Deng et al. (2004)Deng, Y. Y., Chen, Y. P., Wang, L., Hu, Z.Y., Jin, Y.M., Shen, L.M., Zhu, R., & Zhong, Y.W. (2004). Heat-clearing and Blood-activating prescription for middle-advanced crescent nephritis clinical study. Chinese Journal of Integrated Traditional and Western Medicine, 24(12), 1084-1086. [18] |
Methods |
Randomized controlled trial (RCT): randomization mentioned, described in detail. Allocation concealment: not mentioned. Follow-up: not mentioned. Study duration: 3 months. Parallel/crossover/factorial RCT: parallel RCT. Randomization method: random number table. Blinding: no detailed information on blinding was offered. ITT: Not mentioned. |
Participants |
Setting: outpatients. Country: China. Number (randomized/analyzed): treatment group (16/16); control group (16/16). Treatment group: 16 (6 males; 37.5%; 10 females; 62.5%), age 28 - 57 (average 36.1 ± 18.3) years old; disease duration: 2 – 13 (average 0.87 ± 0.62) months. Control group: 16 (7 males; 43.8%; 9 females; 56.2%), age 31 – 76 (average 37.4 ± 17.5) years old; disease duration: 2 – 13 (average 0.87 ± 0.62) months. Biopsy-proven membranous nephropathy (types I, II and III). |
Interventions |
Treatment group: Self-Developed clear hear and activate blood prescription plus supportive therapies combined with specific therapies. Self-Developed clear hear and activate blood prescription: Baihuasheshecao 30 g, Rendongteng 30 g, Zihuadiding 30 g, Chishao 15 g, Shengdi 15 g, Huangjing 15 g, Dangshen 30 g, Danshen 30 g, Zhidahuang 12 g, and Huoxiang 12 g boiled in 3 L of water and decocted to 300 mL. Orally twice daily (bid)/ one dose daily for 3 months. Supportive therapies: Consistent with the control group. Specific therapies: 15 cases were given methylprednisolone shock treatment (dose of 160–480mg/d) for 3 days, with the dose gradually reduced afterward; they were then switched to oral prednisone 0.8–1.0mg/kg/d after 7–14 days. The prednisone dose was then reduced according to the conventional reduction method. While on the reduced prednisone dose, four cases also underwent cyclophosphamide shock treatment 1.5g/d oral, and eight also underwent cyclophosphamide shock treatment 0.8g/month. In the treatment process, only one case did not use immunosuppressant therapy. Control group: supportive therapies combined with specific therapies. Supportive therapies including blood pressure control using amlodipine besylate tablets 5–10 mg/d, subcutaneous erythropoietin 4000–6000 U/week when Hb ≤ 90 g/L, and hemodialysis when SCr > 707 μm. Specific therapies: 16 cases were given methylprednisolone shock treatment (dose of 320–1000 mg/d) for 3 days, with the dose gradually reduced afterward; they were then switched to oral prednisone 0.8–1.0 mg/kg/d after 7–14 days. The prednisone dose was then reduced according to the conventional reduction method. While on the reduced prednisone dose, three patients were also given mycophenolate mofetil 1.5–2.0 g/d oral, and 11 cases also underwent cyclophosphamide shock treatment 0.8 g/ month. In the treatment process, 16 patients used immunosuppressant therapy. |
|
Outcomes |
1. ESKD; 2. SCr, BUN; 3. Hb, HCT; 4. Utilization number of immunosuppressive agents (including Methylprednisolone and prednisone, Mycophenolate Mofetil, and Cyclophosphamide); 5. Oliguria or anuria remission. |
Notes |
1. Mortality: not mentioned; 2. ALT, AST: not mentioned; 3. 24 hour urine volume return to normal time: not mentioned; 4. Quality of life: not mentioned; 5. Tongue coat and pulse condition: not mentioned; 6. Economic index: not mentioned; 7. Adverse events: not mentioned; 8. Withdrawal: not mentioned; 9. Project support: not mentioned; 10. Overall, participant demographic data were similar between groups; 11. The protocol: not mentioned; 12. Informed consent: not mentioned, but we confirmed by telephone that an informed consent form was obtained from each participant; 13. Ethics committee approval: not mentioned. |
Wang et al., 2008Wang, H., Zhang, W. P., & Liao, H. (2008). Integration of traditional Chinese and Western medicine for 21 cases middle-advanced crescent nephritis clinical study. Journal of Sichuan of Traditional Chinese Medicine, 26(4), 57-58. [19] |
Methods |
RCT: randomization mentioned, described in detail. Allocation concealment: not mentioned, but a telephone interview with the author revealed that randomization method described could not allow investigators/participants to know or influence intervention group before eligible participant entered in the study. Follow-up: not mentioned. Study duration: 3 months. Parallel/crossover/factorial RCT: parallel RCT. Randomization method: random number table. Blinding: no detailed information on blinding was offered. A telephone interview with the author revealed that participants did not know drugs used status and blinding of outcome assessment was not used. ITT: Not mentioned |
Participants |
Setting: outpatients. Country: China. Number (randomized/analyzed): treatment group (21/21); control group (21/21). Treatment group: 21 (12 males; 57.1%; 9 females; 42.9%), age 25 - 57 (average 34.6 ± 17.3) years old; disease duration: 3 – 15 (average 0.88 ± 0.65) months. Control group: 21 (11 males; 52.4%; 10 females; 47.6%), age 27-56 (average 35.4 ± 18.2) years old; disease duration: 2-14 (average 0.84 ± 0.62) months. Biopsy proven membranous nephropathy (types I, II and III). |
Interventions |
Treatment group: Chinese medicinal herbs formulae plus supportive therapies combined with specific therapies. 1.Pattern of accumulation of dampness-heat and blood stasis in the kidney collateral: Baihuasheshecao 20 g, Pugongying 12 g, Rendongteng 12 g, Zihuadiding 15 g, Danshen 15 g, Chishao 12 g, Taoren 12 g, Shengdi 18 g, Mugua 12 g, Zhidahuang 6 g, Gancao 6 g; 2. Pattern of kidney yin deficiency and blood stasis in the kidney collateral: Shengdi 18 g, Maidong 12 g, Shanzhuyu 10 g, Huangjing 15 g, Shihu 15 g, Guiban 20 g, Zhimu 12 g, Duzhong 15 g, Huangbai 12 g, Danshen 15 g, Chishao 12 g, Zhidahuang 6 g; 3. Pattern of dual deficiency of the spleen-kidney and blood stasis in the kidney collateral: Huangqi 20 g, Huaishanyao 18 g, Chuanxiong 10 g, Gegen 15 g, Huangjing 15 g, Shanzhuyu 12 g, Xianlingpi 12 g, Bajitian 12 g, Taoren 12 g, Honghua 6 g, Baizhu 15 g, Zhidahuang 6 g. Supportive therapies: Consistent with the control group. Specific therapies: 19 cases were given methylprednisolone shock treatment (dose of 160–480mg/d) for 3 days, with the dose gradually reduced afterward; they were then switched to oral prednisone 0.8–1.0mg/kg/d after 7–14 days. The prednisone dose was then reduced according to the conventional reduction method. While on the reduced prednisone dose, five cases were also given mycophenolate mofetil 1.5g/d oral, and nine cases also underwent cyclophosphamide shock treatment 0.8g/ month. In the treatment process, 2 causes did not use immunosuppressant therapy. Control group: supportive therapies combined with specific therapies. Supportive therapies including blood pressure control by using amlodipine besylate tablet 5–10 mg/d, subcutaneous erythropoietin 4000–6000U/week when Hb ≤ 90 g/L, and hemodialysis when SCr > 707μm. Specific therapies: 21 cases were given methylprednisolone shock treatment (dose of 320–1000mg/d) for 3 days, with the dose gradually reduced afterward; they were then switched to oral prednisone 0.8–1.0mg/kg/d after 7–14 days. The prednisone dose was then reduced according to the conventional reduction method. While on the reduced prednisone dose, three cases were also given mycophenolate mofetil 1.5-2.0g/d oral, 11 cases also underwent cyclophosphamide shock treatment 0.8g/ month. In the treatment process, 21 cases used immunosuppressant therapy. |
|
Outcomes |
1. ESKD; 2. SCr, BUN; 3. Hb, HCT; 4. Utilization number of immunosuppressive agents (including Methylprednisolone and prednisone, Mycophenolate Mofetil, and Cyclophosphamide); 5. Oliguria or anuria remission. |
Notes |
1. Mortality: not mentioned; 2. ALT, AST: not mentioned; 3. 24 hour urine volume return to normal time: not mentioned; 4. Quality of life: not mentioned; 5. Tongue coat and pulse condition: not mentioned; 6. Economic index: not mentioned; 7. Adverse events: not mentioned; 8. Withdrawal: not mentioned; 9. Project support: not mentioned; 10. Overall, participant demographic data were similar between groups; 11. The protocol: not mentioned; 12. Informed consent: not mentioned, but an informed consent form was obtained from each participant by telephone confirmed; 13. Ethics committee approval: not mentioned. |