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Table 2 Characteristics of the included studies

From: The Chinese patent medicine Tongfengding capsule for gout in adults: a systematic review of safety and effectiveness

Tang [40]

 Methods

Randomized controlled trial (RCT): randomization described in detail

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

Follow-up: not mentioned

Study duration: 30 days

Parallel/factorial/crossover RCT: parallel RCT

Randomization method: a random number table was used

Blinding: no details were provided

Intention to treat (ITT): not mentioned

 Participants

Setting: Chinese patients of hospital, but did not mention if inpatients or outpatients

Country: China

Number (randomized/analyzed): Treatment group (90/90); control group (90/90)

Treatment group: 52 males (57.8%) and 38 females (42.2%), age 30–35 (43.7 ± 4.6) years, disease duration: not mentioned

Control group: 54 males (60%) and 36 females (40%), age 30–55 (42.9 ± 4.8) years, disease duration: not mentioned

 Interventions

Treatment group: Chinese patent medicine Tongfengding capsules plus conventional treatment

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

Conventional treatment was the same as that used in the control group

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

 Outcomes

1. BUA

2.CRP

3. ESR

4. Il-6, Il-8, and TNF-α

5. 24-h UTP

 Notes

3. Economic index: not mentioned

4. TCM tongue and pulse assessment (tongue coating and pulse): not mentioned

5. Adverse effects (rash, diarrhea, and gastrointestinal discomfort): not mentioned

5. Source of funding: Project support, Project Number: Sichuan Technological Innovation Funding Project, 2015GF01299

6. Relapse rate: not mentioned

7. Withdrawals: not mentioned; however, the full text suggested that there were no withdrawals

8. The study was approved by the ethics committee and participants provided informed consent

9. Overall, the participant demographic data were similar between groups

Gao et al. [41]

 Methods

Randomized controlled trial (RCT): randomization described in detail

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

Follow-up: 6 months

Study duration: 4 weeks

Parallel/crossover/factorial RCT: parallel RCT

Randomization method: a random number table was used

Blinding: no details were provided

Intention to treat (ITT): not mentioned

 Participants

Setting: outpatients

Country: China

Number (randomized/analyzed): Treatment group (41/41); control group (40/40)

Treatment group: 38 males (92.7%) and 3 females (7.3%), age 41.6 ± 2.8 years, disease duration: 7.8 ± 5.2 years

Control group: 38 males (95%) and 2 females (5%), age 40.2 ± 2.7 years, disease duration: 7.6 ± 6.4 years

 Interventions

Treatment group: Tongfengding capsules plus conventional treatment

Tongfengding capsules containing Huangbai, Qinjiao, and Chishao, the dose was not mentioned. Tongfengding capsules four capsules orally tid for 4 weeks

Conventional treatment was the same as that used in the control group

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

 Outcomes

1. Total effective rate

2. BUA

3. Relapse rate

4. Adverse effects (rash, diarrhea, and gastrointestinal discomfort)

 Notes

1. All-cause mortality: not mentioned

2. CRP: not mentioned

3. ESR: not mentioned

4. Il-6, Il-8, and TNF-α: not mentioned

5. Economic index: not mentioned

6. TCM tongue and pulse assessment (tongue coating and pulse): not mentioned

7.Source of funding: not mentioned

9. Withdrawals: not mentioned; however, the full text suggested that there were no withdrawals

10. The study was approved by the ethics committee and participants provided informed consent

11. Overall, the participant demographic data were similar between groups

Chi and Li [42]

 Methods

RCT: randomization described in detail

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

Follow-up: follow-up was mentioned; however, the follow-up duration was not mentioned

Study duration: 7 days

Parallel/crossover/factorial RCT: parallel RCT

Randomization method: a random number table was used in the study

Blinding: not mentioned

ITT: not mentioned

 Participants

Setting: outpatients and inpatients

Country: China

Number (randomized/analyzed): treatment group (44/44); control group (38/38)

Treatment group and control group: the ratio of male to female and disease duration: not mentioned

 Interventions

Treatment group: Chinese patent medicine Tong-Feng-Ding-Jiao-Nang capsules plus conventional treatment

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

Conventional treatment was the same as that used in the control group

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

 Outcomes

1. Total effective rate

2. SCr

3. BUN

 Notes

1. BUA: not mentioned

2. Relapse rate: not mentioned

3. Adverse effects (rash, diarrhea, and gastrointestinal discomfort): not mentioned

4. All-cause mortality: not mentioned

5. CRP: not mentioned

6. ESR: not mentioned

7. Il-6, Il-8, and TNF-α: not mentioned

8. Economic index: not mentioned

9. TCM tongue and pulse assessment (tongue coating and pulse): not mentioned

10. Withdrawals: not mentioned; however, the full text suggested that there were no withdrawals

11. Source of funding: not mentioned

12. The study was approved by the ethics committee and participants provided informed consent

13. Overall, the participant demographic data were similar between groups

Tang [43]

 Methods

RCT: randomization mentioned, but not described in detail

Allocation concealment: not mentioned in the paper; however, allocation concealment was confirmed in a telephone interview with the author

Follow-up: not mentioned

Study duration: 3 months

Parallel/crossover/factorial RCT: parallel RCT

Randomization method: random number table use was confirmed via telephone interview

Blinding: double-blinding was confirmed via telephone interview

ITT: not mentioned

 Participants

Setting: Chinese patients of hospital, but did not mention if inpatients or outpatients

Country: China

Number (randomized/analyzed): treatment group (40/40); control group (40/40)

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

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

 Interventions

Treatment group: Chinese patent medicine Tongfengding capsules plus conventional treatment

Tongfengding capsules containing Huangbai, Qinjiao, Chishao; the Chinese medicine dose was not mentioned. Tongfengding capsules 4 capsules orally tid for 3 months

Conventional treatment was the same as that used in the control group

Control group: conventional treatment included febuxostat tablets 80 mg orally qd for 3 months

 Outcomes

1. Total effective rate

2. Il-6, Il-8, and TNF-α

3. BUA

 Notes

1. Relapse rate: not mentioned

2. Adverse effects (rash, diarrhea, and gastrointestinal discomfort): not mentioned

3. All-cause mortality: not mentioned

4. CRP: not mentioned

5. ESR: not mentioned

6. Economic index: not mentioned

Economic index: not mentioned

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

11. Overall, the participant demographic data were similar between groups

Ao [44]

 Methods

RCT: randomization was mentioned, but not described in detail

Allocation concealment: not mentioned; however, the use of allocation concealment was confirmed in a telephone interview with the original author

Follow-up: not mentioned

Study duration: 3 months

Parallel/factorial/crossover RCT: parallel RCT

Randomization method: not mentioned; however, a telephone interview with the original author confirmed that a computer was used to generate random sequences

Blinding: not mentioned; however, a telephone interview with the original author confirmed the use of double-blinding

ITT: not mentioned

 Participants

Setting: outpatients

Country: China

Number (randomized/analyzed): treatment group (32/32); control group (32/32)

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

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

 Interventions

Treatment group: Chinese patent medicine Tongfengding capsules plus conventional treatment

Tongfengding capsules containing Huangbai, Qinjiao, and Chishao, the Chinese medicine dose was not mentioned. Tongfengding capsules 4 capsules orally tid for 8 weeks

Conventional treatment was the same as that used in the control group

Control group: conventional treatment included diclofenac sodium double-release enteric capsules, 75 mg orally qd for 8 weeks

 Outcomes

1. Total effective rate

 Notes

1. Il-6, Il-8, and TNF-α: not mentioned

2. BUA: not mentioned

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

13. Overall, the participant demographic data were similar between groups

Wang et al. [45]

 Methods

RCT: random sequences were generated using a random number table

Allocation concealment: allocation concealment was confirmed in a telephone interview

Follow-up: 6 months

Study duration: 4 weeks

Parallel/factorial/crossover RCT: parallel RCT

Randomization method: random number table

Blinding: double-blinding was confirmed in a telephone interview

ITT: not mentioned

 Participants

Setting: outpatients

Country: China

Number (randomized/analyzed): treatment group (60/60); control group (60/60)

Treatment group: 60 (38 males; 63.33%; 22 females; 36.67%), age 45.6 ± 5.7 years, disease duration: 6.8 ± 3.4 years

Control group: 60 (40 males; 66.67%; 20 females; 33.33%), age 46.7 ± 5.3 years, disease duration: 6.5 ± 2.8 years

 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 capsules 4 capsules orally tid for 4 weeks

Conventional treatment was the same as that used in the control group

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

 Outcomes

1. BUA

2. Relapse rate

 Notes

6. Economic index: not mentioned

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

11. Overall, the participant demographic data were similar between groups

  1. RCTs-randomized controlled trials; ITT—intention-to-treat; cholesterol; ESR—erythrocyte sedimentation rate; BUA—blood uric acid; CRP—C-reactive protein; IL-6—interleukin-6; IL-8—interleukin-8; TNF-α—tumor necrosis factor-α; Scr—Serum creatinine; BUN—Blood urea nitrogen; 24-h UTP—24-h urinary total protein