Controversial issues Inmedicine...Dr. Muhammad Sayedul ArefinResident ,Gastroenterology ,BSMMU
List of controversial issuesUse of Steroids in TuberculosisPioglitazone in DiabetesSteroid in strokeProtein restrictio...
Use of STEROID in Tuberculosis
BackgroundCorticosteroids: Decrease inflammation, especially in the subarachnoid space Reduce cerebral and spinal cord ...
Corticosteroids:It may Suppress the immune response to mycobacteria, making the systemic effects worseMay reduce inflamm...
Steroids in TBAlthough much of the morbidity in tuberculosis results from an excessive cellular host response to the baci...
Steroids in TBCorticosteroids are often used as an adjunct in the treatment of various forms of TB and for the prevention...
Steroids in TBBut they have been proven in clinical trials to improve the following outcomes only — death or disability i...
Steroid in Tubercular MeningitisTubercular meningitis (TBM) is uniformly fatal if not treatedAn earlier Cochrane systema...
Steroid in Tubercular MeningitisBut largest-ever RCT done in Vietnam revealed corticosteroids to significantly decrease t...
Steroid in Tubercular MeningitisCorticosteroids may hasten symptomatic improvement when tuberculoma results in mass effec...
Steroid in Tubercular PericarditisPatients with tubercular pericarditis may  developCardiac tamponadeConstrictive peric...
Adrenal TBClinically manifest adrenal insufficiency as a result of TB is an absolute indication for corticosteroidsSubcl...
Steroid in other extrapulmonary TBEvidence is inconclusive for use of corticosteroids inGenitourinary TBLaryngeal TBPe...
Steroid in pulmonary TBThe role of corticosteroids in pulmonary TB modern-day rifampicin-based regimens is  questionable...
Endobronchial TB
Steroid in Tubercular pleural EffusuionMost tubercular pleural effusions resolve spontaneously even without specific ATT....
Steroid in Tubercular pleural EffusuionDifferent studies revealed both positive & negative results regarding improvement ...
Corticosteroids in HIV-related TBParadoxical reactions in TB is defined by a clinical or radiological worsening of pre- e...
Corticosteroids in HIV-related TBThis phenomenon is also noticed in few cases of HIV-negative TBMost cases of paradoxica...
Final WordsThe only clinical indication for which corticosteroids have been demonstrated to be beneficial beyond reasonab...
Patients with diabetes were understandably worried, and their physicians were faced, as often is the case with such media...
Pioglitazone in diabetes
Pioglitazone in diabetes• The type-2 diabetes drug pioglitazone, is at  the center of a great deal of controversy  lately•...
Pioglitazone in diabetesThe European Medicines Agency recently affirmed that the medication should not be taken off the m...
Pioglitazone in diabetes• Piglitazones are usually given when other  medications have proven ineffective• This may mean th...
Pioglitazone in diabetes• For these reasons, the agency only  recommended putting warning labels on  the medication and le...
Pioglitazone in diabetes• Still, some groups are concerned about the  increased risks associated with Actos• The law firm ...
Pioglitazone in diabetes• Much of the concern over the potential side  effects associated with Actos stems from a  review ...
Pioglitazone in diabetes• However, when investigators dug deeper  into the numbers, they found that those who  had been ta...
• Dietary Protein Restriction in CKD
Dietary Protein Restriction in CKD: The Debate                  ContinuesDietary protein restriction has been one ofthe m...
Proven and Controversial Advantages and Disadvantages of        Dietary Protein Restriction in CKD Patient                ...
The role of dietary protein restriction in slowing progression of CKD is more controversial, although several meta- analy...
 Concern has been raised by several investigators  that low-protein diets(LPDs) especially very low  quantities of dietar...
These concerns have been mostly defied by  a number of studies showing well-designed diets planned by skilled  dietitian...
An article published in American Journal of  Kidney Diseases in 2009 by Menon et el.  ignite the controversy by providing...
• These result emphasize the importance of  follow-up when evaluating the impact of  Interventions designed to slow the ch...
Steroid in Stroke
Steroid in StrokeTheoretically, steroids are immunosuppressive agents that Lessen Cerebral edemaDecrease intracranial p...
Steroid in StrokeThese possible benefits have to be weighed against potentially serious steroid-related side effects, suc...
Steroid in StrokePerhaps the only general agreement on the use of steroids in stroke is where vasculitis is suspected or ...
Steroid in StrokeThe effectiveness of steroids as one of the options for the treatment of acute stroke, either hemorrhagi...
Steroid in StrokeIn 2001, Ogun and Odusote performed a prospective double-blind, placebo-controlled, randomized clinical ...
Steroid in Stroke• Of the 27 hemorrhagic stroke patients, 15  were treated with 100 mg dexamethasone  immediately and 16 m...
Steroid in Stroke• This study failed to demonstrate any  benefit of a short-term course of high-dose  steroids in improvin...
SAH• Subarachnoid hemorrhage (SAH) accounts  for 7% to 8% of all strokes and leads to early  death (1 month) in about 30% ...
Steroid in StrokeMineralocorticoid treatment with fludrocortisone acetate prevents plasma volume depletion Glucocorticoi...
Steroid in Stroke• However, a beneficial effect of steroids on  the clinical outcome in patients with SAH  has not been pr...
Summary• Steroids have a very limited role in stroke  therapy• The only definite proven indication of steroids  in stroke ...
Controversies in StrokeSteroids Have No Role in Stroke TherapyNiphon Poungvarin, MD, FRCP, FRCP(E), FRCP(Glasg)+ Author Af...
• THE STEM CELL DEBATE: IS IT OVER
Definition of Stem cell• A stem cell is a generic cell that can make  exact copies of itself indefinitely• stem cell has t...
Types of stem cells• Embryonic stem cells : these are taken  from aborted fetuses or fertilized eggs that  are left over f...
• Adult stem cells - these are not as  versatile for research purposes because  they are specific to certain cell types, s...
Excitement and Controversy• Doctors have been performing bone  marrow stem cell transplants for decades• But when scientis...
Excitement and Controversy• The controversy centered on the moral  implications of destroying human embryos• Political lea...
New Possibilities• But Scientists have learned how to  stimulate a patients own cells to behave  like embryonic stem cells...
The Ethical Questions• Until recently, the only way to get pluripotent  stem cells for research was to remove the  inner c...
The Ethical Questions• Stem cell research thus raised difficult  questions:Does life begin at fertilization, in the womb,...
IPS Cells: Problem Solved?With iPS cells now available as an alternative to hES cells, the debate over stem cell research...
IPS Cells: Problem Solved?• hES cells are a gold standard against  which the "stemness" of iPS cells is  measured• Some ex...
IPS Cells: Problem Solved?• An additional ethical consideration is that  iPS cells have the potential to develop into  a h...
Stem Cell Research Legislation• The U.S. government released new stem  cell guidelines in 2009• The new guidelines cover i...
Medical controversy
Medical controversy
Medical controversy
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Medical controversy

  1. 1. Controversial issues Inmedicine...Dr. Muhammad Sayedul ArefinResident ,Gastroenterology ,BSMMU
  2. 2. List of controversial issuesUse of Steroids in TuberculosisPioglitazone in DiabetesSteroid in strokeProtein restriction in CKDEmbryonic Stem Cell Transplantation
  3. 3. Use of STEROID in Tuberculosis
  4. 4. BackgroundCorticosteroids: Decrease inflammation, especially in the subarachnoid space Reduce cerebral and spinal cord oedema Reduce inflammation of small blood vessels and therefore Reduce damage from decreased blood flow to the underlying brain tissue
  5. 5. Corticosteroids:It may Suppress the immune response to mycobacteria, making the systemic effects worseMay reduce inflammation of the meninges, reducing drug penetration into the subarachnoid spaceCause gastrointestinal haemorrhage, electrolyte imbalance, hyperglycaemia, infections from fungi or bacteria, and psychosis
  6. 6. Steroids in TBAlthough much of the morbidity in tuberculosis results from an excessive cellular host response to the bacillus, the use of steroids in TB management remains controversial
  7. 7. Steroids in TBCorticosteroids are often used as an adjunct in the treatment of various forms of TB and for the prevention of complications, such asConstrictive pericarditisHydrocephalusFocal neurological deficits Pleural adhesionsIntestinal stricture
  8. 8. Steroids in TBBut they have been proven in clinical trials to improve the following outcomes only — death or disability in HIV-seronegative patients with: Tubercular meningitis and Tubercular pericarditisDespite a lack of specific evidence for efficacy in HIV co-infected patients with tubercular meningitis or pericarditis, corticosteroids are generally recommended in them as well
  9. 9. Steroid in Tubercular MeningitisTubercular meningitis (TBM) is uniformly fatal if not treatedAn earlier Cochrane systematic review concluded that corticosteroids significantly improved the mortality among children with TBMBut the effect on mortality in adults was inconclusive
  10. 10. Steroid in Tubercular MeningitisBut largest-ever RCT done in Vietnam revealed corticosteroids to significantly decrease the risk of death and improve the disability-free survival in TBMCentral nervous system TB may at times present as focal space-occupying lesions of the brain parenchyma or the spinal cord (TUBERCULOMA) with or without evidence of meningitis
  11. 11. Steroid in Tubercular MeningitisCorticosteroids may hasten symptomatic improvement when tuberculoma results in mass effect or refractory seizuresBut eficacy of corticosteroids in this clinical setting has not been formally evaluated in clinical trialsParadoxically,tuberculoma may develop in patients being treated for TBM despite the use of adjunctive corticosteroids
  12. 12. Steroid in Tubercular PericarditisPatients with tubercular pericarditis may developCardiac tamponadeConstrictive pericarditisMeta-analysis of different RCTs reveal corticosteroids decreased the risk of all-cause mortality by in tubercular pericarditis• But this reduction failed to achieve statistical significance Corticosteroids did not significantly reduce the need for pericardiectomy also
  13. 13. Adrenal TBClinically manifest adrenal insufficiency as a result of TB is an absolute indication for corticosteroidsSubclinical adrenal insufficiency which is common among patients with pulmonary as well as extrapulmonary TBAdrenal function recovers in most of these patients with ATT alone
  14. 14. Steroid in other extrapulmonary TBEvidence is inconclusive for use of corticosteroids inGenitourinary TBLaryngeal TBPeritoneal TBMiliary TBMediastinal TB lymphadenitis
  15. 15. Steroid in pulmonary TBThe role of corticosteroids in pulmonary TB modern-day rifampicin-based regimens is questionableAnecdotal reports suggest that corticosteroids might be beneficial in patients with endobronchial TBBut in one trial of 34 patients with endobronchial TB, corticosteroids had no appreciable effect on bronchoscopic healing rate, radiological findings, and pulmonary functions
  16. 16. Endobronchial TB
  17. 17. Steroid in Tubercular pleural EffusuionMost tubercular pleural effusions resolve spontaneously even without specific ATT.The resolution is often incomplete leaving behind loculated collections and considerable pleural thickeningIt is believed that corticosteroids might reduce these fibrotic sequelae and hasten the resolution of pleural effusion as well as clinical symptoms
  18. 18. Steroid in Tubercular pleural EffusuionDifferent studies revealed both positive & negative results regarding improvement of pleural effusion & prevention of pleural adhesion by steroidBut no study revealed significant improvement in pulmonary function (evidenced by forced vital capacity at the end of treatment)Thus, the clinical significance of the reduction in pleural thickening by corticosteroids is QUESTIONABLE
  19. 19. Corticosteroids in HIV-related TBParadoxical reactions in TB is defined by a clinical or radiological worsening of pre- existing tuberculous lesions or the development of new lesions, in patients receiving anti-tuberculous medication who initially improved on treatmentThis phenomenon is also known as Immune Reconstitution Inflammatory syndrome (IRIS)This is well-recognised phenomenon, particularly in HIV-infected individuals where they are associated with HAART
  20. 20. Corticosteroids in HIV-related TBThis phenomenon is also noticed in few cases of HIV-negative TBMost cases of paradoxical reactions are self-limited and respond to NSAIDcorticosteroids may be used to treat severe paradoxical reactions and those unresponsive to NSAIDs
  21. 21. Final WordsThe only clinical indication for which corticosteroids have been demonstrated to be beneficial beyond reasonable doubt is TBMCorticosteroids seem to have a potential benefit in patients with tubercular pericarditis, But more robust evidence is requiredThough corticosteroids reduced the risk of pleural thickening,clinical significance of this benefit is unclearHence,the use of corticosteroids is not recommended in tubercular pleural effusion
  22. 22. Patients with diabetes were understandably worried, and their physicians were faced, as often is the case with such media events, with the dilemma of determining what should be the correct advice at a time of limited data availability
  23. 23. Pioglitazone in diabetes
  24. 24. Pioglitazone in diabetes• The type-2 diabetes drug pioglitazone, is at the center of a great deal of controversy lately• Studies have shown that it may carry a substantial risk of side effects• Yet experts say it remains one of the most effective treatments for poorly managed blood sugar
  25. 25. Pioglitazone in diabetesThe European Medicines Agency recently affirmed that the medication should not be taken off the market, despite fears that it may increase the risk of bladder cancerThe agency stated that the studies indicating increases in bladder cancer risk only showed a modest correlation, and pioglitazone is an invaluable medicine for managing blood sugar
  26. 26. Pioglitazone in diabetes• Piglitazones are usually given when other medications have proven ineffective• This may mean that concerns about a slight increase in bladder cancer risk are the least of these patients worries• They should be primarily concerned about poorly managed blood sugar
  27. 27. Pioglitazone in diabetes• For these reasons, the agency only recommended putting warning labels on the medication and letting medical professionals determine whether the risk is worth it• The U.S. Food and Drug Administration issued a similar warning about the medication but declined to pull pioglitazone.
  28. 28. Pioglitazone in diabetes• Still, some groups are concerned about the increased risks associated with Actos• The law firm Williams Kherkher recently initiated a suit against Takeda Pharmaceuticals, the company that makes the medication• Lawyers said the organization may be responsible for the pain, suffering and medical expenses of individuals who have developed bladder cancer while taking Actos
  29. 29. Pioglitazone in diabetes• Much of the concern over the potential side effects associated with Actos stems from a review of the safety and efficacy of the drug conducted by Takeda five years after it was approved by the FDA• The results initially showed little overall correlation between pioglitazone use and bladder cancer
  30. 30. Pioglitazone in diabetes• However, when investigators dug deeper into the numbers, they found that those who had been taking the drug for extended periods of time appeared to have slightly higher rates of cancer• The FDA now warns physicians to be aware of this risk and weigh them against potential benefits
  31. 31. • Dietary Protein Restriction in CKD
  32. 32. Dietary Protein Restriction in CKD: The Debate ContinuesDietary protein restriction has been one ofthe mainstays of nutritional intervention in CKD patientsThe apparent benefits of such dietary manipulation include : Diminishing the accumulation of nitrogenous wastes Limiting the metabolic disturbances,characteristic of advanced CKD
  33. 33. Proven and Controversial Advantages and Disadvantages of Dietary Protein Restriction in CKD Patient Advantage DisadvantageProven Dereased toxin load Predisposition to PEM Slowing progression Complex diet Better BP control Needs close supervision Better phosphorus Decreased muscle mass control Better H⁺control Improved insulin sensitivity Improved proteinuria*Controversial Extending time to ESRD Posible weight gain Increase mortality
  34. 34. The role of dietary protein restriction in slowing progression of CKD is more controversial, although several meta- analyses indicate a beneficial effect, albeit small
  35. 35.  Concern has been raised by several investigators that low-protein diets(LPDs) especially very low quantities of dietary protein (VLPDs), can lead to Deterioration in the nutritional status predispose to adverse clinical outcomes, especially after the initiation long-term of dialysis
  36. 36. These concerns have been mostly defied by a number of studies showing well-designed diets planned by skilled dietitians & followed by motivated & adherent patients are :a)Effectiveb) and do not have harmful effects on nutritional condition
  37. 37. An article published in American Journal of Kidney Diseases in 2009 by Menon et el. ignite the controversy by providing evidence thatCompared with an LPD, ssignment to a very low-protein diet increased the risk of death in long-term follow-up of the MDRD study• But had no impact on delaying the progression to kidney failure & no relatioship with a composite outcome of kidney failure & death
  38. 38. • These result emphasize the importance of follow-up when evaluating the impact of Interventions designed to slow the chronic disease
  39. 39. Steroid in Stroke
  40. 40. Steroid in StrokeTheoretically, steroids are immunosuppressive agents that Lessen Cerebral edemaDecrease intracranial pressure Strengthen the blood-brain barrier
  41. 41. Steroid in StrokeThese possible benefits have to be weighed against potentially serious steroid-related side effects, such as Immunosuppression and infectionDiabetic exacerbationGastrointestinal hemorrhageCompromised wound healing The place of steroids in the management of stroke is still controversial
  42. 42. Steroid in StrokePerhaps the only general agreement on the use of steroids in stroke is where vasculitis is suspected or provenAs a cause of stroke, vasculitis is very rare (<1% of all strokes), but treatment with steroids should be started whenever it is suspected
  43. 43. Steroid in StrokeThe effectiveness of steroids as one of the options for the treatment of acute stroke, either hemorrhagic or infarction, has never been shownSo far only 2 randomized, controlled trials concerning the use of dexamethasone in primary supratentorial intracerebral hemorrhage have been reported
  44. 44. Steroid in StrokeIn 2001, Ogun and Odusote performed a prospective double-blind, placebo-controlled, randomized clinical trial to determineThe effectiveness of a short course of high- dose dexamethasone on mortality and neurological recovery in acute stroke patientForty patients were eligible for the study27 were presumed to have hemorrhagic stroke and 13 patients had cerebral infarction
  45. 45. Steroid in Stroke• Of the 27 hemorrhagic stroke patients, 15 were treated with 100 mg dexamethasone immediately and 16 mg every 6 hours for 2 days, and 12 patients were given placebo• Of the 13 patients with cerebral infarction, 5 were in the steroid group and 8 in the placebo group• At 1 month, 16 patients (80%) in the dexamethasone group and 17 (85%) in the placebo group had died
  46. 46. Steroid in Stroke• This study failed to demonstrate any benefit of a short-term course of high-dose steroids in improving the mortality of acute stroke patients, and the use of these steroids should be discouraged
  47. 47. SAH• Subarachnoid hemorrhage (SAH) accounts for 7% to 8% of all strokes and leads to early death (1 month) in about 30% to 35%• Important contributing factors to the development of delayed cerebral ischemia after aneurysmal SAHDecreasing plasma volumeHyponatremiaImpaired autoregulation of cerebral blood flowReactive inflammation
  48. 48. Steroid in StrokeMineralocorticoid treatment with fludrocortisone acetate prevents plasma volume depletion Glucocorticoid treatment anti-inflammatory effect cerebral vasodilation andImprovement of cerebral blood flow after SAH
  49. 49. Steroid in Stroke• However, a beneficial effect of steroids on the clinical outcome in patients with SAH has not been proven by any well-conducted clinical trial
  50. 50. Summary• Steroids have a very limited role in stroke therapy• The only definite proven indication of steroids in stroke is in patients with vasculitis• Steroid use in acute stroke (either cerebral infarction or hemorrhage) has been confirmed by several well-controlled clinical trials to be of no benefit• With regard to SAH, it is still debatable whether steroids are beneficial and further studies are necessary to document their benefit.
  51. 51. Controversies in StrokeSteroids Have No Role in Stroke TherapyNiphon Poungvarin, MD, FRCP, FRCP(E), FRCP(Glasg)+ Author AffiliationsFrom the Division of Medicine, Department of Neurology, Siriraj Hospital Medical School, Mahidol University, Bangkok, Thailand.Correspondence to Prof Niphon Poungvarin, Mahidol University - Thailand, Siriraj Hospital Medical School, Dept of Medicine/Division of Neurology, Bangkok, 1070 Thailand. E-mail sinpg@mucc.mahidol.ac.th
  52. 52. • THE STEM CELL DEBATE: IS IT OVER
  53. 53. Definition of Stem cell• A stem cell is a generic cell that can make exact copies of itself indefinitely• stem cell has the ability to produce specialized cells for various tissues in the body, such as heart muscle, brain tissue, and liver tissue
  54. 54. Types of stem cells• Embryonic stem cells : these are taken from aborted fetuses or fertilized eggs that are left over from from in vitro fertilization (IVF)• They are useful for medical and research purposes because they can produce cells for almost every tissue in the body
  55. 55. • Adult stem cells - these are not as versatile for research purposes because they are specific to certain cell types, such as blood, intestines, skin, and muscle• The term "adult stem cell" may be misleading because both children and adults have them
  56. 56. Excitement and Controversy• Doctors have been performing bone marrow stem cell transplants for decades• But when scientists learned how to remove stem cells from human embryos in 1998, both excitement and controversy ensued• The excitement was due to the huge potential these cells have in curing human disease
  57. 57. Excitement and Controversy• The controversy centered on the moral implications of destroying human embryos• Political leaders began to debate over how to regulate and fund research involving human embryonic stem (hES) cells
  58. 58. New Possibilities• But Scientists have learned how to stimulate a patients own cells to behave like embryonic stem cells• These so-called induced pluripotent stem (iPS) cells are reducing the need for human embryos in research and opening up exciting new possibilities for stem cell therapies.
  59. 59. The Ethical Questions• Until recently, the only way to get pluripotent stem cells for research was to remove the inner cell mass of an embryo and put it in a dish• The thought of destroying a human embryo can be unsettling, even if it is only five days old
  60. 60. The Ethical Questions• Stem cell research thus raised difficult questions:Does life begin at fertilization, in the womb, or at birth?Is a human embryo equivalent to a human child?Does a human embryo have any rights?Is it justified to destroy a single embryo to cure a countless number of patients?
  61. 61. IPS Cells: Problem Solved?With iPS cells now available as an alternative to hES cells, the debate over stem cell research is becoming increasingly irrelevantBut ethical questions regarding hES cells may not entirely go awayInevitably, some human embryos will still be needed for researchiPS cells are not exactly the same as hES cells, and hES cells still provide important controls
  62. 62. IPS Cells: Problem Solved?• hES cells are a gold standard against which the "stemness" of iPS cells is measured• Some experts believe its wise to continue the study of all stem cell types, since were not sure yet which one will be the most useful for cell replacement therapies
  63. 63. IPS Cells: Problem Solved?• An additional ethical consideration is that iPS cells have the potential to develop into a human embryo, in effect producing a clone of the donor• Many nations are already prepared for this, having legislation in place that bans human cloning
  64. 64. Stem Cell Research Legislation• The U.S. government released new stem cell guidelines in 2009• The new guidelines cover issues such as informed consent of donors and the wording of consent, as well as the issue of financial gain• The National Institutes of Health (NIH) maintains a register of stem cells, including human embryonic lines, that are eligible for government funding.

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