Red Clover
how do i describe how an objective study could be designed to test the effects of red clover on menopausal sym?
how an earth do i do this. any ideas or where i can see a sample would be brill
Testing how well a particular drug works is a really common type of study. When performed in people they are often called clinical studies.
They are like any scientific experiment you need to know what you are testing and how to collect data on it.
First of all I would list all the symptoms of menopause. These will be the symptoms that you are trying to see if red clover can treat.
Now how can you measure them? Often these sorts of symptoms are subjective, or at least very difficult for someone suffering from them to quantify. A way around this is to use a rating scale. Studies into pain use rating scales all the time since it is very difficult to measure how much pain someone is in. Rating scales are a way of quantifying subjective symptoms or symptoms that are difficult to measure in some other way. Sometimes rating scales are just an easier, less invasive way of quantifying a symptom too. Vaginal dryness for instance could possibly be measured by measuring electrical conductivity. But this is a reasonably invasive procedure which you may have trouble convincing your subjects to agree to. Asking them to rate how intensely they suffer from this symptom is another way of measuring the symptom. It is important to realise though that this is more subjective, and you won't be measuring the actual level of dryness but rather how this symptom impacts on the person, which is often quite different.
For each symptom I would draw a line across the page with the words "do not experience", or "don't have" down one end and the words "suffer severely", or "experience intensely" up the other end, or some other suitably descriptive words. The idea is that your subjects will fill this form in by marking with a single pen stroke through the line how strongly they experience each of the symptoms.
There are several things to keep in mind when designing your score sheet:
1) If you are going to include a control group (more about control groups below) I would avoid describing the symptoms on the sheet as symptoms of menopause, since non-menopausal women won't have any symptoms of menopause so therefore they will feel that the questions do not relate to them. Instead just pose the question, "for each question below please rate the degree to which you are currently suffering from this symptom (you will need to tell them how to mark the sheet)
2) I would avoid simply having a 0-9 score to rank as it implies that the intensity of experience is linear, although it would allow you to score the questionnaire more easily. To score a mark through the line you then measure distance to the mark. If you use a number scale you can simply enter the numbers.
3) I would avoid putting too many symptoms or questions on a questionnaire. People will be more likely to spend the time to fill it out if it won't take too much time, say about 10 on a single A4 sheet of paper would be fine.
Next how should you perform the actual study.
Since you want to see the effect of red clover on symptoms, you need to give red clover to a bunch of menopausal women and see if it has any effect on their symptoms.
Now in your question you asked how to design an "objective" study. By this we mean that you have to perform it in such away that any variables that could affect its outcome are controlled for such that you are ONLY testing the variable you are interested in, ie red clover consumption.
What I mean by this is that you might give a woman red clover and ask her to rate her vaginal dryness or her hot flushes. She may say that she has none. So you say great red clover prevents vaginal dryness and hot flushes. But it may be that she never had them before taking the red clover. So you have to account for that.
Another example is that the placebo effect is quite strong in people. By this I mean if someone believes something will cure them of a symptom, they will often feel an improvement of the symptom, even if they were not taking the drug they thought they were taking. So you have to control for that too.
So my advice for designing the experiment:
Recruit your subjects. Recruiting subjects is quite hard, but I will assume you have managed that some how. You then need to divide them up into treatment groups (I will explain this in a sec).
Once in their treatment groups you should administer the initial symptom questionnaire. This will be their base line level for each of the symptoms. After they have had their treatments you would test them again. Remember though that different drugs take different amounts of time to work. You have to use a time frame or a dosage that will likely produce a result.
On the topic of the treatments, to avoid the placebo effect it would be worth making your study double blind. That is neither the experimenter nor the subjects know what they are taking. Get someone else to code the drugs. You only break the code at the end after you have collected and
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