|
Wang et al., 2009 [15] |
|
| Randomized controlled trial (RCT): randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup: not mentioned |
Methods | Study duration: 3 weeks |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: we interviewed the author by telephone and learned that a random number table was used to generate the random sequence |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that single blinding was used |
| ITT: not mentioned |
| Setting: inpatients |
Participants | Country: China |
Number: 106 patients with childhood pneumonia |
| 54 boys (50.8%) and 52 girls (49.2%); age 3–14 years old; disease duration: not mentioned |
Interventions | Treatment group: modified Ma Xing Shi Gan Tang formula plus basic therapy: Mahuang 6 g, Xingren 8 g, Shigao 15 g, Gancao 5 g, Yuxingcao 20 g, lianqiao 15 g, Chanyi 10 g, and Niupangzi 15 g boiled in 3 L water and decocted to 300 mL. Orally twice daily (bid) for 3 weeks |
Control group: basic therapy including intravenous infusion of azithromycin and azithromycin orally |
Outcomes | (1) Total effective rate |
(2) Adverse effects (e.g., nausea, diarrhea, and vomit) |
Notes | (1) Duration of disease: not mentioned; (2) mortality: not mentioned; (3) relapse rate: not mentioned; (4) length of hospital stay: not mentioned; (5) clinical recovery (e.g., cough, fever, rales, and chest films): not mentioned; (6) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (7) economic index: not mentioned; (8) withdrawal rates: not specified; (9) source of funding: none |
|
Zhao and Ji, 2009 [16] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup was not mentioned |
Methods | Study duration: not mentioned |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a telephone interview with the author revealed that a random number table was used to generate the random sequence |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that single blinding was used |
| ITT: not mentioned |
| Setting: inpatients and outpatients |
| Country: China |
Participants | Number: 60 patients with childhood pneumonia |
| Treatment group: 30 patients with childhood pneumonia: 16 boys (53%) and 14 girls (47%); age: 2 months–9 years (mean: 3.5 years); disease duration: 4.00 ± 1.55 years |
| Control group: 30 patients with childhood pneumonia: 17 boys (56.6%) and 13 girls (43.4%); age: month –11 years (mean: 3.25 years); disease duration: 4.00 ± 1.75 years |
Interventions | Treatment group: modified Ma Xing Shi Gan Tang formula plus basic therapy: Mahuang 6 g, Xingren 10 g, Shigao 20 g, Gancao 3 g, Yuxingcao 10 g, and Huangqin 10 g boiled in 3 L water and decocted to 300 mL. Orally twice daily (bid) for 3 weeks |
Control group: basic therapy including intravenous infusion of azithromycin and azithromycin orally |
Outcomes | (1) Total effective rate |
(2) Clinical recovery (e.g., cough, fever, and rales) |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (5) clinical recovery (e.g., chest films): not mentioned; (6) economic index: not mentioned; (7) withdrawal rates: not mentioned; (8) source of funding: none;(9)adverse effects (e.g., nausea, diarrhea, and vomiting): not mentioned |
|
Guo, 1999 [17] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup: not mentioned |
Methods | Not mentioned |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a telephone interview with the author revealed that a random number table was used to generate the random sequence |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that single-blinding was used |
| ITT: not mentioned |
| Setting: not mentioned |
| Country: China |
Participants | Number: 170 patients with childhood pneumonia |
| Treatment group: 86 patients with childhood pneumonia: 45 boys (52.3%) and 41 girls (48.7%); age: 2 months–12 years (mean: 3.8 years) |
| Control group: 84 patients with childhood pneumonia: 44 boys (52.4%) and 40 girls (48.6%); age: 2 months–14 years (mean: 3.2 years) |
Interventions | Treatment group: modified Ma Xing Shi Gan Tang formula plus basic therapy. Mahuang 1.5 g, Xingren 3 g, Shigao 10 g, Gancao 1.5 g, Yuxingcao 9 g, and lianqiao 3 g, boiled in 3 L water and decocted to 300 mL. Taken orally, three times daily (tid) |
Control group: basic therapy included penicillin, Xianfeng Meisu, and ribavirin. Intravenous infusion of azithromycin and azithromycin orally |
Outcomes | (1) Total effective rate |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (5) economic index: not mentioned; (6) withdrawal rates: not specified; (7) source of funding: None; (8) time to measure outcomes: not mentioned; (9) 2. clinical recovery (e.g., cough, fever, rales, and chest films): not mentioned |
|
Zhang, 2012 [18] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup: not mentioned |
Methods | Study duration: 20 days |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a telephone interview with the author revealed that a random number table was used to generate the random sequence |
| Blinding: no detailed information on blindness was offered. Telephone interview with author revealed that blinding was not used |
| ITT: not mentioned |
| Setting: not mentioned |
| Country: China |
Participants | Number: 200 patients with childhood pneumonia |
| Treatment group: 100 patients with childhood pneumonia: 74 boys (74%) and 26 girls (47%); mean age: 6.28 years; disease duration: not mentioned |
| Control group: 100 patients with childhood pneumonia: 68 boys (68%) and 32 girls (32%); age and duration of disease not mentioned |
Interventions | Treatment group: modified Ma Xing Shi Gan Tang formula plus basic therapy. Mahuang 3 g, Xingren 4 g, Shigao 18 g, Gancao 3 g, Yuxingcao 9 g, and Huangqin 3 g boiled in 3 L water and decocted to 300 mL, taken orally twice daily (bid) |
Control group: basic therapy included intravenous infusion of azithromycin and azithromycin orally |
Outcomes | (1) Total effective rate |
(2) Clinical recovery (e.g., cough, fever, rales, and chest films) |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as the tongue coat and pulse condition: not mentioned; (5) economic index: not mentioned; (6) withdrawal rates: not mentioned; (7) source of funding: none; (8) time to measure outcomes: not mentioned; (9) adverse effects: not mentioned |
|
He, 2011 [19] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup: not mentioned |
Methods | Study duration: 5–7 days |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a telephone interview with the author revealed that a random number table was used to generate the random sequence |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that blinding was not used |
| ITT: not mentioned |
| Setting: inpatients |
| Country: China |
Participants | Number: 100 patients with childhood pneumonia |
| Treatment group: 50 patients with childhood pneumonia: 29 boys (54%) and 21 girls (42%); age: 9.6 months–12 years; disease duration: 4–8.5 days |
| Control group: 50 patients with childhood pneumonia: 27 boys (54%) and 23 girls (46%); age: 10.8 months–13 years; disease duration: 5–8 days |
Interventions | Treatment group: modified Ma Xing Shi Gan Tang formula plus basic therapy: Mahuang 3 g, Xingren 6 g, Jinhua 6 g, Yinhua 6 g, Shigao 12 g, Yuxingcao 9 g, Banxia 6 g, and Zhigancao 3 g boiled in 2 L water and decocted to 300 mL; taken orally twice daily (bid) |
Control group: intravenous infusion of azithromycin (10 mg/k · d) |
Outcomes | (1) Total effective rate |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (5) economic index: not mentioned; (6) withdrawal rates: not specified; (7) source of funding: none; (8) time to measure outcomes: not mentioned; (9) adverse effects: not mentioned; (10) clinical recovery (e.g., cough, fever, rales, and chest films): not mentioned |
|
He et al., 2011[20] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup: not mentioned |
Methods | Study duration: 7 days |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a telephone interview with the author revealed that a random number table was used to generate the random sequence |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that blinding was used on outcome assessment |
| ITT: not mentioned |
| Setting: inpatients |
| Country: China |
Participants | Number: 80 patients with childhood pneumonia |
Treatment group: 40 patients with childhood pneumonia: 22 boys (55%) and 18 girls (45%); mean age: 1.8 ± 1.10 years |
| Control group: 40 patients with childhood pneumonia: 21 boys (52.5%) and 19 girls (47.5%); mean age: 1.75 ± 1.151 years |
| Disease duration: 7.50 ± 0.50 days |
Interventions | Treatment group: modified Ma Xing Shi Gan Tang formula plus basic therapy: Mahuang 3 g, Xingren 3 g, Shigao 9 g, Suzi 3 g, Shangbaipi 6 g, Kuandonghua 6 g, Banxia 6 g, Tinglizi 3 g, Yuxingcao 3 g, and Gancao 3 g boiled in 2 L water and decocted to 300 mL, taken orally twice daily (bid) |
Control group: basic therapy included supporting treatment and intravenous infusion of ceftazidime (0.1 g/kg · d) |
Outcomes | (1) Total effective rate |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (5) adverse effects: not mentioned; (6) economic index: not mentioned; (7) withdrawal rates: not mentioned; (8) source of funding: none; (9) time to measure outcomes: not mentioned; (10) clinical recovery (e.g., cough, fever, rales, and chest films): not mentioned |
|
Zhang, 2012 [21] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup: not mentioned |
Methods | Study duration: 5–7 days |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a telephone interview with the author revealed that a computer-generated random-number table was used |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that blinding was used on the outcome assessment |
| ITT: not mentioned |
| Setting: inpatients |
| Country: China |
Participants | Number: 128 patients with childhood pneumonia |
Treatment group: 64 patients with childhood pneumonia in the treatment group |
| Control group: 64 patients with childhood pneumonia in the control group |
| In two groups, 79 boys (55%) and 49 girls (45%); age 1–14 years old; disease duration: 5–7 days |
Interventions | Treatment group: San Ao Tang formula plus basic therapy; Mahuang 3 g, Xingren 12 g, Gancao 3 g boiled in 2 L water and decocted to 250 mL. Taken orally three times daily (tid) |
Control group: basic therapy included symptomatic therapy and orally azithromycin 10 mg/kg one time per day (qd) |
Outcomes | (1) Total effective rate; (2) clinical recovery (e.g., cough, fever, rales, and chest films); (3) adverse effects (e.g., nausea) |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (5) economic index: not mentioned; (6) withdrawal rates: not mentioned; (7) source of funding: none; (8) time to measure outcomes: not mentioned |
|
Wang et al., 2009 [22] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup: not mentioned |
| Study duration: 7 days |
Methods | Parallel/crossover/factorial RCT: parallel |
Randomization method: a telephone interview with the author revealed that a computer-generated random-number table was used |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that blinding was used on outcome assessment |
| ITT: not mentioned |
| Setting: patient source not mentioned |
| Country: China |
| Number: 200 patients with childhood pneumonia |
Participants | Treatment group: 100 patients with childhood pneumonia in the treatment group |
| Control group: 100 patients with childhood pneumonia in the control group |
| Did not mention the number of boys and girls |
| Disease duration: 5–7 days |
Interventions | Treatment group: Zhi Sou San formula plus basic therapy: Jiegeng 6–9 g, Gancao 3–6 g, Ziwan 3–6 g, Chenpi 3–6 g, Xingren 3–6 g, Baiguo 3–6 g, Huangqi 3–6 g, Chaomaiya 3–6 g, Yunling 3–6 g, and Baiqian 3–6 g boiled in 2 L water. Taken orally three times daily (tid) |
Control group: basic therapy included symptomatic therapy and intravenous infusion of erythrocin (30 mg/kg · d) |
Outcomes | (1) Total effective rate; (2) clinical recovery (e.g., cough, fever, and rales); (3) adverse effects (e.g., nausea, vomiting, and gastrointestinal bleeding) |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (5) economic index: not mentioned; (6) withdrawal rates: not mentioned; (7) source of funding: none; (8) time to measure outcomes: not mentioned; (9) chest films: not mentioned |
|
Lv et al., 2009 [23] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup was not mentioned |
Methods | Study duration: 10 days |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a telephone interview with the author revealed that a random number table was used to generate the random sequence |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that blinding was used on the outcome assessment |
| ITT: not mentioned |
| Setting: inpatients |
| Country: China |
Participants | Number: 60 patients with childhood pneumonia |
| Treatment group: 30 patients with childhood pneumonia: 17 boys (56.7%) and 13 girls (43.3%); age: 8 months–13 years; disease duration: 7–18 days; mean: 14 days |
| Control group: 30 patients with childhood pneumonia: 16 boys (53.3%) and 14 girls (46.7%); age: 7 months–12 years; disease duration: 7–18 days; mean: 13.5 days |
Interventions | Treatment group: self-developed TCM prescription plus basic therapy: Mahuang 3 g, Xingren 3 g, Rengongniuhuang 3 g, Bingpian 2 g, Shengshigao 3 g, Zhusha 2 g, Chuanbeimu 2 g, Huanglian 2 g, Banxia 2 g, Dannanxing 2 g, Shangbaipi 2 g, Huangqin 2 g, and Gancao 2 g boiled in 3 L water and decocted to 300 mL. Taken orally three times daily (tid) |
Control group: basic therapy included symptomatic therapy and intravenous infusion of erythrocin (20 mg/kg bid) |
Outcomes | (1) Total effective rate; (2) clinical recovery (e.g., cough, fever, rales, and chest films) |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (5) economic index: not mentioned; (6) withdrawal rates: not mentioned; (7) source of funding: none; (8) time to measure outcomes: mentioned; (9) adverse effects: not mentioned |
|
Lei, 2010 [24] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup: not mentioned |
Methods | Study duration: 7 days |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a telephone interview with the author revealed that a computer-generated random-number table was used |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that blinding was used on the outcome assessment |
| ITT: not mentioned |
| Setting: inpatients |
| Country: China |
Participants | Number: 160 patients with childhood pneumonia |
| Treatment group: 80 patients with childhood pneumonia: 52 boys (65%) and 28 girls (35%); age: 6 months–12 years; disease duration: 2–7 days |
| Control group: 80 patients with childhood pneumonia: 54 boys (67.5%) and 26 girls (32.5%); age: 5 months–13 years; disease duration: 1–6 days |
Interventions | Treatment group: Tanreqing injection plus basic therapy: 30–50 mL/kg Tanreqing injection + 50–100 mL 10% GS intravenous infusion once daily (qd) |
Control group: basic therapy included anti-inflammatory, symptomatic therapy. Did not provide any detailed information about the anti-inflammatory, symptomatic therapy |
Outcomes | (1) Total effective rate; (2) clinical recovery (e.g., cough, fever, and rales). |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (5) economic index: not mentioned; (6) withdrawal rates: not mentioned; (7) source of funding: none; (8) time to measure outcomes: mentioned; (9) chest films: not mentioned; (10) adverse effects: not mentioned |
|
Shi, 2009 [25] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup: not mentioned |
Methods | Study duration: 14 days |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a random number table was used to generate the random sequence |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that blinding was not used on study |
| ITT: not mentioned |
| Setting: inpatients |
| Country: China |
Participants | Number: 80 patients with childhood pneumonia |
| Treatment group: 40 patients with childhood pneumonia: 21 boys (52.5%) and 19 girls (47.5%) |
| Control group: 40 patients with childhood pneumonia: 24 boys (60%) and 16 girls (40%); age: 5 months–13 years, in two groups; disease duration: 1–3 days |
Interventions | Treatment group: Reduning injection plus basic therapy: 0.5–1.0 mL/kg · d Reduning injection + 250 mL 5% GS intravenous infusion once daily (qd) |
Control group: basic therapy included symptomatic therapy and intravenous infusion of 10 mg/kg · d azithromycin for 5 days, stop 3 days, then changed to oral 10 mg/kg · d azithromycin for 3 days |
Outcomes | (1) Total effective rate; (2) clinical recovery (e.g., cough, fever, rales, and chest films) |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (5) economic index: not mentioned; (6) withdrawal rates: not mentioned; (7) source of funding: none; (8) time to measure outcomes: mentioned; (9) adverse effects: not mentioned |
|
Pan, 2011 [26] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup: not mentioned |
Methods | Study duration: 7 days |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a telephone interview with the author revealed that a random number table was used to generate the random sequence |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that the outcome assessment was blinding |
| ITT: not mentioned. |
| Setting: patient source not mentioned. |
| Country: China |
Participants | Number: 140 patients with childhood pneumonia |
| Treatment group: 70 patients with childhood pneumonia: 42 boys (60%) and 28 girls (40%); age: 1–9 years old (mean: 5.1 ± 1.6 years); disease duration: 2–7 days |
| Control group: 70 patients with childhood pneumonia: 36 boys (51.4%) and 34 girls (48.6%); age: 1–10 years old (mean: 5.1 ± 1.6 years); disease duration: 1–7 days |
Interventions | Treatment group: Reduning injection plus basic therapy: 0.5–0.8 mL/kg Reduning injection + 100 mL 5% GS intravenous infusion once daily (qd) |
Control group: intravenous infusion of 10 mg/kg · d azithromycin + 5% GS once daily (qd) |
Outcomes | (1) Total effective rate; (2) clinical recovery (e.g., cough, fever, and rales) |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (5) economic index: not mentioned; (6) withdrawal rates: not mentioned; (7) source of funding: mentioned; (8) time to measure outcomes: not mentioned; (9) adverse effects: not mentioned; (10) chest films: not mentioned |
|
Duan and Feng, 2011 [27] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup was not mentioned |
Methods | Study duration: 14 days |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a telephone interview with the author revealed that a random number table was used to generate the random sequence |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that the outcome assessment was blinded |
| ITT: not mentioned |
| Setting: outpatients and inpatients |
Participants | Country: China |
Number: 60 patients with childhood pneumonia |
| In two groups: 35 boys (58.3%) and 25 girls (41.7%); age: 1–13 years; disease duration: 2–5 days |
Interventions | Treatment group: Reduning injection plus basic therapy: 10–15 mL Reduning injection + 100 mL 5% GS intravenous infusion once daily (qd) |
Control group: intravenous infusion of 10 mg/kg · d azithromycin + 5% GS once daily (qd) |
Outcomes | (1) Total effective rate; (2) clinical recovery (e.g., fever) |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) length of hospital stay: not mentioned; (4) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (5) economic index: not mentioned; (6) clinical recovery (e.g., cough, rales, and chest films): not mentioned; (7) withdrawal rates: not mentioned; (8) source of funding: none; (9) time to measure outcomes: not mentioned; (10) adverse effects: not mentioned |
|
Wei and Feng, 2003 [28] |
|
| RCT: randomization mentioned, but not described in detail |
| Allocation concealment: not mentioned |
| Followup: not mentioned |
Methods | Study duration: 7–10 days |
Parallel/crossover/factorial RCT: parallel |
| Randomization method: a telephone interview with the author revealed that a computer-generated random-number table was used |
| Blinding: no detailed information on blindness was offered. A telephone interview with the author revealed that blinding was not used |
| ITT: not mentioned |
| Setting: inpatients |
| Country: China |
Participants | Number: 180 patients with childhood |
In two groups: 100 boys (55.6%) and 80 girls (44.4%); age: 2 months–5 years (mean: 2.3 years); disease duration: 1–7 days |
| Treatment group: 90 patients with childhood pneumonia; 52 boys (57.8%) and 38 girls (42.2%) |
| Control group: 90 patients with childhood pneumonia; 48 boys (53.3%) and 42 girls (46.7%) |
Interventions | Treatment group: Chuanhuning injection plus basic therapy: 10 mg/kg · d + 50–100 mL 10% GS or NS intravenous infusion once daily (qd) |
Control group: intravenous infusion of 100 mg/kg · d piperacillin twice daily (bid) |
Outcomes | (1) Total effective rate; (2) length of hospital stay; (3) clinical recovery (e.g., cough, fever, rales, and chest films) |
Notes | (1) Mortality: not mentioned; (2) relapse rate: not mentioned; (3) TCM outcomes, such as tongue coat and pulse condition: not mentioned; (4) economic index: not mentioned; (5) withdrawal rates: not mentioned; (6) source of funding: none; (7) time to measure outcomes: not mentioned; (8) adverse effects: not mentioned |
|