Tang [4040 Tang L. Effect of allopurinol combined with Tongfengding capsule on inflammatory factors, hepatorenal functions, and related indicators in gouty patients. J Hainan Med Univ. 2016;22(21):2551–4.] |
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Methods |
Randomized controlled trial (RCT): randomization described in detail |
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Allocation concealment: not mentioned; however, the randomization method would have prevented participants/investigators |
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from knowing or influencing the treatment group before eligible participants were enrolled in the study |
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Follow-up: not mentioned |
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Study duration: 30 days |
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Parallel/factorial/crossover RCT: parallel RCT |
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Randomization method: a random number table was used |
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Blinding: no details were provided |
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Intention to treat (ITT): not mentioned |
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Participants |
Setting: Chinese patients of hospital, but did not mention if inpatients or outpatients |
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Country: China |
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Number (randomized/analyzed): Treatment group (90/90); control group (90/90) |
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Treatment group: 52 males (57.8%) and 38 females (42.2%), age 30–35 (43.7 ± 4.6) years, disease duration: not mentioned |
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Control group: 54 males (60%) and 36 females (40%), age 30–55 (42.9 ± 4.8) years, disease duration: not mentioned |
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Interventions |
Treatment group: Chinese patent medicine Tongfengding capsules plus conventional treatment |
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Tongfengding capsules containing Huangbai, Qinjiao, and Chishao; the Chinese medicine dose was not mentioned. Tongfengding capsules: three capsules orally taken three times daily (tid) for 30 days |
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Conventional treatment was the same as that used in the control group |
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Control group: conventional treatment: Allopurinol tablets (50 mg) orally taken twice daily (bid), extra water, low purine foods, and alcohol consumption prohibited for 30 days |
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Outcomes |
1. BUA |
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2.CRP |
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3. ESR |
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4. Il-6, Il-8, and TNF-α |
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5. 24-h UTP |
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Notes |
3. Economic index: not mentioned |
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4. TCM tongue and pulse assessment (tongue coating and pulse): not mentioned |
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5. Adverse effects (rash, diarrhea, and gastrointestinal discomfort): not mentioned |
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5. Source of funding: Project support, Project Number: Sichuan Technological Innovation Funding Project, 2015GF01299 |
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6. Relapse rate: not mentioned |
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7. Withdrawals: not mentioned; however, the full text suggested that there were no withdrawals |
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8. The study was approved by the ethics committee and participants provided informed consent |
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9. Overall, the participant demographic data were similar between groups |
Gao et al. [4141 Gao Y, Zhang ZR, Tang ZH, Lu J, Su Y. Clinical observation of Benzbromarone combined with Tongfengding capsules in treatment of gouty arthritis. Clin J Med Off. 2015;43(10):1060–2.] |
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Methods |
Randomized controlled trial (RCT): randomization described in detail |
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Allocation concealment: not mentioned; however, the randomization method would have prevented participants/investigators from knowing or influencing the treatment group before eligible participants were enrolled in the study |
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Follow-up: 6 months |
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Study duration: 4 weeks |
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Parallel/crossover/factorial RCT: parallel RCT |
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Randomization method: a random number table was used |
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Blinding: no details were provided |
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Intention to treat (ITT): not mentioned |
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Participants |
Setting: outpatients |
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Country: China |
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Number (randomized/analyzed): Treatment group (41/41); control group (40/40) |
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Treatment group: 38 males (92.7%) and 3 females (7.3%), age 41.6 ± 2.8 years, disease duration: 7.8 ± 5.2 years |
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Control group: 38 males (95%) and 2 females (5%), age 40.2 ± 2.7 years, disease duration: 7.6 ± 6.4 years |
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Interventions |
Treatment group: Tongfengding capsules plus conventional treatment |
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Tongfengding capsules containing Huangbai, Qinjiao, and Chishao, the dose was not mentioned. Tongfengding capsules four capsules orally tid for 4 weeks |
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Conventional treatment was the same as that used in the control group |
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Control group: conventional treatment: benzbromarone capsules, 50 mg orally once daily (qd), taken after breakfast; sodium bicarbonate tablets and dipyridamole tablets 0.5 g orally tid; Indomethacin tablets 25 mg orally tid, continuously for 3 days; a high purine diet was prohibited during the study period |
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Outcomes |
1. Total effective rate |
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2. BUA |
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3. Relapse rate |
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4. Adverse effects (rash, diarrhea, and gastrointestinal discomfort) |
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Notes |
1. All-cause mortality: not mentioned |
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2. CRP: not mentioned |
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3. ESR: not mentioned |
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4. Il-6, Il-8, and TNF-α: not mentioned |
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5. Economic index: not mentioned |
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6. TCM tongue and pulse assessment (tongue coating and pulse): not mentioned |
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7. Source of funding: not mentioned |
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9. Withdrawals: not mentioned; however, the full text suggested that there were no withdrawals |
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10. The study was approved by the ethics committee and participants provided informed consent |
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11. Overall, the participant demographic data were similar between groups |
Chi and Li [4242 Chi S, Li K. Tongfengding capsule treat acute gouty arthritis randomized controlled study. J Pract Tradition Chin Internal Med. 2013;27(11):39–40.] |
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Methods |
RCT: randomization described in detail |
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Allocation concealment: not mentioned; however, the randomization method would have prevented participants/investigators from knowing or influencing the treatment group before eligible participant were enrolled in the study |
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Follow-up: follow-up was mentioned; however, the follow-up duration was not mentioned |
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Study duration: 7 days |
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Parallel/crossover/factorial RCT: parallel RCT |
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Randomization method: a random number table was used in the study |
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Blinding: not mentioned |
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ITT: not mentioned |
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Participants |
Setting: outpatients and inpatients |
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Country: China |
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Number (randomized/analyzed): treatment group (44/44); control group (38/38) |
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Treatment group and control group: the ratio of male to female and disease duration: not mentioned |
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Interventions |
Treatment group: Chinese patent medicine Tong-Feng-Ding-Jiao-Nang capsules plus conventional treatment |
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Tongfengding capsules containing Huangbai, Qinjiao, Chishao; the Chinese medicine dose was not mentioned. Tong-Feng-Ding-Jiao-Nang capsules: 3–4 capsules orally tid for 7 days |
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Conventional treatment was the same as that used in the control group |
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Control group: conventional treatment included colchicine tablets 3 mg orally at first, then 0.5 mg every 1–2 h until the symptoms subsided or adverse effects occurred, with the stipulation of no more than 6 mg per 24 h, and 0.5 to 1 mg per day after 72 h; allopurinol tablets 0.1 g orally bid or tid |
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Outcomes |
1. Total effective rate |
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2. SCr |
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3. BUN |
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Notes |
1. BUA: not mentioned |
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2. Relapse rate: not mentioned |
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3. Adverse effects (rash, diarrhea, and gastrointestinal discomfort): not mentioned |
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4. All-cause mortality: not mentioned |
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5. CRP: not mentioned |
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6. ESR: not mentioned |
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7. Il-6, Il-8, and TNF-α: not mentioned |
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8. Economic index: not mentioned |
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9. TCM tongue and pulse assessment (tongue coating and pulse): not mentioned |
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10. Withdrawals: not mentioned; however, the full text suggested that there were no withdrawals |
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11. Source of funding: not mentioned |
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12. The study was approved by the ethics committee and participants provided informed consent |
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13. Overall, the participant demographic data were similar between groups |
Tang [4343 Tang Y. Effect of febuxostat combined with Tongfengding capsule on inflammatory factors in patients with hyperuricemia. Mod J Integr Tradition Chin West Med. 2017;26(7):737–9.] |
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Methods |
RCT: randomization mentioned, but not described in detail |
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Allocation concealment: not mentioned in the paper; however, allocation concealment was confirmed in a telephone interview with the author |
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Follow-up: not mentioned |
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Study duration: 3 months |
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Parallel/crossover/factorial RCT: parallel RCT |
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Randomization method: random number table use was confirmed via telephone interview |
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Blinding: double-blinding was confirmed via telephone interview |
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ITT: not mentioned |
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Participants |
Setting: Chinese patients of hospital, but did not mention if inpatients or outpatients |
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Country: China |
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Number (randomized/analyzed): treatment group (40/40); control group (40/40) |
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Treatment group: 22 males (55%) and 18 females (45%), age 26–68 (45.6 ± 8.2) years, disease duration: 2–14 (6.3 ± 2.1) years |
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Control group: 24 males (60%) and 16 females (40%), age 23–67 (44.8 ± 7.8) years, disease duration: 1–12 (6.1 ± 1.8) years |
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Interventions |
Treatment group: Chinese patent medicine Tongfengding capsules plus conventional treatment |
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Tongfengding capsules containing Huangbai, Qinjiao, Chishao; the Chinese medicine dose was not mentioned. Tongfengding capsules |
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4 capsules orally tid for 3 months |
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Conventional treatment was the same as that used in the control group |
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Control group: conventional treatment included febuxostat tablets 80 mg orally qd for 3 months |
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Outcomes |
1. Total effective rate |
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2. Il-6, Il-8, and TNF-α |
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3. BUA |
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Notes |
1. Relapse rate: not mentioned |
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2. Adverse effects (rash, diarrhea, and gastrointestinal discomfort): not mentioned |
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3. All-cause mortality: not mentioned |
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4. CRP: not mentioned |
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5. ESR: not mentioned |
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6. Economic index: not mentioned |
|
Economic index: not mentioned |
|
7. TCM tongue and pulse assessment (tongue coating and pulse): not mentioned |
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8. Source of funding: not mentioned |
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9. Withdrawals: not specifically mentioned; however, careful reading of the paper confirmed that no participants withdrew from the study |
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10. Ethics committee approval and signed informed consent were not mentioned in the paper, but were confirmed in a telephone interview |
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11. Overall, the participant demographic data were similar between groups |
Ao [4444 Ao J. Observation on the curative effect of Tongfengding capsule in the treatment of senile gouty arthritis in the elderly. J Clin Med Lit. 2019;6(5):38–9.] |
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Methods |
RCT: randomization was mentioned, but not described in detail |
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Allocation concealment: not mentioned; however, the use of allocation concealment was confirmed in a telephone interview with the original author |
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Follow-up: not mentioned |
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Study duration: 3 months |
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Parallel/factorial/crossover RCT: parallel RCT |
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Randomization method: not mentioned; however, a telephone interview with the original author confirmed that a computer was used to generate random sequences |
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Blinding: not mentioned; however, a telephone interview with the original author confirmed the use of double-blinding |
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ITT: not mentioned |
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Participants |
Setting: outpatients |
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Country: China |
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Number (randomized/analyzed): treatment group (32/32); control group (32/32) |
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Treatment group: 32 (19 males; 59.4%; 13 females; 40.6%), age 61–85 years (75.2 ± 1.2) years, disease duration: 6 months −5 (2.6 ± 0.2) years |
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Control group: 32 (20 males; 62.5%; 12 females; 37.5%), age 63–87 (75.5 ± 1.5) years, disease duration: 7 months −5 (2.8 ± 0.2) years |
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Interventions |
Treatment group: Chinese patent medicine Tongfengding capsules plus conventional treatment |
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Tongfengding capsules containing Huangbai, Qinjiao, and Chishao, the Chinese medicine dose was not mentioned. Tongfengding capsules 4 capsules orally tid for 8 weeks |
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Conventional treatment was the same as that used in the control group |
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Control group: conventional treatment included diclofenac sodium double-release enteric capsules, 75 mg orally qd for 8 weeks |
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Outcomes |
1. Total effective rate |
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Notes |
1. Il-6, Il-8, and TNF-α: not mentioned |
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2. BUA: not mentioned |
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3. Relapse rate: not mentioned |
|
4. Adverse effects (rash, diarrhea, and gastrointestinal discomfort): not mentioned |
|
5. All-cause mortality: not mentioned |
|
6. CRP: not mentioned |
|
7. ESR: not mentioned |
|
8. Economic index: not mentioned |
|
9. TCM tongue and pulse assessment (tongue coating and pulse): not mentioned |
|
10. Source of funding: not mentioned |
|
11. Withdrawals: not specifically mentioned; however, careful reading of the paper confirmed that no participants withdrew from the study |
|
12. Ethics committee approval and signed informed consent were not mentioned in the paper, but were confirmed in a telephone interview |
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13. Overall, the participant demographic data were similar between groups |
Wang et al. [4545 Wang LJ, Xiang Y, Yang QF, Sun QJ. Effects of Tongfengding capsule combined with diclofenac sodium on blood uric acid level and joint swelling and pain score in gout patients. Chin J Biochem Pharm. 2017;37(8):83–4.] |
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Methods |
RCT: random sequences were generated using a random number table |
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Allocation concealment: allocation concealment was confirmed in a telephone interview |
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Follow-up: 6 months |
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Study duration: 4 weeks |
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Parallel/factorial/crossover RCT: parallel RCT |
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Randomization method: random number table |
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Blinding: double-blinding was confirmed in a telephone interview |
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ITT: not mentioned |
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Participants |
Setting: outpatients |
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Country: China |
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Number (randomized/analyzed): treatment group (60/60); control group (60/60) |
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Treatment group: 60 (38 males; 63.33%; 22 females; 36.67%), age 45.6 ± 5.7 years, disease duration: 6.8 ± 3.4 years |
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Control group: 60 (40 males; 66.67%; 20 females; 33.33%), age 46.7 ± 5.3 years, disease duration: 6.5 ± 2.8 years |
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Interventions |
Treatment group: Chinese patent medicine Tongfengding capsule plus conventional treatment |
|
Tongfengding capsules including Huangbai, Qinjiao, and Chishao; the Chinese medicine dose was not mentioned. Tongfengding |
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capsules 4 capsules orally tid for 4 weeks |
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Conventional treatment was the same as that used in the control group |
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Control group: conventional treatment included anti-infection, low purine diet, diclofenac sodium enteric-coated sustained-release capsules 0.1 g orally qid, and indomethacin (dose not mentioned) orally during the acute phase of gout |
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Outcomes |
1. BUA |
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2. Relapse rate |
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Notes |
6. Economic index: not mentioned |
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7. TCM tongue and pulse assessment (tongue coating and pulse): not mentioned |
|
8. Source of funding: not mentioned |
|
9. Withdrawals: not specifically mentioned; however, careful reading of the paper confirmed that no participants withdrew from the study |
|
10. Ethics committee approval and signed informed consent were not mentioned in the paper, but were confirmed in a telephone interview |
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11. Overall, the participant demographic data were similar between groups |