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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ammonium succinate | Patients in main pooled study group received 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. |
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| Placebo | Patients in placebo study group received 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ammonium succinate | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| "Heart beating quickly and strongly" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Feeling tense or nervous" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Difficulty in sleeping" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Excitable" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Attacks of panic" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Difficulty in concentrating" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Feeling tired or lacking in energy" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Spilberger-Hanin (Situational anxiety) | The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale | Week 12 |
| Spilberger-Hanin (Personal anxiety) |
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Inclusion Criteria:
Exclusion Criteria:
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Both studies chosen for pooled analysis recruited women with vasomotor and psychosomatic complaints, in the late phase of the menopausal transition and postmenopause according to the Stages of Reproductive Aging Workshop +10 classification.
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| Name | Affiliation | Role |
|---|---|---|
| Irina V Kuznetsova | Sechenov First Moscow Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sechenov First Moscow Medical University | Moscow | 119991 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27759458 | Background | Radzinskii VE, Kuznetsova IV, Uspenskaya YB, Repina NB, Gusak YK, Zubova OM, Burchakov DI, Osmakova AA. Treatment of climacteric symptoms with an ammonium succinate-based dietary supplement: a randomized, double-blind, placebo-controlled trial. Gynecol Endocrinol. 2016 Oct;32(sup2):64-68. doi: 10.1080/09513590.2016.1232686. | |
| 22343510 |
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| ID | Term |
|---|---|
| D019802 | Succinic Acid |
| ID | Term |
|---|---|
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Placebo | Other | 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. |
|
| "Loss of interest in most things" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Feeling unhappy or depressed" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Crying spells" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Irritability" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Feeling dizzy or faint" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Pressure or tightness in head or body" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Headaches" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Muscle or joint pains" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Loss of feeling in hands or feet" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Breathing difficulties" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Hot flushes" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Sweating at night" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
| "Loss of interest in sex" symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 |
The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale
| Week 12 |
| Spilberger-Hanin (Actual anxiety) | 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. | Week 12 |
| Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, Sherman S, Sluss PM, de Villiers TJ; STRAW 10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. Menopause. 2012 Apr;19(4):387-95. doi: 10.1097/gme.0b013e31824d8f40. |
| 19434881 | Background | Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. doi: 10.1016/j.maturitas.2008.09.011. |
| D009930 |
| Organic Chemicals |