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 Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 11  |  Issue : 3  |  Page : 177-183

An observational study on usefulness of Bromium 30C in atopic respiratory complaints by assessing serum immunoglobulin E levels


Assistant Professor, Department of Practice of Medicine and Homoeopathic Therapeutics, Father Muller Homoeopathic Medical College, Hospital and Research Centre, Mangalore, Karnataka, India

Date of Web Publication15-Sep-2017

Correspondence Address:
B G Akhil
Department of Practice of Medicine and Homoeopathic Therapeutics, Father Muller Homoeopathic Medical College, Hospital and Research Centre, Deralakatte, Mangalore - 575 018, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijrh.ijrh_53_16

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  Abstract 

Background: Atopic disorders represent a major health problem worldwide affecting 5%–30% of the population. The present study evaluates the action of Bromium 30C in reducing serum IgE levels.
Objective: To assess the variation of serum IgE levels before, during and after intervention with Bromium 30C.
Materials and Methods: Thirty cases of atopic respiratory complaints (diagnosed based on clinical history, CMDT guidelines and serum IgE values during the first visit) were selected as per the inclusion criteria using purposive sampling technique. Bromium 30C was prescribed for these cases and followed for 3 months. Bromium 30C was repeated twice daily for 2 weeks and placebos were administered in between. Serum IgE values were checked every month. The data was statistically analysed using mean, standard deviation and analysis of variants (ANOVA).
Results: ANOVA for repeated measures showed P = 0.000, which is highly significant. Pairwise comparison of serum IgE levels in before and during, during and after treatment groups showed P = 0.007, which is highly significant. Pairwise comparison of serum IgE levels in during and after treatment group showed P = 0.016, which is significant.
Conclusion: There is a significant reduction in serum IgE levels in cases of atopic respiratory complaints during and after homoeopathic treatment with Bromium 30C.

Keywords: Analysis of variants, Atopic respiratory complaints, Bromium 30C, Serum immunoglobulin E


How to cite this article:
Akhil B G. An observational study on usefulness of Bromium 30C in atopic respiratory complaints by assessing serum immunoglobulin E levels. Indian J Res Homoeopathy 2017;11:177-83

How to cite this URL:
Akhil B G. An observational study on usefulness of Bromium 30C in atopic respiratory complaints by assessing serum immunoglobulin E levels. Indian J Res Homoeopathy [serial online] 2017 [cited 2017 Dec 18];11:177-83. Available from: http://www.ijrh.org/text.asp?2017/11/3/177/214840


  Introduction Top


Atopic disorders represent a major health problem worldwide affecting 5%–30% of the population. Immediate or Type I hypersensitivity reaction, where production of immunoglobulin E (IgE) antibody causes various changes such as release of vasoactive amines and other mediators from mast cells, recruitment of inflammatory cells, etc., is well understood in the pathogenesis of atopic respiratory complaints.[1] A randomised controlled trial done using the homoeopathic preparation Galphimia glauca 6C with placebo in hay fever/rhinitis cases demonstrated the efficacy of Homoeopathy using one indicated remedy and was defined as high quality by three meta-analyses of Homoeopathy.[2],[3],[4]

Passalacqua et al. conducted a systematic review on complementary and alternative medicine for rhinitis and asthma, concluded that the evidence for a specific effect of Homoeopathy is weak.[5] A pilot study done in India assessed the efficacy of homoeopathic remedies, chosen strictly on individualisation and symptom similarity, in bringing changes in serum IgE level, absolute eosinophil count and allergic rhinitis symptom scores.[6]

Reilly et al[7] studied homoeopathic treatments of hay fever and asthma in one hundred and fifty-eight patients. The responses were judged by using a visual analogue scale, which showed a significantly greater response to the homeopathic therapy and a corresponding reduction in the need for antihistamines in these patients.

There have been a few reviews of randomized, controlled trials published regarding the use of Homeopathy for asthma treatment. Six trials were included in a recent review.[8],[9] These trials were of variable quality and the results of the studies are conflicting in terms of effects on lung function. The authors underlined that standardized treatments in these trials are unlikely to represent common homeopathic practice where treatment tends to be individualized. There is a need for observational data to document the different methods of homeopathic prescribing and how patients respond.[10]

Homoeopathic remedy Bromium has a marked effect on the respiratory system, especially the larynx and trachea.[11] Many of the respiratory symptoms of Bromium bear a close resemblance to atopic respiratory symptomatology. Thus, this observational, cohort, single arm, interventional study was conducted to assess the variation of serum IgE values in cases of atopic respiratory complaints where Bromium 30C is prescribed. This study tries to integrate the knowledge of disease (atopic respiratory complaints), knowledge of medicine (Bromium) and application of this knowledge to confirm whether there exists any role for the remedy Bromium to alter the serum IgE values in atopic respiratory complaints. The present study becomes unique as the action of Bromium 30C alone is studied in relation with serum IgE levels.

Objective

To assess the variation of serum IgE levels before, during and after treatment in cases of atopic respiratory complaints where Bromium 30C is prescribed.


  Materials and Methods Top


Period of study

The study was conducted on the cases available from April 2014 to March 2016.

Sample size

The sample consisted of thirty cases of atopic respiratory complaints visiting the OPD, IPD and Peripheral Centres of Father Muller Homoeopathic Medical College, Mangalore during the specified period.

Type of study

This was a single-arm, quasi-experimental, interventional, prospective, before, during and after treatment comparison pilot study without control.

Inclusion criteria

  • Both sexes aged between 18 and 50 years
  • Cases of atopic respiratory complaints in which serum IgE levels are above 200 IU/ml[12]
  • Cases of atopic respiratory complaints where Bromium is indicated and prescribed the same in the 30th potency were included in the study.


Exclusion criteria

  • Patients who were on homoeopathic medicines other than Bromium 30C
  • Taking medicines from other systems for any other complaint.


Materials

Standardised case record

Serum IgE levels were assessed using Cobas - 6000 fully automated analyser.

Method

Thirty cases of atopic respiratory complaints were selected as per the inclusion criteria using purposive sampling technique. Diagnoses of the cases were made based on relevant clinical history, and serum IgE values obtained during the first visit according to CMDT guidelines.[13] The 30 potency of Bromium was prescribed for the above cases and was followed for a period of 3 months.[11] The data were presented in standardised case record (SCR).

Remedy used

The 30 potency of homoeopathic medicine Bromium, manufactured by Father Muller Homoeopathic Pharmaceutical Division (which prepares the drug according to Homoeopathic Pharmacopoeia of India), was used in the study. Three globules of Bromium 30C (number 40 size) were given twice daily for a period of 2 weeks and placebos were administered in between if needed. Follow-ups were watched and analysed as per criteria set up in each case according to standard guidelines of Homoeopathy using the symptomatology of the patient as mentioned below.

Follow up and Symptomatic assessment

Each follow up was of 2 weeks duration, and assessed according to the guidelines given in standardised case record follow-up sheet where each symptom of the patient pertaining to allergic respiratory complaint was graded according to the intensity, aggravation, amelioration, presence or absence. The major symptoms considered in cases of allergic rhinitis were coryza, sneezing, itching of nose and nose block, and in cases of atopic asthma were breathlessness, cough and wheezing with a strong history of atopy in both diagnoses.

An estimation of serum IgE value for each case was done in the beginning before starting homoeopathic treatment. Over a period of time, when a patient came for consecutive follow-ups, serum IgE values of each patient were estimated again, minimum twice, which was after 1 month and after 3 months of treatment. This provided an idea for comparing serum IgE values in atopic respiratory complaints before, during and after treatment, after prescribing Bromium 30C. The flow chart of study given as [Figure 1].
Figure 1: Flow chart of the study

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Statistical analysis

The collected data were analysed by mean, standard deviation and analysis of variants (ANOVA).

Research hypothesis

There is a significant decrease in serum IgE values in atopic respiratory complaints during and after homoeopathic treatment with Bromium in the 30th potency.

Null hypothesis

There is no significant decrease in serum IgE values in atopic respiratory complaints during and after homoeopathic treatment with Bromium in the 30th potency


  Results Top


This study of thirty patients showed a higher female prevalence (67%) with the 18-23 years’ age group being the most affected (33.33%) by atopic respiratory complaints. Allergic rhinitis constituted the maximum number of cases (80%) and atopic bronchial asthma constituted 20% of the cases [Table 1]. Thirty diagnosed cases of atopic respiratory complaints (allergic rhinitis and atopic bronchial asthma) were studied for a period of minimum 3 months. Serum IgE values were checked thrice, (before, during and after the treatment) with a minimum 1-month interval between each measurement. The following observations were made: mean serum IgE levels before, during and after treatment were 1067.39, 913.59 and 852.393 IU/ml, respectively. ANOVA for repeated measures shows P = 0.000, which denotes a highly significant reduction in mean serum IgE values before, during and after homoeopathic treatment with Bromium 30C in atopic respiratory complaints [Table 2].
Table 1: Baseline characteristics

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Table 2: Mean serum immunoglobulin E levels before, during and after treatment

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Pairwise comparison of serum IgE levels in before and during treatment group shows a mean difference of 153.795, and P = 0.007 denotes that there is a highly significant reduction in serum IgE levels before and during treatment with Bromium 30C. Pairwise comparison of serum IgE levels in during and after treatment group shows a mean difference of 61.99, and P = 0.016 denotes that there is a significant reduction in serum IgE levels during and after treatment with Bromium 30C. Pairwise comparison of serum IgE levels in before and after treatment group shows a mean difference of 214.993, and P = 0.007 denotes that there is a highly significant reduction in serum IgE levels before and after treatment with Bromium 30C [Table 3].
Table 3: Pairwise comparisons – Serum immunoglobulin E levels before, during and after treatment

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  Discussion Top


It was observed that there was a highly significant reduction in serum IgE values in before and after, and before and during treatment groups. Significant reduction in serum IgE value was observed in during and after treatment group.

The strengths of this study are utilising the specific effect of Homoeopathy in allergic rhinitis and atopic asthma using Bromium 30C as the medicine and incorporating Serum IgE levels for the same. The weaknesses are small sample size (n=30), no control group selected to compare the results and no randomisation done.

One systematic review involving a single homoeopathic remedy (G. glauca) for treating allergic rhinitis had been published in English.[14] Three out of four studies included in that review reported significant results in favour of the intervention; however, it only included one homoeopathic medicine. Two important drawbacks of this review were that of the included trials, neither used validated outcome measures nor intention-to-treat analyses. Apart from Ernst, no systematic review evaluating only homoeopathic treatment for allergic rhinitis had been published in English. This study provides scientific evidence in Homoeopathy by nullifying the main drawbacks of the above study using serum IgE values and by utilising intention to treat analysis.

Passalacqua et al.[5] conducted a systematic review on complementary and alternative medicine for rhinitis and asthma, concluded that the evidence for a specific effect of Homoeopathy is weak. This study provides a strong evidence for specific effect of Homoeopathy in rhinitis and asthma using Bromium 30C as the medicine.

A single-arm, experimental, interventional, prospective, non-randomised, before and after comparison pilot study without control was carried on thirty participants suffering from allergic rhinitis in India.[6] The trial was aimed to assess the efficacy of homoeopathic remedies, chosen strictly on individualisation and symptom similarity, in bringing changes in serum IgE level, absolute eosinophil count and allergic rhinitis symptom scores (approved by the Institutional Review Board) by comparing the score before medication (baseline) with score after medication. Outcome measures were assessed and analysed after 1 year. After 1 year of homoeopathic treatment, reduction in serum IgE level, absolute eosinophil count and symptom score were statistically highly significant.[6]

This study assessed the action of a single remedy Bromium 30C (in contrast to various homoeopathic medicines in the above study) and assessed only variations in serum IgE levels before, during and after treatment. The other study assessed changes in absolute eosinophil count also apart from changes in serum IgE but did not include atopic bronchial asthma. Both of these studies followed a similar methodology to study atopic respiratory complaints, though varying parameters and outcome measures were used in the assessment. However, both studies are non-randomised pilot studies which involved only a small group of thirty patients.

A review article published in India comprised 10 selected publications of observational studies and drug oriented studies where Homoeopathic treatment was used for the management of asthma. This review concluded positive outcome in controlling acute episodes of asthma, reducing the frequency and intensity of subsequent episodes and weaning of bronchodilators and other allopathic drugs. But, Homoeopathic medicine Bromium was not prescribed in none of the 10 constituent studies mentioned under the review. The review also recommended further pragmatic trials including randomized control studies, as only observational studies had been conducted.[15]


  Conclusion Top


There is a significant reduction in serum IgE levels with symptomatic improvement in cases of atopic respiratory complaints during and after homoeopathic treatment with Bromium 30C.

Limitations

  • The sample size is small (n = 30)
  • No control group was included along with the study group to compare test results.


Recommendations

  • A study on a larger scale with randomisation and double blinding could be undertaken
  • Bigger sample with extended time of research would provide better results
  • A quality of life questionnaire for atopic bronchial asthma could be added to the parameters used in this study.


Financial support and sponsorship

Nil.

Conflicts of interest

None declared.

 
  References Top

1.
Paul WE. Fundamental Immunology. 5th ed. Philadelphia, USA: Lippincott Williams and Wilkins; 2003. p. 1439-72.  Back to cited text no. 1
    
2.
Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, et al. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997;350:834-43.   Back to cited text no. 2
    
3.
Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JA, et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet 2005;366:726-32.   Back to cited text no. 3
    
4.
Kleijnen J, Knipschild P, ter Riet G. Clinical trials of homoeopathy. BMJ 1991;302:316-23.   Back to cited text no. 4
    
5.
Passalacqua G, Bousquet PJ, Carlsen KH, Kemp J, Lockey RF, Niggemann B, et al. ARIA update: I – Systematic review of complementary and alternative medicine for rhinitis and asthma. J Allergy ClinImmunol 2006;117:1054-62.   Back to cited text no. 5
    
6.
Ghosh S, Saha S. Allied health – 3006. Homeopathy in treating allergic rhinitis – An interventional pilot study. World Allergy Organ J 2013;6Suppl 1:P182.   Back to cited text no. 6
    
7.
Reilly, DT, Taylor, MA, McSharry, C, and Aitchison, T. Is homoeopathy a placebo response? Controlled trial of homoeopathic potency, with pollen in hayfever as model. Lancet 1986;2:881-86.  Back to cited text no. 7
    
8.
Kleijnen J, Knipschild P, ter Riet G. Clinical trials of homoeopathy. Br Med J 1991;302:316-23.  Back to cited text no. 8
    
9.
McCarney RW, Lasserson TJ, Linde K, Brinkhaus B. An overview of two Cochrane systematic reviews of complementary treatments for chronic asthma: Acupuncture and homeopathy. Respir Med. 2004;98:687-96.  Back to cited text no. 9
    
10.
Ziment I, Tashkin DP. Alternative medicine for allergy and asthma. Journal of Allergy and Clinical Immunology 2000;106:603-14.   Back to cited text no. 10
    
11.
Boericke W. Pocket Manual of Homoeopathic Materia Medica. Reprint Edition. New Delhi: Indian Books & Periodicals Publishers; 2011. p. 130-2.  Back to cited text no. 11
    
12.
Stanley Davidson. Davidsons Principles and Practice of Medicine, 20th ed. Philadelphia: Churchill Livingstone, Elsevier Limited; 2006. p. 69-70.  Back to cited text no. 12
    
13.
Maxine A Papadakis, Stephen J McPhee, Michael W Rabow. Current Medical Diagnosis & Treatment, 54th ed. New York: McGraw-Hill Education; 2015. p. 218, 240-2.  Back to cited text no. 13
    
14.
Ernst E. Homeopathic Galphimia glauca for hay fever: A systematic review of randomized clinical trials and a critique of a published meta-analysis. Focus Altern Complement Ther 2011;16:200-3.  Back to cited text no. 14
    
15.
Sharma B, Narula RH, Manchanda RK. Homoeopathy for the management of Asthma- A review of Council's Clinical Research, Indian Journal of Research in Homoeopathy 2015;9:69-78.  Back to cited text no. 15
    


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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