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109]

Original Article

An open‑label prospective observational trial for assessing

the effect of homoeopathic medicines in patients suffering
from gout
Sangita Saha1*, Paulami Sarkar1, Rajat Chattopadhyay1, Subhranil Saha2
1
The Calcutta Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India, 2Independent Researcher

Abstract
Background: Gout is an inflammatory arthritis associated with hyperuricaemia and intra‑articular monosodium urate crystals, resulting in
pain, activity limitation, disability and impact on patients’ quality of life. Objective: The objective of this study was to examine the effects of
individualised homoeopathic medicines in serum uric acid level and quality of life in patients suffering from gout. Methods: A prospective,
single‑arm, non‑randomised, open‑label, observational trial was conducted on 32 adults suffering from gout (diagnosed as per the American
College of Rheumatology–European League Against Rheumatism gout classification criteria) at the Outpatient Department of The Calcutta
Homoeopathic Medical College and Hospital, Kolkata. Serum uric acid level was the primary outcome (baseline vs. 3 months); Gout Assessment
Questionnaire v2.0 (GAQ2; baseline vs. 3 months) and Measure Yourself Medical Outcome Profile v2.0 (MYMOP2; baseline, every month
and up to 3 months) were the secondary outcomes. Intention‑to‑treat sample (n = 32) was analysed in SPSS®IBM® version 20. Results: The
mean age of patients was 47.6 years; the male: female ratio was 5:3. Both serum uric acid level (mg/dl) (7.6 ± 1.4 vs. 6.0 ± 1.5; mean reduction:
1.6, 95% confidence interval [CI] = 1.1, 2.1, P < 0.001, Student’s t‑test) and GAQ2 total score (45.0 ± 9.1 vs. 21.0 ± 14.0; mean reduction:
24.0, 95% CI 19.1, 29.0, P < 0.001, Student’s t‑test) reduced significantly over 3 months. MYMOP2 scores obtained longitudinally at four
different time points also revealed statistically significant reductions (P < 0.001, one‑way repeated measures ANOVA). The most frequently
indicated medicine was Benzoicum acidum. Conclusion: This study, though preliminary, revealed a positive treatment effect of individualised
homoeopathic medicines in alleviating the symptoms of gout and improving the quality of life. More studies like randomised controlled trials
with greater scientific rigour are warranted.

Keywords: American College of Rheumatology–European League against Rheumatism, Gout, Gout Assessment Questionnaire v2.0, Gout
classification criteria, Homoeopathy, Measure Yourself Medical Outcome Profile v2.0

Introduction Community Oriented Program for Control of Rheumatic

Diseases.[4]
Gout is an inflammatory arthritis associated with hyperuricaemia
and intra‑articular sodium urate crystals resulting in painful The presence of monosodium urate  (MSU) monohydrate
joint inflammation  (arthritis). The prevalence of gout has crystals in a symptomatic joint/bursa  (i.e.  synovial fluid)
increased substantially in the past two decades to 2.5% or in a tophus is a sufficient criterion for the diagnosis of
in the UK.[1] and 3.9% in the USA.[2] Modernisation and gout, and does not require further scoring, but its use is often
affluence on lifestyle, including decreased physical activity,
*Address for correspondence: Dr. Sangita Saha,
increased consumption of foods rich in purine, fructose Department of Organon of Medicine and Homoeopathic Philosophy,
and alcoholic beverages and smoking, have been shown to The Calcutta Homoeopathic Medical College and Hospital,
contribute to hyperuricaemia resulting in gout,[3] and thus, 265‑266 A.P.C Road, Kolkata ‑ 700 009, West Bengal, India.
developed countries tend to have a higher burden of gout than E‑mail: [email protected]
developing countries. Its incidence is 2‒6 fold higher in men Received: 20.06.2019; Accepted: 05.12.2019; Published: 27.12.2019.
than in women. The prevalence of gout in India is 0.12% as
per the International League of Nations against Rheumatism, This is an open access journal, and articles are distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 4.0 License, which allows others to
Access this article online remix, tweak, and build upon the work non‑commercially, as long as appropriate credit
Quick Response Code: is given and the new creations are licensed under the identical terms.
Website:
For reprints contact: [email protected]
www.ijrh.org

How to cite this article: Saha S, Sarkar P, Chattopadhyay R, Saha S.

DOI: An open-label prospective observational trial for assessing the effect of
10.4103/ijrh.ijrh_48_19 homoeopathic medicines in patients suffering from gout. Indian J Res
Homoeopathy 2019;13:236-43.

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Saha, et al.: Homoeopathic treatment of gout

restricted to secondary and tertiary care centres. Identification institution  (CHMCH/IEC/13/2018, dated 05  January 2018)
of MSU crystals in a primary care setting is usually not retrospectively. The trial could not, however, be registered
feasible as it requires both expertise in joint puncture and with the Clinical Trials Registry of India due to a retrospective
expensive equipment those are not readily accessible. In approval of the Ethical Committee. Each patient was provided
patients suffering from acute arthritis and in whom synovial with a patient information sheet in local vernacular Bengali
fluid analysis is difficult, the diagnosis of gout flare should language detailing the objectives, methods, risks and benefits
be based on certain suggestive clinical features and the of participating and confidentiality issues. Before enrolment,
serum uric acid level in a primary care setting.[5] The 2015 written informed consent was taken from the patients.
American College of Rheumatology–European League Against
Rheumatism (ACR-EULAR gout classification criteria[6,7]
Inclusion and exclusion criteria
Individuals of either of the sexes of age 18 years and above,
is a standardised and highly specific approach to identify
relatively homogeneous group of individuals who have the who had scored 8 or more in the 2015 ACR‑EULAR gout
clinical entity of gout in a primary care setup. The entry classification criteria, having no unstable psychiatric illness or
criterion requires the occurrence of at least 1 (one) episode other systemic disease and who have not used any medication
of peripheral joint or bursal swelling, pain or tenderness. The in the past 1 month were enrolled. Patients who did not give
domains of this criterion include clinical (pattern of joint/bursa consent were excluded. Case taking was done for each patient
involvement, characteristics and time course of symptomatic in accordance with the standardized homoeopathic principles.
episodes), laboratory  (serum urate and MSU‑negative Cases with manifestation of causes for secondary gout were
synovial fluid aspirate) and imaging (double contour sign on ruled out. All the cases were diagnosed only on the basis
ultrasound or urate on dual‑energy computed tomography and of serum uric acid and clinical assessment. Radiological or
radiographic gout‑related erosion). synovial fluid examination was not done, as those were not
available at the institution. Patients with score more than or
PubMed search revealed total 17,736 studies on gout, of which equal to 8 were included, without the score of the said two
only five used the Gout Assessment Questionnaire  (GAQ) examinations.
and only three studies[8‑10] used Homoeopathy. However, no
study result could be elucidated with GAQ2, Measure Yourself Outcome assessment
Medical Outcome Profile v2.0 (MYMOP2) and Homoeopathy. • Primary outcome  –  Serum uric acid level
As per AYUSH Research Portal, total 21 clinical research (baseline vs. 3 months)
works on gout under AYUSH system were carried out, but of • Secondary outcomes – GAQ2[13] (baseline vs. 3 months)
those, only one was with Homoeopathy. It was a qualitative and MYMOP2 [14]  (baseline, every month and up to
study in which ten individuals presented themselves within 3 months).
5 days of the onset of acute gout and participated in a 15‑day All outcomes were recorded in pre‑designed follow‑up forms;
study period. Serum uric acid levels were tested on day 1 and influence of gout on health‑related quality of life of patients
day 6 to assess hyperuricaemia. Treatment effect was evaluated was assessed through GAQ2 measured at baseline and at the
on days 1, 3 and 6 based on day subjective. This single‑arm, 3rd month. GAQ2 is a disease‑specific patient‑reported outcome
open‑label study generated some promising results in favour measure with 24 items, consisting of 5 different subscales:
of Homoeopathy in treatment of acute gout within 6 days, but gout concern overall, gout medication side effects, well‑being
due to its obvious methodological shortcomings, the results during attack, unmet gout treatment needs and gout concern
can be considered as preliminary only.[11] Thus, literature during attack. Each item of the GAQ2 is rated ‘strongly agree’
on homoeopathic medicines in the treatment of gout with to ‘strongly disagree’, ‘all of the time’ to ‘none of the time’ or
improvement in the quality of life remains insufficient. As the ‘not a bit’ to ‘extremely’ on a 5‑point Likert scale. A higher
existing evidences remain miniscule, at the very first attempt, score denotes a greater impact of disease. It has five domains:
we aimed to generate some preliminary data about any possible gout concern overall, gout medication side effects, well‑being
effects of Homoeopathy in gout in pre–post comparison design, during attack, unmet gout treatment needs and gout concern
to be subjected to explanatory robust trials in future. during attack.
Patients’ responses were assessed through MYMOP2 initial
Methods and follow‑up forms, measured and analysed at baseline,
Setting and design after the 1 st, 2 nd  and 3 rd  months. The most troublesome
A prospective, single‑arm, non‑randomised, open‑label, symptom of gout in each case was recorded as Symptom 1,
observational trial was conducted from November 2017 to the intensity of which was marked by a patient on a 7‑point
April 2018 on 32 adult individuals suffering from gout (as per scale (from 0 to 6, 0 = as good as it can be and 6 = as bad as it
the ACR‑EULAR gout classification criteria) at the Outpatient can be); simultaneously, activity, well‑being of the individual
Department of The Calcutta Homoeopathic Medical College and other associated symptom in each case was recorded as
and Hospital (CHMC and H), Kolkata. The proposed plan of Symptom 2 and the intensity was scored. Patients presented
work adhered to the ethical guidelines of the Declaration of with pain in heels, pain in knee, pain in toes and swelling of toe
Helsinki[12] and was approved by the Ethical Committee of the with pain as Symptom 1, and as Symptom 2, the participants

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Saha, et al.: Homoeopathic treatment of gout

presented with varied ailments like gastrointestinal complaints Preliminary screening (n = 55)
such as bleeding per rectum, constipation, bloated abdomen Excluded (n = 10), reasons:
and mucoid stool; urinary complaints such as scanty urine, 1. Taking medicines for
burning in micturition and offensive urine and sleeplessness. gout (n = 8)
2. Taking medicines for
depression (n = 1)
Intervention and follow‑up 3. Lactating mother (n = 1)
All patients were given appropriate individualised homoeopathic Assessed for eligibility (n = 45)
medicines based on homoeopathic principles. Patients were Excluded (n = 09); reasons:
ACR-EULAR gout score less than 8
advised to take care of their lifestyle by altering the diet and
regimen. Cases were repertorized if required. Repetition was Eligible participants (n = 36)

done depending on the individual requirement of the cases. Denied consent (n = 4)

Each patient enrolled was intervened for a period of 3 months,
Consent obtained and enrolled (n = 32)
and follow‑up was conducted at least once a month or earlier,
as required by the patient. Dropped out (n = 2)

Statistical analysis Followed up (n = 30)

Both descriptive and inferential statistics were used.
Intention‑to‑treat sample was subjected to statistical analysis.
Completed study and considered for intention to treat analysis (n = 32)
Missing values were replaced by last value carried forward
method. Student’s t‑test and one‑way repeated measures Figure 1: Study flow diagram
ANOVA were used keeping P < 0.05 two‑tailed as statistically
significant. Statistical Package for the Social Sciences, version
Table 1: Sociodemographic profile of the patients (n=32)
20.0 (IBM Corp., IBM SPSS Statistics for Windows, Armonk,
NY: USA) was used for analysis. Characteristics Estimates
Age (years)#, mean±SD 47.6±11.3
Sex§, n (%)
Results Male 20 (62.5)
Study flow Female 12 (37.5)
A total of 55 patients were preliminarily screened on the Economic status§, n (%)
basis of entry criterion of occurrence of at least one episode Lower 2 (6.3)
of peripheral joint or bursal swelling, pain or tenderness and Middle 28 (87.5)
serum uric acid level. Of which, 45 were assessed for eligibility. Upper 2 (6.3)
No patient underwent radiological examination or synovial Marital status§, n (%)
fluid examination, as they were not available at the institution. Married 29 (90.6)
The ACR‑EULAR gout score was <8 in 9 patients and 4 did Others 3 (9.4)
not give consent. Hence, only 32 patients could be enrolled in Residence§, n (%)
the study after screening them according to the inclusion and Urban 16 (50)
exclusion criteria [Figure 1]. Semi‑urban 9 (28.1)
Rural 7 (21.9)
Baseline features Duration of suffering§, n (%)
The maximum number of patients belonged to the age group of 0-4 weeks 8 (25)
31–40 years (n = 11; 34.4%) and 41–50 years (n = 11; 34.4%), 4-12 weeks 3 (9.4)
followed by 51–60 years (n = 7; 21.9%) [Table 1]. Male patients 3 months-1 year 14 (43.8)
were the majority (n = 20; 62.5%). Further, 65.6% (n = 21) 1-5 years 7 (21.9)
of the patients had mixed type of diet, 9  patients  (28.1%)
#
Data presented as mean±SD, §Categorical data presented as absolute
values (%). SD: Standard deviation
had regular smoking habit, 1  patient had a habit of regular
consumption of alcohol and 11 patients (34.4%) occasionally
took alcohol. Dietary habit of intake of red meat regularly was sleeplessness in 2 patients, urinary complaints in 4 patients,
presented in 9.4% (n = 3) patients, whereas 37.5% (n = 12) of scanty menses with engorgement of breast before menses
the patients occasionally consumed red meat and 21 (65.6%) in one patient and warm sensation, wet sensation, itching,
patients occasionally consumed soft drinks [Table 2]. The mean burning sensation on legs, chronic intertrigo and otorrhoea in
ACR–EULAR gout score was 8.2, with 62.5% (n = 20) having one patient each.
a score of 8 and 34.4% (n = 11) with score of 11. None of the Symptom profile
patients were with score 12 and above [Table 2]. Among the total 32 patients enrolled for the study, 2 patients
The other comorbid conditions recorded in Symptom 2 of presented with classical acute gout, i.e. sudden development of
MYMOP2  were–  gastrointestinal complaints  (6  patients), a painful, swollen, warm metatarsophalangeal joint, whereas
haemorrhoids with bleeding per rectum  (2  patients), 7 patients had involvement of monoarticular joint and rest of
constipation  (1  patient), mucoid stool  (1  patient), cough, the 23 patients had polyarticular joint involvement.

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Saha, et al.: Homoeopathic treatment of gout

Pre–post comparison reduction: 24.0, 95% CI = 19.1, 29.0, P < 0.001, Student’s

Among the 32 patients, only one patient had an increase of t‑test) reduced significantly over  3  months  [Table  3]. The
uric acid level after 3 months’ follow‑up and two dropped out pre‑medication mean score of concern of gout medication side
of the study. The uric acid level reduced from 6.70 mg/dl to effects reduced from 4.7 to 1.6 after 3 months of treatment,
5.48 mg/dl and 8.15 mg/dl to 6.32 mg/dl in female and male whereas the mean score of concern of well‑being during attack
patients, respectively, after 3 months of treatment. Both serum reduced from 19.3 to 9.5 and after medication gout concern
uric acid level (mg/dl) (7.6 ± 1.4 vs. 6.0 ± 1.5; mean reduction: during attack reduced from 8.1 to 3.9 [Table 3]. The mean pain
1.6, 95% confidence interval [CI] = 1.1, 2.1, P < 0.001, Student’s intensity score of MYMOP2  (Symptom 1) improved from
t‑test) and GAQ2 total score (45.0 ± 9.1 vs. 21.0 ± 14.0; mean 5.2 (baseline) to 4.3 (at the 1st month), 3.8 (at the 2nd month) and
finally 3 (at the 3rd month). The mean activity score improved
from 4.8  (baseline) to 3.9  (at the 1st  month), 3.5  (at the
Table 2: Eating habit and predisposing factors of the 2nd month) and finally 2.7 (at the 3rd month) after medication.
patients (n=32) The mean well‑being score of the patients with gout also
Features Estimates improved from 5.1 (baseline) to 4.1 (at the 1st month), 3.5 (at
Diet§, n (%) the 2nd month) and finally 2.5 (at the 3rd month). A significant
Vegetarian 3 (9.4) improvement in the mean intensity score of associated
Non‑vegetarian 8 (25.0) symptom in each case (recorded as Symptom 2) was changed
Mixed 21 (65.6) from 3.9 at baseline to 1.6 after the 3rd month [Table 4].
Smoking habit§, n (%)
Never 15 (46.9) Homoeopathic medicines used
Quit 4 (12.5) As per the totality of symptoms, at the baseline, Benzoicum
Occasional 4 (12.5) acidum was prescribed in 8  patients  (25%) and Lachesis
Regular 9 (28.1) mutus, Lycopodium clavatum, Pulsatilla nigricans and Rhus
Alcohol intake§, n (%) toxicodendron were prescribed in 3 patients (9.4%) each. In
Never 18 (56.3) the subsequent prescriptions also, Benzoicum acidum was
Quit 2 (6.3) the most frequently used medicine, followed by Colchicum
Occasional 11 (34.4) autumnale. The indicated medicines were prescribed in
Regular 1 (3.1) different potencies as per the susceptibility of each individual
Red meat intake§, n (%) patient and guidelines of the Organon of Medicine. Medicines
Never 13 (40.6) were changed as per the demand of each case, when there was
Quit 4 (12.5) no such marked improvement or totality of symptoms changed.
Occasional 12 (37.5)
Placebo was prescribed as long as improvement continued.
Regular 3 (9.4)
Among the 32 patients, no change of medicine was required
Seafood intake§, n (%)
for 18  patients, though repetition or prescription of higher
Never 6 (18.8)
potencies was prescribed when cases came to a standstill and
Quit 2 (6.3)
Occasional 23 (71.9)
the same potency was not enough to cure the case. The lists of
Regular 1 (3.1)
prescribed medicines and the indications of the most frequently
Soft drink intake§, n (%) prescribed remedies are given in Tables 5 and 6, respectively.
Never 7 (21.9)
Occasional 21 (65.6) Discussion
Regular 4 12.5)
Compared to baseline, serum uric acid, GAQ2 and MYMOP2
Exercise§, n (%)
scores of participants reduced significantly over three months.
Never 19 (59.4)
As per the totality of symptoms, twenty different homoeopathic
Occasional 10 (31.3)
Regular 3 (9.4)
medicines were used, Benzoicum acidum being the most
Family history of hyperuricaemia§, n (%)
common.
None 23 (71.9) It was observed that many associated symptoms of the patient,
Maternal 4 (12.5) such as acidity, sleeplessness, bleeding per rectum, constipation,
Paternal 4 (12.5) cough and itching  (MYMOP2, Symptom 2), improved,
Both 1 (3.1) suggesting Homoeopathy as a holistic care therapeutic method.
Serum uric acid level#, mean±SD
This study elicited the potential effect of individualised
Male 8.2±1.4
homoeopathic medicines in not only reducing the serum
Female 6.7±0.7
uric acid but also improvement in activity and well‑being of
ACR‑EULAR score#, mean±SD 8.5±0.8
#
Data presented as mean±SD, §Categorical data presented as absolute
patients with gout, without any substantial medicinal adverse
values (%). SD: Standard deviation, ACR‑EULAR: American College of effects. The methodological strengths of the study were its
Rheumatology-European League against Rheumatism prospective design, use of validated questionnaires, such as

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Saha, et al.: Homoeopathic treatment of gout

GAQ2 and MYMOP2, treatment by qualified and experienced to compare the findings of MYMOP2. The single published
homoeopathic physicians schooled in and practicing classical study[8] was an open‑label, single‑arm trial involving only ten
Homoeopathy in dealing with a challenging condition like individuals who presented within 5 days of the onset of acute
gout  –  a single, simple medicine in minimum dose based gout. Three outcome measures were used – serum uric acid
on totality of symptoms in each individual case. No such level, joint improvement score and Ritchie’s score of joint
published homoeopathic studies on gout could be identified swelling and joint tenderness – all assessed on days 1, 3 and

Table 3: Comparison of outcome measures at baseline and after 3 months by paired t‑test
Outcomes Mean±SD t31 P
score
Baseline Month 3 Change 0-3 (95% CI)
Serum uric acid 7.6±1.4 6.0±1.5 1.6±1.3 (1.1-2.1) 7.208 <0.001*
GAQ2 scores
Total 45.0±9.1 21.0±14.0 24.0±13.7 (19.1-29.0) 9.955 <0.001*
Concern overall 13.0±2.1 6.0±4.3 7.0±4.5 (5.4-8.6) 8.770 <0.001*
Medication side effects 4.7±1.5 1.6±1.5 3.1±1.8 (2.4-3.7) 9.464 <0.001*
Well‑being during attack 19.3±5.7 9.5±6.8 9.8±6.6 (7.4-12.2) 8.347 <0.001*
Concern during attack 8.1±2.8 3.9±2.8 4.2±3.4 (2.9-5.4) 7.015 <0.001*
GAQ2: Gout Assessment Questionnaire v2.0, SD: Standard deviation, CI: Confidence interval

Table 4: Changes in repeatedly Measure Yourself Medical Outcome Profile v2.0 over 3 months
MYMOP2 scores Mean±SD P
Baseline Month Month Month Change 0-1 Change 0-2 Change 0-3
1 2 3 (95% CI) (95% CI) (95% CI)
Pain intensity 5.2±0.9 4.3±1.1 3.8±1.3 3.0±1.5 0.8±0.9 (0.5-1.2)* 1.3±1.1 (0.9-1.7)** 2.2±1.4 (1.7-2.7)*** <0.001****
Activity score 4.8±1.2 3.9±1.3 3.5±1.3 2.7±1.5 0.8±1.1 (0.5-1.2)# 1.3±1.1 (0.8-1.7)## 2.1±1.6 (1.5-2.7)### <0.001####
Well‑being score 5.1±1.0 4.1±0.9 3.5±1.0 2.5±1.4 0.9±0.9 (0.6-1.3) ¥
1.5±1.2 (1.1-2.0) ¥¥
2.6±1.5 (2.0-3.1)¥¥¥
<0.001¥¥¥¥
Symptom 2 intensity 3.9±0.9 3.0±0.7 2.4±0.9 1.6±1.3 0.9±0.8 (0.6-1.2)ψ
1.5±0.9 (1.2-1.8)ψψ
2.3±1.3 (1.8-2.7) ψψψ
<0.001ψψψψ
*t31=5.400, P<0.001, **t31=6.466, P<0.001, ***t31=8.752, P<0.001 (pairwise comparison using paired t‑test), ****Wilks’ λ=0.278, F3, 29=25.112, partial
η2=0.722 (One‑way repeated measures ANOVA), #t31=4.543, P<0.001, ##t31=6.225, P<0.001, ###t31=7.629, P<0.001 (pairwise comparison using paired
t‑test), ####Wilks’ λ=0.346, F3, 29=18.291, partial η2=0.654 (One‑way repeated measures ANOVA), ¥t31=5.593, P<0.001, ¥¥t31=7.314, P<0.001, ¥¥¥t31=9.655,
P<0.001 (pairwise comparison using paired t‑test), ¥¥¥¥Wilks’ λ=0.252, F3, 29=27.641, partial η2=0.748 (One‑way repeated measures ANOVA), ψt31=6.241,
P<0.001, ψψt31=9.644, P<0.001, ψψψt31=10.114, P<0.001 (pairwise comparison using paired t‑test), ψψψψWilks’ λ=0.201, F3, 29=38.544, partial η2=0.799
(One‑way repeated measures ANOVA). MYMOP2: Measure Yourself Medical Outcome Profile v2.0, SD: Standard deviation, CI: Confidence interval

Table 5: Medicines prescribed during the study

Medicine prescribed at Medicine prescribed at Medicine prescribed at Medicine prescribed at
baseline the end of the 1st month the end of the 2nd month the end of the 3rd month
Apis mellifica (n=1) Benzoicum acidum (n=6) Benzoicum acidum (n=5) Benzoicum acidum (n=3)
Benzoicum acidum (n=8) Calcarea phosphorica (n=1) Calcarea phosphorica (n=2) Calcarea phosphorica (n=1)
Calcarea phosphorica (n=1) Causticum (n=1) Colchicum autumnale (n=2) Causticum (n=2)
Causticum (n=1) Colchicum autumnale (n=3) Kalium carbonicum (n=1) Colchicum autumnale (n=1)
Colchicum autumnale (n=1) Kalium carbonicum (n=1) Ledum palustre (n=1) Lachesis mutus (n=1)
Kalium carbonicum (n=1) Ledum palustre (n=1) Lycopodium clavatum (n=2) Natrum sulphuricum (n=1)
Lachesis mutus (n=3) Medorrhinum (n=1) Natrum muriaticum (n=1) Placebo (n=21)
Ledum palustre (n=1) Natrum sulphuricum (n=1) Sepia officinalis (n=1)
Lycopodium clavatum (n=3) Pulsatilla nigricans (n=2) Colchicum autumnale (n=1)
Mercurius solubilis (n=1) Thuja occidentalis (n=1) Urtica urens (n=1)
Natrum sulphuricum (n=1) Urtica urens (n=3) Placebo (n=13)
Nux vomica (n=1) Placebo (n=10)
Pulsatilla nigricans (n=3)
Rhus toxicodendron (n=3)
Sulphur (n=1)
Thuja occidentalis (n=1)
Urtica urens (n=1)

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Saha, et al.: Homoeopathic treatment of gout

opportunity of carrying out this study. Deep regards to

Table 6: Indications of the most frequently prescribed
Prof.  (Dr.) Satadal Das for his guidance in framing the
medicines
study protocol. A sincere regards to Prof. Dr. Rakesh Singh,
Medicines Indications Dr.  Rajib Purkait, Dr.  Samit Dey and Dr.  Debarsi Das for
Benzoicum Tearing, stitching pain in toe, aggravated at night, support. We acknowledge the Institutional Ethical Committee,
acidum open air with strong smelling urine all the visiting physicians, all hospital staff, patients and library
Lachesis Swelling in knee aggravated after walking, sharp staff for their co‑operation that provided an opportunity to
mutus agonising pain with red or bluish painful swelling
in climacteric age complete the study.
Lycopodium Swelling of the legs, toes with red, burning spots,
Financial support and sponsorship
clavatum pain ameliorated by walking in open air, nocturnal
pain with numbness associated with bloating, The study was conducted as one of the projects under the Short
flatulence, constipation, etc. Term Studentship in Homoeopathy (STSH) scheme of CCRH.
Pulsatilla Red hot swelling of foot with heaviness, pain
nigricans associated with chill, aggravated in the evening, Conflicts of interest
allowing the feet to hang down, with flatulence, and None declared.
thirstlessness
Rhus Arthritic nodosities, tearing, aching pain aggravated
toxicodendron by initial motion, damp weather and ameliorated by References
continued motion, warm application 1. Kuo CF, Grainge MJ, Mallen C, Zhang W, Doherty M. Rising burden of
Colchicum Shifting rheumatism, pain goes from left to right, gout in the UK but continuing suboptimal management: A nationwide
autumnale inflammation of great toe, cannot bear to be population study. Ann Rheum Dis 2015;74:661‑7.
touched, aggravated in change of weather, nausea 2. Zhu  Y, Pandya  BJ, Choi  HK. Prevalence of gout and hyperuricemia
and appetite lost from smell of food in the US general population: The National Health and Nutrition
Examination Survey 2007‑2008. Arthritis Rheum 2011;63:3136‑41.
3. Ralston  SH, Mclnnes  IB. Gout: Rheumatology and Bone disease.
6. All the acute symptoms of gout were found to be resolved In: Brian  W, Colledge Nicki  R, Ian  P, Stuart  R, editors. Davidson’s
within a span of 6  days only. Among the used medicines, Principles & Practice of Medicine. 22nd ed. United Kingdom: Elsevier;
2014. p. 1087‑9.
Benzoic acid, Causticum, Rhus toxicodendron, Ledum palustre, 4. Chopra A, Patil J, Billempelly V, Relwani J, Tandle HS; WHO‑ILAR
Colchicum autumnale and Calcarea carbonica were common. COPCORD Study WHO International League of Associations
The findings were preliminary only and further studies were from Rheumatology Community Oriented Program from Control
warranted. The period of study was, however less to evaluate of Rheumatic Diseases. Prevalence of rheumatic diseases in a rural
population in western India: A WHO‑ILAR COPCORD Study. J Assoc
the effect of treatment in reducing the progress of the disease Physicians India 2001;49:240‑6.
and in preventing acute attacks. In the absence of control 5. Richette  P, Doherty  M, Pascual  E, Barskov  V, Becce  F,
arm, there is always chance of overestimation of treatment Castaneda  J, et al. Updated European league against rheumatism
effect sizes. In comparison, our study was better than this in evidence‑based recommendations for the diagnosis of gout. Ann
Rheum Dis 2019. pii: annrheumdis-2019-215315. doi: 10.1136/
terms of number of patients, use of validated questionnaires annrheumdis-2019-215315. [Epub ahead of print].
as secondary outcomes, longer duration of follow‑ups and 6. Neogi  T, Jansen  TL, Dalbeth  N, Fransen  J, Schumacher  HR,
comparatively rigorous statistical analysis. Adequately Berendsen  D, et al. 2015 Gout classification criteria: An American
powered randomised controlled trials are warranted to arrive College of Rheumatology/European League Against Rheumatism
collaborative initiative. Arthritis Rheumatol 2015;67:2557‑68.
at a definite conclusion regarding the efficacy of homoeopathic 7. Janssens  HJEM, Fransen  J, Janssen  M, Neogi  T, Schumacher  HR,
medicines in gout. Jansen TL, et al. Performance of the 2015 ACR‑EULAR classification
criteria for gout in a primary care population presenting with
monoarthritis. Rheumatology (Oxford) 2017;56:1335‑41.
Conclusion 8. Helmstädter A. Parenteral administration of formic acid in alternative
Homoeopathic management has adequate potential in not only medicine. Med Ges Gesch 2001;20:197‑211.
9. Kluczykowska  B. Effect of homeopathic remedies. Przegl Lek
alleviating the serum uric acid in gout but also a significant 1985;42:794‑6.
role in improving the well‑being, activity and quality of 10. ColciGel – A homeopathic colchicine gel for gout. Med Lett Drugs Ther
life of patients with gout, without any adverse effects. This 2016;58:5‑6.
prospective observational trial, though preliminary, revealed 11. Cara R, Tikky M, Solomon EM, Deroukakis M. Homeopathic Treatment
of Acute Gout. Am J Homeopathic Med 2007;100:40‑9.
a positive treatment effect of homoeopathic medicines in gout. 12. World Medical Association. WMA Declaration of Helsinki  –  Ethical
The study findings need to be interpreted with caution and principles for medical research involving human subjects. JAMA
further be experimented in randomised placebo‑controlled 2013;310:2191‑4.
design with enhanced methodological rigor and longer 13. Hirsch JD, Lee SJ, Terkeltaub R, Khanna D, Singh J, Sarkin A, et al.
Evaluation of an instrument assessing influence of Gout on health‑related
follow‑up. quality of life. J Rheumatol 2008;35:2406‑14.
14. Polus  BI, Kimpton AJ, Walsh  MJ. Use of the measure your medical
Acknowledgement outcome profile  (MYMOP2) and W‑BQ12  (Well‑Being) outcomes
The authors would like to express their regards to Central measures to evaluate chiropractic treatment: An observational study.
Council for Research in Homoeopathy for giving the Chiropr Man Therap 2011;19:7.

Indian Journal of Research in Homoeopathy  ¦  Volume 13  ¦  Issue 4  ¦  October-December 2019 241
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Saha, et al.: Homoeopathic treatment of gout

xkmV ls ihfM+r jksfx;ksa esa gksE;ksiSfFkd nokvksa ds izHkko dk vkadyu djus ds fy, ,d laHkkfor voyksdu ijh{k.kA
i`’BHkwfe % xfB;k ,d lwtu ;qDr tksM+ksa dk nnZ gS tks gkbi;wZfjfe;k ls tqM+k gksrk gS vkSj baVªk&vkfVZdqyj eksuks lksfM;e ;wjsV fØLVy ¼,e,l;w½
ds fp=.k ds ifj.kkeLo#i nnZ] xfrfof/k dh lhek] fodykaxrk vkSj jksxh ds thou dh xq.koRrk ij izHkko iM+rk gSA
mn~ns”; % xfB;k ls ihfM+r jksfx;ksa esa lhje ;wfjd ,flM Lrj vkSj thou dh xq.koRrk esa O;fDrxr gksE;ksiSfFkd nokvksa ds izHkkoksa dh tkap djukA
fof/k % dksydkrk] gksE;ksiSfFkd esfMdy dkWyst ,oa gkWfLiVy] dksydkrk ds ckg~; jksxh foHkkx esa xfB;k ls ihfM+r 32 O;Ldksa ¼,lhvkj&bZ;wyj
xkmV oxhZdj.k ekunaMksa ds vuqlkj funku½ ij ,d laHkkfor] ,dy gkFk] xSj ;kn`fPNd] [kqyk] voyksdu ijh{k.k fd;k x;k FkkA lhje ;wfjd
,flM Lrj esa ifjorZu izkFkfed ifj.kke Fkk ¼cslykbu cuke 3 eghus½( xkmV vlslesaV iz”ukoyh v2.0 ¼GAQ2; vk/kkjHkwr cuke 3 eghus½ vkSj
mik; [kqn dks esfMdy vkmVde izkQkby v2.0 ¼MYMOP2; vk/kkjHkwr gj eghus] 3 eghus rd½ ek/;fed ifj.kke FksA baVsa”ku&Vw&VªhV lSaiy
¼n=32½ dk fo”ys’k.k SPS®IBM®v.20 esa fd;k x;k Fkk
ifj.kke % jksfx;ksa dh vkSlr vk;q 47-6 o’kZ Fkh( iq#’k o efgyk vuqikr 5%3 FkkA nksuksa lhje ;wfjd ,flM Lrj ¼feyhxzke@Mh,y½ ¼7.6 ± 1.4
cuke 6.0 ± 1.5; vkSlr deh : 1.6, 95% CI 1.1, 2.1, P<0.001, LVwMsaV~l Vh VsLV½ vkSj GAQ2 dk dqy Ldksj ¼45.0 ± 9.1 cuke 21.0 ±
14.0; vkSlr deh% 24.0, 95% CI 19.1, 29.0, P<0.001, LVwMsaV~l t VsLV½ 3 eghuksa esa dkQh de gks x;kA MYMOP2 Ldksj us 4 vyx&vyx
le; fcanqvksa ij vuqnS/;Z #i ls izkIr fd;k] lkaf[;dh; #i ls egRoiw.kZ dVkSrh ¼P<0.001, ,d rjg ls nksgjk;k ,uksok½ dk irk pykA vf/
kdka”kr% fufnZf’Vre nok csatksbde ,flMe FkhA
fu’d’kZ % bl v/;;u esa xfB;k ds y{k.kksa dks de djus vkSj thou dh xq.koRrk esa lq/kkj ykus esa O;fDrxr gksE;ksiSfFkd nokvksa ds mipkj ds
izHkko dk irk pykA

Un essai d'observation prospectif pour évaluer l'effet des médicaments homéopathiques chez les patients souffrant de goutte
Contexte : La goutte est une arthrite inflammatoire associée à l’hyperuricémie et au dépôt de cristaux d'urate monosodique
inter-articulaire (MSU), entraînant de la douleur, une limitation de l'activité, un handicap et ayant un impact sur la qualité de vie
du patient. Objectif : Examiner les effets des médicaments homéopathiques personnalisés sur le taux d'acide urique sérique et
la qualité de vie chez les patients souffrant de goutte. Méthodes : Un essai d’observation prospectif ouvert non randomisé sur
groupe unique a été mené sur 32 adultes souffrant de goutte (diagnostiqués selon les critères de classification de la goutte ACR-
EULAR) au service de consultations externes de l’hôpital ‘Calcutta Homoeopathic Medical College and Hospital’ à Kolkata.
Les changements dans le taux d'acide urique sérique étaient le principal résultat (au départ par rapport à après 3 mois) ; le
questionnaire ‘Gout Assessment Questionnaire v2.0’ (GAQ2 – Questionnaire d’évaluation de la goutte ; au départ par rapport à
après 3 mois) et le ‘Measure Yourself Medical Outcome Profile v2.0’ (MYMOP2 – Profil après l’auto-évaluation des résultats
médicaux) ; au départ, chaque mois, jusqu'à 3 mois) étaient les résultats secondaires. L'échantillon ‘intention de traiter’ (n =
32) a été analysé dans SPSS®IBM®v.20. Résultats : L'âge moyen des patients était de 47,6 ans; le ratio hommes/femmes était
de 5:3. Le taux d’acide urique sérique (mg/dl) chez les deux [7,6 ± 1,4 contre 6,0 ± 1,5 ; réduction moyenne 1,6, 95 % CI 1.1,
2,1, P<0,001, Test t de Student] et le score GAQ2 total [45,0 ± 9,1 contre 21,0 ± 14,0 ; réduction moyenne : 24,0, 95 % CI
19,1, 29,0, P<0,001, test t de Student] ont baissé de manière sensible sur la période de 3 mois. Les scores MYMOP2 obtenus
longitudinalement à 4 moments différents ont également révélé des réductions statistiquement significatives (P<0,001, mesure
répétée à sens unique ANOVA). Le médicament le plus souvent prescrit était le Benzoicum acidum. Conclusion : Cette étude
a révélé un effet thérapeutique prometteur de médicaments homéopathiques personnalisés pour soulager les symptômes de la
goutte et améliorer la qualité de vie.

242 Indian Journal of Research in Homoeopathy  ¦  Volume 13  ¦  Issue 4  ¦  October-December 2019
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Saha, et al.: Homoeopathic treatment of gout

Ensayo prospectivo observacional para evaluar el efecto de los medicamentos homeopáticos en pacientes con gota
Fundamentos: La gota es una artritis inflamatoria asociada a hiperuricemia y depósito de cristales de urato monosódico (UMS)
que da lugar a dolor, limitación de la actividad y discapacidad, además de tener un impacto en la calidad de vida. Objetivos:
Examinar los efectos de los medicamentos homeopáticos individualizados sobre los niveles de ácido úrico en suero y la calidad
de vida de los pacientes que sufren de gota. Métodos: Se ha realizado un ensayo prospectivo, de brazo único, no aleatorizado,
abierto y observacional en 32 adultos con gota (diagnóstico establecido conforme a los criterios de clasificación ACR-EULAR
Gout) en el departamento ambulatorio del The Calcutta Homoeopathic Medical College and Hospital, Kolkata, India. El
parámetro principal fueron los cambios en los niveles de ácido úrico (inicio frente a 3 meses); mientras que los secundarios
fueron el Cuestionario de Evaluación de la Gota v2.0 (GAQ2; inicio frente a 3 meses) y el perfil Measure Yourself Medical
Outcome Profile v2.0 (MYMOP2; inicio, cada mes, hasta 3 meses). La muestra de intención de tratamiento (n=32) se analizó en
el programa SPSS®IBM®v.20. Resultados: La edad media de los pacientes era de 47,6 años, la relación de hombres/mujeres de
5:3. Los niveles séricos de ácido úrico (mg/dl) [7,6 ± 1,4 frente a 6,0 ± 1,5; reducción media: 1,6, IC del 95 % 1,1, 2,1, P<0,001,
prueba t de Student] y la puntuación total GAQ2 [45,0 ± 9,1 frente a 21,0 ± 14,0; reducción media: 24,0, IC del 95% 19,1, 29,0,
P<0,001, prueba t de Student] se fueron reduciendo significativamente a lo largo de 3 meses. Las puntuaciones MYMOP2
obtenidas en 4 diferentes momentos también mostraron reducciones estadísticamente significativas (P<0,001, ANOVA unilateral
de mediciones repetidas). El medicamento más frecuentemente indicado fue Benzoicum acidum. Conclusiones: Este estudio
mostró un efecto terapéutico prometedor de los medicamentos homeopáticos individualizados en aliviar los síntomas de gota
y mejorar la calidad de vida.

Prospektive Beobachtungsstudie Beurteilung der Wirkung homöopathischer Arzneimittel in Gichtpatienten

Hintergrun: Die Gicht ist eine entzündiche Arthritis, die mit Hyperurikämie und Ablagerung intraartikulärer mononatriumurat
enthaltende Krystalle einhergeht, und in Schmerzen, Einschränkung der Tätigkeiten, Behinderung und Beeinträchtigung
der Lebensqualität entartet. Zielsetzung: Untersuchung der Auswirkungen individualisierter homöopathischer Arzneimittel
auf den Harnstoffspiegel im Serum und die Lebensqualität der mit Gicht erkrankten Patienten.. Methode: Es wurde eine
prospektive, einarmige, nicht randomisierte, offene Beobachtungsstudie an 32 erwachsenen Gichtpatienten (Diagnose nach
den Klassifikationskriterien der ACR-EULAR Gout) in der Ambulanzabteilung des Calcutta Homoeopathic Medical College
and Hospital, Kolkata. Die Veränderungen im Harnstoffspiegel im Serum stellen den primären Endpunkt dar (Anfang vs. 3
Monate) dar, während die sekundären Endpunkte in der Beurteilung des Gout Assessment Questionnaire v2.0 (GAQ2; Anfang
vs. 3 Mante) und der Measure Yourself Medical Outcome Profile v2.0 (MYMOP2; Anfang, jeden Monat bis zu 3 Monaten)
bestanden. Die Intention-to-treat Analyse (n=32 Patienten) wurde mit dem Program SPSS®IBM®v.20 durchgeführt. Ergebnisse:
Das Durchschnittsalter der Patienten war 47,6 Jahre; das Verhältniss Männer:Frauen war 5:3. Der Harnstoffspiegel im Serum (mg/
dl) [7,6 ± 1,4 vs. 6,0 ± 1,5; durchschnittliche Senkung 1,6, 95% CI 1,1, 2,1, P<0,001, Student’s t Test] und die Gesamtpunktzahl
GAQ2 [45,0 ± 9,1 vs. 21,0 ± 14,0; durchshnittliche Senkung: 24,0, 95% CI 19,1, 29,0, P<0;001, Student’s t Test] zeigten eine
signifikante Senkung während eines Zeitraums von 3 Monaten. Die longitudinal an 4 unterschiedlichen Zeitpunkten erhaltenen
MYMOP2-Scores zeigten auch statisch signifikante Senkungen (P<0.001, wiederholte einseitige ANOVA). Das am häufigsten
angezeigte Arzneimittel war Benzoicum acidum. Fazit: Diese Studie zeigt eine vielversprechende therapeutische Wirkung
seitens individualisierter homöopathischer Arzneimittel in Bezug auf die Erleichterung der Gichtsymptome und die Besserung
der Lebensqualität.

前瞻性觀察研究：評估順勢療法療劑對痛風病人的效用
背景：痛風是一種炎症性關節炎，伴有高尿酸血症和關節內尿酸鈉晶體（MSU）沉積，導致疼痛、活動受限、殘疾，
影響患者的生活品質。
目的：探討個人化順勢療法藥物對痛風患者血尿酸水平及生活品質的效用。
方法：在加爾各答順勢療劑法醫學院和醫院的門診部，對32位成人痛風患者（根據ACR-EULAR痛風分類標準診斷）
進行前瞻性、單組、非隨機、開放性、觀察性試驗。血清尿酸水平的變化是主要結果（基線vs 3個月）；痛風評估
問卷v2.0（GAQ2；基線 vs 3個月）和測量自己的醫療結果v2.0（MYMOP2；基線，每月，3個月以上）是次要結果。
在 SPSS®IBM®v.20中以治療意向 (ITT) 樣本（n=32）作分析。
結果：患者平均年齡47.6歲，男女比例5:3。血清尿酸水平（mg/dl）[7.6±1.4 vs.6.0±1.5；平均下降1.6,95%CI 1.1,2.1
，P<0.001，學生t檢驗 ] 和GAQ2總分 [45.0±9.1 vs.21.0±14.0；平均下降24.0，95% CI 19.1,29.0，P<0.001，學生t檢驗 ] 在
3個月內顯著下降。在4個不同時間點縱向獲得的MYMOP2得分也顯示出統計學上的顯著降低（P<0.001，單因子獨立
變異數分析 ANOVA）。最常指引出的藥物是安息香酸 。
結論：本研究顯示，個人化的順勢療法藥物在舒緩痛風症狀、提高生活品質方面具有良好的治療效果。

Indian Journal of Research in Homoeopathy  ¦  Volume 13  ¦  Issue 4  ¦  October-December 2019 243