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Study flow diagram.
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Figure 1

Study flow diagram.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Forest plot of comparison: 1 SMP (GMP/G600) versus control (SMP/lactose), outcome: 1.1 Number of gout flares per month, after 3 months SMP (GMP/G600) versus control (SMP/lactose).
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Figure 3

Forest plot of comparison: 1 SMP (GMP/G600) versus control (SMP/lactose), outcome: 1.1 Number of gout flares per month, after 3 months SMP (GMP/G600) versus control (SMP/lactose).

Forest plot of comparison: 1 SMP (GMP/G600) versus control (SMP/lactose), outcome: 1.2 Physical Function.
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Figure 4

Forest plot of comparison: 1 SMP (GMP/G600) versus control (SMP/lactose), outcome: 1.2 Physical Function.

Forest plot of comparison: 1 SMP (GMP/G600) versus control (SMP/lactose), outcome: 1.3 Participant withdrawals due to adverse events.
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Figure 5

Forest plot of comparison: 1 SMP (GMP/G600) versus control (SMP/lactose), outcome: 1.3 Participant withdrawals due to adverse events.

Comparison 1 SMP (GMP/G600) versus control (SMP/lactose), Outcome 1 Number of gout flares per month, after 3 months SMP (GMP/G600) versus control (SMP/lactose).
Figuras y tablas -
Analysis 1.1

Comparison 1 SMP (GMP/G600) versus control (SMP/lactose), Outcome 1 Number of gout flares per month, after 3 months SMP (GMP/G600) versus control (SMP/lactose).

Comparison 1 SMP (GMP/G600) versus control (SMP/lactose), Outcome 2 Physical Function.
Figuras y tablas -
Analysis 1.2

Comparison 1 SMP (GMP/G600) versus control (SMP/lactose), Outcome 2 Physical Function.

Comparison 1 SMP (GMP/G600) versus control (SMP/lactose), Outcome 3 Participant withdrawals due to adverse events.
Figuras y tablas -
Analysis 1.3

Comparison 1 SMP (GMP/G600) versus control (SMP/lactose), Outcome 3 Participant withdrawals due to adverse events.

Summary of findings for the main comparison. Skim milk enriched with GMP/G600 compared to skim milk & lactose powder for chronic gout

Skim milk enriched with GMP/G600 compared to skim milk & lactose powder for chronic gout

Patient or population: patients with chronic gout
Settings: outpatient, community
Intervention: Skim milk enriched with GMP/G600
Comparison: skim milk & lactose powder

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Skim milk & lactose powder

Skim milk enriched with GMP/G600

Acute gout attack frequency
participant self‐report using gout flare diary
Follow‐up: 3 months

The mean acute gout attack frequency in the control groups was
0.6997 Number of gout flares per month

The mean acute gout attack frequency in the intervention groups was
0.21 lower
(0.76 lower to 0.34 higher)

120
(1 study)

⊕⊕⊝⊝
low1

Not statistically significant2

Participant withdrawals due to adverse events
participant and study investigator reported
Follow‐up: 3 months

Study population

RR 1.27
(0.53 to 3.03)

120
(1 study)

⊕⊕⊝⊝
low1

Not statistically significant3

138 per 1000

175 per 1000
(73 to 417)

Moderate

Joint pain reduction
10‐point Likert scale (0 is no pain)
Follow‐up: 3 months

The mean joint pain reduction in the control groups was
‐0.942

The mean joint pain reduction in the intervention groups was
1.03 lower
(1.96 to 0.1 lower)

120
(1 study)

⊕⊕⊝⊝
low1

Absolute risk difference = ‐10% (‐20% to ‐1%). Relative percentage change = ‐39% (‐74% to ‐4%). NNTB = 10 (5 to 100)2

Tophus regression ‐ not measured

See comment

See comment

Not estimable

See comment

Not measured

Physical function
HAQ‐II. Scale from: 0 to 3; 0 is minimal loss of function.
Follow‐up: 3 months

The mean physical function in the control groups was
0.11

The mean physical function in the intervention groups was
0.03 lower
(0.14 lower to 0.08 higher)

120
(1 study)

⊕⊕⊝⊝
low1

Absolute risk difference = ‐1% (‐5% to 3%). Relative percentage change = ‐13% (‐58% to 33%)

NNT n/a, not statistically significant2

Serum urate normalisation4 ‐ not reported

See comment

See comment

Not estimable4

See comment

Not reported

Serious adverse events
participant and study investigator reported
Follow‐up: 3 months

38 per 1000

50 per 1000
(9 to 287)

RR 1.33
(0.23 to 7.66)

120
(1 study)

⊕⊕⊝⊝
low1

Gastrointestinal AEs (diarrhoea, nausea and flatulence) reported most commonly. SAE related to hospital admissions ‐ none were due to the study products.3

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 There was selective reporting of post‐hoc comparisons between skim milk powder enriched with GMP/G600 and one of the two study controls (lactose) in relation to change in gout attack frequency from baseline
2 Number needed to benefit (NNTB) = N/A when result is not statistically significant. NNT for continuous outcomes calculated using the Wells calculator software available from the CMSG editorial office.
3 Number needed to harm (NNTH) = N/A when result is not statistically significant. NNT for dichotomous outcomes calculated using Cates NNT calculator (http://nntonline.net/ebm/visualrx/try.asp).
4 Results only presented graphically

Figuras y tablas -
Summary of findings for the main comparison. Skim milk enriched with GMP/G600 compared to skim milk & lactose powder for chronic gout
Comparison 1. SMP (GMP/G600) versus control (SMP/lactose)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of gout flares per month, after 3 months SMP (GMP/G600) versus control (SMP/lactose) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

2 Physical Function Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Subtotals only

3 Participant withdrawals due to adverse events Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Figuras y tablas -
Comparison 1. SMP (GMP/G600) versus control (SMP/lactose)