A randomized control study for evaluating the efficacy of individualized homoeopathic medicine as an adjuvant therapy in mild to moderate cases of COVID-19

INTRODUCTION

The COVID-19 pandemic has created global havoc. While conventional treatment methods are at the forefront, homoeopaths have been prescribing homoeopathic medicines singularly or as an adjuvant in this pandemic. The Ministry of AYUSH, Government of India, had declared the Homoeopathic medicine Arsenicum album 30C useful for preventing COVID-19 and increasing an individual’s immune status.^[1]

Homoeopathy has been used for many years in epidemic diseases, from scarlet fever to the Spanish flu of 1918. It has shown excellent results in viral and parasite-borne diseases (e.g., dengue and chikungunya), as well as other epidemic diseases. Homoeopathy has been prescribed using various approaches: Individualized prescription, genus epidemicus,^[2] isopathy, and combination remedies. Belladonna was used as a genus epidemicus during scarlet fever; acute diarrhea in children in Nicaragua was treated using individualized prescriptions. In an epidemic of dengue fever in Pakistan, a combination of ten medicines (Bryonia alba, Rhus toxicodendron, Gelsemium, Aconite napellus, Eupatorium perfoliatum, China boliviana, Hamamelis, Critrulus colocynthis, Crotalus horridus, and Phosphorus) was used. Use of potentized mustard gas as a preventive measure in chemical injury due to mustard gas during World War II in London is an example of isopathic use of homoeopathy.^[3]

Vaishampayan et al. treated 104 patients with homoeopathy as an adjuvant in 2 COVID-19 treatment centers on the outskirts of Mumbai, India, from mid-June to mid-July 2020 and found that the hospital stay reduced by 5–7 days. During this study, Mercurius solubilis was found to be indicated medicine in most patients in individual repertorization, as well as repertorization of combined symptomatology. Thus, they proposed Mercurius solubilis as a possible genus epidemicus.^[4]

What seemed to be a simple viral contagious disease at the onset of the pandemic was soon determined to have a multi-faceted and dangerous presentation. Waisse et al.^[5] have described in detail the multi-organ influence of the virus, including the pulmonary and extra-pulmonary manifestations. Due to significant variation in the manifestations, the genus epidemicus approach for homoeopathy is unlikely. This is further supported by the fact that the virus has been active since 2019 and no single genus epidemicus has evidently come up, yet homoeopathic medicines have shown results when applied according to the principle of Similia Similubus Curentur.

In Hong-Kong, To and Fok^[6] prescribed homoeopathic medicines to 18 patients on the basis of individual symptomatology, where Gelsemium was indicated in 12 and B. alba in 4 cases. Masiello^[7] in New York City studied 30 cases of COVID-19 wherein Gelsemium, Senega, and Antimonium arsenicum were prominent remedies.

Jethani et al. conducted a retrospective cohort study of 138 confirmed cases of mild to moderate COVID-19 in New Delhi, India, where homoeopathy was prescribed as an adjuvant to conventional treatment. It was observed that the patients receiving homoeopathic adjuvant recovered without major complications. The frequently indicated medicines during this study were B. alba (33.3%), A. album (18.1%), Pulsatilla nigricans (13.8%), Nux vomica (8%), R. toxicodendron (7.2%), and Gelsemium sempervirens (5.8%).^[8]

A study conducted in Kerala in 2020 concluded that the homoeopathic medicine A. album 30C was effective in upregulating the immunological markers such as absolute CD4 count, absolute CD8 count, absolute CD3 count, absolute lymphocyte count, and CD4:CD8 ratio among the residents of COVID-19 hot spots.^[1]

Homoeopathy has shown positive results not just in pulmonary manifestations but also in extra pulmonary manifestations. Waisse reports a case of a 66-year-old lady with suspected COVID-19, who presented with fever, giant urticarial patches, and hyper-coagulability. The patient showed positive results with Apis 30C, wherein the hyper-coagulability state settled markedly within 12 hours and the thromboinflammation settled over 10 days of follow-up.^[9]

Thus, several various types of studies have showed the effectiveness of Homoeopathy in COVID-19. However, the need of the hour is a systematic randomized control study based on the principles propounded by Dr. Hahnemann to establish the role of Homoeopathy in COVID-19. It is important to study the effect of homoeopathic medicine on the subjective as well as objective parameters.

Although homoeopathy has the potential to provide better and cost-effective results, it has always been the alternative and never a mainstream line of treatment. This is due to lack of prospective clinical trials, particularly randomized trials.^[10] The clinical trials with homoeopathy as an adjuvant to the standard care in hospitalized cases of COVID-19 have been initiated eventually in some parts of the world, including India. These primarily refer to mild and moderate cases. Seeking permissions for such trials and getting clearance of the ethical committees of the hospitals for such trials are a challenge in itself. This paper demonstrates the results of one such Randomized Control Trial (RCT) conducted at a Tertiary Care Super Speciality Hospital in the city of Pune, India.^[11]

MATERIALS AND METHODS

Data collection, recording, and analysis

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The participants in both the groups were analyzed using the following parameters

1. Subjective

   1. Fever

   2. Dry Cough

   3. Dyspnea

   4. Headache

   5. Loss of taste/smell

   6. GIT symptoms

   7. Body ache/Weakness.

2. Objective

   1. Oxygen requirement

   2. Oxygen requirement status on 4^th day in moderate cases

   3. Duration of hospitalization

   4. Mortality rate

   5. Shifting to the ICU.

RESULTS

1. Demographic data

   1. Age

   2. Sex distribution

   Both groups had equal distribution of male and female patients.

   As indicative in [Figures 1 and 2]. A total of 68.8% male and 32.2% female patients were in the mild category. A total of 48.1% male and 51.9% female patients were in the moderate category.

2. Classification according to severity, comorbidities, and supplemental oxygen requirement on admission

   1. Severity of cases [Figure 3] indicates severity of cases in both the groups. The mild cases age group ranged from 30 to 55 years with the median age being 42 years. The moderate cases age group ranged from 45 to 70 years with median age being 54 years. As seen in [Table 3].

   2. Comorbidities in both groups

   3. [Figure 4] indicates co-morbidities in both groups. Supplemental oxygen required in both groups on admission. [Figure 5] indicates the oxygen requirement in both groups on admission

3. Frequency of homoeopathic remedies used and the number of cases

   1. [Figure 6 and Table 4] indicated in the study the frequency of homoeopathic remedies The frequent indicated remedies in mild cases were Antimony tartaricum, A. album, Bromium, Bryonia, Pulsatilla, and Lycopodium, whereas in moderate cases they were A. album, Kali bichromicum, Lycopodium, Natrum muriaticum, Bryonia, and Pulsatilla.

   2. Intercurrent remedy: At the level of qualitative susceptibility, high activity of Tubercular miasm was seen, requiring Tuberculinum bovinum in nine out of a total of 50 cases.

4. Potency: The 30C potency was used in most cases and was found effective.

5. After applying test of statistical significance to the experimental and control groups using pre-decided parameters

   1. Subjective parameters: Fever, dry cough, dyspnea, headache, loss of taste, loss of smell, body ache, weakness, and gastrointestinal symptoms

      1. Complete recovery on day 4 in subjective parameters [Figure 7]

      2. Percentage improvement subjective parameters on day 4 [Figure 8]

      On day 4, 70% relief in intensity of subjective symptoms was noted in 37.5% patients in Group A and 7.7% patients in Group B on day 4. Similarly, 50% relief in intensity of subjective symptoms was noted in 6.3% of patients in Group A and 0% in Group B on day 4.

      Thus, 93.5% of patients in Group A were either asymptomatic or relieved by 70% by day 4 in Group A whereas it was only 22.7% in Group B.

   2. Objective parameters

      1. Reduction in oxygen requirement

         Oxygen requirements significantly reduced in 85.2% patients from the treatment group compared to 5.6% from the control group [Figure 9].

         (P = 0.000 statistically significant) [Tables 1 and 2]

      2. Oxygen requirement status on day 4 [Figure 10]

      3. As seen in [Figure 9], Oxygen requirement on the 4^th day was significantly lower (among 95.8% patients) in Group A as compared to that among placebo patients (among 30.6% patients) in Group B (P = 0.002 – statistically significant).

      4. Reduction in duration of hospital stay

         As shown in [Figure 11], there was significant reduction in the hospital stay in the treatment group (6 days) compared to the control group (9 days).

         (P = 0.002 statistically significant) [Tables 1 and 2]

         Mild cases had an average hospital stay of 3 days, whereas moderate cases had average hospital stay of 6 days in Group A.

      5. Trends toward reduced mortality/increased survival.

         As shown in [Figure 11], although mortality was lower in the treatment group (14.8%) than in the placebo group (22.2%) the difference was not statistically significant. No mortality was seen among the mild category of patients [Figure 12].

      6. Reducing the need of shifting to the ICU As shown in [Figure 13], there was significant (P = 0.026) reduction in the patients requiring to be shifted to ICU in the treatment group (0%) compared to the control group (16.7%).

         (P = 0.026 statistically significant) [Tables 1 and 2]

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Figure 1:

Indicate sex distribution according to severity of cases.

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Figure 2:

Indicate sex distribution in moderate cases.

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Figure 3:

Classification according to severity.

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Figure 4:

Comorbidities in both groups.

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Figure 5:

Supplemental oxygen requirement on admission in both groups.

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Figure 6:

Frequency of indicated homoeopathic remedies used in Group A.

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Figure 7:

Percentage of complete symptomatic recovery on day 4.

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Figure 8:

Percentage of patients with 70% relief in intensity of symptoms by day 4.

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Figure 9:

Reduction in oxygen requirement in both groups.

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Figure 10:

Oxygen requirement day 4 onward in both groups.

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Figure 11:

Average duration of hospitalization in both groups.

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Figure 12:

Trends toward reduced mortality/increased survival..

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Figure 13:

Need to shift patients to the ICU.

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DISCUSSION

A randomized control trial of indicated homoeopathic medicines as adjuvant to standard treatment protocol for management of COVID-19 was conducted at DMH from the period of June 1, 2020, to Aug 30, 2020. As the sample size of this study was small, the reduction in mortality was not found to be statistically significant. The frequently used homoeopathic remedies in the study were A. album, Lycopodium, B. alba, Bromium, and Antimony arsenicum.

In the previous studies on treatment of COVID-19 with homoeopathy, remedies such as A. album, Antimony arsenicum^[7], Gelsemium,^[6,7] and B. alba^[6] were observed frequently. A similar group of remedies was noted in this study, the exception being Lycopodium and Bromium that were frequently seen in this study compared to Gelsemium in the previous studies. However, none of the previous studies have been case control studies. It was also observed in this study that nine out of 50 cases need T. bovinum as an intercurrent remedy due to heightened activity of Tubercular miasm in these cases. The use of intercurrent remedy has not been noted in any other study.

CONCLUSION

The study confirmed the efficacy of indicated homoeopathic remedies as an adjuvant to standard line of treatment. Homoeopathic remedies reduced oxygen requirement, shortened the hospital stay, prevented the progress of the disease from mild/moderate to severe, and reduced mortality in patients with COVID-19. The frequently indicated remedies that were found effective in the study were A. album, Lycopodium, Bryonia, Bromium, and Antimony arsenicum. 30C potency was used in most cases and was found effective.