Could you have PMS?

(Premenstrual Syndrome)

What is the purpose of the study?

This study is interested in testing whether St John’s Wort (SJW), a herbal remedy that is available over the counter, is an effective treatment for Premenstrual Syndrome (PMS). It will look at the effect taking SJW has on the major symptoms of PMS, including depression, anxiety, aggression and impulsivity levels. Another aim of this study is to better characterise PMS, in order to provide a better description of the symptoms involved in the syndrome and its biological characteristics.

What is the drug or procedure that is being tested?

SJW, a herb that is easily accessible and available over the counter, has been used for centuries for medicinal purposes. It has become increasingly popular in the last decade, especially for the treatment of mood disorders. Many studies have shown SJW to be effective for the treatment of anxiety and depression. As anxiety and depression are two of the major symptoms of PMS, the role of SJW for the treatment of PMS deserves attention. To date, few studies have looked at this. During the part of the study where you would be given SJW, you would be given a dose of 900mg/day, in tablet form.

What will I have to do if I take part?

As a participant in the research, you would be required to take part for 10 consecutive menstrual cycles. As women differ in their menstrual cycle length, the study will take approximately one year to complete.

Throughout the study you would be given weekly diaries to monitor your premenstrual symptoms in detail. Each day you would be required to complete a daily symptom checklist, where you would be asked to rate how much you have experienced 20 core PMS symptoms that day, on a scale from 0 (not present at all) to 4 (severe). At the end of the week, you would complete a longer questionnaire, asking you about your symptoms in more detail.

You would be required to visit the Institute of Psychological Sciences, at the University of Leeds, a total of 11 times during the study. On all of these occasions you would be asked to perform a simple cognitive task, which would involve you looking at a series of words written in different colours, where you would be asked to simply say what colour the word is written in. On 10 of these visits you would be asked to have a small blood sample taken. Your visits would last approximately 30 minutes.

As the study will compare the effectiveness of SJW with placebo tablets for the treatment of PMS, you would take both SJW and placebo tablets at some point during the study. Placebo tablets are dummy tablets that look like the real thing, but are not. They contain no active ingredients.

What are the possible benefits of taking part?

You would discover if you do actually suffer from PMS. If you do, you may find that SJW helps you. However, this cannot be guaranteed. You would also be helping research to move forward, which may show that SJW, a herbal medication available over the counter, is effective for treating PMS. This would be of huge benefit as many women prefer to turn to herbal medications rather than take prescribed medication, especially if their symptoms are milder. Also, many products are targeted at women even though there is little evidence to show that they are effective. This study would clarify whether SJW should be used for PMS.

Where is the study taking place?

This study has been set up by the University of Leeds, in collaboration with the Rosalind Bolton PMS clinic at Leeds General Infirmary. Your visits would be to the Institute of Psychological Sciences, University of Leeds.

If you would be interested in taking part in this study, then please complete the online questionnaire and leave your details at the end. The researcher, Sarah Canning, will then contact you with further information about the study.

Questionnaire