Journal of Traditional Chinese Medicine ›› 2022, Vol. 42 ›› Issue (3): 432-438.DOI: 10.19852/j.cnki.jtcm.2022.03.010
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Efficacy and safety of Mianyi granules (+mianyi+) for reversal of immune nonresponse following antiretroviral therapy of human immunodeficiency virus-1: a randomized, double-blind, multi-center, placebo-controlled trial
LIU Ying1, ZOU Wen1, XIAN Qingfei1, DENG Xin2, ZHANG Fuchun3, WANG Li4, LI Yonghong5, LUN Wenhui6, WANG Jian1(
)
- 1 Traditional Chinese Medicine Center for Acquired Immune Deficiency Syndrome Prevention and Treatment, China Academy of Chinese Medical Sciences, Beijing 100700, China
2 Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, China
3 Infectious Disease Department of Guangzhou Eighth People’s Hospital, Guangzhou 510060, China
4 Internal Medicine Department of Traditional Chinese Medicine, Yunnan Provincial Academy of Traditional Chinese Medicine, Kunming 650031, China
5 Department of Hepatology, Shenyang Sixth People’s Hospital, Shenyang 110006, China
6 Department of Dermatology, Beijing Ditan Hospital, Beijing 100015, China
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Received:2021-09-02Accepted:2021-11-21Online:2022-06-15Published:2022-05-20 -
Contact:WANG Jian -
About author:Prof. WANG Jian, TCM Center for AIDS Prevention and Treatment, China Academy of Chinese Medical Sciences, Beijing 100700, China. 62tiger@163.com,Telephone: + 86-10-64089765
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Supported by:Fun:Supported by the State Major Science & Technology Specific Projects, Prevention and Treatment of Serious Infectious Diseases such as Acquired Immune Deficiency Syndrome and Viral Hepatitis(2017ZX10205501);Fun:Supported by the State Major Science & Technology Specific Projects, Prevention and Treatment of Serious Infectious Diseases such as Acquired Immune Deficiency Syndrome and Viral Hepatitis(2013ZX10005-001);National Nature Science Foundation of China, Mechanism of PD-1 Receptor Mediated Immunosuppression based on the Improvement of Digestive Tract Mucosal Function in HIV/AIDS Patients by Removing Dampness and Detoxification(82174221)
Cite this article
LIU Ying, ZOU Wen, XIAN Qingfei, DENG Xin, ZHANG Fuchun, WANG Li, LI Yonghong, LUN Wenhui, WANG Jian. Efficacy and safety of Mianyi granules (+mianyi+) for reversal of immune nonresponse following antiretroviral therapy of human immunodeficiency virus-1: a randomized, double-blind, multi-center, placebo-controlled trial[J]. Journal of Traditional Chinese Medicine, 2022, 42(3): 432-438.
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Figure 1 Study flow diagram HIV: human immunodeficiency virus; FAS: full analysis set; SS: security data set.
Figure 1 Study flow diagram HIV: human immunodeficiency virus; FAS: full analysis set; SS: security data set.
Table 1 Enrolment and completion cases at each study center (n)
| Centre | Plan to enroll | Actual into the group | Complete trial | PPS | |
|---|---|---|---|---|---|
| 01 | Beijing Ditan Hospital | 50 | 50 | 48 | 45 |
| 02 | Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine | 110 | 110 | 103 | 99 |
| 03 | Guangzhou Eighth People’s Hospital | 80 | 79 | 78 | 73 |
| 04 | Yunnan Provincial Academy of Traditional Chinese Medicine | 110 | 110 | 107 | 102 |
| 05 | Shenyang sixth People’s Hospital | 50 | 47 | 46 | 42 |
| Total | 400 | 396 | 384 | 361 |
Table 1 Enrolment and completion cases at each study center (n)
| Centre | Plan to enroll | Actual into the group | Complete trial | PPS | |
|---|---|---|---|---|---|
| 01 | Beijing Ditan Hospital | 50 | 50 | 48 | 45 |
| 02 | Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine | 110 | 110 | 103 | 99 |
| 03 | Guangzhou Eighth People’s Hospital | 80 | 79 | 78 | 73 |
| 04 | Yunnan Provincial Academy of Traditional Chinese Medicine | 110 | 110 | 107 | 102 |
| 05 | Shenyang sixth People’s Hospital | 50 | 47 | 46 | 42 |
| Total | 400 | 396 | 384 | 361 |
Table 2 Comparison of CD4 cell counts (cells/mm3) at baseline and post-treatment in patients receiving Mianyi granule or placebo ($\bar{x}\pm s$)
| Interview point | Treatment group (n =189 ) | Control group (n = 172 ) | Stats methods | Statistics | P value |
|---|---|---|---|---|---|
| Pre-treatment | 193±71 | 200±75 | Wilcoxon test | 12880.5 | 0.376 |
| 12 week | 222±111 | 211±88 | Wilcoxon test | 11073.5 | 0.694 |
| 24 week | 226±93 | 227±108 | Wilcoxon test | 9348.0 | 0.876 |
| 36 week | 236±96 | 229±88 | Wilcoxon test | 9678.0 | 0.814 |
| 48 week | 259±121 | 252±158 | Wilcoxon test | 8182.0 | 0.309 |
| 60 week | 269±126 | 267±120 | Wilcoxon test | 6625.5 | 0.933 |
| 72 week | 288±131 | 264±124 | Wilcoxon test | 8035.5 | 0.045 |
Table 2 Comparison of CD4 cell counts (cells/mm3) at baseline and post-treatment in patients receiving Mianyi granule or placebo ($\bar{x}\pm s$)
| Interview point | Treatment group (n =189 ) | Control group (n = 172 ) | Stats methods | Statistics | P value |
|---|---|---|---|---|---|
| Pre-treatment | 193±71 | 200±75 | Wilcoxon test | 12880.5 | 0.376 |
| 12 week | 222±111 | 211±88 | Wilcoxon test | 11073.5 | 0.694 |
| 24 week | 226±93 | 227±108 | Wilcoxon test | 9348.0 | 0.876 |
| 36 week | 236±96 | 229±88 | Wilcoxon test | 9678.0 | 0.814 |
| 48 week | 259±121 | 252±158 | Wilcoxon test | 8182.0 | 0.309 |
| 60 week | 269±126 | 267±120 | Wilcoxon test | 6625.5 | 0.933 |
| 72 week | 288±131 | 264±124 | Wilcoxon test | 8035.5 | 0.045 |
Table 3 Participants whose CD4 cells increased or decreased by more than 50 cells/mm3 (n)
| Group | 12 week | 24 week | 36 week | 48 week | 60 week | 72 week | |
|---|---|---|---|---|---|---|---|
| Treatment | Increase | 30 | 39 | 46 | 58 | 67 | 87 |
| Decrease | 13 | 11 | 8 | 8 | 5 | 0 | |
| Control | Increase | 28 | 26 | 39 | 48 | 58 | 55 |
| Decrease | 15 | 12 | 12 | 12 | 4 | 3 | |
Table 3 Participants whose CD4 cells increased or decreased by more than 50 cells/mm3 (n)
| Group | 12 week | 24 week | 36 week | 48 week | 60 week | 72 week | |
|---|---|---|---|---|---|---|---|
| Treatment | Increase | 30 | 39 | 46 | 58 | 67 | 87 |
| Decrease | 13 | 11 | 8 | 8 | 5 | 0 | |
| Control | Increase | 28 | 26 | 39 | 48 | 58 | 55 |
| Decrease | 15 | 12 | 12 | 12 | 4 | 3 | |
Table 4 Participants whose CD4 cells increased or decreased by more than 100 cells/mm3 (n)
| Group | 12 week | 24 week | 36 week | 48 week | 60 week | 72 week | |
|---|---|---|---|---|---|---|---|
| Intervention | Increase | 14 | 14 | 15 | 29 | 34 | 37 |
| Decrease | 2 | 1 | 1 | 3 | 2 | 0 | |
| Control | Increase | 7 | 13 | 17 | 16 | 15 | 17 |
| Decrease | 2 | 4 | 2 | 5 | 1 | 1 | |
Table 4 Participants whose CD4 cells increased or decreased by more than 100 cells/mm3 (n)
| Group | 12 week | 24 week | 36 week | 48 week | 60 week | 72 week | |
|---|---|---|---|---|---|---|---|
| Intervention | Increase | 14 | 14 | 15 | 29 | 34 | 37 |
| Decrease | 2 | 1 | 1 | 3 | 2 | 0 | |
| Control | Increase | 7 | 13 | 17 | 16 | 15 | 17 |
| Decrease | 2 | 4 | 2 | 5 | 1 | 1 | |
Table 5 Comparison of CD4/CD8 ratios at baseline and post-treatment in patients receiving Mianyi granule or placebo ($\bar{x}\pm s$)
| Interview point | Treatment group (n =189) | Control group (n = 172) | Stats methods | Statistics | P value |
|---|---|---|---|---|---|
| 12 week | 0.36±0.22 | 0.37±0.20 | Wilcoxon test | 12030 | 0.315 |
| 24 week | 0.40±0.24 | 0.42±0.32 | Wilcoxon test | 10687 | 0.456 |
| 36 week | 0.78±0.75 | 0.50±0.46 | Wilcoxon test | 11054.5 | 0. 157 |
| 48 week | 0.71±0.22 | 0.45±0.28 | Wilcoxon test | 8775.5 | 0.216 |
| 60 week | 0.70±0.22 | 0.43±0.23 | Wilcoxon test | 7301 | 0.193 |
| 72 week | 0.74±0.25 | 0.46±0.26 | Wilcoxon test | 8507.5 | 0.178 |
Table 5 Comparison of CD4/CD8 ratios at baseline and post-treatment in patients receiving Mianyi granule or placebo ($\bar{x}\pm s$)
| Interview point | Treatment group (n =189) | Control group (n = 172) | Stats methods | Statistics | P value |
|---|---|---|---|---|---|
| 12 week | 0.36±0.22 | 0.37±0.20 | Wilcoxon test | 12030 | 0.315 |
| 24 week | 0.40±0.24 | 0.42±0.32 | Wilcoxon test | 10687 | 0.456 |
| 36 week | 0.78±0.75 | 0.50±0.46 | Wilcoxon test | 11054.5 | 0. 157 |
| 48 week | 0.71±0.22 | 0.45±0.28 | Wilcoxon test | 8775.5 | 0.216 |
| 60 week | 0.70±0.22 | 0.43±0.23 | Wilcoxon test | 7301 | 0.193 |
| 72 week | 0.74±0.25 | 0.46±0.26 | Wilcoxon test | 8507.5 | 0.178 |
Table 6 Comparison of CD45RA (cells/mm3) at baseline and post-treatment in patients receiving Mianyi granule or placebo ($\bar{x}\pm s$)
| Interview point | Treatment group (n=189) | Control group (n=172) | Stats methods | Statistics | P value |
|---|---|---|---|---|---|
| Pre-treatment | 34±32 | 37±33 | Wilcoxon test | 14393.5 | 0.198 |
| 12 week | 38±32 | 37±29 | Wilcoxon test | 11712.5 | 0.959 |
| 24 week | 38±32 | 41±36 | Wilcoxon test | 8621.5 | 0.389 |
| 36 week | 35±26 | 37±30 | Wilcoxon test | 9687.5 | 0.504 |
| 48 week | 43±45 | 44±49 | Wilcoxon test | 8763.5 | 0.676 |
| 60 week | 41±31 | 46±43 | Wilcoxon test | 6439.5 | 0.505 |
| 72 week | 53±62 | 48±37 | Wilcoxon test | 6738.5 | 0.035 |
Table 6 Comparison of CD45RA (cells/mm3) at baseline and post-treatment in patients receiving Mianyi granule or placebo ($\bar{x}\pm s$)
| Interview point | Treatment group (n=189) | Control group (n=172) | Stats methods | Statistics | P value |
|---|---|---|---|---|---|
| Pre-treatment | 34±32 | 37±33 | Wilcoxon test | 14393.5 | 0.198 |
| 12 week | 38±32 | 37±29 | Wilcoxon test | 11712.5 | 0.959 |
| 24 week | 38±32 | 41±36 | Wilcoxon test | 8621.5 | 0.389 |
| 36 week | 35±26 | 37±30 | Wilcoxon test | 9687.5 | 0.504 |
| 48 week | 43±45 | 44±49 | Wilcoxon test | 8763.5 | 0.676 |
| 60 week | 41±31 | 46±43 | Wilcoxon test | 6439.5 | 0.505 |
| 72 week | 53±62 | 48±37 | Wilcoxon test | 6738.5 | 0.035 |
Figure 2 Survival analysis of CD4 cell count restoration (30% increase) in patients treated with Mianyi granules or placebo
Figure 2 Survival analysis of CD4 cell count restoration (30% increase) in patients treated with Mianyi granules or placebo
Table 7 Comparison of symptom frequency at baseline and post-treatment in patients receiving Mianyi granule or placebo ($\bar{x}\pm s$)
| Interview point | Treatment group (n = 189) | Control group (n = 172) | Stats methods | Statistics | P value |
|---|---|---|---|---|---|
| 12 week | 1.9±2.8 | 1.9±2.7 | Wilcoxon test | 17643 | 0.864 |
| 24 week | 1.7±2.6 | 1.9±2.6 | Wilcoxon test | 16808 | 0.540 |
| 36 week | 1.8±2.2 | 1.8±2.3 | Wilcoxon test | 16496 | 0.665 |
| 48 week | 1.7±2.0 | 1.4±1.8 | Wilcoxon test | 17067 | 0.283 |
| 60 week | 1.4±1.8 | 1.3±1.8 | Wilcoxon test | 15202 | 0.352 |
| 72 week | 1.2±1.5 | 1.1±1.7 | Wilcoxon test | 14660.5 | 0.248 |
Table 7 Comparison of symptom frequency at baseline and post-treatment in patients receiving Mianyi granule or placebo ($\bar{x}\pm s$)
| Interview point | Treatment group (n = 189) | Control group (n = 172) | Stats methods | Statistics | P value |
|---|---|---|---|---|---|
| 12 week | 1.9±2.8 | 1.9±2.7 | Wilcoxon test | 17643 | 0.864 |
| 24 week | 1.7±2.6 | 1.9±2.6 | Wilcoxon test | 16808 | 0.540 |
| 36 week | 1.8±2.2 | 1.8±2.3 | Wilcoxon test | 16496 | 0.665 |
| 48 week | 1.7±2.0 | 1.4±1.8 | Wilcoxon test | 17067 | 0.283 |
| 60 week | 1.4±1.8 | 1.3±1.8 | Wilcoxon test | 15202 | 0.352 |
| 72 week | 1.2±1.5 | 1.1±1.7 | Wilcoxon test | 14660.5 | 0.248 |
Table 8 Comparison of WHO Quality of Life Scale results in patients receiving Mianyi granules or placebo ($\bar{x}\pm s$)
| Interview point | Treatment group (n = 189) | Control group (n = 172) | Stats methods | Statistics | P value |
|---|---|---|---|---|---|
| 24 week | 93±9 | 93±9 | Wilcoxon test | 17418 | 0.698 |
| 48 week | 93±10 | 92±9 | Wilcoxon test | 15688.5 | 0.142 |
| 72 week | 93±10 | 92±10 | Wilcoxon test | 14766 | 0.300 |
Table 8 Comparison of WHO Quality of Life Scale results in patients receiving Mianyi granules or placebo ($\bar{x}\pm s$)
| Interview point | Treatment group (n = 189) | Control group (n = 172) | Stats methods | Statistics | P value |
|---|---|---|---|---|---|
| 24 week | 93±9 | 93±9 | Wilcoxon test | 17418 | 0.698 |
| 48 week | 93±10 | 92±9 | Wilcoxon test | 15688.5 | 0.142 |
| 72 week | 93±10 | 92±10 | Wilcoxon test | 14766 | 0.300 |
Table 9 Adverse events in patients receiving Mianyi granules or placebo (n)
| Severity | Event | Treatment group (n = 189) | Control group (n = 172) |
|---|---|---|---|
| Mild | Hepatic dysfunction Cholecystitis diarrhea | 3 2 1 | 5 3 2 |
| Moderate | 0 | 0 | |
| Severe | 1 | 1 | |
| Total | 7 | 11 |
Table 9 Adverse events in patients receiving Mianyi granules or placebo (n)
| Severity | Event | Treatment group (n = 189) | Control group (n = 172) |
|---|---|---|---|
| Mild | Hepatic dysfunction Cholecystitis diarrhea | 3 2 1 | 5 3 2 |
| Moderate | 0 | 0 | |
| Severe | 1 | 1 | |
| Total | 7 | 11 |
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