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SYSTEMATIC REVIEW
Year : 2017  |  Volume : 10  |  Issue : 3  |  Page : 222-228  

Evidence-based safety and efficacy of Ayurvedic herbo-metallic preparations containing gold, iron, and mercury with special reference to pediatrics


1 Department of Rasashastra and Bhaishajya Kalpana, CCRAS, Patna, India
2 Department of Rasashastra and Bhaishajya Kalpana, Regional Ayurveda Research Institute for Infectious Diseases, CCRAS, Patna, India
3 Department of Dravyaguna, Shree VM Mehta Institute of Ayurveda, Rajkot, Gujarat, India
4 Department of Rasashastra and Bhaishajya Kalpana, Institute for Postgraduate Research and Teaching in Ayurveda, Jamnagar, Gujarat, India
5 Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi, India

Date of Web Publication19-May-2017

Correspondence Address:
Rahul K Shingadiya
Department of Rasashastra and Bhaishajya Kalpana, Institute for Postgraduate Research and Teaching in Ayurveda, Gujarat Ayurved University, Jamnagar - 361 008, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0975-2870.206579

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  Abstract 

Background: Safety and efficacy of herbo- metallic or mineral formulations in Ayurvedic therapeutics is subject of great concern in present era. Especially in paediatrics in which, a number of herbo-metallic formulations are found in practice for prevention as well as for the treatment of paediatric disorders. Among various herbo-metallic preparations mentioned in Ayurveda, gold, iron and mercurial formulations are more popular in paediatric practices. Present study has been conducted to highlight an evidence based safety and efficacy of metallic preparations in paediatrics. Material and Method: Subject related published research articles from reputed journals were searched through four online search engines Pubmed, Google scholar and Ayush research portal and DHARA online. The data of the articles were analysed to confirm their safety and efficacy in paediatrics. Results: Total 10 clinical studies showing safety and efficacy of Ayurvedic herbo-metallic preparations in paediatric disorders were compiled, which included 3 formulations of gold, 4 of iron and 3 mercurial formulations. Children suffering from Chronic tonsillitis, Iron deficiency anaemia, Sickle cell anaemia and Bronchial asthma were treated with significant effect and positive changes in haematological parameters. No any adverse or toxic effect of any of these formulations was noticed. Conclusion: Metallic preparations of gold, iron and mercury are found quite safe to the use in pediatric disorders with proper dose and adjuvant. They are also found effective in the diseases which are chronic and diffi cult to treat such as sickle cell anemia, seizure, and acute lymphoblastic leukemia.

Keywords: Ayurveda, Bhasma, hematinics, herbomineral, mercurials, Swarna prashana


How to cite this article:
Shingadiya RK, Chaudhary S, Joshi K, Bedarkar P, Patgiri B J, Prajapati P K. Evidence-based safety and efficacy of Ayurvedic herbo-metallic preparations containing gold, iron, and mercury with special reference to pediatrics. Med J DY Patil Univ 2017;10:222-8

How to cite this URL:
Shingadiya RK, Chaudhary S, Joshi K, Bedarkar P, Patgiri B J, Prajapati P K. Evidence-based safety and efficacy of Ayurvedic herbo-metallic preparations containing gold, iron, and mercury with special reference to pediatrics. Med J DY Patil Univ [serial online] 2017 [cited 2017 Sep 20];10:222-8. Available from: http://www.mjdrdypu.org/text.asp?2017/10/3/222/206579


  introduction Top


Ayurveda, an Indian system of medicine, is well known for its unique therapeutic techniques and formulations. Herbo-metallic formulations are one of them which have drawn attention of the world. These formulations are more popular in therapeutics because of its smaller dose, palatability, shelf life, and efficacy.[1] Herbo-metallic formulations are prepared from processed metals (mercury, gold, iron, arsenic, etc.), minerals, alloys, or their compounds. By various pharmaceutical processes, these metals are converted into nontoxic forms suitable for the treatment of various diseases. Herbal drugs are also used in pharmaceutical process which act as a chelating agent and provide large number of trace elements.[2] Ayurvedic classics have described some basic rules for all formulations (herbal or herbo-metallic/mineral) regarding their preparation [3] and prescription [4] such as dose, duration, adjuvant, and diet restriction. In short, safety and efficacy of herbal and herbo-metallic formulations depend on proper pharmaceutical procedures and judicious prescription.

In pediatric disorders, some herbo-metallic formulations have also found in routine practice such as Swarna prashana,[5]Krimi kuthara rasa,[6]Kumara kalyana rasa,[7] and Swasa kasa chintamani rasa[8]. These formulations are widely prescribed by ayurvedic physicians since the ancient age, and they are found safe and efficacious in pediatric diseases. However, nowadays, some cases have been recorded indicating the toxicity in children taking herbo-metallic formulations such as acute renal failure in a 2-year-old child taking ayurvedic medicine [9] and two cases of lead poisoning in 2–4 years children taking Pravala pishti and Swarna malini vasanta rasa.[10] Such incidences have raised questions regarding their safety and efficacy. Present work is a humble effort to collect and highlight some evidences regarding safety and efficacy of the herbo-metallic formulations in pediatrics. By going through literature review, it was observed that majority of the formulations were prepared from Rasaushadhi predominantly containing three metals, i.e., gold, iron, and mercury. Considering this, only herbo-metallic formulations containing gold, iron, and mercury were included in the review.


  Materials and Methods Top


Data sources and review process

Subject-related published research articles from reputed journals were searched through four online search engines - PubMed, Google Scholar, AYUSH research portal, and DHARA online. Articles published in English language between 2000 and June 2016 were included in the review. Full text of these studies is available in pdf format through the related publishing websites. PubMed database and Google Scholar are international databases comprise standard biomedical literature from different life science journals.[11] AYUSH research portal and Digital Helpline for Ayurveda Research Articles (DHARA) are comprehensive online indexing service for the articles published in the field of Ayurveda implemented by the Ministry of AYUSH, Government of India, and AVT Institute for research, respectively. The key words in our study were Ayurveda, herbomineral, herbo-metallic, pediatrics, gold, iron, mercurial, clinical trial, swarna, loha, mandura, and bhasma. The major key words Ayurveda and herbomineral were combined with other key words separately. For example, Ayurveda and gold and pediatrics or Ayurveda and bhasma, etc., were used, and first ten pages of every result were included for selection. Articles satisfying the search criteria were entered into a review process, and the full texts collected according to the criteria were further reviewed.

Types of studies

Only clinical trials described in proper scientific manner were included in this review. Randomized or nonrandomized trials; open label, single, or double-blinded trials; and the trials evaluated safety and efficacy of ayurvedic herbo-metallic formulations containing gold, iron, or mercury in pediatric disorders were included in the review. Case reports, case series, pharmacological studies, and observational studies were excluded from the review. Clinical studies on ayurvedic herbal formulations or herbo-metallic formulations not containing gold, iron, and mercury were also excluded from the review.

Types of participants

Patients or healthy volunteers of age <16 years were included in the review. The inclusion criteria for selections of patients varied study to study according to diseases.

Types of interventions

Studies designed to treat pediatric disorders by ayurvedic herbo-metallic preparations containing gold, iron, or mercury were included in the review. In all the studies, herbo-metallic interventions were given by oral route. Herbo-metallic formulations were prescribed in proper dose along with proper adjuvant.

Types of outcome measurement

For the outcome measurement, assessment of before and after intervention and a follow-up period were essential for the review. Hematological and biochemical investigations have been taken as a safety measures.

Quality of evidence

Studies that were nonrandomized, limited, inconsistent, indirect, or imprecise or exhibited publication bias were considered as low-quality evidence. Studies that were randomized trial were considered for medium- to high-quality evidence, and the Jadad criteria (based of randomization, blinding, reliability, and external validity) were applied on them.

Data extraction

Standard pro forma was prepared for data analyzing that comprised the following items: author, year, study design, participants, disease, age, intervention, safety measures, and results (efficacy).


  Observations and Results Top


Study selection and exclusion

In AYUSH research portal, 45 clinical trials on pediatrics, 3 on Swarna, 5 on Loha, and 6 on Mandura were found. In Google Scholar, DHARA, and PubMed, total 18, 14, and 7 clinical trials of ayurvedic formulations in pediatrics were found, respectively. Some articles repeated in two or three databases were counted as single article. Among these selected articles, thirty articles relating to herbo-metallic preparation in pediatrics were identified through full-text reading. Among them, 11 review articles, 2 case reports, and 7 clinical studies not fulfilling the criteria were excluded from the review. Rest ten studies were included after assessing the descriptions of the full-text articles.

Among the ten studies, three studies are involved gold formulations [Table 1];[12],[13],[14] four studies are involved iron formulations [Table 2];[15],[16],[17],[18] three studies are involved mercurial formulations [Table 3].[19],[20],[21]
Table 1: Clinical studies containing gold formulations

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Table 2: Clinical studies containing iron formulations

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Table 3: Clinical studies containing mercurial formulations

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Effects of intervention

Two studies (Shailja et al. and Arun Raj et al.) suggest the significant role of Kumarabharana rasa in chronic tonsillitis (Tundikeri). Children presenting the classical symptoms of Tundikeri, i.e., enlargement of tonsils (Kathina shotha), hyperemia (Ragatwa), dysphagia (Galoparodha), halitosis (Mukha daurgandhya), enlargement of lymph nodes (Lasikagranthi vriddhi), and fever (Jwara) were included and prescribed only Kumarabharana rasa with honey. Both the studies had found statistically highly significant relief in these symptoms. Ramteke et al. had evaluated the effect of Swarna prashana in healthy children by dividing them into two groups (male and female children) and compared with standard control (honey suspension). Significant (P < 0.05) result was found in weight gain of male and female children in comparison with control group.

Management of childhood anemia with herbo-metallic formulations is described in four studies, in which three are on iron deficiency anemia (IDA) and rest is on sickle cell disease (SCD) anemia. Dhatri lauha and Gudadi mandura were prescribed in syrup form in two parallel groups in cases of IDA by Dhaked et al. and found statistically highly significant results on hematological parameters and significant result on clinical features. Comparatively, Gudadi mandura was found more effective. Mandura bhasma was prescribed with and without honey by Gupta et al. and Garai et al. prescribed it along with honey and Amalaki churna in IDA. Both studies showed promising results. Gupta et al. had found significant increase in serum iron/total iron binding capacity ratio in both groups, but it was more in the group prescribed Mandura bhasma with honey. In the cases of SCD, Gomeda mandura Kasisa bhasma showed improvement in Hb % and significant faster relief in signs and symptoms in comparison to standard control (folic acid).

Effect of Swasa kasa chintamani rasa in bronchial asthma was evaluated by two studies. Patients having the signs and symptoms of breathlessness, cough, fever, running nose, chest pain, restlessness, wheeze, etc., were included in the studies. Both the studies found significant relief in sign and symptoms. Kumara kalyana rasa and Sitopaladi churna were prescribed to healthy children and observed twenty different parameters physical growth by Rekhraj et al. The results were encouraging and indicating the role of this mercurial formulation on growth and development of a child.

Adverse drug reactions

Gupta et al. and Kumar et al. had reported that abdominal pain, burning, or discomfort (in epigastric region) was appeared just after the ingestion of Swasa kasa chintamani rasa and persisted for 2–3 min and subsided without any medication. This adverse effect may be due to ingestion of fresh garlic. The similar side effect has also been reported due to ingestion of raw garlic and its preparation.[22]

Quality of evidence

Among selected nine studies, six nonrandomized trials were taken as low-quality evidences. Rest three randomized trial were applied the Jadad scale to assess their quality of evidences. According to the Jadad scale, no study provided high quality of evidence. Hence, overall quality of evidence was medium to poor quality [Table 4].
Table 4: Quality assessment of randomized trials with Jadad scale

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  Discussion Top


Role of herbo-metallic formulations in efficacy

In chronic tonsillitis, microbial infections, especially streptococcal infection, cause the inflammation of tonsils. The ingredients of Kumara kalyana rasa are showing proven anti-inflammatory, antimicrobial, and immunomodulatory effects. The gold Bhasma of the formulation plays a key role in overall efficacy as nanoparticles (Bhasma) of gold have possess immunomodulatory activity,[23] free radical scavenging activity,[24] antistress effect,[25] and analgesic activity.[26] It is also found significantly effective in healthy children by increasing their physical growth. The research works had been proven antioxidant property of the gold nanoparticles which effectively helps regulate antigen-specific immune response and improves the health.[27] Thus, herbo-metallic formulations containing gold are effective in illness as well as improving health.

Loha bhasma is reported to possess hematinic effect and hemoglobin regeneration efficiency in comparison to control and standard ferrous sulfate.[28]Mandura bhasma had shown hepatoprotective activity on CCL4-induced hepatic injury.[29] Iron formulation Punarnavadi mandura (PRAK 20) had also proven hepatoprotective, antifibrotic, anti-inflammatory, detoxifying, and antiviral properties.[30] Thus, iron preparations are found safe and effective remedies.

Related safety evidences of herbo-metallic formulations

In Ayurveda, metals and minerals are used as a medication in the incinerated form which is called as Bhasma. Bhasma of gold contains nanoparticles of gold (56–57 nm).[31] These nanoparticles would reach the target site of action through blood after gastrointestinal uptake.[32] Acute toxicity studies of Swarna bhasma concluded that no mortality was found in mice up to 1 ml/20 g body weight of suspension containing 1 mg of Swarna bhasma. It was also found safe in chronic toxicity study.[24]Bhasma of Loha, Mandura, and Kasisa is comes under the umbrella of iron formulations. Lauha bhasma and Mandura bhasma are found safe at five times therapeutic effective dose in Charles Foster albino rats.[33]

Bhasma of metals and minerals is the source of bioaccessible trace aliments. Swarna bhasma is reported to contain Arsenic (As) and Nb as trace elements [34] while Loha bhasma is reported to contain potassium (K), copper (cu), zinc (Zn), manganese (Mn), and magnesium (Mg) in trace amount.[35] Some mercurial formulations such as Rasasindura, Rasakarpura, and Sameerpannagarasa have found safe at acute and chronic toxicity studies.[36] Herein, all the formulations prescribed dose of the gold, iron, and mercurial were too small and within the permissible limit [Table 5].
Table 5: Formulation composition and daily consumption of metallic forms

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Review strengths

The articles were searched through the most popular databases that comprise articles from ayurvedic science. Full-text articles published in English language and written in proper scientific manner with possible scientific discussion and justification were included in this study. Overall quality assessment of evidences through the Jadad criteria is also strength of the study.

Review limitations

There may be a chance of bias in the search and selection procedure used in this study. Large numbers of formulations are mentioned in ayurvedic classics. Here, an attempt was made to search the articles through possible key words relating to the study, but some articles having unusual title or formulation names may be missed to search through. Some articles may be located in other databases. Many articles of Ayurveda published earlier are still not available online. Hence, studies from them could not be included in the study.

Suggestions

It is the great need in the field of Ayurveda to improve the quality of evidences. In clinical trials, quality can be improved by the tools such as randomization and blinding. Controlled trial should be also planned if possible. Larger sample size should be included in the clinical study.


  Conclusion Top


This was a systematic review investigating the evidence regarding safety and efficacy of ayurvedic herbo-metallic preparations in pediatrics patients. In this review, ayurvedic herbo-metallic preparations are found quite safe to the use in pediatric disorders with proper dose and adjuvant. They are also found effective in the diseases which are chronic and difficult to treat such as sickle cell anemia, seizure, and acute lymphoblastic leukemia. However, based on the Jadad criteria, the evidences are graded as moderate to poor quality. This treatment approach should be investigated further on large sample size to determine its most effective clinical use.

Acknowledgment

Authors duly acknowledge the authorities of the Department of Rasashastra and Bhaishajya Kalpana, Institute for Postgraduate Research and Teaching in Ayurveda, Gujarat Ayurved University, for their kind permission and support.

Financial support and sponsorship

The study was supported by Institute for Postgraduate Research and Teaching in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India.

Conflicts of interest

There are no conflicts of interest.

 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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