Posts Tagged ‘research’

Draft Template for Writing Homeopathic Clinical Trial Protocols – Version-I


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Calcium supplements boost heart-attack risk: Meta-analysis


Calcium supplements boost heart-attack risk: Meta-analysis

Source: http://www.theheart.org/article/1108009.do

The use of calcium supplements without co-administered Vitamin D is associated with an increased risk of myocardial infarction (MI) [1]. The finding, from a meta-analysis encompassing 15 randomized trials and up to 11 921 participants, warrants a reassessment of the role of calcium supplements in the management of osteoporosis, researchers report online July 29, 2010 in BMJ.

Most guidelines for the prevention or treatment of osteoporosis recommend the use of calcium supplements, despite the fact that they reduce the risk of fracture only marginally, write Dr Mark J Bolland (University of Auckland, New Zealand) and colleagues.

Studies have yielded conflicting results about their use, with some observational studies suggesting that high calcium intake is protective against vascular disease, and others showing that calcium supplements speed vascular calcification and increase mortality in patients with kidney failure and increase cardiovascular events and MI in women.

Senior author Dr Ian R Reid (University of Auckland) told heartwire that women should discuss the finding from his study with their doctors, but that in most cases, “discontinuation of calcium would seem appropriate.”

The researchers had previously found an adverse effect from calcium supplements in a clinical trial, which they published in BMJ in 2008 [2], Reid explained. They repeated electronic database searches in March of this year to consolidate those findings.

Their current meta-analysis looked at randomized trials of calcium supplements that supplied at least 500 mg/day of elemental calcium vs placebo. Each of the trials lasted for at least a year and had at least 100 participants with a mean age of 40 years or older. Cardiovascular outcomes were obtained from self-reports, hospital admissions, and death certificates.

In a combined analysis of the five studies that had contributed patient-level data, the investigators found that calcium supplements were associated with about a 30% increase in the incidence of MI (hazard ratio 1.31; 95% CI 1.02–1.67; p=0.035) and smaller, non-significant increases in the risk of stroke and mortality.

The findings were consistent across trials, and the risk of MI with calcium supplements tended to be greater in those with higher dietary calcium intake. The MI risk was independent of age, sex, and type of supplement.

A similar analysis of 11 trials that contributed trial-level data showed a 1.27 relative risk of MI (95% CI 1.01–1.59; p=0.038) associated with calcium supplements.

“Clinicians should tell their patients that, for most older people, the risks of calcium supplements outweigh the benefits. Changing to calcium-rich foods may be appropriate,” Reid said.

Calcium Supplements Causing Heartburn, Not MI?

In an editorial accompanying the article [3], Dr John Cleland (Castle Hill Hospital, Kingston upon Hull, UK) and colleagues wonder why calcium supplements should increase cardiovascular risk, as found in this meta-analysis. “Accumulation of calcium in the arterial wall leading to reduced compliance would be expected to take years, but the increased risk of myocardial infarction reported by Bolland and colleagues occurred early after calcium supplementation (median follow-up of 3.6 years).”

Cleland et al suggest that the increased risk of MI may not be a true effect, because the increased risk of MI was not accompanied by an increase in mortality. “Calcium supplements could simply be causing gastrointestinal symptoms that could be misdiagnosed as cardiac chest pain,” they write, adding that even if the supplements are safe, the neutral effect on mortality “casts doubt on whether they are effective prophylaxis for fractures.”

Until more becomes known about the best way to prevent osteoporotic fractures, the editorialists conclude that “patients with osteoporosis should generally not be treated with calcium supplements, either alone or with vitamin D, unless they are also receiving an effective treatment for osteoporosis for a recognized indication.” They add that research on whether such supplements are needed in addition to effective osteoporosis treatment is “urgently required.”

Dr John Schindler (University of Pittsburgh Medical Center, PA), who isn’t a coauthor of the study from Bolland et al, told heartwire that the increased MI risk in the study, although quite modest, is concerning because of the large numbers of people who take calcium supplements. He also questioned whether vascular calcifications could be the cause, because of the trials’ relatively short follow-up times.

Gender Differences May Be Important

For Schindler, research into gender differences may yield answers to the increased risk of MI seen in this meta-analysis.

“In this analysis, 88% of the participants were women, and we know that cardiovascular disease in women is radically different from cardiovascular disease in men. The same holds true for cerebrovascular disease. There is something we need to get at, and at this point, no one has really been able to do so.”

Schindler also said that the real risk of MI appeared to be in people who took calcium supplements on top of high levels of dietary calcium. “I think the safest thing to tell your patients right now is if you can get your dietary calcium from good dietary sources, such as yogurt, sardines, and skim milk, that potentially might be all you need to ward off the risk of osteoporosis. Then we don’t have to deal with this increased cardiovascular risk.”

He added that it is important to consider the potential safety concerns along with the benefits of bone health. “The benefits of calcium supplementation in older women with a low risk of fracture may not outweigh the potential cardiovascular risk.”

Finally, Schindler noted the absence in the meta-analysis of the Women’s Health Initiative, a large study that looked at the role of calcium supplementation with vitamin D in reducing osteoporotic fracture. “There are a lot of data that show that vitamin D is protective from a cardiovascular standpoint. They excluded studies with vitamin D probably because they are trying to isolate one variable. They didn’t want to cloud the picture.”

This study was funded by the Health Research Council of New Zealand and the University of Auckland School of Medicine Foundation. Bolland, Cleland, and Schindler have reported no relevant financial interests. Reid reported financial relationships with Fonterra.

References

  1. Bolland MJ, Avenell A, Baron JA, et al. Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis. BMJ 2010; DOI:10.1136/bmj.c3691. Available at: http://www.bmj.com. Abstract
  2. Bolland MJ, Barber PA, Doughty RN, et al. Vascular events in healthy older women receiving calcium supplementation: Randomised controlled trial. BMJ 2008; 336:262-266. Abstract
  3. Cleland JG, Witte K, Steel S. Calcium supplements in people with osteoporosis. BMJ 2010; 341; DOI:10.1136/bmj.c3856. Available at: http://www.bmj.com. Abstract

Additional Resources

The National Institutes of Health has an online fact sheet about calcium supplementation for health professionals.

Clinical Context

Calcium supplements are used to treat osteoporosis among older patients but are only modestly effective in increasing bone density, with a number needed to treat of 39 to 48 patients for 5 years each to prevent 1 fracture. Calcium supplementation has also been associated with adverse effects, including higher mortality rates in patients with renal failure and an increased risk for cardiovascular disease.

This is a meta-analysis of trials examining calcium supplementation to determine the effect on cardiovascular disease outcomes and death.

Study Highlights

  • The investigators searched the databases of MEDLINE, EMBASE, and the Cochrane register for randomized controlled trials of calcium supplements.
  • Included were double-blind randomized controlled trials with calcium supplementation of 500 mg/day or more, participant mean age of at least 40 years, 100 or more participants, and duration of at least 1 year.
  • Excluded were trials that provided both vitamin D and calcium supplementation because vitamin D supplementation has been associated with decreased mortality rates, and trials using dietary modification as calcium addition or in which participants had an indication other than osteoporosis.
  • The researchers considered diagnoses of MI, stroke, and death by using words describing the events or referring to International Classification of Diseases, Ninth Revision, codes.
  • The prespecified primary endpoints were time to first MI; first stroke; and first composite event of MI, stroke, or sudden death.
  • The secondary endpoint was time to death (all-cause mortality).
  • Analysis was performed at the patient level and at the trial level, and random-effects models were used to pool summary data at the trial level.
  • There were 15 eligible trials, of which 5 contributed patient level data with 8151 participants.
  • The median duration of follow-up was 3.6 years in the 5 patient level trials.
  • The HR for MI was 1.31 (95% CI, 1.02 – 1.67; P = .035) in these trials (143 vs 111 MIs for calcium vs no calcium supplementation).
  • The HR for stroke was 1.20 (95% CI, 0.96 – 1.50; P = .11), but the increase was not significant.
  • There was no significant increase in the risk for the composite of MI, stroke, or sudden death for the calcium supplementation group.
  • The number needed to treat for calcium supplementation for 5 years was 69 for MI; 100 for stroke; 61 for the composite of MI, stroke, or sudden death; and 77 for death.
  • Higher calcium intake (> a median of 805 mg/day) was associated with a higher HR (1.85; 95% CI, 1.28 – 2.67) for MI, and intake below the median was not associated with an increased risk for MI.
  • The HRs were 1.18 for an intake of less than 500 mg/day, 0.68 for an intake of 500 to 699 mg/day, 2.28 for an intake of 700 to 899 mg/day, 1.81 for an intake of 900 to 1099 mg/day, and 1.41 for an intake of more than 1100 mg/day.
  • Recurrent cardiovascular disease occurred among 10% to 17% of participants and was more frequent among those who were supplemented with calcium, although this was not statistically significant.
  • Trial level analysis of all 11 trials showed an increased risk for MI with a pooled relative risk for 1.27 (95% CI, 1.01 – 1.59; P = .038) for calcium supplementation but not for stroke, the composite endpoint, or all-cause mortality.
  • The increased risk for MI with calcium was independent of age, sex, and type of supplement.
  • The authors concluded that calcium supplementation without vitamin D added, especially with an intake of more than 805 mg/day, was associated with an increased risk for MI with a trend toward an increased risk for stroke and sudden death but not all-cause death.
  • They recommended a reconsideration of using calcium supplementation to treat osteoporosis in older adults because the risk for MI may be translated into a large disease burden in the population.

http://cme.medscape.com/viewarticle/727002?src=cmenews&uac=131172FT

Logical Homeopathy


Samuel Hahnemann Memorial at Scott Circle in W...

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It is not a matter of wonder that Homoeopathy is existing but is a matter of science and nature’s law which is saving Homoeopathy for centuries to disappear in darkness. For hundred of years it remained in era of darkness, ignored by the brilliant minds. It was in late 1700’s when Hahnemann observed the pattern of nature’s law of cure. To his surprise he went on to uncover its validity and find the real truth. It took him decades to refine and research into the real meaning of Homoeopathy. Today also Hanhnemann is the authority and our master. This all happened because of laborious work and hard efforts which he put in his life time towards Homoeopathy.
Homoeopathy is nothing magical, its logical. Logical only when we are willing to understand the in depths. It’s a human tendency to search for the truth and criticize the unknown. The same thing happens with Homoeopathy also, those who know it cherish it, others feel unhappy. Homoeopathy as we all know is a therapeutic science of symptom similarity discovered some 200 years back. This means that it was present before that also whose examples are written in Organon of Medicine.
Let us go back to the initial publication of Hanhnemann, “Medicine of Experience”, now why I emphasized on experience is because it is related to experience of a judgmental and rational mind. There were no complex investigative modalities at that time in Hanhnemann’s era, it was all based on what you could see, prove and presented in easy words. This is the reason why many of Hahnemann’s theories and writings are still mysterious and loaded with vast experiences and observations of him written in pure language.
It’s a saying that ten people will ten opinions on one thing, this is very obvious with respect to the complexity of human mind. The same goes for the theories and principles of Homoeopathy. We know what is true, but still we express that in different forms and words.

The whole of Hahnemann’s teaching are close to ground realities. He accepted the limitations with the aim that we will learn to cross those after a substantial research. But somewhere this is lacking (what i perceived over these few years being a homeopath), not only we lack in funds and opportunities, but because many of us are not open to new ideas and work. It’s not the question for us, “Does Homoeopathy works?”, but it’s a pressure on us to explain how it works. I know that it is impossible (as now) to explain how it works on cellular and metaphysical level, but we cannot deny the well-known philosophy of ours “EVIDENCE BASED MEDICINE”. If some effects are being produced then there must be a stimulus (strong enough then psychological and placebos effects). This we can only observe by contrast (James Krauss in Introduction to Organon of Medicine, 6th edition)… to be continued…

Question your failures!!!


I will start with one of the quotation Dr Hari Singh quoted during the symposium organized by SBL at Russian center for science on 5th of september 2010. It stated:-

“Question the FAILURES!!!”

Question the SUCESSES TOO!!!”

“The scientist is not a person who gives the right answers, he is one who asks the right questions”,

the quotation is by Claude Levi-Strauss, and rightly describe the quality of a good researcher and scientist. Many a times we are entangled in spurious questions and answers just to passify the audience or the counter parts. Only few of us have the guts to face the criticism and put forward the requisite of scientist. Its not always you learn from the success but many a time we learn from our failures. The same way Hahnemann did. If he would have been satisfied by his early success and miracles he would have not been walked so far. Till the time he died, he kept thinking about the refinements, alterations for the benefit of this great science, changes, new concepts and many things.

At the symposium there were four speakers who presented well in their stipulated time, and despite have diversity in approaches they all agreed to the common thought…”Homeopathy must be benefited by us, so that we can benefit our fraternity and patients”.. there must be guidelines and approaches with clear indications to which every Homeopathy can agree. I know this is difficult, but not impossible. It will take time for us to grow larger. The fake fight has just begun…”who is right?”…. who is more potent and successful then others?….. “who has more link then others?…..

I will relate one small quote here…. there is quote….“dont question what your country have give you, answer what you have given to your country”, the same goes with our pathy… many a time (or probably most of time, if it is a younger Homeopath) we complain, what Homeopathy has given us… not what we have contributed honestly to this….. the one who contributed honestly are still quoted as stalwarts….. It takes time and energy….

There is another facet of this question or you can say thought… that i will discuss in another entry….. till then…

“Question the FAILURES!!!”

Question the SUCESSES TOO!!!”

and you will see the difference… in your practice and approach……..

Thank you so much for sparing few mins for my thoughts….

Regards….

-Dr Saurav Arora

RESEARCH IN HOMOEOPATHY: PRESENT AND FUTURE PERSPECTIVE


Published in Homoeopathi Heritage, a publication from the house of B Jain publishers in June 2010 issue


Dr Archana Narang M.O. (T), Dr Saurav Arora (SRF), Dr Latika Nagpal (SRF)

Dr. B. R. Sur Homoeopathic Medical College, Hospital & Research Centre,

Nanak Pura, Moti Bagh, New Delhi 110021

shmc.thyroidclinic@gmail.com

Research is an endeavour to discover answers to intellectual and practical problems through the application of scientific method.

CITATIONS FROM THE ORGANON

  • Experimentation is for one of the two purposes, observation for induction, or verification of inductions. Experimentation is analysis, deduction, analytic deduction…….We observe by contrast.
  • “….not, however, to construct so called systems, by interweaving empty speculations and hypotheses….
  • “…..cease to deceive suffering mankind with mere talk, and begin now, instead, for once to act, that is, really to help and cure.”

ABSTRACT

Research is a necessity in the ever growing era of modern science and we are now more prone for criticism and authenticity. Research and science is nothing new to us, we have been rooted on these grounds since the “Apple” fall on “Newton’s head”. Hahnemann was one of the four epochal figures in the history of practice of medicine. His experiment with materialistic doses of cinchona bark is theroot of logical thinking. From Hahnemann’s era we have been scientific, logical and philosophical. We need upgradation in the field of homoeopathy to compete in today’s world and to make ourselves more strong, clear and confident. Many a times we are questioned about our principles and methods of practice. To answer all the queries, we must prepare ourselves so strong that our existence doesn’t go in vain. The hard work of our forefathers has brought us where we stand today. The need of hour is scientific research, and this doesn’t mean only test tubes and laboratories, but it is a step ahead of it. Research can be done in numerous ways. The right research depends upon our insight and aims. There is a researcher and a scientist in every one of us, the need is to bring it to the front and think logically, the same way our master taught us. This article will try to touch the latest research methodologies in Homoeopathy, keeping in mind the basis of our philosophy.

INTRODUCTION

A basic research process can be defined as, “An inquiry process that has clearly defined parameters and involves discovery and creation of knowledge for testing, building, revision, confirmation, refutation of knowledge and theory by means of investigation of a problem for local decision making”. The first basic thing Hahnemann did to prove, there exists a science beyond the materials, was by means of experimentation and observation, observing it to the levels of criticism and analysing it to the depths of history. Research not only means noting down the observations and findings but to analyse them and to reach to a conclusionwhich is the landmark for future research.

OBJECTIVES OF RESEARCH

The purpose of research is to discover answers through the application of scientific procedures. Until and unless we are not clear about our objectives we cannot lead to a fruitful finding. The objectives can be:

  • To gain familiarity with a phenomenon or to achieve new insights into it – Exploratory or Formulative Research. This kind of research is key point to our trials regarding the action of remedies onto various systems in our body.
  • To portray accurately the characteristics of a particular individual, situation or a group – Descriptive Research, i.e., drug pictures, disease pictures, individualized case studies, research regarding group studies.
  • To determine the frequency with which something occurs or with which it is associated with something else – Diagnostic Research, i.e., action of various remedies in specific conditions and vice versa.
  • To test a hypothesis of a causal relationship between variables – Hypothesis-Testing Research, i.e., clinical trials of (new or old) drugs on conditions which were not appeared drug proving but were benefitted in therapeutics, for example action of certain remedies on cancers.

CHARACTERISTICS OF A GOOD RESEARCH

A good research has some characteristics associated with it, without these it is nothing but a bundle of papers on table. The characteristics help us to learn the simple meaning of research methodologies. These characteristics also help us to understand the outcomes of such research; it is likewise applying a constitutional remedy to an individual. The purpose of the research should be clearly defined. The process which we are planning to adopt should be detailed. Once we have decided upon the area we want to work research protocol should be thoroughly made and planned. To make the protocol scientific and unbiased high ethical standards should be applied. If any limitations to the study are present they should be clearly defined and accepted. Once data is collected its proper analysis should be done by an expert, such as bio statistician. Logic is to be applied to every possible test to validate the data collected and conclusions reached. The outcomes of research should be presented with rationale and truthfulness and once the analysis is properly done the justified conclusions should be drawn from it and should be published for other’s benefit.

So, the linear research process consists of:

TYPES OF RESEARCH

There are numerous ways by which we can do research activities. The type of research depends upon our aim. There can be a mixed type of research on one topic also. The common types are:-

·         Descriptive: as in description of drugs and their Symptomatology.

·         Analytical: as in analysing already proved drugs for new spheres of actions.

·         Conceptual: as in making new treatment concepts in different diseases.

·         Empirical: research based on experience or observations.

·         Quantitative: as in drug standardization.

·         Qualitative: as in action of different potencies in different conditions.

·         Applied: as in application of remedies in specific conditions.

·         Fundamental: as in clinical proving, clinical verifications and collaborative research.

·         Diagnostic: as in action of various remedies in specific conditions and vice versa.

RESEARCH METHODOLOGY IN HOMOEOPATHY

Following are the few areas worth discussing regarding research in Homoeopathy:

·         Drug standardization: Aphorism 122, “In these experiments – on which depends the exactitude of the whole medical art, and the weal of all future generations of mankind – no other medicines should be employed except such as are perfectly well known, and of whose purity, genuineness and energy we are thoroughly assured.” This drug standardization is conducted to ensure quality, genuiness, and authenticity of raw drugs and to evaluate the safety and efficacy of drugs. Physico chemical standardization studies include ash values, extractive values, colour reactions, physical constants of mother tinctures and thin layer chromatography (TLC) profiles of extracts and mother tinctures. Pharmacogonostic studies include morphology, anatomy, histochemistry, powder-microscopy and prelimiary chemical tests. Pharmacological tests include toxicity studies, antifertility activity, motor activity, hypoglycemic effects, Blood Pressure, CNS toxicity study etc.

  • Homoeopathic pathogenetic trials (HPTs): Human pathogenetic trials or commonly known as Drug Proving is the core activity we aim for. This goes in accordance with our philosophy and laws to know the effect of medicines on healthy human beings. Drug proving technique has been the same since the first time it was introduced by Hahnemann some 200 years ago. In the recent times the process and methodology of HPTs has improved greatly. The techniques have been unified to record and process the results of HPTs.
  • Clinical research: Clinical research is one of the major research activities in Homoeopathy in the past few years. The concept of “Evidence based medicine” is propagated through clinical research everywhere, and is welcomed everywhere. Councils, institutions, agencies, associations and physicians are now coming together in clinical research activities to promote Homoeopathy as “Evidence” based science. In the past few years many clinical research papers have been published in peer reviewed journals. The aim of the clinical research process is to gather scientific data at one place and to support & propagate Homoeopathy as evidence based science.
  • Clinical verification: To make clinical proving and research more authentic and scientific, clinical verifications are done at multicentric levels. This helps us to gain finer shades of remedies in terms of ethnicities, climates, populations etc.
  • Collaborative and fundamental research studies: Collaboration component of research is necessary to explore more on ground level. Collaborative studies are critically analysed and presented to larger masses of other fields. Further there are many areas where Homoeopathy is new as a science, thus collaborating with other institutes and individuals helps Homoeopathy to be rooted to those areas. This generates waves of new dimensions and horizons. Collaboration also provides us with the latest techniques and methods which otherwise are difficult to approach in day to day practice. Many of the research studies are done with renowned institutes like AIIMS, ICMR, BHU, INMAS etc.

SUMMARY AND CONCLUSION

Homoeopathy, the rational art of healing is based on scientific fundamental principles. As we all know that in today’s world research is an imparative part of any science, so for further development of homoeopathic practices and for the affirmation of the fundamental principles on which Homoeopathy is based, we have to focus on research oriented activities in our system of medicine. To strengthen the scientific base, improving Homoeopathic practice and verifying the clinical efficacy, research in Homoeopathy should be carried out and encouraged.

Research in Homoeopathy should aim at making Homoeopathy more effective and reliable in wider range of conditions. Research should improve the practice of Homoeopathy and at the same time evolve methods to make it easier to practice. We can achieve scientific credibility only by collecting clinical evidences for the efficacy of our drugs in various clinical conditions.

Sometimes it is very difficult for many of us to correlate scientific attitude with homoeopathy we are doing at our clinics and hospitals. Most of the time, we are afraid of the complexity of research, funding issues, absence of proper data collection, difficult access to published studies; online resources, and many more unaswered issues. Our aim towards research is very clear, to cure and benefit our patients, to become more scientific, to gather data, to grow stronger on philosophical and logical grounds.All practicing Homoeopaths can contribute to the progress of Homoeopathy by making data of their clinical experiences, by applying drugs on large number of cases and writing down the outcomes carefully. We can also identify the most reliable indications of each drug on which prescriptions can be made even while working at bedside in IPDs, OPDs or in our clinics. Every one of us can contribute to the data verification, repertory verification and proving the efficacy of drugs of our Materia Medica. Unbiased observation and data verification has been emphasised by, Hahnemann in aphorism 6 of Organon of Medicine, “The unprejudiced observer is well aware of the futility of transcendental speculations…..”

REFERENCES

1.      Organon of Medicine, Vth Edition.

2.      Directorate General of Health Services (DGHS). Ministry of Health and Family Welfare, Govt. of India. Good clinical practices for clinical research in India, 2006.

3.      Central council for research in Homoeopathy. Workshop on research methodology and standardization, 2006.

AOBUT THE AUTHORS

  • Dr Archana Narang (MD) is Medical Officer (T) at NHMC and is currently working as Co-Investigator in a research project on Thyroid disorders by CCRH at INMAS (Ministry of defense) & SHMC (Govt of Delhi). The author has many papers published at National & International level to her credit.
  • Dr Saurav Arora and Dr Latika Nagpal are working as Senior Research Fellow at SHMC.in
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