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CHINESE MEDICINAL HERBS IN RELIEVING PERIMENOPAUSAL DEPRESSION: A RANDOMIZED, PLACEBO-CONTROLLED TRIAL
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8th European Congress on Menopause (EMAS) / Maturitas 63, Supplement 1 (2009) S1–S136
451 CHINESE MEDICINAL HERBS IN RELIEVING PERIMENOPAUSAL DEPRESSION: A RANDOMIZED, PLACEBO-CONTROLLED TRIAL F. Qu 1 , J. Zhou 2 . 1 School of Medicine, Zhejiang University, Hangzhou, China; 2 College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, China Objectives: To explore the effects of a classic defined formula of Chinese medicinal herbs—Liu Wei Di Huang Wan (LWDHW) in relieving perimenopausal depression of Chinese women. Methods: Sixty-five Chinese women were randomly divided into LWDHW group (n=21), Hormone Replacement Therapy (HRT) group (n=26) and Placebo group (n=18). Depressive symptoms were rated with the 24-item Hamilton Depression Scale (HAMD). The serum levels of follicle stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2 ) were respectively detected before and after the treatment. Results: After treatment of 12 weeks, the HAMD scores of the three groups all decreased significantly, and the LWDHW group and HRT group decreased more significantly. The follow-up of 4 weeks showed that the HAMD scores of LWDHW and HRT groups had not changed significantly compared to post-treatment and there was no significant difference between them. However, the HAMD scores of the Placebo group had significantly increased to a similar level to pre-treatment. After treatment, the levels of FSH decreased significantly and the level of E2 increased significantly in LWDHW group and HRT group. The serum levels of FSH, LH and E2 of HRT group changed more significantly than LWDHW group. No side-effect was reported during the period of the treatment and the follow-up phase. Conclusions: Chinese medicinal herbs can be used as an alternative treatment for the women with perimenopausal depression, who are unable or do not want to receive HRT. Keywords: Chinese medicinal herb; Liu Wei Di Huang Wan (LWDHW); perimenopausal depression, Hormone Replacement Therapy (HRT).
452 REASONS OF DEMAND FOR PHYTOTHERAPY DRUGS IN THE CLIMACTERIC S.M.R.R. Lima, B.F. Reis, S. Saito, S. Postigo, T. Aoki. FCMSCSP, DOGI, Sao Paulo, Brazil Objective: To assess the reasons why symptomatic women at the time of the climacteric, spontaneously sought attention at the Climacteric Phytotherapy Outpatient Clinic. Methods: We included 230 women aged from 40 to 65 years, with time after menopause greater than a year. All women had not had hormonal treatment or other nutritional supplements for this indication at least six months before the start of the study. The reason why they sought the Service was asked at the start of treatment and the other risk factors that contra-indicate the traditional hormonal therapy. Results: The average age of women assessed was 54.1±5.59 years, with the menopausal age of 45.7±6.03 years and after menopause period of 1 to 20 years, with an average of 6.9±6.9 years. The reasons for the preferred phytoterapy were: 70% preference for phytomedications, 11.8% contra-indications for hormone-dependent diseases; 11.6% without preference for any kind of the treatments and 5.8% noncompliance of hormonal therapy. The fear of the increased incidence of cancers reported as one of the side effects of hormonal therapy was the main reason for the choice of phytomedications. Conclusion: Currently there is a great demand for medical services that offer a range of therapeutic possibilities for the remission of symptoms among them includes therapy with phytomedications. Most of the women (70%) who sought phytomedications instead of traditional hormone therapy, did so with main reason being the fear of developing cancer. Keywords: Clinical epidemiology, complementary and alternative medicine.
453 STANDARDS ASSESSMENT IN A SPECIALISED MULTIDISCIPLINARY MENOPAUSE SERVICE S. Saso, J. Woodman, S. Sharma, M. Cohen, J. Pitkin. Northwick Park & St Mark’s Hospitals, Menopause Clinical and Research Unit, Harrow, United Kingdom Objective: The audit compared how this menopause service performed
against the standards recommended by the RCOG [1] and evaluated patient satisfaction [2]. Methods: Variables investigated were: 1. Indications for referral to clinic, 2. Standards of care, and 3. Patients’ satisfaction. Results: Indications for referral Indication for referral (n=153)
Percentage (more than one indication for referral included)
Symptom control Difficulty with hormone replacement therapy Young menopause Breast cancer
72% 19% 17% 12%
Patient focus criteria - Documentation standards Patient focus criteria (n=100) – Documentation standards Indication for HRT Long term HRT complications Side effects of HRT
Percentage well documented 100% 65% 41%
The third variable – Patient Satisfaction Questionnaire confirmed 85-90% felt welcomed, had sufficient time to make an informed decision with a health professional. Sixty percent agreed there were clear directions to the clinic and the paperwork facilitatory. Only 44% thought clinics ran punctually and 36% were informed of the length of delay. Conclusion: The quality of clinical service was objectively assessed and areas of improvement for the clinicians and managements were identified. Patients deserve a high quality seamless service provision. A re-audit is planned. References: [1] Clinical Standards (2002) - Advice on Planning the Service in Obstetrics and Gynaecology. RCOG. [2] Isabelle Gasquetet al. Health and Quality of Life Outcomes 2004, 2:43 Keywords: Standards, patient satisfaction, audit.
454 RANDOMISED PLACEBO CONTROLLED PILOT STUDY ON COMPARING RED CLOVER (P-07) VERSUS PLACEBO FOR THE TREATMENT OF PREMENSTRUAL SYNDROME S. Taher 1 , A. Cahill 1 , J. Eliahoo 2 , M. Calvin 1 , C. Rothon 1 , N. Panay 1 . 1 Imperial College, Queen Charlotte’s, West London Menopause & PMS Centre, London, United Kingdom; 2 Imperial College, Statistical Advisory Department, London, United Kingdom Objectives: To evaluate and compare the efficacy and safety of 40mg isoflavones (P-07) as a plant extract versus placebo for the reduction of premenstrual syndrome symptoms using a validated symptom diary. Red Clover (isoflavinoid phytoestrogens) has a similar structure to oestrogens with 100-1000 times weaker than oestradiol. Methods: 19 patients randomly assigned to either placebo or active 40 mg Isoflavone treatment according to predetermined randomisation code in a double-blind protocol. Pre and post randomisation serum lipids, free and total isoflavon daily urine execration were determined. the Primary outcome measure is Change in total, exponentially smoothed, average maximum score (total-ESAmax) of 7 common premenstrual symptoms derived from Trigg’s trend analysis from baseline (average of the 2 screening cycle) during the double-blinded treatment phase. Results: There is significant difference in total and median-ESAmax in Isoflavon (P-07) group before and after treatment (36.48% symptom reduction (P value <0.04). In placebo group, There is moderate difference in total and median-ESAmax before and after treatment (29.07% symptom reduction). In Isoflavon (P-07) group, there is evidence of a significant difference of crying, fatigue and swelling symptoms pre and post-treatment (P<0.05) however the evidence of difference was borderline in anxiety, and depression symptom (P=0.07). Conclusions: Administration of an isoflavone extracted from red clover was associated with a significant reduction in some premenstrual syndrome symptoms in total and in particular psychological symptoms. Keywords: Premenstrual syndrome (PMS) isoflavons, Red clover, (P-07)
8th European Congress on Menopause (EMAS) / Maturitas 63, Supplement 1 (2009) S1–S136
451 CHINESE MEDICINAL HERBS IN RELIEVING PERIMENOPAUSAL DEPRESSION: A RANDOMIZED, PLACEBO-CONTROLLED TRIAL F. Qu 1 , J. Zhou 2 . 1 School of Medicine, Zhejiang University, Hangzhou, China; 2 College of Pharmaceutical Sciences, Zhejiang University, Hangzhou, China Objectives: To explore the effects of a classic defined formula of Chinese medicinal herbs—Liu Wei Di Huang Wan (LWDHW) in relieving perimenopausal depression of Chinese women. Methods: Sixty-five Chinese women were randomly divided into LWDHW group (n=21), Hormone Replacement Therapy (HRT) group (n=26) and Placebo group (n=18). Depressive symptoms were rated with the 24-item Hamilton Depression Scale (HAMD). The serum levels of follicle stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2 ) were respectively detected before and after the treatment. Results: After treatment of 12 weeks, the HAMD scores of the three groups all decreased significantly, and the LWDHW group and HRT group decreased more significantly. The follow-up of 4 weeks showed that the HAMD scores of LWDHW and HRT groups had not changed significantly compared to post-treatment and there was no significant difference between them. However, the HAMD scores of the Placebo group had significantly increased to a similar level to pre-treatment. After treatment, the levels of FSH decreased significantly and the level of E2 increased significantly in LWDHW group and HRT group. The serum levels of FSH, LH and E2 of HRT group changed more significantly than LWDHW group. No side-effect was reported during the period of the treatment and the follow-up phase. Conclusions: Chinese medicinal herbs can be used as an alternative treatment for the women with perimenopausal depression, who are unable or do not want to receive HRT. Keywords: Chinese medicinal herb; Liu Wei Di Huang Wan (LWDHW); perimenopausal depression, Hormone Replacement Therapy (HRT).
452 REASONS OF DEMAND FOR PHYTOTHERAPY DRUGS IN THE CLIMACTERIC S.M.R.R. Lima, B.F. Reis, S. Saito, S. Postigo, T. Aoki. FCMSCSP, DOGI, Sao Paulo, Brazil Objective: To assess the reasons why symptomatic women at the time of the climacteric, spontaneously sought attention at the Climacteric Phytotherapy Outpatient Clinic. Methods: We included 230 women aged from 40 to 65 years, with time after menopause greater than a year. All women had not had hormonal treatment or other nutritional supplements for this indication at least six months before the start of the study. The reason why they sought the Service was asked at the start of treatment and the other risk factors that contra-indicate the traditional hormonal therapy. Results: The average age of women assessed was 54.1±5.59 years, with the menopausal age of 45.7±6.03 years and after menopause period of 1 to 20 years, with an average of 6.9±6.9 years. The reasons for the preferred phytoterapy were: 70% preference for phytomedications, 11.8% contra-indications for hormone-dependent diseases; 11.6% without preference for any kind of the treatments and 5.8% noncompliance of hormonal therapy. The fear of the increased incidence of cancers reported as one of the side effects of hormonal therapy was the main reason for the choice of phytomedications. Conclusion: Currently there is a great demand for medical services that offer a range of therapeutic possibilities for the remission of symptoms among them includes therapy with phytomedications. Most of the women (70%) who sought phytomedications instead of traditional hormone therapy, did so with main reason being the fear of developing cancer. Keywords: Clinical epidemiology, complementary and alternative medicine.
453 STANDARDS ASSESSMENT IN A SPECIALISED MULTIDISCIPLINARY MENOPAUSE SERVICE S. Saso, J. Woodman, S. Sharma, M. Cohen, J. Pitkin. Northwick Park & St Mark’s Hospitals, Menopause Clinical and Research Unit, Harrow, United Kingdom Objective: The audit compared how this menopause service performed
against the standards recommended by the RCOG [1] and evaluated patient satisfaction [2]. Methods: Variables investigated were: 1. Indications for referral to clinic, 2. Standards of care, and 3. Patients’ satisfaction. Results: Indications for referral Indication for referral (n=153)
Percentage (more than one indication for referral included)
Symptom control Difficulty with hormone replacement therapy Young menopause Breast cancer
72% 19% 17% 12%
Patient focus criteria - Documentation standards Patient focus criteria (n=100) – Documentation standards Indication for HRT Long term HRT complications Side effects of HRT
Percentage well documented 100% 65% 41%
The third variable – Patient Satisfaction Questionnaire confirmed 85-90% felt welcomed, had sufficient time to make an informed decision with a health professional. Sixty percent agreed there were clear directions to the clinic and the paperwork facilitatory. Only 44% thought clinics ran punctually and 36% were informed of the length of delay. Conclusion: The quality of clinical service was objectively assessed and areas of improvement for the clinicians and managements were identified. Patients deserve a high quality seamless service provision. A re-audit is planned. References: [1] Clinical Standards (2002) - Advice on Planning the Service in Obstetrics and Gynaecology. RCOG. [2] Isabelle Gasquetet al. Health and Quality of Life Outcomes 2004, 2:43 Keywords: Standards, patient satisfaction, audit.
454 RANDOMISED PLACEBO CONTROLLED PILOT STUDY ON COMPARING RED CLOVER (P-07) VERSUS PLACEBO FOR THE TREATMENT OF PREMENSTRUAL SYNDROME S. Taher 1 , A. Cahill 1 , J. Eliahoo 2 , M. Calvin 1 , C. Rothon 1 , N. Panay 1 . 1 Imperial College, Queen Charlotte’s, West London Menopause & PMS Centre, London, United Kingdom; 2 Imperial College, Statistical Advisory Department, London, United Kingdom Objectives: To evaluate and compare the efficacy and safety of 40mg isoflavones (P-07) as a plant extract versus placebo for the reduction of premenstrual syndrome symptoms using a validated symptom diary. Red Clover (isoflavinoid phytoestrogens) has a similar structure to oestrogens with 100-1000 times weaker than oestradiol. Methods: 19 patients randomly assigned to either placebo or active 40 mg Isoflavone treatment according to predetermined randomisation code in a double-blind protocol. Pre and post randomisation serum lipids, free and total isoflavon daily urine execration were determined. the Primary outcome measure is Change in total, exponentially smoothed, average maximum score (total-ESAmax) of 7 common premenstrual symptoms derived from Trigg’s trend analysis from baseline (average of the 2 screening cycle) during the double-blinded treatment phase. Results: There is significant difference in total and median-ESAmax in Isoflavon (P-07) group before and after treatment (36.48% symptom reduction (P value <0.04). In placebo group, There is moderate difference in total and median-ESAmax before and after treatment (29.07% symptom reduction). In Isoflavon (P-07) group, there is evidence of a significant difference of crying, fatigue and swelling symptoms pre and post-treatment (P<0.05) however the evidence of difference was borderline in anxiety, and depression symptom (P=0.07). Conclusions: Administration of an isoflavone extracted from red clover was associated with a significant reduction in some premenstrual syndrome symptoms in total and in particular psychological symptoms. Keywords: Premenstrual syndrome (PMS) isoflavons, Red clover, (P-07)