Journal of Traditional Chinese Medicine ›› 2024, Vol. 44 ›› Issue (6): 1254-1267.DOI: 10.19852/j.cnki.jtcm.20240806.005
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Clinical efficacy and safety evaluation of Buzhongyiqi pills (补中益气丸) on appetite improvement in patients with colorectal cancer receiving chemotherapy: a pilot randomized cross-over clinical trial
QIAN Jianan1,2, XU Yan3, HU Hongyi4(
), ZHAO Aiguang3()
- 1 Department of Gastroenterology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China
2 Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
3 Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
4 Department of Gastroenterology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
-
Received:2023-05-02Accepted:2023-09-02Online:2024-12-15Published:2024-08-06 -
Contact:ZHAO Aiguang, Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. aiguangzhao@qq.com Telephone: +86-18918799919; +86-13661472241
HU Hongyi, Department of Gastroenterology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. hongyihu2003@shutcm.edu.cn -
Supported by:Shanghai Municipal Administrator of Traditional Chinese Medicine-funded Project: Ding’s Clinical Medicine Huang Wendong Base Li Dongyuan "Yin Fire" Theory Inheritance and Innovation Team(2021LPTD-009)
Cite this article
QIAN Jianan, XU Yan, HU Hongyi, ZHAO Aiguang. Clinical efficacy and safety evaluation of Buzhongyiqi pills (补中益气丸) on appetite improvement in patients with colorectal cancer receiving chemotherapy: a pilot randomized cross-over clinical trial[J]. Journal of Traditional Chinese Medicine, 2024, 44(6): 1254-1267.
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Table 1 EORTC QLQ-C30 (V3.0) subscales and scoring methods
| Scales | Category | Number of items | Scoring range | Scoring formula |
|---|---|---|---|---|
| Physical functioning | Multi-item functional scales | 5 | 3 | (Q1+Q2+Q3+Q4+Q5)/5 |
| Role functioning | 2 | 3 | (Q6+Q7)/2 | |
| Emotional functioning | 4 | 3 | (Q21+Q22+Q23+Q24)/4 | |
| Cognitive functioning | 2 | 3 | (Q20+Q25)/2 | |
| Social activity | 2 | 3 | (Q26+Q27)/2 | |
| Global health | A global health status sub-scale | 2 | 6 | (Q29+Q30)/2 |
| Fatigue | Multi-item symptom scales | 3 | 3 | (Q10+Q12+Q18)/3 |
| Nausea and vomiting | 2 | 3 | (Q14+Q15)/2 | |
| Pain | 2 | 3 | (Q9+Q19)/2 | |
| Dyspnea | Single items | 1 | 3 | Q8 |
| Insomnia | 1 | 3 | Q11 | |
| Appetite loss | 1 | 3 | Q13 | |
| Constipation | 1 | 3 | Q16 | |
| Diarrhea | 1 | 3 | Q17 | |
| Financial difficulties | 1 | 3 | Q28 |
Table 1 EORTC QLQ-C30 (V3.0) subscales and scoring methods
| Scales | Category | Number of items | Scoring range | Scoring formula |
|---|---|---|---|---|
| Physical functioning | Multi-item functional scales | 5 | 3 | (Q1+Q2+Q3+Q4+Q5)/5 |
| Role functioning | 2 | 3 | (Q6+Q7)/2 | |
| Emotional functioning | 4 | 3 | (Q21+Q22+Q23+Q24)/4 | |
| Cognitive functioning | 2 | 3 | (Q20+Q25)/2 | |
| Social activity | 2 | 3 | (Q26+Q27)/2 | |
| Global health | A global health status sub-scale | 2 | 6 | (Q29+Q30)/2 |
| Fatigue | Multi-item symptom scales | 3 | 3 | (Q10+Q12+Q18)/3 |
| Nausea and vomiting | 2 | 3 | (Q14+Q15)/2 | |
| Pain | 2 | 3 | (Q9+Q19)/2 | |
| Dyspnea | Single items | 1 | 3 | Q8 |
| Insomnia | 1 | 3 | Q11 | |
| Appetite loss | 1 | 3 | Q13 | |
| Constipation | 1 | 3 | Q16 | |
| Diarrhea | 1 | 3 | Q17 | |
| Financial difficulties | 1 | 3 | Q28 |
Figure 1 Flow chart of the study Note: placebo-BZYQP: treated with placebo during the first three cycles of chemotherapy and with Buzhongyiqi pills during the last three cycles of chemotherapy; BZYQP-placebo: treated with Buzhongyiqi pills during the first three cycles of chemotherapy and with placebo during the last three cycles of chemotherapy. BZYQP: Buzhongyiqi pills; ECOG PS: Eastern Cooperative Oncology Group performance status; BMI: body mass index; SNAQ: simplified nutrition appetite questionnaire; EORTC QLQ-C30 (V3.0): the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (version 3.0); ECG: electrocardiogram; CTCAE: Common Terminology Criteria for Adverse Events; AEs: adverse events.
Figure 1 Flow chart of the study Note: placebo-BZYQP: treated with placebo during the first three cycles of chemotherapy and with Buzhongyiqi pills during the last three cycles of chemotherapy; BZYQP-placebo: treated with Buzhongyiqi pills during the first three cycles of chemotherapy and with placebo during the last three cycles of chemotherapy. BZYQP: Buzhongyiqi pills; ECOG PS: Eastern Cooperative Oncology Group performance status; BMI: body mass index; SNAQ: simplified nutrition appetite questionnaire; EORTC QLQ-C30 (V3.0): the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (version 3.0); ECG: electrocardiogram; CTCAE: Common Terminology Criteria for Adverse Events; AEs: adverse events.
Table 2 Baseline characteristics of all patients
| Variable | Placebo-BZYQP (n = 29) [n (%)] | BZYQP-Placebo (n = 33) [n (%)] | P value | |
|---|---|---|---|---|
| Age (years) | <50 | 7 (11.3) | 9 (14.5) | 0.165 |
| ≥50 | 22 (35.5) | 24 (38.7) | ||
| 61.79±8.99 | 59.55±8.98 | 0.330 | ||
| Sex | Male | 17 (27.4) | 23 (37.1) | 0.363 |
| Female | 12 (19.4) | 10 (16.1) | ||
| Diagnosis | Colon cancer (right) | 7 (11.3) | 6 (9.7) | 0.225 |
| Colon cancer (left) | 15 (24.2) | 12 (19.4) | ||
| Rectal cancer | 7 (11.3) | 15 (24.2) | ||
| Stage | Ⅱa | 2 (3.2) | 5 (8.1) | 0.577 |
| Ⅲ | 22 (35.5) | 21 (33.9) | ||
| Ⅳ | 5 (8.1) | 7 (11.3) | ||
| Surgical situation | postoperative | 24 (82.8) | 26 (78.8) | 0.693 |
| non-operative | 5 (17.2) | 7 (21.2) | ||
| ECOG PS | 0 | 5 (17.2) | 8 (24.2) | 0.713 |
| 1 | 20 (69.0) | 22 (66.7) | ||
| 2 | 4 (13.8) | 3 (9.0) | ||
| Height (cm) | 162.12±8.31 | 162.54±7.92 | 0.631 | |
| Weight (kg) | 63.13±10.76 | 63.91±10.12 | 0.991 | |
| BMI (kg/m2) | 24.02±3.71 | 24.19±3.93 | 0.773 | |
| SNAQ | SNAQ score | 14.00±0.96 | 14.15±0.91 | 0.526 |
| SNAQ item 1 | 3.34±0.61 | 3.27±0.45 | 0.598 | |
| SNAQ item 2 | 3.55±0.51 | 3.76±0.44 | 0.090 | |
| SNAQ item 3 | 3.00±0.38 | 3.18±0.47 | 0.099 | |
| SNAQ item 4 | 4.10±0.41 | 3.94±0.24 | 0.056 | |
| EORTC QLQ C30 (V3.0) | PF | 2 (1.4) | 1.6 (1.6) | 0.092 |
| RF | 3.5 (1.5) | 2.0 (1.5) | 0.195 | |
| EF | 2.0 (0.5) | 1.75 (0.75) | 0.057 | |
| CF | 2.5 (1.0) | 2.0 (0.5) | 0.916 | |
| SA | 3.0 (0) | 3.0 (0) | 0.578 | |
| GH | 4.5 (0.8) | 5.0 (0.5) | 0.070 | |
| FA | 2.67 (0.67) | 2.67 (0.0) | 0.475 | |
| NV | 2.5 (1.5) | 1.5 (1.5) | 0.173 | |
| PA | 3.0 (1.5) | 2.0 (2.0) | 0.059 | |
| DY | 1.0 (1.0) | 2.0 (1.0) | 0.091 | |
| SL | 1.0 (2.0) | 3.0 (2.0) | 0.198 | |
| AL | 1.0 (1.0) | 1.0 (1.0) | 0.070 | |
| CO | 1.0 (1.0) | 1. 0 (0.0) | 0.164 | |
| DI | 1.0 (1.0) | 1.0 (0.0) | 0.128 | |
| FD | 2.0 (0.0) | 2.0 (1.0) | 0.200 |
Table 2 Baseline characteristics of all patients
| Variable | Placebo-BZYQP (n = 29) [n (%)] | BZYQP-Placebo (n = 33) [n (%)] | P value | |
|---|---|---|---|---|
| Age (years) | <50 | 7 (11.3) | 9 (14.5) | 0.165 |
| ≥50 | 22 (35.5) | 24 (38.7) | ||
| 61.79±8.99 | 59.55±8.98 | 0.330 | ||
| Sex | Male | 17 (27.4) | 23 (37.1) | 0.363 |
| Female | 12 (19.4) | 10 (16.1) | ||
| Diagnosis | Colon cancer (right) | 7 (11.3) | 6 (9.7) | 0.225 |
| Colon cancer (left) | 15 (24.2) | 12 (19.4) | ||
| Rectal cancer | 7 (11.3) | 15 (24.2) | ||
| Stage | Ⅱa | 2 (3.2) | 5 (8.1) | 0.577 |
| Ⅲ | 22 (35.5) | 21 (33.9) | ||
| Ⅳ | 5 (8.1) | 7 (11.3) | ||
| Surgical situation | postoperative | 24 (82.8) | 26 (78.8) | 0.693 |
| non-operative | 5 (17.2) | 7 (21.2) | ||
| ECOG PS | 0 | 5 (17.2) | 8 (24.2) | 0.713 |
| 1 | 20 (69.0) | 22 (66.7) | ||
| 2 | 4 (13.8) | 3 (9.0) | ||
| Height (cm) | 162.12±8.31 | 162.54±7.92 | 0.631 | |
| Weight (kg) | 63.13±10.76 | 63.91±10.12 | 0.991 | |
| BMI (kg/m2) | 24.02±3.71 | 24.19±3.93 | 0.773 | |
| SNAQ | SNAQ score | 14.00±0.96 | 14.15±0.91 | 0.526 |
| SNAQ item 1 | 3.34±0.61 | 3.27±0.45 | 0.598 | |
| SNAQ item 2 | 3.55±0.51 | 3.76±0.44 | 0.090 | |
| SNAQ item 3 | 3.00±0.38 | 3.18±0.47 | 0.099 | |
| SNAQ item 4 | 4.10±0.41 | 3.94±0.24 | 0.056 | |
| EORTC QLQ C30 (V3.0) | PF | 2 (1.4) | 1.6 (1.6) | 0.092 |
| RF | 3.5 (1.5) | 2.0 (1.5) | 0.195 | |
| EF | 2.0 (0.5) | 1.75 (0.75) | 0.057 | |
| CF | 2.5 (1.0) | 2.0 (0.5) | 0.916 | |
| SA | 3.0 (0) | 3.0 (0) | 0.578 | |
| GH | 4.5 (0.8) | 5.0 (0.5) | 0.070 | |
| FA | 2.67 (0.67) | 2.67 (0.0) | 0.475 | |
| NV | 2.5 (1.5) | 1.5 (1.5) | 0.173 | |
| PA | 3.0 (1.5) | 2.0 (2.0) | 0.059 | |
| DY | 1.0 (1.0) | 2.0 (1.0) | 0.091 | |
| SL | 1.0 (2.0) | 3.0 (2.0) | 0.198 | |
| AL | 1.0 (1.0) | 1.0 (1.0) | 0.070 | |
| CO | 1.0 (1.0) | 1. 0 (0.0) | 0.164 | |
| DI | 1.0 (1.0) | 1.0 (0.0) | 0.128 | |
| FD | 2.0 (0.0) | 2.0 (1.0) | 0.200 |
Table 3 Tests of within-subjects effects at Visit 0 to Visit 5
| Source | Sum of squares | df | Mean squares | F value | P value |
|---|---|---|---|---|---|
| Visit point | 75.840 | 1.000 | 75.840 | 14.952 | < 0.001 |
| Visit point * group | 682.722 | 1.000 | 682.722 | 134.595 | < 0.001 |
| Error (visit point) | 304.345 | 60.000 | 5.072 |
Table 3 Tests of within-subjects effects at Visit 0 to Visit 5
| Source | Sum of squares | df | Mean squares | F value | P value |
|---|---|---|---|---|---|
| Visit point | 75.840 | 1.000 | 75.840 | 14.952 | < 0.001 |
| Visit point * group | 682.722 | 1.000 | 682.722 | 134.595 | < 0.001 |
| Error (visit point) | 304.345 | 60.000 | 5.072 |
Table 4 Change in SNAQ score between treatment groups at Visit 0 to Visit 5
| Variable | Visit point | Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value |
|---|---|---|---|---|
| SNAQ score (V0) | baseline, Pre cycle 1 | 14.0±1.0 | 14.1±0.9 | 0.526 |
| SNAQ score (V01) | Post cycle 1 | 11.9±1.8 | 15.2±1.4 | < 0.001a |
| SNAQ score (V02) | Pre cycle 2 | 12.0±1.6 | 15.2±0.9 | < 0.001a |
| SNAQ score (V03) | Post cycle 2 | 10.7±1.5 | 14.9±0.6 | < 0.001a |
| SNAQ score (V04) | Pre cycle 3 | 10.6±2.1 | 17.6±0.8 | < 0.001a |
| SNAQ score (V05) | Post cycle 3 | 9.1±1.8 | 17.6±1.7 | < 0.001a |
Table 4 Change in SNAQ score between treatment groups at Visit 0 to Visit 5
| Variable | Visit point | Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value |
|---|---|---|---|---|
| SNAQ score (V0) | baseline, Pre cycle 1 | 14.0±1.0 | 14.1±0.9 | 0.526 |
| SNAQ score (V01) | Post cycle 1 | 11.9±1.8 | 15.2±1.4 | < 0.001a |
| SNAQ score (V02) | Pre cycle 2 | 12.0±1.6 | 15.2±0.9 | < 0.001a |
| SNAQ score (V03) | Post cycle 2 | 10.7±1.5 | 14.9±0.6 | < 0.001a |
| SNAQ score (V04) | Pre cycle 3 | 10.6±2.1 | 17.6±0.8 | < 0.001a |
| SNAQ score (V05) | Post cycle 3 | 9.1±1.8 | 17.6±1.7 | < 0.001a |
Table 5 Tests of within-subjects effects at Visit 6 to Visit 11
| Source | Sum of squares | df | Mean squares | F value | P value |
|---|---|---|---|---|---|
| Visit point | 90.727 | 1.000 | 90.727 | 22.951 | < 0.001 |
| Visit point * group | 967.845 | 1.000 | 967.845 | 244.828 | < 0.001 |
| Error (visit point) | 237.189 | 60.000 | 3.953 |
Table 5 Tests of within-subjects effects at Visit 6 to Visit 11
| Source | Sum of squares | df | Mean squares | F value | P value |
|---|---|---|---|---|---|
| Visit point | 90.727 | 1.000 | 90.727 | 22.951 | < 0.001 |
| Visit point * group | 967.845 | 1.000 | 967.845 | 244.828 | < 0.001 |
| Error (visit point) | 237.189 | 60.000 | 3.953 |
Table 6 Change in SNAQ score between treatment groups at Visit 6 to Visit 11
| Variables | Visit point | Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value |
|---|---|---|---|---|
| SNAQ score (V06) | after Washout Period, Pre cycle 4 | 11.0±1.9 | 17.3±2.0 | < 0.001a |
| SNAQ score (V07) | Post cycle 4 | 11.5±1.8 | 14.6±1.3 | < 0.001a |
| SNAQ score (V08) | Pre cycle 5 | 14.0±1.6 | 14.6±1.4 | 0.148 |
| SNAQ score (V09) | Post cycle 5 | 13.4±1.6 | 13.2±1.5 | 0.667 |
| SNAQ score (V10) | Pre cycle 6 | 14.4±2.1 | 12.8±1.1 | < 0.001a |
| SNAQ score (V11) | Post cycle 6 | 14.8±1.8 | 11.2±1.3 | < 0.001a |
Table 6 Change in SNAQ score between treatment groups at Visit 6 to Visit 11
| Variables | Visit point | Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value |
|---|---|---|---|---|
| SNAQ score (V06) | after Washout Period, Pre cycle 4 | 11.0±1.9 | 17.3±2.0 | < 0.001a |
| SNAQ score (V07) | Post cycle 4 | 11.5±1.8 | 14.6±1.3 | < 0.001a |
| SNAQ score (V08) | Pre cycle 5 | 14.0±1.6 | 14.6±1.4 | 0.148 |
| SNAQ score (V09) | Post cycle 5 | 13.4±1.6 | 13.2±1.5 | 0.667 |
| SNAQ score (V10) | Pre cycle 6 | 14.4±2.1 | 12.8±1.1 | < 0.001a |
| SNAQ score (V11) | Post cycle 6 | 14.8±1.8 | 11.2±1.3 | < 0.001a |
Table 7 EORTC score (Visit 0 to Visit 5)
| Variable | Visit point | Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value |
|---|---|---|---|---|
| PF | V0, Pre | 2 (1.4, 3.8) | 1.6 (1.0, 3.0) | 0.092 |
| V05, Post | 3.0 (1.4, 4.0) | 1.6 (1.4, 3.0) | 0.000a | |
| RF | Pre | 3.5 (1.0, 4.0) | 2.0 (1.0, 3.5) | 0.195 |
| Post | 4.0 (1.5, 4.0) | 2.0 (1.0, 3.0) | < 0.001a | |
| EF | Pre | 2.0 (1.0, 2.75) | 1.75 (1.0, 2.75) | 0.057 |
| Post | 3.0 (1.3, 3.8) | 1.3 (1.0, 3.0) | < 0.001a | |
| CF | Pre | 2.5 (1.0, 4.0) | 2.0 (1.0, 2.5) | 0.916 |
| Post | 3.5 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a | |
| SA | Pre | 3.0 (1.0, 4.5) | 3.0 (1.0, 4.0) | 0.578 |
| Post | 3.0 (1.0, 4.0) | 2.0 (1.0, 3.0) | < 0.001a | |
| GH | Pre | 4.5 (2.5, 5.5) | 5.0 (3.0, 6.0) | 0.070 |
| Post | 4.0 (1.0, 6.0) | 4.0 (2.0, 6.0) | 0.971 | |
| FA | Pre | 2.67 (1.0, 3.67) | 2.67 (1.0, 3.3) | 0.475 |
| Post | 4.0 (1.7, 4.0) | 1.7 (1.7, 3.0) | < 0.001a | |
| NV | Pre | 2.5 (1.0, 2.5) | 1.5 (1.0, 2.5) | 0.173 |
| Post | 2.5 (1.0, 3.0) | 1.0 (1.0, 2.5) | < 0.001a | |
| PA | Pre | 3.0 (1.0, 3.0) | 2.0 (1.0, 3.0) | 0.059 |
| Post | 3.5 (1.0, 3.5) | 3.0 (1.0, 3.0) | 0.169 | |
| DY | Pre | 1.0 (1.0, 4.0) | 2.0 (1.0, 2.0) | 0.091 |
| Post | 2.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a | |
| SL | Pre | 1.0 (1.0, 4.0) | 3.0 (1.0, 4.0) | 0.198 |
| Post | 1.0 (1.0, 4.0) | 2.0 (1.0, 3.0) | 0.014a | |
| AL | Pre | 1.0 (1.0, 3.0) | 1.0 (1.0, 3.0) | 0.070 |
| Post | 3.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a | |
| CO | Pre | 1.0 (1.0, 4.0) | 1.0 (1.0, 4.0) | 0.164 |
| Post | 1.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | 0.164 | |
| DI | Pre | 1.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | 0.128 |
| Post | 2.0 (1.0, 4.0) | 1.0 (1.0, 2.0) | < 0.001a | |
| FD | Pre | 2.0 (1.0, 5.0) | 2.0 (1.0, 3.0) | 0.200 |
| Post | 3.0 (1.0, 5.0) | 3.0 (1.0, 3.0) | 0.971 |
Table 7 EORTC score (Visit 0 to Visit 5)
| Variable | Visit point | Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value |
|---|---|---|---|---|
| PF | V0, Pre | 2 (1.4, 3.8) | 1.6 (1.0, 3.0) | 0.092 |
| V05, Post | 3.0 (1.4, 4.0) | 1.6 (1.4, 3.0) | 0.000a | |
| RF | Pre | 3.5 (1.0, 4.0) | 2.0 (1.0, 3.5) | 0.195 |
| Post | 4.0 (1.5, 4.0) | 2.0 (1.0, 3.0) | < 0.001a | |
| EF | Pre | 2.0 (1.0, 2.75) | 1.75 (1.0, 2.75) | 0.057 |
| Post | 3.0 (1.3, 3.8) | 1.3 (1.0, 3.0) | < 0.001a | |
| CF | Pre | 2.5 (1.0, 4.0) | 2.0 (1.0, 2.5) | 0.916 |
| Post | 3.5 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a | |
| SA | Pre | 3.0 (1.0, 4.5) | 3.0 (1.0, 4.0) | 0.578 |
| Post | 3.0 (1.0, 4.0) | 2.0 (1.0, 3.0) | < 0.001a | |
| GH | Pre | 4.5 (2.5, 5.5) | 5.0 (3.0, 6.0) | 0.070 |
| Post | 4.0 (1.0, 6.0) | 4.0 (2.0, 6.0) | 0.971 | |
| FA | Pre | 2.67 (1.0, 3.67) | 2.67 (1.0, 3.3) | 0.475 |
| Post | 4.0 (1.7, 4.0) | 1.7 (1.7, 3.0) | < 0.001a | |
| NV | Pre | 2.5 (1.0, 2.5) | 1.5 (1.0, 2.5) | 0.173 |
| Post | 2.5 (1.0, 3.0) | 1.0 (1.0, 2.5) | < 0.001a | |
| PA | Pre | 3.0 (1.0, 3.0) | 2.0 (1.0, 3.0) | 0.059 |
| Post | 3.5 (1.0, 3.5) | 3.0 (1.0, 3.0) | 0.169 | |
| DY | Pre | 1.0 (1.0, 4.0) | 2.0 (1.0, 2.0) | 0.091 |
| Post | 2.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a | |
| SL | Pre | 1.0 (1.0, 4.0) | 3.0 (1.0, 4.0) | 0.198 |
| Post | 1.0 (1.0, 4.0) | 2.0 (1.0, 3.0) | 0.014a | |
| AL | Pre | 1.0 (1.0, 3.0) | 1.0 (1.0, 3.0) | 0.070 |
| Post | 3.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a | |
| CO | Pre | 1.0 (1.0, 4.0) | 1.0 (1.0, 4.0) | 0.164 |
| Post | 1.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | 0.164 | |
| DI | Pre | 1.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | 0.128 |
| Post | 2.0 (1.0, 4.0) | 1.0 (1.0, 2.0) | < 0.001a | |
| FD | Pre | 2.0 (1.0, 5.0) | 2.0 (1.0, 3.0) | 0.200 |
| Post | 3.0 (1.0, 5.0) | 3.0 (1.0, 3.0) | 0.971 |
Table 8 EORTC scores (Visit 6-Visit 11)
| Variable | After washout period | Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value |
|---|---|---|---|---|
| PF | V06, Pre | 3.5 (1.5, 4.0) | 1.6 (1.4, 3.0) | < 0.001a |
| V11, Post | 2.0 (1.4, 3.4) | 1.8 (1.0, 4.0) | 0.018a | |
| RF | Pre | 3.5 (1.5, 4.0) | 2.0 (1.5, 3.0) | < 0.001a |
| Post | 2.0 (1.0, 4.0) | 2.5 (1.5, 4.0) | < 0.001a | |
| EF | Pre | 2.3 (1.0, 3.8) | 1.0 (1.0, 3.0) | < 0.001a |
| Post | 1.5 (1.0, 3.0) | 1.8 (1.0, 4.0) | 0.040a | |
| CF | Pre | 2.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a |
| Post | 1.0 (1.0, 3.5) | 2.0 (1.0, 4.0) | < 0.001a | |
| SA | Pre | 2.5 (1.0, 4.0) | 2.0 (1.0, 3.0) | < 0.001a |
| Post | 2.0 (1.0, 4.5) | 3.0 (1.0, 4.0) | 0.001a | |
| GH | Pre | 4.5 (1.0, 6.0) | 4.0 (3.0, 6.0) | < 0.001a |
| Post | 5.0 (3.0, 6.0) | 4.0 (1.0, 6.0) | < 0.001a | |
| FA | Pre | 3.3 (1.7, 3.7) | 1.7 (1.7, 3.0) | < 0.001a |
| Post | 1.7 (1.3, 3.7) | 3.0 (1.0, 3.7) | < 0.001a | |
| NV | Pre | 1.0 (1.0, 3.0) | 1.0 (1.0, 2.5) | 0.243 |
| Post | 1.0 (1.0, 3.0) | 1.0 (1.0, 2.5) | 0.594 | |
| PA | Pre | 3.0 (1.0, 3.0) | 2.0 (1.0, 3.0) | 0.059 |
| Post | 1.5 (1.0, 3.0) | 1.5 (1.0, 4.0) | 0.729 | |
| DY | Pre | 2.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a |
| Post | 1.0 (1.0, 4.0) | 2.0 (1.0, 4.0) | < 0.001a | |
| SL | Pre | 1.0 (1.0, 4.0) | 2.0 (1.0, 3.0) | 0.054 |
| Post | 3.5 (1.0, 3.5) | 3.0 (1.0, 3.0) | 0.169 | |
| AL | Pre | 3.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a |
| Post | 1.0 (1.0, 3.0) | 3.0 (1.0, 4.0) | < 0.001a | |
| CO | Pre | 1.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | 0.064 |
| Post | 1.5 (1.0, 3.0) | 1.5 (1.0, 4.0) | 0.729 | |
| DI | Pre | 2.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a |
| Post | 2.0 (1.0, 4.0) | 1.0 (1.0, 4.0) | < 0.001a | |
| FD | Pre | 3.0 (1.0, 3.0) | 2.0 (1.0, 2.5) | 0.060 |
| Post | 3.0 (1.0, 5.0) | 3.0 (1.0, 3.0) | 0.607 |
Table 8 EORTC scores (Visit 6-Visit 11)
| Variable | After washout period | Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value |
|---|---|---|---|---|
| PF | V06, Pre | 3.5 (1.5, 4.0) | 1.6 (1.4, 3.0) | < 0.001a |
| V11, Post | 2.0 (1.4, 3.4) | 1.8 (1.0, 4.0) | 0.018a | |
| RF | Pre | 3.5 (1.5, 4.0) | 2.0 (1.5, 3.0) | < 0.001a |
| Post | 2.0 (1.0, 4.0) | 2.5 (1.5, 4.0) | < 0.001a | |
| EF | Pre | 2.3 (1.0, 3.8) | 1.0 (1.0, 3.0) | < 0.001a |
| Post | 1.5 (1.0, 3.0) | 1.8 (1.0, 4.0) | 0.040a | |
| CF | Pre | 2.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a |
| Post | 1.0 (1.0, 3.5) | 2.0 (1.0, 4.0) | < 0.001a | |
| SA | Pre | 2.5 (1.0, 4.0) | 2.0 (1.0, 3.0) | < 0.001a |
| Post | 2.0 (1.0, 4.5) | 3.0 (1.0, 4.0) | 0.001a | |
| GH | Pre | 4.5 (1.0, 6.0) | 4.0 (3.0, 6.0) | < 0.001a |
| Post | 5.0 (3.0, 6.0) | 4.0 (1.0, 6.0) | < 0.001a | |
| FA | Pre | 3.3 (1.7, 3.7) | 1.7 (1.7, 3.0) | < 0.001a |
| Post | 1.7 (1.3, 3.7) | 3.0 (1.0, 3.7) | < 0.001a | |
| NV | Pre | 1.0 (1.0, 3.0) | 1.0 (1.0, 2.5) | 0.243 |
| Post | 1.0 (1.0, 3.0) | 1.0 (1.0, 2.5) | 0.594 | |
| PA | Pre | 3.0 (1.0, 3.0) | 2.0 (1.0, 3.0) | 0.059 |
| Post | 1.5 (1.0, 3.0) | 1.5 (1.0, 4.0) | 0.729 | |
| DY | Pre | 2.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a |
| Post | 1.0 (1.0, 4.0) | 2.0 (1.0, 4.0) | < 0.001a | |
| SL | Pre | 1.0 (1.0, 4.0) | 2.0 (1.0, 3.0) | 0.054 |
| Post | 3.5 (1.0, 3.5) | 3.0 (1.0, 3.0) | 0.169 | |
| AL | Pre | 3.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a |
| Post | 1.0 (1.0, 3.0) | 3.0 (1.0, 4.0) | < 0.001a | |
| CO | Pre | 1.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | 0.064 |
| Post | 1.5 (1.0, 3.0) | 1.5 (1.0, 4.0) | 0.729 | |
| DI | Pre | 2.0 (1.0, 4.0) | 1.0 (1.0, 3.0) | < 0.001a |
| Post | 2.0 (1.0, 4.0) | 1.0 (1.0, 4.0) | < 0.001a | |
| FD | Pre | 3.0 (1.0, 3.0) | 2.0 (1.0, 2.5) | 0.060 |
| Post | 3.0 (1.0, 5.0) | 3.0 (1.0, 3.0) | 0.607 |
Table 9 Frequency of Chemotherapy-induced AEs
| Variable | Grade 1-4 | Grade 3/4 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value | Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value | |||||||
| n | % | n | % | n | % | n | % | |||||
| Leukopenia | 15 | 51.7 | 5 | 15.2 | 0.002a | 2 | 6.9 | 1 | 3.0 | 0.479 | ||
| Neutropenia | 10 | 34.5 | 3 | 9.1 | 0.014a | 2 | 6.9 | 0 | 0.0 | 0.125 | ||
| Thrombocytopenia | 5 | 17.2 | 0 | 0.0 | 0.013a | 0 | 0.0 | 0 | 0.0 | - | ||
| Anemia | 12 | 41.4 | 5 | 15.2 | 0.021a | 3 | 10.3 | 0 | 0.0 | 0.058 | ||
| Elevated alkaline phosphatase | 3 | 10.3 | 0 | 0.0 | 0.058 | 1 | 3.4 | 0 | 0.0 | 0.282 | ||
| Hyperbilirubinemia | 5 | 17.2 | 2 | 6.1 | 0.165 | 2 | 6.9 | 0 | 0.0 | 0.125 | ||
| Gastrointestinal bleeding | 1 | 3.4 | 0 | 0.0 | 0.282 | 0 | 0.0 | 0 | 0.0 | - | ||
| Diarrhea | 13 | 44.8 | 4 | 12.1 | 0.004a | 6 | 20.7 | 0 | 0.0 | 0.006a | ||
| Nausea and vomiting | 18 | 62.1 | 3 | 9.1 | 0.000a | 7 | 24.1 | 0 | 0.0 | 0.003a | ||
| Neurotoxicity | 1 | 3.4 | 0 | 0.0 | 0.282 | 0 | 0.0 | 0 | 0.0 | - | ||
| Allergic reaction | 2 | 6.9 | 0 | 0.0 | 0.125 | 0 | 0.0 | 0 | 0.0 | - | ||
| Fever | 1 | 3.4 | 0 | 0.0 | 0.282 | 0 | 0.0 | 0 | 0.0 | - | ||
| Rash | 1 | 3.4 | 0 | 0.0 | 0.282 | 0 | 0.0 | 0 | 0.0 | - | ||
| Alopecia | 4 | 13.8 | 0 | 0.0 | 0.027a | 0 | 0.0 | 0 | 0.0 | - | ||
| Pain | 4 | 13.8 | 1 | 3.0 | 0.120 | 2 | 6.9 | 0 | 0.0 | 0.125 | ||
| Hand-foot syndrome | 7 | 24.1 | 0 | 0.0 | 0.003a | 0 | 0.0 | 0 | 0.0 | - | ||
Table 9 Frequency of Chemotherapy-induced AEs
| Variable | Grade 1-4 | Grade 3/4 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value | Placebo-BZYQP (n = 29) | BZYQP-Placebo (n = 33) | P value | |||||||
| n | % | n | % | n | % | n | % | |||||
| Leukopenia | 15 | 51.7 | 5 | 15.2 | 0.002a | 2 | 6.9 | 1 | 3.0 | 0.479 | ||
| Neutropenia | 10 | 34.5 | 3 | 9.1 | 0.014a | 2 | 6.9 | 0 | 0.0 | 0.125 | ||
| Thrombocytopenia | 5 | 17.2 | 0 | 0.0 | 0.013a | 0 | 0.0 | 0 | 0.0 | - | ||
| Anemia | 12 | 41.4 | 5 | 15.2 | 0.021a | 3 | 10.3 | 0 | 0.0 | 0.058 | ||
| Elevated alkaline phosphatase | 3 | 10.3 | 0 | 0.0 | 0.058 | 1 | 3.4 | 0 | 0.0 | 0.282 | ||
| Hyperbilirubinemia | 5 | 17.2 | 2 | 6.1 | 0.165 | 2 | 6.9 | 0 | 0.0 | 0.125 | ||
| Gastrointestinal bleeding | 1 | 3.4 | 0 | 0.0 | 0.282 | 0 | 0.0 | 0 | 0.0 | - | ||
| Diarrhea | 13 | 44.8 | 4 | 12.1 | 0.004a | 6 | 20.7 | 0 | 0.0 | 0.006a | ||
| Nausea and vomiting | 18 | 62.1 | 3 | 9.1 | 0.000a | 7 | 24.1 | 0 | 0.0 | 0.003a | ||
| Neurotoxicity | 1 | 3.4 | 0 | 0.0 | 0.282 | 0 | 0.0 | 0 | 0.0 | - | ||
| Allergic reaction | 2 | 6.9 | 0 | 0.0 | 0.125 | 0 | 0.0 | 0 | 0.0 | - | ||
| Fever | 1 | 3.4 | 0 | 0.0 | 0.282 | 0 | 0.0 | 0 | 0.0 | - | ||
| Rash | 1 | 3.4 | 0 | 0.0 | 0.282 | 0 | 0.0 | 0 | 0.0 | - | ||
| Alopecia | 4 | 13.8 | 0 | 0.0 | 0.027a | 0 | 0.0 | 0 | 0.0 | - | ||
| Pain | 4 | 13.8 | 1 | 3.0 | 0.120 | 2 | 6.9 | 0 | 0.0 | 0.125 | ||
| Hand-foot syndrome | 7 | 24.1 | 0 | 0.0 | 0.003a | 0 | 0.0 | 0 | 0.0 | - | ||
Table 10 Assessment of AEs: drug safety
| Variable | Grade 1-4 | Grade 3/4 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo-BZYQ pills (n = 29) | BZYQ pills-Placebo (n = 33) | P value | Placebo-BZYQ pills (n = 29) | BZYQ pills-Placebo (n = 33) | P value | |||||
| n | % | n | % | n | % | n | % | |||
| Hepatic dysfunction events* | 10 | 34.5 | 2 | 6.1 | 0.005a | 1 | 3.4 | 0 | 0.0 | 0.282 |
| Acute kidney injury | 4 | 13.8 | 2 | 6.1 | 0.304 | 1 | 3.4 | 0 | 0.0 | 0.282 |
Table 10 Assessment of AEs: drug safety
| Variable | Grade 1-4 | Grade 3/4 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo-BZYQ pills (n = 29) | BZYQ pills-Placebo (n = 33) | P value | Placebo-BZYQ pills (n = 29) | BZYQ pills-Placebo (n = 33) | P value | |||||
| n | % | n | % | n | % | n | % | |||
| Hepatic dysfunction events* | 10 | 34.5 | 2 | 6.1 | 0.005a | 1 | 3.4 | 0 | 0.0 | 0.282 |
| Acute kidney injury | 4 | 13.8 | 2 | 6.1 | 0.304 | 1 | 3.4 | 0 | 0.0 | 0.282 |
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