| Methods |
Randomised clinical trial |
| Participants |
Country: Bangladesh.
Number randomised: 50.
Post‐randomisation drop‐outs: 20 (40%).
Revised sample size: 30.
Average age: 42 years.
Females: 23 (76,7%).
NASH: 30 (100%).
Diabetics: 8 (26,7%).
Average follow‐up period in months: 12.
Inclusion criteria
1. Patients aged 18 to 65 years in whom NAFLD activity score ≥ 5 in liver histology.
Exclusion criteria
1. Alcohol intake > 20 g/day.
2. Presence of comorbid conditions such as chronic hepatitis of other causes, chronic obstructive pulmonary disease, chronic kidney disease, congestive cardiac failure, history of recent myocardial infarction, hypothyroidism.
3. Decompensated cirrhosis of liver.
4. Alanine aminotransferase (ALT) > five times upper normal limit.
5. History of taking angiotensin receptor blocker or angiotensin converting enzyme inhibitors. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: telmisartan (N = 20).
Further details: telmisartan 40 mg OD.
Group 2: control (N = 10).
Further details: control: no intervention.
Duration of treatment: 12 months. All people also underwent lifestyle modification. |
| Outcomes |
Outcomes reported: 1. Mortality 2. Adverse events 3. Decompensated liver disease 4. Liver transplantation 5. Cirrhosis 6. Change in fibrosis score 7. Change in NAS score 8. Resolution of fatty liver disease. |
| Notes |
Authors provided additional information in September 2016
Reasons for post‐randomisation drop‐outs: lack of interest in undergoing liver biopsy. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Random sequence was generated by lottery. Each subject was requested to pick up one among folded papers on which their destined group name was inscribed".
Comment: author replies. |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Random sequence was generated by lottery. Each subject was requested to pick up one among folded papers on which their destined group name was inscribed".
Comment: author replies. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "This was an open‐label RCT". |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Quote: "This was an open‐label RCT". |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Comment: there were post‐randomisation drop‐outs, which may be related to the treatment that the participants received. |
| Selective reporting (reporting bias) |
Low risk |
Comment: mortality and adverse events were reported. |
| For‐profit bias |
Low risk |
Quote: "Alam S, Kabir J, Mustafa G, Gupa UD, Hasan SKMN and Alam KAK declare that there is no financial relation with any person or organization for this study". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
