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Selenium supplementation in the management of thyroid autoimmunity during pregnancy: results of the "SERENA study", a randomized, double-blind, placebo-controlled trial.
Mantovani, G, Isidori, AM, Moretti, C, Di Dato, C, Greco, E, Ciolli, P, Bonomi, M, Petrone, L, Fumarola, A, Campagna, G, et al
Endocrine. 2019;(3):542-550
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Abstract
PURPOSE Selenium is frequently in nutraceuticals for pregnancy, given its role on fertility and thyroid metabolism. However, most evidence rise from non-controlled studies. We aimed to evaluate the protective effect of selenium against thyroid autoimmunity during and after pregnancy. METHODS A multicenter, randomized, double-blind, placebo-controlled trial was performed and promoted by the Young Italian Endocrinologists Group (EnGioI)-Italian Society of Endocrinology. Forty-five women with thyroiditis in pregnancy were enrolled and randomly assigned to L-selenomethionine (L-Se-Met) 83 mcg/day or placebo (PLB) and evaluated at 10 ± 2 (T1), 36 ± 2 weeks of gestation (T2) and 6 months after delivery (postpartum, PP). RESULTS We measured a significant reduction of autoantibodies after pregnancy in L-Se-Met group [at PP: TgAb 19.86 (11.59-52.60), p < 0.01; TPOAb 255.00 (79.00-292.00), p < 0.01], and an antibodies titer's rebound in PLB group (TgAb 151.03 ± 182.9, p < 0.01; TPOAb 441.28 ± 512.18, p < 0.01). A significant increase in selenemia was measured in L-Se-Met group at T2 (91.33 ± 25.49; p < 0.01) and PP (93.55 ± 23.53; p = 0.02). Two miscarriage occurred in PLB. No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications. CONCLUSIONS SERENA study demonstrated a beneficial effect of L-Se-Met supplementation on autoantibody titer during pregnancy and on postpartum thyroiditis recurrence.
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Use of curcuminoids in a cohort of patients with oral lichen planus, an autoimmune disease.
Chainani-Wu, N, Collins, K, Silverman, S
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2012;(5):418-23
Abstract
OBJECTIVES To summarize long-term open-label use of curcuminoids and experience of side-effects in 53 patients with the autoimmune condition oral lichen planus (OLP) who had previously participated in randomized controlled trials (RCTs) of curcuminoids at UCSF. METHODS This descriptive retrospective cohort study conducted in 2009 collected information from clinic charts and patient interview on the over-the-counter (OTC) use of curcuminoids during a 1-5 year follow-up period. Of the 53 eligible patients, 33 had previously participated in a RCT (2003-2004) that evaluated a dose of 2000mg/day of curcuminoids and which was ended early for futility and 20 had participated in a RCT (2007-2008) that evaluated a dose of 6000mg/day which demonstrated its efficacy. At the last study visit of each of the 2 RCTs all participants were given current published information about curcuminoids, and some went on to take OTC curcuminoids. RESULTS Follow-up data was available on 43 participants [25/33 (75%) from the first and 19/20 (95%) from the second RCT]. 18/25 (72%) participants from the first trial took OTC curcuminoids after completion of the trial period. The mean total daily dose was 2137.5mg (SD=793, range 500-3000mg) and mean duration of curcuminoids use was 30 months (SD=27.5). The total follow-up time after completion of the RCT for the 18 participants was mean 68.2 months (SD 5.9). 10/18 (56%) reported that curcuminoids controlled OLP symptoms, and the mean duration of use among these patients was 35.8 months (SD 27.4). 8/18 (44%) were unsure whether curcuminoids helped and the mean duration of use was 21.0 months (SD 27.3). 2 of 18 patients (11%) reported a side-effect (SE) of diarrhea. 19/19 (100%) patients from the second trial took OTC curcuminoids after completion of the trial period. The mean total daily dose was 5058mg (SD=1445, range 1000-6000mg) and mean duration of curcuminoids use 9.6 months (SD=8.04). The total follow-up time after completion of the RCT for the 19 participants was mean 15.8 months (SD 4.8). 12/19 (63%) reported that curcuminoids controlled OLP symptoms, and the mean duration of use was 14.1 months (SD 6.7). 2/19 (11%) reported lack of improvement with a daily dose of 1500mg and 2500mg for 3 months each. 5/19 (26%) were unsure whether curcuminoids helped and the mean duration of use was 1.5 months (1.2 SD). Six of these 19 patients (32%) reported SEs, three had abdominal discomfort, two diarrhea and one slight urgency in defecation on the capsule but not the tablet formulation. The SEs resolved with dose reduction to 4500mg/day in one and 3000mg/day in two patients, while two patients [2/19 (11%)] discontinued curcuminoids due to the SE. CONCLUSIONS A total of 22/37 (60%) of patients reported a reduction of symptoms with curcuminoids, 13/37 (35%) were unsure and 2/37 (5%) reported that it did not help in reduction of symptoms. Side-effects included abdominal discomfort and diarrhea, however occurrence was dose-related, and complaints were mild.
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Alendronate protects premenopausal women from bone loss and fracture associated with high-dose glucocorticoid therapy.
Okada, Y, Nawata, M, Nakayamada, S, Saito, K, Tanaka, Y
The Journal of rheumatology. 2008;(11):2249-54
Abstract
OBJECTIVE We assessed the efficacy of bisphosphonate in premenopausal women (n = 47) commencing high-dose glucocorticoid (GC) therapy in protection against induced bone loss and bone fracture. METHODS. Subjects had just developed systemic autoimmune diseases and were randomized to be treated with 1 mg/kg/day prednisolone and alfacalcidol 1 microg/day alone (alfacalcidol group; n = 22), or prednisolone and alfacalcidol 1 microg/day with alendronate 5 mg/day (alendronate group; n = 25), each for 18 months. RESULTS The percentage changes in lumbar spine bone mineral density (BMD) after 6 months of the therapy were -10.5% +/- 0.8% in the alfacalcidol group, but only -2.1% +/- 1.2% in the combined group. The rate of bone loss in the lumbar spine was significantly lower in the combined group than in the alfacalcidol group at 6 months. At 12 months of treatment, the percentage change in lumbar spine BMD was increased by 1.7% +/- 1.4% in the combined group, but decreased by 9.9% +/- 1.9% in the alfacalcidol group; the difference was significant. Bone fracture occurred at 12 months or later in 4 patients of the alfacalcidol groups, but not in the combined group, even at up to 18 months. CONCLUSION Our results indicate that alendronate with alfacalcidol can maintain BMD and protects against high-dose GC-induced bone loss and bone fracture.
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Effect of alendronate on glucocorticoid-induced osteoporosis in Japanese women with systemic autoimmune diseases: versus alfacalcidol.
Takeda, S, Kaneoka, H, Saito, T
Modern rheumatology. 2008;(3):271-6
Abstract
Glucocorticoids-induced osteoporosis is a serious problem for patients with systemic autoimmune disease requiring relatively long-term glucocorticoid treatment. Effectiveness of alendronate for the prevention of glucocorticoids-induced osteoporosis was evaluated in comparison with that of alfacalcidol in Japanese women with autoimmune disease excluding rheumatoid arthritis. Loss of bone mass was evaluated with bone mineral density (BMD) of lumber vertebrae, bone resorption was with urinary N-telopeptide for type I collagen (NTX), and bone formation was with serum bone-specific alkaline phosphatase (B-ALP). A total of 33 patients who were treated with oral glucocorticoids (>or=5 mg/day of prednisolone equivalence) for more than 6 months were randomized into two groups; alendronate group (n = 17) received 5 mg/day of alendronate, and alfacalcidol group (n = 16) received 1.0 mug/day of alfacalcidol for 24 months with glucocorticoids. The dose of alendronate was the maximal dose approved in Japan. BMD had tendency to decrease with alfacalcidol, while increase with alendronate. The difference in BMD change between the two groups was significant by 4.3% at 18 months and by 4.2% at 24 months (both P < 0.05). Bone resorption was significantly reduced only with alendronate; NTX was decreased by 28 to 35% at 6 to 24 months (P < 0.05), but not changed with alfacalcidol at 24 months. The bone formation was found to be unchanged according to the B-ALP measured between the two groups. In conclusion, the treatment of 5 mg alendronate daily is more effective than alfacalcidol for preventing the glucocorticoid-induced osteoporosis by the mechanism of reducing bone resorption in Japanese women with systemic autoimmune disease.
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[Effect of multi-glycosides of tripterygii on latent autoimmune diabetes in adults in early stage].
Lei, T, Zhang, XZ, He, M
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2006;(6):511-3
Abstract
OBJECTIVE To observe the effect of multi-glycosides of tripterygii (MT) on latent autoimmune diabetes of adults (LADA) in early stage. METHODS The diabetic patients were divided randomly into the control group treated with insulin alone and the treated group treated with insulin and MT. Levels of insulin, C-peptide, glutamic acid decarboxylase antibody (GADAb) and islet cell antibody (ICA) were detected and clinical features of the disease were observed. RESULTS There was no difference between the control group and the treated group in body mass index (BMI), the occurrence of diabetic keto-acidosis and the function of liver and kidney (P >0.05). After 6 months' treatment, the positive rate of GADAb and ICA decreased, plasma levels of fasting and 2 hrs post-prandial C-peptide and also 2 hrs post-prandial true insulin in the treated group increased (P <0.01), while all the above indexes improved more significantly after 1 year's treatment (P <0.01). CONCLUSION Compared treatment of insulin with multi-glycosides of tripterygii in early stage of LADA has better effects in relieving autoimmune injury and recovering function of pancreatic island than insulin alone.
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Sodium enoxaparin treatment of sensorineural hearing loss: an immune-mediated response?
Mora, R, Jankowska, B, Passali, GC, Mora, F, Passali, FM, Crippa, B, Quaranta, N, Barbieri, M
The international tinnitus journal. 2005;(1):38-42
Abstract
The authors propose the existence of a new entity of autoimmune sensorineural hearing loss on the basis of diagnostic study and treatment experience with a series of 30 patients. Immunological mechanisms play an important role in the pathogenesis and natural course of various inner-ear diseases. Patients may present clinically with symptoms resembling Ménière's disease or even with sudden deafness. Currently, no widely used standard protocol for treatment of this autoimmune sensorineural hearing loss exists. Prompted by such observations, we implemented a protocol using a particular kind of heparin--sodium enoxaparin--with a low molecular weight. Patients were randomly assigned to two groups; to those in the first group, enoxaparin was administered subcutaneously at a dose of 2,000 IU twice daily for 10 days; the patients in the second group were treated with placebo. At the beginning and at the end of the therapy period, the patients were evaluated by instrumental examinations. Specifically excluded were patients with abnormal known coagulation. On discharge, all patients treated with enoxaparin presented both a subjective and objective decrease in symptoms. No patient experienced side effects from this treatment. The results indicate that administration of sodium enoxaparin abates sensorineural hearing loss in patients with autoimmune diseases. The clinical response to therapy can confirm diagnosis.
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Restoration of immune-mediated sensorineural hearing loss with sodium enoxaparin: a case report.
Mora, R, Mora, F, Passali, FM, Cordone, MP, Crippa, B, Barbieri, M
Acta oto-laryngologica. Supplementum. 2004;(552):25-8
Abstract
The aim of the study was to assess the efficacy of sodium enoxaparin in the treatment of autoimmune sensorineural hearing loss. A small number of patients with unilateral sensorineural hearing loss were selected and divided randomly into two numerically equal groups (groups A and B) if they fulfilled the inclusion criteria, i.e. being between 20 and 65 years of age, had been affected by systemic lupus erythematosus, had presented with a hearing loss of at least 30 dB of audibility threshold involving the medium frequencies (2000-4000 Hz), and had provided informed consent. Group A received sodium enoxaparin while group B (control) received placebo. In group A, all patients except one showed an improvement in hearing after sodium enoxaparin treatment. In group B, no patients showed an improvement in auditory function. In conclusion, our results underline the important role of sodium enoxaparin in the therapeutic management of this disease. The low number of patients suggests that further studies are required to confirm this initial data but this study suggests that sodium enoxaparin provides encouraging results in the treatment of autoimmune sensorineural hearing loss.
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Transplantation osteoporosis and corticosteroid-induced osteoporosis in autoimmune diseases: experience with alfacalcidol.
Dequeker, J, Borghs, H, Van Cleemput, J, Nevens, F, Verleden, G, Nijs, J
Zeitschrift fur Rheumatologie. 2000;:53-7
Abstract
The effect of alfacalcidol therapy on bone mineral density at the spine and proximal femur was evaluated in 112 transplant recipients (59 heart, 26 liver and 27 lung); 45 transplant cases served as controls (included in a randomised way in a placebo group) and in 42 rheumatoid arthritis cases. Liver and lung transplantation cases had before transplantation a lower bone density at the spine and femur compared to heart transplant cases. Heart transplant cases lost considerably more bone immediately after transplantation than liver and lung transplant recipients. A positive effect of 2 years alfacalcidol treatment (0.5-1 microgram/day) on bone loss was observed in all treated groups. Alfacalcidol was particularly effective against trabecular bone loss at the spine in rheumatoid arthritis patients and transplant recipients. There is a manifest difference in evolution between organ transplant groups and bone sites measured. Liver and lung transplant recipients respond better to therapy than cardiac recipients.