Trends in management of rheumatoid arthritis Dr.Neena Mehan Rheumatoid Arthritis (RA) is an auto-immune disease in which body mistakenly considers some parts of its own system as pathogens and attacks them.

2. Rheumatoid Arthritis (RA) is an auto-immune disease in which body
mistakenly considers some parts of its own system as pathogens
and attacks them.
Epidemiological study of Rheumatoid Arthritis are dependent on
the criteria used to define the disease. This is challenging, because
no aetiological agent has been identified and there is no unique
clinical or laboratory features that can be used to define the disease
clearly. The prevalence of rheumatoid arthritis (RA) varies between
0.3% and 1% worldwide and is more common in women of age 30-
40 yrs, and in developed countries.
Rheumatoid arthritis (RA) is a chronic systemic inflammatory
illness with prevalence of approximately 0.75% in India.
It is characterized by symmetrical polyarticular synovitis, which
causes joint swelling, stiffness, and tenderness, eventually leading
to cartilage damage, bone erosions, and joint destruction,
associated with significant activity limitations and disability, lost
productivity, reduced social functioning, and inflicting enormous
costs on health and social care systems . Direct and indirect costs
are also enormous.

3. RA, even in its early stage can cause considerable impact on health
related quality of life . Aggressive early treatment has been found
to prevent much of the long term damage associated with RA .
However, apart from various adverse drug reactions (ADRs) of non-steroidal
anti-inflammatory drugs (NSA IDs) and gluco-corticoids,
different biological and non-biological disease-modifying anti-rheumatoid
drugs (DMARDs) also were found to be toxic to some
extent; hence, combination therapies are mostly preferred
Rheumatologic problems are among the commonest disease
conditions encountered by complementary and alternative
medicine (CAM) practitioners and the therapies offered in this field
are perceived as natural and safe by the patients .
Patients with RA often take CAM therapies , including
homeopathy . A review of the expectations of CAM users showed
an expectation that these interventions will influence the natural
history of the disease, prevent illness and be free of adverse
effects . Homeopathy is a popular CAM therapy for chronic
conditions with patients reporting considerable satisfaction ,but
its use attracts much debate.

4. There is evidence for the therapeutic benefits of the consultation
process on health outcomes in both conventional medicine and
CAM. These contextual effects include factors that are not the
active components of the treatment but are inherent within the
whole treatment package. Research into the homeopathic
consultation has identified contextual factors such as empathy
and empowerment, which may mediate the homeopathic process.
Homeopathy consultations involve a complete exploration of the
patient's emotional, spiritual and physical well-being to enable
treatment of the whole person not just the illness.
An analysis evaluating homeopathy for RA (three trials employing
individualized and one using complex homeopathy identified an
odds ratio of 2.0 favoring homeopathy in spite of contradictory
evidence for the specific efficacy of homeopathy over placebo;
homeopathic intervention appears to be clinically beneficial for RA.
There is no commonly accepted mechanism for ultra-molecular
dilutions and it has been suggested that any clinical benefit results
from the placebo effects attributable to the clinical consultations
rather than the remedies but this has not been formally assessed.

5. The results showed that homeopathy had an advantage over control
in treatment of RA; however, statistical significance could not be
established. The evidence was not convincing because of
methodological inconsistencies which prohibited the formation of a
definite conclusion. Further replications are warranted provided the
trials are methodologically consistent, rigorous and systematic.

6. Before we start any study/trial the foremost point is
what key /research /review question this study would
investigate.
Key question(s)
• Is homeopathy nothing better than placebo?
• Is homeopathy safe.
• Is homeopathy cost effective.
• What is the psychosocial and economic burden of rheumtoid
arthritis on patients.
Searches
MEDLINE via PubMed, Cochrane, Google scholar,
Language: English
Publication Period: 1980-2014

7. Types of study to be included
Prospective, double-blind, randomized, placebo-controlled trials.
Condition or domain being studied
Rheumatoid arthritis.
Participants/ population
Patients suffering from rheumatoid arthritis.
Intervention(s), exposure(s)
Individualized homeopathic medicines.
Comparator(s)/ control
Placebo

8. Outcome(s)
Primary outcomes
Patients assessed globally as improved.
Secondary outcomes
Pain score, morning stiffness.

9. Studies performed to evaluate the effectiveness of
homeopathic remedies for rheumatoid arthritis have returned
mixed results.
All these trials are randomized controlled trials (RCTS) which are
deemed the ‘gold standard’ for evaluating treatment efficacy in
health research and all these use individually prescribed
homeopathic remedies, which resembles the true classical
homeopathy scenario. Odds ratio above 1 indicated benefit.
These trials were selected for this review if:
(1) they compared only individualized homeopathy applied for
treatment of rheumatoid arthritis with placebo or conventional
therapies;
(2) allocation to homeopathy and control was randomized; and
(3) a complete, accessible, peer-reviewed, research journal paper
was available in English language published between 1950 and
2013.

10. Gibson et al in 1980 found a significant improvement in subjective
pain, articular index, stiffness and grip strength in those patients
receiving homoeopathic remedies whereas no change was noted in
the patients who received placebo. Odds ratio of 2.060 and p-value
of0.195.
This trial lasted only six months compared to the previous study
of twelve months. The latter would be considered a more realistic
timescale for the treatment of a chronic condition, potentially
revealing statistically improved results in favor of homeopathy. In
spite of this, and the small sample size (46), the enhanced
response to homeopathy suggests that it may be a useful addition
for the treatment of RA.
Gibson et al 1978 reported the results of a pilot study in which 41
patients with rheumatoid arthritis were treated with high doses of
salicylate and the results were compared with 54 similar patients
treated with homoeopathic drugs. The patients who received
homoeopathic drugs showed better response than those who
received salicylate. Odds ratio of2.822 and p-value of .008.

11. Gibson et al. highlighted that the initial trial was methodologically
flawed for the following reasons:-
Patients who received homeopathic treatment were allowed to
continue with previous orthodox anti-inflammatory medication,
whereas patients who received Salicylates, had to discontinue
other orthodox treatment.
Patients who received homeopathic remedies were treated by a
different team of doctors than the salicylate group, therefore it
could be argued that the homeopathic response may have been
influenced by the prescriber.
Andrade et al analyzed 44 patients with active Rheumatoid
Arthritis treated with homeopathic drugs in a 6-month double-blind
placebo controlled trial. No statistically significant difference
was found between both the treatment groups. It was concluded
that the response to homeopathic drugs could be due to placebo
effect. Odds ratio of 1.406 and p-value of 0.609.

12. A number of medical tests for RA indicators were undertaken at
baseline, three and six months, in order to establish whether the
condition had worsened, stabilized or improved during the trial
These tests concluded that there was not any statistical change
from the baseline results in either group.
Although remedy prescriptions were individualized according to
patient requirements, the potencies used were limited to 5 – 30C.
This is not reflective of homeopathic practice, as many factors are
accounted for when choosing potency and dosage such as ‘energy’
of the patients, whether conventional medication is used
regularly, and the length of duration of the chronic condition
(Vithoulkas, 1980).
Again the study sample was small and patients were authorized to
continue with, or alter dosage of NSAIDs and steroidal drugs at the
physician’s discretion, thereby not eliminating this variable.
Fischer P. in sept 2001.
Fisher and Scott undertook this trial to test the hypothesis that
homeopathy is effective in reducing the symptoms of joint
inflammation in RA using a six-month randomized, cross-over,
double-blind, placebo-controlled study design.

13. Inclusion criteria
– the patient was seropositive for rheumatoid factor
– the patient was receiving stable doses of single NSAIDs for more than three
months or DMARDs with or without NSAIDs for more than six months
Exclusion criteria
– Patients with severe disability, had taken systemic steroids in the previous
six months, or had withdrawn from DMARD therapy in the previous twelve
months were excluded
Although the initial recruitment of participants was higher in number
(112) compared to the previous trials analyzed, there was a high attrition
rate , Fifty-four patients withdrew before completing the trial. Thirty-one
changed conventional medication, 10 had serious intercurrent illness or
surgery, 12 failed to attend and three withdrew consent. Placebo and
active homeopathy had different effects on pain scores; mean pain scores
were significantly lower after 3 months' placebo therapy than 3 months'
active therapy results could have been biased if the whole group was not
analyzed.
– (P=0.032 . and odds ratio of 0.344) Articular index, ESR and morning
stiffness were similar with active and placebo homeopathy.

14. A crossover trial design was utilised, and at the three month interval
participants changed over to placebo or active therapy. This type of
design is less common as there is a possibility of a residual effect of
therapy which may continue during the next period of treatment,
thereby potentially skewing results (Lewith et al., 2002). This may be
true, as remedies prescribed may affect a person’s health levels for some
time after the final dose (Gibson et al., 1980).
Finally Fisher and Scott conclude that a new investigational approach is
required which will try to discover whether homeopaths can genuinely
control patient symptoms rather than continuing to compare homeopathy
to a placebo response.
Brien S, Lachance L, Prescott P, McDermott C, Lewith G. Homeopathy has
clinical benefits in rheumatoid arthritis patients which are attributable to
the consultation process not the homeopathic remedy. A randomised
controlled clinical trial. Rheumatology. 2010. doi:
10.1093/rheumatology/keq234.

15. To assess whether any benefits from adjunctive homeopathic intervention in
patients with RA are due to the homeopathic consultation, homeopathic
remedies or both.
Exploratory double-blind, randomized placebo-controlled trial conducted
from January 2008 to July 2008, in patients with active stable RA receiving
conventional therapy. Eighty-three participants from three secondary care
UK outpatient clinics were randomized to 24 weeks of treatment with
either homeopathic consultation (further randomized to individualized
homeopathy, complex homeopathy or placebo) or non-homeopathic
consultation (further randomized to complex homeopathy or placebo).
The two primary outcome measures were: (i) the proportion of patients
meeting the ACR 20% improvement criteria (ACR20 response )
Improvement in the patient's GA of health [100-mm visual analogue scale
(VAS).
Secondary outcome were DAS 28 score , It includes both objective (ESR or
CRP and swollen joints count) and subjective (tender joint counts and
patient GA score) measures.

16. Adverse events were recorded at clinic visits (study nurse) and
between visits (patient recorded) using standardized forms.
Fifty-six completed treatment phase. No significant differences
were observed for either primary outcome. There was no clear
effect due to remedy type.
Homeopathic consultations but not homeopathic remedies are
associated with clinically relevant benefits for patients with active
but relatively stable RA.
Brien SB, Leydon GM, Lewith G. Homeopathy enables rheumatoid
arthritis patients to cope with their chronic ill health. A qualitative
study of patients' perceptions of the homeopathic consultation.
Patient Educationand Counselling. 2011; doi:
10.1016/j.pec.2011.11.008
The role of the consultation in mediating improved clinical
outcomes has been demonstrated in both conventional and
complementary medicine but to date no depth study has explored
how complementary medical consultations achieve such benefits.

17. Although no significant group differences in either of the primary
outcomes were observed, statistical and clinically relevant
improvements did occur for those receiving consultations in secondary
outcomes.
The homeopathic consultation, regardless of treatment allocation,
significantly improved standard objective markers of RA: DAS-28
ACR20) and swollen joint count. Minimizing disease activity reduces
radiological progression and improves long-term functional outcome.
RA participants perceived homeopathic consultations helped them
cope better through either enabling improved physical health,
wellbeing and/or illness management. Four themes associated with
improved coping were: receiving emotional support; exploring the
illness; exploring self; and gaining advice. Exploring the wider
narrative of their illness, enabled participants to address their
individual needs and for some, this process of increased awareness
changed their perception resulting in the perceived benefits.(p-value
=1.000)odds ratio of 1.000
Homeopathic consultations enable RA patient to cope better.

18. Practice implications
– Homeopathic consultations may provide an additional resource
for RA patients. Identifying and employing the ‘‘active
ingredients’’ that confer benefit may be appropriate for other
clinicians to maximise patient benefits from consultations.
– Synthesis of results: A total of 474 patients were recruited in the
five studies mentioned and 236 entered into the final analysis.
Study duration ranged between three months and one year.
– Majority of the studies (three out of five, 60%) reported at least
a trend in favor of the group getting homeopathic therapy

19. Summary of evidence: A total of five clinical trials on RA testing
individualized homeopathy were included in analysis. The study by
Gibson R et al yielded the most positive results favouring
homeopathy, and the study by Fisher P et al showed the poorest,
in fact, negative results.
There is evidence that studies with better methodological quality
yield less positive results in favour of homeopathy. Studies with
the higher methodological qualities, i.e. those done by Fisher P et
al and Brien S et al produced negative and null results respectively
for homeopathy. The overall pooled odds ratio of 1.259 , though
showing slightly positive trend in favor of homeopathy, but could
not produce any statistically significant difference (p=0.577).

20. Strengths and Limitations: Combining the results of individual studies
increases power and precision in estimating intervention effects.
The broad nature of the question asked in meta-analysis makes it difficult
to use conventional meta-analysis technique. A frequent criticism of
meta-analysis is that a common estimate is obtained for heterogeneous
trials, combining apples, oranges and cabbages. The pooled treatment
effect size only has clear meaning when all the trials included the similar
patients ,different interventions and endpoints. As the trials identified
vary in terms of using homeopathic treatment in a single disease RA
using different end-points , the assumption of a common underlying
treatment effect size used , seems to be inappropriate . Thus
heterogeneity, though ignored, existed in terms of using differing
outcome measures, differing intervention and comparators (either
placebo, or conventional therapies; differing in dosage, duration, mode
of intervention), differing study design (randomized / quasi-randomized;
single / double blind etc), and differing statistical tests applied. So, p-values
and combination of p values has been chosen as a more
appropriate statistical approach.
The rationale for this choice was that all the trials explored the same
broad question, i.e. “is homeopathic treatment efficacious at all?” If the
results are interpreted with suffiecient caution , this approach may
provide a way to combine results from very dissimilar trials with differing
out comes and statistical tests.

21. Immunological studies on Rheumatoid Arthritis treated with
Homeopathic drugs: Results of the Pilot Study.
Prakash Rao & Nagalakshmi Prasanna CCRH
Introduction & Objective: Rheumatoid Arthritis (RA), a systemic
disease, is characterized by a chronic inflammatory reaction in the
synovium of joints. The inflammation is mediated by inflammatory
cytokines. The objective of the study was to evaluate efficacy of
homeopathic drugs and changes in the cytokine profile of
rheumatoid arthritis patients treated with homeopathic drugs.
Materials and Methods: A total of 35 rheumatoid arthritis patients
and 10 healthy controls completedthis pilot study. The patients
were treated with Rhus tox. (8), Pulsatilla (8) and Medorrhinum
(9)according to totality of symptoms. The control group (10)
received placebo. The patients were evaluated for disease activity
at the time of enrollment in the study and after 3 weeks of therapy.
Serum cytokine levels (IL-1α, IL-1β, IL-2, IL-6 and TNF-α) were
measured at baseline and after 3 weeks of treatment.

22. Result: Patients receiving Rhus tox. showed significant
improvement in Patient Visual Analogue Score (VAS) for global
assessment of disease after 3 weeks of therapy compared to
placebo group. Patients receiving Pulsatilla showed a significant
improvement in tender joint count at the end of 3 weeks compared
to baseline. They also showed significant decrease in ESR as
compared to placebo. However, hs-CRP values in treatment groups
did not show significant difference when compared to the placebo
group at baseline and after therapy. There was a significant
decrease in IL 6 levels after 3 weeks of therapy in the patients
treated with Rhus tox. and Medorrhinum compared to placebo.
Surprisingly, there was a significant increase in IL 6 level in the
placebo group compared to their baseline values , suggesting
ineffectiveness of placebo and worsening of the disease process.
Conclusion: In the present open label placebo controlled pilot
study patients treated with 3 weeks of homeopathic drugs showed
improvement in clinical features, reduction in parameters of
inflammation and IL6 levels. These observations suggest a possible
immunomodulatory role of homeopathic drugs in Rheumatoid
Arthritis which need to be confirmed by further studies.

23. Discussion
Rheumatoid arthritis (RA) is a systemic autoimmune disease localized preferentially
in the synovial joints, resulting in joint destruction and permanent disability. There
is growing evidence suggesting that proinflammatory cytokines such asTumour
Necrosis Factor alpha (TNF-alpha), interleukin-1 (IL-1), interferon gamma (IFN-gamma)
andinterleukin-6 (IL-6), play an important role in thepathogenesis of this
disease. These inflammatory cytokines are present in the rheumatoid synovial
lmembrane and participate in cell proliferation as well as in the synthesis of
prostaglandins,metalloproteinases and other cytokines.
In the present study, patients with Rheumatoid Arthritis received homeopathic
drugs Rhus tox. (30C,200C, 1M), Pulsatilla (30C, 200C, 1M), Medorrhinum(30C,
200C, 1M) and the control group was givenplacebo. Patients receiving Rhus tox.
(group A) showeda significant improvement in Patient Visual AnalogueScore
(Patient VAS) for global assessment of diseaseat the end of 3 weeks compared to
placebo group (p =0.03). The difference was not significant at the baseline.Patients
receiving Pulsatilla (group B) showed a significant improvement only in tender
joint count (p =0.01). There was no significant improvement in other clinical
parameters of disease activity. There was no significant change in clinical
parameters in patients treated with Medorrhinum (group C). Patients receiving
placebo (group D) showed worsening in Physicianassessed Visual Analogue Score (
physician VAS) forglobal assessment of disease (p = 0.03). Patientsreceiving
Pulsatilla showed a significant decrease inESR (p = 0.02). However, hs-CRP values in
treatmentgroup did not show any significant change

24. Recently, Sivalingam et al demonstrated the cytokine profiles in RA
patients with active and inactive joint disease in a cohorot of Chinese
rheumatoid arthritis (RA) patients. The pro-inflammatory cytokines (IL-1,
IL-6, IL-8, IL-18 and TNF-á) were significantly elevated in patients with
RA, while TGF-â, an immunomodulatory cytokine, was elevated in control
individuals. When these patients were categorized as active or inactive
based on DAS scores, similar cytokines profiles were observed in the both
the disease sub-groups.
However, sTNF-R1 and sTNFR-2 were noted to be significantly elevated in
inactive RA when compared to active disease. It appears that production
of cytokine inhibitors may be associated with diminished disease
activity. Similar phenomena can explain absence of any change in TNF
alpha levels despite clinical response, in the treatment group in study.
Conforti and Lussignoli have observed reduction in IL6 levels in rat paw
edema model of inflammation.
Al Santo et al have shown Rhus tox. reduces Caraagreenan induced rat
paw edema.

25. There is no literature on cytokine profile in Rheumatoid arthritis
patients treated with homeopathic drugs. In the present study, a
significant decrease was found in IL 6 level at the end of 3 weeks of
therapy in Rhus tox and Medorrhinum groups compared to placebo
The baseline values were not significantly different in both the
groups. However, there was a significant increase in IL 6 level at the
end of 3 weeks of therapy in placebo group, compared to baseline
values suggesting worsening of the disease process due to
ineffectiveness of Placebo.
At present it is still not clear whether the homeopathic drugs are
‘ineffective, the observed clinical effects are ‘placebo response’ or
genuine clinical effects. In the present open label placebo
controlled pilot study homeopathic treatment was found to be
effective in some patients with rheumatoid arthritis and changes
were noticed in a few inflammatory parameters. No side effects
were reported in patients treated with homeopathic drugs.
However, the significance of the results of this pilot study cannot
be judged at present due to a small sample size and measurement
of only a few inflammatory cytokines.

26. The initial trend shown by the present pilot study suggests that
some homeopathic drugs may be superior to placebo in the
treatment of Rheumatoid Arthritis. Of the measured cytokines, we
found that IL6 was reduced following treatment, suggesting an
immunomodulatory effect. Homeopathic drugs may work by
reducing pro-inflammatory and increasing anti inflammatory
cytokines. Confirmation of the immunomodulatory properties of
the homeopathic drugs requires measurement of a large number
of pro and anti-inflammatory cytokines. It should further be
confirmed by in-vitro proliferation .

27. To evaluate the role of homoeopathic medicines as add-on
therapy in patients with rheumatoid arthritis on NSAIDs: A
retrospective study.
DR KUNDU IJRH APRIL 2014.
Background: Conventional management of Rhematiod Arthritis (RA)
includes administration of Non- Steroidal Anti- Inflammatory Drugs
(NSAIDs), disease modifying anti-rheumatic drugs (DMARDs) like
Methotrixate and anti-tumor necrosis factor . Gastric ulcers, bleeding and
perforation are the most common known adverse reactions found
associated with excessive consumption of NSAIDs. The homoeopathic
system of medicine improves the general well being, that is, Quality of
Life (QoL) in addition to reducing the pain and disability.
Objective: To evaluate the patients with RA receiving homoeopathic
medicines with respect to QoL, Disease Activity Score (DAS), Erythrocyte
Sedimentation Rate (ESR), morning stiffness/pain and frequency of
analgesics after homoeopathic intervention.
Design: This is a retrospective analysis of the role of homoeopathic
medicines in RA. Patients diagnosed as sero-positive for RA antigen
receiving homeopathic medicines were analysed for DAS, QoL, frequency
of analgesics, ESR and pain/morning stiffness.

28. Materials and Methods: Ten cases testing sero-positive for RA with at
least four clinical signs were evaluated from single homoeopathic Out-
Patient Department (OPD) from February 2009 and February 2011. Cases
were analysed to find out the role of homoeopathic constitutional
similimum in people with RA. Changes in DAS, ESR, pain/morning stiffness
and QoL were considered as outcome measure.
Results: Homoeopathic constitutional medicines were found to reduce
the intensity of pain in patients with RA along with reduction in
consumption of NSAIDs . The DAS reduced in all 10 patients . The QoL
was also found to improve under homoeopathic medication and no
further deterioration joint/disability was observed in any of the 10
patients. Mean ESR improved to 19.5 from 38.1 . Out of 10, 3 (30%)
patients were found to be sero-negative after homoeopathic
constitutional similimum.
Conclusion: Homoeopathic constitutional similimum improves the QoL of
patients with RA by reducing intensity of pain, limiting disability and
reducing disease activity, thus causing improvement in general and
disease condition in particular. It also limits the need of analgesics and
DMARDs in RA.,

29. Discussion
RA, a destructive joint disease, affects the articular cartilages leading to limited
movement at the affected joint or in advance cases causing deformity of the joint
making the patient disabled and dependent. The diagnosis is made by the clinical
signs and symptoms along with positive serological tests. Joint count is a major
component of DAS,( Joint tenderness, joint swelling) and ESR are measures of
inflammatory activity and are included in the core data set of measures of DAS for
use in clinical research and control of inflammatory activity according to these
measures is regarded as an effective strategy to prevent long-term damage. Joint
score includes swelling, tenderness and pain on motion, limited motion and
deformity. Holistic treatment of the disease involves relief of the symptoms of
disease, that is pain, tenderness and limited mobility of joints, and also the
improvement in the QoL to carry out daily activities independently
A minimum difference of 4 in pain scale was considered significant. QoL also was
found to improve under homoeopathic constitutional similimum. The change from
one grade to another was considered as significant. Arsenic album, Belladonna,
Calcarea carb, Lachesis, Pulsatilla, Causticum, Nux vomica, Silicea, Cocculus,
Sulphur, Sepia, Aurum metallicum were used as constitutional similimum given
singly at one occasion depending upon the totality of symptoms . The potency,
dose and its repetition was done according to the individual susceptibility. Rhus
tox and Bryonia alba were prescribed in cases where patient did not respond
after administration of constitutional drug for next 2 days in acute phase. The
patients are continuing homoeopathic medicines as required on account of pain
caused by climactic

30. There were two distinct observations during the study. i) Patients
revealed negative rheumatoid factor on laboratory investigations
still complained of occasional arthralgia on weather change. ii)
Where the serum is positive for rheumatoid factor but no or
minimal physical symptoms are complained by the patients.
These varied reactions during the treatment period with
homoeopathic medication to the individual susceptibility and
sensitivity, need to be further studied by considering large samples.
The results of this observational study lead to investigate the
efficacy of homoeopathic medicines in such degenerative
disorders from controlled trials on large sampleand namely on
two different samples, namely sero-negative and sero-positive RA.
No HAQ(health assessment quesstionnare) was used in the study.

31. Physical, psychosocial and economic impact of rheumatoid
arthritis: A pilot study of patients seen at a tertiary care referral
centre
AMITA AGGARWAL, SHELLY CHANDRAN, RAMNATH MISRA
Nationall Medical Journal of India 2006;19:187–91
Background. Rheumatoid arthritis is associated with marked physical
disability. In addition, it has an impact on patients’ psyche and social
well-being, and entails a major financial burden. The impact of the
disease in different cultural and social backgrounds is varied. Limited
data are available from India on this aspect.
Methods. Patients with rheumatoid arthritis satisfying the 1987 modified
American College of Rheumatology criteria were included. Besides
demographic data, functional impact was assessed using the Health
Assessment Questionnaire (HAQ). The psychosocial impact was
measured using the medical outcomes study short form 36 (SF-36) with
minor modifications. Data on direct and indirect health costs were
collected by direct interview.

32. Results. The mean age of 101 patients (90 women) was 43.2 years
and mean duration of disease was 8 years. Their mean (SD) HAQ
score was 0.97 (0.69) with 8 patients having scores >2. On the SF-
36 scale (0–100) the mean (SD) score for various domains were:
physical functioning 49.90 (28.55), social functioning 55.51 (20.59),
role limitation due to physical problems 32.67 (41.34), role
limitation due to emotional problems 47.54 (40.08), mental health
47.36 (7.99), general health perception 52.38 (8.30), energy and
vitality 58.56 (6.09), and bodily pain 49.26 (18.87).
The summary score for the physical component was 37.95 (9.03)
and for the mental component it was 47.71 (4.81). The annual
average total cost burden per patient was Rs 16 758, of which Rs
11 617 (67%) was spent on health services and the rest on non-health
services (travel, home help and loss of wages).
Conclusion. Rheumatoid arthritis causes significant physical and
social disability besides being an economic burden. Indian patients
had good scores for mental and social health suggesting good
family support systems or reluctance to express their feelings
despite physical disability.

33. INTRODUCTION
Patients with RA have a 7-fold higher risk of disability as compared
with age- and gender-matched controls. They gradually lose their
functional capacity and at the end of 15 years nearly 30%–50% of
the patients are in functional class III/IV and need help for
vocational/self-care activities.
Along with functional disability, RA has an impact on the
emotional and psychological functioning of the patient. support
system. Thus, it is likely that the impact of RA will be different in
India .
In India, it is difficult to make an accurate assessment of economic
burden as most patients with RA are homemakers and calculating
their contribution in economic terms is difficult. We assessed the
direct costs incurred on the disease such as cost of drugs,
laboratory tests and travel for consultations. Indirect costs
included loss of wages, need for home help, etc.

34. DISCUSSION
This is possibly the first study in India to show that RA has a major economic impact
and the cost does not increase proportional to disability due to limited income. Our
data also show that RA has a considerable impact on the physical, emotional and mental
health of patients. Further, the mental and social scores are better than the physical
scores
Spending nearly Rs 17 000 annually on RA means that almost 15% of the household
income is spent on expenses related to the disease. Direct costs constituted two-thirds
of the total costs. In the West, indirect costs are more than the direct costs due to loss
of wages, home help, etc. In India, as most patients are either homemakers or men
working in a joint family business or government jobs, loss of wages is not a major
contributor to the cost of RA. In the only study available, in Parkinson disease, the
annual expenditure was reported to be Rs 7372. This difference could be due to a
difference in treatment for the two diseases as well as the lower average annual
income of those patients compared with our group .
In most studies from the West, the cost of RA increases with the duration of the
disease due to accumulation of damage. In contrast, we did not find any association
with duration of the disease, as most patients could not afford joint replacement,
special devices, biological agents, etc. A correlation has also been found between
healthcare costs and SF-36/HAQ-DI scores This is due to an increase in visits to the
physician, hospitalization and drug costs with increasing disability. However, due to a
ceiling effect on spending related to low income of the family we did not find a good
correlation between HAQ and cost of treatment.

35. study has a few limitations.
First, it is a cross-sectional study, SF-36 can change over a period of time
with control of disease activity.
Second, SF-36 has not been validated in our population as an instrument
for QOL.
Third, the direct and indirect cost calculations are at best a rough
estimate. Furthermore, our patient population consists of middle class
people, so these data may not be applicable to the general population.
Thus, RA causes significant disability in all domains of health. Indian patients
have better scores on mental health, probably due to a better family support
system. Due to a low income, most patients cannot afford the current state-of-
the-art treatment. Early effective treatment may not only postpone and
retard disease progression, thereby improving the QOL, but also decrease
costs by preserving productivity and reducing the need for surgery and
admission to hospital. Data are beginning to accumulate on the excess costs
associated with biological therapies and other new second-line drugs. There is
a need to analyse the economic impact of RA in India in a larger sample size,
so that policy-makers can provide ways to optimize the treatment of
patients with RA.

36. CONCLUDING COMMENTS BY VITHOULKAS
Clinical trial of homeopathy in rheumatoid arthritis, Letter to the Editor, Homeopathy (2011)
100, 300, G Vithoulkas
According to my clinical experience, in severe pathology such as rheumatoid arthritis
of long standing, there is a need for a series of homeopathic remedies and long follow
ups for 2 or 3 years2,3 in order to achieve substantial amelioration. Prolonged
treatment is required to give the organism enough time to slowly decrease the intake
of anti-inflammatory drugs replacing them with the correct homeopathic remedies as
indicated by the altered symptomatology. In this study this parameter was ignored.
Unlimited use of anti-inflammatory drugs causes the following problems:
The homeopathic prescription of the indicated remedy is based on fine individual
characteristic symptoms.
When the organism is treated with strong chemical drugs the symptoms on which a
homeopathic prescription is based are masked, changed or totally suppressed so the
homeopath cannot find the ‘totality’ of the symptoms required in order to discover the
indicated remedy.

37. Even if the correct remedy was found, daily anti-inflammatory drugs
would nullify the beneficial effect of the homeopathic remedy. It is
well known in homeopathy that even the daily use of coffee can
nullify the effect of the treatment, that is why even one cup of
coffee is not allowed during treatment though it contains a
relatively small amount of caffeine.
• In homeopathy only one remedy will act curatively. It acts like an
allergen in a sensitive organism. But if the correct remedy was
given there will be a prolong initial aggravation which may lead to
increased intake of drugs. Only if patients are informed about this
aggravation can tolerate it.
• Initial aggravation indicates that the remedies prescribed were the
correct ones. The lack of such an aggravation in the study proves
that the remedies prescribed were mostly wrong and therefore
ineffective.

38. • Furthermore, the choice of the potency was unfortunate as the 50
millesimal potencies that were used in the experiment are the
weakest in our armamentarium, to be used only in simple
pathology cases and certainly not together with chemical drugs.
• In deep chronic cases of rheumatoid arthritis where swellings of
joints, deformities and pain are present, homeopathy cannot offer
an immediate curative effect. If there is any possibility for a
substantial amelioration-reduction of the deformities, swelling of
joints and pains-such an amelioration will come gradually after a
series of remedies over a period of 2-3 years.
• The conclusion of the study that the effect was due to ‘consultation’
and not to the homeopathic remedy appears to be biased for two
reasons:
• There was no substantial amelioration of the pathology in any
group to compare and on which to base conclusions.
• The placebo effect in such deep pathology cases is superficial and
transient as the patient remains in essence with the same frame of
pathology.

39. Anti-rheumatoid and anti-oxidant activity of homeopathic
Guaiacum officinale in an animal model
Homeopathy
Volume 103, Issue 2, April 2014, Pages 133–138
Background
Homeopathy is a popular form of complementary and alternative medicine. Guaiacum extract is
said to be useful for pain and inflammation, but there appears to be no scientific evidence to
support this.
Aims
The aim of the present study was to evaluate the anti-rheumatic and anti-oxidant activity of
homeopathic preparations of Guaiacum officinale (Gua) on experimental animal model.
Design
Rheumatoid arthritis (RA) was induced in male albino rats by Freund's complete adjuvant (FCA) at
a dose of (0.25 mg heat killed Mycobacterium tuberculosis/ml of emulsion). Gua mother tincture
(MT) (prepared from the latex part of the plant) (MT), Gua 30cc and 200cc were purchased
commercially from King Company, Kolkata, India. Male albino Wistar rats (130 ± 10 g) were divided
into 6 groups: Sham control; Arthritis control; Standard treatment
indomethacin (0.25 mg 100 g−1 p.o. × 5 alternative days), Gua MT (1 ml kg−1 p.o. × 5 days)
treated; Gua (30c 1 ml kg−1 p.o. × 5 days) treated; Gua (200c; 1 ml kg−1 p.o. × 5 days) treated. Anti-rheumatic
activity was examined through physical, urinary, serum parameters. All the results were
expressed in terms of mean ± SEM (statistical error of mean n = 6) at each dose level. The level of
significance was determined through one-way analysis of variance (ANOVA), p < 0.05 was
considered significant.

40. Results
It was observed that body weight, ankle and knee diameter, urinary
parameters (hydroxyproline (OH-P), glucosamine, calcium (Ca2+),
creatinine (CRE), phosphate (PO4
3−)), serum ACP (acid
phosphatase)/ALP (alkaline phosphatase)/Ca2+/CRE/PO4
3−/gamma-glutamyl
transferase (GGT)/Lipid peroxidation (LPO)/Glutathione
(GSH)/Superoxide dismutase (SOD)/Catalase, serum GGT, serum
interleukins like TNF-α/IL-6, IL-12/IL-4/IL-6 levels were significantly
affected. After treatment with Guaiacum in all 3 regimes was
associated with normalization of these parameters compared to
control group.
Conclusion
These findings suggest that homeopathic G. officinale possesses
anti-rheumatic and anti-oxidant activity in experimental animal and
these activities may be more significant in higher potencies.

41. MISCELLANIOUS
Subcutaneous nodules are seen in 5% to 10% of cases in India
compared to 25% in Western counterparts. These nodules vary in
size and are seen over the pressure points like the olecranon
process, scapula, sacrum and the occiput.

42. • International Journal of Clinical Cases and Investigations 2012.
Volume 4 (Issue 3), 67:74, 1st October 2012
•
• Abstract:
•
• Two rare cases of vasculitis in rheumatoid arthritis patients are
reported. Studies have shown that the 5-year mortality rate is 30%
to 50%, with even higher rates of morbidity related to disease
complications or vasculitis treatment–related toxicity. Thus early
diagnosis of rheumatoid vasculitis with proper selection of the most
appropriate treatment option is critical to reduce morbidity &
mortality due to disease complications & vasculitis treatment
related toxicity.

43. • Rheumatoid vasculitis is a rare but serious complication of
rheumatoid arthritis. Incidence of Rheumatoid vasculitis is
approximately 1% of all rheumatoid arthritis cases8. Rheumatoid
vasculitis is defined as a clinicopathologic manifestation of RA
characterized by tissue damage or ischemia verified pathologically
by vasculitis1.
•
• The skin or peripheral nerves are involved in more than 80% of
patients13. Major organ system involvement of the heart, bowel, or
kidney is much less common but can lead to significant morbidity
and mortality, including myocardial infarction, bowel ischemia, and
renal failure.
•

44. • Uncontrolled systemic inflammation promotes early and more
aggressive atherosclerotic vascular disease that may mimic
vasculitis manifestations. Thus histopathologic confirmation of
vasculitis is diagnostic. Histopathology reveals mononuclear cells or
neutrophilic infiltration of the vessel wall of small and medium
vessels. Features of vessel wall destruction are often found,
including necrosis, leukocytoclasis, and disruption of the internal
and external elastic lamina. Inflammation of greater than three cell
layers of the vessel is a sensitive and specific finding to distinguish
rheumatoid vasculitis from RA without vasculitis18
•
• Skin manifestations include petechiae, purpura, ulcers, digital
infarct, digital gangrene & pyoderma while peripheral nervous
system manifestations include distal sensory or motor neuropathy
& mononeuritis multiplex. Other major systemic involvement could
be in the form of corneal ulceration, scleromalacia, alveolar
hemorrhage, fibrosing alveolitis, myocardial infarction,
cardiomyopathy, interstitial nephritis, glomerulonephritis, gastro-intestinal-
ulcerations, ischemic bowel, arteritis of liver, spleen,
pancreas, seizures, transient ischemic attack & stroke.

45. • Biopsy of skin lesions has the highest yield of up to 75% in diagnosing
rheumatoid vasculitis where as sural or peroneal nerve and gastrocnemius,
rectus femoris or peroneous brevis muscle biopsies has minimal morbidity
and yield of around 50%18. Angiographic findings are nonspecific and
should not be substituted for a tissue-confirmed diagnosis, except in the
setting of bowel ischemia. Other lab findings include anaemia of chronic
inflammation, raised ESR or CRP, polyclonal hypergammaglobulinemia, RA-associated
autoantibodies, reduced complement levels during active
disease.
• Atypical features found in both of our cases were early age of presentation,
shorter duration of disease & no joint deformities/bony erosions where as
rheumatoid vasculitis normally occurs in older age, long disease duration &
with joint deformities & other extraarticular manifestations

49. Compiled by:
Dr Neena Mehan (Reader NFSG)
Dr Pavneet Kaur

50. REFERENCES
• Rheumatology (Oxford). 2011 Jun.
Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation
process but not the homeopathic remedy: a randomized controlled clinical trial.
Brien S1, Lachance L, Prescott P, McDermott C, Lewith G.
• Immunological studies on Rheumatoid Arthritis treated with Homeopathic drugs: Results of the Pilot Study
Prakash Rao & Nagalakshmi Prasanna M
Vol. 2, No. 4, October-December 20
• Musculoskeltal comlaints improve with homeopathy.
www.alternativ.no/Nyheter/pdfnyhet/rapport_homeopati_muskel.pdf
• Inducing remission in Rheumtoid arthritis.
www.thelancet.com/journals/lancet/article/PIIS0140-6736(81)90065-9
• Research in Homoeopathy - Hpathy.com
hpathy.com › Scientific Research
• A Randomized Controlled Trial to Evaluate the Effectiveness ...
informahealthcare.com/doi/abs/10.3109/03009749109103022
by LEC Andrade - 1991.
• Latest research in Homeopathy - Scribd
www.scribd.com/doc/34274168/Latest-research-in-Homeopathy.