OBJECTIVE: To demonstrate similarities and differences between the various instruments used by clinical trialists for measurement of premenstrual syndrome, and to encourage development of consensus of measurement to aid future research.
DESIGN: Computer and manual searches of all trials of drugs used for premenstrual syndrome supplemented by retrieval of all questionnaires and scales cited. Letters were sent to the main manufacturers to identify trials not in the public domain.
MAIN OUTCOME MEASURES: Number of scales in current use for classifying premenstrual syndrome; the symptoms included within them; their organisation of symptoms into clusters; the numerical values used in the scaling; the most frequently used items; and the extent of overlap in the criteria used.
RESULTS: Three hundred and fifty clinical trials of 115 different drugs were identified. The most common symptoms or signs used in the scales were (frequency in square brackets) irritability [44], headache or migraine [40], depression [37], tearfulness [34], tension [31], anxiety [31], breast tenderness [31], mood swings or lability [30], back pain [30], weight gain [29], abdominal bloating [28], lack of concentration [28], food craving [28], and increased appetite [26]. Sixty-five different questionnaires or scales were used to classify premenstrual syndrome and for assessing entry eligibility and treatment outcomes; of these 65, 47 included sufficient details for a formal analysis and 18 scales grouped the symptoms or items into clusters or subgroups.
CONCLUSION: There is wide diversity in the scales used for assessing entry eligibility and treatment outcomes in premenstrual syndrome. This makes comparative evaluation of possible treatments extremely complex and difficult. It is recommended that authorities and organisations involved in conducting trials of treatments for premenstrual syndrome develop a consensus statement about the best instrument to be used. Regulatory authorities could perhaps provide guidance to which scales they would accept when clinical trials of drugs for premenstrual syndrome are submitted to them for assessment. This would ensure that industry-sponsored trials provide objective data. Consensus is required given the poor performance of most current treatments of premenstrual syndrome.
We attempted a quantitative overview (meta-analysis) of PMS treatments to try to identify the most appropriate treatments. However, it became obvious that a major problem in the overview was the disparate methods used by the many clinical trialists to identify and classify women with PMS and to measure treatment outcomes. Different studies were investigating women with divergent symptoms using a heterogeneous range of scales. As a first step, we decided to survey those scales systematically.
Budeiri, D. J. and A. Li Wan Po, J.C. Dornan
Disease Category: Gynaecology
Disease Name: Premenstrual syndrome
Age Range: Unknown
Sex: Female
Nature of Intervention: Not specified
- None
- Systematic review of outcome measures/measurement instruments
- Systematic review of outcomes measured in trials
- Systematic review
A search of the literature was carried out using commercially available databases. The initial Medline search covered 1966 to April 1993. Mesh words used included premenstrual syndrome, premenstrual tension, late luteal phase dysphoric disorder, cyclic mastalgia, and clinical trials. A further search was carried out using the Science Citation Index (BIDS) with the same mesh words. The searches were supplemented with an Index Medicus search on each drug used in the treatment of the premenstrual syndrome. If possible, hard copies of any clinical trials identified were obtained and read to identify methods, scales and questionnaires used for assessing entry eligibility and/or treatment outcomes. Copies of any trials not identified by the primary searches but cited in the reviews or in references of research papers, were also obtained for detailed assessment. Symposium proceedings and dissertations on the management of the premenstrual syndrome were identified for the period 1964 to October 1992. Keywords used included premenstrual tension, premenstrual syndrome, essential fatty acids, evening primrose oil, mastalgia, benign breast disease, bromocriptine, progesterone, oestrogen and menstrual cycle. Letters were sent to the drug information officers of the UK manufacturers of drugs used for the treatment of premenstrual syndrome. Letters to the editor, abstracts and articles not in English were excluded from detailed analysis.