that rosiglitazone was associated with a significant increase in the risk of myocardial infarction.
89 In vitro fertilization with preimplantation genetic screening.
7/5/07
Because of the concern that low pregnancy rates in older women undergoing in vitro fertilization (IVF) may be due to the increased prevalence of chromosomal abnormalities, the use of genetic screening had become increasingly common. This trial comparing IVF with and without preimplantation genetic screening found that screening actually reduced rates of ongoing pregnancies and live births
90 A multicenter, randomized controlled trial of dexamethasone for bronchiolitis
7/26/07
This trial showed that a single dose of an oral steroid administered in the emergency room, although a common practice, did not reduce the rate of hospital admission or improve either the child’s respiratory status after four hours or later outcomes, in children with moderate-to-severe bronchiolitis.
91 Saline or albumin for fluid resuscitation in patients with traumatic brain injury
8/30/07
Because there was no consensus on the best choice of fluids for fluid resuscitation in patients with traumatic brain injury, both albumin and saline were used. This study showed that fluid resuscitation with albumin was associated with higher mortality rates.
92 High-dose melphalan versus melphalan plus dexamethasone for AL amyloidosis
9/13/07
At the time of this study, high-dose melphalan with autologous hematopoietic stem-cell rescue was commonly used to treat patients with AL amyloidosis,
but transplant-related mortality was high. This randomized trial showed that AL amyloidosis treatment with high-dose melphalan plus autologous hematopoietic stem-cell transplant was not superior to the outcome with standard-dose melphalan plus dexamethasone.
93 Outcomes at 2 years of age after repeat doses of antenatal corticosteroids
9/20/07
Studies 93 and 94 both look at the use of steroids in women before the birth of preterm infants. The studies showed that multiple doses of steroids (which had become common), compared to the standard single dose, reduced neonatal morbidity but did not change survival free of major neurosensory disability or body size at 2 years of age.
94 Long-term outcomes after repeat doses of antenatal corticosteroids
9/20/07
See study 93.
95 Early treatment with prednisolone or acyclovir in Bell’s palsy
10/18/07
Because Bell’s palsy is thought to be caused by a viral infection and is associated with inflammation, both an antiviral and anti-inflammatory steroids were commonly used in its treatment. This randomized, controlled trial showed that while the steroid significantly improved the chances of complete recovery, the antiviral was not beneficial.
96 Lung transplantation and survival in children with cystic fibrosis
11/22/07
This study looked at the difficult issue of how to treat the sickest children with cystic fibrosis. Lung transplantation is the most aggressive therapy for end-stage lung disease from cystic fibrosis. This large study showed that lung transplantation improved survival in less than 1 percent of patients with cystic fibrosis and suggested that lung transplantation should not be expected to prolong life.
97 Rosuvastatin in older patients with systolic heart failure
11/29/07
This randomized controlled trial showed that a cholesterol-lowering drug did not reduce the rate of death from cardiovascular causes or death from any cause in patients with systolic heart failure. It did reduce the number of cardiovascular hospitalizations, but this was not the trial’s primary end point.
98 Dexamethasone in Vietnamese adolescents and adults with bacterial meningitis
12/13/07
Steroids are commonly added to antibiotics in the treatment of bacterial meningitis. This randomized controlled trial showed that a steroid, dexamethasone, did not significantly improve outcomes in Vietnamese adolescents and adults with bacterial meningitis. (There may be some beneficial effect for patients with biologically proven disease, including those who have previously received antibiotic treatment.)
99 Corticosteroids for bacterial meningitis in adults in sub-Saharan Africa
12/13/07
This study considered the same question in an area of high HIV prevalence. The randomized controlled trial took place in Malawi and showed that dexamethasone did not reduce mortality or morbidity.
100 Hydrocortisone therapy for patients with septic shock
1/10/08
This study overturned the use of short-term, high-dose steroids to treat septic shock.
101 Intensive insulin therapy and pentastarch resuscitation in severe sepsis
1/10/08
Another study of patients with sepsis, this one questioned the practice of aggressively controlling blood glucose in these patients. In this study, not only was no mortality benefit noted, but the trial was stopped early because of severe hypoglycemic events leading to prolonged ICU stays.
102 Aprotinin during coronary-artery bypass grafting and risk of death
2/21/08
Studies 102 and 103 showed that aprotinin, used in cardiac surgery to reduce blood loss and maintain platelet function, had greater harms than the previous standard.
103 The effect of aprotinin on outcome after coronary-artery bypass grafting
2/21/08
See study 102.
104 Vasopressin versus norepinephrine infusion in patients with septic shock
2/28/08
This is another trial showing that a new intervention, which was being used clinically to treat ICU patients, was no better than the previous standard.
105 Anesthesia awareness and the bispectral index
3/13/08
The bispectral index (BIS) is an important brain-function monitor for anesthesiologists to prevent sensory perception (patient awareness) during surgery. This trial showed that the monitor resulted neither in lower rates of anesthesia awareness nor in lower use of volatile anesthetic gas.
106 Simvastatin with or without ezetimibe in familial hypercholesterolemia
4/3/08
In this trial, the use of the commonly used drug ezetimibe was found to lower cholesterol but not improve a surrogate end point.
107 Metformin versus insulin for the treatment of gestational diabetes
5/8/08
This is a reversal in that a beneficial medication was being withheld because of unfounded concerns. The drug metformin was considered beneficial for treatment for gestational diabetes, but its use became controversial because of the question of adverse perinatal effects. When metformin was compared with insulin in this open-labeled random controlled trial, there was no significant increase in perinatal complications.
108 A comparison of aprotinin and lysine analogues in high-risk cardiac surgery
5/29/08
This is a study, similar to studies 70, 102, and 103, on the negative effects of aprotinin.
109 Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes
6/12/08
This trial (ADVANCE) and the next (ACCORD) both demonstrated that very aggressive control of blood sugar in (at least certain) patients with type 2 diabetes—an approach advocated by many doctors—is not beneficial and carries real risks.
110 Effects of intensive glucose lowering in type 2 diabetes
6/12/08
See study 109.
111 Rhythm control versus rate control for atrial fibrillation and heart failure
6/19/08
Similar to studies 25 and 26, this trial showed that converting patients from atrial fibrillation to sinus rhythm was no better than just controlling their heart rate.
112 Noninvasive ventilation in acute cardiogenic pulmonary edema
7/10/08
In order to avoid the complications of endotracheal intubation (use of a breathing machine), noninvasive ventilation strategies are often used in patients with heart failure. Although this study demonstrated some improvements with this approach, there was no difference in the effect on short-term mortality between standard oxygen therapy and noninvasive ventilation.
113 A randomized trial of arthroscopic surgery for osteoarthritis of the knee
9/11/08
Similar to study 21, this trial failed to show a benefit of arthroscopic surgery for treatment of osteoarthritis of the knee.
114 Prolonged therapy of advanced chronic hepatitis C with low-dose peginterferon
12/4/08
Given more recent advances, this reversal is unimportant, but at the time it showed that not all means of suppressing the hepatitis C virus would lead to clinically important benefits.
115 Oral prednisolone for pre-school children with acute virus-induced wheezing
1/22/09
Several sets of national guidelines recommended that oral corticosteroids be given to preschool-aged children who are brought to a hospital with virus-induced wheezing. This large randomized, double-blind, placebo-controlled trial found no benefit in this approach.
116 Quality of life after late invasive therapy for occluded arteries
2/19/09
This study extended the findings of study 81.
117 Intensive versus conventional glucose control in critically ill patients
3/26/09
Similar to trial 101, this study showed that aggressive control of blood sugar in patients in the intensive care unit actually increased the absolute risk of death at 90 days.
118 Mortality
results from a randomized prostate-cancer screening trial
3/26/09
The mortality benefit of routine prostate-cancer-specific antigen (PSA) screening continues to be debated but has been accepted practice for two decades. This large, randomized trial failed to detect any mortality benefit of routine screening among American men.
119 Rosuvastatin and cardiovascular events in patients undergoing hemodialysis
4/2/09
Because of their significant cardiovascular risk, people on dialysis for kidney failure were often prescribed cholesterol-lowering statin medicines. This study found no benefit in the combined end point of myocardial infarction, stroke, or death from cardiovascular causes among these patients, despite significant improvements in LDL cholesterol.
120 Efficacy of esomeprazole for treatment of poorly controlled asthma
4/9/09
Because acid reflux is thought to exacerbate asthma, people with poorly controlled asthma are commonly tested for reflux and, if it is diagnosed, treated. This study found that, despite a substantial incidence of reflux, the addition of reflux treatment did not confer benefit.
121 Cognitive function at 3 years of age after fetal exposure to antiepileptic drugs
4/16/09
Multiple guidelines do not distinguish among antiepileptic drugs used during pregnancy with respect to risk to the fetus. This study found that valproic acid, as compared with other commonly used drugs, was associated with poorer cognitive function in the child, at 3 years of age.
122 Early versus delayed provisional eptifibatide in acute coronary syndromes