Abstract
Background:
Homeopathy – one of the key members of the Traditional, Complementary and Integrative Heath (TCIH) systems - has a long tradition stretching to the early 1800’s in the management of acute infectious epidemic disease.
Purpose:
This audit aims to assess the clinical effectiveness of telehealth interventions in an out-patient, individualized homeopathy clinical setting for 305 individuals with symptoms of positive or probable COVID-19 by a team of professional homeopaths working together in the United States during spring and summer of 2020.
Methods:
This retrospective audit, spanning March to August 2020, examines the merits of the initiative considering accessibility, effectiveness, safety, efficiency, and appropriateness of the care model.
Results:
Positive intervention outcomes were found in every measure: individual remedy prescriptions (83.4% positive), final outcomes of interventions (76.2% positive), and degree of recovery following homeopathic interventions (74.4%). Additionally, ease of access for a range of users, a high level of safety of the interventions, and efficiency of care and team resources indicated consistently positive outcomes.
Conclusion:
Given the significant strain on conventional healthcare systems during the early stages of the pandemic, the complementary medicine interventions studied here offer important considerations for meeting the demands for COVID-19 acute care with agile and adaptive complementary medicine models.
Background
Homeopathy
Complementary medicine (CM)—healthcare not traditionally associated with the conventional medical profession or medical curriculum 1 —includes a diverse field of treatments (e.g., aromatherapy, reflexology), mind–body practices (e.g., yoga, meditation), natural products (e.g., vitamins, herbal medicines), and systems of medicines (e.g., traditional Chinese medicine and homeopathy). 2 Homeopathy is one of the whole health systems and practices under this CM umbrella. Homeopathic remedies are prescribed according to a specific principle: similarity to the total symptom profile of the client. 3 Individualized homeopathic treatment is intended to stimulate a self-healing response which reduces or removes symptoms and helps an individual move toward a stronger, dynamic state of health. 4 In this system of healing, when treating individual illness associated with epidemic/pandemic disease, rather than in everyday individualized practice, the combined symptoms of a large group of people come to define the “genus epidemicus”—a small cluster of homeopathic remedies which match the larger pattern of the disease 5 and inform clinical decisions. The medical system of homeopathy has clear guidelines for the control of infectious epidemics, established long before the advent of modern sanitation, vaccination, and antibiotics, with its first documented use in the successful treatment of scarlet fever in 1799. 6 Homeopathic medicines have been successful in treating several epidemics, including typhoid, diphtheria, cholera, yellow fever, scarlet fever, smallpox, Spanish flu, meningitis, and polio, which contributed to the popularity of Homeopathy in the USA and Europe in the nineteenth century. 7
COVID-19
On January 5, 2020, the World Health Organization issued its first Disease Outbreak News Report, which introduced the world to a cluster of cases of pneumonia of unknown etiology in Wuhan, China. On February 11, 2020, the World Health Organization announced the official name for the disease as SARS-CoV-2, the virus that causes COVID-19, a novel coronavirus not previously identified in humans. 8 As the world confronted the appearance and rapid spread of a virus producing bewildering patterns of symptoms and long-term complications, conventional and CM providers alike worked to understand its effects on the human body and how the impact of COVID-19 may be most effectively mitigated. The authors suggest that designing, implementing, and assessing CM clinical interventions against the backdrop of a pandemic is of utmost importance and that the design and applicability of this clinical audit is unique in its replicability, urgency, and applicability for ongoing and future care models. The clinical audit reported here spans 5 months, from March to August 2020.
Homeopathy Help Now initiative
Homeopathy Help Now (HHN) is a working group of professional homeopathy practitioners, administrative volunteers, and independent researchers. It was created to respond to the urgent need of care for the burgeoning number of cases of COVID-19 in the United States. The initiative was launched with a core group of nine professional, certified practitioners of homeopathy on March 18, 2020. At that time in the United States, there were 6,427 confirmed COVID cases; this number grew to 5.67 million in the 5 months this audit covers. At the time, it was clear that health services were being over-run, and many professional homeopaths were contacted by clients who had been turned away from or were unable to access conventional healthcare services. HHN sought to make a positive impact on the health of as many people as possible through the application of best homeopathy practices, while maximizing modern digital capabilities for remote access to care and communication with clients, such as stream-lined record-keeping and data collection and working very closely as a team via digital virtual meeting platforms. Clients requested care by submitting a secure online intake form, and each client was seen remotely by an individual homeopath. Symptoms were assessed, and homeopathic remedies and dosages were recommended. Each practitioner followed the case to resolution or to the last available point of client contact. Team members discussed cases and closely tracked emerging patterns of symptoms and homeopathic remedy responses.
HSR and the value of clinical audit
In keeping with the broad scope of Health Services Research (HSR),9,10 the research team decided that a clinical audit of HHN data was the most appropriate research method to undertake, given the specific circumstances. The wide research methodologies associated with HSR allow researchers to identify prevalence of health services used, evaluate the services being accessed by individuals and populations, and bridge the gap of clinical research and real-world clinical settings. 11 As a quality improvement tool evaluating clinical effectiveness, the clinical audit is an important research measure of the degree to which health was maintained or improved following a clinical intervention. 12
Objectives of the clinical audit
The objective of this audit was to assess the clinical effectiveness of homeopathic interventions in out-patient, individualized homeopathic care for clients with symptoms of positive or probable COVID-19 by a team of professional homeopaths working together in the United States during spring and summer of 2020. The clinical and diagnostic status of the cases are discussed later in the Methods section. At the time of writing, the work of the team is ongoing (with more than five thousand cases seen) and the unique context of an evolving pandemic continues. This audit serves to assess the initiative’s clinical effectiveness to improve quality and inspire additional efforts to offer effective treatment using innovative model of care structures in a time of global health uncertainty. Drawing on 5 months of HHN clinical data, this audit assesses and explores clinical outcomes using the measures of Effectiveness, Safety, Appropriateness, Efficiency, and Accessibility. 12
Methods
Data collection
Self-selecting individuals who were COVID-19 positive or probable seeking assistance for symptoms navigated to the HHN web portal. Data collected through the online intake form include name, demographic details (including client location, gender, date of birth, preexisting conditions, familiarity with homeopathy, current work with a homeopath, access to remedies, referral pathway, and preferred method of communication), synopsis of symptoms, date illness began, the nature of the health concern, and noted any conventional medications taken for the acute condition. All clients were required to sign a legal consent form affirming their agreement to be consulted by a professional homeopathy practitioner. Following a consultation (conducted on phone or video conferencing software such as Zoom, as appropriate to the client’s condition and accessibility to technology), additional relevant clinical data were added to the case notes during the consultations with the assigned practitioner. This information included presenting symptoms, COVID-19 status at intake (tested positive, tested negative, suspected due to case symptoms, suspected due to known exposure to COVID-positive person), other types of practitioners/modalities used, comorbidities, outcome at final contact, individual remedy intervention outcome, and remedy prescription details. To assess the effectiveness of care by HHN practitioners—compared against published results in other studies of individuals with COVID-19 symptoms who do not seek homeopathic treatment—a number of additional indicators were used: verbatim case notes, practitioner observation; reported observations by family of young children or hospitalized clients, and objective indices such as x-rays, results of testing, hospital admissions/readmissions/discharges, etc. 13
Data entry
Once cases were closed, practitioners submitted them to the data team for review and processing. Any incomplete data were noted, and clarification from individual practitioners was sought. All cases were coded for deidentification and included a practitioner code as well as practitioner location (country and state) before being extracted to Excel. Deidentified data were uploaded to an HHN portal and subsequently shared with additional data-collection projects including American Institute of Homeopathy, Clinical File Collection and National University of Natural Medicine (Helfgott Research Institute), and others.
Sample
The audit sample includes clinical data from March 23, 2020, to August 23, 2020 (Table 1).
Audit Sample
The final sample for analysis resulted after a process of data cleaning which included removal of duplicates, cross-checking for accuracy of data entry, and adding missing data from case notes. Many factors—both predicted and unforeseen—impacted data inclusion and exclusion criteria in this study, and these factors have evolved over the course of the pandemic as more definitive information became known. For example, in the early days of the pandemic, widespread limitations to testing hindered diagnostic confirmation—especially in situations without known point of exposure. As testing became more available, the questionable reliability of tests14–16 muddied clear diagnoses, as did questions about immunity, reinfection, and the continually emerging array of symptoms and body systems impacted by the virus. Individuals whose symptoms were determined to be of chronic nature or were clearly outside of the COVID-19 cluster of symptoms were referred-out of the HHN initiative for support from other homeopathy practitioners. Practitioners who were a part of the team were also seeing individual COVID-19 cases in their private practices. These cases have not been included in this study to facilitate a clear data sample.
Clinical outcome standards
HHN’s work as a team to deliver homeopathic interventions to individuals with symptoms of positive or probable COVID-19 during the period of this audit was assessed using the following standards:
12
,
15
,
16
Results
Effectiveness
The audit demonstrates that all measures met or exceeded the FOUR standards of effectiveness The first measure (capturing health status relative to COVID illness following intervention) showed that at final contact, 76.2% had a positive outcome: 70% of all clients seeking treatment showed full recovery and 6.3% made partial recovery. Of the clients who sought and received preventative care, 100% remained uninfected throughout the follow-up period of 1 to 2 weeks. The outcome of cases that remained unresolved (21.8%) is unknown because clients either did not reply to initial practitioner contact, changed their mind about homeopathic care, recovered before intake, or fell out of contact for an unknown reason with the practitioner before resolution was known. The second measure of effectiveness was degree of recovery following homeopathic intervention using a 5-point Likert Scale. It showed a large majority of clients (74.4%) with a positive outcome (resolved 69.2%, much better 5.2%) compared with less desirable outcomes (unresolved 2%, worse .3%). A third measure of effectiveness is a homeopathy discipline-specific case management item assessing the response to individual remedy prescriptions. The results of our sample of 238 clients who received a distributed total of 986 remedy recommendations and were seen to the close of the case show that 83.4% had a positive remedy response. Fewer showed no improvement (14.4%), and some had a negative reaction to individual prescriptions (2.3%). The fourth measure of effectiveness considered speed of resolution of symptoms. The majority of cases were resolved in under 21 days from first intervention (74.7%), and of those, 29.2% were resolved in under 5 days. This finding compares favorably to the only study found which looked at symptomatic nonhospitalized adults returning to their prior state of health within 2–3 weeks after testing. 18 These results show a positive rate of improvement compared with recovery time of non-treated COVID-positive individuals. The HHN standard of a measurable positive outcome in reduction in or recovery of COVID-19 symptoms following the homeopathic intervention was met in every measure: individual remedy prescriptions (83.4% positive), final outcome after intervention (76.2% positive), degree of recovery following homeopathic intervention (74.4%), and speed of resolution of symptoms under 21 days of first intervention (74.7%) (Table 2).
Effectiveness of Intervention
Safety
Results collected relating to safety showed HHN’s clinical interventions met the standard of having minimal medically adverse reactions during the audit period. Standards for medically adverse reactions included hospitalization or death following the homeopathic intervention. Of the four clients who were hospitalized at first and final contact, none was able to receive the prescribed homeopathic remedy while in isolation at the hospital. Similarly, the sole client who died while in hospital was unable to receive and take the recommended remedy. Two clients were able to receive remedies while in the hospital and were later released with full recovery.
Efficiency
A review of efficiency of the HHN administrative team as well as systems for processing client requests and practitioner assignment shows high levels of efficiency. The time from form submission to first consultation and remedy recommendation met the goal of being consistently under 48 h: 94.9% of cases were given remedy recommendations within 24 h (9.4%) or less (85.5%). This high number of same-day consults speaks to the efficiency of the administrative systems as well as the availability of practitioners. The number of consultations is another measure of how the available team resources are used to the best advantage. Consultations are counted as: any client exchange with a practitioner which includes calls, emails, and texts. The large majority of cases were resolved in five or less consults (73.2%). There was no clear correlation found between days ill before intervention and length of time between first intervention and resolution; in other words, not all clients with the longest time to resolution (5.6% in range of 51–107 days) were ill long before intervention, and conversely, some clients who sought treatment early in their illness did not resolve quickly (Table 3).
Efficiency of Intervention
Appropriateness
The form and level of interaction and care provided by the administrative team and practitioners were found to be largely appropriate based on several indicators. First, positive recovery rates were found among clients who had been turned away from hospital care due to capacity constraints during a time when some hospitals could only admit patients needing ventilators or intubation. Second, the demand for care with HHN during the audit period was high despite no formal outreach or promotion of the services. Following this point, the third indicator is the number of requests that were referred out for care elsewhere. Of the 573 requests, 184 were referred out (15%) when the complaints did not match the focus of the team—for acute care with symptoms and etiology which were evidently not COVID-related and for individuals needing care for chronic complaints.
Accessibility
A review of accessibility reveals that an adaptable infrastructure allowed for flexibility in systems and data capture and cost of care. For example, when care was requested from a low technology-using community, an HHN phone line was set up and monitored by a volunteer who took audio-recorded consent and manually entered initial case/demographic information. Practitioners managed these cases by phone only. To serve requests from non-English speaking clients, consultations were also offered in Spanish, French, and Hebrew. Many clients noted that they were impacted financially due to the pandemic. As a 501c3 charity, HHN provided care free of charge with a suggestion for donation by those who were able, making this a critical point of access for the service. Taken together, the online and phone systems indicate a high level of accessibility.
A wide range of individuals sought care by the HHN team for COVID-related symptoms. The majority identified as female (64%), hailed from the United States (96.7%), and were between the ages of 31–45 (40.3%). There were 54 pediatric cases and 246 adult cases, with an average adult age of 45 years. The large majority sought care for symptom management (97%) as opposed to preventative care (3%). 42% reported using other conventional prescriptions or over the counter medications before care by HHN, the most common being tylenol (27.6%) and ibuprofen (10.2%). Of 126 clients reporting preexisting conditions, 24 reported asthma (19%), followed by 17 who reported hypertension (13.5%). COVID-19 status at intake showed a range with the majority falling between suspected COVID-positive due to symptoms (59%), tested COVID-positive (19%), and COVID-positive due to known exposure (11%). A large majority were not currently working with a homeopath at the time of care (68%). Likewise, a majority reported not using other modalities or practitioners for their current acute condition (59%) (Table 4).
Client Demographics
Discussion
This study examines the merits of the initiative considering effectiveness, safety, efficiency, appropriateness, and accessibility of care in telehealth interventions in an out-patient, individualized homeopathy clinical setting for 305 individuals with symptoms of positive or probable COVID-19 by a team of professional homeopaths.
In relation to the effectiveness of the service, this study showed effectiveness of intervention through its positive outcomes—as measured by degree of recovery (74.4% positive outcome) and individual homeopathic remedy response (83.4% positive response). Following published clinical studies showing the efficacy of homeopathic intervention in acute illness,31,32 our audit measures of effectiveness looked for this evidence of positive effect to bear out in practice. Given the lack of antiviral therapies recommended for individuals with COVID-19 who are not hospitalized 17 during the audit period, and the significant—though falling—mortality rates of patients with severe symptoms needing hospitalization, 33 the evidence of need for effective alternative outpatient care among clients with mild to moderate symptoms is demonstrated. The implications of this initial audit show promise for homeopathy to help address this gap in epidemic care.
From the guiding questions used by our team, speed of recovery remains an important and dynamic indicator of clinical effectiveness for both conventional and CM practitioners. Published averages for length of illness from COVID-19 for mild–moderate cases tend to be 1–2 weeks and 6 weeks or longer for severe cases. 34 It is also estimated that 20% to 50% of patients continue to face health challenges after being discharged from the hospital.35,36 Of the cases in this audit which resolved between 51 and 107 days, some were also ill for a significant amount of time before treatment. Conversely, some clients who sought treatment early in their illness did not have resolution quickly. This wide range in time to resolution is likely attributable to many factors, some that have not yet been fully studied or identified and deserve further investigation. Some factors may include preexisting conditions, use of high potency and/or combination homeopathic remedies before seeking care at HHN, level of compliance (including following remedy dosing instructions and timely updates to practitioners), practitioner use of second-choice remedies due to lack of availability of first-choice remedies, pattern of relapsing symptoms in COVID-19, and the emerging pattern of quasichronic, postviral syndrome. 37
In relation to safety and effectiveness, none of the clients in the sample who took prescribed remedies needed hospitalization following the intervention, and none died following use of the homeopathic intervention. The relatively small number of negative reactions to individual remedy prescriptions (2.3%) is not considered a medically adverse reaction; rather, from the perspective of homeopathic philosophy, they represent minor, temporary aggravations to existing symptoms, and can be a part of the healing process. While these HHN cases do imply effectiveness regarding safety of homeopathy during the COVID-19 pandemic, the authors suggest that further research into standards of safe care in times of large-scale integrative healthcare needs is warranted.
In relation to accessibility and appropriateness of the service, an under researched challenge was identified by the HHN team, namely, timely access to remedies during a public health crisis. It was observed in the first months of the pandemic in the United States, that pharmacies dispensing homeopathic remedies became overwhelmed by orders from nonprofessional users, restricting access to professionals and impacting the timely identification of genus-remedies (here defined as a small cluster of homeopathic remedies understood to address the whole pattern of the epidemic disease as if it affects one person.).3,7,38 In addition, a review of the accessibility of the service reveals that the same adaptive and dynamic features of the HHN initiative supported positive clinical outcomes and satisfactory data collection. A consequence of the pandemic has been the emergence of a clear and urgent need has arisen for diversified, agile, and accessible health support modalities, especially given the long-term nature of this pandemic challenge. 39
Considerations around appropriateness of care delivered by HHN practitioners were confounded on many fronts, especially in the early days of the pandemic when hospitals were full and out-patient treatments not yet available. While HHN practitioners were instructed to refer high-risk clients and clients experiencing moderate to severe symptoms, to seek conventional care, the reality was that HHN saw clients who were denied conventional care, who refused conventional care, who had partial recovery from hospital stays, and who used homeopathic treatment while hospitalized. In areas that had been hardest hit with early cases, especially in New York City, some clients reported being refused by ambulances and turned away from hospitals. It is possible that, given that the conventional medical system was stretched to its limits in many localities during the dates of this audit, 40 more people were likely motivated to try CM approaches than would have otherwise used them under different circumstances. The HHN audit provides insights into the ways in which homeopathy is being used acutely in our sample, given the low number of people with existing homeopaths (19%). The majority of clients were not using other modalities/practitioners beyond homeopathy for their current acute condition (59%), and less than half (42%) were currently taking conventional medications while ill. This insight provides some questions for further research into the prevalence and use of homeopathy in what is in general a sparsely researched area 41 and how consumers of homeopathy both expand their scope of medical care sought in acute illness and integrate their treatments with other CM and conventional approaches.
Limitations
In this study, data analysis was impacted by several factors, including the complication of working with unknown clients, making it sometimes difficult to clearly distinguish between an individual’s acute and chronic state of health, a clinical feature that is important in the delivery of homeopathic medicine. Additional limitations consisted of clients’ difficulty getting access to COVID-19 tests, limits to testing reliability, and client lack of familiarity with homeopathy. In the first month of the work, the HHN practitioners became familiar with how quickly a client’s symptoms could change and their health status seriously decline. In some cases, timely access to first-choice remedies became a challenge with practitioners reporting second-choice, more easily available remedies being taken by clients while waiting for the more indicated remedy to be ordered or sourced locally. These limitations also point to additional research questions, such as if homeopaths sometimes recommended a second-choice remedy due to availability yet still had high rates of effectiveness and recovery in those cases, to what extent could this lead to an underestimation of what more consistent use of first-choice remedies might have produced in individual cases.
Given the very wide range of HHN clients’ familiarity with homeopathy, it is not surprising that 22% of final intervention outcomes are unknown due to lack of client compliance during care, including: lack of client response to initial contact by the practitioner following case assignment-often in the same day as request submission, as well as remedy and follow-up appointment compliance. These compliance challenges raise questions related to appropriateness of care for the individuals using HHN. It is possible that for some of these nonresponsive individuals new to homeopathy that their initial request may have been driven by a sense of urgency for help navigating frightening or severe symptoms or made at the behest of a family member or friend more familiar with homeopathy. As a consequence, this study highlights an area of research currently absent in homeopathy, pertaining to client compliance in outpatient telehealth acute care. Some studies in conventional medicine show high levels of compliance in use of telehealth monitoring of out-patient care through hotlines 42 and the use of connected devices, especially among lower-income patients. 43 In these studies, no significant difference was found between telehealth and nontelehealth groups in readmission and compliance measures, 44 perhaps indicating an important place for telehealth to address a gap in care in the context of overrun emergency facilities.
Conclusions
Notwithstanding these important limitations, this study provides insights into the effectiveness, accessibility, efficiency, appropriateness, and safety of homeopathy in helping individuals recover from symptoms of positive or probable COVID-19. The clinical audit of 5 months of data shows that the work of the HHN team of professional homeopathy practitioners has made a positive impact on the health of the 305 individuals who received acute care. The HHN standards of positive intervention outcome were met in every measure: individual remedy prescriptions (83.4% positive), final outcome of intervention (76.2% positive), degree of recovery following homeopathic intervention (74.4%), and speed of resolution of symptoms under 21 days of first intervention (74.7%). Consistently positive outcomes, ease of access for a range of users, safety of the interventions, efficiency of care and resources, and most importantly, a high rate of improvement and resolution of symptoms are encouraging results for an audit of such a new and quickly formed initiative. Additional audit findings highlight significant known and emerging areas warranting further research including patterns of compliance and uptake of CM and homeopathy in particular during pandemic/global health crises.
Footnotes
Authors’ Contributions
P.P. processed the experimental data, performed the analysis, drafted the article and designed the figures (lead) and designed the methodology (equal). A.G. supervised the work (lead), designed the methodology and aided in interpreting the results and worked on the article revision (equal). D.S. contributed to review and editing the article (equal). All authors discussed the results and commented on the article: P.P., A.G., D.S.
Author Disclosure Statement
No competing financial interests exist.
Funding Information
This study was funded by donations to HOHM Partners and to Homeopathy Help Network by clients and community members.