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Janice Rymer

Publications and source records attributed to Janice Rymer.

At least 19 recordsLinked to original sources
PubMed2006

Endometrial effects of tibolone.

BACKGROUND AND OBJECTIVES: The Tibolone Histology of the Endometrium and Breast Endpoints Study is a multicenter, randomized, double-blind study designed to address the conflicting reports in the literature about the endometrial safety of tibolone (1.25 or 2.5 mg/d). Tibolone was compared with continuous combined conjugated equine estrogen (CEE) plus medroxyprogesterone acetate (MPA) (0.625 + 2.5 mg/d). METHODS: Subjects were randomized in a 1:1:2 ratio to tibolone 1.25 mg/d, 2.5 mg/d, and CEE/MPA, respectively. The one-sided 95% confidence interval (CI) has been evaluated for the incidence of abnormal endometrial histology (hyperplasia or carcinoma) and hyperplasia and carcinoma separately for each of the two treatment groups and the treatment groups combined after 1 and 2 yr of treatment with tibolone, compared with CEE/MPA. RESULTS: A total of 3240 women were randomized, with 3224 receiving at least one dose of study medication. The incidence and upper one-sided 95% CI for the incidence of abnormal endometrium (hyperplasia or carcinoma), and hyperplasia and carcinoma separately, were calculated at end point, yr 1, and yr 2. The incidence (upper one-sided 95% CI) of abnormal endometrium at end point was 0.0 (0.5), 0.0 (0.4), and 0.2 (0.5) in the tibolone 1.25 mg, 2.5 mg, and CEE/MPA groups, respectively. During the entire treatment period, amenorrhea was reported more frequently with tibolone 1.25 mg (78.7%) and 2.5 mg (71.4%) than CEE/MPA (44.9%). CONCLUSION: The Tibolone Histology of the Endometrium and Breast Endpoints Study results confirm previous findings that tibolone does not induce endometrial hyperplasia or carcinoma in postmenopausal women, and it is associated with a better vaginal bleeding profile than CEE/MPA.

Aged↗
PubMed2006

Effects of tibolone and continuous combined conjugated equine estrogen/medroxyprogesterone acetate on the endometrium and vaginal bleeding: results of the OPAL study.

OBJECTIVES: The primary objective of the Osteoporosis Prevention and Arterial effects of tiboLone study was to compare the effect of tibolone and placebo on the progression of the common carotid artery intima-medial thickness; the common carotid artery intima-medial thickness and bone data will be presented elsewhere. A secondary objective was to assess the effects of tibolone (2.5 mg), continuous combined conjugated equine estrogen/medroxyprogesterone acetate [0.625/2.5 mg], and placebo on the endometrium and vaginal bleeding; these results are the subject of this report. STUDY DESIGN: This 3-year, three-arm, international, randomized, double-blind, parallel group, placebo-controlled clinical trial enrolled 866 postmenopausal women (aged 45-79 years). The endometrium was assessed by annual transvaginal ultrasound scans and end-of-study biopsies (United States/United Kingdom centers only). Vaginal bleeding was recorded in daily diaries. RESULTS: Endometrial thickness measured by transvaginal ultrasound scan increased slightly during the first year with tibolone and conjugated equine estrogen/medroxyprogesterone acetate, without any further progression. After 3 years, there were no significant differences between the tibolone, conjugated equine estrogen/medroxyprogesterone acetate, and placebo groups in the incidence of proliferation (1.4%, 4.8%, and 0%, respectively), endometrial hyperplasia (0% in all groups), or cancer (1, 0, and 1 case, respectively). During the first 3 months, bleeding/spotting rates were greater with conjugated equine estrogen/medroxyprogesterone acetate (48%) than with tibolone (18%; P < .001) or placebo (3%; P < .001). During 3 years of treatment, the incidence of bleeding/spotting was 66%, 48%, and 23% for conjugated equine estrogen/medroxyprogesterone acetate, tibolone, and placebo, respectively. The mean number of bleeding/spotting days was greater in the conjugated equine estrogen/medroxyprogesterone acetate than the tibolone or placebo groups (61, 28, and 7 days, respectively; P = .023 vs tibolone; P < .0001 vs placebo). The mean number of bleeding/spotting episodes was also greater in the conjugated equine estrogen/medroxyprogesterone acetate group (13 episodes) compared with the tibolone group (six episodes; P < .001) and placebo group (four episodes; P < .001). Vaginal bleeding was more commonly reported as an adverse event with conjugated equine estrogen/medroxyprogesterone acetate than tibolone (26.4% vs 10.8%, P < .0001) and as the reason for premature discontinuation (9% vs 2%, P = .001). CONCLUSION: Compared with conjugated equine estrogen/medroxyprogesterone acetate, tibolone has a better tolerability profile with respect to vaginal bleeding but with a similar endometrial safety. These results reinforce the endometrial safety profile of tibolone.

Aged↗
PubMed2005

Menopausal symptoms.

Explore the source record for details and available documents.

Drug Therapy, Combination↗
PubMed2004

Long-term effects of tibolone on mammographic density.

OBJECTIVE: To investigate the long-term effect of tibolone on mammographic density. DESIGN: Open-label, nonrandomized study. SETTING: Academic research environment. PATIENT(S): Postmenopausal women. INTERVENTION(S): Tibolone was administered orally, mammograms were performed annually. MAIN OUTCOME MEASURE(S): Mammographic density according to the Wolfe classification, performed by two independent radiologists, both of whom were blinded to treatment group. RESULT(S): No statistically significant differences were found between the two groups in baseline demographic data. There were no statistically significant differences in mammographic density between the control and active groups at baseline or at 10 years. CONCLUSION(S): This pilot study shows that tibolone does not adversely alter the mammographic density of the breasts over 10 years of treatment.

Administration, Oral↗
PubMed2003

Can gynaecology teaching associates provide high quality effective training for medical students in the United Kingdom? Comparative study.

OBJECTIVES: To train laywomen to become professional patients in order to teach medical students speculum and bimanual examination, to assess their effectiveness in this role, and to incorporate this method of teaching into the undergraduate curriculum of a medical school in the United Kingdom. DESIGN: Comparative study. SETTING: Guy's, King's, and St Thomas's School of Medicine, London. PARTICIPANTS: 44 medical students trained by gynaecology teaching associates; 48 control students. MAIN OUTCOME MEASURE: Skills in pelvic examination. RESULTS: Six laywomen were recruited and all successfully graduated to become gynaecology teaching associates. At assessment 1, in the third week of the reproductive and sexual health block, the mean score achieved by students trained by gynaecology teaching associates was 155, compared with 104 for control group students (difference in mean scores 51 (95% confidence interval 41 to 61), P < 0.001). Similar results were obtained at assessment 2, at the end of the attachment-the mean score for trained students was 148, compared with a mean score of 114 for control group students (difference in mean scores 34 (21 to 46), P < 0.001). CONCLUSIONS: Laywomen can be trained to teach pelvic examination to medical students in the United Kingdom. Students who receive this training have better skills than students who receive the traditional training alone.

Clinical Competence↗
PubMed2003

Consent for teaching: the experience of women attending a gynaecology clinic.

OBJECTIVES: To examine women's experience of the consent process for involvement in medical education in a teaching hospital. DESIGN: Questionnaire survey. PARTICIPANTS: The study involved 181 (90% response rate) women aged 17-79 years who attended 1 gynaecology clinic. SETTING: A gynaecology clinic in an inner London teaching hospital. RESULTS: Women were broadly positive about the presence of students in gynaecology clinics. The current process relies on implied consent and women actively opting out of involvement. Despite hospital policy to inform all outpatients in their appointment letter that students may be present at the clinic, 58% of patients did not recall being informed in this way. Although 91% of women did not object to student presence, only 65% reported having been asked if they wanted it. Subjective feeling of choice about the student presence was associated with advance notice, either by letter or previous experience of students at clinics. Women differentiated between consent for different aspects of interaction with students. CONCLUSION: Notification of the presence of students in standard appointment letters does not adequately inform patients. Clinical teachers need to ensure that the measures in place to inform women and to seek their active consent about involvement in teaching are robust.

Adolescent↗
PubMed2002

Trough oestradiol levels associated with cognitive impairment in post-menopausal women after 10 years of oestradiol implants.

RATIONALE: Oestrogen treatment has been found to improve memory in healthy post-menopausal women, but the effects are small, especially when socio-economic status is controlled. There is some evidence that with long-term treatment the benefits decline, or reverse. OBJECTIVE: To examine the effects of 10 years of oestradiol implants on attention, memory and frontal lobe function in healthy women (aged 51-72 years) who had undergone a surgical menopause. METHODS: In an open study, patients were recruited from the Guy's Hospital menopause clinic and were tested just before receiving a new implant. Exclusion criteria included any form of psychoactive medication, IQ<90, English not the first language and anxiety or depression scores in the clinical range. All patients had been receiving HRT with an oestradiol implant for about 10 years. Each patient was pair-matched to a woman who had never received HRT. Eighteen pairs were matched for age, IQ, socio-economic status, years of secondary education, and occupation. They completed questionnaires, mood rating scales and a battery of cognitive tests. RESULTS: The patients with oestradiol implants had significantly greater psychological and somatic menopausal symptoms and significantly worse mental flexibility (rule reversal) and long-term episodic memory than did the control group who had never received HRT. Analysis of covariance showed that the difference in menopausal symptoms did not account for the cognitive differences. There were no differences in a test of sustained attention or in a category generation task or in self-ratings of mood after the stress of cognitive testing. CONCLUSIONS: Long-term treatment with oestradiol implants does not convey cognitive benefits and may lead to impaired function.

Affect↗
PubMed2002

Serum lipoprotein (A) and apolipoproteins during pregnancy and postpartum in normal women.

This study was designed to investigate whether serum lipoprotein (a) is affected by pregnancy and to relate this to changes in other lipids, lipoproteins and apolipoproteins. The study involved twenty-nine healthy Caucasian pregnant women at term and 27 non-pregnant women matched for age who acted as controls. Samples of venous blood were obtained from 29 pregnant women at term (between 37 and 42 weeks) and 22 of these women provided a second sample after 12 weeks post-partum. Twenty-seven non-pregnant women acted as controls. Samples were taken for Lp(a) and also cholesterol, triglyceride, HDL-cholesterol, apolipoprotein (apo) A and B1. No significant difference was found in the serum concentrations of Lp(a). However, the pregnant women had significantly higher serum concentrations of cholesterol, triglyceride, apo A1 and B (P<0.001) than the controls. The ratio of apo A1: apo B was significantly lower than controls (P<0.001). HDL-cholesterol was not altered by pregnancy but was lower (P<0.05) than the controls after a period of 12 weeks post-partum. Despite a hyperlipidaemia in pregnancy the serum concentrations of Lp(a) are not affected suggesting different metabolic control for this lipoprotein.

Adult↗
PubMed2002

Cognitive effects of 10 years of hormone-replacement therapy with tibolone.

In an open study, self-ratings of bodily symptoms, mood (before and after stress), and cognitive performance were investigated in 25 women (aged 54-66 years) who for approximately 10 years had been taking an oral preparation of hormone replacement therapy (HRT), tibolone (Livial; 2.5 mg/ day). Tibolone has a unique profile, with estrogenic, progestogenic, and androgenic actions. The control group of 25 women had never taken HRT. Each woman in this group was pair-matched to one in the tibolone group on age, years since menopause, IQ, years of secondary education, and occupation. The groups were matched on their anxiety and depression scores on the Hospital Anxiety and Depression rating scale. Exclusion criteria were scores on this scale in the clinical range and any current illness or recent use of psychoactive medication. The women who were taking tibolone felt significantly less clumsy and had less severe palpitations than the control group. After exposure to a mildly stressful test, the control group felt more anxious, but this change was not seen in the group receiving tibolone. The group taking tibolone had significantly better semantic memory (memory for facts), as assessed in a category generation task, but they did not differ in tests of episodic memory (memory for events). An unexpected finding was that the tibolone group performed significantly worse on a sustained attention task and a planning task, tasks that are associated with frontal lobe function. Our results suggest that the effects of HRT on cognition may be influenced by the type of HRT, the duration of treatment, the nature of the tests, and the brain region controlling the cognitive function.

Arousal↗