Bergasa 2006.

Methods	RCT Placebo‐controlled Parallel‐group design
Participants	Pruritus: CP Description: participants with cholestasis Number of participants randomised: 16 Number of participants evaluable: 13 Gabapentin: 7 Placebo: 6 Number of participants enrolled: 15 (1 withdrawal prior to randomisation) Gabapentin: 8 Placebo: 7 Withdrawals/dropouts: 3 Gabapentin: 1 Placebo: 1 Prior to randomisation: 1 Reason for dropout: Gabapentin: vomiting Placebo: persistent severe pruritus within 2 weeks Prior to randomisation: participant did not want to be hospitalised Age (years): median: 49 (range 44 to 63) Sex (male/female): 0/16 Underlying disease(s): PBC (n = 9), chronic liver disease secondary to infection with hepatitis C (n = 6), PSC (n = 1) Participant pool: single‐centre Setting: inpatient Haemodialysis: NA Duration/severity of pruritus:1‐12 years, except one participant for whom it was 4 months; antipruritic drugs had not provided satisfactory relief Baseline parameters: no information
Interventions	Intervention 1: gabapentin (starting dose of 300 mg/d (100 mg, 3x/d), increased if necessary and in the absence of side effects by 300 mg (100 mg, 3x/d) every 3 days to a maximum of 2400 mg/d or until pruritus relief) Intervention 2: placebo Additional medication: Antipruritic drugs were discontinued 5 days before collecting baseline data. Participants who took antihistamines to sleep were kept on those doses. Route of administration: oral Duration of treatment: 4 weeks Follow‐up: no information
Outcomes	Pruritus assessment: VAS Hourly scratching activity (HSA) Interviews Adverse events Additional outcomes: At baseline: complete blood count, coagulation, comprehensive metabolic panels Dermatological evaluation: None of the participants had a dermatological disease associated with pruritus. Psychiatric evaluation: Hamilton depression rating scale and Structured Clinical Interview Questionnaire; the results of the psychiatric evaluations suggested that liver disease and pruritus might have contributed to the depressive symptomatology of the subject.
Notes	Gabapentin was discontinued in 5 participants during the study and 2 more after completing the study; 2 participants took gabapentin after completing treatment with placebo;1 dropped because of side effects.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"[R]andomised to receive the placebo or the active drug according to a randomisation code generated and kept at the research pharmacy."
Allocation concealment (selection bias)	Low risk	" [A]ccording to a randomisation code generated and kept at the research pharmacy."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"The study was a double‐blind . . ." Unclear who was blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	Gabapentin was discontinued in 5 participants; unclear if used intention‐to‐treat analysis
Selective reporting (reporting bias)	Low risk	No indication
Size of study (possible biases confounded by small size)	High risk	Number of participants randomised: 16
Other bias	Unclear risk	Washout period only 5 days; co‐medication with antihistamines