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. 2022 Nov 14;2022(11):CD012956. doi: 10.1002/14651858.CD012956.pub2

Nickel 2004.

Study characteristics
Methods 8‐week trial with 2 arms:

  1. topiramate

  2. placebo


Duration of trial: 8 weeks
Country: Germany
Setting: outpatient
Participants Method of recruitment of participants: no information
Overall sample size: 31
Diagnosis of borderline personality disorder: DSM‐IV
Means of assessment: SCID‐II
Mean age: 26.05 years (SD = no information; range = no information)
Sex: 100% women
Comorbidity: no information
Inclusion criteria

  1. Women

  2. Age between 20 and 35 years

  3. Disturbed by moodiness, distrustfulness, impulsivity, and painful and difficult relationships

  4. Subjective feelings of constantly increasing anger caused by participants life situation


Exclusion criteria

  1. Actively suicidal patients

  2. Abusing alcohol or drugs

  3. Major depression

  4. Schizophrenia

  5. Bipolar disorder

  6. Current use of topiramate or other psychotropic medication

  7. Psychotherapy

  8. Somatically ill

  9. Pregnant or planning to become pregnant
Interventions Experimental group
Treatment name: topiramate
Number randomised to group: 21
Duration: 8 weeks
Control/ comparison group
Comparison name: placebo
Number randomised to group: 10
Duration: 8 weeks
Both groups
Concomitant psychotherapy: not allowed
Concomitant pharmacotherapy: not allowed
Proportions of participants taking standing medication during trial observation period: no information; however, concomitant medication was not allowed.
Outcomes Primary outcomes: none
Secondary outcomes

  1. Anger, measured by STAXI trait anger subscale. Assessed at baseline and every week for 8 weeks (EOT)

  2. Impulsivity, measured by STAXI anger‐out subscale. Assessed at baseline and every week for 8 weeks (EOT)

  3. Attrition

  4. Adverse effects, measured by non‐structured questionnaire. Assessed every week for 8 weeks
Notes Sample calculation: yes, "According to a power analysis, 21 patients were required for a topiramate trial." (Nickel 2004, p. 1516)
Ethics approval: yes, "[The trial design] was approved by the clinic's "Ethikkomision" (the German equivalent of the Committee on Human Subjects". (Nickel 2004, p. 1516)
Funding source: unclear funding
Conflicts of interest: No conflicts of interest were reported.
Comments from trial authors (limitations)

  1. "The sample size was (in spite of a valid power analysis) relatively small". (Nickel 2004, p. 1518)

  2. "[...] the sample consisted only of women with borderline personality disorder. Whether these results could also be replicated with men meeting the criteria for borderline personality disorder is unknown". (Nickel 2004, p. 1518)

  3. "[...] the sample was composed of moderately ill outpatients who were not suffering from a concurrent major depressive episode and were not abusing substances or taking concurrent medications." (Nickel 2004, p. 1518‐9)

  4. "[...] the length of this trial was only 2 months, which may have reduced the dropout rate". (Nickel 2004, p. 1519)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: The article mentioned that the trial was randomised, however, there was insufficient information on how the randomisation procedure was carried out to permit a judgement of low or high risk of bias.
Allocation concealment (selection bias) Unclear risk Quote: "Randomization was carried out confidentially by the clinic administration." (Nickel 2004, p. 1516)
Comment: Allocation sequence appeared to have been confidential, however, there was insufficient information on how this confidentiality was maintained to permit a judgement of low or high risk of bias.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "Tablets were supplied in numbered boxes. Both subjects and clinicians were blinded regarding topiramate/placebo assignment." (Nickel 2004, p. 1516).
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote: "Tablets were supplied in numbered boxes. Both subjects and clinicians were blinded regarding topiramate/placebo assignment." (Nickel 2004, p. 1516).
Comment: Unclear if clinicians were also outcome assessors, therefore insufficient information to permit judgement of low or high risk of bias.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "Two subjects, who failed to appear 2 to 3 times for the weekly evaluations, dropped out of the study, and their data were not further analysed. Finally, data from 29 women [...] were evaluated." (Nickel 2004, p. 1516)
Comment: continuous outcomes based on available case analysis. Of the 31 patients enrolled, 29 completed treatment. Reasons for early termination:
Failed to appear at least 2 times for weekly evaluation, no further details: 2 in topiramate group/0 in placebo group
Selective reporting (reporting bias) Unclear risk Comment: no protocol found
Vested Interest (funding and/or author affiliations) Unclear risk Quote: "The authors report no financial affiliation or other relationship relevant to the subject matter of this article." (Nickel 2004, p. 1515)
Other bias Low risk Comment: No apparent other sources of bias found