Menopause Related Conditions
Conditions
Keywords
menopause, ammonium succinate
Brief summary
This study is a pooled statistical analysis of the data from 2 studies concerning efficacy of ammonium-succinate based dietary supplement. In both studies group 1 took the ammonium-succinate based dietary supplement and the group 2 took placebo.
Detailed description
Both studies were conducted previously and were randomized, double-blind and placebo-controlled. They followed very similar protocols, were of nearly identical design, had common inclusion and exclusion criteria. Both studies achieved statistical significance for ammonium succinate-based dietary supplement on most of pre-specified endpoints of Greene Climacteric Scale symptoms severity reduction at week 12. Nevertheless, some minor variation in the patient population, both within the studies (e.g., between different centres, as well as seasonal variability) and between the studies can be expected. Naturally occuring estrogen deficiency over the course of the menopausal transition and postmenopause causes hot flushes and other psychosomatic and vasomotor symptoms. Menopausal hormone therapy is a method of choice, however in many cases it is contraindicated or unacceptable for other reasons. Many alternatives exist, generally acting via estrogen receptors (ER). The dietary supplement tested in the aforementioned studies contains ammonium succinate, which does not bind to ER, instead acting by supporting the Krebs cycle. It does not have phytoestrogenic ingredients.
Interventions
DIETARY_SUPPLEMENTAmmonium succinate
2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days.
OTHERPlacebo
2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days.
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
42 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* vasomotor and psychosomatic complaints * ability to comply to study protocol * signed informed consent
Exclusion criteria
* cancer (current or prior, based on medical history) * conditions requiring planned hospitalization in the next 6 months; * endocrine diseases with abnormal hormonal secretion (hypercorticism, hyperprplactinemia, hypersomatotropism, thyroid disorders et c.); * any surgeries within 1 year of the screening; * hormone therapy within 6 months of the screening; * psychiatric diseases; * diabetes mellitus; * taking other supplements or medications that may affect the climacteric syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loss of interest in sex symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Breathing difficulties symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Hot flushes symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Sweating at night symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Heart beating quickly and strongly symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Feeling tense or nervous symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Difficulty in sleeping symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Excitable symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Attacks of panic symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Difficulty in concentrating symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Feeling tired or lacking in energy symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Loss of interest in most things symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Feeling unhappy or depressed symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Crying spells symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Irritability symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Feeling dizzy or faint symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Pressure or tightness in head or body symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Parts of body feeling numb or tingling symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Headaches symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Muscle or joint pains symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
| Loss of feeling in hands or feet symptom (Greene Climacteric Scale) | Week 12 | Statistically significant reduction in designated symptom severity, compared between arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spilberger-Hanin (Personal anxiety) | Week 12 | The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale |
| Spilberger-Hanin (Actual anxiety) | Week 12 | The decrease of actual anxiety, measured as statistically significant reduction of the score in corresponding subscale. Actual anxiety as a sum of situational and personal anxiety scores was introduced by Hanin in his modification of original State-Trait Anxiety Inventory. |
| Spilberger-Hanin (Situational anxiety) | Week 12 | The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale |
Countries
Russia
Outcome results
None listed