Title: Randomised clinical trial: 3-year interim analysis results of the VISION trial to
evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive
oesophagitis
Version: 1 Date: 14 Dec 2022
Reviewer's report:
Randomized clinical trial: 3-year interim analysis results of the VISION trial to evaluate the
long-term safety of vonoprazan as maintenance treatment in patients with erosive oesophagits.
The study design was straightforward and the writing was clear and professional, although a
few details are required to be added. I have several comments as follows. This study mainly
evaluated histopathological change of the gastric mucosal under 3-year maintenance therapy,
which showed no neoplastic/dysplastic alteration of epithelial cells.
1. The authors should mention the histological evaluation method, at least clarify the biopsy
position (e.g. antrum or fornix) and add “Gastrin” in line 180.
2. The definition of G-cell hyperplasia, atrophy ECM and hyperplastic ECM was unclear.  Some
of patients (VPZ:32.8%, LPZ: 25.4%) exhibited G-cell hyperplasia at the start of healing phase.
Was G-cell hyperplasia recognized in control as well?
3. The authors concluded that no neoplastic/dysplastic alteration of epithelial cells in
pathological examination, however, one patient presented foveolar-type adenoma at week 156.
The authors should mention about this patient.
4. 10 patients (7.4%) in the vonoprazan group discontinued treatment because of AE. This should
be mentioned in detail and discussed to evaluate the long-term safety of vonoprazan.
5. The authors showed that pepsinogen I and pepsinogen II were elevated (Figs. 5,6,8). If any
speculation, it would be better to discuss it.
Title: Randomised clinical trial: 3-year interim analysis results of the VISION trial to
evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive
oesophagitis
Version: 1 Date: 14 Dec 2022
Reviewer's report:
Randomized clinical trial: 3-year interim analysis results of the VISION trial to evaluate the
long-term safety of vonoprazan as maintenance treatment in patients with erosive oesophagits.
The study design was straightforward and the writing was clear and professional, although a
few details are required to be added. I have several comments as follows. This study mainly
evaluated histopathological change of the gastric mucosal under 3-year maintenance therapy,
which showed no neoplastic/dysplastic alteration of epithelial cells.
1. The authors should mention the histological evaluation method, at least clarify the biopsy
position (e.g. antrum or fornix) and add “Gastrin” in line 180.
2. The definition of G-cell hyperplasia, atrophy ECM and hyperplastic ECM was unclear.  Some
of patients (VPZ:32.8%, LPZ: 25.4%) exhibited G-cell hyperplasia at the start of healing phase.
Was G-cell hyperplasia recognized in control as well?
3. The authors concluded that no neoplastic/dysplastic alteration of epithelial cells in
pathological examination, however, one patient presented foveolar-type adenoma at week 156.
The authors should mention about this patient.
4. 10 patients (7.4%) in the vonoprazan group discontinued treatment because of AE. This should
be mentioned in detail and discussed to evaluate the long-term safety of vonoprazan.
5. The authors showed that pepsinogen I and pepsinogen II were elevated (Figs. 5,6,8). If any
speculation, it would be better to discuss it.
Please review this paper.
user
Title: Randomised clinical trial: 3-year interim analysis results of the VISION trial to
evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive
oesophagitis
Version: 1 Date: 14 Dec 2022
Reviewer's report:
Randomized clinical trial: 3-year interim analysis results of the VISION trial to evaluate the
long-term safety of vonoprazan as maintenance treatment in patients with erosive oesophagits.
The study design was straightforward and the writing was clear and professional, although a
few details are required to be added. I have several comments as follows. This study mainly
evaluated histopathological change of the gastric mucosal under 3-year maintenance therapy,
which showed no neoplastic/dysplastic alteration of epithelial cells.
1. The authors should mention the histological evaluation method, at least clarify the biopsy
position (e.g. antrum or fornix) and add “Gastrin” in line 180.
2. The definition of G-cell hyperplasia, atrophy ECM and hyperplastic ECM was unclear.  Some
of patients (VPZ:32.8%, LPZ: 25.4%) exhibited G-cell hyperplasia at the start of healing phase.
Was G-cell hyperplasia recognized in control as well?
3. The authors concluded that no neoplastic/dysplastic alteration of epithelial cells in
pathological examination, however, one patient presented foveolar-type adenoma at week 156.
The authors should mention about this patient.
4. 10 patients (7.4%) in the vonoprazan group discontinued treatment because of AE. This should
be mentioned in detail and discussed to evaluate the long-term safety of vonoprazan.
5. The authors showed that pepsinogen I and pepsinogen II were elevated (Figs. 5,6,8). If any
speculation, it would be better to discuss it.
assistant