The Journal of Obstetrics and Gynaecology of India
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VOL. 73 NUMBER 3 May-June  2023

Effectiveness of Tibolone in Relieving Postmenopausal Symptoms for a Short-Term Period in Indian Women

Renuka Malik1 · P. Meghana Reddy1

Renuka Malik

renucam@yahoo.co.in

1 Department of OB‑GYN, ABVIMS & Dr RML Hospital, New Delhi, India

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Dr. Renuka Malik is working as a consultant OB-GYN in ABVIMS and Dr. RML Hospital, New Delhi. She is an alumni of Lady Hardinge Hospital, New Delhi. Her areas of interest include highrisk obstetrics and menopause. She runs the menopause clinic at her institution. Dr. P. Meghana Reddy is Resident, OB-GYN, ABVIMS & Dr. RML Hospital, New Delhi.

Background Tibolone is an alternative to conventional estrogen and progesterone in relieving post-menopausal symptoms in Indian women.

Material and Methods A prospective short-term observational study was done at a tertiary care teaching hospital in New Delhi from November 2019 to September 2021. Fifty-three women, less than 60 years of age, presenting with moderate to severe intensity of menopausal symptoms as assessed by measuring menopausal rating score (MRS > 8) were enrolled and given Tibolone 2.5 mg daily for 3 months. Improvements in symptoms were seen at 1 month and 3 months. Side effects were also noted.

Results Marked improvement was seen as reduction in scores of psychological, somatic and genitourinary symptoms was noted. The psychological symptoms reduced from 8.92 ± 1.959 to 2.905 ± 1.042, the somatic symptoms decreased from 8.33 ± 2.299 to 3.4 ± 1.167, and genitourinary symptoms decreased from 3.64 ± 1.42 to 2.150 ± 0.948 after 3 months of treatment with Tibolone. Only 3 patients (5.6%) experienced vaginal spotting with no major side effects.

Conclusions Tibolone is a highly effective and well accepted drug to reduce moderate to severe menopausal symptoms, especially psychological symptoms including depression.

Keywords : Tibolone · Menopausal symptoms · Hot flushes · Hormone replacement therapy · Genitourinary symptoms of menopause · Psychological symptoms at menopause · Somatic symptoms at menopause

Menopause is a naturally occurring event in all women after the reproductive age. The menopausal symptoms adversely affect the quality of life in menopausal women. Hormonal replacement therapy helps to alleviate the bothersome symptoms. Tibolone, which is a STEAR (Selective Tissue Estrogenic Activity Regulator), is used for the treatment of women with menopausal symptoms. It possesses estrogenic, progestogenic, and androgenic properties [1]. This study was done to see the effectiveness of Tibolone in alleviating postmenopausal symptoms in Indian women.

A short-term prospective observational study was conducted in the department of obstetrics and gynecology, from November 2019 to September 2021. Inclusion criteria were women with age less than 60 years having moderate to severe intensity of menopausal symptoms as assessed by Menopausal Rating Score (MRS > 8). The exclusion criteria were postmenopausal women with endometrial thickness greater than 4 mm, women with breast cancer or family history of breast cancer, severe medical disorders (cardiac, liver, renal diseases), undiagnosed vaginal bleeding, history of psychiatric illness diagnosed before menopause, and women with an active or past history of thromboembolic disorders.

A total of 150 patients attending menopausal OPD were screened for enrollment, which included a detailed history, examination, and ultrasound evaluation for endometrial thickness. Out of these, 76 patients who met the inclusion criteria were enrolled in the study. Enrolled patients were given Tibolone 2.5 mg once daily for a period of 3 months and were assessed for improvement in menopausal symptoms objectively by MRS questionnaire at 1 month and 3 months after taking Tibolone. Side effects at 15 days, 1 month, and 3 months were noted.

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