Intramuscular neridronate for the treatment of complex regional pain syndrome type 1: a randomized, double-blind, placebo-controlled study

Background: Complex regional pain syndrome type-1 (CRPS-1) is a severely disabling painful disease challenging to treat. This multicenter, randomized, double-blind placebo-controlled trial examined the efficacy of intramuscular (i.m.) neridronate in CRPS-1 patients. Methods: A total of 78 patients diagnosed with CRPS-1 (aged 59.5 ± 10.3, 66.7% female) were randomly assigned to 25 mg (i.m.) neridronate ( N = 41) given once daily for 16 consecutive days or placebo control ( N = 37). Efficacy was assessed after 30 days using a visual analogue scale (VAS) pain score and the number of patients achieving ⩾50% reduction in VAS score. Change in clinical signs and symptoms, quality of life (QoL) using Short Form Health Survey (SF-36) and the McGill Pain Questionnaire were also assessed. Results: After 30 days, VAS score decreased significantly to a greater extent in neridronate-treated patients versus placebo (31.9 ± 23.3 mm versus 52.3 ± 27.8 mm, p = 0.0003). Furthermore, the proportion of patients achieving a VAS reduction of ⩾50% was greater in the neridronate group (65.9% versus 29.7%, p = 0.0017). Clinical signs and symptoms were improved significantly in the neridronate group versus placebo for edema (72.5% versus 79.9%, p = 0.03), pain during motion (70% versus 83.3%, p = 0.0009), allodynia (20% versus 63.3%, p = 0.0004), and hyperalgesia (20% versus 56.7%, p = 0.0023). Whereas no difference was observed for QoL measures using the SF-36 questionnaire, three of the four pain variables using the McGill Pain Questionnaire improved significantly in the neridronate group. No serious drug-related adverse events were reported during the study. Conclusion: In patients with acute CRPS-1, i.m. injections of 25 mg neridronate were associated with clinically relevant benefit compared with placebo controls. Trial registration: EU Clinical Trials Register: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-001156-28

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Treatment of Complex Regional Pain Syndrome type 1: a randomised, double-blind, placebo-controlled study with S(+)-ketamine

http://isrctn.org/> ◽

10.1186/isrctn38472359 ◽

2012 ◽

Author(s):

M.J. Sigtermans

Keyword(s):

Complex Regional Pain Syndrome ◽

Pain Syndrome ◽

Controlled Study ◽

Syndrome Type ◽

Double Blind ◽

Double Blind Placebo

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(429) CREATE-1 study: a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of AXS-02 (disodium zoledronate tetrahydrate) administered orally to subjects with Complex Regional Pain Syndrome Type 1 (CRPS-1)

Journal of Pain ◽

10.1016/j.jpain.2016.01.406 ◽

2016 ◽

Vol 17 (4) ◽

pp. S81-S82 ◽

Cited By ~ 1

Author(s):

L. Kapural ◽

A. Goebel ◽

M. Serpell ◽

A. Jones ◽

R. Kaye ◽

...

Keyword(s):

Complex Regional Pain Syndrome ◽

Pain Syndrome ◽

Controlled Study ◽

Syndrome Type ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo

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Children With Influenza A Infection: Treatment With Rimantadine

PEDIATRICS ◽

10.1542/peds.80.2.275 ◽

1987 ◽

Vol 80 (2) ◽

pp. 275-282

Author(s):

Caroline Breese Hall ◽

Raphael Dolin ◽

Christine L. Gala ◽

David M. Markovitz ◽

Yu Qin Zhang ◽

...

Keyword(s):

Influenza A ◽

Clinical Signs ◽

Severity Of Illness ◽

Signs And Symptoms ◽

Clinical Isolates ◽

Double Blind Study ◽

Double Blind ◽

Viral Shedding ◽

Development Of Resistance ◽

Clinical Signs And Symptoms

Treatment with rimantadine of influenza in children and the potential development of resistance in clinical isolates associated with therapy have not been previously studied. We compared rimantadine to acetaminophen therapy in a controlled, double-blind study of 91 children with influenza-like illness. Of 69 children with proven influenza A/H3N2 infection, 37 received rimantadine and 32 received acetaminophen for five days. Children receiving rimantadine showed significantly greater reduction in fever and improvement in daily scores for symptoms and severity of illness during the first three days. Viral shedding also diminished significantly during the first two days but subsequently increased such that by days 6 and 7 the proportion of children shedding virus, as well as the quantity of virus shed, was significantly greater in the rimantadine group. During the seven-day study, of the 22 children in the rimantadine group with serial isolates tested, ten (45.5%) had resistant isolates compared with two (12.5%) of those with serial isolates in the acetaminophen group (P < .03). Thus, of the total 37 children in the rimantadine group, 27% were found to have resistant isolated compared with 6% in the total group receiving acetaminophen (P < .04). Furthermore, the mean inhibitory concentration of rimantadine increased with time in the rimantadine group (r = .4, P = .002) but not in the acetaminophen group. Rimantadine therapy, thus, appears to be significantly more effective than acetaminophen in ameliorating the clinical signs and symptoms of influenza in children. Treatment with rimantadine was also associated with increased viral shedding after the medication was discontinued and with the development of resistance in the clinical isolates, the significance of which is unknown.

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MicroRNA-Based Therapeutic Perspectives in Myotonic Dystrophy

International Journal of Molecular Sciences ◽

10.3390/ijms20225600 ◽

2019 ◽

Vol 20 (22) ◽

pp. 5600 ◽

Cited By ~ 3

Author(s):

Arturo López Castel ◽

Sarah Joann Overby ◽

Rubén Artero

Keyword(s):

Myotonic Dystrophy ◽

Rna Binding ◽

Clinical Symptoms ◽

Clinical Signs ◽

Neuromuscular Diseases ◽

Signs And Symptoms ◽

Disease Biomarkers ◽

Clinical Signs And Symptoms

Myotonic dystrophy involves two types of chronically debilitating rare neuromuscular diseases: type 1 (DM1) and type 2 (DM2). Both share similarities in molecular cause, clinical signs, and symptoms with DM2 patients usually displaying milder phenotypes. It is well documented that key clinical symptoms in DM are associated with a strong mis-regulation of RNA metabolism observed in patient’s cells. This mis-regulation is triggered by two leading DM-linked events: the sequestration of Muscleblind-like proteins (MBNL) and the mis-regulation of the CUGBP RNA-Binding Protein Elav-Like Family Member 1 (CELF1) that cause significant alterations to their important functions in RNA processing. It has been suggested that DM1 may be treatable through endogenous modulation of the expression of MBNL and CELF1 proteins. In this study, we analyzed the recent identification of the involvement of microRNA (miRNA) molecules in DM and focus on the modulation of these miRNAs to therapeutically restore normal MBNL or CELF1 function. We also discuss additional prospective miRNA targets, the use of miRNAs as disease biomarkers, and additional promising miRNA-based and miRNA-targeting drug development strategies. This review provides a unifying overview of the dispersed data on miRNA available in the context of DM.

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Omalizumab for Severe Asthma: Beyond Allergic Asthma

BioMed Research International ◽

10.1155/2018/3254094 ◽

2018 ◽

Vol 2018 ◽

pp. 1-10 ◽

Cited By ~ 6

Author(s):

C. C. Loureiro ◽

L. Amaral ◽

J. A. Ferreira ◽

R. Lima ◽

C. Pardal ◽

...

Keyword(s):

Allergic Asthma ◽

Severe Asthma ◽

Clinical Signs ◽

Signs And Symptoms ◽

Allergen Exposure ◽

Response To Therapy ◽

Double Blind ◽

Clinical Signs And Symptoms ◽

Underlying Mechanisms

Different subsets of asthma patients may be recognized according to the exposure trigger and the frequency and severity of clinical signs and symptoms. Regarding the exposure trigger, generally asthma can be classified as allergic (or atopic) and nonallergic (or nonatopic). Allergic and nonallergic asthma are distinguished by the presence or absence of clinical allergic reaction and in vitro IgE response to specific aeroallergens. The mechanisms of allergic asthma have been extensively studied with major advances in the last two decades. Nonallergic asthma is characterized by its apparent independence from allergen exposure and sensitization and a higher degree of severity, but little is known regarding the underlying mechanisms. Clinically, allergic and nonallergic asthma are virtually indistinguishable in exacerbations, although exacerbation following allergen exposure is typical of allergic asthma. Although they both show several distinct clinical phenotypes and different biomarkers, there are no ideal biomarkers to stratify asthma phenotypes and guide therapy in clinical practice. Nevertheless, some biomarkers may be helpful to select subsets of atopic patients which might benefit from biologic agents, such as omalizumab. Patients with severe asthma, uncontrolled besides optimal treatment, notwithstanding nonatopic, may also benefit from omalizumab therapy, although currently there are no randomized double-blind placebo controlled clinical trials to support this suggestion. However, omalizumab discontinuation according to each patient’s response to therapy and pharmacoeconomical analysis are questions that remain to be answered.

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Use of Lozenges Containing Lactobacillus brevis CD2 in Recurrent Aphthous Stomatitis: A Double-Blind Placebo-Controlled Trial

Ulcers ◽

10.1155/2011/439425 ◽

2011 ◽

Vol 2011 ◽

pp. 1-6 ◽

Cited By ~ 5

Author(s):

Vito Trinchieri ◽

Stefano Di Carlo ◽

Maurizio Bossu' ◽

Antonella Polimeni

Keyword(s):

Controlled Trial ◽

Clinical Signs ◽

Signs And Symptoms ◽

Lactobacillus Brevis ◽

Recurrent Aphthous Stomatitis ◽

Aphthous Stomatitis ◽

Rapid Improvement ◽

Double Blind ◽

Rapid Healing ◽

Clinical Signs And Symptoms

Recurrent aphthous stomatitis is a common disorder of the oral cavity, affecting mainly young people. It is characterized by small ulcers which can be very painful and generally heal spontaneously within 7–14 days. There is currently no therapy that can provide rapid healing. This study evaluated the efficacy and rapidity of response of a lozenge containing Lactobacillus brevis CD2. 30 patients were randomized to take 4 lozenges a day of active product or placebo for 7 days. Signs and symptoms as well as laboratory parameters in the saliva were assessed at the start of the study and after 7 days of treatment. The study demonstrated the efficacy and the rapidity of response of the Lactobacillus brevis CD2 lozenges in resolving the clinical signs and symptoms of aphthous stomatitis, with a significantly rapid improvement of pain. This is the first study confirming the efficacy of a probiotic product in this pathology.

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Genitourinary syndrome of menopause (GSM) and laser VEL: a review

Hormone Molecular Biology and Clinical Investigation ◽

10.1515/hmbci-2019-0024 ◽

2019 ◽

Vol 0 (0) ◽

Cited By ~ 1

Author(s):

David Elia ◽

Marco Gambacciani ◽

Nicolas Berreni ◽

Jean Marc Bohbot ◽

René Druckmann ◽

...

Keyword(s):

Clinical Signs ◽

Cervix Uterus ◽

Hormonal Treatment ◽

Signs And Symptoms ◽

Sexual Life ◽

Double Blind ◽

Natural Menopause ◽

Genitourinary Syndrome Of Menopause ◽

Double Blind Placebo ◽

Genitourinary Syndrome

Abstract The purpose of this publication is to summarize the results of the vaginal erbium:yttrium-aluminum-garnet (Er:YAG) Smooth® laser (VEL) on the vaginal atrophy component of the genitourinary syndrome of menopause (GSM). GSM has two categories of clinical signs related to estrogen deficiency: symptoms of vulvovaginal atrophy (VVA) and urinary symptoms. This symptomatology is chronic, progressive over the years and affects a majority of women concerned by natural menopause but not exclusively: we must also consider the growing number of survivors of gynecological or non-gynecological cancers (breast, cervix, uterus, vagina, anus, etc.). At a time when hormonal treatment of menopause is contested as is the installation of under urethra prosthesis, the innovation provided by the VEL technology has the merit of offering the women concerned an effective therapeutic alternative with the security of a patent. The VEL technology has an original and unique process: acting only by thermal effect and not by ablation on tissue, VEL is a safe solution in terms of side effects and potential complications. Studies have been increasing since 2012 and all demonstrate a significant improvement in the GSM signs and symptoms, as well as an improved sexual life after VEL treatment. Double-blind, placebo-controlled, randomized studies are expected in order to ultimately confirm the safety and effectiveness of VEL.

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Signs and symptoms of complex regional pain syndrome type 1:consequences for diagnosis

European Journal of Anaesthesiology ◽

10.1097/00003643-200100001-00456 ◽

2001 ◽

Vol 18 (Supplement 21) ◽

pp. 128 ◽

Cited By ~ 3

Author(s):

R. S.G.M. Perez ◽

M. J.M. Bauer ◽

W. W.A. Zuurmond ◽

J. J. de Lange

Keyword(s):

Complex Regional Pain Syndrome ◽

Pain Syndrome ◽

Signs And Symptoms ◽

Syndrome Type

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Clinical Efficacy and Safety of Benjakul Remedy Extract for Treating Primary Osteoarthritis of Knee Compared with Diclofenac: Double Blind, Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/9593580 ◽

2017 ◽

Vol 2017 ◽

pp. 1-9

Author(s):

Patamaporn Rachawat ◽

Piya Pinsornsak ◽

Puritat Kanokkangsadal ◽

Arunporn Itharat

Keyword(s):

Clinical Efficacy ◽

Safety Issue ◽

Controlled Trial ◽

Clinical Signs ◽

Signs And Symptoms ◽

Controlled Study ◽

Efficacy And Safety ◽

Double Blind ◽

Primary Osteoarthritis ◽

Clinical Signs And Symptoms

Background. The purpose of this study was to investigate the clinical efficacy and safety of Benjakul (BJK) extract for treating primary osteoarthritis (OA) of the knee compared with diclofenac. Methods. A phase 2, double blind, randomized, and controlled study was conducted. The BJK group received 300 mg of BJK extract per day, while another group received 75 mg of diclofenac per day. All patients were followed up at 14 and 28 days. The changing of visual analogue scale (VAS) for pain, 100-meter walking times, the modified Thai WOMAC index scores, and the global assessment were evaluated for efficacy. For safety issue, clinical signs and symptoms, complete physical examination, and renal and liver function were evaluated. Results. 39 and 38 patients for BJK extract group and diclofenac group were evaluated. For efficacy, all patients from both groups reported a decrease in the VAS pain score and 100-meter walking times but only the diclofenac group showed significant reduction of both measurements when compared with day 0. The modified Thai WOMAC scores of both groups were significantly reduced from baseline. However, all efficacy outcomes were not significantly different for both groups. For safety outcomes, the patients from both groups had no severe adverse events reported and only BJK had no toxicity in renal and liver functions. Conclusions. The BJK remedy extract showed equal clinical efficacy in relieving symptoms of OA knee when compared with diclofenac.

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