Forest plots and diagnostic meta-analysis plots

National Guideline Centre (UK)

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National Guideline Centre (UK). Non-Alcoholic Fatty Liver Disease: Assessment and Management. London: National Institute for Health and Care Excellence (NICE); 2016 Jul. (NICE Guideline, No. 49.)

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Non-Alcoholic Fatty Liver Disease: Assessment and Management.

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Appendix KForest plots and diagnostic meta-analysis plots

K.1. Risk factors for NAFLD

K.2. Diagnosis of NAFLD

K.2.1. Diagnosing steatosis ≥5%

K.2.1.1. Coupled sensitivity and specificity forest plots and pooled diagnostic meta-analysis plots

Figure 30. CAP for diagnosing steatosis >5%

Figure 31. Diagnostic meta-analysis of CAP with a threshold range of 250-300 for diagnosing steatosis ≥5%

Figure 32. FLI for diagnosing steatosis ≥5%

Figure 33. MRI-DE for diagnosing steatosis ≥5%

Figure 34. MRI fat-fraction for diagnosing steatosis ≥5%

Figure 35. MRI fat-water ratio for diagnosing steatosis ≥5%

Figure 36. MRI PDFF for diagnosing steatosis ≥5%

Figure 37. MRI %RSID for diagnosing steatosis ≥5%

Figure 38. MRI-TE for diagnosing steatosis ≥5%

Figure 39. MRS for diagnosing steatosis ≥5%

Figure 40. Diagnostic meta-analysis of MRS with a threshold range of 0-5 for diagnosing steatosis ≥5%

Figure 41. NAFLD-LFS for diagnosing steatosis ≥5%

Figure 42. SteatoTest for diagnosing steatosis ≥5%

Figure 43. Ultrasound (no threshold specified) for diagnosing steatosis ≥5%

Figure 44. Diagnostic meta-analysis of ultrasound for diagnosing steatosis ≥5%

Figure 45. Ultrasound (hepatorenal contrast) for diagnosing steatosis ≥5%

K.2.1.2. Area under the curve plot

Figure 46. CAP steatosis ≥5%

Figure 47. FLI steatosis ≥5%

Figure 48. MRI steatosis ≥5%

Figure 49. MRS steatosis ≥5%

Figure 50. SteatoTest steatosis ≥5%

Figure 51. Ultrasound steatosis ≥5%

K.2.2. Diagnosing steatosis ≥30%

K.2.2.1. Coupled sensitivity and specificity forest plots and pooled diagnostic meta-analysis plots

Figure 52. CAP for diagnosing steatosis ≥30%

Figure 53. Diagnostic meta-analysis of CAP with threshold range of 250-300 for diagnosing steatosis ≥30%

Figure 54. FLI for diagnosing steatosis ≥30%

Figure 55. MRI-DE for diagnosing steatosis ≥30%

Figure 56. MRI-PDFF for diagnosing steatosis ≥30%

Figure 57. MRI %RSID for diagnosing steatosis ≥30%

Figure 58. MRS for diagnosing steatosis ≥30%

Figure 59. NAFLD LFS for diagnosing steatosis ≥30%

Figure 60. SteatoTest for diagnosing steatosis ≥30%

Figure 61. Ultrasound (no threshold specified) for diagnosing steatosis ≥30%

Figure 62. Diagnostic meta-analysis of ultrasound for diagnosing steatosis ≥30%

Figure 63. Ultrasound (hepatorenal contrast) for diagnosing steatosis ≥30

K.2.2.2. Area under the curve plot

Figure 64. CAP steatosis ≥30%

Figure 65. FLI steatosis ≥30%

Figure 66. MRI steatosis ≥30%

Figure 67. MRS steatosis ≥30%

Figure 68. NAFLD-LFS steatosis ≥30%

Figure 69. SteatoTest steatosis ≥30%

Figure 70. Ultrasound steatosis ≥30%

K.3. Diagnosing the severity of NAFLD

K.3.1. Diagnosing NASH

K.3.1.1. Coupled sensitivity and specificity forest plots

Figure 71. ALT levels for diagnosing NASH at increasing thresholds from 19 to 100

Figure 72. CK 18 [M30] for diagnosing NASH at increasing thresholds from 121.6 to 670

Figure 73. CK 18 [M65] for diagnosing NASH at increasing thresholds from 242.82 to 1183

Figure 74. Ferritin for diagnosing NASH at increasing thresholds from 160 to 240

K.3.1.2. Area under the curve plots

Figure 75. ALT for NASH

Figure 76. CK 18 [M30] for NASH

Figure 77. CK 18 [M65] for NASH

Figure 78. Ferritin for NASH

K.3.2. Diagnosing any fibrosis (≥F1)

K.3.2.1. Coupled sensitivity and specificity forest plots

Figure 79. Enhanced Liver Fibrosis (ELF) score for diagnosing any fibrosis at increasing thresholds from -0.207 to 9.28

Figure 80. Ferritin for diagnosing any fibrosis at increasing thresholds from 208 to 500

Figure 81. NAFLD fibrosis score for diagnosing any fibrosis at increasing thresholds from −1.455 to 0.676

Figure 82. MR elastography for diagnosing any fibrosis

Figure 83. Transient elastography for diagnosing any fibrosis at increasing thresholds from 4.3 to 7.3

K.3.2.2. Area under the curve plots

Figure 84. ELF any fibrosis

Figure 85. Ferritin any fibrosis

Figure 86. MRE any fibrosis

Figure 87. TE any fibrosis

K.3.3. Diagnosing advanced fibrosis

K.3.3.1. Coupled sensitivity and specificity forest plots and pooled diagnostic meta-analysis plots

Figure 88. APRI for diagnosing advanced fibrosis at increasing thresholds from 0.5 to 1

Figure 89. Diagnostic meta-analysis of APRI at a threshold of 0.98–1 for diagnosing advanced fibrosis

Figure 90. AST/ALT ratio for diagnosing advanced fibrosis at increasing thresholds from 0.67 to 1.6

Figure 91. Diagnostic meta-analysis of AST/ALT ratio at a threshold of 0.8 for diagnosing advanced fibrosis

Figure 92. Diagnostic meta-analysis of AST/ALT ratio at a threshold of 1 for diagnosing advanced fibrosis

Figure 93. BARD for diagnosing advanced fibrosis

Figure 94. Diagnostic meta-analysis of BARD at a threshold of 2 for diagnosing advanced fibrosis

Figure 95. ELF for diagnosing advanced fibrosis at increasing thresholds from -3.37 to 10.51

Figure 96. ELF + NAFLD fibrosis score for diagnosing advanced fibrosis at increasing thresholds from -0.2826 to 0.0033

Figure 97. Ferritin for diagnosing advanced fibrosis at increasing thresholds from 250 to 500

Figure 98. FIB-4 for diagnosing advanced fibrosis at increasing thresholds from 1.3 to 3.25

Figure 99. Diagnostic meta-analysis of FIB-4 at a threshold of 1.3 for diagnosing advanced fibrosis

Figure 100. Diagnostic meta-analysis of FIB-4 at a threshold of 2.67 for diagnosing advanced fibrosis

Figure 101. Diagnostic meta-analysis of FIB-4 at a threshold of 3.25 for diagnosing advanced fibrosis

Figure 102. FibroTest for diagnosing advanced fibrosis at increasing thresholds from 0.3 to 0.7

Figure 103. NAFLD fibrosis score for diagnosing fibrosis at increasing thresholds from -2.16 to 0.735

Figure 104. Diagnostic meta-analysis of NAFLD fibrosis score at a threshold of −1.455 for diagnosing advanced fibrosis

Figure 105. Diagnostic meta-analysis of NAFLD fibrosis score at a threshold of 0.676 for diagnosing advanced fibrosis

Figure 106. ARFI for diagnosing advanced fibrosis at increasing thresholds from 1.77 to 4.24

Figure 107. MR elastography for diagnosing advanced fibrosis at increasing thresholds from 3.64 to 4.15

Figure 108. Transient elastography [M probe] for diagnosing advanced fibrosis at increasing thresholds from 7.8 to 12

Figure 109. Diagnostic meta-analysis of transient elastography with the M probe at a threshold range of 7.8–7.9 kPa for diagnosing advanced fibrosis

Figure 110. Diagnostic meta-analysis of transient elastography with the M probe at a threshold range of 8.7-9 kPa for diagnosing advanced fibrosis

Figure 111. Diagnostic meta-analysis of transient elastography with the M probe at a threshold range of 9.6-9.9 kPa for diagnosing advanced fibrosis

Figure 112. Transient elastography [XL probe] for diagnosing advanced fibrosis at increasing thresholds from 5.7 to 9.3

K.3.3.2. Area under the curve plots

Figure 113. APRI advanced fibrosis

Figure 114. AST/ALT ratio advanced fibrosis

Figure 115. BARD advanced fibrosis

Figure 116. ELF advanced fibrosis

Figure 117. ELF + NAFLD fibrosis score advanced fibrosis

Figure 118. Ferritin advanced fibrosis

Figure 119. FibroTest advanced fibrosis

Figure 120. FIB-4 advanced fibrosis

Figure 121. NAFLD fibrosis score advanced fibrosis

Figure 122. ARFI advanced fibrosis

Figure 123. MRE advanced fibrosis

Figure 124. TE advanced fibrosis

Figure 125. TE [XL probe] advanced fibrosis

K.4. Monitoring NAFLD progression

NB. The GDG requested that the forest plots be titled with ‘favouring’ indicating a higher chance of fibrosis progression, rather than indicating less likely to have a negative outcome as is the normal NGC practice.

K.4.1. Fibrosis progression rate: NAFLD patients (no fibrosis at baseline)

Figure 126. Fibrosis progression rate for NAFLD patients (no fibrosis at baseline)

K.4.2. Fibrosis progression rate: NAFL patients (no fibrosis at baseline)

Figure 127. Fibrosis progression rate for NAFL patients (no fibrosis at baseline)

K.4.3. Fibrosis progression rate: NASH (no fibrosis at baseline)

Figure 128. Fibrosis progression rate for NASH patients (no fibrosis at baseline)

K.4.4. Fibrosis progression rate: NAFLD (any fibrosis baseline status)

Figure 129. Fibrosis progression rate for NAFLD patients (any fibrosis at baseline)

K.4.5. Factors measured at baseline associated with change in biopsy fibrosis

Figure 130. HOMA-IR score>10 as a risk factor for fibrosis progression

Figure 131. Lobular deposition of fibronectin >1 at baseline as a risk factor for fibrosis progression

Figure 132. Hypertension as a risk factor for fibrosis progression

Figure 133. FIB-4 score at baseline as a risk factor for fibrosis progression

K.4.6. Factors measured at follow up associated with change in biopsy fibrosis

Figure 134. Change in HbA1C as a risk factor for fibrosis regression

Figure 135. Treatment with insulin as a risk factor for fibrosis regression

Figure 136. Diabetes type 2 as a risk factor for fibrosis progression

Figure 137. Change in waist circumference from baseline for predicting NAFLD progression (OR for each 1 cm increment)

Figure 138. High baseline low density lipoprotein-cholesterol as a risk factor for fibrosis progression

Figure 139. FIB-4 score at follow up as a risk factor for fibrosis progression

K.5. Extra-hepatic conditions

K.5.1. Cardiovascular disease

K.5.1.1. Atrial fibrillation

Figure 140. NAFLD as a risk factor for atrial fibrillation in people with diabetes

K.5.1.2. Cardiovascular events

Figure 141. Hepatic steatosis as a risk factor for cardiovascular events

Figure 142. Fat content as a risk factor for cardiovascular events

Figure 143. Hepatic steatosis as a risk factor for cardiovascular events in people with Type 2 diabetes

K.5.1.3. Cardiovascular mortality

Figure 144. NAFLD as a risk factor for cardiovascular-related death

Figure 145. NASH as a risk factor for cardiovascular-related death

Figure 146. Advanced fibrosis as a risk factor for cardiovascular-related death in people with dyslipidaemia and/or type 2 diabetes

Figure 147. Severe steatosis as a risk factor for cardiovascular-related death in people with dyslipidaemia and/or type 2 diabetes

K.5.1.4. Coronary artery disease

Figure 148. Fatty liver as a risk factor for coronary artery disease in people who have undergone coronary angiogram

K.5.1.5. Hypertension

Figure 149. Fatty liver + increased ALT as a risk factor for hypertension compared to no fatty liver and normal ALT

Figure 150. Fatty liver status over time as a risk factor for hypertension in comparison to those without fatty liver at baseline or follow-up

Figure 151. NAFLD as a risk factor for hypertension in men

K.5.2. Colorectal cancer

Figure 152. Fatty liver as a risk factor for colorectal cancer in women

Figure 153. NAFLD as a risk factor for colorectal adenoma

K.5.3. Diabetes

Figure 154. NAFLD as a risk factor for diabetes

Figure 155. Fatty liver as a risk factor for diabetes

Figure 156. NAFLD as a risk factor for diabetes in men

Figure 157. Fatty liver as a risk factor for diabetes according to gender

Figure 158. Severity of NAFLD and fibrosis score as a risk factor for diabetes in comparison with no NAFLD

Figure 159. NAFLD and high fibrosis score as a risk factor for diabetes in comparison with NAFLD and low fibrosis score

Figure 160. Improvement in NAFLD as a risk factor for diabetes in comparison with sustained NAFLD

Figure 161. Fatty liver as a risk factor for diabetes or impaired fasting glucose

K.5.4. Chronic kidney disease

Figure 162. NAFLD as a risk factor for chronic kidney disease in men

Figure 163. NAFLD as a risk factor for chronic kidney disease in people with type 2 diabetes

Figure 164. NAFLD as a risk factor for chronic kidney disease in people with either type 1 or type 2 diabetes

K.6. Dietary modification and supplements

K.6.1. Probiotics verses placebo or usual care: RCT

Figure 165. NAFLD progression; MRS hepatic triglyceride content (adults), ≥3 months to <12 months

Figure 166. NAFLD progression; transient elastography fibrosis score (adults), ≥3 months to <12 months

Figure 167. ALT (U/l) (adults), ≥3 months to <12 months

Figure 168. ALT (U/l) (children / young adults), ≥3 months to <12 months

Figure 169. AST (U/l) (adults), ≥3 months to <12 months

Figure 170. Weight (kg) adults, ≥3 months to <12 months

Figure 171. Weight loss (BMI at end of study) (children / young people), ≥3 months to <12 months

Figure 172. Any adverse event (adults), ≥3 months to <12 months

Figure 173. Serious adverse event (adults), ≥3 months to <12 months

K.6.2. Omega-3 fatty acids verses placebo or usual care: RCTs

Figure 174. NAFLD progression; liver fat (%) determined by MRS, (adults), ≥12 months

Figure 175. NAFLD progression; NAFLD fibrosis score, (adults), ≥12 months

Figure 176. NAFLD progression; composite of NAS ≤3/fibrosis unchanged and/or NAS decrease ≥2/fibrosis unchanged (adults), combined omega 3 doses (1800 mg/day and 2700 mg/day), ≥12 months

Figure 177. NAFLD progression; NAS ≤3/fibrosis unchanged, combined doses (adults), combined omega 3 doses (1800 mg/day and 2700 mg/day), ≥12 months

Figure 178. NAFLD progression; NAS decrease ≥2/ fibrosis unchanged, combined doses (adults), combined omega 3 doses (1800 mg/day and 2700 mg/day), ≥12 months

Figure 179. NAFLD progression; NAS, (adults), ≥12 months

Figure 180. NAFLD progression; % reduction in MRI hepatic fat fraction, (children and young people) ≥3 months to <12 months

Figure 181. ALT (U/l), (adults)

Figure 182. AST (U/l) (adults)

Figure 183. ALT (U/l) (children and young people), ≥3 months to <12 months

Figure 184. ALT (U/l) (children and young people), ≥12 months

Figure 185. Weight (kg) (adults), ≥12 months

Figure 186. Weight loss ≥5% (children and young people), 6 months

Figure 187. Final BMI levels (children and young people), 6 months

Figure 188. BMI reduction ≥5% (children and young people), 6 months

Figure 189. BMI (kg/m²) (children and young people) ≥12 months

Figure 190. Any adverse event (adults), combined omega 3 doses (1800 mg/day and 2700 mg/day), ≥12 months

Figure 191. Any adverse event (children and young people) Mild abdominal discomfort 6 months

Figure 192. Serious adverse event (adults), combined omega 3 doses (1800 mg/day and 2700 mg/day), ≥12 months

Figure 193. Severe adverse event (adults), combined omega 3 doses (1800 mg/day and 2700 mg/day), ≥12 months

K.7. Exercise interventions

K.7.1. Exercise versus control

Figure 194. NAFLD progression; MRS intrahepatic lipid CH₂-water or intrahepatic triglyceride (%) (adults), ≥3 months to <12 months

Figure 195. NAFLD progression; liver biopsy NAS (range 0 to 8) (adults), ≥3 months to <12 months

Figure 196. ALT levels (U/l) (adults), ≥3 months to <12 months

Figure 197. AST levels (U/l) (adults), ≥3 months to <12 months

Figure 198. Weight (kg) (adults), ≥3 months to <12 months

K.8. Lifestyle modification

K.8.1. Lifestyle modification (any diet plus exercise plus behavioural modification) versus control (usual care) (RCTs)

K.8.1.1. <12 months

Figure 199. NAS (0-8, final value)

Figure 200. Fat (0-3, final value)

Figure 201. Parenchymal inflammation (0-3, final value)

Figure 202. Ballooning injury (0-2, final value)

Figure 203. Fibrosis (0-4, final values)

K.8.1.2. >12 months

Figure 204. ALT levels (U/l, final values)

Figure 205. AST levels (U/l, final values)

Figure 206. Intrahepatic triglyceride (¹H-MRS) (%, final value)

Figure 207. Liver stiffness (ultrasound) (kPa, final value)

Figure 208. Body weight (kg, final value)

K.8.2. Lifestyle modification (any diet plus exercise plus behavioural modification) versus control (usual care) (cohort study) >12 months

Figure 209. ALT (U/l, final values)

Figure 210. AST (U/l, final values)

Figure 211. NAFLD (prevalence (ultrasound)

K.8.3. Diet and exercise versus control (usual care) (RCTs) >12 months

Figure 212. ALT (U/l, change scores)

Figure 213. AST (U/l, change score)

Figure 214. NAFLD activity score (0–8, change score)

Figure 215. Body weight (kg, change score)

K.8.4. Diet and exercise versus control (Chen 2008: no control details, Ueno 1997: usual care) (cohort studies) <12 months

Figure 216. ALT (U/l, final values)

Figure 217. AST (U/l, final values)

Figure 218. NAFLD progression with fibroscan (0–3 severity scale, final values)

Figure 219. Body weight (kg, final values)

K.8.5. Diet and exercise versus exercise (RCTs) <12 months

Figure 220. ALT (U/l, change score)

Figure 221. AST (U/l, change score)

Figure 222. NAFLD activity score (0–8, change score)

Figure 223. Body weight (kg, change score)

K.8.6. Diet and exercise versus exercise (cohort study) <12 months

Figure 224. ALT (U/l, final value)

Figure 225. AST (U/l, final value)

Figure 226. Body weight (kg, final value)

K.8.7. Diet and exercise versus diet (RCTs) <12 months

Figure 227. ALT (U/l, final values)

Figure 228. AST (U/l, final values)

K.9. Alcohol advice

K.9.1. Fibrosis progression

Figure 229. Heavy episodic drinking >1 a month (>60 g males/48 g females ethanol in one episode)

K.9.2. Presence of fatty liver disease

Figure 230. Light drinker (40-140 g ethanol/week)

Figure 231. Moderate drinker (140-280g ethanol/week)

K.10. Caffeine advice

Figure 232. Presence of NAFLD determined by ultrasound

Figure 233. Coffee consumption in people with NAFLD vs controls

K.11. Pharmacological interventions

K.11.1. Pioglitazone versus placebo for adults with NAFLD

K.11.1.1. Progression of NAFLD (CRITICAL)

Figure 234. Decrease in fibrosis [>12 months]

Figure 235. Increase in fibrosis [> 12 months]

Figure 236. Improvement in fibrosis [>12 months]

Figure 237. Reduction in fibrosis score of ≥2 [≥3 months to <12 months]

Figure 238. Reduction in fibrosis [≥3 months to <12 months]

Figure 239. Decrease in steatosis [>12 months]

Figure 240. Increase in steatosis score [> 12 months]

Figure 241. Improvement in steatosis [>12 months]

Figure 242. Reduction in steatosis score of ≥2 [≥3 months to <12 months]

Figure 243. Decrease in hepatocellular injury [>12 months]

Figure 244. Increase in hepatocellular injury [>12 months]

Figure 245. Improvement in hepatocellular ballooning [>12 months]

Figure 246. Improvement in ballooning necrosis [≥3 months to <12 months]

Figure 247. Decrease in lobular inflammation [>12 months]

Figure 248. Increase in lobular inflammation [>12 months]

Figure 249. Improvement in lobular inflammation [>12 months]

Figure 250. Improvement in lobular inflammation [≥3 months to <12 months]

Figure 251. Decrease in portal inflammation [>12 months]

Figure 252. Increase in portal inflammation [>12 months]

Figure 253. Decrease in Mallory-Denk bodies [>12 months]

Figure 254. Increase in Mallory-Denk bodies [>12 months]

Figure 255. Improvement in histologic features of the liver [>12 months]

Figure 256. Resolution of definite NASH [>12 months]

K.11.1.2. Serious adverse events (CRITICAL)

Figure 257. Severe adverse events [>12 months]

K.11.1.3. Liver function tests (IMPORTANT)

Figure 258. ALT levels – final values [>12 months]

Figure 259. ALT levels – final values [≥3 months to <12 months]

Figure 260. AST levels – final values [≥3 months to <12 months]

K.11.1.4. Adverse events (IMPORTANT)

Figure 261. Adverse cardiovascular events [>12 months]

K.11.2. Metformin versus placebo for adults with NAFLD

K.11.2.1. Progression of NAFLD (CRITICAL)

Figure 262. Proportion with improvement in NAFLD activity score [≥3 months to <12 months]

Figure 263. Proportion with improvement in fibrosis score [≥3 months to <12 months]

Figure 264. Proportion with improvement in steatosis [≥3 months to <12 months]

Figure 265. Proportion with improvement in lobular inflammation [≥3 months to <12 months]

Figure 266. Proportion with improvement in ballooning [≥3 months to <12 months]

K.11.2.2. Liver function test (IMPORTANT)

Figure 267. Final ALT levels [>12 months]

Figure 268. Final ALT levels [≥3 months to <12 months]

Figure 269. Final AST levels [>12 months]

Figure 270. Final AST levels [≥3 months to <12 months]

K.11.3. Metformin versus placebo for children and young people with NAFLD

K.11.3.1. Progression of NAFLD (CRITICAL)

Figure 271. Change in NAFLD activity score [>12 months]

Figure 272. Change in fibrosis score [>12 months]

Figure 273. Change in steatosis score [>12 months]

Figure 274. Change in ballooning degeneration score [>12 months]

Figure 275. Change in lobular inflammation score [>12 months]

Figure 276. Resolution of NASH [>12 months]

K.11.3.2. Quality of life (CRITICAL)

Figure 277. Change in parent-reported paediatric QOL-physical inventory [>12 months]

Figure 278. Change in children's self-reported paediatric QOL-physical inventory [>12 months]

Figure 279. Change in parent-reported paediatric QOL-psychosocial inventory [>12 months]

Figure 280. Change in children's self-reported paediatric QOL- psychosocial inventory [>12 months]

K.11.3.3. Liver function tests (IMPORTANT)

Figure 281. ALT levels [>12 months]

Figure 282. ALT levels [≥3 months to <12 months]

Figure 283. AST levels [>12 months]

Figure 284. AST levels [≥3 months to <12 months]

K.11.4. Vitamin E versus placebo for adults with NAFLD

K.11.4.1. Progression of NAFLD (CRITICAL)

Figure 285. Improvement in histologic features of the liver [>12 months]

Figure 286. Improvement in steatosis [>12 months]

Figure 287. Improvement in lobular inflammation [>12 months]

Figure 288. Improvement in hepatocellular ballooning [>12 months]

Figure 289. Improvement in fibrosis [>12 months}

Figure 290. Resolution of definite NASH [>12 months]

K.11.4.2. Serious adverse events (CRITICAL)

Figure 291. Serious adverse events [>12 months]

K.11.4.3. Mortality (CRITICAL)

Figure 292. Mortality [>12 months]

K.11.4.4. Adverse events (IMPORTANT)

Figure 293. Adverse cardiovascular events [>12 months]

K.11.5. Vitamin E versus placebo for children and young people with NAFLD

K.11.5.1. Progression of NAFLD (CRITICAL)

Figure 294. Change in NAFLD activity score [>12 months]

Figure 295. Change in fibrosis score [>12 months]

Figure 296. Change in ballooning degeneration score [>12 months]

Figure 297. Change in lobular inflammation score [>12 months]

Figure 298. Resolution of NASH [>12 months]

K.11.5.2. Quality of life (CRITICAL)

Figure 299. Change in parent-reported paediatric QOL-physical inventory [>12 months]

Figure 300. Change in children's self-reported paediatric QOL-physical inventory [>12 months]

Figure 301. Change in parent-reported paediatric QOL-psychosocial inventory [>12 months]

Figure 302. Change in children's self-reported paediatric QOL- psychosocial inventory [>12 months]

K.11.5.3. Liver function tests (IMPORTANT)

Figure 303. Change in ALT levels [>12 months]

Figure 304. Change in ALT levels [≥3 months to <12 months]

Figure 305. Change in AST levels [>12 months]

K.11.6. Ursodeoxycholic acid (UCDA) versus placebo for adults with NAFLD

K.11.6.1. Progression of NAFLD (CRITICAL)

Figure 306. Change in NAFLD activity score [>12 months]

Figure 307. Change in fibrosis [>12 months]

Figure 308. Change in steatosis [>12 months]

Figure 309. Final steatosis values [>12 months]

Figure 310. Change in ballooning [>12 months]

Figure 311. Change in lobular inflammation [>12 months]

Figure 312. Change in hepatic density [>12 months]

K.11.6.2. Liver function tests (IMPORTANT)

Figure 313. Normalised ALT levels [>12 months]

Figure 314. Change in ALT levels [>12 months]

Figure 315. Normalised ALT levels [≥3 months to <12 months]

Figure 316. Final ALT levels [≥3 months to <12 months]

Figure 317. Change in AST levels [>12 months]

K.11.7. Pentoxifylline versus placebo for adults with NAFLD

K.11.7.1. Progression of NAFLD (CRITICAL)

Figure 318. NAFLD activity score decreased by ≥2 points [>12 months]

Figure 319. Change in NAFLD activity score [>12 months]

Figure 320. Change in fibrosis [>12 months]

Figure 321. Change in steatosis [>12 months]

Figure 322. Change in ballooning [>12 months]

Figure 323. Change in lobular inflammation [>12 months]

K.11.7.2. Liver function tests (IMPORTANT)

Figure 324. Normalisation in ALT levels [>12 months]

Figure 325. Change in ALT levels [>12 months]

Figure 326. Final ALT levels [≥3 months to <12 months]

Figure 327. Normalisation of AST levels [>12 months]

Figure 328. Change in AST levels [>12 months]

Figure 329. Final AST levels [≥3 months to <12 months]

K.11.7.3. Adverse events (IMPORTANT)

Figure 330. Adverse events [>12 months]

K.11.8. Statins versus placebo for adults with NAFLD

K.11.8.1. Progression of NAFLD (CRITICAL)

Figure 331. Final fibrosis stage [>12 months]

Figure 332. Final percentage of steatosis [>12 months]

Figure 333. Necroinflammatory activity [>12 months]

K.11.8.2. Progression of NAFLD (CRITICAL)

Figure 334. Final ALT levels [>12 months]

Figure 335. Final AST levels [>12 months]

K.11.9. Orlistat versus placebo for adults with NAFLD

K.11.9.1. Progression of NAFLD (CRITICAL)

Figure 336. ≥1 degree of improvement in fibrosis [≥3 months to <12 months]

Figure 337. Improved steatosis [≥3 months to <12 months]

Figure 338. Reversal of fatty liver [≥3 months to <12 months]

K.11.9.2. Liver function tests (IMPORTANT)

Figure 339. Change in ALT levels [>12 months]

Figure 340. Change in AST levels [>12 months]

K.11.10. Pioglitazone versus Metformin for adults with NAFLD

K.11.10.1. Liver function tests (IMPORTANT)

Figure 341. Change in ALT levels [>12 months]

Figure 342. Change in AST levels [>12 months]

K.11.11. Pioglitazone versus Vitamin E for adults with NAFLD

K.11.11.1. Progression of NAFLD (CRITICAL)

Figure 343. Improvement in histologic features of the liver [>12 months]

Figure 344. Improvement in steatosis [>12 months]

Figure 345. Improvement in lobular inflammation [>12 months]

Figure 346. Improvement in hepatocellular inflammation [>12 months]

Figure 347. Improvement in fibrosis [>12 months]

Figure 348. Resolution of definite NASH [>12 months]

K.11.11.2. Mortality (CRITICAL)

Figure 349. Mortality [>12 months]

K.11.11.3. Serious adverse events (CRITICAL)

Figure 350. Serious adverse events [>12 months]

K.11.11.4. Adverse events (IMPORTANT)

Figure 351. Adverse cardiovascular events [>12 months]

K.11.12. Metformin versus Vitamin E for adults with NAFLD

K.11.12.1. Liver function tests (IMPORTANT)

Figure 352. Normalised ALT levels [>12 months]

K.11.13. Metformin versus Vitamin E for children and young people with NAFLD

K.11.13.1. Health related quality of life (CRITICAL)

Figure 353. Change in self-reported paediatric QoL Inventory (physical, 0-100) [>12 months]

Figure 354. Change in self-reported paediatric QoL Inventory (psychological 0-100) [>12 months]

Figure 355. Change in parent/guardian-reported paediatric QoL Inventory (physical, 0-100) [>12 months]

Figure 356. Change in Parent/guardian-reported paediatric QoL Inventory (physical, 0-100) [>12 months]

K.11.13.2. Progression of NAFLD (CRITICAL)

Figure 357. Change in fibrosis score [>12 months]

Figure 358. Change in steatosis score [>12 months]

Figure 359. Change in lobular inflammation score [>12 months]

Figure 360. Change in ballooning degeneration score [>12 months]

Figure 361. Change in NAFLD activity score [>12 months

Figure 362. Resolution of NASH [>12 months]

Figure 363. Remission of NAFLD (ultrasound), Metformin 1g/day [<12 months]

Figure 364. Remission of NAFLD (ultrasound), Metformin 1.5g/day [<12 months]

K.11.13.3. Liver function tests (IMPORTANT)

Figure 365. Change in triglycerides [≥3 months to <12 months]

Figure 366. Change in ALT levels [>12 months]

Figure 367. Change in AST levels [>12 months]

K.11.13.4. Adverse events (IMPORTANT)

Figure 368. Adverse events [≥3 months to <12 months]

K.11.14. Pentoxifylline versus Pioglitazone for adults with NAFLD

K.11.14.1. Progression of NAFLD (CRITICAL)

Figure 369. Final fibrosis stage [≥3 months to <12 months]

Figure 370. Final steatosis grade [≥3 months to <12 months]

Figure 371. Final hepatocellular ballooning [≥3 months to <12 months]

Figure 372. Final lobular inflammation [≥3 months to <12 months]

K.11.14.2. Liver function tests (IMPORTANT)

Figure 373. Final ALT levels [≥3 months to <12 months]

Figure 374. Final AST levels [≥3 months to <12 months]

K.11.15. UDCA + Vitamin E versus UDCA alone for adults with NAFLD

K.11.15.1. Progression of NAFLD (CRITICAL)

Figure 375. Final steatosis value [>12 months]

K.11.16. UDCA + Vitamin E versus Placebo alone for adults with NAFLD

K.11.16.1. Progression of NAFLD (CRITICAL)

Figure 376. Final steatosis value [>12 months]

K.11.17. Orlistat + Vitamin E versus Vitamin E alone for adults with NAFLD

K.11.17.1. Liver function tests (IMPORTANT)

Figure 377. Final ALT levels [≥3 months to <12 months]

Figure 378. Final AST levels [≥3 months to <12 months]

K.11.18. Pioglitazone + Vitamin E versus Vitamin E alone for adults with NAFLD

K.11.18.1. Liver function tests (IMPORTANT)

Figure 379. Normalisation of ALT levels [≥3 months to <12 months]

Bookshelf ID: NBK384711

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