Objective: To investigate the effects of 3-month supplementation with oral probiotics on quality of life in young women with primary dysmenorrhoea Design Randomized, double blind, placebo-controlled trial Setting A tertiary university hospital in Malaysia Population Women aged 18 to 45 years old suffering from primary dysmenorrhoea Methods: 72 patients were randomized to receive either oral sachets containing Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium bifidum, Bifidobacterium longum, and Bifidobacterium infantis 107 mg each or placebo twice daily for three months. Main outcome measures Visual Analog Score (VAS) of pain, Verbal Rating Scale (VRS) of severity, frequency of non-steroidal anti-inflammatory drugs (NSAIDs) use, and quality of life (QoL) scores derived from Short Form 12 item version 2 (SF12v2) questionnaire Results Both groups showed improvement in quality of life scores. There was a non-statistically significant lower NSAIDs use in probiotic group compared to placebo group (median 1 vs 2, p-value = 0.26). Placebo group showed better severity score (VRS) on day 2 of menses compared to probiotic group (median 0 vs 1, p-value <0.05). No difference in other quality of life scores was noted. In subgroup of non-NSAIDs users, the pain score (VAS) was lower in the probiotic group compared to placebo, which was not statistically significant (p-value = 0.59) Conclusion Probiotic supplement may reduce NSAIDs use in women with primary dysmenorrhoea Funding This study receives supply of the oral probiotic sachets and placebo from the manufacturing company Hexbio Sdn Bhd Keywords Primary dysmenorrhea, probiotics, quality of life, menstrual disorders

ABSTRACT Background: The Polycystic Ovary Syndrome health related Questionnaire (PCOSQ) is a reliable instrument for measuring the health related quality of life (HRQoL) in women with polycystic ovary syndrome(PCOS). The study is aimed to develop a Malay version of PCOSQ (Mal-PCOSQ) to evaluate the HRQoL of Malaysian women with PCOS and to test its reliability and validity. Methods: Participants were women who were diagnosed with PCOS attending the gynaecology clinic. Reliability was determined by internal consistency using Cronbach’s coefficient alpha and test-retest reliability using intra-class correlation coefficient. Validity was assessed through convergent and discriminant validity. Examining the correlation between similar content on the Mal-PCOSQ and the Short Form 36 version 2 (SF 36v2) assessed convergent validity. Whereas the discriminant validity was assessed using the known groups comparison. Results: Cronbach’s coefficient alpha was over 0.70 for total scale and over 0.60 for each subscale. Known groups comparison support its discriminant validity whereby the Mal-PCOSQ differentiated well between sub-groups of women who differ in PCOS specific symptoms. Convergent validity was consistent with a good positive correlation between related subscales of the two instruments. Women with PCOS in Malaysia scored lowest for weight (3.74) and infertility (3.41) domains indicating worse health in these domains. Body hair (5.42) was the least troublesome for the local population. Conclusion: The Mal-PCOSQ is reliable and valid tool in assessing the health related quality of life and can be used to objectively assess the HQoL of Malaysian women with PCOS and evaluate their responsiveness to treatment.