biochemical adverse drug reactions on liver, kidney and glucose markers, and self-reported adverse drug reactions versus placebo

no effect

Not recorded as a finding: the supporting sentence never names the compound

There were no statistically significant self-reported ADRs versus placebo (see Table 2).

PMID 23431291 · one of two readings recorded this

biochemical adverse drug reactions on liver, kidney and glucose markers

no effect

There was no biochemical ADRs on liver, kidney, or glucose markers

PMID 23431291 · one of two readings recorded this

blood urea nitrogen (BUN)

no effect, p = 0.2

but this reduction was not significant when compared to placebo (P = 0.20)

PMID 23431291 · one of two readings recorded this

blood urea nitrogen (BUN)

decreases, p = 0.01

The combination of grape extract and low-dose pterostilbene decreased BUN by 7.1% from baseline (P = 0.01)

PMID 23431291 · one of two readings recorded this

other electrolyte markers

no effect

There were no other significant effects on electrolyte markers

PMID 23431291 · one of two readings recorded this

patients lost to follow up

n = 60

Among the pterostilbene groups (n = 60), 2 patients were lost to follow up and 2 patients withdrew from the trial

PMID 23431291 · one of two readings recorded this

patients withdrawn from the trial

n = 60

Among the pterostilbene groups (n = 60), 2 patients were lost to follow up and 2 patients withdrew from the trial

PMID 23431291 · one of two readings recorded this

safety markers: ALT, AST, serum creatinine and blood glucose (biochemical adverse drug reactions), 6-8 weeks, pterostilbene 50 or 125 mg twice daily versus placebo

no effect

Not recorded as a finding: the supporting sentence never names the compound

There was no biochemical ADRs on liver, kidney, or glucose markers (See Figure 1).

PMID 23431291 · one of two readings recorded this

self-reported adverse drug reactions

no effect

There were no statistically significant self-reported ADRs versus placebo

PMID 23431291 · one of two readings recorded this

serum bicarbonate

decreases, p = 0.02

There was a significant 3.6% reduction in bicarbonate in the high-dose group versus placebo (P = 0.02) with a similar trend in both low-dose groups

PMID 23431291 · one of two readings recorded this

serum bicarbonate

decreases

There was a significant 3.6% reduction in bicarbonate in the high-dose group versus placebo (P = 0.02) with a similar trend in both low-dose groups

PMID 23431291 · one of two readings recorded this

serum bicarbonate

decreases

There was a significant 3.6% reduction in bicarbonate in the high-dose group versus placebo (P = 0.02) with a similar trend in both low-dose groups

PMID 23431291 · one of two readings recorded this

HDL cholesterol

no effect

Not recorded as a finding: The only sentences are agentless (no significant change in the primary analysis) or a subgroup (patients not on cholesterol medication, high dose); no compound-naming whole-population sentence

There was no significant change in HDL in the primary efficacy analysis.

PMID 25057276 · one of two readings recorded this

HDL cholesterol

no effect

There was no significant change in HDL in the primary efficacy analysis

PMID 25057276 · one of two readings recorded this

HDL cholesterol

decreases, p = 0.033

Subgroup analysis demonstrated a reduction of HDL with high dose pterostilbene monotherapy in patients not on cholesterol medication at baseline (−5.03 mg/dL; P = 0.033)

PMID 25057276 · one of two readings recorded this

LDL cholesterol

no effect, p = 0.47

This increase was not significant in the GE combination group (P = 0.47)

PMID 25057276 · one of two readings recorded this

LDL cholesterol

increases, p = 0.001

LDL increased with pterostilbene monotherapy (high dose and low dose groups combined) 17.1 mg/dL (P = 0.001), regardless of dose

PMID 25057276 · one of two readings recorded this

LDL cholesterol

decreases

The presence of a baseline cholesterol medication appeared to attenuate this LDL increase in all groups

PMID 25057276 · one of two readings recorded this

LDL cholesterol

increases

These findings were consistent regardless of baseline LDL ≤130 mg/dL versus >130 mg/dL

PMID 25057276 · one of two readings recorded this

triglycerides

no effect

There was no significant change in triglycerides across all groups

PMID 25057276 · one of two readings recorded this

appropriate statin use per 2013 ACC/AHA guidelines

no effect

appropriate statin use at baseline and final was 59% across all treatment arms

PMID 25057276 · one of two readings recorded this

ASCVD risk score at baseline

no effect, p = 0.1

All treatment arms had similar ASCVD risk scores at baseline (P > 0.1 for all)

PMID 25057276 · one of two readings recorded this

ASCVD risk score

no effect, p = 0.72

placebo: +0.59%, P = 0.33; high dose: +0.13%, P = 0.72; low dose: +0.02%, P = 0.96; GE combination: −0.83%, P = 0.11

PMID 25057276 · one of two readings recorded this

ASCVD risk score

no effect, p = 0.96

placebo: +0.59%, P = 0.33; high dose: +0.13%, P = 0.72; low dose: +0.02%, P = 0.96; GE combination: −0.83%, P = 0.11

PMID 25057276 · one of two readings recorded this

ASCVD risk score

no effect, p = 0.33

placebo: +0.59%, P = 0.33; high dose: +0.13%, P = 0.72; low dose: +0.02%, P = 0.96; GE combination: −0.83%, P = 0.11

PMID 25057276 · one of two readings recorded this

ASCVD risk score

no effect, p = 0.11

placebo: +0.59%, P = 0.33; high dose: +0.13%, P = 0.72; low dose: +0.02%, P = 0.96; GE combination: −0.83%, P = 0.11

PMID 25057276 · one of two readings recorded this

BMI

no effect

Not recorded as a finding: Agentless sentence that never names the compound; the BMI decrease is reported only in a subgroup not on cholesterol medication

There was no significant change in BMI in the primary efficacy analysis.

PMID 25057276 · one of two readings recorded this

BMI

no effect

There was no significant change in BMI in the primary efficacy analysis

PMID 25057276 · one of two readings recorded this

BMI

decreases

Subgroup analysis demonstrated a decrease in BMI with (1) low dose, (2) pterostilbene monotherapy, and (3) overall population (all 3 groups combined) in patients not on cholesterol medication at baseline

PMID 25057276 · one of two readings recorded this

BMI

decreases

Subgroup analysis demonstrated a decrease in BMI with (1) low dose, (2) pterostilbene monotherapy, and (3) overall population (all 3 groups combined) in patients not on cholesterol medication at baseline

PMID 25057276 · one of two readings recorded this

BMI

decreases

Subgroup analysis demonstrated a decrease in BMI with (1) low dose, (2) pterostilbene monotherapy, and (3) overall population (all 3 groups combined) in patients not on cholesterol medication at baseline

PMID 25057276 · one of two readings recorded this

body mass index, primary efficacy analysis

no effect

Not recorded as a finding: Agentless sentence that never names the compound or the comparator.

There was no significant change in BMI in the primary efficacy analysis.

PMID 25057276 · one of two readings recorded this

diastolic blood pressure

decreases

There was a significant reduction versus placebo in SBP and DBP with high dose pterostilbene (see Figure 2)

PMID 25057276 · one of two readings recorded this

HDL cholesterol, primary efficacy analysis

no effect

Not recorded as a finding: Agentless sentence that never names the compound or the comparator.

There was no significant change in HDL in the primary efficacy analysis.

PMID 25057276 · one of two readings recorded this

LDL cholesterol, fasting lipid panel (assay not stated)

increases, 17.1 mg/dL, p = 0.001

Not recorded as a finding: The sentence reports an increase with pooled monotherapy arms but never says versus placebo, so it may be a within-arm change; the ldl-cholesterol node needs a between-arm contrast.

LDL increased with pterostilbene monotherapy (high dose and low dose groups combined) 17.1 mg/dL (P = 0.001), regardless of dose (see Figure 2).

PMID 25057276 · one of two readings recorded this

overall attrition rate

There was an 8.8% overall attrition rate

PMID 25057276 · one of two readings recorded this

serum triglycerides, all groups

no effect

Not recorded as a finding: Agentless sentence that never names the compound or the comparator.

There was no significant change in triglycerides across all groups.

PMID 25057276 · one of two readings recorded this

systolic blood pressure, grape-extract combination arm

decreases, -6.72 mmHg, p = 0.016

Not recorded as a finding: Combination arm (pterostilbene 50 mg plus grape extract) is absent from the comparator

A reduction in SBP was also seen in the GE combination group (−6.72 mmHg; P = 0.016).

PMID 25057276 · one of two readings recorded this

systolic blood pressure

decreases

There was a significant reduction versus placebo in SBP and DBP with high dose pterostilbene (see Figure 2)

PMID 25057276 · one of two readings recorded this

systolic blood pressure

decreases, p = 0.016

A reduction in SBP was also seen in the GE combination group (−6.72 mmHg; P = 0.016)

PMID 25057276 · one of two readings recorded this

total cholesterol

increases

total cholesterol (TC) increased accordingly with both low dose and high dose pterostilbene

PMID 25057276 · one of two readings recorded this

trial completion

The majority of patients completed the trial (91%) and demonstrated at least 80% compliance (81% of completers)

PMID 25057276 · one of two readings recorded this

triglycerides, fasting serum

no effect

Not recorded as a finding: Agentless sentence that never names the compound

There was no significant change in triglycerides across all groups.

PMID 25057276 · one of two readings recorded this

superoxide dismutase

no effect, p = 0.83

Superoxide Dismutase (µg/ml) | 3.89 ± 0.43 | 2.99 ± 0.51* | 3.89 ± 0.42 | 2.96 ± 0.57* |.83

PMID 37671486 · one of two readings recorded this

urea

no effect

Urea | 20.43 ± 4.66 | 21.56 ± 6.06 | 23.05 ± 5.17* | 21.57 ± 6.68 | 20.67 ± 1.00 | 22.71 ± 5.47 |.80

PMID 37671486 · one of two readings recorded this

urea

no effect, p = 0.8

Urea | 20.43 ± 4.66 | 21.56 ± 6.06 | 23.05 ± 5.17* | 21.57 ± 6.68 | 20.67 ± 1.00 | 22.71 ± 5.47 |.80

PMID 37671486 · one of two readings recorded this

bilirubin

no effect

Bilirubin | 0.70 ± 0.31 | 0.60 ± 0.20 | 0.60 ± 0.30 | 0.60 ± 0.25 | 0.70 ± 0.20 | 0.60 ± 0.21 |.72

PMID 37671486 · one of two readings recorded this

bilirubin

no effect, p = 0.72

Bilirubin | 0.70 ± 0.31 | 0.60 ± 0.20 | 0.60 ± 0.30 | 0.60 ± 0.25 | 0.70 ± 0.20 | 0.60 ± 0.21 |.72

PMID 37671486 · one of two readings recorded this

uric acid

no effect

Uric Acid | 4.64 ± 1.26 | 4.78 ± 1.26 | 4.62 ± 1.27 | 3.97 ± 0.95 | 4.06 ± 1.37 | 4.21 ± 1.41* |.24

PMID 37671486 · one of two readings recorded this

uric acid

no effect, p = 0.24

Uric Acid | 4.64 ± 1.26 | 4.78 ± 1.26 | 4.62 ± 1.27 | 3.97 ± 0.95 | 4.06 ± 1.37 | 4.21 ± 1.41* |.24

PMID 37671486 · one of two readings recorded this

chloride

no effect

Chloride | 104.86 ± 2.10 | 103.38 ± 2.43* | 102.34 ± 2.18* | 103.77 ± 2.01 | 102.57 ± 2.90* | 102.57 ± 1.85* |.66

PMID 37671486 · one of two readings recorded this

chloride

no effect, p = 0.66

Chloride | 104.86 ± 2.10 | 103.38 ± 2.43* | 102.34 ± 2.18* | 103.77 ± 2.01 | 102.57 ± 2.90* | 102.57 ± 1.85* |.66

PMID 37671486 · one of two readings recorded this

potassium

no effect

Potassium | 4.55 ± 0.82 | 4.93 ± 0.58* | 4.90 ± 0.59* | 4.46 ± 055 | 4.58 ± 0.55 | 4.77 ± 0.66 |.42

PMID 37671486 · one of two readings recorded this

potassium

no effect, p = 0.42

Potassium | 4.55 ± 0.82 | 4.93 ± 0.58* | 4.90 ± 0.59* | 4.46 ± 055 | 4.58 ± 0.55 | 4.77 ± 0.66 |.42

PMID 37671486 · one of two readings recorded this

hemoglobin

no effect

Hemoglobin | 13.99 ± 1.7 | 14.50 ± 1.93* | 14.44 ± 2.02* | 14.44 ± 2.27 | 14.62 ± 2.52 | 14.48 ± 2.21 |.94

PMID 37671486 · one of two readings recorded this

hemoglobin

no effect, p = 0.94

Hemoglobin | 13.99 ± 1.7 | 14.50 ± 1.93* | 14.44 ± 2.02* | 14.44 ± 2.27 | 14.62 ± 2.52 | 14.48 ± 2.21 |.94

PMID 37671486 · one of two readings recorded this

malondialdehyde

no effect, p = 0.17

Malondialdehyde (µM) | 0.42 ± 0.04 | 0.42 ± 0.06 | 0.42 ± 0.04 | 0.40 ± 0.05 |.17

PMID 37671486 · one of two readings recorded this

eGFR

no effect

eGFR | 130.81 ± 24.54 | 123.15 ± 24.71 | 118.60 ± 19.21* | 124.06 ± 21.7 | 135.01 ± 28.42* | 124.56 ± 29.81 |.36

PMID 37671486 · one of two readings recorded this

eGFR

no effect, p = 0.36

eGFR | 130.81 ± 24.54 | 123.15 ± 24.71 | 118.60 ± 19.21* | 124.06 ± 21.7 | 135.01 ± 28.42* | 124.56 ± 29.81 |.36

PMID 37671486 · one of two readings recorded this

GGT

no effect

GGT | 24.18 ± 8.13 | 23.00 ± 9.96 | 23.82 ± 9.63 | 25.50 ± 8.44 | 22.88 ± 8.00 | 22.6 ± 9.51 |.63

PMID 37671486 · one of two readings recorded this

GGT

no effect, p = 0.63

GGT | 24.18 ± 8.13 | 23.00 ± 9.96 | 23.82 ± 9.63 | 25.50 ± 8.44 | 22.88 ± 8.00 | 22.6 ± 9.51 |.63

PMID 37671486 · one of two readings recorded this

AST

no effect

AST | 27.46 ± 7.14 | 26.74 ± 5.79 | 26.26 ± 5.46 | 25.21 ± 7.43 | 24.91 ± 3.60 | 27.53 ± 8.55 |.49

PMID 37671486 · one of two readings recorded this

AST

no effect, p = 0.49

AST | 27.46 ± 7.14 | 26.74 ± 5.79 | 26.26 ± 5.46 | 25.21 ± 7.43 | 24.91 ± 3.60 | 27.53 ± 8.55 |.49

PMID 37671486 · one of two readings recorded this

ALP

no effect

ALP | 80.52 ± 17.13 | 80.72 ± 19.58 | 80.48 ± 13.85 | 82.13 ± 22.43 | 85.33 ± 29.13 | 85.47 ± 25.52 |.36

PMID 37671486 · one of two readings recorded this

ALP

no effect, p = 0.36

ALP | 80.52 ± 17.13 | 80.72 ± 19.58 | 80.48 ± 13.85 | 82.13 ± 22.43 | 85.33 ± 29.13 | 85.47 ± 25.52 |.36

PMID 37671486 · one of two readings recorded this

ALT

no effect

ALT | 25.52 ± 14.98 | 25.17 ± 16.57 | 22.46 ± 9.80 | 19.63 ± 7.41 | 20.78 ± 7.25 | 19.98 ± 11.89 |.39

PMID 37671486 · one of two readings recorded this

ALT

no effect, p = 0.39

ALT | 25.52 ± 14.98 | 25.17 ± 16.57 | 22.46 ± 9.80 | 19.63 ± 7.41 | 20.78 ± 7.25 | 19.98 ± 11.89 |.39

PMID 37671486 · one of two readings recorded this

basophils

no effect

Basophils | 0.75 ± 0.31 | 0.87 ± 0.41 | 1.21 ± 0.56* | 0.85 ± 0.42 | 0.92 ± 0.34 | 1.41 ± 0.53* |.16

PMID 37671486 · one of two readings recorded this

basophils

no effect, p = 0.16

Basophils | 0.75 ± 0.31 | 0.87 ± 0.41 | 1.21 ± 0.56* | 0.85 ± 0.42 | 0.92 ± 0.34 | 1.41 ± 0.53* |.16

PMID 37671486 · one of two readings recorded this

blood glutathione, potassium phosphate-EDTA method

increases, mean change 14.41 nM/mL in PME arm (11.3% from baseline)

Not recorded as a finding: Sentence says the PME change was comparatively higher but gives no between-group test; Table 5 between-group P is .42, so neither direction is recordable.

The mean change from baseline to final visit in the PME arm was 14.41 (increase of 11.3% from baseline), comparatively higher than in the placebo arm.

PMID 37671486 · one of two readings recorded this

blood urea, reported as urea not urea nitrogen

no effect

Not recorded as a finding: blood-urea-nitrogen node requires the nitrogen scale; the paper reports urea.

Renal function parameters like urea, uric acid, creatinine, glomerular filtration rate, sodium, potassium, and chloride levels were comparable between placebo and PME at all time points (Table 4 and Table S5, S6).

PMID 37671486 · one of two readings recorded this

BMI

no effect

At the end of the study, both groups showed no significant change in body weight, BMI, blood pressure, body temperature, pulse rate, and respiratory rate

PMID 37671486 · one of two readings recorded this

body temperature

no effect

Temperature (oF) | 98.36 ± 0.61 (96.98, 99.14) | 98.36 ± 0.78 (96.80, 99.42) | 98.15 ± 0.84 (96.84, 99.42) | 98.39 ± 0.51 (97.39, 98.90) | 98.34 ± 0.64 (97.10, 99.04) | 98.43 ± 0.72 (96.94, 99.47) |.17

PMID 37671486 · one of two readings recorded this

body temperature

no effect, p = 0.17

Temperature (oF) | 98.36 ± 0.61 (96.98, 99.14) | 98.36 ± 0.78 (96.80, 99.42) | 98.15 ± 0.84 (96.84, 99.42) | 98.39 ± 0.51 (97.39, 98.90) | 98.34 ± 0.64 (97.10, 99.04) | 98.43 ± 0.72 (96.94, 99.47) |.17

PMID 37671486 · one of two readings recorded this

body weight, BMI, blood pressure, pulse rate, body temperature, respiratory rate

no effect

Not recorded as a finding: The sentence is a within-group statement with no compound named and no between-arm contrast; the between-group P values appear only in Table 2

At the end of the study, both groups showed no significant change in body weight, BMI, blood pressure, body temperature, pulse rate, and respiratory rate (Table 2) and no change was observed after 30 days of supplementation (Table S1, S2).

PMID 37671486 · one of two readings recorded this

body weight

no effect

At the end of the study, both groups showed no significant change in body weight, BMI, blood pressure, body temperature, pulse rate, and respiratory rate

PMID 37671486 · one of two readings recorded this

diastolic blood pressure

no effect

DBP (mm Hg) | 77.21 ± 3.60 (70.0, 80.0) | 77.01 ± 4.40 (70.0, 83.2) | 76.54 ± 4.91 (68.8, 82.0) | 78.34 ± 3.45 (70.0, 83.1) | 77.41 ± 4.12 (70.0, 82.2) | 75.61 ± 5.05 (70.0, 83.10) |.47

PMID 37671486 · one of two readings recorded this

diastolic blood pressure

no effect, p = 0.47

DBP (mm Hg) | 77.21 ± 3.60 (70.0, 80.0) | 77.01 ± 4.40 (70.0, 83.2) | 76.54 ± 4.91 (68.8, 82.0) | 78.34 ± 3.45 (70.0, 83.1) | 77.41 ± 4.12 (70.0, 82.2) | 75.61 ± 5.05 (70.0, 83.10) |.47

PMID 37671486 · one of two readings recorded this

ECG abnormal, clinically significant (CS)

no effect

Abnormal (CS) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%) | 0 (0.00%)

PMID 37671486 · one of two readings recorded this

ECG abnormal, not clinically significant (NCS)

no effect

Abnormal (NCS) | 0 (0.00%) | 1 (3.45%) | 1 (3.33%) | 2 (6.67%)

PMID 37671486 · one of two readings recorded this

ECG normal participants

no effect

ECG Normal | 29 (100.00%) | 28 (97.55%) | 29 (96.67%) | 28 (93.33%)

PMID 37671486 · one of two readings recorded this

eGFR, estimating equation not stated

no effect

Not recorded as a finding: egfr node requires a stated estimating equation; the paper names none.

Renal function parameters like urea, uric acid, creatinine, glomerular filtration rate, sodium, potassium, and chloride levels were comparable between placebo and PME at all time points (Table 4 and Table S5, S6).

PMID 37671486 · one of two readings recorded this

eosinophils

no effect

Eosinophils | 5.51 ± 3.74 | 5.06 ± 2.71 | 5.60 ± 2.45 | 4.46 ± 2.26 | 5.78 ± 3.72* | 5.15 ± 2.92 |.52

PMID 37671486 · one of two readings recorded this

eosinophils

no effect, p = 0.52

Eosinophils | 5.51 ± 3.74 | 5.06 ± 2.71 | 5.60 ± 2.45 | 4.46 ± 2.26 | 5.78 ± 3.72* | 5.15 ± 2.92 |.52

PMID 37671486 · one of two readings recorded this

erythrocyte count

no effect

Erythrocyte | 5.13 ± 0.53 | 5.22 ± 0.57* | 5.19 ± 0.54 | 5.18 ± 0.59 | 5.19 ± 0.63 | 5.17 ± 0.61 |.89

PMID 37671486 · one of two readings recorded this

erythrocyte count

no effect, p = 0.89

Erythrocyte | 5.13 ± 0.53 | 5.22 ± 0.57* | 5.19 ± 0.54 | 5.18 ± 0.59 | 5.19 ± 0.63 | 5.17 ± 0.61 |.89

PMID 37671486 · one of two readings recorded this

fasting blood sugar (median at end of study)

no effect

Fasting blood sugar was 87 [72.20 to 132.20] mg/dL in PME and 86 [70.90 to 106.65] mg dl−1 at the end of the study

PMID 37671486 · one of two readings recorded this

fasting blood sugar

no effect, p = 0.26

FBS | 83.31 ± 5.59 | 89.58 ± 14.13 | 81.84 ± 7.64 | 86.04 ± 9.55 |.26

PMID 37671486 · one of two readings recorded this

glutathione mean change from baseline to final visit

increases

The mean change from baseline to final visit in the PME arm was 14.41 (increase of 11.3% from baseline), comparatively higher than in the placebo arm

PMID 37671486 · one of two readings recorded this

glutathione

no effect, p = 0.42

Glutathione (nM/ml) | 128.25 ± 28.32 | 142.28 ± 39.46 | 132.46 ± 25.55 | 134.45 ± 34.42 |.42

PMID 37671486 · one of two readings recorded this

glycosylated haemoglobin and fasting blood sugar

no effect

Not recorded as a finding: Sentence is agentless about the arm contrast and gives per-group medians; no two-sided between-arm statement anchors it

Similarly, no significant change was observed in glycosylated hemoglobin percentages 5.50 [5.00 to 6.08] g% and 5.50 [5.00 to 5.90] g% for PME and placebo, respectively.

PMID 37671486 · one of two readings recorded this

glycosylated haemoglobin, method not stated

no effect, 5.50 g% PME and 5.50 g% placebo, medians

Not recorded as a finding: Agentless no-change sentence that may be within-arm; it gives the two arms' medians but no between-group statement.

Similarly, no significant change was observed in glycosylated hemoglobin percentages 5.50 [5.00 to 6.08] g% and 5.50 [5.00 to 5.90] g% for PME and placebo, respectively.

PMID 37671486 · one of two readings recorded this

glycosylated hemoglobin (HbA1c, median at end of study)

no effect

no significant change was observed in glycosylated hemoglobin percentages 5.50 [5.00 to 6.08] g% and 5.50 [5.00 to 5.90] g% for PME and placebo, respectively

PMID 37671486 · one of two readings recorded this

glycosylated hemoglobin (HbA1c)

no effect, p = 0.64

Hb1AC | 5.39 ± 0.26 | 5.46 ± 0.34 | 5.44 ± 0.40 | 5.50 ± 0.32 |.64

PMID 37671486 · one of two readings recorded this

HDL cholesterol (median)

no effect

HDL | 41(34.5, 47.5) | 38(33, 42.5) | 35(32.5, 45) | 41(35,49) | 36(32, 46.5) | 40(30.5, 46) |.95

PMID 37671486 · one of two readings recorded this

HDL cholesterol (median)

no effect, p = 0.95

HDL | 41(34.5, 47.5) | 38(33, 42.5) | 35(32.5, 45) | 41(35,49) | 36(32, 46.5) | 40(30.5, 46) |.95

PMID 37671486 · one of two readings recorded this

hematological parameters (relative change screening to final)

no effect

relative change from screening to final visit between PME and placebo group was not statistically significant

PMID 37671486 · one of two readings recorded this

LDL cholesterol (median)

no effect

LDL-C | 112 (96.3,133.3) | 120.2 (102.1, 37.3) | 98.2 (84.8, 126.8) * | 109.3 (95.8, 121.3) | 103.1 (79.3, 120.3) | 106.2 (86.8, 115.9) |.21

PMID 37671486 · one of two readings recorded this

LDL cholesterol (median)

no effect, p = 0.21

LDL-C | 112 (96.3,133.3) | 120.2 (102.1, 37.3) | 98.2 (84.8, 126.8) * | 109.3 (95.8, 121.3) | 103.1 (79.3, 120.3) | 106.2 (86.8, 115.9) |.21

PMID 37671486 · one of two readings recorded this

leukocyte count

no effect

Leukocyte | 7.13 ± 1.43 | 7.60 ± 1.66 | 7.92 ± 1.80 | 7.54 ± 1.64 | 7.48 ± 1.87 | 7.95 ± 1.89 |.95

PMID 37671486 · one of two readings recorded this

leukocyte count

no effect, p = 0.95

Leukocyte | 7.13 ± 1.43 | 7.60 ± 1.66 | 7.92 ± 1.80 | 7.54 ± 1.64 | 7.48 ± 1.87 | 7.95 ± 1.89 |.95

PMID 37671486 · one of two readings recorded this

lipid profile (TC, TG, LDL-C, HDL-C, VLDL-C), serum, assay not stated

no effect

Not recorded as a finding: The only between-arm sentence does not name any lipid, so no object span anchors a node

No statistically significant differences were observed between the PME and placebo groups (Table 4 and Table S4).

PMID 37671486 · one of two readings recorded this

lymphocytes

no effect

Lymphocytes | 35.54 ± 7.26 | 36.56 ± 6.84 | 36.96 ± 5.57 | 32.52 ± 7.53 | 35.99 ± 7.97 | 34.04 ± 7.46 |.09

PMID 37671486 · one of two readings recorded this

lymphocytes

no effect, p = 0.09

Lymphocytes | 35.54 ± 7.26 | 36.56 ± 6.84 | 36.96 ± 5.57 | 32.52 ± 7.53 | 35.99 ± 7.97 | 34.04 ± 7.46 |.09

PMID 37671486 · one of two readings recorded this

malondialdehyde, lipid peroxidation method

no effect

Not recorded as a finding: Sentence is a within-arm statement against baseline in both groups, not a between-arm contrast.

Malondialdehyde remained unchanged at the final visit compared to baseline values in both the PME and placebo groups.

PMID 37671486 · one of two readings recorded this

mean corpuscular hemoglobin concentration (MCHC)

no effect

MCHC | 33.04 ± 0.99 | 33.39 ± 1.01 | 33.52 ± 0.83 | 33.15 ± 1.16 | 33.47 ± 1.29 | 33.46 ± 1.02 |.80

PMID 37671486 · one of two readings recorded this

mean corpuscular hemoglobin concentration (MCHC)

no effect, p = 0.8

MCHC | 33.04 ± 0.99 | 33.39 ± 1.01 | 33.52 ± 0.83 | 33.15 ± 1.16 | 33.47 ± 1.29 | 33.46 ± 1.02 |.80

PMID 37671486 · one of two readings recorded this

mean corpuscular hemoglobin (MCH)

no effect

MCH | 27.27 ± 2.95 | 27.71 ± 2.25 | 27.98 ± 1.58 | 27.84 ± 2.97 | 28.22 ± 3.04 | 27.95 ± 2.28 |.95

PMID 37671486 · one of two readings recorded this

mean corpuscular hemoglobin (MCH)

no effect, p = 0.95

MCH | 27.27 ± 2.95 | 27.71 ± 2.25 | 27.98 ± 1.58 | 27.84 ± 2.97 | 28.22 ± 3.04 | 27.95 ± 2.28 |.95

PMID 37671486 · one of two readings recorded this

mean corpuscular volume (MCV)

no effect

MCV | 82.81 ± 7.06 | 82.53 ± 5.50 | 82.97 ± 4.21 | 83.61 ± 5.81 | 83.80 ± 6.76 | 83.35 ± 5.74 |.77

PMID 37671486 · one of two readings recorded this

mean corpuscular volume (MCV)

no effect, p = 0.77

MCV | 82.81 ± 7.06 | 82.53 ± 5.50 | 82.97 ± 4.21 | 83.61 ± 5.81 | 83.80 ± 6.76 | 83.35 ± 5.74 |.77

PMID 37671486 · one of two readings recorded this

mean platelet volume (MPV)

no effect

MPV | 10.56 ± 0.92 | 10.62 ± 0.85 | 10.52 ± 1.07 | 10.68 ± 0.65 | 10.74 ± 0.76 | 10.97 ± 0.65 |.06

PMID 37671486 · one of two readings recorded this

mean platelet volume (MPV)

no effect, p = 0.06

MPV | 10.56 ± 0.92 | 10.62 ± 0.85 | 10.52 ± 1.07 | 10.68 ± 0.65 | 10.74 ± 0.76 | 10.97 ± 0.65 |.06

PMID 37671486 · one of two readings recorded this

monocytes

no effect

Monocytes | 8.01 ± 1.59 | 7.71 ± 2.14 | 7.48 ± 1.32 | 7.88 ± 1.87 | 7.42 ± 1.68 | 7.38 ± 1.87 |.94

PMID 37671486 · one of two readings recorded this

monocytes

no effect, p = 0.94

Monocytes | 8.01 ± 1.59 | 7.71 ± 2.14 | 7.48 ± 1.32 | 7.88 ± 1.87 | 7.42 ± 1.68 | 7.38 ± 1.87 |.94

PMID 37671486 · one of two readings recorded this

neutrophils

no effect

Neutrophils | 49.99 ± 9.95 | 49.68 ± 8.74 | 49.07 ± 5.74 | 54.07 ± 8.68 | 49.63 ± 10.2* | 51.14 ± 7.98* |.26

PMID 37671486 · one of two readings recorded this

neutrophils

no effect, p = 0.26

Neutrophils | 49.99 ± 9.95 | 49.68 ± 8.74 | 49.07 ± 5.74 | 54.07 ± 8.68 | 49.63 ± 10.2* | 51.14 ± 7.98* |.26

PMID 37671486 · one of two readings recorded this

packed cell volume (PCV)

no effect

PCV | 42.40 ± 5.08 | 43.04 ± 5.67 | 42.93 ± 5.64 | 43.42 ± 5.92 | 43.50 ± 6.37 | 43.14 ± 6.25 |.89

PMID 37671486 · one of two readings recorded this

packed cell volume (PCV)

no effect, p = 0.89

PCV | 42.40 ± 5.08 | 43.04 ± 5.67 | 42.93 ± 5.64 | 43.42 ± 5.92 | 43.50 ± 6.37 | 43.14 ± 6.25 |.89

PMID 37671486 · one of two readings recorded this

platelet count

no effect

Platelet | 291.53 ± 57.0 | 307.86 ± 63.3 | 294.03 ± 75.7 | 278.38 ± 57.6 | 284.82 ± 55.3 | 285.50 ± 58.3 |.62

PMID 37671486 · one of two readings recorded this

platelet count

no effect, p = 0.62

Platelet | 291.53 ± 57.0 | 307.86 ± 63.3 | 294.03 ± 75.7 | 278.38 ± 57.6 | 284.82 ± 55.3 | 285.50 ± 58.3 |.62

PMID 37671486 · one of two readings recorded this

pulse rate

no effect

Pulse Rate (beats/min) | 76.62 ± 5.10 (68.00, 89.00) | 76.97 ± 5.08 (72.00, 88.00) | 76.24 ± 4.74 (66.00, 84.00) | 75.27 ± 4.37 (68.00, 85.00) | 76.87 ± 4.52 (68.00, 88.00) | 76.53 ± 4.17 (72.00, 84.00) |.80

PMID 37671486 · one of two readings recorded this

pulse rate

no effect, p = 0.8

Pulse Rate (beats/min) | 76.62 ± 5.10 (68.00, 89.00) | 76.97 ± 5.08 (72.00, 88.00) | 76.24 ± 4.74 (66.00, 84.00) | 75.27 ± 4.37 (68.00, 85.00) | 76.87 ± 4.52 (68.00, 88.00) | 76.53 ± 4.17 (72.00, 84.00) |.80

PMID 37671486 · one of two readings recorded this

respiratory rate

no effect

Respiratory Rate/ min) | 16.03 ± 1.96 (12.40, 18.00) | 17.37 ± 1.32 (15.40, 20.00) | 16.99 ± 1.10 (14.80, 18.00) | 15.6 ± 1.98 (12.00, 18.00) | 17.31 ± 1.07 (16.00, 19.10) | 17.03 ± 1.00 (16.00, 18.00) |.88

PMID 37671486 · one of two readings recorded this

respiratory rate

no effect, p = 0.88

Respiratory Rate/ min) | 16.03 ± 1.96 (12.40, 18.00) | 17.37 ± 1.32 (15.40, 20.00) | 16.99 ± 1.10 (14.80, 18.00) | 15.6 ± 1.98 (12.00, 18.00) | 17.31 ± 1.07 (16.00, 19.10) | 17.03 ± 1.00 (16.00, 18.00) |.88

PMID 37671486 · one of two readings recorded this

serum creatinine

no effect

S Cr | 0.68 ± 0.16 | 0.71 ± 0.16 | 0.72 ± 0.16 | 0.69 ± 0.11 | 0.66 ± 0.13* | 0.69 ± 0.13 |.44

PMID 37671486 · one of two readings recorded this

serum creatinine

no effect, p = 0.44

S Cr | 0.68 ± 0.16 | 0.71 ± 0.16 | 0.72 ± 0.16 | 0.69 ± 0.11 | 0.66 ± 0.13* | 0.69 ± 0.13 |.44

PMID 37671486 · one of two readings recorded this

sodium

no effect

Sodium | 140.28 ± 1.73 | 139.59 ± 2.58 | 138.07 ± 2.56* | 140.10 ± 1.54 | 139.20 ± 3.04 | 138.30 ± 2.65* |.73

PMID 37671486 · one of two readings recorded this

sodium

no effect, p = 0.73

Sodium | 140.28 ± 1.73 | 139.59 ± 2.58 | 138.07 ± 2.56* | 140.10 ± 1.54 | 139.20 ± 3.04 | 138.30 ± 2.65* |.73

PMID 37671486 · one of two readings recorded this

systolic blood pressure

no effect

SBP (mm Hg) | 117.48 ± 5.01 (110.0, 125.0) | 118.57 ± 4.62 (110.0, 125.2) | 118.88 ± 4.18 (110.8, 124.0) | 117.68 ± 3.96 (110.0, 124.2) | 118.23 ± 4.02 (110.0, 124.0) | 117.33 ± 4.96 (110.0, 124.0) |.20

PMID 37671486 · one of two readings recorded this

systolic blood pressure

no effect, p = 0.2

SBP (mm Hg) | 117.48 ± 5.01 (110.0, 125.0) | 118.57 ± 4.62 (110.0, 125.2) | 118.88 ± 4.18 (110.8, 124.0) | 117.68 ± 3.96 (110.0, 124.2) | 118.23 ± 4.02 (110.0, 124.0) | 117.33 ± 4.96 (110.0, 124.0) |.20

PMID 37671486 · one of two readings recorded this

T3 at final visit (group not stated)

T3, T4 and TSH at the final visit were 1.44 ± 0.2(ng/mL), 9.20 ± 2.23(μg/dL), and 2.62 ± 1.37(μIU/mL), respectively

PMID 37671486 · one of two readings recorded this

T3 at screening visit (group not stated)

The mean serum-triiodothyronine (T3), serum-tera-iodothyronine (T4), and serum-thyroid stimulating hormone (TSH) were 1.40 ± 0.18(μg/dL), 8.49 ± 1.98(μg/dL), and 3.02 ± 2.19(μIU/ mL), respectively, at the screening visit

PMID 37671486 · one of two readings recorded this

T3

no effect

T3 | 1.41 ± 0.18 | 1.36 ± 0.21 | 1.45 ± 0.2 | 1.44 ± 0.14 | 1.39 ± 0.21* | 1.46 ± 0.2 | 1.00

PMID 37671486 · one of two readings recorded this

T3

no effect, p = 1

T3 | 1.41 ± 0.18 | 1.36 ± 0.21 | 1.45 ± 0.2 | 1.44 ± 0.14 | 1.39 ± 0.21* | 1.46 ± 0.2 | 1.00

PMID 37671486 · one of two readings recorded this

T4 at final visit (group not stated)

T3, T4 and TSH at the final visit were 1.44 ± 0.2(ng/mL), 9.20 ± 2.23(μg/dL), and 2.62 ± 1.37(μIU/mL), respectively

PMID 37671486 · one of two readings recorded this

T4 at screening visit (group not stated)

The mean serum-triiodothyronine (T3), serum-tera-iodothyronine (T4), and serum-thyroid stimulating hormone (TSH) were 1.40 ± 0.18(μg/dL), 8.49 ± 1.98(μg/dL), and 3.02 ± 2.19(μIU/ mL), respectively, at the screening visit

PMID 37671486 · one of two readings recorded this

T4

no effect

T4 | 8.40 ± 1.98 | 8.93 ± 2.39 | 9.10 ± 2.23 | 8.31 ± 1.92 | 8.68 ± 1.90 | 8.77 ± 1.87 |.51

PMID 37671486 · one of two readings recorded this

T4

no effect, p = 0.51

T4 | 8.40 ± 1.98 | 8.93 ± 2.39 | 9.10 ± 2.23 | 8.31 ± 1.92 | 8.68 ± 1.90 | 8.77 ± 1.87 |.51

PMID 37671486 · one of two readings recorded this

thyroid function panel (T3, T4, TSH), immunoassay not stated

no effect

Not recorded as a finding: Sentence names a panel, not TSH or free T4 or free T3 individually; total T3 and T4 have no node and the FT4 and FT3 nodes need free fractions.

No statistically significant changes were observed in the thyroid function test outcomes for the PME group compared to the placebo at all time points (Table 4 and Table S7).

PMID 37671486 · one of two readings recorded this

thyroid function tests: total T3, total T4 in ug/dL, TSH

no effect

Not recorded as a finding: Sentence names only 'thyroid function test outcomes', not an individual analyte; T3 and T4 here are total hormone, not the free-hormone nodes

No statistically significant changes were observed in the thyroid function test outcomes for the PME group compared to the placebo at all time points (Table 4 and Table S7).

PMID 37671486 · one of two readings recorded this

total cholesterol (median)

no effect

TC | 179 (132, 238) | 188 (124, 255) | 175 (99, 229) | 170.5 (152, 192) | 158.5 (143, 188.5) | 160.5 (148, 183.5) |.47

PMID 37671486 · one of two readings recorded this

total cholesterol (median)

no effect, p = 0.47

TC | 179 (132, 238) | 188 (124, 255) | 175 (99, 229) | 170.5 (152, 192) | 158.5 (143, 188.5) | 160.5 (148, 183.5) |.47

PMID 37671486 · one of two readings recorded this

triglycerides (median)

no effect

TG | 113 (76, 141.5) | 127 (88, 202.5) ** | 125(88.5, 211.5) *** | 117(84, 151) | 132.5(85.5, 201) * | 143 (115.5,208.5) *** |.86

PMID 37671486 · one of two readings recorded this

triglycerides (median)

no effect, p = 0.86

TG | 113 (76, 141.5) | 127 (88, 202.5) ** | 125(88.5, 211.5) *** | 117(84, 151) | 132.5(85.5, 201) * | 143 (115.5,208.5) *** |.86

PMID 37671486 · one of two readings recorded this

TSH at final visit (group not stated)

T3, T4 and TSH at the final visit were 1.44 ± 0.2(ng/mL), 9.20 ± 2.23(μg/dL), and 2.62 ± 1.37(μIU/mL), respectively

PMID 37671486 · one of two readings recorded this

TSH at screening visit (group not stated)

The mean serum-triiodothyronine (T3), serum-tera-iodothyronine (T4), and serum-thyroid stimulating hormone (TSH) were 1.40 ± 0.18(μg/dL), 8.49 ± 1.98(μg/dL), and 3.02 ± 2.19(μIU/ mL), respectively, at the screening visit

PMID 37671486 · one of two readings recorded this

TSH

no effect

TSH | 2.34 ± 2.19 | 2.42 ± 1.48 | 2.51 ± 1.37 | 2.50 ± 1.26 | 2.20 ± 1.44 | 2.64 ± 1.52 |.61

PMID 37671486 · one of two readings recorded this

TSH

no effect, p = 0.61

TSH | 2.34 ± 2.19 | 2.42 ± 1.48 | 2.51 ± 1.37 | 2.50 ± 1.26 | 2.20 ± 1.44 | 2.64 ± 1.52 |.61

PMID 37671486 · one of two readings recorded this

VLDL cholesterol (median)

no effect

VLDL | 22.6 (15.2, 28.3) | 25.4 (17.6,40.5) ** | 25 (17.7, 42.3) *** | 23.4 (16.8, 30.2) | 26.5 (17.1, 40.2) * | 28.6 (22.3,41.7) *** |.86

PMID 37671486 · one of two readings recorded this

VLDL cholesterol (median)

no effect, p = 0.86

VLDL | 22.6 (15.2, 28.3) | 25.4 (17.6,40.5) ** | 25 (17.7, 42.3) *** | 23.4 (16.8, 30.2) | 26.5 (17.1, 40.2) * | 28.6 (22.3,41.7) *** |.86

PMID 37671486 · one of two readings recorded this

blood miR-193b expression level

increases

In the analysis of blood miRNA expression levels, miR-34a and miR-193b showed very high increases at week 4 and after week 4 of intake, respectively

PMID 40024751 · one of two readings recorded this

blood miR-34a expression level

increases

In the analysis of blood miRNA expression levels, miR-34a and miR-193b showed very high increases at week 4 and after week 4 of intake, respectively

PMID 40024751 · one of two readings recorded this

Hallmark pathway, interferon-alpha response (GSEA)

increases

The most significant molecular changes affected by the addition of PT was the activation of the interferon-alpha response pathway

PMID 40227411 · one of two readings recorded this

Hallmark pathways, oxidative phosphorylation, glycolysis, hypoxia and mTOR signaling (GSEA)

decreases

The comparison of GSEA in MA-treated tumors to PT+MA-treated tumors demonstrated pathways suppressed by PT, and included important pathways central to tumor progression, including oxidative phosphorylation, glycolysis, hypoxia, and mTOR signaling

PMID 40227411 · one of two readings recorded this

Histological response (GOG-211), endometrial patients only

no effect

A subset of endometrial patients only (Arm 1, n = 14 and Arm 2, n = 14) did not reveal any differences between arms

PMID 40227411 · one of two readings recorded this

Histological response (GOG-211)

no effect

Histological response was high in both arms (>90%), likely contributing to lack of statistical significance between arms

PMID 40227411 · one of two readings recorded this

IHC biomarkers of response (CDK4, Cyclin D1, BCL2, p-STAT3, p-ERK1/2, ER, PR)

no effect

The results showed no significant differences between Arm 1 (n = 19) and Arm 2 (n = 18)

PMID 40227411 · one of two readings recorded this

Ki-67 index, global score, percent change

no effect, p = 0.25, n = 29

The global score for endometrioid patients was -38.0% and MA score −28.2%; p = 0.25 [(post−pre)/pre]

PMID 40227411 · one of two readings recorded this

Ki-67 index, hot spot score, percent change

no effect, p = 0.14, n = 29

The endometrioid PT+MA group demonstrated a larger decrease in Ki-67 with a -33.8% change compared to −20.1% in the MA group, which was not statistically significant (p = 0.14, one-sided)

PMID 40227411 · one of two readings recorded this

Ki-67 index, hot spot score, pre- vs post-treatment standard deviations

no effect

The hot spot score for Ki-67 analysis showed standard deviations were not significantly different between pre-treatment and post-treatment values

PMID 40227411 · one of two readings recorded this

Ki-67 proliferation index by immunohistochemistry (MIB-1, hot spot score), pre- vs post-treatment hysterectomy specimen, primary endpoint; also histological response by GOG-211 criteria, IHC biomarkers, tumour transcriptome, and lipid panel (HDL, LDL, triglycerides), glucose, weight, BMI

-33.8% vs -20.1% change in Ki-67 (endometrioid subcohort, PT+MA vs MA), p = 0.14

Not recorded as a finding: this platform holds no node for the endpoint

The endometrioid PT+MA group demonstrated a larger decrease in Ki-67 with a -33.8% change compared to −20.1% in the MA group, which was not statistically significant (p = 0.14, one-sided).

PMID 40227411 · one of two readings recorded this

Ki-67 proliferation index, immunohistochemistry (MIB-1, hot spot score), change from pre-treatment biopsy to post-treatment hysterectomy specimen; PT+MA versus MA, megestrol acetate given to both arms

endometrioid subcohort only: -33.8% change in PT+MA versus -20.1% in MA, p = 0.14

Not recorded as a finding: this platform holds no node for the endpoint

The endometrioid PT+MA group demonstrated a larger decrease in Ki-67 with a -33.8% change compared to −20.1% in the MA group, which was not statistically significant (p = 0.14, one-sided).

PMID 40227411 · one of two readings recorded this

Lipid metabolism parameters (HDL, LDL, triglycerides), pre- vs post-treatment

no effect

The evaluation of parameters related to lipid metabolism revealed no significant differences between pre- and post-treatment when analyzed in both arms (Arm 1, n = 17 and Arm 2, n = 16)

PMID 40227411 · one of two readings recorded this

Number of differentially expressed genes, PT+MA vs MA

modulates

Among endometrioid tumors, comparison of gene expression between PT+MA versus MA alone resulted in 117 differentially expressed genes between the arms (fold-change > 1.5, p < 0.05)

PMID 40227411 · one of two readings recorded this