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Study aim
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Evaluation of efficacy and safety of bupropion on sexual dysfunction in female patients with multiple sclerosis
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 64 patients. Block permutated randomization method has been used for randomization.
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Settings and conduct
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The study site of MS Clinic is Bu Ali Sina Hospital in Sari. The study was double-blind and participants and researchers were blinded. The questionnaires will be filled in at the beginning of the study, at the end of the sixth week and at the end of the twelfth week.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Adult women over 18 years,
The duration of MS is more than six months,
Having been sexually active for the past six months,
No known acute mental disorder,
Husband monogamy,
Exclusion criteria:
The study included moderate to severe depression using the HADS questionnaire (score 11 and above),
Consumption of silicotropic drugs and benzodiazepines and SSRIs during the study,
Known acute mental disorder,
Pregnancy or breastfeeding
Environmental problems of the genitourinary system lead to sexual dysfunction
Facing severe crises such as the death of loved ones during the last six months
Withdrawal from study and incomplete answers to the questionnaires so that more than 20% of the questions in each questionnaire are unanswered.
History of seizures,
History of bulimia and anorexia.
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Intervention groups
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The intervention group received bupropion tablets 75 mg daily for the first week and then 75 mg morning and night until the end of the study period, and the control group received placebo instead of bupropion while maintaining all the conditions of the intervention group. The duration of the study is 12 weeks.
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Main outcome variables
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Quality of Life; Intimacy and sexual activity; Side effects; Fatigue; Sphincter disorder; Anxiety and depression;