Homeopathy (2012) 101, 84e91

Ó 2012 The Faculty of Homeopathy

doi:10.1016/j.homp.2012.02.002, available online at http://www.sciencedirect.com

ORIGINAL PAPER

Homeopathy in chronic sinusitis: a prospective

multi-centric observational study
Chaturbhuja Nayak1, Vikram Singh1, VP Singh1, Praveen Oberai1,*, Varanasi Roja1, Shashi Shekhar Shitanshu1,
MN Sinha2, Deepti Deewan2, BC Lakhera3, Sunil Ramteke4, Subhash Kaushik5, Sarabjit Sarkar6, NR Mandal7,
PG Mohanan8, JR Singh9, Sabyasachi Biswas9 and Georgekutty Mathew6
1
Central Council for Research in Homoeopathy, New Delhi, India
2
Regional Research Institute (H), Jaipur, Rajasthan, India
3
Clinical Research Unit (H), Gangtok, Sikkim, India
4
Regional Research Institute (H), Shimla, Himachal Pradesh, India
5
Central Research Institute (H), Noida, Uttar Pradesh, India
6
Clinical Research Unit (H), Shillong, Meghalaya, India
7
Clinical Research Unit (H), Agartala, Tripura, India
8
Central Research Institute (H), Kottayam, Kerala, India
9
Regional Research Institute (H), Guwahati, Assam, India

Objective: The primary objective was to ascertain the therapeutic usefulness of

homeopathic medicine in the management of chronic sinusitis (CS).
Materials and methods: Multicentre observational study at Institutes and Units of the
Central Council for Research in Homoeopathy, India. Symptoms were assessed using the
chronic sinusitis assessment score (CSAS). 17 pre-defined homeopathic medicines were
shortlisted for prescription on the basis of repertorisation for the pathological symptoms
of CS. Regimes and adjustment of regimes in the event of a change of symptoms were
pre-defined. The follow-up period was for 6 months. Statistical analysis was done using
SPSS version 16.
Results: 628 patients suffering from CS confirmed on X-ray were enrolled from eight
Institutes and Units of the Central Council for Research in Homoeopathy. All 550 patients
with at least one follow-up assessment were analyzed. There was a statistically signifi-
cant reduction in CSAS (P = 0.0001, Friedman test) after 3 and 6 months of treatment.
Radiological appearances also improved. A total of 13 out of 17 pre-defined medicines
were prescribed in 550 patients, Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of
55), Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to be most useful having
marked improvement. 4/17 medicines were never prescribed. No complications were
observed during treatment.
Conclusion: Homeopathic treatment may be effective for CS patients. Controlled trials
are required for further validation. Homeopathy (2012) 101, 84e91.

Keywords: Chronic sinusitis; Prospective observational study; Homeopathy

*Correspondence: Praveen Oberai, Central Council for Research
in Homoeopathy, Clinical Research, 61-65, Institutional Area,
Janakpuri, New Delhi 10058, India.
E-mail: oberai.praveen@gmail.com
Received 3 May 2011; revised 14 December 2011; accepted 6
February 2012
Introduction
Respiratory tract infections are the most common type of
infections managed by health care providers. Of all the
respiratory infections, sinusitis is one of the most common,
it interferes with patient’s quality of life and loss of work
productivity. Chronic rhinosinusitis (CS) is characterized
by inflammation of the mucosa of the nose and paranasal
sinuses of at least 12 weeks duration.1 The cause of CS is
multi-factorial: anatomic, genetic and environmental

which leads to a vicious cycle of infection, swelling and
blockage.2 It is the fifth most common disease for which
antibiotics are prescribed.3
The treatment of CS remains an unmet need. Awide range
of medical and surgical therapies have been used to treat CS.
Medical therapy includes antibiotics, corticosteroids, decon-
gestants, antihistamines, anti-leukotrienes, nasal douching,
immunotherapy and reduction of environmental factors.2
Systemic and topical antibiotics are used in CS with an
aim to eliminate infection and inflammation, however antibi-
otics are often prescribed inappropriately and this leads to
increased drug resistance among respiratory pathogens4
and treatment costs.5 Nasal saline irrigation as a sole modal-
ity and as an adjunct to medical treatment is beneficial.6
Surgical treatment is reserved for refractory cases only.6
Homeopathic therapy is associated with improvement in
a range of chronic and recurring pathologies7e10 and
respiratory disorders.10,11 Several controlled trials12e15 and
observational studies16e19 were carried out on sinusitis
(acute and chronic) with homeopathic combination
remedies, but these studies may be questioned on grounds
of lack of individualization.20 In India homeopathy has
wide acceptance and about 12.66% of Indian population pre-
fers homeopathy amongst other AYUSH system.21
Peters et al.22 suggested certain homeopathic medicines
after repertorising the disease symptoms of sinusitis but to
be prescribed after individualization according to homeo-
pathic principles. These include Mercurius (Merc.), Kalium
bichromicum (Kali bi.), Silicea (Sil.), Kalium iodatum (Kali.
Iod.), Lycopodium clavatum (Lyc.), Nux vomica (Nux vom.),
Pulsatilla (Puls.), Arsenicum album (Ars.), Graphites
(Graph.), Sticta pulmonaria (Stic.). A study previously con-
ducted by Central Council for Research in Homoeopathy
(CCRH) on sinusitis showed positive results23 but lacked
proper investigations. A study by Witt et al.24 showed
improvement in symptoms related to CS and quality of
life. Questions have been raised as to whether clinical trials
reflect ‘real-world’ clinical care25 while observational stud-
Homeopathy in chronic sinusitis
C Nayak et al
85
ies using large cohort of patients and long period of follow up
have been used to monitor the pragmatic everyday practice
and can provide useful information.9 This observational
study on CS was based on individual symptom complexes
together with positive findings on X-ray.
Objectives
The primary objective of this study was to ascertain ther-
apeutic usefulness of homeopathic medicine(s) in the man-
agement of chronic sinusitis (CS). The secondary objective
was to assess the effect of homeopathic medicines on
changes radiological appearances of CS.
Materialand methods
Study design
This is a prospective observational study. Patients were
recruited between October 2005 and March 2010 from
eight Institutes and Units of the CCRH, India. These
were the Central Research Institutes (H), Kottayam and
Noida; Regional Research Institutes (H), Shimla,
Guwahati, and Jaipur; Clinical Research Units (H),
Agartala, Gangtok and Shillong. Investigators with at least
5 years experience of homeopathic practice were responsi-
ble for prescribing homeopathic medicines, collecting data
and for follow ups. The investigators were trained in the
protocol before initiation of the study. All patients gave
written informed consent. The study received ethical
approval from the ethical committee of the CCRH and
complied with the Declaration of Helsiniki.26
The symptoms and signs of patients were rated using
a chronic sinusitis assessment score (CSAS) (Table 1).
This symptom score consists of 17 questions related to
CS, it was developed by the Council to assess the symp-
toms of enrolled patients. Each symptom is scored 0e3.
The CSAS at baseline was subdivided into mild (3e10),
moderate (11e17) and severe (18e24).

Table 1 Chronic sinusitis assessment score (CSAS)

Symptoms/signs Score

0 1 2 3

Nasal obstruction Nil Some times of the day Always Bilateral compelled to
breathe through mouth
Post nasal drip Nil Infrequent Frequent
Nasal discharge Nil Infrequent Frequent
Headache Nil Mild to moderate Severe
Facial pain or pressure Absent Present
Sense of smell Normal Hyposmia Anosmia
Epistaxis Absent Present
Cough Nil Infrequent Constant/frequent
Halitosis Absent Present
Fever Absent Present
Nasal mucosa Normal Swollen, red
Turbinates Normal Swollen
Maxillary sinus tenderness Absent Present
Frontal sinus tenderness Absent Present
Ethmoidal sinus tenderness Absent Present
Pharynx Healthy Unhealthy
X-ray sinuses Translucent Haziness/Opaque

Total Score = 24; mild (3e10), moderate (11e17) and severe (18e24).

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Physicians specialized in ear, nose & throat and a radiol-
ogist were involved as consultants for diagnosis and follow
up throughout the study period at each centre.
Inclusion and exclusion criteria
Patients aged between 10e60 years of both sexes, with
positive findings of sinusitis in X-ray, who were able to
stop all other treatments for at least 2 weeks before enrol-
ment and resided within reasonable travelling distance
from the study site were included in the study.
Patients suffering from diabetes mellitus and other sys-
temic diseases, acute sinusitis (<12 weeks duration), nasal
polypus, severe deviated nasal septum, CS with complica-
tions (orbital cellulitis, orbital abscess, frontal sub periosteal
abscess, epidermal abscess, subdural empyema, meningitis,
cerebral abscess, dural vein thrombophlebitis, cavernous
sinus thrombosis), or who did not match the prescribing
criteria for one of the predefined medicines were excluded
from the study.
Selection of the pre-defined trial medicines and follow up
The selection of pre-defined trial medicines was arrived at
by repertorising the disease symptoms of CS.27 Repertorisa-
tion was done using the Complete Repertory from CARA
professional software28 (Table 2). The first 17 medicines
ranking first or second grade in the rubric “inflammation,
chronic, sinusitis” were taken as pre-defined trial medicines.
These are: Kalium iodatum (Kali.i.), Silicea (Sil.), Calcarea
carbonica (Calc.), Kalium bichromicum (Kali. bi.), Lycopo-
dium (Lyc.), Hepar sulphuris Calcareum (Hep.), Mercurius
solubilis (Merc.), Arsenicum album (Ars.), Phosphorus
(Phos.), Pulsatilla nigricans (Puls.), Sanguinaria canaden-
sis (Sang.), Hydrastis canadensis (Hydr.), Cuprum metalli-
cum (Cupr.), Nux vomica (Nux v.), Thuja occidentalis
(Thuj.), Kalium chloricum (Kali.chl.), and Kreosotum
(Kreos.). The first prescription and subsequent prescriptions
if required were from these 17 medicines.
Selection of the specific medicine for each patient was
on the basis of the highest value on repertorisation of the
presenting signs and symptoms of the patient and further
guided by the characteristic mental/emotional and physical
attributes of the patient verified from Materia Medica.
The investigator was free to change prescription up to three
times including first prescription. However, if the selected
medicine based on individualization was not one of those
included in the pre-defined trial medicines then the patient
was not included in the study but was treated in general
Outpatient Department.

Table 2 Repertorial chart for consideration of 17 pre-defined trial medicines

Rubrics Sil. Kali. Calc. Kali Bi Lyc. Hep. Merc. Ars. Phos. Puls. Hydr. Sang. Cupr. Nux.v. Thuja Kali. Kreos.
Iod Chlor.

22/9 20/11 19/10 19/11 18/8 17/8 17/9 16/8 16/10 15/9 14/6 14/9 13/6 12/6 11/8 10/6 7/5

INFLAMMATION chronic, sinusitis 3 2 2 2 3 2 3 2 2 2 3 2 2 2 2 2 2

PAIN general extending sinus,
to frontal
HEAVINESS, forehead sinuses, 1
frontal
GENERAL, catarrhal closure of
frontal sinuses, due to
DULL forehead extending
to sinuses
PAIN pressing sinus, maxillary
LOCALIZATION forehead middle 3 1 2 2 2 2
frontal sinuses from chronic
PRESSING forehead middle, 2 1 2 1 2 1
frontal sinuses
CATARRH general extending 1 1 1
to antrum of highmore maxillary
sinuses
CATARRH general extending 3 2 2 2 3 2 3 2 2 2 3 2 2 2 2 2 2
to frontal sinuses
PAIN general sinuses ethmoidal
PAIN general sinuses maxillary
SINUSES, complaints of 3 2 1 1 1 2 1 1 1 1 3 1 1
SINUSES, complaints of frontal 1 1 1 1 1 1 1 1 1 1 1 1
Nose obstruction general
PAIN, extending to nose root
of nose
PAIN, forehead, nose, above 3 2 1 2 1 2 1 3 1 1 1
root of
Catarrh, post nasal 2 2 2 3 2 3 1 2 1 1 2 1
(posterior nares)
Smell, wanting, lost 3 2 3 2 2 3 3 2 3 3 2 2
OBSTRUCTION general 3 2 3 3 3 2 2 3 3 3 2 2 2 3 1 2 1
OBSTRUCTION general night 1 2 1 3 2 1 1 1 3
OBSTRUCTION general night
cannot breath through nose
OBSTRUCTION general 1 1 1 1
headache with

Homeopathy

The prescription of the selected medicine started with
30CH potency, in a single dose (four pills of globule No.
30) followed by placebo (four pills of unmedicated glob-
ules No. 30), daily. Follow up was weekly for the 1st
month, fortnightly for the next 2 months and monthly for
the remaining period until completion of 6 months. On
each of these visits, clinical assessment was done by the in-
vestigator, ENT specialist. Radiological examination was
conducted at baseline, 3 months and 6 months by the radi-
ologist at the respective centres. Patients were free to report
at any time during adverse events or emergency situations.
In event of any adverse emergent condition, patients were
to be referred for emergency medical care.
All the patients were advised to use steam inhalation once
a day, to drink plenty of warm fluid, to do breathing exer-
cises and avoid swimming as part of general management.
Any change (improvement/deterioration) triggered ad-
ministration of placebo or change in potency (from 30C
to 200C or 1M) or change in remedy following the guide-
lines of Hahnemann20 and Kent.29 The guidelines were:
Homeopathy in chronic sinusitis
C Nayak et al
87
4. If amelioration of presenting complaints is accompanied
by recurrence of old symptoms: continue placebo, till the
improvement continues.
5. If old symptoms recur but do not resolve spontaneously:
same medicine in same potency repeated and then follow
3 above. If there was no perceptible improvement after
adequate repetition of medicine in different potencies,
change of medicine to be considered.
For acute exacerbations of CS, the medicine selected
was either a continuation of the pre-selected medicine, or
a better indicated trial medicine. This medicine was pre-
scribed repeatedly according to the intensity of the acute
exacerbation.
Outcome assessment and statistical analysis
Outcome status of the treatment was calculated using the
formula:
Baseline score  Score at end
Outcome ¼  100
Baseline score

1. If improvement continues (CSAS score reduced): pla- Changes were graded as:
cebo to continue.  Marked improvement (75e100%),
2. If improvement stops (same score): repeat the medicine  Moderate improvement (50% to <75%),
(first prescription) in the same potency.  Mild improvement (25% to <50%),
3. If no further amelioration occurs after medicine is given  Not significant improvement (<25%),
in same potency or improvement lasts for a very short  Static (no change), and
period: give higher potency of same medicine.  Worse (increase in CSAS).

ASSESSED FOR ELIGIBILITY

N= 2265

TOTAL CASES EXCLUDED & REASONS THEREOF: N=1637

Severe DNS=80
Failed to undergo investigation after screening=46
Investigations found to be negative=229
Investigation not reported=3
Neck stiffness=17
Diabetes mellitus=109
Nasal polypus=118
Headache for other reasons=89
Other chronic diseases =81
Acute sinusitis=104
Refused to participate=498
Failed to report again=68
Chronic sinusitis with complications=33
Unable to comply study protocol=80
Other reasons=64
Rejected by ENT specialist=9
Systemic disease=9

TOTAL RECRUITED: N=628

LOST TO FOLLOW UP: N=117

Loss to follow up before 3 months=67
Data lost completely=2
Non-adherent to protocol=9
Dropped after 3 months of treatment but
were considered for analysis under ITT
principle=39

ANALYZED: N=550
(511 followed up for 6 months
irrespective of x-ray follow up +
39 dropped after three months
of treatment)

Figure 1 Flow of patients throughout the study.

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Statistical analysis (Statistical Package for Social Sci- Table 3 Baseline data of patients in the study
ence version 16) followed the intention to treat approach: Baseline population n (%) Mean  sd Median
patients who were followed for $3 months were included (IQR)
in the intention to treat analysis. The last observation carry
forward method was used to fill the missing values. Total patients 550 (100)
Age in yrs
As most data had skewed distribution non-parametric  Total 550 (100) 29.7  11.6
methods were used, therefore dispersion is represented  Male 257 (47) 30.01  12.1
with median and interquartile range (IQR). Non-paramet-  Female 293 (53) 29.44  11.1
Institutes/units
ric statistical tests were applied. Effect p
size
ffiffiffiffi was calculated  RRI (H), Jaipur 102 (18.6)
basing on the formula: Effect size = Z= N , where Z is the  RRI (H), Shimla 101 (18.4)
Z score and N represents total number of observations.30  CRU (H), Gangtok 96 (17.4)
 CRI (H), Noida 81 (14.7)
Effect size is classified as r = 0.5, large; r < 0.3, medium;  RRI (H), Guwahati 66 (12.0)
r = 0.1, small. P-value < 0.05 was considered as significant.  CRI (H), Kottayam 47 (8.5)
 CRU (H), Agartala 31 (5.6)
 CRU (H), Shillong 26 (4.7)
Results Duration disease 550 (100) 13.74  35.5
in years
A total of 628 patients were enrolled in the study at the Sinusitis
 Maxillary 410 (74.5)
eight centres. Figure 1 shows the flow of patients through  Frontal 24 (4.4)
the study. This paper reflects the analysis of 550 patients  Ethmoidal 1 (0.2)
suffering from CS including 39 patients who dropped out  Pansinusitis 8 (1.4)
 Maxillary + frontal 84 (15.2)
from the study after 3 months of treatment. A total of  Maxillary + ethmoidal 4 (0.7)
355 patients, had a full set of X-rays done at baseline, 3  Frontal + ethmoidal 1 (0.2)
and 6 months. Of the 17 pre-defined trials medicines,  Maxillary + frontal + 18 (3.3)
ethmoidal
four medicines were not prescribed as they did not cover Causative factor
the prescribing totality identified by the treating doctor.  Allergic rhinitis 326 (59.2)
These are Kreos., Kali. chl., Hydr., Cupr. So the data of  Deviated nasal 55 (10.0)
septum (mild)
13 medicines out of 17 pre-defined trial medicines will  Not known 163 (29.6)
be discussed henceforth. Throughout the study period Symptoms/signs of CS
each enrolled patient was prescribed one medicine of these  Nasal obstruction 535 (97.3) 2.12  0.9 2 (1e3)
 Posterior nasal dripping 503 (91.4) 1.42  0.6 2 (1e2)
medicines only. A change of prescription was also amongst  Nasal discharge 512 (93.1) 1.53  0.6 2 (1e2)
the 13 pre-defined medicines only. Table 3 shows the base-  Headache 541 (98.4) 1.49  0.5 2 (1e2)
line status of patients who were analyzed. All the patients  Facial pain on pressure 469 (85.3) 0.86  0.4 1 (1e1)
 Sense of smell 331 (60.2) 0.78  0.7 1 (0e1)
analyzed in the study presented with more than one symp- (hyposmia/anosmia)
tom on the CSAS (Table 3).  Epistaxis 169 (30.7) 0.31  0.5 0 (0e1)
 Cough 453 (83.4) 1.13  0.7 1 (1e2)
 Halitosis 233 (42.4) 0.43  0.5 1 (0e1)
Effects on symptoms, intensity of disease  Fever 224 (40.7) 0.41  0.5 0 (1e1)
Table 4 summarizes the results of Friedman test for indi-  Nasal mucosa 513 (93.3) 0.93  0.3 1(0e1)
vidual symptoms and total CSAS score reported over swollen &red
 Swollen turbinates 491 (89.3) 0.89  0.3 1 (0e1)
6 months. There was a statistically significant reduction  Unhealthy pharynx 502 (91.3) 0.91  0.3 1 (0e1)
in individual symptoms and total CSAS score Total CSAS 550 (100) 17 (13e19)
(P = 0.0001). Subgroup analysis according to initial sever- Intensity of CS
 Mild (3e10) 61 (11) 8.98  1.2 9 (8e10)
ity intensity was also performed using the Friedman test.  Moderate (11e17) 250 (44.5) 14.29  2.1 14 (12e16)
All intensities of CS showed a response.  Severe (18e24) 239 (43.5) 19.63  1.3 19 (19e21)
Marked, moderate and mild improvement was found in
340 (61.8%), 137 (24.9%), and 55 (10%) patients respec-
tively. There was no significant improvement in 17 patients maintained upto 6 months. There is a significant effect of ho-
and worsening in one patient. The outcome status accord- meopathic medicines on CS patients at 3 months (Mdn = 4,
ing to intensity of CS in percentage is shown in Table 5. Z = 20.2, r = 0.6, P < 0.001) which was maintained upto at
77.5% patients (n = 426) had an initial CSAS score 13 or 6 months (Mdn = 3, Z = 20.32, r = 0.6, P < 0.001).
above, IQR (13e17). By considering the threshold score at
baseline to be 13, we calculated the improvement status: Radiography
65.3% (278 out of 426) had marked improvement (>75% 355 patients, a subset of the 550 patients, had radio-
to <100%), 21.4% (91 out of 426) had moderate improve- graphic investigations at baseline, 3 months and 6 months
ment (>50% and <75%), 10.1% (43 out of 426) had mild (Table 6). The most commonly affected sinuses were max-
improvement (25% to <50%), 3.3% (14 out of 426) had illary (n = 283) followed by both maxillary and frontal in
no significant improvement (<25%). 86.7% patients had combination (n = 40). By the end of 6 months pathological
at least 50% improvement at the end of the treatment. appearances in maxillary sinuses and pathological frontal
The effect size as mentioned above was calculated. There sinuses were found in 128 patients and 2 patients compared
was large effect size at 3 months of treatment and this was to 283 and 15 at baseline respectively. Thus homeopathic

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Table 4 Results of Friedman test in all the analyzed patients of all the prescribed 13 pre-defined medicines for CS after
(n = 550) about individual symptom score, total CSAS and intensity 6 months of homeopathic treatment is shown in Table 6.
of CSAS at baseline, 3 and 6 months

Symptoms/signs Median (IQR) Chi-square DF

Discussion
Baseline 3 6
months months CS is a disorder of multi-factorial origin. Irrespective of
viral, bacterial, environmental cause, this prospective ob-
Nasal obstruction 2 (2) 1 (1) 0 (1) 753.28 2
Post Nasal drip 2 (1) 0 (1) 0 (1) 704.66 2 servational study reflects a potential positive role of classi-
Nasal discharge 2 (1) 0 (1) 0 (1) 692.94 2 cal homeopathy in treating CS, reducing the symptom
Headache 2 (1) 0 (1) 0 (0) 738.13 2 severity and improving radiological appearances. Overall
Facial pain or 1 (0) 0 (0) 0 (0) 637.21 2
pressure 61.8% patients with CS benefited from the treatment
Sense of smell 1 (1) 0 (0) 0 (0) 464.39 2 with marked improvement.
Epistaxis 0 (1) 0 (0) 0 (0) 293.76 2 Patients in this study were enrolled from primary care
Cough 1 (1) 0 (0) 0 (0) 647.64 2
Halitosis 0 (1) 0 (0) 0 (0) 306.12 2 and were included irrespective of disease severity. We
Fever 0 (1) 0 (0) 0 (0) 347.02 2 have therefore been able to monitor prospectively patients
Nasal mucosa 1 (0) 0 (1) 0 (0) 636.84 2 representing a spectrum from mild to severe intensity,
Swollen turbinates 1 (0) 0 (1) 0 (0) 555.31 2
Maxillary tenderness 1 (0) 0 (1) 0 (0) 627.31 2 which gives strength and relevance to the results. CS is
Frontal tenderness 1 (1) 0 (0) 0 (0) 468.91 2 more common in females compared to males.31,32 The
Ethmoidal tenderness 0 (0) 0 (0) 0 (0) 192.25 2 symptoms presented by CS patients in this study are
Pharynx 1 (0) 0 (1) 0 (0) 622.77 2
X-ray 1 (0) 1 (0) 1 (0) 153.49 2 similar to those found by other researchers.31
Total CSAS 17 (6) 4 (4) 3 (4) 906.49a 2 In earlier studies both observational16e19,23e24 and
Intensity of CSAS controlled trials12e15 in sinusitis, symptomatic
Mild 9 (2) 5 (3.5) 4 (2.5) 100.66 2 improvement was observed but this, to our knowledge, is
Moderate 14 (4) 4 (3.25) 6 (4) 417.41 2
Severe 19 (3) 4 (5) 2 (6) 388.65 2
the first study to examine radiological changes. The
findings in this study are congruent with the research
IQR (Q3eQ1).
a
results of Witt et al.24 and Sharma et al.23 Witt et al.’s24
Friedman test was significant from baseline to 3 & 6 months
(P = 0.0001).
study also reflects long-term improvement in quality of
life in patients with CS lasting for 8 years, which is lacking
in our study. The treatment effect size was found to be large
medicines could help in reversing the pathological changes which runs in parallel with Witt et al.’s24 findings.
found in X-ray sinuses due to CS. The pre-defined homeopathic medicines in our study are
supported by the medicines suggested by Peters et al.22 in
Outcome their paper “How I would treat CS”. Lycopodium is one of
The medicines prescribed at baseline are shown in Table the pre-defined trial medicines which showed positive re-
5. Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of 55), sults and this was true with the findings of Witt et al.24 also.
Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to Several controlled studies with homeopathic combinations
be most useful medicine showing marked improvement. (oral and nasal spray)12e19 (not classical homeopathy) also
Five and 11 patients required a change of prescription (med- yielded positive results but some homoeopaths may
icine) within 3rd and 6th month respectively. The outcome question the prescribing in these studies since it was not

Table 5 Outcome status of useful medicines and intensity of CS in percentage

Medicine Outcome status in percentage

N Marked improvement Moderate improvement Mild improvement Not Significant Worse

Sil. 210 55.2 24.8 14.3 5.7 0

Cal. 98 67.3 25.5 5.1 2 0
Lyco. 55 69.1 23.6 3.6 1.8 1.8
Phos. 45 66.7 20 13.3 0 0
Kali.i. 40 65 20 15 0 0
Kali bi. 32 62.5 21.9 12.5 3.1 0
Puls. 31 67.7 32.3 0 0 0
Ars. 11 63.6 18.2 9.1 9.1 0
Hep. 8 62.5 37.5 0 0 0
Nux. v. 7 57.1 28.6 14.3 0 0
Merc. 6 83.3 16.7 0 0 0
Thuja 5 40 60 0 0 0
Sang. 2 0 100 0 0 0
Intensity of CS
Mild 61 37.7 44.3 13.1 3.3 1.6
Moderate 250 62.8 26.8 9.6 0.8 0
Severe 239 66.95 17.99 9.62 5.44 0

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Table 6 Comparative data of sinuses (positive/negative) on all patients who had X-rays at baseline, 3 months and 6 months. (Friedman’s test)

Sinuses affected Baseline n (%) 3 months n (%) 6 months n (%) Chi-square DF P-value

Positive Positive Negative Positive Negative

Maxillary 283 (79.7) 213 (75.3) 70 (24.7) 128 (45.2) 155 (54.8) 206.960 2 0.0001
Frontal 15 (4.2) 11 (73.3) 4 (26.7) 2 (13.3) 13 (86.7) 20.462 2 0.0001
Ethmoidal 1 (0.28) 0 1 0 1 NA NA NA
Maxillary + frontal 40 (11.3) 35 (87.5) 5 (12.5) 25 (62.5) 15 (37.5) 19.444 2 0.0001
Maxillary + ethmoidal 4 (1.1) 4 (100) 0 0 4 (100) 8.000 2 0.018
Frontal + ethmoidal 1 (0.28) 0 1 0 1 NA NA NA
Maxillary + frontal ethmoidal 8 (2.2) 8 (100) 0 2 (20) 6 (80) 12.000 2 0.002
Pansinusitis 3 (0.85) 2 1 2 1 3.000 2 0.223

individualised. Classical or individualised homeopathy takes
account of physical and mental attributes as well as
pathological symptoms with strong modalities when
selecting a suitable similimum for a suffering patient.
We observed that most of the patients had maxillary si-
nusitis either alone or associated with other sinuses this is
in line with the results of Sharma et al.23 Our study for the
first time suggests that homeopathic medicines may reverse
the pathological changes found in X-ray sinuses.
There are several limitations in this study. 117 patients
were lost to follow up (Figure 1). Of these 67 patients had
less than 3 months follow up, nine violated the protocol,
data of two patients were lost, 39 patients who followed up
for $3 months and had some improvement in their symp-
toms, but were not willing to come for regular follow up as
per protocol were analyzed as per intention to treat. Some pa-
tients moved residence or were uncontactable thus could not
be traced. Only 355 out of 550 patients had a full set of
X-rays. The remainder of the patients, although they gave
their consent for X-ray investigations at the beginning of
the study, during the treatment period were not willing to
have X-rays. Out of 628 patients enrolled, only 12.4% pa-
tient’s data could not be considered for analysis for reasons
mentioned above. Taking into account the analysis of 87.6%
patients, it can be assumed that homeopathic medicines have
potential in giving relief to patients suffering from CS.
Kuehnemund et al.33 showed that subjective symptoms
improve spontaneously inapproximately 25% in patients
with CS over a 4-week period whereas objective clinical
parameters vary insignificantly. They also observed that
messenger RNA of Interleukins (IL-1b, IL-6), Monocyte
Chemotactic Protein-1, and Tumour Necrosis Factor-a,
Peptido-leukotriene, Prostaglandin E2 levels are detectable
and that these appear to play a role in the persistence of in-
flammation in CS, concluding that objective pathological
changes are difficult to remove without medicinal, or in re-
fractory cases, surgical intervention. In our study we found
that homeopathic intervention was associated with im-
proved X-ray appearances significantly which further sub-
stantiates the findings.
life styles and socioeconomic background. And therefore
has a high degree of external validity that extends to usual
medical practice.
Although no firm conclusions can be drawn about the ef-
ficacy of homeopathic treatment these results certainly
contribute to the growing evidence that homeopathy is
a safe and beneficial treatment strategy for chronic diseases
in primary care settings. Observational studies of patients
with CS such as the present one can provide important in-
sights and form a reference for design and performance of
clinical trials. A double blind placebo-controlled trial using
a disease specific questionnaire, health related quality of
life and inflammatory markers is indicated to further estab-
lish the efficacy of this treatment.
Conclusion
There was highly significant improvement in symptoms
and X-ray appearances between baseline and end of treat-
ment in patients with CS. Homeopathy may be effective
for CS patients. Controlled trials are required for further
validation.
Conflict of interest
The authors declare no conflict of interest.
Acknowledgements
The authors acknowledge Dr Alok Kumar, Director
General In-charge for his valuable support. The authors
also acknowledge all the programme officers of the Insti-
tutes/Units for their administrative support, Dr Sunil Pra-
sad, for his technical support, Dr Aabha Agarwal, Deputy
Director, National Institute of Medical Statistics,
Mr Arvind Kumar, statistical Assistant, CCRH for their
statistical support, and finally the patients for their endeav-
our to make this study successful. The authors acknowl-
edge contributions of Dr Debadatta Nayak, Research
Officer (H), for his inputs in literature review.

Weaknesses and strengths

This study has several important biases, particularly the
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