Abstract
Adverse drug reactions are a significant public health concern due to widespread drug usage and over-the-counter purchases, necessitating Pharmacovigilance studies to understand treatment outcomes and prevent life-threatening conditions. A case reported was a 3-month-old girl diagnosed with infantile atopic dermatitis presented with reddish maculopapular eruptions, but after receiving Rhus toxicodendron medication, there was severe aggravation of her complaints. Regarding Rhus toxicodendron, no definitive report on previously reported ADRs was found. The homeopathic medicine Sulphur, 6C was prescribed on the basis of totality of symptoms, Materia Medica and miasm. Infantile atopic dermatitis was reduced considerably within 10 days, and it disappeared completely in 1 month 27 days and no recurrence was observed for another 5 months as well. ADRs are crucial to public health, and medical professionals must be educated to report any adverse reactions. Further research and documentation are urgently needed to advance the global acceptance of Homoeopathic drugs.
Introduction
The main aim of the Pharmacovigilance programme is to identify the unknown adverse reactions of the medicines (1). By definition it is stated as science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem (2). A drug or medicine is any substance in a pharmaceutical product which is used to modify or explore physiological systems or pathological states for the benefit of the recipient. The drug reaction or adverse drug reaction is the response to the medicine used in humans or animals (3). According to the literature in western countries, the incidence of ADRs is estimated to be 2.4-6.5%, with only 6-10% of all ADRs are reported (4). Adverse drug reaction (ADR) comes under the umbrella of Pharmacovigilance defined as any noxious and unintended effect of a drug or combination of two or more drugs which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease or for the modification of physiological function. It is estimated that ADRs represent the fourth leading cause of death in the United States and Canada behind heart disease, cancer and stroke. Further, it is estimated that ADRs are the sixth leading cause of death worldwide (5). Thus the programme was initiated to collect, analyze and to establish an evidence-based clinical safety profile for documentation and to keep track of adverse drug reactions (ADRs) from the Ministry of AYUSH, Government of India, for ASU and H drugs.
Case report
Presenting complaint
A 3 months old Indian, female child presented in the OPD of Mahesh Bhattacharyya Homoeopathic Medical and Hospital, on February 21, 2024, with OPD number 138639 for the complaint of dry, reddish maculopapular eruptions all over the body and scalp since 10 days (Figures 2-3 ). At first the eruptions were present only over the back and both forearms with mild itching. She was under treatment of a homoeopathic physician where she was prescribed the homoeopathic medicine Rhus toxicodendron 30C/5doses on February 12, 2024. After taking the medicine her skin eruptions were aggravated and spread all over the body and scalp with excessive itching from February 16, 2024 onwards. There is probable chance of Adverse drug reaction (ADR) as per the ADR Probability Scale as shown in Table 1.
Table 1 Showing ADR Probability Scale
Questions | Yes | No | Don’t Know | |
1 | Are there previous conclusive reports on the reactions? | +1 | ✔0 | 0 |
2 | Did the ADR appear after the suspected drug was administered? | ✔+2 | -1 | 0 |
3 | Did the ADR improve when the drug was discontinued a specific antagonist was administered? | +1 | ✔0 | 0 |
4 | Did the adverse reaction reappear when the drug was re-administered? | +2 | -1 | ✔0 |
5 | Are there alternatives causes that could solely have caused the ADR? | -1 | ✔+2 | 0 |
6 | Was the drug detected in the blood (or other fluids) in a concentration known to be toxic? | +1 | 0 | ✔0 |
7 | Was the reaction more severe when the dose was increased or less severe when the dose was decreased? | +1 | 0 | ✔0 |
8 | Did the patient have a similar reaction to the same or similar drugs in any previous exposure? | +1 | 0 | ✔0 |
9 | Was the adverse event confirmed by objective evidence? | +1 | ✔0 | 0 |
Total Score | 4 | |||
The ADR Probability Scale lies between this range (1-4 = Possible)Score: > 9 = Certain; 5-8 = Probable; 1-4 = Possible; 0 = Unlikely |
Family history
On further enquiry it was found that her mother had gastric problem and her father had hypertension. The patient had one brother, and he had recurrent cough and cold. Her grandfather died, who also suffered from hypertension like her father. Her grandfather also had psoriasis in whole body. Her grandmother was alive and suffering from diabetes and rheumatism.
Mental generals
On enquiry, it was found that the patient was crying and became irritable due to itching. She was cross and irritable and had a weeping tendency.
Physical generals
She had good appetite, cravings for sweets and moderate thirst. Her mother told that at the time of defecation she cries a lot although the stool was soft in consistency and there was redness around the anus. She had poor sleep and restlessness. She was basically a ‘hot patient’, her palms and soles were hot to touch.
Physical Examination
On careful examination, it was found that, there was excessive itching all over the body and scalp. The itching was aggravated by covering and warmth and ameliorated by gentle rubbing and in open air.
Diagnosis
The patient was provisionally diagnosed with infantile atopic dermatitis ICD-10 code: L20.83. Diagnosis was made on the basis of clinical symptoms, signs and physical examination of the patient.
Analysis and evaluation of symptoms
The Analysis and evaluation of symptoms are given in Table 2 (6)
Table 2 Showing Analysis and evaluation of symptoms with miasmatic analysis
Sl. No. | Symptoms type | Symptoms | Evaluation of Symptoms | Miasmatic Analysis |
1. | Mental general | Cross & irritable | ++ | Sycosis |
2. | Mental general | Weeping tendency | + | Psora |
3. | Physical general | Craving for sweet | ++ | Psora |
4. | Physical general | Redness around the anus | ++ | Psora |
5. | Physical general | Hot sensation of the whole body | + | Psora |
6. | Physical general | Palms & soles are hot to touch | + | Psora |
7. | Particular symptom | Dry, reddish skin eruption over whole body & scalp | +++ | Psora |
8. | Particular symptom | Itching aggravated by covering | ++ | Psora |
9. | Particular symptom | Itching aggravated by warmth | ++ | Psora |
10. | Particular symptom | Itching ameliorated by gentle rubbing | + | Psora |
11. | Particular symptom | Itching ameliorated in open air | + | Psora |
Prescription
The patient was prescribed 2 doses of Sulphur 6C once daily in the morning with empty stomach on February 21, 2024 along with placebo two times daily for 5 days after taking the meal.
Selection of Remedy with Justification
After reportorial analysis with the help of Hompath Firefly by Mind Technologies (7) (Figure 1), it was observed that Sulphur was covering the maximum number of rubrics (10 out of 11) with highest marks (26). Other remedies covering the totality were Lycopodium clavatum (18/8), Calcarea carbonica (16/8), Phosphorus (15/7) and Mercurius solubilis (14/8). On consulting Materia Medica (8), (9), Sulphur was selected on the basis of the mental and physical symptoms as well as thermal relation of the patient.
Selection of Potency with Justification
It was based on the susceptibility of the patient (10), (11).
Follow up
A follow-up was conducted after one week and then at the interval of two weeks. In the follow-up visits that followed, a placebo was administered in the light of patient’s progressive improvement (Figures 4-7). All symptoms were completely resolved after 1 month and 27 days of treatment (total treatment period February 21, 2024 to April 17, 2024). Table 3 provides a comprehensive timeline of the treatment, while Table 4 presents an examination of MONARCH.
Table 3 Showing Follow-up visits of the case
Date of visit | Symptoms | Medicine with doses,
repetition |
Justification |
28/02/2024 |
|
Placebo 30/ 1 drachm /BD for 7 days | 7 days after analysing the case history, found mild improvement and no new symptoms arose. |
06/03/2024 |
|
Placebo 30/ 1 drachm /BD for 14 days | 7 days after analysing the case history, found much improvement and no new symptoms seen. Again Placebo 30 was prescribed and called after 14 days. |
20/03/2024 |
|
Placebo 200/ 1 drachm /BD for 14 days | 14 days after analysing the case history, found better, redness around the anus much improved and no new symptoms seen. Again prescribed Placebo 200 and called after 14 days. |
03/04/2024 |
|
Placebo 200/ 1 drachm /BD for 14 days | After 14 days by analysing the case history, she was found much better, with no new symptoms arising. Again prescribed her Placebo 200 and called her again after 14 days. |
17/04/2024 |
|
Placebo 200/ 1 drachm /BD for 14 days | 14 days after analysing her case history, found that all symptoms were better, no visible eruptions were seen over the body and scalp.
Total treatment period 21/02/2024 to 17/04/2024. Only one medicine was given during this period of treatment, and this covered all the symptoms. |
Figure 2-3: Infantile atopic dermatitis before treatment (dated February 21, 2024).
Figure 4-5: Infantile atopic dermatitis during follow-up (dated March 20, 2024).
Figure 6-7: Infantile atopic dermatitis during follow-up (dated April 17, 2024).
Table 4 Showing MONARCH score of the case
Items | Yes | No | Not Sure |
1. Was there an improvement in the main symptom or condition, for which the homoeopathic medicine was prescribed? | +2 | ||
2. Did the clinical improvement occur within a plausible time frame relative to the drug intake? | +1 | ||
3. Was there a homoeopathic aggravation of symptoms? (need to define in glossary) | 0 | ||
4. Did the effect encompass more than the main symptom or condition, i.e., were other symptoms, not related to the main presenting complaint, improved or changed? | +1 | ||
5. Did overall well-being improve? (suggest using a validated scale or mention about changes in physical, emotional and behavioral elements) | +1 | ||
6: (a) Direction of cure: Did some symptoms improve in the opposite order of the development of symptoms of the disease? | 0 | ||
6: (b) Direction of cure: Did at least one of the following aspects apply to the order of improvement of symptoms:
|
0 | ||
7. Did “old symptoms” (defined as non-seasonal and non-cyclical symptoms that were previously thought to have resolved) reappear temporarily during course of improvement? | 0 | ||
8. Are there alternate causes (other than the medicine) that – with a high probability – could have caused the improvement? (consider known course of disease, other forms of treatment and other clinically relevant interventions) | +1 | ||
9. Was the health improvement confirmed by any objective evidence? (e.g., investigations, clinical examination, etc.) | +2 | ||
10. Did repeat dosing, if conducted, create similar clinical improvement? | 0 | ||
Total Score – 8 |
Discussion
Pharmacovigilance is of prime importance in the present situation in order to ensure safety of the drugs, reduce side effects, maximize patient benefit, and enrich Homoeopathy. By preventing ADRs, we can maintain patient safety, develop a treatment plan that minimizes potential side effects, identify the patient subgroup most likely to experience an adverse effect, and modify the treatment choice accordingly (12). Therefore it is our primary responsibility to report ADRs that can benefit mankind.
In this case report, at first, the patient had the eruptions only over the back and both forearms with mild itching. After taking the homoeopathic medication Rhus toxicodendron 30C once daily for 5 days (from 12/02/2024 to 16/02/2024) under medical supervision patient developed dry, reddish maculopapular eruptions over the whole body and scalp and excessive itching all over the body. As the patient had not taken any other medication in the mean time, it is evident that this reaction was purely from the application of homoeopathic medicine Rhus toxicodendron 30C and not because of other oral medications. There were no other previous ADRs or any other conclusive reports on the same being reported. It is important to determine whether the reaction was due to any undesired method followed during the manufacturing of this particular batch product or from the default during the authentication of drugs collected initially, and if there are any other impacts present, then those have to be ruled out. Thus, it is important to document the reaction and forward it for further evaluation to the concerned centers.
Conclusion
Keeping in view of the exponential expansion and use of Homoeopathy, Homoeopathic practice should be under strict vigilance to ensure public safety and to promote the healthy development of the Homoeopathic system. That is why Pharmacovigilance in Homoeopathy is as essential as for any other system of therapeutics; it will make this system more scientifically validated and safe for consumption. In recent times, malpractices and misleading advertisements in respect of homoeopathic drugs and practices have increased, and that leads to an adverse drug reaction (ADR), which is a great cause of concern. So there is a need to educate all the medical professionals and encourage them to analyse and report any adverse drug reaction or adverse effects that occur in a patient. Thereby, the reporting culture among the homoeopaths will be improved. ADR, after proper verification, can enrich our Materia medica as ADR may give new indications for that homoeopathic medicine. Therefore, the Homoeopathic system of medicine, under the preview of the initiative – Pharmacovigilance of ASU&H drugs by the Ministry of AYUSH, Govt. of India, will help to establish a database support for safety use of homoeopathic drugs, safeguard the image of Homoeopathy by preventing the unwanted ADRs and misleading advertisements, and increase the credibility of Homoeopathy among the scientific community.
Compliance with ethical standards
Disclosure of conflict of interest
None declared.
Statement of informed consent
Informed consent was obtained from all individual participants included in the study.
Acknowledgement
The authors express profound gratitude to Dr. Kumar Gaurav, Lecturer & HOD, Department of Pathology & Microbiology, for his constant support in treating the case clinically. Cooperation of the patient and her parents are also gratefully acknowledged who came for follow-ups timely during the treatment and expressed their willingness to share this case for academic purpose.
References
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About the Author:
Chandrima Roy 1, Shankhadeep Pal 2
- BHMS, MD (Hom), Lecturer & HOD, Department of Homoeopathic Pharmacy and Coordinator of Peripheral Pharmacovigilance Centre, Mahesh Bhattacharyya Homoeopathic College and Hospital, Government of West Bengal, Dr. B. N. Chakraborty Sarani (Drainage Canal Road) Doomurjala, Howrah – 711104, West Bengal, India.
2. Shankhadeep Pal, BHMS, Junior Research Fellow, Peripheral Pharmacovigilance Centre, Mahesh Bhattacharyya Homoeopathic College and Hospital, Government of West Bengal, Dr. B. N. Chakraborty Sarani (Drainage Canal Road) Doomurjala, Howrah – 711104, West Bengal, India.