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Chapter 2: Problem 58

The San Luis Obispo Tribune (May 7,2002 ) reported that "a new analysis has found that in the majority of trials conducted by drug companies in recent decades, sugar pills have done as well as-or better than-antidepressants." What effect is being described here? What does this imply about the design of experiments with a goal of evaluating the effectiveness of a new medication?

Short Answer

Expert verified
The effect being described here is the placebo effect. This implies that the design of the experiments must account for the placebo effect to determine the true efficacy of a new medication. Specifically, double-blind placebo-controlled studies are suggested.

Step by step solution

01

Define the Effect

The described effect here is the placebo effect. The placebo effect is a phenomenon where a patient experiences a perceived improvement in their condition due to their belief in the efficacy of a treatment, rather than the treatment itself actually having any therapeutic properties. In the case of this problem, sugar pills (placebos) have shown to be as effective (or more) than actual antidepressants.
02

Analyze the placebo effect and its implications

A strong placebo effect in these drug trials suggests that patient perception and expectation play a significant role in the treatment of their condition when dealing with diseases that can be affected by psychological status such as depression. This can affect the results of drug trials, as perceived improvement can occur irrespective of whether a patient is given a placebo or an active drug.
03

Implications on Designing Experiments

This strong placebo implies that in designing future trials to assess the effectiveness of new medication, drug companies need to consider very carefully how they structure their trials. One common method is to design double-blind placebo-controlled studies. In such studies neither the patient nor the healthcare providers know whether they are receiving/giving a placebo or the actual drug. This helps in minimizing bias in the results caused due to placebo effect.

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Key Concepts

These are the key concepts you need to understand to accurately answer the question.

Experimental Design
Designing an experiment is all about planning how to answer a specific research question. In the realm of drug trials, this usually revolves around determining the effectiveness of a new medication. A well-structured experimental design ensures that the results are reliable and valid. There are several key attributes in experimental design:
  • Randomization: This process involves randomly assigning participants to either the treatment group or the control group. It helps prevent bias, ensuring that differences in results are due to the medication and not other factors.
  • Control Groups: Having a control group, which receives a placebo, allows researchers to compare effects and determine if changes in the treatment group are due to the drug itself rather than other variables.
  • Blinding: Keeping both participants and experimenters in the dark about who is receiving the treatment ensures results are not skewed by expectations.
In summary, a thoughtful experimental design is crucial to accurately discern a medication's effectiveness, eliminating as much external influence as possible.
Double-Blind Studies
Double-blind studies are a gold standard in experimental research, especially in drug trials. They are designed to minimize bias and are essential for obtaining accurate and reliable results. In these studies, neither the participants nor the researchers know who is receiving the actual treatment or a placebo. This helps in two major ways:
  • Eliminating Expectation Bias: Neither party, influenced by expectations about which treatment is administered, can unconsciously or consciously skew the results.
  • Objective Assessment: Without knowledge of the treatment allocation, the analysis of outcomes is more likely to be based on objective data rather than subjective impressions.
This design is particularly important when studying conditions that can be influenced by psychological factors, such as depression. By reducing the influence of the placebo effect and other biases, double-blind studies produce more trustworthy evidence about a drug's efficacy.
Drug Trials
A drug trial is a critical phase in the development of new medications. These trials are essential for ensuring that new treatments are safe and effective before they are made available to the public. There are several phases in a drug trial, each with its specific goal:
  • Phase 1: This initial phase tests the drug on a small group of people to evaluate its safety, dosage range, and side effects.
  • Phase 2: Conducted on larger groups, this phase continues safety assessments, while beginning to evaluate effectiveness.
  • Phase 3: This phase involves large-scale testing to confirm effectiveness, monitor side effects, and compare it to commonly used treatments.
  • Phase 4: After the drug is marketed, studies continue to collect information about its effects in various populations and any long-term side effects.
Throughout each phase, rigorous standards are maintained to ensure that the benefits of the drug outweigh any risks. By the time a drug trial concludes, researchers possess a comprehensive understanding of a new drug's safety and effectiveness.

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Most popular questions from this chapter

Can choosing the right music make wine taste better? This question was investigated by a researcher at a university in Edinburgh ( www.decanter.com/news). Each of 250 volunteers was assigned at random to one of five rooms where they were asked to taste and rate a glass of wine. In one of the rooms, no music was playing and a different style of music was playing in each of the other four rooms. The researchers concluded that cabernet sauvignon is perceived as being richer and more robust when bold music is played than when no music is heard. a. Is the study described an observational study or an experiment? b. Can a case be made for the researcher's conclusion that the music played was the cause for the higher rating? Explain.

The article "Tots' TV-Watching May Spur Attention Problems" (San Luis Obispo Tribune, April 5. 2004) describes a study that appeared in the journal Pediatrics. In this study, researchers looked at records of 2500 children who were participating in a long-term health study. They found that \(10 \%\) of these children had attention disorders at age 7 and that hours of television watched at age 1 and age 3 was associated with an increased risk of having an attention disorder at age \(7 .\) a. Is the study described an observational study or an experiment? b. Give an example of a potentially confounding variable that would make it unwise to draw the conclusion that hours of television watched at a young age is the cause of the increased risk of attention disorder.

"Crime Finds the Never Married" is the conclusion drawn in an article from USA Today (June 29 . 2001). This conclusion is based on data from the Justice Department's National Crime Victimization Survey, which estimated the number of violent crimes per 1000 people, 12 years of age or older, to be 51 for the never married, 42 for the divorced or separated, 13 for married individuals, and 8 for the widowed. Does being single cause an increased risk of violent crime? Describe a potential confounding variable that illustrates why it is unreasonable to conclude that a change in marital status causes a change in crime risk.

Suppose that a group of 1000 orange trees is laid out in 40 rows of 25 trees each. To determine the sugar content of fruit from a sample of 30 trees, researcher \(\mathrm{A}\) suggests randomly selecting five rows and then randomly selecting six trees from each sampled row. Researcher B suggests numbering each tree on a map of the trees from 1\. to 1000 and using random numbers to select 30 of the trees. Which selection method is preferred? Explain.

Red wine contains flavonol, an antioxidant thought to have beneficial health effects. But to have an effect, the antioxidant must be absorbed into the blood. The article "Red Wine is a Poor Source of Bioavailable Flavonols in Men" (The Journal of Nutrition [2001]: 745-748) describes a study to investigate three sources of dietary flavonol- red wine, yellow onions, and black tea-to determine the effect of source on absorption. The article included the following statement: We recruited subjects via posters and local newspapers. To ensure that subjects could tolerate the alcohol in the wine, we only allowed men with a consumption of at least seven drinks per week to participate ... Throughout the study, the subjects consumed a diet that was low in flavonols. a. What are the three treatments in this experiment? b. What is the response variable? c. What are three extraneous variables that the researchers chose to control in the experiment?
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