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Alpha Lipoic Acid (ALA) Effects on Subchorionic Hematoma: Preliminary Clinical Results

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Alpha Lipoic Acid (ALA) Effects on Subchorionic Hematoma: Preliminary Clinical Results Eur opean Rev iew for Med ical and Pharmacol ogical Sci ences 2015; 19: 3426-3432 Alpha Lipoic Acid (ALA) effects on subchorionic hematoma: preliminary clinical results G. PORCARO 1, E. BRILLO 1, I. GIARDINA 1, R. DI IORIO 2 1Department of Obstetrics and Gynecology, University of Perugia, Perugia, Italy 2Department of Obstetrics, Gynecology and Urology, San Pietro Fatebenefratelli Hospital, Sapienza University, Rome, Italy Abstract. – OBJECTIVE : The clinic use of al - Key Words: pha Lipoic Acid (ALA) is linked to its capability Threatened miscarriage, Alpha Lipoic Acid (ALA), to exert antioxidant effects and, more interest - Progesterone, Randomized controlled study, Subchori - ingly, to counteract the pathologic changes of onic hematoma. complex networks of cytokines, chemokines and growth factors, restoring their physiological state. The aim of this randomized controlled clin - ical trial was to test the contribution of oral sup - Introduction plementation of ALA to the standard treatment with Progesterone vaginal suppositories, in heal - Threatened miscarriage is characterized by ing subchorionic hematomas in patients with vaginal bleeding , other than spotting , and pelvic threatened miscarriage. Controls were adminis - pain within the first 20 weeks of gestation. It af - tered only Progesterone suppositories. fects around 20% of women, and spontaneous PATIENTS AND METHODS : Nineteen pregnant abortion occurs approximately in half of these women in the first trimester of gestation, with pregnancies 1. Up to 80% of these losses appear threatened miscarriage and ultrasound evidence 2 of subchorionic hematoma, were included in the to be caused by genetic abnormalities . Also in - trial and randomly divided in two groups: con - flammatory processes and immunologic disor - trols, treated with 400 mg Progesterone (200 mg ders can induce miscarriage 3-4 . The presence of a 2 times per day), given by vaginal suppositories, first-trimester subchorionic hematoma is a suit - and case study treated with the same Proges - able marker of patients at greater risk for adverse terone dosage, plus ALA, given orally at the pregnancy outcome 5. In particular, the presence dose of 600 mg (300 mg 2 times per day, DAV®, of a very large first-trimester subchorionic Lo.Li. Pharma srl, Italy). Sixteen patients com - hematoma has been suggested to be associated pleted the trial. Treatment was performed until complete resolution of the clinical picture. with a 46% risk of adverse pregnancy outcome RESULTS: In both groups, the subjects im - (spontaneous abortion and premature rupture of proved significantly but, in general, a better and membranes) 6. Therefore, its resorption represents faster evolution in the major signs of threatened a fundamental target to prevent preterm delivery. miscarriage was observed in the subjects treat - Th1, Th2, Th17 and regulatory T (Treg) cells 7 ed with ALA and Progesterone. In these patients, are essential in immunity 8 and pregnancy 9 and the speed of resorption of subchorionic are involved in boosting and/or dampening in - hematoma was significantly ( p ≤ 0.05) superior 10-12 compared to controls. The ALA and Proges - flammation . Th1 cells secrete inflammatory terone group showed a faster decrease or disap - cytokines, such as Tumor Necrosis Factor (TNF) pearance of all symptoms than that observed in and Interferon-gamma (IFN-gamma), but also In - the control group, however the difference was terleukine-10 (IL-10 ). Instead, Th2 cells produce not significant. several Interleukins, such as IL-4, IL-10, etc. 8 Fi - CONCLUSIONS: These preliminary results nally, Th17 cells , similarly involved in suggest that ALA supplementation significantly pregnancy 13 , produce the proinflammatory cy - contributes to speed up the process of restora - tokine IL-17 7,14-15 . On the other side, Treg cells tion of physiological conditions in threatened miscarriage and ameliorates the medical condi - play an essential role in the development of im - tions of both the mothers and the foetus, proba - munoregulation and induction of tolerance. IL-1 bly modulating the networks of cytokines, beta, a pro-inflammatory cytokine , mainly re - growth factors and other molecules . leased by monocytes and macrophages, is also 3426 Corresponding Author: Giusi Porcaro, MD; e-mail: [email protected] Alpha Lipoic Acid (ALA) effects on subchorionic hematoma: preliminary clinical results involved in gestation, exerting either an aborto - with pelvic pain and/or vaginal bleeding, and genic effect (probably prevailing) or a protection subchorionic hematomas, observed by ultrasound from miscarriage 16 . The maintenance of a healthy examination. The exclusion criteria were the gestation needs an adequate interplay between presence of multiple pregnancy, pre-pregnancy or Th1- and Th2-mediated immunity . Furthermore, gestation pathologies (arterial hypertension, ma - a broad spectrum of different molecules, such as ternal autoimmune diseases, antiphospholipid growth factors, cytokines and chemokines, are syndrome) , treatment with anti-hypertensive and implicated in acute wound and in its healing. anti-coagulant drugs, that could be confusing fac - TNF-alpha, IL-1 and IL-6 induce inflammation tors . The study was approved by the Bioethics in the acute wound (as well known, inflammation Committee SIFIOG (Italian Society of Phytother - is required for fighting infection ), and are in - apy and Dietary Supplements in Obstetrics and volved also in reepithelialization 17 . Vascular En - Gynecology ). All pregnant women were in - dothelial Growth Factor (VEGF ) stimulates ep - formed about the nature of the study and verbally ithelialization and collagen deposition in acceded to participate to it. The clinical trial was wounds 18 , and Alpha-Smooth Muscle Actin (al - a randomized controlled study, with 1:1 alloca - pha-SMA ) takes part in fibrogenesis 19 , i.e. vascu - tion ratio. The study had two groups: controls , logenesis and angiogenesis. Inflammation, extra - with 400 mg Progesterone (200 mg 2 times per cellular matrix (ECM) degradation and remodel - day ), given by vaginal suppositories, and treated ing of new ECM are positively affected also by (case study) with the same Progesterone dosage , matrix metalloproteases (MMPs), though a selec - plus ALA (DAV ®, Lo.Li. Pharma srl , Rome, tive control of their activity is necessary to avoid Italy ), given orally at the dose of 600 mg (300 the wound worsening 20 . mg 2 times per day, in the morning and in the The use of progesterone in the managing of evening ,). In our study we used only these two threatened miscarriage, is prescribed by thera - groups of treatment , because it was impossible to peutic protocols, although, few evidences support add a third arm without treatment , owing to the its efficacy 21 . Bioethics Committee refusal to accept this possi - Our aim was to verify whether alpha lipoic bility. The protocol prescribed to administer all acid (ALA), a natural and safe molecule with an compounds until complete resolution of the clini - anti-inflammatory and antioxidant profile 22-24 , cal picture . can improve efficaciously the therapy with prog - Primary outcome: reduction/disappearance of esterone . The reason why ALA was used de - subchorionic hematoma detected by sonography , pends on its capability to counteract the patho - vaginal bleedings, pelvic pain and uterine con - logic changes of complex networks of cytokines, tractions . The size of the hematoma was com - chemokines and growth factors , restoring their pared with the size of the gestational sac during physiological state, and in consideration that the examination and classified as small (< 20% such factors are involved also in inducing threat - of the gestational sac), medium (20 %- 50% of the ened miscarriage . gestational sac), or large (> 50% of the gestation - The clinical trial has evaluated the innovative al sac) 6. In the case study the hematoma was therapeutic effects of ALA, by oral route, and medium-sized in five patients, and large in four Progesterone vaginal suppositories, compared cases, whereas three controls had a large with Progesterone alone, in reducing significant - hematoma and four a medium-sized one . Pro - ly the subchorionic hematomas and other symp - gressive hematoma resorption during treatment toms linked to spontaneous abortion . was calculated as percentage between two subse - quent time points for each patient and the medi - um value for each group has been obtained and Patients and Methods compared. With the aim of recording systemati - cally the changes in pain symptomatology for the Pregnant women with threatened miscarriage subsequent analysis and evaluation, patients re - were assessed for eligibility from March 2013 to ceived a sheet where they had to note the daily February 2014 at the Division of Obstetrics and number of contractions during the time period Gynecology, University of Perugia, Italy . We ap - between two medical examinations . plied the following inclusion criteria: the subjects Secondary outcomes : placental abruption, de - had to be between 20 and 40 years old, between crease of miscarriage incidence and preterm de - 6th and 13 th week of physiological pregnancy, livery . 3427 G. Porcaro, E. Brillo, I. Giardina, R. Di Iorio The improvements have been monitored dur - At ultrasounds hematoma appears such as an ing all study, and evaluated respect to the base - anechoic area (i.e., echo free on a sonographic line (t = 0). image) of variable size, located between the uter
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