Table 1.
Reported biomarker changes in mineral oil placebo groups from cardiovascular disease and diabetes studies
| Author | n a | Dose and mineral oil used | Patient population | Statins | Duration of treatment | TG (% change, BL to EOT) | LDL-C (% change, BL to EOT) | Non–HDL-C (% change, BL to EOT) | HDL-C (% change, BL to EOT) |
|---|---|---|---|---|---|---|---|---|---|
| Bhatt et al.,8 2019 | 4090 | 4 g/day, mineral oil | Aged ≥45 years with established CV disease or aged ≥50 years with diabetes and ≥1 additional CV risk factor | Required; 63.0% moderate intensity; 30.0% high intensity | Median 4.9 years | −6.5% | +10.5% | +4.6% | +5.0% |
| Bays et al.,9 2011 | 75 | 4 g/day, LLP | TG ≥500 mg/dL and ≤2000 mg/dL | Allowed | 12 weeks | +9.7% | −3.0% | +7.8% | 0% |
| Ballantyne et al.,10 2012 | 227 | 4 g/day, not specified | TG ≥200 and <500 mg/dL; LDL-C ≥40 mg/dL and <100 mg/dL | Required | 12 weeks | +5.9% | +8.8% | +9.8% | +4.8% |
| Kabir et al.,37 2007 | 14 | 3 g/day, paraffin oil | Type 2 diabetes mellitus; without HTG | Allowed (n = 5) | 8 weeks | +10.5% | 0% | NR | +7.1% |
| Gholamhosseini et al.,38 2015 | 31 | Edible paraffin | Men with CV disease | 84% in placebo group on statin | 8 weeks | −11.2% | +6.7% | NR | +12.2% |
| Hosseini et al.,39 2013 | 35 | 5 mL/day, mineral oil | Type 2 diabetes mellitus | NR | 2 months | +6.0% | +3.0% | NR | +3.9% |
| Mortazavi et al.,40 2018 | 23 | 4 g/day, edible paraffin | Male subjects aged 45–55 years with CV disease and ≥50% occlusion in 1 coronary artery | NR | 8 weeks | Decreased 21.59 mg/dL | Increased 9.43 mg/dL | NR | Increased 3.81 mg/dL |
| Golzari et al.,41 2019 | 18 | 2 g/day, edible paraffin | Diabetes for ≥1 year, aged 35–50 years, and taking antidiabetic drugs for ≥3 months | NR | 8 weeks | +3.1% | +3.4% | NR | +0.4% |
| Agh et al.,42 2017 | 21 | Edible paraffin |
Men with CAD, ≤50% stenosis in ≥1 major coronary artery in the last 3 months, and BMI ≤30 kg/m2 Individuals using warfarin excluded from participation |
Statin therapy in 92% (does not refer specifically to the control arm) | 8 weeks | −11.5% | +9.2% | NR | +27.9% |
| Mazaherioun et al.,43 2017 | 44 | 2.7 g, edible paraffin | Men aged >30 years and premenopausal women aged >30 years; BMI 25–40 kg/m2 with type 2 diabetes | NR | 10 weeks | +3.0% | +1.7% | NR | −3.9% |
| Ramezani et al.,44 2018 | 20 | 4 soft gel edible paraffin capsules/day | Coronary vascular disease |
NR Patients not taking fibrates |
8 weeks | −8.9% | +8.5% | NR | +3.0% |
BL, baseline; BMI, body mass index; CAD, coronary artery disease; CV, cardiovascular; EOT, end of treatment; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; NR, not reported; OM3, omega-3 fatty acid; TG, triglycerides.
a
Number of participants in the mineral oil placebo group.