The Effect of Hawthorn on Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics

Study Overview
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Brief Summary
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Importance: The problems of side effects of metabolic disturbances in schizophrenic patients have been of worldwide concern for some time. Patients with dyslipidemia have an increased risk of cardiovascular diseases. A Chinese herb, Hawthorn, is widely used for the treatment of dyslipidemia. Objective: Therefore, this study aimed to investigate the effect of Hawthorn on lipid profile levels in schizophrenic patients treated with antipsychotics. Design, Setting, and Participants: A longitudinal case-control study was used in a general hospital in Taiwan. A total of 59 schizophrenics treated with antipsychotics, and 76 healthy adult subjects, who were all hospital workers, were enrolled in this study. Main outcomes and measures: All participants received Hawthorn at a dose of 3 gm/day for six months.

Detailed Description
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The problem of metabolic disturbances in schizophrenic patients who take antipsychotics has always been a cause for global concern and discussion. Although Hawthorn is widely used in the treatment of heart problems and the lowering of blood lipid levels, it is unknown whether Hawthorn has an effect in schizophrenic patients treated with antipsychotics. Hence, there are several areas of interest in the present study: 1) the effect of Hawthorn on lipid profile levels in schizophrenic patients treated with antipsychotics; 2) a comparison of lipid profile levels between schizophrenic patients and healthy adults; 3) the contributing factors that relate to changes in lipid profile levels in patients who take Hawthorn.

Official Title
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The Disparity of Hawthorn Effects to Triglyceride/High-density Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: Hawthorn
* Drug: SGAs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in case group who had to meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). All participants in the case group had previously received antipsychotic treatment for a period of time. Exclusion Criteria: Patients who had comorbid serious medical illnesses, and may therefore present substantial clinical risk due to pharmacotherapy, were excluded from the sample Participants were pregnant and lactating women in both group, were excluded.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: case control study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hawthorn and SGAs<br>SGAs has a dose of 3-20 gm/day, Hawthorn at a dose of 3 gm/day for six months. | Other: Hawthorn<br>* Hawthorn tablet<br>Drug: SGAs<br>* SGAs tablet<br>* Other names: second-generation antipsychotics;|
| Active Comparator: Hawthorn<br>Hawthorn at a dose of 3 gm/day for six months. | Other: Hawthorn<br>* Hawthorn tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profiles | lipid profiles (including TC, TG, HDL, LDL) were collected three times (at first week, 12th week and 24th week. Total collecting day were three days. | three days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dyslipidemia, schizophrenia, antipsychotics, Hawthorn, TG/HDL ratio