Systematic Overview of Bacopa monnieri (L.) Wettst. Dominant Poly-Herbal Formulas in Children and Adolescents
Abstract
:1. Introduction
2. Materials and Methods
- Randomised, double-blind, controlled trial design;
- Investigating an extract B.monnieri dominant extract;
- Sample consisting of children or adolescents (aged 4–18);
- Participants were not taking any other intervention during study period;
- Sample size ≥20 (10 if a cross-over study);
- Duration of intervention ≥1 month;
- Have measurable outcomes on cognition or behavior;
- Full paper in English.
2.1. Effect Size
2.2. Behavioural Data
2.3. Cognitive Data
2.4. Methodological Quality Rating
- Was the study described as randomised?
- Was the randomisation protocol detailed and appropriate?
- Was the study described as double-blind?
- Was the blinding process detailed and appropriate?
- Did the study have a control group?
- Was the control detailed and appropriate?
- Was there an adequate exclusion criteria?
- Was the intervention used at a therapeutic dose?
- Was there a description of withdrawals and dropouts?
- Were the data clearly and adequately reported?
3. Results
3.1. Cognition
3.2. Learning
3.3. Behaviour
3.4. Quality Rating
4. Discussion
Acknowledgments
Author Contributions
Conflicts of Interest
References
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Formula | Ingredient | mg |
---|---|---|
Mentat | Bacopa monnieri | 144 |
Centella asiatica | 70 | |
Withania somnifera | 52 | |
Evovulus alsinodes | 52 | |
Nardostachys jatamansi | 52 | |
Valeriana wallichii | 50 | |
Embelia ribes | 50 | |
Prunus amygdalus | 50 | |
Tinospora cordifolia | 36 | |
Terminalia chebula | 36 | |
Emblica officinalis | 36 | |
Oroxylum indicum | 32 | |
Celastrus paniculatus | 32 | |
Mucuna pruriens | 1.8 | |
Elettaria cardamomum | 1.8 | |
Terminalia arjuna | 1.8 | |
Foeniculum vulgare | 1.8 | |
Ipomoea digitata | 1.8 | |
Orchis mascula | 1.8 | |
Zingiber officinale | 1.4 | |
Terminalia belirica Syn. T.bellirica | 1.4 | |
Myristica fragrans | 1.4 | |
Syzygium aromaticum | 1 | |
Manas Niyamak Yoga Granule * (MN1 Granule) | Bacopa monnieri | N/A |
Centella asiatica | N/A | |
Convolvulus pluricaulis | N/A | |
Nardostachys jatamansi | N/A | |
Acorus calamus | N/A | |
Withania somnifera | N/A | |
Embelia ribes | N/A | |
Glycyrrhiza glabra | N/A | |
Plumbago zeylanica | N/A | |
Piper longum | N/A | |
Compound Herbal Preparation (CHP) | Bacopa monnieri | N/A |
Paeoniae alba | N/A | |
Withania somnifera | N/A | |
Centella asiatica | N/A | |
Spirulina platensis | N/A | |
Melissa officinalis | N/A | |
Memomet | Bacopa monnieri | 125 |
Convolvulus pluricaulis | 100 | |
Centella asiatica | 100 |
Author | Intervention | n | Male (%) | Duration | Population | Safety | Dropouts (%) | Results (ES) |
---|---|---|---|---|---|---|---|---|
D’souza & Chavda (1991) | Mentat × 1–2 Tsp p/d (BM: 144–288 mg p/d) PL × 1–2 Tsp p/d | 60 30 (B) 30 (P) | 82 | 3-months | 3–16 yrs Behavioural Problems | Not declared | 0 | YBI- Hyperactivity (ES: 6.55); Tractability (ES: 5.57); Habituation (ES: 5.20); Negative effects (ES: 4.31); Social (ES: 4.88); Academia (ES: 3.52); Impulsivity (ES: 5.10) |
Patel & Pereira (1991) | Mentat × 2 Tsp p/d (BM: 288 mg p/d) PL x 2 Tsp p/d | 40 20 (B) 20 (P) | N/A | 3–7-months | 2–7 yrs approx. Hyperkinesis | Nil side effects reported by participants | N/A | YBI-ES: N/A I.Q.-ES: N/A |
Dave et al. (Study I) (1993) | Mentat × 2 Tsp 3/d (BM: 864 mg p/d) PL × 2 Tsp 3/d | 19 10 (B) 9 (P) | N/A | 3-months | 1–18 yrs Mental retardation | Not declared | 5 | CBI-ES: 5.77 |
Quadri (1993) | Mentat × 2–4 Tabs p/d (BM: 272–544 mg p/d) PL × 2–4 Tabs p/d | 50 30 (B) 20 (P) | 70 | 20-months | 4–12 yrs Mental retardation Behavioural issues | Nil side effects reported by participants a | 12 | Behavioural Changes-ES: N/A |
Kalra et al. (2002) | Mentat × 2 Tabs p/d (BM: 272 mg p/d) PL × 2 Tabs p/d | 60 30 (B) 30 (P) | 78 | 6-months | 6–12 yrs ADHD Diagnosed | Not declared | 17 | CPRS-ES: N/A |
Upadhyay et al. (2002) | Group N-PL Group P-Mentat Group S/F-PL Group R/G-Mentat (BM: unknown) | 100 25 (P) 25 (B) 25 (P) 25 (B) | 0 | 6-months | 11–16 yrs Learning disability | Not declared b | 5 | Group P-Coding (TES: 1.48); Sequential (TES: 1.77); Full scale I.Q. (TES: 0.94); Arithmetic (TES: 1.41); Digit Span (TES: 1.14). Group R/G-Coding (TES: 1.95); Sequential (TES: 2.45); Full Scale I.Q. (TES: 1.78); Performance I.Q. (TES: 1.40); Arithmetic (TES: 2.39); Digit Span (TES: 1.52). |
Ojha et al. (2007) | A-MN1 × 200 mg/kg/d B-MN1 × 200 mg/kg/d + Shirodhara c C-PL × 2/d D-PL + Shirodhara (BM: unknown) | 48 d 10 (B) 10 (B) 10 (B) 10 (P) | 80 * | 3-months | 6–15 yrs ADHD Diagnosed | Nil side effects were reported by participants | 17 | ADHD Sx—ES: N/A CDA (TES: A—1.96; B—4.49; D—1.38) RT (TES: A—3.73; B—6.74; D—4.24). |
Katz et al. (2010) | CHP × 3 mL 3/d PL × 3 mL 3/d (BM: unknown) | 120 80 (B) 40 (P) | 77 * | 4-months | 6–12 yrs ADHD Diagnosed | Safety well monitored. Few adverse events were reported e | 18 | TOVA: Response time (ES: 0.70) Variability (ES: 1.02) Overall (ES: 1.11). |
Dutta et al. (2012) | Memomet × 1 Tsp 2/d (BM: 250 mg p/d) PL × 1 Tblsp 2/d | 86 56 (B) 30 (P) | 86 | 4-months | 6–12 yrs ADHD Diagnosed | Nil side effects were reported by participants | 15 | MISIC (ES: 0.90) CPRS (ES: 0.86) YBI (ES: N/A) |
Cognitive Ability/Behaviour | D’souza (1991) (Mentat) | Dave (Study I) (1993) (Mentat) | Dutta (2012) (Memomet) | Katz (2010) (CHP) | Ojha (2007) (MN1 Granule) | Upadhyay (2002) (Mentat) |
---|---|---|---|---|---|---|
Reasoning | Conceptual Dysfunction a | Picture Arrangement a; Word Reasoning a; Object Assembly a | Picture arrangement; Object Assembly | |||
Visual Perception | Block Design; Mazes | Response Time ** | Reaction Time ** | Picture Completion; Block Design; Mazes | ||
Auditory Perception | ||||||
Language behaviour | Language * | Language; Comprehension a; Vocabulary a | Comprehension; Vocabulary | |||
Number Facility | Arithmetic a; Digit span a | Arithmetic **; Digit span ** | ||||
Mental Speed | Digit Symbol a | Digit Symbol** | ||||
Memory | ||||||
Free recall Memory | Information a | Information | ||||
Associative Memory | Similarities a | Similarities | ||||
Memory Span | ||||||
Visual Memory | ||||||
Auditory Memory | Letter-Number Sequencing a | |||||
Meaningful Memory | ||||||
Learning | Academics *; Habituation * | YBS-Academic; YBS-Habituation | ||||
Behaviour | ||||||
Hyperactivity | Hyperactivity * | Incongruous Behavioura | CRS-Hyperactivity; YBS-Hyperactivity | DSM-Hyperactivity ** | ||
Inhibition/Impulsivity | Impulsivity *; Tractability * | CRS-Impulsivity; YBS-Impulsivity; YBS-Tractability | Commission Errors ** | DSM-Impulsivity * | ||
Attention | Attention * | YBS-Attention | Omission Errors ** | DSM-Attention *; Coefficient of Division of Attention ** | ||
Peer Relations | CD Socialized * | Incongruous Ideationa; Self-Depreciation a | YBS-CD Socialized | |||
Aggression | CD Aggressive | Anger-Hostility a | YBS-CD Aggressive |
Modified Jadad Scale | DAVE | D’SOUZA | DUTTA | KALRA | KATZ | OJHA | PATEL | QUADRI | UPADHYAY |
---|---|---|---|---|---|---|---|---|---|
1. Was the study described as randomised? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
2. Was the randomisation protocol detailed and appropriate? | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
3. Was the study described as double-blind? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
4. Was the blinding process detailed and appropriate? | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 |
5. Did the study have a control group? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
6. Was the control detailed and appropriate? | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 |
7. Was there an adequate exclusion criteria? | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 |
8. Was the intervention used at a therapeutic dose? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 |
9. Was there a description of withdrawals and dropouts? | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 |
10. Were the data clearly and adequately reported? | 0 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 1 |
Quality Rating | 5 | 6 | 8 | 8 | 10 | 9 | 5 | 5 | 5 |
Poly-Herbal Formulas—All Extracts |
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Centalla asiatica (C.asiatica) is a perennial herbaceous creeper belonging to the family Umbellifere (Apiceae) and known in India as mandukparni as listed in the “Sushruta Samhita” an ancient Indian medical text. Clinical trials have investigated the effect of C.asiatica on vascular injury in adults with improved microcirculatory parameters in chronic venous hypertensive patients [59,60], capillary permeability [50], and oedema’s in people suffering venous hypertension [61]. More recent clinical trials found improvements in cognition and mood following large daily chronic doses (750 mg per day) in adults [49]. One clinical trial found improvements in general mental ability in mentally retarded children following six months administration [62]. |
Withania somnifera (W.somnifera), or commonly known as Ashwagandha, is from the Solanaceae family and is widely used in the Ayurvedic medicinal system [63]. Research has investigated benefits on anxiety [64], cognition [65], psychomotor performance [66], and more recent studies on its effectiveness on age-related disorders, neuronal atrophy and synaptic loss [67]. A recent review demonstrated the safety of W.somnifera at 700 mg/day, 1000 mg/day, and 1250 mg/day in healthy human adults, with only one person withdrawing from the trial following adverse events at the lowest dose (increased appetite, libido, and hallucinogenic effects) [68]. |
Evovulus alsinodes (E.alsinodes), also known as Dwarf Morning Glory or Shankhpushpi, is from the Convolvulaceae family and is deemed a “sacred flower” in Kerala, a south-west state on India’s Malabar coast [69]. Its traditional uses have been to treat symptoms of fever, cough and cold, venereal diseases, azoospermia, adenitis, depression, whereas specific to the Ayurvedic system it has been purportedly used as a “brain tonic” to aid neurodegenerative diseases, asthma and amnesia [70]. |
Nardostachys jatamansi (N.jatamansi), from the Valerianceae family grows in the Himalayas of Nepal, China, and India. In Ayurveda it is classified as a hypno-sedative and has been used to treat insomnia, hysteria, and depressive illness [71]. In animal models, N.jatamansi has been found to not only improve learning and memory in mice, but reverse diazepam induced amnesia using a 200 mg/kg dose [72]. A study by Amin, Dixit, and Pathak (1961) investigated the effects of N.jatamansi (60 gm) on reaction times of medical students with significant sedative effects in the treatment group [73]. |
Valeriana wallichii (V.wallichii) is a rhizome herb and is another member of the Valerianaceae family. It is popularly known as Indian Valerian (a sometimes substitute for the European V.officianalis) [74]. Phytochemicals in Valerian have been used to treat mild to moderate insomnia [75] as well as gastrointestinal discomfort [76], as well as increased CNS activity in mice at 200, 400, and 600 mg/kg doses as well as increased relaxant activity at 800 mg/kg [77,78]. One human study highlighted the safety and efficacy of V.wallichii on stress related disorders at a dose of 1000 mg per day [79]. |
Embelia ribes (E.ribes) is from the species Myrsinaceae found throughout India, is also known as “False Black Pepper” or “Vidanga” from the Sanskrit “Vidang” [56]. It is commonly used for its antibiotic properties [57]. Recent work has investigated the significant antioxidant activities capabilities of E.ribes [56], and one study investigated the potentiality of E.ribes on acetylcholinesterase-inhibitory activity with significant results indicating possible cognitive benefits [80]. |
Tinospora cordifolia (T.cordifolia) from the Menispermaceae family, has been traditionally used in India’s Ayurvedic medicinal system [81] and Indonesia’s Jamu medicinal system [82]. It is well-known for its ability to statistically reduce symptoms of hay fever (allergic rhinitis) in adults [81] and has shown indications for the relief of constipation if taken regularly at high doses [83]. In a recent combination formula trial, T.cordifolia was found to be more beneficial for cognition when in combination with Bacopa and E.alsinoides than as a single extract in a rat model [84]. |
Terminalia chebula (T.chebula) from the Terminalia species is native to Asia, India, Nepal, China, Sri Lanka, and Vietnam [85]. It is a dried fruit that has exhibited various benefits including anticancer [86], antidiabetic [87], antimutagenic [88], antibacterial [89], antifungal [90], and antiviral properties [91]. A trial in Belgium school children (12–15 years old) found that a mouthrinse preparation of T.chebula substantially reduced salivary Streptococcus mutans compared to placebo, a clear demonstration of the herbs antibacterial properties. Further studies have validated the antioxidant and anti-inflammatory properties [92] of the herb. |
Emblica officinalis (E.officinalis), otherwise known as the Indian Gooseberry, is derived from a tree of the Phyllanthaceae species. Recent studies have demonstrated E.officinalis has excellent antioxidant activity in single extract form [93] and in polyherbal formulas [94], and has also demonstrated anti-inflammatory properties [95,96,97]. |
Oroxylum indicum (O.indicum) from the Bignoniaceae family is a large tree with trumpet-like flowers that bloom at night. Otherwise known as “Midnight Horror” (derived from the way its leaves wither and fall at its base resembling piles of broken bones), O.indicum is used for the treatment of diabetes by the Sikkim tribal people of India. Animal models have demonstrated O.indicum’s positive effects on antioxidant status, cholesterol and HDL levels and showed enhanced responses to insulin sensitivity [98]. |
Celastrus paniculatus (C.paniculatus) is a deciduous vine whose seeds are utilised for their fatty acid lipid content [99,100]. Indian researchers have found the oil derived from the plant is an effective acetylcholinesterase inhibitor and thereby is classed as a nootropic medication (memory enhancer) [101]. |
Mucuna pruriens (M.pruriens) produces a seed that contains L-DOPA, the precursor to dopamine neurotransmitters leading to investigations of its use in treating Parkinsons Disease [102,103,104,105,106]. The ethanolic extract of M.pruriens leaves has also demonstrated an antiepileptic and anticataleptic effect in animal models [107]. Unfortunately retrieving the seeds from the tree is quite tricky with each seed pod covered in spicules that contain serotonin causing severe itching, which is where its name feijões malucos the “mad beans” comes from. |
Elettaria cardamomum (E.cardamomum) otherwise known as Green Cardamom contains a number of alkaloids, flavonoids, saponins, sterols, and tannins and has long been used to treat the symptoms of asthma [108]. A methanol prepared extract of E.cardamomum was shown to have significant antibacterial properties [109]. |
Terminalia arjuna (T.arjuna) was first used as an ancient Ayurveda treatment for the treatment of heart disease in 7th century by Indian physician Vāgbhata [110]. Its powdered tree bark contains glycosides, flavonoids, tannins and minerals [111]. Research around T.arjuna still focuses on its influence upon the cardiovascular system with newer trials investigating its phytochemical levels and their capabilities as an antibacterial remedy [112], an antioxidant, and anti-inflammatory agent [113]. |
Foeniculum vulgare (F.vulgare), or Fennel, comes from the Apiaceae family. Known in Ayurveda as “Sanuf”, F.vulgare has previously been used to treat stomach pains, constipation, and intestinal tract issues [77,114], as well as acting as an analgesic [115], an anti-inflammatory [115,116], and having memory-enhancing effects [78]. |
Ipomoea digitata (I.digitata), commonly referred to as Morning Glory or Aligator Yam, is one of 500 species of the Convolulaceae family. It is used most commonly as an antibacterial agent [117], however more recent therapeutic benefits include menorrhea, gastrointestinal disorders, and as a libido enhancer [118]. |
Orchis mascula (O.mascula) from the Orchidaceae orchid family, is a perennial herbaceous plant with small yet bright violet flowers. Modern uses for the plant are for the treatment of hypertension and dyslipidemia [119]. O.mascula has also demonstrated significant anticholinesterase enzyme inhibiting activity [120]. |
Zingiber officinale (Z.officinale), the rhizome of the Ginger plant, has an extensive history in medicine as an anti-cancer intervention by reducing or slowing the growth of tumours in patients [121]. More recent studies have focused on the abilities of Z.officinale to reduce nausea and vomiting in various illnesses [122,123,124]. Z.officinale has also shown to be beneficial for reducing muscle pain following exercise [125], as well as having significant anxiolytic effects in animals models [126]. |
Terminalia belirica (T.bellirica), or Bastard Myrobalan, has a history in Hinduism for being evil, with Hindus in the north of the country refusing to sit in its shade for fear of the tree being possessed by demons [127]. As a part of other herbal formulations, T.bellirica has shown to improve infected, inflamed or degenerating eye disorders [128], as well as having antiviral properties [129]. |
Myristica fragrans (M.fragrans), or Nutmeg, is a spice native to Indonesia that has demonstrated anticholinesterase activity [130]. The spices antioxidant activity has been well documented [131,132,133,134], as well as having anti-inflammatory effects in the treatment of periodontitis [135]. In terms of memory, M.fragrans has shown significant memory improvements in mice models, which may or may not be attributed to its antioxidant, anti-inflammatory, or procholinergic activity [136]. |
Syzygium aromaticum (S.aromaticum), or Clove, has significant antioxidant properties [137], attributed to its heightened levels of polyphenols [138]. Research has also found it has significant antimicrobial activity [139] as well as relieve neuropathic pain [140]. |
Asparagus racemosus (A.racemosus), a root extract from the asparagus species, has potential as an anti-dandruff ingredient [141]. Further high performance thin layer chromatography (HPTLC) analysis has demonstrated that A.racemosus had high levels of flavonoids, has demonstrated immunomodulatory capabilities [142], and has shown protection against xanthine oxidase, an enzyme that generates reaction oxygen species [143]. |
Acorus calamus (A.calamus) is from the Acoraceae family and has been traditionally used as a fragrance [144]. Its uses are far reaching and include, but not limited to, nervous disorders, appetite loss, bronchitis, chest pain, colic, cramps, diarrhoea, digestive disorders, flatulence, gas, indigestion, rheumatism, sedative, cough, fever, bronchitis, inflammation, depression, tumors, haemorrhoids, skin diseases, numbness, general debility and vascular disorders [145]. |
Xanthium strumarium (X.strumarium), known as Rough Cocklebur, is from the Asteraceae family. The fruit of the plant has been used extensively in China for rhinitis, tympanitis, urticarial, and arthritis [146]. Contrary to its benefits, the fruit and seeds of X.strumarium are quite toxic and need to be consumed with caution. Recent research has demonstrated X.strumarium also has potent anti-inflammatory activities [147]. |
Convolvulous pluricaulis (C.pluricaulis) is a herb that is more commonly known as Shankhapushpi. The herb, much like Bacopa, is known as a Medhya, a drug used to improve memory and intellect. It has demonstrated cognitive enhancing capabilities with respect to improved learning and memory enhancement [148]. When compared to E.alsinoides, C.pluricaulis displayed increased nootropic effects, but to a lesser extent that E.alsinoides [149]. |
Glycyrrhiza glabra (G.glabra), or Liquorice, has significant anti-inflammatory and anti-excitotoxic properties, providing well documented neuroprotection through the inhibition of a high-mobility group box 1 protein (HMGB1) induction and release [150]. It has also been implicated in Chinese treatments for insomnia [151], as well as having immunomodulating, antispasmodic, and antiallergic properties that provide for significant improvements in cough suppression [152]. |
Plumbago zeylanica (P.zeylanica) is derived from the species Plumbago. The main research outcomes have found it to be a significant antimalarial compound [153], however there has been significant research into the capabilities of P.zeylanica in terms of skin diseases [154] and more significantly, in the treatment of cancer cell growth [155]. |
Piper longum (P.longum) is from the Piperaceae family and is otherwise known as Indian Long Pepper. Research has shown it has immunomodulatory and cytoprotective effects [156] as well as antidepressant effects [157] through the suppression of behavioural and biochemical induced changes following corticosterone injections in mouse models [158]. |
Paeoniae Alba (P.alba) has been traditionally used gout, osteoarthritis, fever, respiratory tract illnesses, and cough. As a part of another formula, P.alba demonstrated use as a potential Parkinsonian adjunct treatment in reducing the adverse effects of L-DOPA treatment [159]. |
Spirulina platensis (S.platensis) is a Cyanobacterium that was traditionally used by the Aztecs up until the 16th Century [160]. It has high levels of protein and has demonstrated improved exercise capacity in human trials [161]. However most recent clinical research conducted has investigated the effects of S.platensis on cancer cells in animal models [162,163,164]. |
Mellissa officinalis (M.officinalis) has been traditionally used as a mild sedative, an anxiolytic and a hypnotic medicine [165]. Recent research has examined its capabilities as a stress ameliorating intervention [166], memory-enhancing supplement [167], and as a gastrointestinal and anti-inflammatory treatment [168]. |
Saussurea lappa (S.lappa) has exhibited anticancer, anti-inflammatory, gastro protective activitives as well as anticonvulsant, anti-ulcerative, hepatoprotective antimicrobial and antiviral activity [169]. Alternate names for the plant include costus or kuth root and the activities it exhibits have been well established lending promise to future drug discovery. |
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Kean, J.D.; Downey, L.A.; Stough, C. Systematic Overview of Bacopa monnieri (L.) Wettst. Dominant Poly-Herbal Formulas in Children and Adolescents. Medicines 2017, 4, 86. https://doi.org/10.3390/medicines4040086
Kean JD, Downey LA, Stough C. Systematic Overview of Bacopa monnieri (L.) Wettst. Dominant Poly-Herbal Formulas in Children and Adolescents. Medicines. 2017; 4(4):86. https://doi.org/10.3390/medicines4040086
Chicago/Turabian StyleKean, James D, Luke A Downey, and Con Stough. 2017. "Systematic Overview of Bacopa monnieri (L.) Wettst. Dominant Poly-Herbal Formulas in Children and Adolescents" Medicines 4, no. 4: 86. https://doi.org/10.3390/medicines4040086