Meta AnalysisID 2415
雷洛昔芬治疗女性精神分裂症的疗效和安全性：系统评价和Meta分析
CRD42016047959
We aim to evaluate the clinical efficacy of raloxifene taken as an adjunct to standard antipsychotic medication, compared to adjunct placebo, for women with schizophrenia spectrum disorders. We aim to evaluate the safety
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Record Fields
Scalar fields from the final meta_analysis record.
- Meta Analysis Id
- 2415
- Evidence Id
- 10973
- Core Evidence Id
- 10973
- Source Meta Analysis Id
- 2404
- Herb2 Meta Analysis Id
- HBMA002404
- Crd Id
- CRD42016047959
- Title
- Efficacy and safety of raloxifene in women with schizophrenia: a systematic review and meta-analysis
- Review Question
- We aim to evaluate the clinical efficacy of raloxifene taken as an adjunct to standard antipsychotic medication, compared to adjunct placebo, for women with schizophrenia spectrum disorders. We aim to evaluate the safety of raloxifene taken as an adjunct to standard antipsychotic medication, compared to adjunct placebo, for women with schizophrenia spectrum disorders.
- Study Type Included
- We will include all relevant RCTs. Quasi-randomised and non-randomised studies, as well as open-label studies, will be excluded from this review. When studies are reported to be randomised but methods are not clearly explained, authors will be contacted to substantiate study design. When studies report results for both men and women combined, authors will be contacted for female data. Authors will be contacted by their listed email address on the respective publication. RCTs of all durations will be included. Hormone modulation is well-acknowledged to have rapid onset, with studies of raloxifene in the treatment of schizophrenia showing the majority of symptom improvement in as little as four weeks (Usall 2016; Kulkarni 2016). Therefore, we will include trials of all treatment duration, and identify mean change from baseline to study endpoint. We will not restrict studies by year of publication, and studies in all languages will be included.
- Condition Being Studied
- Hormone treatment for women with schizophrenia.
- Participant
- Women 18+ years of age, inpatient or community-dwelling who meet diagnostic criteria for schizophrenia, schizoaffective or schizophreniform disorder, will be included in this review. A diagnosis based on criteria from either the DSM-IV, DSM-V or ICD-10 (American Psychiatric Association 2000, American Psychiatric Association 2013; World Health Organization 1992) will be allowed, to account for revisions of criteria that have occurred since the study of raloxifene for schizophrenia commenced. Men will be excluded from this review due to anticipated differential effects of hormone modulation in males and females, which likely extend to the effects of raloxifene in treatment trials for schizophrenia.
- Animal
- Human Disease Modelled
- Intervention
- The intervention considered in this review will be oral raloxifene hydrochloride, in all therapeutic doses (Kulkarni 2010; Usall 2011). We will evaluate the efficacy of oral raloxifene hydrochloride, as an adjunctive to standard antipsychotic medication (e.g. quetiapine, risperidone, olanzapine, aripiprazole).
- Comparator Control
- Adjunctive oral placebo.
- Main Outcome
- Mean change in overall psychotic illness severity from baseline to study endpoint; based on the Positive and Negative Syndrome Scale (PANSS). Proportion of withdrawals due to adverse events (AEs).
- Outcome Measure
- Additional Outcome
- Mean change in positive psychotic symptoms from baseline to study endpoint; based on the PANSS positive subscale score. Mean change in negative psychotic symptoms from baseline to study endpoint; based on the PANSS negative subscale score. Mean change in general psychotic symptoms from baseline to study endpoint; based on the PANSS general subscale score. Proportion of patients with adverse events as an outcome.
- Study Method
- Systematic review
- Keyword
- Female; Humans; Raloxifene Hydrochloride; Safety; Schizophrenia;
- Contact
- Jasmin Grigg [email protected]
- Organisational Affiliation
- Monash Alfred Psychiatry Research Centre maprc.org.au
- Funding Source
- No funding source or sponsor
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Australia
- Review Stage
- Review Ongoing
- First Submission Date
- Registration Date
- 2016-12-07
- Anticipated Start Date
- 2016-08-11
- Anticipated Completion Date
- 2017-02-11
- Title Cn
- 雷洛昔芬治疗女性精神分裂症的疗效和安全性：系统评价和Meta分析
- Title En
- Efficacy and safety of raloxifene in women with schizophrenia: a systematic review and meta-analysis
- Bilingual Status
- complete