Keywords
homeopathy - data collection - clinical data - rubrics - India
Introduction
Homeopathy, a widely used treatment choice worldwide,[1] utilizes highly diluted and potentized medicines to stimulate the body's healing
mechanisms. With nearly 200 million users globally[2] and a significant following in India,[3] where it is preferred alongside other AYUSH therapies,[4] there is a clinical environment that is conducive to integrating homeopathy into
mainstream health care.[5]
[6] However, despite its popularity and positive impact, the scientific community frequently
challenges its validity.[7]
[8] To address these claims about its clinical impact and generate quality research
evidence, systematic collection, compilation and digitalization of data recordings
at health care centers is crucial. By observing patterns and trends of data generated
at clinics, the usage and applicability of homeopathy can be more precisely understood.
Clinical trials can assess the efficacy, safety and cost-effectiveness of homeopathic
medicines, whilst data collection studies, which are more representative of usual
care, have their own relevance in understanding key aspects of epidemiological and
clinical data.[9] Nevertheless, real-world data collection is susceptible to various biases, such
as selection bias (errors in participant selection), information bias (mis-classification
of data), recall bias (selective recollection), centripetal bias (the reputation of
certain clinicians and institutions cause individuals with specific disorders or exposures
to gravitate toward them) and detection bias (unequal event capture)—unlike randomized
controlled trials that control such issues—but these biases can be mitigated through
appropriate data collection tools and study methods.[10]
[11]
[12] The use of artificial intelligence-based data collection tools has begun to address
these concerns to some extent.[13]
[14] In turn, data collection software itself can introduce biases, such as practitioner's
confirmation bias (selecting symptoms indicating a medicine for which he or she has
an intuitive preference) and repertorization bias (use of varied and sometimes unvalidated
repertorization software, and in a different manner by different practitioners). In
one study, confirmation bias, lowering of symptom threshold, and keynote prescribing
were identified as the most important sources of bias.[15]
Altogether, at present, there is insufficient literature about the variations within
individual data collection techniques and, hence, in the outcomes as well. The current
study focuses on collecting data from patients receiving only homeopathic treatment
at outpatient clinics associated with homeopathy research units/institutes of the
Central Council for Research in Homoeopathy (CCRH) across several Indian states. These
clinics had faced challenges with manual and non-uniform clinical data recording styles,
making it difficult retrospectively to analyze the recorded data for research purposes.
The present study was thus planned to digitally record such data, and it involved
research officers who collected and managed clinical data generated from the outpatient
departments (OPDs) of the clinics. An online database program was used for prospective
data collection.
Data collection studies related to homeopathy have been conducted in the past. These
have been instrumental in understanding patients' profiles and their morbidity trends,
such as a patient benefit survey conducted in 2001 at the Liverpool Regional Department
of Homoeopathic Medicine in the United Kingdom.[16] The survey included data from 1,100 patients and utilized the Glasgow Homoeopathic
Hospital Outcome Scale, a 9-point Likert-like scoring system that is now referred
to as Outcome Related to Impact on Daily Living (ORIDL), to assess outcomes. The study
also reported patient demographics, prevalent disease conditions, follow-up visits,
and conventional medication usage. However, there was a lack of reporting regarding
the specific homeopathic medicine prescribed and the process of repertorization. Another
study in the UK evaluated the health changes observed in routine homeopathic care
for 6,544 patients over 6 years at the Bristol Homeopathic Hospital.[17] The main outcome was measured with a 7-point Likert-type scale. A pilot data collection
in all five homeopathic hospitals in the UK over a 4-week period collected data from
1,797 patients pertaining to their demographics, main medical complaints, patient-reported
change in health using ORIDL and complementary medicine usage.[18] Other studies have used varying means of data collection, such as a database, Excel
spreadsheet or hard-copy version of a spreadsheet, or standardized paper-based questionnaires.[19]
[20] There have been several other initiatives as well for homeopathy data collection
in Europe.[21]
[22]
Whilst these studies have shed light on the characteristics of homeopathy users in
different locations worldwide, further exploration of these aspects, particularly
in India, is necessary. The current study aimed to understand the patients' profiles
and ailments treated at the homeopathic outpatient departments (OPDs), while gathering
preliminary information on the repertorization process for prescription. The principal
objective of the study was to collect clinical data from OPDs across India, record
patient-reported outcomes (assessed using a 6-point Likert-like scale) and identify
the range and preponderance of medical complaints treated with homeopathy. The secondary
objectives were to derive further insights from those real-world clinical data, including
consultation trends and the frequency of the rubrics and medicines used.
Methods
Study Design
This was a multi-center, observational study for which data were collected prospectively
through an online software program, using pre-formatted (repertory-based) symptom
entries and algorithm-based references for prescription. Subsequently, a retrospective
analysis was conducted based on the generated data.
Ethics-Related Matters
All procedures of data collection were in accordance with Good Clinical Practice guidelines
and ethical standards as per the Declaration of Helsinki of 1975, as revised in 2013.[23] The study was approved in the 22nd meeting of the Institutional Ethical Committee
of CCRH [1-3/2019-20/CCRH/Tech./22nd EC/536, dated 18th June 2019] and was registered
with the Clinical Trial Registry of India (CTRI/2019/11/022068) on 20th November 2019.
Study Setting
The study was conducted at the OPDs of 14 institutes/units of CCRH, India: Drug Standardization
Unit, Hyderabad; National Homoeopathy Research Institute in Mental Health, Kottayam;
Anjali Chatterjee Regional Research Institute of Homoeopathy, Kolkata; D P Rastogi
Central Research Institute of Homoeopathy, Noida; Regional Research Institute, Guwahati;
Regional Research Institute, Imphal; Regional Research Institute, Navi Mumbai; Clinical
Research Unit, Siliguri; Regional Research Institute, Agartala; Clinical Research
Unit, Puducherry; Clinical Research Unit, Tirupati; Homoeopathic Drug Research Institute,
Lucknow; Clinical Research Unit, Gangtok; Regional Research Institute, Puri ([Supplementary Fig. S1] [map of study sites], available in the online version). These are homeopathic clinics
where patients visit for homeopathy treatment for one or more conditions and, unless
advised so, they continue with their ongoing conventional medications for other co-morbidities.
The data were collected for 1 year, spanning from November 20th, 2019 to November
19th, 2020, including the follow-up visits.
The investigators for this study are research officers stationed at each research
center, all of whom are post-graduate homeopathic physicians with a minimum of 5 to
10 years of professional experience. They were trained in the study protocol and data
collection software, thus ensuring consistency of data entry across research centers.
Data Collection
An internet-based software program, Vithoulkas Compass (VC), was used for electronic
data collection, due to the feasibility of its use as per the requirements of this
study. All recordings in the VC software were done under unique patient serial numbers.
The investigators recorded patients' symptoms, including main complaints, physical
and mental generals, and other characterizing symptoms during the initial visit. They
recorded in the software every notable complaint reported by the patient and reached
a diagnosis. During data analysis, these diagnoses were categorized as per their respective
International Classification of Diseases 11th Revision (ICD-11) codes.[24] However, prescriptions were based on repertorial suggestions resulting from totality,
which included both pathological and individualizing symptoms. Each symptom was recorded
along with its degree of intensity as assigned to it by the prescriber, at the baseline,
and then in every follow-up: this value ranged from 0 to 4 ([Supplementary Fig. S2], available in the online version).
During the follow-up visits, an assessment form was also filled in to record the treatment
outcome, which was the change in the patient's state in comparison with the initial
appointment. This improvement assessment form, embedded in the software, facilitated
outcome assessment of each case during the follow-up, in comparison with the baseline
consultation. The range of improvement based on the prescriber's assessment for each
case varied from large improvement to moderate, small or no improvement, as well as
“Remedy did not act as expected” and “‘Not sure” ([Table 1]).
Table 1
Prescription feedback
Effect
|
Interpretation
|
Large improvement/effect
|
Significant improvement or elimination of the chief complaint.
Marked improvement of the general condition.
Strong reaction with resurfacing of old symptoms.
|
Moderate improvement/effect
|
Moderate improvement of the chief complaint(s) and general condition.
Clear reaction to the remedy, possibly prolonged, or resurfacing of old symptoms.
|
Small improvement/effect
|
Small improvement of some symptoms.
Light reaction to the remedy.
No general condition improvement.
|
No effect
|
Remedy did not seem to have any effect.
|
Remedy did not act as expected
|
Sudden new turn of events that the remedy is not expected to have/precipitate.
|
Not sure
|
Effect of remedy cannot be ascertained from the outcome.
|
The extracted data were anonymized with registration numbers, stored in Microsoft
Excel spreadsheets and used to generate pivot tables for analysis.
The software stored all sorts of patient details: registration, chief complaints,
case totality, repertorization, prescriptions, follow-ups and outcome assessments.
The investigator had the flexibility to choose from various prescription methods,
including flat repertorization, numerical analysis, and other forms of differential
analysis (repertorization based on main keynotes, small remedy symptoms, case-specific
differential symptoms and main differential symptoms). The software also played a
facilitating role in data storage, retrieval and simplifying repertorization. It integrated
an internet search, providing access to homeopathy-related websites and also Materia
medicae by Boericke, Clarke, Allen and Kent. It is crucial to acknowledge that such
features might influence remedy selection and case outcomes. The software served as
a comprehensive tool for record-keeping of cases, decision-making in prescriptions,
addressing biases and analyzing data.
Participants
The participants comprised patients of either sex, attending homeopathic OPDs and
not enrolled in any research studies, a regular activity of these centers. Informed
consent was obtained from each patient to utilize his or her anonymized data for analysis
and publication.
Variables
The data were extracted under the following categories: case number, event number,
event type (analysis, prescription, follow-up), event date, age, sex, case notes/main
medical complaint, rubrics with intensities (0 to 4), prescribed remedy, and clinical
outcome assessment. The data were further categorized under the following headings:
number of follow-ups, symptom totality, morbidity profile (ICD-11 classification),
prescribed medicines, most common rubrics, rubrics for the top three prescribed medicines,
and clinical outcome assessment (assessed using the 6-point Likert-like scale that
is embedded in the VC software—see above).
Broad groupings of the data were made for quantitative variables, such as age (categorized
into children, adolescents, young adults, middle-aged, and older adults), sex, number
of follow-ups, and morbidity profiling. The complaints were categorized as per the
ICD-11 codes, used for classifying disease data: this was done because ICD coding
is contemporary and easily integrated with electronic health records, as well as being
generated from the software used in the present study. The commonly used rubrics and
medicines were identified through pivot tables in Excel and categorized further to
gain insights into individual and overall prescription patterns.
Bias
Experienced, post-graduate research officers trained for data collection recorded
patient data in the software to reduce bias. To ensure consistency, online meetings
with all the doctors were held regularly. The software also played a role in addressing
confirmation bias that results from the practitioners' intuitive preference for a
medicine, by producing a medicine chart based on non-intuitive, symptomatology-based
scoring of remedies. However, bias related to the repertories or rubrics identification
could have existed. The necessity of entering the intensity of every symptom/rubric
during every follow-up could have helped in minimizing this bias to some extent.
Statistical Methods
For statistical analysis, Microsoft Excel was used to generate pivot tables, summarizing
the extensive data into user-friendly tables and graphs. All incomplete entries were
filtered out to maintain a fixed sample size. Trends were identified and visually
represented using bar graphs and tables.
Results
A total of 2,811 patients visited during the study period, out of which 2,468 were
new patients and 343 were solely follow-up cases. Among the new patients, the prescriptions
of 2,200 individuals were obtained using the software. The rest of the entries did
not mention the prescribed medicine in the software. Of those prescribed, 2,172 entries
showed homeopathic medicines as the first prescription, while the other 28 showed
that placebos were given as the first prescription. For those 2,172 patients, a total
of 3,491 prescriptions were recorded (including follow-ups). Outcome assessment forms
were available for 868 patients, based on one or more follow-ups, thus totaling 1,628
follow-up entries ([Fig. 1]). The number of follow-ups of each patient varied from 1 to 13, with 13 follow-ups
being the maximum recorded for one patient, as depicted in [Fig. 2].
Fig. 1 Study flow chart.
Fig. 2 Trend of follow-up distribution (n = 868).
Demographic Data
Out of the 2,811 patients whose entries were registered in the software, 56.10% were
females (n = 1,577) and 37.35% were males (n = 1,050); gender was not recorded for 6.55% (n = 184) patients. The highest patient count belonged to the age group 20–49 years,
while older patients (above 60 years) were the least represented ([Fig. 3]). Age was not recorded for 273 patients.
Fig. 3 Distribution by age (n = 2,811).
Morbidity Profile
The medical complaints were classified according to the ICD-11 system and further
grouped into 28 categories of this schemed coding. Some category names were modified
for readability (e.g., “Infections of the foetus or newborn” to “Infections of newborn”).
Complaints not falling into any of the 28 categories were mentioned as “Others”. Complaints
of the musculoskeletal system were recorded as the highest, followed by skin and respiratory
disorders ([Fig. 4]). The top 25 specific complaints are detailed in [Table 2], with joint pain being the most reported, followed by dermatitis/eczema, low back
pain, cough and headache, consistent with the system-wise classification trends.
Table 2
Morbidity profile (n = 2,811)
No.
|
Disease condition
|
ICD-11 disease code
|
No. of patients
|
Gender
|
Age (in years)
|
No. of new patients
|
No. of follow-ups
|
Male
|
Female
|
Unknown
|
Age ≤30
|
Age >30
|
1
|
Pain in joint
|
ME82
|
204
|
56
|
144
|
4
|
36
|
168
|
177
|
136
|
2
|
Dermatitis or eczema, unspecified
|
EA8Z
|
137
|
66
|
60
|
11
|
72
|
65
|
122
|
90
|
3
|
Low back pain
|
ME84.2
|
129
|
39
|
78
|
12
|
28
|
101
|
110
|
91
|
4
|
Cough
|
MD12
|
98
|
34
|
55
|
9
|
50
|
48
|
90
|
52
|
5
|
Headache, not elsewhere classified
|
MB4D
|
74
|
20
|
46
|
8
|
28
|
46
|
60
|
51
|
6
|
Asthma
|
CA23
|
72
|
29
|
34
|
9
|
28
|
44
|
69
|
21
|
7
|
Hemorrhoids
|
DB60
|
68
|
32
|
33
|
3
|
19
|
49
|
56
|
53
|
8
|
Type 2 diabetes mellitus
|
5A11
|
61
|
37
|
23
|
1
|
7
|
54
|
58
|
23
|
9
|
Localized abdominal pain
|
MD81.1
|
54
|
16
|
33
|
5
|
25
|
29
|
48
|
44
|
10
|
Polycystic ovary syndrome
|
5A80.1
|
51
|
0
|
50
|
1
|
42
|
9
|
42
|
17
|
11
|
Allergic rhinitis
|
CA08.0
|
47
|
22
|
23
|
2
|
25
|
22
|
43
|
29
|
12
|
Acute nasopharyngitis
|
CA00
|
45
|
18
|
26
|
1
|
24
|
21
|
41
|
24
|
13
|
Osteoarthritis, unspecified
|
FA0Z
|
44
|
16
|
28
|
0
|
3
|
41
|
26
|
39
|
14
|
Seropositive rheumatoid arthritis
|
FA20.0
|
42
|
4
|
30
|
8
|
21
|
21
|
40
|
2
|
15
|
Constipation
|
ME05.0
|
41
|
17
|
23
|
1
|
10
|
31
|
37
|
37
|
16
|
Gastroenteritis or colitis without specification of infectious agent
|
1A40.Z
|
37
|
22
|
14
|
1
|
17
|
20
|
34
|
9
|
17
|
Hypothyroidism
|
5A00
|
34
|
6
|
27
|
1
|
11
|
23
|
28
|
17
|
18
|
Urinary tract infection, site not specified
|
GC08
|
34
|
14
|
19
|
1
|
17
|
17
|
30
|
11
|
19
|
Acne
|
ED80
|
33
|
10
|
22
|
1
|
30
|
3
|
29
|
9
|
20
|
Gastritis
|
DA42
|
33
|
8
|
24
|
1
|
11
|
22
|
25
|
26
|
21
|
Essential hypertension
|
BA00
|
31
|
11
|
19
|
1
|
5
|
26
|
27
|
21
|
22
|
Dermatophytosis, unspecified
|
1F28.Z
|
31
|
14
|
16
|
1
|
13
|
18
|
28
|
10
|
23
|
Common warts
|
1E80
|
30
|
14
|
14
|
2
|
14
|
16
|
26
|
13
|
24
|
Functional dyspepsia
|
DD90.3
|
30
|
20
|
8
|
2
|
5
|
25
|
30
|
7
|
25
|
Anxiety
|
MB24.3
|
30
|
11
|
17
|
2
|
11
|
19
|
28
|
8
|
26
|
Others (357 diseases)
|
|
1,321
|
513
|
712
|
96
|
584
|
737
|
1,164
|
788
|
Grand total
|
2,811
|
1,049
|
1,578
|
184
|
1,136
|
1,675
|
2,468
|
1,628
|
Fig. 4 System-wise distribution of main medical complaints (n = 2,811).
Rubrics and Prescriptions
The frequently used rubrics for the most prescribed medicines were analyzed. “Desire
for sweets” was the most common rubric, followed by “Desire for spices” and “Thirstless”
([Fig. 5]). Among the prescribed medicines, Sulphur ranked the highest, followed by Rhus toxicodendron, Natrum muriaticum and Nux vomica ([Table 3]). Sulphur was predominantly prescribed for skin disorders, Rhus toxicodendron for musculoskeletal issues, and Natrum muriaticum for genito-urinary disorders. The most frequently used rubrics of the top three medicines
are shown in [Fig. 6]: interestingly, the rubrics “Desire for sweets” and “Constipation” were covered
prominently by each of these three medicines.
Table 3
Distribution of top 20 homeopathic remedies prescribed across broad diagnostic groups
(n = 3,491)
No.
|
Prescribed remedy
|
Mu
|
Sk
|
R
|
D
|
GU
|
ENM
|
Nr
|
M
|
C
|
N
|
E
|
In
|
F
|
Sl
|
B
|
V
|
AI
|
P
|
IF
|
O
|
Grand total
|
1
|
Sulph.
|
54
|
128
|
12
|
60
|
10
|
12
|
13
|
2
|
4
|
3
|
3
|
|
|
|
|
|
2
|
|
|
16
|
319
|
2
|
Rhus-t.
|
199
|
16
|
14
|
11
|
2
|
4
|
9
|
1
|
1
|
|
1
|
6
|
|
|
|
|
|
|
|
1
|
265
|
3
|
Nat-m.
|
26
|
29
|
17
|
26
|
36
|
16
|
27
|
4
|
10
|
2
|
|
|
1
|
2
|
1
|
1
|
|
|
|
3
|
201
|
4
|
Nux-v.
|
33
|
9
|
23
|
75
|
16
|
|
3
|
3
|
4
|
2
|
|
|
|
1
|
|
|
|
|
|
2
|
171
|
5
|
Ars.
|
8
|
26
|
77
|
24
|
12
|
5
|
4
|
5
|
2
|
|
|
|
|
1
|
|
|
|
|
|
4
|
168
|
6
|
Puls.
|
38
|
12
|
17
|
33
|
22
|
18
|
5
|
1
|
8
|
|
6
|
|
2
|
|
|
1
|
|
1
|
|
|
164
|
7
|
Phos.
|
14
|
12
|
53
|
19
|
13
|
21
|
6
|
9
|
3
|
5
|
1
|
|
|
|
4
|
|
|
|
|
4
|
164
|
8
|
Lyc.
|
17
|
10
|
16
|
50
|
23
|
9
|
6
|
1
|
10
|
3
|
2
|
3
|
|
1
|
|
1
|
|
|
|
8
|
160
|
9
|
Calc.
|
20
|
16
|
34
|
23
|
13
|
11
|
6
|
4
|
|
2
|
|
|
|
|
|
|
2
|
2
|
1
|
5
|
139
|
10
|
Sep.
|
14
|
36
|
5
|
9
|
17
|
7
|
7
|
|
4
|
1
|
|
|
1
|
1
|
|
|
|
|
|
1
|
103
|
11
|
Sil.
|
11
|
32
|
12
|
11
|
2
|
1
|
3
|
2
|
|
|
4
|
1
|
|
|
|
|
|
|
|
7
|
86
|
12
|
Bry.
|
42
|
2
|
13
|
10
|
5
|
3
|
7
|
|
1
|
|
|
|
|
|
|
|
|
|
|
3
|
86
|
13
|
Merc.
|
3
|
14
|
14
|
19
|
7
|
2
|
1
|
1
|
|
1
|
1
|
|
|
|
|
|
|
|
|
|
63
|
14
|
Thuja
|
6
|
15
|
6
|
10
|
12
|
3
|
|
|
|
6
|
|
|
|
|
|
|
|
|
|
3
|
61
|
15
|
Hep.
|
|
9
|
33
|
3
|
4
|
|
|
|
|
|
1
|
1
|
|
|
|
|
|
|
|
4
|
55
|
16
|
Calc-p.
|
14
|
5
|
15
|
4
|
5
|
|
4
|
|
2
|
3
|
|
|
|
|
|
|
|
|
|
2
|
54
|
17
|
Graph.
|
4
|
21
|
3
|
3
|
5
|
6
|
1
|
|
3
|
|
|
|
|
|
|
|
|
|
2
|
4
|
52
|
18
|
Caust.
|
16
|
6
|
4
|
2
|
|
1
|
11
|
|
2
|
|
2
|
|
|
|
|
|
|
|
|
2
|
46
|
19
|
Nit-ac.
|
1
|
9
|
4
|
20
|
5
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
43
|
20
|
Arn.
|
22
|
2
|
|
6
|
3
|
|
2
|
1
|
|
|
|
5
|
|
|
|
|
|
|
|
1
|
42
|
|
Total
|
542
|
409
|
372
|
418
|
212
|
119
|
115
|
34
|
58
|
28
|
21
|
16
|
4
|
6
|
5
|
3
|
4
|
3
|
3
|
70
|
2,442
|
Abbreviations: AI, autoimmune disorders; B, blood-related disorders; C, circulatory
system; D, digestive disorders; E, ear or mastoid process; ENM, endocrine, nutritional
or metabolic diseases; F, feeling ill or fatigue; GU, genitourinary disorders; IF,
infections of newborn; In, injuries; M, mental disorders; Mu, musculoskeletal system;
N, neoplasms; Nr, neurological disorders; O, others; P, pregnancy, childbirth or the
puerperium; R, respiratory diseases; Sk, skin diseases; Sl, sleep disorders; V, visual
system.
Fig. 5 Distribution of most common rubrics used for prescription (n = 3,491).
Fig. 6 Prevalence of most frequent rubrics of top three prescribed medicines (n = 3,491).
Outcome Assessment
A detailed patient outcome assessment was done on every follow-up to compare the patient's
present state with the baseline consultation. Of the 868 patients who visited for
at least one follow-up, 86% witnessed some sort of symptom relief with the homeopathic
treatment (11% reported large improvement, 35% moderate and 40% reported small improvement);
14% witnessed no improvement. There were no responses for the categories “Remedy did
not act as expected” or “Not sure”.
Discussion
The present study reports the findings of data collection conducted in a routine homeopathic
outpatient setting using software for case recording and data collection. The demographic
data of the patients, such as predominantly younger age group of patients[25] and a higher proportion of female patients than male patients,[16]
[18]
[21] are comparable with the available literature. Whilst above 60-year-olds were the
least represented in the present study, other data collections found the highest frequencies
among the 46 to 60,[16] 49 to 64[17] and 40 to 60[18] years age groups. Such findings suggest that homeopathy users are not limited to
a particular age group and that a wide range of patients utilize homeopathy across
different settings.
Most of the patients had consulted for chronic disease, as was the case in another
study.[16] In particular, the major diagnostic groups in the present study were musculoskeletal
complaints, followed by skin and respiratory disorders, consistent with other studies:
musculoskeletal conditions, followed by dermatological conditions, respiratory diseases,
chronic fatigue syndrome and post-viral fatigue syndrome, gynecological problems,
headaches, psychiatric problems, and gastrointestinal diseases[16]; dermatology, neurology and rheumatology[17]; and eczema, chronic fatigue syndrome, menopausal disorder, osteoarthritis, and
depression.[18] A survey conducted at the OPD of the Royal London Homoeopathic Hospital in the UK
reported that musculoskeletal system problems were the most frequent diagnostic group.[26] Complementary and integrative medicine, as a whole, has also been found to be used
most frequently for neoplasms and musculoskeletal diseases.[20] In the present study, there were few patients with type 2 diabetes mellitus who
were younger than 30 years ([Table 2]); also, male diabetic patients outnumbered female diabetics. These trends are consistent
with observed trends in diabetes epidemiology in India.[27] Polycystic ovary syndrome was also much more prevalent below the age of 30 years,
which is in line with other studies.[28]
Furthermore, in our study, 62% of the consultations were follow-up visits, suggesting
good patient adherence to the treatment; it is notably higher than the 45% reported
in another study.[18] A positive response to homeopathic treatment was recorded for 86% of follow-up cases
in our study. This surpasses the improvement or positive health changes earlier reported
to be 76%,[16] 70%[17] and 50%.[21] Our numbers for large improvement, however, are lower than two of those earlier
studies: 11% compared with 32%[16] and 25%.[17]
This study is the outcome of real-world data analysis from 14 health clinics in different
parts of India. Such pragmatic-setting studies in homeopathy—including in the context
of randomized controlled trials (RCTs)—are far from being numerous.[29] More case reports highlighting responses to homeopathic treatment,[30] as well as clinical trials designed specifically for this therapeutic modality,
are crucial to show the potential of homeopathy.[31] There will always be a divide between the worthiness of RCTs conducted in a controlled
situation in an often homogeneous sample of patients and real-world effectiveness
studies from routine health care in the clinic setting. In particular, it is rightly
argued that placebo-controlled RCTs often are not representative of the patient population
encountered in clinical practice.[9] For observational studies, clinical data collection can be either prospective or
retrospective in design and take place over a long time period: such real-world evidence
has emerged as an important means to understand the utility of medical interventions
in a broader, more representative, patient sample.[9] Thus, real-world data from the homeopathic clinics can be a valuable resource to
understand the usefulness of homeopathy in different settings.
In homeopathic practice, the process of detailed history taking, case analysis and
individualization-based selection of a medicine is an elaborate one. Recording these
details electronically, in a standardized format, can save time, as well as enrich
the homeopathy data pool through retrospective analysis of the recorded data in spreadsheet
or database programs. The database programs are more user-friendly, but pivot-table
analysis in spreadsheets is also gaining popularity for its ease and practicality.
In contrast to the modern methods of data collection, the historic clinical data of
most of the homeopathic clinics in India lie dormant in disconnected, inaccessible
repositories, hindering crucial linkage, analysis and meaningful interpretation.[32] Compared with the old standard practice of recording crucial details on paper cards,
our study implemented a digital data collection system. This shift from unreliable,
fragmented records to a comprehensive, electronic platform streamlined data analysis
and ensured consistency. In addition, the symptoms could be recorded in the form of
repertory rubrics, along with change in their intensity, during follow-ups. Further,
the VC software assisted in repertorization, homeopathic medicine selection, and helped
counter practitioners' bias in prescriptions. These factors highlight the advantage
of digital clinical data recording for future analysis.
Whilst the use of software-based data collection has clear benefits, we also recognize
its potential limitations. First, the fact that VC software is mainly based on Kent's
repertory served as a limitation, since all the cases—whether or not with sufficient
mental or physical generals—were repertorized using this software. Hence, the bias
of repertory selection could not be addressed in the present study. Also, since entries
were based on the software's pre-determined schema, the outcome assessment scale was
not modifiable, thus providing no scope to make it more balanced to reflect clinical
deterioration as well as improvement. Other more accepted outcome assessment scales,
such as ORIDL and MYMOP, could therefore not be used, a limitation that must be taken
into consideration in future data collection studies in homeopathy that use dedicated
software.
Elaborate homeopathy interviews in busy OPD settings may result in incomplete data
recording by doctors, pointing to the likelihood that more complete records would
be obtainable in the in-patient setting. The ICD-11 classification of the disease
in the present study was done retrospectively, which in some cases was difficult when
the diagnosis needed to be supplemented by further details. In addition, possible
confounders such as the absence of standard diagnostic criteria, spontaneous recovery
in acute cases, recall bias of patients, and no record about concurrent conventional
treatments, should be addressed in future work.
Thus, the learnings as well as the findings from this study can be a valuable source
of information for subsequent data collection studies in homeopathy, including growing
a substantive nationwide data inventory for outpatients and in-patients across India.
Conclusion
Homeopathy is prescribed in CCRH outpatient clinics for a wide range of ailments in
people across India, with some degree of clinical improvement in most cases. With
a large-scale systematic data collection such as this, useful information about the
use and clinical value of homeopathy in India can be recorded to build a substantive
nationwide data inventory over time.
Highlights
-
• This data collection study of 2,811 patients was conducted with the aid of internet-based
software in homeopathy clinics across India.
-
• The most common complaints for which patients visited the homeopathic clinics were
musculoskeletal, skin and respiratory problems.
-
• The frequently used rubrics for the most prescribed medicines were analyzed.
-
• Polychrests such as Sulphur, Rhus toxicodendron, Natrum muriaticum and Nux vomica were the most prescribed homeopathic medicines.
-
• A positive outcome of homeopathic treatment was reported by 86% of follow-up patients.