Rachna Gupta

Address for correspondence* Rachna Gupta Department of Pharmacology University College of Medical Sciences,University of Delhi,India EMail address: [email protected] e ISSN: 2277-7253 © 2012 Asian J Med Res [12] patient's answers can then be used for numerical comparisons . Data regarding the effect of drugs on QoL in PMS is limited. This report describes findings from a randomized placebocontrolled clinical trial performed in women with PMS, in which treatment with bromocriptine and pyridoxine was evaluated with respect to their impact on QoL. MATERIAL AND METHODS The study was conducted in the department of pharmacology in association with department of obstetrics & gynaecology, S. N. Medical College, Agra, India. Patients attending gynaecology out-patient were interviewed during the study period. The ethical approval was obtained from the Institutional Ethics Committee. A written informed consent was taken from the patients or their attendants. Women of age group between 20–45 years, with regular menstrual cycle (22–35 days) having premenstrual symptoms for at least 2 or 3 menstrual cycles, were selected for the present study. These symptoms were physical, psychological and behavioural. Physical symptoms included were headache, breast tenderness and swelling, swelling of extremities, bloated abdomen, weight gain, fatigue and dizziness/fainting. The psychological symptoms included were depression, irritability, anxiety, mood swings, angry outburst, over-sensitivity while the behavioral symptoms were increased appetite, food cravings, social withdrawal, forgetfulness, easy crying, confusion, sleepless-ness. For each symptom a score was given between 1 to 3 depending upon the severity of symptoms-mild, moderate or severe. Scoring and grading of the symptoms was followed according to the method of [13] Steiner . The women having menorrhagia, chronic psychiatric illness, breast disease/swelling, anaemia, chronic fatigue syndrome and patients taking oral contraceptives were not included in the study. University College of Medical Sciences and GTB Hospital, New Delhi 110095, Lady Hardinge Medical College & Smt. S.K. Hospital, New Delhi,India. Sarojini Naidu Medical College & Hospital, Agra,India.. Premenstrual symptom score was graded as: Grade 0 – no symptoms, Grade 1 – mild symptoms not interfering with activities, Grade 2 – symptoms interfere with activity but it is not disturbing, Grade 3 – severe, disabling symptoms. Thus possible minimum and maximum score could be between 0 to 60. The women were diagnosed with PMS, if premenstrual symptom score was more than 5 or not less than twice the postmenstrual symptom score. The patients were categorized as mild PMS (score 6–20), moderate PMS (score 21–40 or at least 5 symptoms of grade 2) and severe PMS (score 41–60 or at least 5 symptoms of grade 3). The short form of the Quality of Life Enjoyment and [14] Satisfaction [QOLES] questionnaire was completed by the subjects before treatment. The QOLES questionnaire is a selfreport form composed of 15 items each rated on a 5-point scale that indicates the degree of enjoyment or satisfaction experienced during the past week. A total score of items 1 to 14 was computed and expressed as a percentage of the maximum possible score of 70. The 14 items evaluated each subjects' satisfaction with her physical health; social relations; ability to function in daily life; ability to get around physically; mood; family relations; sexual drive and interest; ability to work on hobbies, work, leisure time activities; economic status; household activities; living/housing situation; and overall sense of well-being. There was a global item, number 15, that is not included in the QOLES questionnaire's total score: satisfaction with medication. Grouping, drugs and dosage Subjects were randomly allocated to any of the 3 groups: Group I (control, n = 20): Placebo, ferrous sulphate tablets, 100 mg, orally daily for 3 months. Group II (bromocriptine, n = 20): Bromocriptine initially started in the dose of 1.25 mg at bed time for 2–3 days and then increased up to 5 mg/day in 2 divided doses, up to the beginning of the next cycle. Group III (pyridoxine, n = 20): Pyridoxine 100 mg/day, orally daily for 3 months. Improvement assessment All women completed the QOLES questionnaire and treated for 3 consecutive cycles. They were followed up monthly for 3 months. At the end of 3 months subjects again completed the QOLES questionnaire. Statistical Analysis: Data were analyzed using the statistical package of the NCSS 2004. One way MANOVA was applied to compare the initial and post treatment scores of the 3 groups. Kruskal-Wallis one-way ANOVA on ranks was applied 2 followed by ÷ test to compare the initial and post-treatment scores of QoL (individual items) in all the three groups. RESULTS Baseline Data Baseline demographic characteristics including age, marital status and parity were well balanced across treatment groups. There were no marked differences across treatment groups with respect to baseline scores of the QoL items. Global assessments of disease severity at baseline revealed the presence of mild to moderate illness that was accompanied by substantial impairment in areas of social functioning (work life, social life, 143 and family life). All the study participants completed the questionnaire. The split-half reliability of the QOLES questionnaire was assessed using Cronbach's á on the data for all the groups separately on items for physical health and psychological and social health. Cronbach's á based on the standardized items for the scale ranged from 0.68 – 0.84 indicating good reliability. A one-way MANOVA revealed a significant multivariate main effect for bromocriptine [Wilks' ë = 0.23, F (15, 24) = 5.27, p < 0.001] and pyridoxine treatment [Wilks' ë = 0.05, F (15, 24) = 32.8, p < 0.001] but not for placebo [Wilks' ë = 0.54, F (15, 24) = 1.39, p = 0.23] given for 3 months. Further analysis by Kruskal-Wallis one-way ANOVA 2 followed by ÷ test showed that after 3 months of the treatment with bromocriptine, there was a significant improvement in mean scores of seven itemsphysical health, mood, work, household activities, ability to function in daily life, living or housing situation and ability to get around physically, of QOLES questionnaire. In pyridoxine group, there was a significant improvement in mean scores of all of the 15 items of QOLES questionnaire. Women treated with pyridoxine scored significantly better on all the dimensions of QOLES questionnaire, while those assigned bromocriptine treatment scored significantly better on items indicative primarily of physical health (Table 1). Also, satisfaction with medication was reported only with pyridoxine treatment.