Efficacy and safety of the "mother's kiss" technique: a systematic review of case reports and case series

ObjectiveOur aim was to perform an updated systematic review and meta-analysis on the efficacy and safety of adjunctive minocycline as a treatment of schizophrenia.MethodsWe conducted a PubMed/Scopus database search from inception to 3 February 2016 for randomized, placebo-controlled trials (RCTs), open non-randomized studies, and case reports/series evaluating minocycline in patients with schizophrenia. Random-effects meta-analysis of positive, negative, depressive, and cognitive symptom rating scales, discontinuation and adverse effects rates calculating standardized mean difference (SMD), and risk ratios±95% confidence intervals (CI95%) were calculated.ResultsSix RCTs were eligible (minocyclinen=215, placebon=198) that demonstrated minocycline’s superiority versus placebo for reducing endpoint Positive and Negative Syndrome Scale (PANSS) total scores (SMD=–0.59;CI95%=[1.15, –0.03];p=0.04), negative (SMD=–0.76;CI95%=[–1.21, –0.31];p=0.001); general subscale scores (SMD=–0.44;CI95%=[–0.88, –0.00];p=0.05), Clinical Global Impressions scores (SMD=–0.50;CI95%=[–0.78, –0.22];p<0.001); and executive functioning (SMD=0.22;CI95%=[0.01, 0.44];p=0.04). Endpoint PANSS positive symptom scores (p=0.13), depression rating scale scores (p=0.43), attention (p=0.47), memory (p=0.52), and motor speed processing (p=0.50) did not significantly differ from placebo, before execution of a trim-and-fill procedure. Minocycline did not differ compared to placebo on all-cause discontinuation (p=0.56), discontinuation due to inefficacy (p=0.99), and intolerability (p=0.51), and due to death (p=0.32). Data from one open-label study (N=22) and three case series (N=6) were consistent with the metaanalytic results.ConclusionsMinocycline appears to be an effective adjunctive treatment option in schizophrenia, improving multiple relevant disease dimensions. Moreover, minocycline has an acceptable safety and tolerability profile. However, more methodologically sound and larger RCTs remain necessary to confirm and extend these results.

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A Systematic Review on the Use of Intrathecal Rituximab in CNS Lymphoma

Blood ◽

10.1182/blood.v118.21.4987.4987 ◽

2011 ◽

Vol 118 (21) ◽

pp. 4987-4987 ◽

Cited By ~ 1

Author(s):

Ahraaz Wyne ◽

Leslie Skeith ◽

Joy E. Mangel ◽

Anargyros Xenocostas ◽

Alejandro Lazo-Langner

Keyword(s):

Systematic Review ◽

Complete Remission ◽

Cell Lymphoma ◽

Case Reports ◽

Case Series ◽

Cns Lymphoma ◽

Efficacy And Safety ◽

Off Label Use ◽

Cns Involvement ◽

Off Label

Abstract Abstract 4987 Introduction: Central nervous system (CNS) involvement by non-Hodgkin lymphoma (NHL) is a rare but serious complication with a high mortality rate and few effective therapeutic options. Rituximab is an anti-CD20 monoclonal antibody that is administered systemically in combination with chemotherapy, but can also be given intrathecally. When administered intrathecally (IT), rituximab achieves more predictable and higher cerebrospinal fluid (CSF) concentrations compared to its intravenous administration, however the efficacy and safety of IT rituximab are unknown (Rubenstein et al., J Clin Oncol 2007). We recently treated a 52 year old woman for a CNS relapse of diffuse large B-cell lymphoma (DLBCL) using a combination of IT rituximab, cytarabine, methotrexate and hydrocortisone, as well as craniospinal radiation. After initial improvement, she developed subacute combined degeneration (SCD) of the spinal cord. This prompted the present systematic review of the literature in order to explore the efficacy and safety of administering rituximab directly into the CSF for the treatment of CNS involvement by NHL. Methods: We identified all relevant citations in MEDLINE/EMBASE/CINAHL/BIOSIS Previews from their date of inception to June 20th, 2011. Prospective studies, case reports and case series reporting on intrathecal or intraventricular (via ommaya-reservoir) use of rituximab in relapsed primary (PCNSL) or secondary CNS-lymphoma were included. All articles citing the included articles, as well as the reference lists of included articles were reviewed to ensure capture of all relevant studies. In some cases, authors were contacted to gather additional information. Two authors independently evaluated study eligibility. Disagreements were resolved by consensus and agreement was assessed using the kappa statistic. All non-human studies were excluded. Due to the nature of the studies, a meta-analysis was not performed. Results: The search strategy identified 148 potential reports published between 2002–2011 of which 22 were included (3 prospective trials, 2 phase-I trials, 2 case-series and 15 case reports). The kappa value for inter-author agreement was 0.881. A total of 74 patients, aged 4–84 years old (Mean age 48), with PCNSL (28%) or secondary CNS-Lymphoma (ALL 14%, DLBCL 8%, Burkitt's 4%, Mantle Cell Lymphoma 5%, Post-transplant lymphoproliferative disorder 4%, Unknown histology 37%), received 1 to 22 doses of 10–50mg of intrathecal (43%) or intraventricular (IVT) rituximab, either alone or in combination with other therapies. At a mean follow-up of 43 weeks (Range 2–178), 34% of patients were in complete remission and 28% showed a partial response. Patients having both leptomeningeal and parenchymal involvement of CNS lymphoma were the most likely to have progression of disease with IT/IVT rituximab (44%), as compared to those with isolated disease in the leptomeninges (29%) or parenchyma (33%). Fifty percent of patients with isolated disease in the leptomeningeal compartment showed complete remission with IVT/IT rituximab therapy. Fatigue, nausea/vomiting and paresthesias were the most commonly reported side effects. In one series, seven patients developed arachnoiditis. There was a single case of Hepatitis B virus reactivation in a patient with parenchymal PCNSL. In addition, our patient developed symptoms and findings consistent with SCD and in whom a relation between SCD and rituximab could not be ruled out. Conclusion: In case series and reports, IT rituximab appears to be a safe and modestly effective therapy when used in conjunction with other salvage therapies for the management of refractory CNS-lymphoma. The overall proportion of complications appears to be reasonably low. To our knowledge, our patient is the first case of SCD reported in a patient who received IT rituximab. Further studies with a particular emphasis on safety are needed before widespread use can be recommended. Disclosures: Off Label Use: Systematic literature review on the use of intrathecal rituximab for CNS lymphoma (off-label use). Lazo-Langner:Leo Pharma: Honoraria; Pfizer Inc.: Honoraria.

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A systematic review of the efficacy and safety of second generation antipsychotics in the treatment of mania

European Psychiatry ◽

10.1016/j.eurpsy.2005.02.002 ◽

2006 ◽

Vol 21 (1) ◽

pp. 1-9 ◽

Cited By ~ 8

Author(s):

R.M. Jones ◽

C. Thompson ◽

I. Bitter

Keyword(s):

Systematic Review ◽

Second Generation ◽

Case Reports ◽

Case Series ◽

Antipsychotic Agents ◽

Efficacy And Safety ◽

Open Label ◽

Second Generation Antipsychotics ◽

Second Generation Antipsychotic ◽

Randomised Controlled

AbstractSecond generation antipsychotic agents are increasingly used in the management of acute mania. A systematic review of the efficacy and safety of these agents, as both monotherapy and in combination with mood stabilisers, was performed to establish the evidence for their use. Randomised controlled trials (RCTs) were critically appraised in more detail than studies that presented lower levels of evidence such as case reports, case series and open label follow up studies. We found 11 RCTs reporting on patients treated with second generation antipsychotics for acute bipolar mania, of which three included randomisation between the second generation antipsychotic and placebo, and eight between a mood stabiliser combined with either the second generation antipsychotic or placebo. Data from non-randomised trials is also presented.

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Systematic review of the efficacy and safety of biological therapy for inflammatory conditions in HIV-infected individuals

International Journal of STD & AIDS ◽

10.1177/0956462416675109 ◽

2016 ◽

Vol 28 (2) ◽

pp. 110-119 ◽

Cited By ~ 13

Author(s):

DL Fink ◽

L Hedley ◽

RF Miller

Keyword(s):

Systematic Review ◽

Immune Cell ◽

Biologic Therapy ◽

Case Reports ◽

Case Series ◽

Biologic Agents ◽

Efficacy And Safety ◽

Biologic Therapies ◽

Inflammatory Conditions ◽

Randomised Control Trials

Biologic therapies are injectable immunomodulatory agents directed against specific immune cell or chemical targets. They have transformed the lives of HIV-uninfected individuals with severe inflammatory conditions including psoriasis, rheumatoid arthritis, and ulcerative colitis. The perceived increased infection risk associated with these agents means that HIV-infected individuals have not been included in randomised control trials of these drugs. The literature for use of biologic therapies in HIV-infected populations is limited to case reports and case series. There are additional data on use of rituximab, a monoclonal antibody against B lymphocytes, in the setting of HIV-associated haematological malignancy. We performed a systematic review of efficacy and safety of biologic therapy for inflammatory conditions in HIV-infected individuals. Our systematic review identified 37 treatment episodes with six different biologic agents encompassing 10 different inflammatory conditions. Broadly, efficacy of the agents studied was comparable to reports from HIV-uninfected patients. Both infectious and non-infectious sequelae were also comparable with trial data from HIV-uninfected patients. HIV control, even for the minority of individuals not receiving anti-retroviral therapy (ART) at the time of biologic therapy, was not adversely affected. However, detail was limited concerning ART regimens and both immunological and virological parameters of follow-up. Overall available literature is of very low quality and likely subject to publication bias of successful cases. Firm conclusions are not possible regarding the efficacy and safety of biologic agents in HIV-infected individuals; however, there appear to be sufficient data to warrant inclusion of individuals with well-controlled HIV in future trial studies.

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Venous Thromboembolism Treatment with Low-Molecular-Weight Heparin during Pregnancy: A Systematic Review.

Blood ◽

10.1182/blood.v104.11.1780.1780 ◽

2004 ◽

Vol 104 (11) ◽

pp. 1780-1780

Author(s):

Ian A. Greer ◽

Catherine Nelson-Piercy

Keyword(s):

Systematic Review ◽

Molecular Weight ◽

Venous Thromboembolism ◽

Low Molecular Weight Heparin ◽

Case Reports ◽

Safety Data ◽

Case Series ◽

Low Molecular Weight ◽

Efficacy And Safety ◽

Vein Thrombosis

Abstract Introduction Low-molecular-weight heparin (LMWH) has become the standard therapy for managing acute venous thromboembolism (VTE) during pregnancy. In the UK, Europe and Australasia, LMWH is widely used for the treatment of both deep-vein thrombosis and pulmonary embolism occurring during pregnancy, and this practice is endorsed by a peer-reviewed Royal College of Obstetricians and Gynaecologists (RCOG) guideline. However, there are currently no LMWHs licensed for use during pregnancy, and efficacy and safety data are derived mostly from small case series. Our aim was to evaluate the efficacy and safety of LMWH for VTE treatment during pregnancy by performing a systematic review of data from published literature. Methods Data from published studies included in this systematic review were identified by searching MEDLINE and EMBASE up to the end of 2003. The reference lists from identified articles were also hand searched. Data on the LMWH treatment regime, VTE recurrence, and side effects of VTE treatment were extracted and entered into pre-piloted forms. Results Sixteen studies (including six case reports) reporting 177 patients were included. One hundred and eight (61%) women were treated with enoxaparin, 49 (28%) with dalteparin and 20 (11%) with nadroparin. In 31 (18%) cases, VTE was initially treated with unfractionated heparin for two days to two weeks after diagnosis. LMWH was administered twice daily in 154 (87%) cases. Recurrent VTE was reported in three (1.7%) women: one receiving dalteparin 10,000 IU od, one receiving enoxaparin 40 mg bd, and one receiving enoxaparin 1mg/kg bd. There were no maternal deaths. Severe maternal bleeding occurred in three (1.7%) women. In two cases, the LMWH could have contributed to the extent of bleeding originating primarily from obstetric causes, and in the other from epistaxis. Minor allergic reactions occurred in two (1.1%) women, thrombocytopenia (unrelated to LMWH) in one (0.6%) woman, and osteoporosis in none. Conclusion Our findings are consistent with LMWH being both effective and safe in the treatment of acute VTE during pregnancy.

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Cannabis-associated arteritis

VASA ◽

10.1024/0301-1526/a000004 ◽

2010 ◽

Vol 39 (1) ◽

pp. 43-53 ◽

Cited By ~ 17

Author(s):

Grotenhermen

Keyword(s):

Systematic Review ◽

Case Reports ◽

Case Series ◽

Cardiovascular Effects ◽

Causative Factor ◽

Cannabis Use ◽

Thromboangiitis Obliterans ◽

Pathological Features ◽

Scientific Support ◽

Clinical And Pathological Features

Background: To investigate the hypothesis that cases of arteritis similar to thromboangiitis obliterans (TAO) and associated with the use of cannabis were caused by cannabis or THC (dronabinol), or that cannabis use is a co-factor of TAO. Patients and methods: A systematic review on case reports and the literature on so-called cannabis arteritis, TAO, and cardiovascular effects of cannabinoids was conducted. Results: Fifteen reports with 57 cases of an arteritis associated with the use of cannabis and two additional case series of TAO, in which some patients also used cannabis, were identified. Clinical and pathological features of cannabis-associated arteritis do not differ from TAO and the major risk factor of TAO, tobacco use, was present in most, if not in all of these cases. The proposed pathophysiological mechanisms for the development of an arteritis by cannabis use are not substantiated. Conclusions: The hypothesis of cannabis being a causative factor or co-factor of TAO or an arteritis similar to TAO is not supported by the available evidence. The use of the term cannabis arteritis should be avoided until or unless more convincing scientific support is forthcoming.

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Mechanical thrombectomy in pediatric stroke: systematic review, individual patient data meta-analysis, and case series

Journal of Neurosurgery Pediatrics ◽

10.3171/2019.5.peds19126 ◽

2019 ◽

Vol 24 (5) ◽

pp. 558-571 ◽

Cited By ~ 3

Author(s):

Kartik Bhatia ◽

Hans Kortman ◽

Christopher Blair ◽

Geoffrey Parker ◽

David Brunacci ◽

...

Keyword(s):

Systematic Review ◽

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Mechanical Thrombectomy ◽

Case Reports ◽

Meta Analysis ◽

Case Series ◽

Neurological Outcomes

OBJECTIVEThe role of mechanical thrombectomy in pediatric acute ischemic stroke is uncertain, despite extensive evidence of benefit in adults. The existing literature consists of several recent small single-arm cohort studies, as well as multiple prior small case series and case reports. Published reports of pediatric cases have increased markedly since 2015, after the publication of the positive trials in adults. The recent AHA/ASA Scientific Statement on this issue was informed predominantly by pre-2015 case reports and identified several knowledge gaps, including how young a child may undergo thrombectomy. A repeat systematic review and meta-analysis is warranted to help guide therapeutic decisions and address gaps in knowledge.METHODSUsing PRISMA-IPD guidelines, the authors performed a systematic review of the literature from 1999 to April 2019 and individual patient data meta-analysis, with 2 independent reviewers. An additional series of 3 cases in adolescent males from one of the authors’ centers was also included. The primary outcomes were the rate of good long-term (mRS score 0–2 at final follow-up) and short-term (reduction in NIHSS score by ≥ 8 points or NIHSS score 0–1 at up to 24 hours post-thrombectomy) neurological outcomes following mechanical thrombectomy for acute ischemic stroke in patients < 18 years of age. The secondary outcome was the rate of successful angiographic recanalization (mTICI score 2b/3).RESULTSThe authors’ review yielded 113 cases of mechanical thrombectomy in 110 pediatric patients. Although complete follow-up data are not available for all patients, 87 of 96 (90.6%) had good long-term neurological outcomes (mRS score 0–2), 55 of 79 (69.6%) had good short-term neurological outcomes, and 86 of 98 (87.8%) had successful angiographic recanalization (mTICI score 2b/3). Death occurred in 2 patients and symptomatic intracranial hemorrhage in 1 patient. Sixteen published thrombectomy cases were identified in children < 5 years of age.CONCLUSIONSMechanical thrombectomy may be considered for acute ischemic stroke due to large vessel occlusion (ICA terminus, M1, basilar artery) in patients aged 1–18 years (Level C evidence; Class IIb recommendation). The existing evidence base is likely affected by selection and publication bias. A prospective multinational registry is recommended as the next investigative step.

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