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Improvement of climacteric symptoms with a novel sublingual product, TALITHA ® , containing trans-Resveratrol
Improvement of climacteric symptoms with a novel sublingual product, TALITHA ® , containing trans-Resveratrol
Improvement of climacteric symptoms
with a novel sublingual product,
TALITHA ® , containing trans-Resveratrol
Investigator:
Dott.ssa Roberta Milia
Specialised in Obstetrics & Gynecology
Monza (Italy)
Presented at:
23 rd International Scientific Conference of
Obstetrical and Gynaecological Society of Bangladesh,
Dhaka, Bangladesh, September 25 – 27, 2014

Objectives: study the amount of improvement of climacteric symptoms, especially hot flushes, evaluated analyzing the total score of Menopause Rating Scale at baseline and after administration of TALITHA ® . Materials and Methods: 30 women with symptoms suggestive of climacteric syndrome present for at least one month, with or without associated ame- norrhea, and evaluated according to the standardized Menopause Rating Scale (MRS) (1) were enrolled in an open, uncontrolled study. TALITHA ® Sublingual Spray was administered: 4-5 puffs 2 times/day for 3 months. The scoring system is straightforward: the score increases point by point with increasing severity of subjectively perceived complaints in each of the 11 items (severity expressed from 0 to 4 points in each item).

Results Menopause Rating Scale total score - This reduction was statistically significant at the 0.05 level (Figure 1). Moreover, a statistically significant difference was also observed with a significance level of 0.01. Hot flushes total score - This reduction was statistically significant at the 0.05 level (Figure 2). Moreover, a statistically significant difference was also observed with a significance level of 0.01. MTS Single items mean total score - Other than hot flashes, also the following items showed a statistically significant reduction (p<0.05) (Figure 3): • Heart discomfort; • Sleep problems; • Depression mood; • Irritability; • Physical and mental discomfort; • Joint and muscular discomfort. Moreover no patient experienced any side effects and compliance was optimal.

Improvement of climacteric symptoms with a novel sublingual product, TALITHA ® , containing trans-Resveratrol

Total MRS score Hot flushes mean score 20 2,5 2 15 1,5 10 1 5
Total MRS score
Hot flushes mean score
20
2,5
2
15
1,5
10
1
5
0,5
0
0
TfT0
T0
Tf
T0
T0
Tf
Tf
Fig. 1 The Menopause Rating Scale mean total score was 18.3 (SD: ±6.2) at baseline.
Fig. 2 The hot flushes mean score was 2.20 (SD: ±1.12) at baseline. By three months,
By three months, a reduction was observed in all patients, with a mean value of 7.4
a reduction was observed in all patients, with a mean value of 0.57 (SD: ±0.86).
(SD: ±4.5).
with a mean value of 7.4 a reduction was observed in all patients, with a mean

Discussion: Resveratrol is a powerful phytoestrogen (2) . that can be used as an alternative to hormone replacement therapy. Because of its mechanism of action, it is considered particu- larly useful to tackle many of the derangements associated with climacteric syndrome, including vasomotor symptoms. TALITHA ® is formulated as a sublingual spray emulsion, by which resveratrol is rapidly absorbed through the sublingual mucosa reaching the systemic circulation, without being metabolized and thus inactivated by the liver, as it happens with the conventional oral preparation (3) .

Conclusions: The results of this study, despite the small sample size, show that TALITHA ® , a novel trans-Resveratrol-based Sublingual Spray, produces a statistically significant reduc- tion of the main symptoms associated with menopause when measured with a validated method.

Potthoff P, Heinemann LAJ, Schneider HPG, Rosemeier HP, Hauser GA. Menopause-Rating Skala (MRS): Methodische Standardisierung in der deutschen Bevölkerung. Zentralbl Gynakol 2000; 122:280-286. Barry D. Gehm, Joanne M. McAndrews, Pei-Yu Chien, J. Larry Jameson. Resveratrol, a polyphenolic compound found in grapes and wine, is an agonist for the estrogen receptor. Proc. Natl. Acad. Sci. USA Vol. 94, pp. 14138–14143, December 1997. Walle T. Bioavailability of resveratrol. Ann N Y Acad Sci. 2011 Jan;1215:9-15.

1)

2)

3)

Individual Symptoms Total Scores 80 70 60 50 T0 40 Tf 30 20 10 0
Individual Symptoms Total Scores
80
70
60
50
T0
40
Tf
30
20
10
0
sweatingflushes,Hot
discomfortHeart
problemsSleep
Fig. 3 MRS single items total score: changing from baseline to the end of use.
moodDepressive
Irritability Anxiety
andPhysical
exhaustionmental
problemsSexual
problemsBladder
vaginaofDryness
muscularandJoint
discomfort
Anxiety andPhysical exhaustionmental problemsSexual problemsBladder vaginaofDryness muscularandJoint discomfort
Anxiety andPhysical exhaustionmental problemsSexual problemsBladder vaginaofDryness muscularandJoint discomfort

Clinical study highlights The cessation of ovarian function at the time of menopause and resulting hormonal changes, mainly estrogens deficiency, are associated with specific health conditions that may lead to quality of life impairment, especially hot flushes and night sweats, that may also be associated with sleep and mood disturbances, as well as vaginal epithelium atrophy and decreased cognitive function. These symptoms had been primarily managed with long-term hormone replacement therapy that has been demonstrated to cause serious adverse effects including stroke, gallbladder disease, as well as endometrial, uterine and breast cancers. Products containing “natural” estrogens, or phytoestrogens, that are functionally and structurally similar to steroidal estrogens in the body, such as estradiol, provide most of the benefits in addressing climacteric syndrome including vasomotor symptoms and postmenopausal health risks, as well as bone formation promoting properties, without side effects.

bone formation promoting properties, without side effects. Resveratrol and trans -Resveratrol are powerful

Resveratrol and trans-Resveratrol are powerful phytoestrogens, present in the skins of grapes and in other plant like Polygonum cuspidatum. The bioavailability of Resveratrol administered by oral route is essentially zero as it is metabolized by the liver and small intestine in other substances before reaching the bloodstream. For this reason, a sublingual formulation of trans-Resveratrol, (TALITHA ® ), able to bypass gastro-enteric tract en- tering directly the systemic circulation has been developed. TALITHA ® is a sublingual spray emulsion containing: trans-Resveratrol, Vitamin E (powerful antioxidant) and Vi- tamin D 3 (essential for normal bone formation).

A clinical study on 30 women with climacteric syndrome symptoms present for at least one month, with or without associated amenorrhea, was conducted to establish the usefulness of TALITHA ® administered for 3 months (4-5 puffs 2 times / day) in terms of:

improving climacteric symptoms, especially hot flushes, evaluated by mean of the validated Menopause Rating Scale (MRS);

recording the occurrence of any adverse event.

The MRS is a scoring system in which the severity of each of the subjectively perceived 11 symptoms (hot flushes, sweating; heart discomfort; sleep problems; depressive mood; irritability; anxiety; physical and mental exhaustion; sexual problems; bladder problems; dryness of vagina; joint and muscular discomfort) is expressed with a 0 to 4 increasing score.

In all patients after three months of administration the following were observed:

a reduction of severity of hot flushes/sweating, the most disabling symptoms: the item hot flushes showed a statistically significant reduction (p<0.01) demonstrating that TALITHA ® statistically reduces hot flushes and episodes of sweating;

an improvement of all the climacteric symptoms: the Menopause Rating Scale mean total score showed a statis- tically significant reduction (p<0.01). TALITHA ® was particularly useful in improving the following symptoms

(p<0.01):

heart discomfort (unusual awareness of heart beat, heart skipping, heart racing, tightness)

sleep problems (difficulty in falling asleep, difficulty in sleeping through, waking up early

depression mood (feeling down, sad, on the verge of tears, lack of drive, mood swings)

irritability (feeling nervous, inner tension, feeling aggressive)

physical and mental exhaustion (general decrease in performance, impaired memory, decrease in concentration, forgetfulness)

joint and muscular discomfort (pain in the joints, rheumatoid complaints) No adverse events were registered.

The results showed that TALITHA ® , a novel trans-Resveratrol-based Sublingual Spray, is able to statistically reduce both hot flushes and sweating, the most disabling symptoms, as well as the other main symptoms associated with menopause.

both hot flushes and sweating, the most disabling symptoms, as well as the other main symptoms
both hot flushes and sweating, the most disabling symptoms, as well as the other main symptoms