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Incorrect results in promotions motivated medical research

The oration for Dr. M.P.M. Cooray Gold Medal was made by Dr. Dennis J. Aloysius at the annual sessions of the Sri Lanka College of General practitioners, at the SLMA Auditorium last week.

Dr. Dennis J. Aloysius
Dr. Dennis J. Aloysius

Speaking on the subject of Trials, Tribulations and Triumphs in Research in Family Medicine he quoted Dr. Chris Uragoda He had once said that "In Sri Lanka what propelled most people to do research was to get promotions and such research generally yielded incorrect results".

First research project: A badly designed one

Referring to the first research project of the college in 1979 on "Piroxicam" Dr. Aloysius said".

"This was a badly designed trial, and it could be used as a case study to demonstrate how a trial should not be conducted". He goes on "we were novices then and we conducted ourselves in that manner. It was a poor quality trial, the like of which I hope never to get involved again".

My next research had rewarding results.

This was a simple piece of research but it had a tremendous impact and rewarding consequences for me. In this I teamed up with late Prof. Lionel to do a retrospective study of 1000 consecutive prescriptions in my family practice and their relevance to the Essential Drug List (EDL) of the WHO.

I am recalling this in order to demonstrate that research need not have to be sophisticated to be recognized.

When I presented this paper at the SLMA Annual Sessions in 1980, (R) Dr. W.A. S. de Silva also made a preliminary presentation on the work that he had done with Lionel on the EDL. This was a prospective study in hospital practice. He had completed an analysis of 1000 prescriptions. Each of us, de Silva and I, were surprised to note that our findings, in 2 different sectors, hospital practice and general practice, were somewhat similar.

He and I had used 94 and 80 pharmaceutical preparations respectively and the drugs used outside the EDL were 15 by him and 11 by me. In our presentations (table) there was an overlap in some of the drugs used outside the EDL. Both Dr. de Silva and I working independently came to the conclusion that the EDL with some modifications would be useful in both hospital and general practice. Subsequently in 1981, de Silva in his Presidential Address to Section A of the Sri Lanka Association for the Advancement of Science (R) made special references to our 2 papers on the EDL and made several comparisons of our results.

In 1985 I had a pleasant surprise when I received an invitation from Dr. Hafdan Mahler the Director - General of the World Health Organization to attend a Conference of Experts in Kenya on the "Rational Use of Drugs".

This Conference turned out to be a historic meeting in WHO history and from it arose a seminal publication on the 'Rational Use of Drugs" (R). It pleased me to be told in a letter that I was being invited in my "individual capacity".

Invited to the International Expert Group At this conference I asked with uncharacteristic humility from the hierarchy of WHO why they chose to invite me.

The answer was that it was because of my "writings and it is not often that a general practitioner does research on the Essential Drug List".

This is being related here to show that it is not only necessary to do research but it is equally important to publish the findings no matter how simple the trial design is.

Subsequently in 1987 I was invited to be a member of an International Group of Experts in Geneva to draw up "Ethical Criteria for Medicinal Drug Promotion".

Family medicine research in Sri Lanka was and is a relatively fertile field for a researcher. There is also a vital need for research in this field. There is a paucity of information on health problems in ambulatory care in Sri Lanka.

There has been valuable work done by the College, IPS and a few individuals in important areas such as health, manpower, morbidity, prescribing patterns and health services. Should Family Physicians involve themselves in basic research? I believe that the time has not yet come for us to indulge in this luxury.

We General Practitioners do a lot to research on "what we know we are doing" before they move into areas when "we don't know what we are doing".

Problems and difficulties in research in general practice:

A survey among those who have done research in Family Medicine in Sri Lanka revealed the following:

* Paucity of educational programmes in research methodology and techniques

* Lack of motivation and encouragement

* Little or no benefit to the family practice

* The practice patient load becomes markedly less when conducting a research project

* Little time available in a busy practice especially for data collection, data entry

* Patients get irritable about delays and perceived time-consuming unnecessary questions

* Patients do not return for follow-up. If they are better they do not report; If worse-they indulge in doctor shopping and health tourism

* Availability of financial support and research grants

Research has its costs and some individual or agency has to pay for it.

In Family Medicine it is invariably the Family Physician who has to bear these. The cost of support material is often not small.

* In a solo practice there is a lack of team support. Over 65% of the Family Practices in Sri Lanka are solo practices.

* Difficulties in analysis and poor support from statisticians

* Lack of computer facilities

In the seventies and eighties most of the Family Physician researchers had to make an unguided choice of the topic of the research project. They had no department or institution to instruct or guide them. The College established a Research Committee in its early days.

Formal systematic and sophisticated research in Family Medicine in Sri Lanka owes a lot to the MD (Family Medicine) of the PGIM, which is by a research thesis.

This is currently a two to four year research project in a family medicine location on a topic relevant to the discipline. It requires research of a high quality and thus there has been created a group of persons who could engage in such research and more importantly assist and train new researchers. The quality of these research theses has been remarkably high.

Clinical research in family medicine

There has been a paucity of clinical research in family medicine in Sri Lanka. What is the reason for this?

Clinical research does not necessarily require a huge financial input and the main component namely clinical material is there in abundance. In addition the other important co-factor is that coterie of willing potential researchers in the discipline was always there. But these persons were heavily burdened with their routine clinical commitments that they had little or no time for research.

Early research in Family Medicine in Sri Lanka took place due to the enthusiasm of individual researchers.

It was an exciting but exhausting and expensive exercise for those who were courageous enough to embark on it.

According to Uragoda (R) there are various types of motivation that propel a person to do research. However he adds that in some instances there is no apparent motive. The reason why a large number of persons do research in Sri Lanka is to obtain promotions. This is specially so in the University sector. This is strong motivation but does it produce the correct results.

In Sri Lanka, until 3 decades ago there was little or no research done in family medicine. In the sixties the name of our discipline was General Practice but family physicians were usually erroneously referred to by colleagues working in the state sector and the academia as "Private Practitioners" and not general practitioners.

Family physicians, who handled over 30% of the community morbidity were, for some inexplicable reason, categorized as those who practised hospital medicine outside the hospital in an inferior manner. Need for more research

In the last 2 decades a large quantum of research has been done in the field of Family Medicine in Sri Lanka. However there is still a great need for more research in order to further augment our databases and also resolve some important hypotheses.


What really is - 'Lasik' surgery ... is it safe?

Following several letters we had from our readers for information on - "Lasik, the latest in eye surgery for correction of refractive defects without glasses which is now available in the Apollo Hospital, Narahenpita.


Dr. Fogla performing a ‘Lasik’ surgery on a patient. The procedure takes only 15 minutes, and the patient is ready to leave the hospital within hours.
Dr. Fogla performing a ‘Lasik’ surgery on a patient. The procedure takes only 15 minutes, and the patient is ready to leave the hospital within hours.

Health Watch spoke to Dr. Rajesh Fogla, Consultant Ophthalmologist, Sankara Nethralaya (India) who is heading the Apollo 'Lasik' Unit.

According to him this is a specialised laser technique procedure to correct the refractive defects - (either short sighted or long sightedness) which eliminates the use of glasses or contact lenses.

Most people with refractive defects, who find it cumbersome to wear glasses find this method developed by an Indian doctor Rangaswamy Srinivasan in America in 1987, very convenient.

The technique which has been in practice in many countries for over 15 years now is very safe, done in the proper way. However it is not everybody who can undergo this procedure for there are age limitations and other eye conditions to be met.

Both PRK and LASIK procedures are absolutely painless and are performed as outpatient procedure using topical anesthetic eyedrops. The entire procedure lasts for only 10-15 minutes and you will be awake during the entire procedure. The procedure costs about Rs. 100,000 in Sri Lanka and almost the same in India, reputed hospitals. Cheaper procedures are somewhat risky.

He explained "While most patients are eligible for LASIK, not everyone is.

An ideal candidate for refractive surgery

* Must be at least 18 years of age with stable refraction for 6 months.

* No associated eye disease.

* No connective tissue disorders.

* Must discontinue contact lens wear 2 weeks prior to refractive surgery.

Eligibility also depends on the amount of refractive error, the curvature and thickness of the cornea and a number of other factors that an ophthalmologist must evaluate. Proper patient selection is vital for successful refractive surgery and a satisfied patient.

How is the procedure performed?

Photo Refractive Keratectomy (PRK)

In this procedure the laser treatment is directly performed on the surface of the cornea to reshape it for correction of refractive errors.

This is usually performed for people with smaller refractive errors. The surface layer usually takes 3-4 days to heal and the vision gradually improves thereafter.

Laser in situ keratomileusis (LASIK)

This procedure involves first creating a thin flap of cornea with an instrument called the microkeratome.

Followed by lifting of the flap and laser treatment to reshape the cornea.

The flap is then repositioned in its original place.

Improvement in vision is noted right from the next day.

 

 

 


Health Watch article results in 'SIDS' study

Dear Mr. Edward Arambawela,

I am sending you a copy of the study questionnaire on SIDS, which was received from the Department of Forensic Medicine and Toxicology, University of Colombo. You may recall the problem of SIDS was high-lighted in your Health Watch, on January 4th 2002. A clipping is enclosed for easy reference.

It is, therefore, encouraging to find that the question of SIDS in Sri Lanka is now under study by the University of Colombo.

With kind regards and best wishes,

Dr. Terrance Perera,

Ex-Senior Advisor WHO.


The Study

Prof. Ravindara Fernando,

Professor of Forensic Medicine & Toxicology's

Circular to doctors.

Sudden Infant Death Syndrome or Sudden Unexpected Death in Infancy (Cot death) is almost unheard of in Sri Lanka. Many paediatricians and pathologists abroad believe that Sri Lankan doctors are missing such cases. Some of them are surprised that doctors in Sri Lanka rarely, if at all, report or certify infant deaths as cot deaths.

We wish to know your views and experience of this condition. We would be grateful to you if you could complete the questionnaire and post it to us in the stamped addressed envelope provided. We sincerely thank you for your co-operation in advance.

Health Watch article of 4th Jan. 2002

No SIDS in our country

Dr. Terrance Perera (Consultant Paediatrician and former Senior advisor WHO) in a letter to us on - Sudden Infant Death Syndrome (SIDS) says that this refers to infants dying in playpens due to suffocation caused by soft bedding or extra mattresses in playpens. Ann Brown, Chairman of the Consumer Product Safety Commission in America in a communication to Paediatricians in July 2001 on this topic states:

"Since 1988 there have been more than 200 cases of babies dying in playpens in America.

In about half of these cases it has been found that soft bedding or extra mattresses were present in the playpens which may have caused the deaths. Parents and caretakers generally use playpens today as places for infants and toddlers to both, play and sleep. For that reason we want to alert parents all over the world to this possible hazard of using soft bedding or extra mattress in playpens.

Dr. Perera adds:- "In this regard Professor Lamabadusuriya, Head of the Department of Paediatrics of the University of Colombo, to whom I casually mentioned about this, informed me that as far as he was aware not a single case of SIDS has been reported in our country for some reason or another.

This to me is an interesting observation. Health Watch - In any case, we feel that it is good for parents to be made aware about this. Thank you Dr. Perera for writing to us, and we take this opportunity to wish you well.

*****

Vacutainer for safer blood collection

In developed countries blood specimen collection procedure has been subjected to many changes in par with the development of analysis technologies with special emphasis to safety of Laboratory personnel from possible infection due to handling potentially infectious patients or specimen especially after the identification of deadly viruses such as HIV, HTLV, Hepatitis B and Hepatitis C, where the contamination of Blood and body fluids is the only mode of infection. The close system of blood specimen collection became the method of choice to address this high-risk situation.

The close system of blood collection includes the use of an evacuated specimen collection tube called Vacutainer with or without anticoagulant depending on the requirement of the type of analysis, a special kind of needle which has pointed ends on both side and a plastic device called vacutainer needle holder which can be used several times because it is the only non-invasive part of the procedure. These container closures (usually rubber or plastic stoppers) are colour coded for easy identification and is internationally accepted.

Sent by C. Wijesinghe, Chief MLT - Eurolab Colombo

*****

A paying Elders home for Buddhists

Reference the querry in the Health Watch 'Letter Box' column, I wish to inform the senior citizen who wants to have some information of a suitable 'Home' to spend the evening of their lives together, even away from the City, that there is a 'Home' for Elders (who could afford to pay), put up by late Sir Cyril de Zoysa, former President, Colombo YMBA, known as the "Home", situated at Kalutara South, at Pembroke Estate, on the top of a hill in a Rubber plantation, in a beautiful environment, and it is an ideal quiet place for an old couple and wish to spend the evening of their lives in a Buddhist atmosphere. There are double rooms available in this Home. It is on the Kalutara - Matugama Main road, a couple of miles from Kalutara town.

The spot is motorable right up to the Home. It is also in close proximity to the Nagoda General Hospital where all medical facilities are available, including Specialist Doctors.

You please ring 034 - 81694 and call for the Manager of this 'Home' and ask for the information you wish to know, or you may write to the Chairman of the Kalutara Bodhi Trust, Kalutara, who happens to be a close kinsman of late Sir Cyril, under whose management this Elders Home is being managed. You can ask him whether the facilities you require are available here. I have been to this Home on several occasions as I have a family friend who is an inmate here. Hence this information.

Lionel L. Leanage - Ambalangoda


Health watch Question Box

Replies to questions in this column are all being answered by Dr. D. P. Atukorale, Consultant Cardiologist and Member Health Watch Medical Advisory Panel.

On captopril

Q: R. Weerasekera from Gampola, explaining his medical condition and the treatment he is presently taking which includes captopril 100 mg. bd. wants to know whether a high dose of this is bad. Reply:

Your question has two parts: (a) use of very high doses of captopril in the management of hypertension; (b) management of uncontrolled hypertension. I fully agree with you that you are getting a very high dose of captopril (100 mg twice daily). Captopril is an excellent drug for management of hypertension in the elderly patients.

In addition to controlling blood pressure (BP), captopril has the added advantage of preventing the onset of diabetic nephropathy (involvement of the kidneys due to diabetes).

Majority of physicians use a maintenance dose of 25 mg of captopril twice daily and a maximum maintenance dose of 50 mg twice a daily and very rarely 50 mg three times a day (BNF 43, March 2002). My advice for you is to consult your physician again and I am sure he or she will reduce the captopril dose and he may increase diltiazem to 90 mg of diltiazem retard twice daily.

In spite of above treatment if your hypertension is still out of control, your physician may add a third drug such as amlodipine or felocard to above drug regime. Although as medical students (1958-1964) we were taught that control of diastolic BP is more important than control of systolic BP, now we know that it is important to control both systolic BP as well as diastolic BP. Some authorities believe that from the point of heart attacks and strokes, control of systolic BP is more important then control of diastolic BP.


Controversy about cashew nuts and avocado

by Dr. D. P. Atukorale

I am very grateful to R. Wickramasinghe (R. W.) for his comments on the value of cashew nuts (Kadju nuts) and avocado in increasing the serum level of HDL (good cholesterol) and lowering the serum level of LDL (bad cholesterol) and for referring to my previous articles in Health Watch (Health Watch Letter Box 15-11-2002) R. W. wishes to know on what basis I have come to the above conclusions.

I am quoting from "The guide To Vegetarian Living" by Peter Cox (Bloomsbury) 1994 which is in an encyclopedia of vegetarian living which I consider as the ultimate authoritative guide on vegetarian nutrition. "Cashewnuts are a particularly good snack for lunch boxes and for growing children since most of their energy comes from the healthiest type of fat, monounsturates".

"25g (1oz) of roasted cashew nuts contain 13.16g of total fat (7.76g of monounsaturated fat, 2.23g of poly-unsaturated fat and 2.60g of saturated fat), 4.35g of protein, 0.20g of fibre, 19.65 mg of folic acid, 12.70mg of calcium, 1.70,mg of iron and 1.59 mg of zinc. Cashew nuts is also a good source of trace metal selenium now known to be essential in the prevention of cancer and in the effective function of body's immune system (pages 195-196 of Peter Cox's encyclopedia on vegetarian living).

Avocado

Peter Cox says that "Australian scientists report that people consuming anything from half to one-and-a-half avocado a day can actually lower their cholesterol more than people eating a very low fat diet.

Once again avocado's high content of mono-unsaturates (same fatty acid present in olive oil) is thought to be responsible.

"Avocado Pear (200g) contains 30.79g of total fat (19.31g of mono-unsaturated fat, 3.93g of polyunsaturated fat, 4.90g of saturated fat), 15.88mg of vitamin C, 0.22mg of thiamine (Vit. B1), 0.25mg of riboflavin, 3.85mg of nicotinic acid, 0.56mg of vitamin B 6, 124.42mg of folic acid, 122.61 RE of Vit. A, 22.11mg of calcium, 2.05mg of iron, 0.84mg of Zinc and 3.98mg of protein". (Page 180 of Peter Cox's encyclopedia).

It is common knowledge among doctors that in view of the high content of heart healthy mono-unsaturated fats and polyunsaturated fats which increase your serum HDL cholesterol and decrease your serum L D L cholesterol, all heart patients and all patients suffering from hyperlipidaemia should consume avocado and nuts such as cashew nuts, peanuts, hazel nuts, Brazil nuts and walnuts whenever it is possible as these contain very high quantities of monounsaturated fats and polyunsaturated fats.

"28g (1oz) of peanuts contain 13.79g of fat (6.84g of monounsaturated fat, 4.36g of polyunsaturated fat and 1.91g of saturated fat). One cup of hazelnuts (60g) contain 39.15g of total fat (30.68g of monounsaturated fat, 3.75g of polyunsaturated fat and 2.88g of saturated fat).

One ounce of walnuts (dried) i.e. 25g contain 17.57g of total fat (4.03g of monounsaturated fat, 11.11g of polyunsaturated fat and 1.59g of saturated fat).

One ounce of Brazil nuts (28g) on the other hand contain 18.81g of total fat (6.54g of mono-unsaturated fat, 6.85g of polyunsaturated fat and 4.59g of saturated fat)". (Peter Cox).

"Researchers at the Harward Medical School found that men who ate a couple of handfuls of nuts each week had a 47% lower risk of sudden death due to cardiac arrest than who ate nuts less often. Why nuts are so heart healthy may be because they are high in unsaturated fats (mono-unsaturated and polyunsaturated fats), magnesium and vitamin E. Munching nuts may also help protect against dementia"

(Readers Digest November 2002).

******

Where to do chelation therapy

Q: De Mel from Moratuwa writes

First and foremost let me thank you most sincerely for the wonderful services you are providing through the medium of the "Press" via "Health Watch" to educate the public on health matters pertaining to heart disease and associated problems thereto;

I kindly request you to give your valuable and expert opinion whether I could benefit by undergoing "Chelation Therapy" for my heart condition. I am 65 years of age. I am said to be on maximum medication according to my Cardiologist. I have occasional Angina at rest and on some occasions when I walk. I am a Land Surveyor and I do field work about 3 days per week and I feel utterly exhausted & tired at the end of the day but at such times I do not have Angina.

Copies of relevant Documents of Investigations done are forwarded herewith for your kind perusal.

Reply:-

Chelation Therapy for resistant angina

I read your case history and as there appears to be no satisfactory response to treatment of your angina (coronary artery disease), diabetes mellitus and hypertension, by your cardiologist and as your heart condition is not amenable to surgery, I am sure that your cardiologist will not have any objection of your undergoing chelation therapy.

EDTA chelation therapy which began, more than four decades ago, has not resulted in any serious side-effects after treating more than one million patients for occlusive atherosclerosis. More than 20 million infusions of EDTA have been given in USA without any mortality or morbidity. (Reference Bypassing Bypass surgery by Elmer M Cranton M.D., 2nd edition, 2001, Hampton Roads Publishing Company).


Calling all heart patients!

The recently formed Heart Patients' Association (HPA), invites all those who are suffering from heart ailments to join the HPA.

President of the HPA, S. De Alwis said that the main objective of the Association was to raise awareness among the patients, to have better care, to help the families of the patients, to provide medical advice and to stress the importance of doing exercises after the surgery.

The inaugural ceremony was held at the Ward No. 36 of the Colombo National Hospital (CNH) under the patronage of Dr. Hector Weerasinghe, Director of the CNH, who stressed that, the HPA served a timely need offering counselling prior to surgery.

The HPA intends to hold an awareness program once a month at Ward No. 36 at the CNH.

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