TABLE 5.
Summary of meta-analysis of polyherbal combinations used in Clinical studies in patients with MetS according to SPIDER model, concentration, quality control and chemical classifications reports.
| S | P | I | D | E | R | Other targets | References | Concentration | Quality control reported | Chemical analysis reported | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| S. No | Sample (size) | Population | Intervention/Phenomenon of interest | Study Design | Evaluation [MetS parameters assessed out of 5] | Evaluation Outcome (Parameters met) | Research Type (quantitative/qualitative) | |||||
| 1 | 100 (50 control, 50 treatment) | Subjects with MetS complicated with MAU | Yiqi Huazhuo Gushen herbal formula (Optis chinensis, Pollen typhae, the rhizome of oriental water plantain, Mung bean peel, Serissa serissoides, Radix Aconiti lateralis praeparata)+ valsartan | Double-blinded and placebo-controlled | 5/5: BMI, FPG, 2hPG, HbA1c, (HOMA-IR), SBP and DBP, MABP, TC, TG, LDL, HDL | 4/5: reduced BMI, WHR, SBP, MAP, FPG, 2hPPG, HbA1c, reduce TG, increased HDL, LDL-c | Quantitative | Reductions in MAP, UACR, 24hTP and urinary β2 microglobulin | Tian-zhan et al. (2019) | Yes | No | No |
| 2 | 60 (treatment = 30; control group = 30) | Subjects with MetS | Yiqi Huaju Qingli Formula with western medicine: Radix Astragali, Rhizoma Coptidis, Pollen Typhae, Artemisiae Rhizoma Alismatis, Testa Vignae Radiatae, Serissa Japonica, and Radix Aconiti Lateralis Preparata | Randomized placebo-controlled | 5/5: BMI, WC, WHR, FPG, 2-hPPG, HbA1c, homeostasis model assessment for insulin resistance (HOMA-IR), TC, LDL, TG, HDL, BP | 4/5: decreased BMI, WC, WHR, FPG, 2-hPPG, HbA1c, TG, increased HDL | Quantitative | reduced Urinary MA, UACR | Wang et al. (2013) | Yes | No | No |
| 3 | 75 (Sesame+ vitamin E = 25, Sesame = 25; Sunflower oil = 25) | Subjects with MetS (aged 30–70 years) | Sesame oil and vitamin E | Randomized, single-blind controlled | 4/5 = dietary intake, BP, FBG, serum insulin, TC, TG, HDL | 4/5 = reduced TC, TG, FBG, HOMA-IR, SBP, DBP. increased HDL-c | Quantitative | MDA, Hs-CRP, | Farajbakhsh et al. (2019) | Yes | No but it was recruited from company | No |
| 4 | 250 (63 per group; 4 groups | Subjects with MetS | Curcuma longa and Nigella sativa | Double blind randomized controlled | 5/5: BMI, BF%, WC, HC, BP, TC, HDL-c LDL-c, TG, FBG | 3/5: reduced BMI (weight, HC, BF%) FBG, TG, TC, LDL-c | Quantitative | CRP. | Amin et al. (2015b) | Yes | No | No |
| 5 | N = 116divided in 5 different groups | Type 2 diabetic subjects with MetS | Diabegon, (Momordica charantia, Swertia chirata, Gymnema sylvestre, Trigonella foenumgraecum, Plumbago zeylanica, Eugena jambolana, Aegle marmelos, Terminalia chebula, Terminelia balerica, Emblica officinalis, Curcuma longa, Pterocarpus marsupium, Berberis aristata, Cytrullus culocynthis, Cyperus rotondus, Piper longum, root of Piper longum, Zingiber officinale, and Asphaltum punjabinum | Double-blinded and placebo-controlled | 4/5: BMI, FBG, TC, TG, LDL, HDL, VLDL | 3/5: reduction in FBG, reduced TC, LDL, TG, increase HDL | Quantitative | reduction in uric acid, creatinine. Maintained LFTs (SGOT and SGPT) | Yadav et al. (2014) | Yes | No | No |
| 6 | 21 | Subjects with MetS (17–70 years) | Modified Lingguizhugan decoction (MLD)+ weekend fasting: (MLD = Poria, Ramulus Cinnamomi, Rhizoma Atractylodis Macrocephalae, and Radix Glycyrrhizae) | N/A | 5/5: FPG, 2-h post-prandial blood glucose, fasting serum insulin (FINS), BP, BMI, WC, HOMA-IR, TG, TC, LDL-C, HDL-C | 3/5: reduced FPG, HOMA-IR, PG, SBP, DBP, BMI, WC, LDL-C, decreased significantly | Quantitative | Yang et al. (2014b) | Yes | No but Pharmaceutical company provided it | No | |
| 7 | 450 (treatment = 225, Metformin = 225) | Type 2 diabetes | Dahuang Huanglian Xiexin Decoction (JTTZ): Aloe vera, Coptis chinensis, Rhizoma Anemarrhenae, red yeast rice, Momordica charantia, Salvia miltiorrhiza, Schisandra chinensis, and dried ginger | Positive-Controlled, Open-label | 3/5: BMI, weight, WC, HC HbA1c, Total cholesterol, TG, FPG, 2 h PG, HOMA-IR, (HOMA-β), TC, LDLC | 3/5: decreased HbA1c, FPG levels, TG and LDL-C levels, BMI, WC, HC | Quantitative | Yu et al. (2018) | No. established formula. Dose and duration given | Yes | Yes | |
| 8 | 30 (placebo = 15; treatment = 15) | Subjects with MetS | Nutraceuticals (Armolipid Prev, Rottapharm, Monza, Italy) + dietary intervention | Randomized, controlled, double-blind, parallel-group, single-centre | 5/5: BMI, FBG, TG, HDL, SBP and DBP, TC, LDL | 3/5: Reduce SBP and DBP, TG, LDL-C, TC, Increase HDL. MetS prevalence reduced from 15 to 5 | Quantitative | N/A | Rozza et al. (2009) | registered drug so concentration may be in fixed preparation. Authors have not mentioned | No | No |
| 9 | 100 (treatment = 50; placebo = 50 | Subjects with MetS | Altilix® Supplement Containing Chlorogenic Acid and Luteolin | Randomized, Double-Blind | 4/5: Body weight and BMI, FBG, HbA1c, Insulin resistance, pancreatic b cell function (HOMA-IR), TC, TG, LDL-C, HDL | 3/5: Weight and BMI, improved Glycemic variables (HbA1c, HOMA-IR, and HOMA-β), reduced TC, TG, and LDL-C) | Quantitative | ALT, AST, GGT and AST/ALT ratio improved FLI, FMD, and cIMT improved, ghrelin levels reduced | Castellino et al. (2019) | No (prepared supplement-registered) | No | No |
| 10 | 117 (treatment = 59; placebo = 58) | subjects with MetS | Curcuminoids (95% curcuminoids, of which at least 70% is curcumin) + piperine to enhance bioavailability | Randomized double-blind placebo-controlled | 2/5: weight and BP | 2/5 = reduction in Weight, height, SBP, DBP, | Quantitative | SOD, MDA, hs-CRP, | Panahi et al. (2015) | Patented ratio is mentioned but exact concentration not given | No | No |
| 11 | 100 (placebo = 50; treatment = 50 | Subjects with MetS | Curcuminoids (95% curcuminoids, of which at least 70% is curcumin) + piperine to enhance bioavailability | Randomized double-blind placebo-controlled parallel-group | 2/5: TC, LDL-C, HDL-C, TG, LDL, lipoprotein and non-HDL-C | 2/5: Reduced TG, elevated HDL-c, reduced TC, LDL-C, non-HDL-C | Quantitative | Panahi et al. (2014) | 1000 mg curcuminoids per day with 10 mg piperine | No | No | |
| 12 | 50 (placebo = 26; treatment = 24) | Subjects with MetS | Red yeast rice and olive extract | Double blind placebo controlled randomized | 5/5 | 2/5 | Quantitative | CK elevation, ApoA1, ApoB, HbA1c and oxLDL | Verhoeven et al. (2015) | commercially available food supplement | Yes | Yes |
| 13 | 30 healthy males; 45 obese divided into two groups | Centrally Obese men | Yiqi Sanju Formula | Randomized controlled | 2/5 = Insulin Resistance, BMI | 2/5 = HOMA-IR and BMI reduced | Quantitative | high levels of CRP, FFA and PAI, t-PA was low | He et al. (2007) | |||
| 14 | 106 (treatment = 54; placebo = 52) | Adult subjects with MetS | Red yeast rice, bitter gourd, chlorella, soy protein, and licorice | double-blinded study | 5/5 = BMI, BP, FBG, OGTT, TC, TGs, HDL, LDL | 2/5 = reduced TG, BP, TC, LDL-c | Quantitative | No changes in LFT (ALT, AST, ALK-P) and renal functions test (serum creatinine, urea nitrogen, uric acid) | Lee et al. (2012) | Yes | Not mentioned but manufactured | No |
| 15 | 100 (placebo = 46; treatment = 46) | subjects with MetS | Keishibukuryogan: Cinnamomi Cortex, Paeoniae Radix, Moutan Cortex, Persicae Semen, and Hoelen | controlled clinical trial with crossover design. Open labelled study; Quasi randomized | 5/5 = BMI, HDL, LDL, FBG, TG, BP | 0/5 | Quantitative | L RHI increased, serum NEFA, MDA, and soluble vCAM1 decreased | Nagata et al. (2012) | Yes | No | No |
Abbreviations: 24hTP, 24 h total urinary protein; 2hPPG, 2 h post prandial glucose; AST, aspartate aminotransferase; ALT, alanine transaminase; ALP, alkaline phosphatase; BP, blood pressure; BMI, body mass index; CDKAL = CDK5 Regulatory Subunit Associated Protein 1 Like 1); CETP, cholesteryl ester transfer protein; CRP, C-reactive protein; FBG: fasting blood glucose; FFA, free fatty acid; GLUT-4, glucose transporter 4; GGT, glutamyl-transferase; HC, hip circumference; HDL-C, high density lipoproteins; HFD, high fat diet; HOMA-IR, homeostatic model assessment for insulin resistance; ICAM-1, intercellular adhesion molecules; IRS-1, Insulin receptor substrate 1; KKAy, cross between diabetic KK and lethal yellow; LDL, low density lipoprotein; Monocyte chemoattractant protein-1; MAU/MA, microalbuminuria; MDA, malondialdehyde; NAFA, non-esterified fatty acids; NF-kB, Nuclear Factor kappa-light-chain-enhancer of activated B cells; PI3K phosphoinositide 3-kinase SREBP, sterol regulatory element-binding transcription factor; PPAR-γ/a, Peroxisome proliferator-activated receptor gamma/alpha; SD Rats, Sprague Dawley rats; SGOT, Serum glutamic oxaloacetic transaminase; SGPT, Serum glutamic pyruvic transaminase; SOD, superoxide dismutase; TC, total cholesterol; TG, triglycerides; TNF, Tumor necrosis factor; vLDL, very low density lipoprotein; UACR, urea creatinine albumin ratio; vCAM-I, Vascular cell adhesion molecule 1; WC, waist circumference; WHR, waist hip ratio; WKy, Wistar Kyoto.