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The study was a 8-week, randomized, double-blind, placebo-controlled trial. Berberine (300 mg，three times a day), as an adjuvant therapy has been used on the basis of the Second-generation antipsychotics（SGAs） monotherapy. All participants were randomly divided into two groups.Any SGA + berberine (BBR) or any SGA +placebo.Positive and Negative Syndrome Scale (PANSS) has been used for psychiatric symptoms.The treatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects.Glucose and lipid profile, inflammatory factors，adiponectin，leptin were obtained at 0, 4,8 weeks.
Glucose and lipid profile:Fasting blood samples for Fasting blood glucose(FBG),Insulin, Hemoglobin A1c(HbA1c), Total cholesterol(TC), Low-density lipoprotein cholesterol(LDL-C),High-density lipoprotein cholesterol(HDL-C), Triglycerides (TG),Apolipoprotein A(ApoA),Apolipoprotein B(ApoB),Lipoprotein-a(Lp-a) .
Inflammatory factors:C-reaction protein(CRP),Interleukine-1 beta(IL-1β), Interleukine-6 (IL-6), Tumor necrosis factor-α (TNF-α).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| berberine group | Experimental |
| |
| control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine | Drug | Berberine 300mg（three times a day） plus any atypical antipsychotic drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of negative symptoms | Positive and Negative Syndrome Scale（PANSS）has been used to assess symptom severity in schizophrenia.Of the items included in PANSS ,seven constitute a Positive scale,seven form a Negative scale and sixteen constitute a General Psychopathology scale.7-point rating instrument was conceived.A total Score is computed three subscales.Minimum scores is 30 and maximum scores is 210.The higher score are considered the psychiatric symptoms more serious. | changes within 0,4,8weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Fasting blood samples for Fasting blood glucose(FBG) | The levels of FBG has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8 weeks |
| Changes of Insulin | The levels of Insulin has been obtained at 3 point intervals: 0, 4, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35037116 | Derived | Li M, Qiu Y, Zhang J, Zhang Y, Liu Y, Zhao Y, Jia Q, Fan X, Li J. Improvement of adjunctive berberine treatment on negative symptoms in patients with schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2022 Jun;272(4):633-642. doi: 10.1007/s00406-021-01359-4. Epub 2022 Jan 17. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001599 | Berberine |
| ID | Term |
|---|---|
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| atypical antipsychotic |
| Drug |
Any atypical antipsychotic drug as the basic treatment |
|
| placebo | Drug | The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles |
|
| changes within 0,4,8 weeks |
| Changes of TC | The levels of TC has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8 weeks |
| Changes of TG | The levels of TG has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks |
| Changes of HDL-C | The levels of HDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks |
| Changes of LDL-C | The levels of LDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks |
| Safety | Evaluate the safety of berberine | changes within 0,4,8weeks |
| Changes of CRP | The levels of CRP has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks |
| Changes of IL-1β | The levels of IL-1β has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks |
| Changes of IL-6 | The levels of IL-6 has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks |
| Changes of TNF-α | The levels of TNF-α has been obtained at 3 point intervals: 0, 4, 8 weeks | changes within 0,4,8weeks |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |