Treatment of climacteric symptoms with an ammonium succinate-based dietary supplement: a randomized, double-blind, placebo-controlled trial

Figures & data

Table 1. The Greene Climacteric Scale results.

			Number (%) of women with symptom
	Group	N	Before treatment	After treatment	p^2
1. Heart palpitation	Amberen	62	38 (61.3%)	25 (40.3%)	0.0528
	Placebo	63	45 (71.4%)	43 (68.3%)	0.0985
	p^1		0.1193	0.0198
2. Feeling tense or nervous	Amberen	62	53 (85.5%)	47 (75.8%)	0.0070
	Placebo	63	49 (77.8%)	49 (77.8%)	>0.05
	p^1		0.5311	0.1567
3. Difficulty sleeping	Amberen	62	52 (83.9%)	26 (41.9%)	0.0000
	Placebo	63	44 (69.8%)	47 (74.6%)	0.0220
	p^1		0.0217	0.0000
4. Increased excitability	Amberen	62	46 (74.2%)	26 (41.9%)	0.0013
	Placebo	63	44 (69.8%)	46 (73.0%)	0.9068
	p^1		0.2183	0.0052
5. Panic attacks	Amberen	62	20 (32.3%)	11 (17.7%)	0.1489
	Placebo	63	14 (22.2%)	16 (25.4%)	0.8712
	p^1		0.3410	0.5444
6. Difficulty concentrating	Amberen	62	50 (80.6%)	16 (25.8%)	0.0000
	Placebo	63	37 (58.7%)	50 (79.4%)	0.0573
	p^1		0.0478	0.0000
7. Feeling tired or lacking energy	Amberen	62	60 (96.8%)	30 (48.4%)	0.0000
	Placebo	63	59 (93.7%)	61 (96.8%)	0.0267
	p^1		0.1085	0.0000
8. Loss of interest in most things	Amberen	62	42 (67.7%)	16 (25.8%)	0.0000
	Placebo	63	26 (41.3%)	42 (66.7%)	0.0295
	p^1		0.0304	0.0001
9. Sadness or depression	Amberen	62	51 (82.3%)	17 (27.4%)	0.0000
	Placebo	63	42 (66.7%)	51 (81.0%)	0.0021
	p^1		0.0817	0.0000
10. Crying spells	Amberen	62	33 (53.2%)	24 (38.7%)	0.0343
	Placebo	63	30 (47.6%)	32 (50.8%)	0.9335
	p^1		0.4564	0.3178
11. Irritability	Amberen	62	59 (95.2%)	25 (40.3%)	0.0000
	Placebo	63	56 (88.9%)	56 (88.9%)	>0.05
	p^1		0.0494	0.0000
12. Dizziness or fainting	Amberen	62	28 (45.2%)	21 (33.9%)	0.2613
	Placebo	63	20 (31.7%)	22 (34.9%)	0.8937
	p^1		0.4967	0.8032
13. Feeling pressure or tightness in the head or other body parts	Amberen	62	38 (61.3%)	25 (40.3%)	0.0292
	Placebo	63	31 (49.2%)	29 (46.0%)	0.8552
	p^1		0.3902	0.1816
14. Numbness or tingling in some body parts	Amberen	62	35 (56.5%)	28 (45.2%)	0.1855
	Placebo	63	37 (58.7%)	37 (58.7%)	>0.05
	p^1		0.6233	0.0777
15. Headaches	Amberen	62	52 (83.9%)	34 (54.8%)	0.0000
	Placebo	63	51 (81.0%)	51 (81.0%)	>0.05
	p^1		0.0259	0.0000
16. Muscle and joint pain	Amberen	62	53 (85.5%)	36 (58.1%)	0.0000
	Placebo	63	59 (93.7%)	56 (88.9%)	0.7615
	p^1		0.0965	0.0000
17. Numbness of hands and feet	Amberen	62	30 (48.4%)	22 (35.5%)	0.3088
	Placebo	63	27 (42.9%)	28 (44.4%)	0.4656
	p^1		0.3106	0.7469
18. Difficulty breathing	Amberen	62	26 (41.9%)	21 (33.9%)	0.4517
	Placebo	63	20 (31.7%)	23 (36.5%)	0.9479
	p^1		0.5025	0.8800
19. Hot flashes	Amberen	62	53 (85.5%)	24 (38.7%)	0.0000
	Placebo	63	48 (76.2%)	52 (82.5%)	0.0063
	p^1		0.1514	0.0000
20. Night sweats	Amberen	62	49 (79.0%)	22 (35.5%)	0.0000
	Placebo	63	49 (77.8%)	50 (79.4%)	0.0573
	p^1		0.3150	0.000
21. Loss of interest in sex	Amberen	62	51 (82.3%)	26 (41.9%)	0.0000
	Placebo	63	40 (63.5%)	50 (79.4%)	0.0961
	p^1		0.0009	0.0000

Number of women with climacteric syndrome symptoms before and after treatment. p¹ represents p values, amberen and placebo groups before and after treatment comparison; p² represents p values, parameters before and after treatment within each group comparison (χ² test). Bold values indicates statistically significant p values.

Table 2. Spielberger–Hanin test results.

Anxiety	Time	Amberen (n = 62)	Placebo (n = 63)	p^1
SA	Initial evaluation	0.52 ± 9.72	−4.16 ± 10.08	0.0094
	30 days	−3.69 ± 10.51	−2.52 ± 8.34	0.2850
	60 days	−8.02 ± 7.82	−0.86 ± 9.63	0.0000
	90 days	−10.02 ± 7.78	−0.14 ± 10.05	0.0000
	p^2	<0.05	<0.05
PA	Initial evaluation	15.94 ± 10.32	10.48 ± 8.86	0.0019
	30 days	9.92 ± 9.37	12.76 ± 8.05	0.0348
	60 days	6.13 ± 8.05	15.25 ± 8.76	0.0000
	90 days	3.40 ± 7.12	16.68 ± 8.92	0.0000
	p^2	<0.05	<0.05
AA	Initial evaluation	51.50 ± 18.86	41.30 ± 17.8	0.0023
	30 days	41.13 ± 18.42	45.32 ± 15.48	0.0479
	60 days	33.11 ± 14.72	49.44 ± 17.58	0.0000
	90 days	28.39 ± 13.99	51.81 ± 18.22	0.0000
	p^2	<0.05	<0.05

Indicated values are mean for normal and median for non-normal distribution, ±SD. p¹ represents p values, amberen and placebo groups before and after treatment comparison (Mann–Whitney test, Student’s t-test); р² represents p values, difference in parameters during the course of the study within each group (Friedman test). Bold values indicates statistically significant p values.

Table 3. Blood plasma hormone levels.

Hormones	Time	Amberen (n = 62)	Placebo (n = 63)	p^1
Estradiol, pg/ml	Initial	34.25 ± 13.65	43.27 ± 28.52	0.0009
	30 days	49.32 ± 38.19	42.27 ± 27.77	0.0520
	60 days	59.26 ± 38.19	41.33 ± 26.72	0.0000
	90 days	66.12 ± 118.35	40.67 ± 25.10	0.0000
	p^2	<0.05	<0.05
FSH, мМЕ/ml	Initial	55.69 ± 29.38	49.36 ± 19.91	0.1222
	30 days	53.28 ± 27.38	49.31 ± 18.85	0.2719
	60 days	50.24 ± 25.07	48.37 ± 18.13	0.9018
	90 days	46.88 ± 22.44	46.38 ± 18.82	0.9370
	p^2	<0.05	>0.05
LH, мМЕ/ml	Initial	33.40 ± 13.19	29.33 ± 11.97	0.1047
	30 days	32.17 ± 14.48	30.11 ± 10.50	0.1706
	60 days	31.32 ± 11.80	29.32 ± 10.21	0.5568
	90 days	28.94 ± 10.52	28.93 ± 10.39	0.9449
	p^2	<0.05	>0.05
Leptin, ng/ml  (0.5–13.8)	Initial	29.82 ± 26.96	25.34 ± 25.27	>0.1*
	90 days	18.16 ± 16.63	26.45 ± 25.39	<0.005*
	p^2	0.0000*	0.0025*

Indicated values are mean for normal and median for non-normal distribution, ±SD. p¹ represents p values, amberen and placebo groups before and after treatment comparison (Mann–Whitney test, *Kolmogorov–Smirnov test); р² represents p values, difference in parameters during the course of the study within each group (Friedman test, *Mann–Whitney test). Bold values indicates statistically significant p values.