What is a Double-Blind Study All about - Research Paper Example

?Despite the fact that double-blind studies are a popular only a few recognize their true importance. It’s easy enough to understand their importance only it is more difficult to accept their consequences. This is mainly because they go against relying on one’s direct personal experience. The insight that is given by double blind studies has been particularly challenging for alternative medicine since these root from tradition and anecdote. They might seem to be good sources of information however this is a statement contradicted by double blind studies. This is mainly due to the presence of confounding variables. So a double blind study serves not just to be a proof of efficacy but also a solid indication as to whether a treatment really works or not. What is a Double-Blind Study? It is in the nature of a randomized double-blind trial which is also placebo controlled that is medical in nature to have subjects that are given false treatment, also known as a placebo, and the researchers as well as the subjects are unable to distinguish between the two right up till the point when the study is concluded. This is why the study is referred to as ‘blind’. Also the way the subjects are given the treatment or the placebo is through random selection and hence the term ‘randomized’. Why Double-Blind Studies? There are several reasons why for a number of treatments the most effective question that can address the research question is that of a randomized double-blind, placebo controlled study. These studies which mainly aim to address the central question: “Does a certain Treatment X benefit Condition Y?” In order to fully understand the significance and the role that a randomized double blind study plays is by looking at the numerous problems that can rise when we attempt to address this question in any other way. Firstly the major significance of randomized double blind studies is reflected in the fact that medical investigations are an area of study in which the application of direct common sense observation does not confirm the accumulation of accurate results. It was only through the use of double-blind studies that researchers came to the realization that their own sense of sight was unreliable; the simple reason being a number of confounding factors. The Confounding Factors The influences which have an impact on the research and can make it seem like treatments that are ineffective are actually effective. These confounding elements are the sole reason for which medical treatments done over centuries is deemed of no value. Some of the key confounding factors are: Placebo effect The placebo effect is the procedure by which the influence of suggestion is what results in an improvement in symptoms. There are certain kinds of research that respond positively to a placebo treatment. Some examples of conditions that are responsive to a placebo treatment are menopausal hot flashes and certain kinds of pain. Although statistics show that only 30 percent of people are responsive to placebos but it can be as high as 70 percent for some treatments (McLennan, 2001) The results of placebo effects are astounding to those who experience it. An example is that of arthroscopic surgery where surgeons would think it really worked for knee arthritis. Then a research came out that showed that a pretend surgery would end up with the same level of satisfaction and long term advantages as the real one (Moseley et al., 2002). Generally individuals do not react happily when told that the positive effects were a result of a placebo. However the positive results of a placebo treatment are in a lot of cases undeniable. For example, in a double-blind, placebo controlled study done on the carpal tunnel syndrome of about thirty subjects showed that the use of a static magnet had a lot of advantages and it was found the same results were achieved with the use of fake magnets. Also in a randomized double-blind trial with about 67 subjects who were suffering from hip pain produced noteworthy improvements only by placing needles in random spots by the use of acupuncture ( Fink et al., 2001). Statistical Illusions To understand the confounding factor of statistical illusions you can look at a relevant example; suppose you come up with a very terrible treatment that is incapable of helping the majority however it aids one in a hundred individuals. Depending on the amount of the sample you give this treatment to, say a thousand; you will manage to get at least a hundred good reviews which will make the overall treatment sound good. Suppose that you administer a treatment which aims to improve a subject’s mental function and you then use twenty different methods to test mental function. So based on the law of averages there will be a certain amount of improvement on some level even if the treatment doesn’t really work. This information can then be utilized to support the sales of the product even though the results might not be solely based on the treatment’s effectiveness. Observational studies The trickiest aspect of statistical illusion is that of observational studies. It is in this factor that no treatment is actually given but the researchers simply observe the behavior of a vast amount of people. For example, a study was conducted on the health of nurses using a sample of 100,000 nurses in order to find a link between their lifestyle habits and sickness. It was then found that nurses who eat more fruits and vegetables have less cancer. Using this observation it was inferred that eating fruits and vegetables prevents cancer. But this would not be an accurate inference. From what we know that high consumption of fruits and vegetables is linked with less cancer and not that it is the reason for less cancer. So while eating them might make them healthy it won’t prevent cancer (Manson et al, 2003). Self-Limiting Illness There are many illnesses that are naturally combated by the body. A worthless treatment given during the course of this an illness of this kind could falsely be associated with curing a sickness which in truth heals naturally. The Regressive Fallacy This confounding factor is mostly applied to chronic conditions but is a lot alike self limiting illnesses. So a treatment that is administered while the condition is at its worst will be most likely to result in an improvement since it is at its worst and can only get better. The Hawthorne effect The Hawthorne effect was first observed ina work setting when it was found that a staff would perform better if attention was paid to them. Simply by taking some interest there was an increase in productivity. Similarly this effect was observed in medical trials when patients were singled out to be a part of trial and monitored which resulted in a behavior which was better than their normal one. For example, diabetic subject who were given a new pill would try to eat better and exercise more regularly simply because they were a part of a trial; so any improvement was a result of altered behavior and not the treatment. Randomized Controlled Trial (RCT) A Randomized controlled trial is a kind of a clinical trial which is primarily used to test the safety, meaning extensive information regarding adverse drug reactions, and how effective health care services are. The main distinguishing factors most common in the RCT is that the subjects after appraisal of eligibility and enrollment, but before the study beings, are randomly allotted to receive different forms of treatments under the study (Moher et al, 2010). The concept although seems complex however after randomization the subjects are treated in similar ways with the only difference being between the care that they get, for example, this could be the procedures, tests, follow up etc. should be those inherent to the treatments that are being evaluated. A key advantage being that it eliminates to a great extend allocation bias, matching prognostic factors, in the project of treatments. The term RCT and randomized trial imply two different things; RCTs are used to contrast treatment groups with control groups which do not receive any cure, which is a placebo controlled study whereas randomized trials refer to the comparison between a number of treatment groups with each other. RCTs also refer to randomized clinical trials which have to do a lot with clinical research however it is used in other fields like criminology, education and social work. Randomized controlled double blind trial While a double blind trail can be best described as a study in which the experimenter as well as the subject both do not know the nature of the treatment which they are receiving a randomized controlled double blind trail is one in which the subject/drug tester and the researcher both are unaware of what the drug is and what is the exact reason for which the drug aims to test. For example, there will be multiple diseases under observation at the same time and only a tiny dosage is administered to prevent side effects. Importance of Double-Blind Studies After thorough investigation and reaching several false conclusions as far as other kinds of research is concerned medical researchers have come to realize that without the use of double blind studies on treatment it is extremely hard to know for sure whether the treatment works. Whether the treatment seems credible in the way it has been of significant contribution of traditional use in the field of medicine, tradition it has been learnt for most part been very wrong. The fact that doctors and the patients believe the treatment works is of little value. It is critical that they both keep an eye out to observe benefits even if the treatment used is fake. Any guesses that are made by relying on bad evidence can do more harm than good. Furthermore double-blind studies are not all the created in the same way. The designing, performing and reporting of most studies have a great number of pitfalls and this is where the double blind studies deserve more credit than the others. Studies that run for a very short course tend to be weaker in their findings and unless there are multiple laboratories with corroborating results, the chance of bias and fraud grows significantly. Thus a treatment is only deemed accurate when several double blind studies with a sample size of over 200 people, conducted by a number of researchers, with the highest standards being observed, carried out at a number of institutions and published in peer reviewed journal. Weaker evidence only shows a slight inclination of effectiveness and might be side tracked or put aside when other extensive studies are conducted. So even when there are some supplements that have been adopted which might show a certain level of solid proof, most alternative therapies still have not. Treatments which have not been assessed by the use of double blind studies leave there to be simply no other way to be sure if they work up to any known measure unless they are put through the trouble and high cost of a double blind trail. Key advantages The first advantage of conducting a double blind randomized trial is that it eliminates the presence of bias in the research, especially those concerned with selection bias and confounding. Also it aids blinding of the identity of the treatment which is conducted from subjects, researchers and evaluators. Furthermore it allows the use of probability theory to depict the possibility that any variation in outcome between treatment groups simply is a reflection of chance. References MacLennan A, Lester S, Moore V. Oral estrogen replacement therapy versus placebo for hot flushes: a systematic review. Climacteric.2001;4:58-74. Moseley JB, O'Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med.2002;347:81-8 Fink M, Karst M, Wippermann B, et al. Non-specific effects of traditional Chinese acupuncture in osteoarthritis of the hip: a randomized controlled trial. Complement Ther Med. 2001;9:82–88. Manson JE, Hsia J, Johnson KC, et al. Women's Health Initiative Investigators. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med. 2003;349:523-34. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG (2010). "CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials". Br Med J 340: c869. doi:10.1136/bmj.c869.PMC 2844943. Read More