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LETTER TO EDITOR
Year : 2014  |  Volume : 3  |  Issue : 2  |  Page : 143-144

Randomized control trials, evidence-based medicine and guidelines


Department of Medicine, Jagadguru Sri Shivarathreeshwara Medical College, Jagadguru Sri Shivarathreeshwara University, Mysore, Karnataka, India

Date of Web Publication19-May-2014

Correspondence Address:
K A Sudharshana Murthy
Department of Medicine, Jagadguru Sri Shivarathreeshwara Medical College, Jagadguru Sri Shivarathreeshwara University, Mysore 570 015, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2278-344X.132712

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How to cite this article:
Sudharshana Murthy K A. Randomized control trials, evidence-based medicine and guidelines. Int J Health Allied Sci 2014;3:143-4

How to cite this URL:
Sudharshana Murthy K A. Randomized control trials, evidence-based medicine and guidelines. Int J Health Allied Sci [serial online] 2014 [cited 2023 Jun 8];3:143-4. Available from: https://www.ijhas.in/text.asp?2014/3/2/143/132712

Sir,

Science is a dynamic process and keeps changing with emergence of newer evidences. Medical science is not an exception to this. Guidelines are formed based on these evidences. Evidences are derived from the randomized controlled trials (RCTs)-, though other available sources play a minor role. All the leading international journals publish these RCTs as landmark trials influencing everyone to practice the same. India is not an exception though the percentage of doctors practicing evidence-based medicine is not great due to various reasons. Recently published "2014 Evidence-Based Guidelines for the Management of High Blood Pressure in Adults (JNC 8)", [1] has totally changed the way hypertension has to be managed with respect to blood pressure (BP) and the drugs used. This addresses management of BP in blacks and non-blacks. Where do we Indians stand Though India came out with its own guidelines to manage hypertension, it was more of a replica of the west with minor tinkering. [2]

If RCTs are the best way of deriving evidences, then why are earlier guidelines riddled with controversies, did not stand the test of time and failed to evoke any consensus? Can anyone deny the influence of pharma giants on these trials? It is with due concern I have to write that western journals have a mindset towards articles from the subcontinent. Rarely do they consider them for publication citing reasons of they not being RCTs, sample size being inadequate, not focused, nothing much to add to the existing literature, to mention a few. It is time they introspect about large scale RCTs and publish them as guidelines. Honest observations are probably the need of the hour.

The first decade of twenty first century was a "decade of tight control" for physicians. "The lower the better" (for BP control) [3] and "Tight Glycemic Control" (for sugar) [4] were the slogans propagated by Pharma Industries day in and day out across the globe through so called experts who are like stage artists performing as per the instructions of a director. The result was an increased mortality. [5],[6],[7],[8]

Before the next set of guidelines emerged, the existing guidelines would have caused much damage in various ways. How do these journals undo the damage done to beta blockers and rosiglitazone? [9] What were the financial implications over the last 7 to 8 years of goal BP being fixed at lower levels by JNC 7? [10]

It is time Indians move in a direction to frame their own guidelines based on their experiences, evidences and patient centered approach.

An astute physician creates his own evidence based on his experience.

 
  References Top

1.James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, et al. 2014 Evidence-based guideline for the management of high blood pressure in adults: Report from the panel members appointed to the eighth joint national committee (JNC 8). JAMA 2014;311:507-20.  Back to cited text no. 1
    
2.Indian guidelines on hypertension (I.G.H) -III - 2013. J Assoc Physicians India 2013;61:6-36.  Back to cited text no. 2
    
3.Grossman E. Blood pressure: The lower, the better: The con side. Diabetes Care 2011;34:S308-12.  Back to cited text no. 3
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4.Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:837-53.  Back to cited text no. 4
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5.ACCORD Study Group, Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, et al. The effect of intensive blood pressure control in type 2 diabetes mellitus. N Engl J Med 2010;362:1575-85.  Back to cited text no. 5
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6.ADVANCE Collaborative Group, Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 Diabetes. N Engl J Med 2008;358:2560-72.  Back to cited text no. 6
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7.Cooper-DeHoff RM, Gong Y, Handberg EM, Bavry AA, Denardo SJ, Bakris GL, et al. Tight blood pressure control and cardiovascular outcomes among hypertensive patients with diabetes and coronary artery disease. JAMA 2010;304:61-8.  Back to cited text no. 7
    
8.Haller H, Ito S, Izzo JL Jr, Januszewicz A, Katayama S, Menne J, et al. ROADMAP Trial Investigators. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med 2011;364:907-17.  Back to cited text no. 8
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9.FDA Lifts Rosiglitazone Prescribing Restrictions. Medscape. Nov 25, 2013. Available from: http://www.medscape.com/viewarticle/814964. [Last accessedon 2013 Nov 25].  Back to cited text no. 9
    
10.Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, et al., National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: The JNC 7 Report. JAMA 2003;289:2560-72.  Back to cited text no. 10
    




 

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