Oral Intake of Royal Jelly Has Protective Effects Against Tyrosine Kinase Inhibitor-Induced Toxicity in Patients with Renal Cell Carcinoma: A Randomized, Double-Blinded, Placebo-Controlled Trial

Round 1

Reviewer 1 Report

This study is well designed and performed. Although the number of patient is low, as the authors discussed it could be improved later by another clinical trail.

Author Response

We thank you for evaluating our manuscript. We agree with your opinions and your advice has helped us greatly improve the manuscript. Our responses to your comments are provided below (page and line numbers in the revised version of the manuscript are indicated). In addition, the manuscript has been proofread by a native English-speaking editor from a professional English language editing service.

Although the number of patient is low, as the authors discussed it could be improved later by another clinical trial.

We agree with your opinion. According to your suggestion, we added comments on the number of patients in other trials, in addition to ours (Discussion; 5th. paragraph, lines 4 – 6).

Reviewer 2 Report

Authors hypothesizted protective effects of royal jelly (RJ) on TKI-induced toxicities in renal cell carcinoma, and recruited 33 patients for a randomized, double-blinded, placebo-controlled trial consisting of 17 placebo- and 16 RJ-treated subjects. Authors pointed out that fatigue and anorexia frequencies were significantly lower in the RJ group, and also TKI dose reduction or discontinuation was significantly lower in the RJ group. The presented data clearly evidence that RJ is beneficial for maintaining the quality of life and medication compliance in TKI-treated RCC patients.

The Introduction contains all required information to introduce the study, the methods are described in sufficient details, the results are presented in sufficient quality and described in enough details. The Discussion is appropriate and contains also the possible limitations of the study.

Author Response

Authors hypothesizted protective effects of royal jelly (RJ) on TKI-induced toxicities in renal cell carcinoma, and recruited 33 patients for a randomized, double-blinded, placebo-controlled trial discontinuation was significantly lower in the RJ group. The presented data clearly evidence that RJ is beneficial for maintaining the quality of life and medication compliance in TKI-treated RCC patients. The Introduction contains all required information to introduce the study, the methods are described in sufficient details, the results are presented in sufficient quality and described in enough details. The Discussion is appropriate and contains also the possible limitations of the study.

We thank you for evaluating our manuscript and providing encouraging comments. According to your suggestion, the manuscript has been proofread by a native English-speaking editor from a professional English language editing service.