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DOUBLE BLIND PLACEBO CONTROLLED CLINICAL TRIALS OF
HOMOEOPATHIC MEDICINES IN 
WARTS AND MOLLUSCUM CONTAGIOSUM

Dr. R.K. Manchanda, Deputy Director (Homoeopathy),
Deptt. of Medicine, Nehru Homoeopathic Medical College and Hospital.
Dr. Neena Mehan, Assistant Professor, Practice of Medicine, Deptt. of Medicine,
Dr. B.R.Sur Homoeopathic Medical College and Hospital.
Dr. Ritu Bahl, Homoeopathic Physician
Dr. Rajni Atey, Homoeopathic Physician

Introduction

       Wart is one of the common dermatological disorders caused by DNA viruses, which grow in the epidermis. The source of infection is other infected individuals and the disease is transmitted by direct or close contact. It has very low infectivity; a casual contact with an infected individual is unlikely to result in the disease. The virus enters into the skin through minor or microscopic injuries. Clinically the lesions are asymptomatic and manifest in different forms, have irregular verrrucous surface and keep on growing slowly. The number of warts varies from single to several hundred. The individuals with depressed cell-mediated immunity due to treatment with immunosuppressive drugs, Hodgkins'disease, malignant lymphomas and lymphocytic leukaemia are more likely to have a large number of warts. The different varieties of warts include the following :

Common Warts or Verruca Vulgaris: These are characterized by firm, skin colour papules of various sizes with verucous surfaces and can occur on any parts of the body but are most commonly present on the dorsum of the hands and fingers.

Plain Warts or Verruca Plana : It presents as skin colored, slightly raised flat -topped papules and are usually present on dorsum of hand and face.

Filiform Warts: These are finger like projections with irregular surface and are usually seen on the neck, face and scalp.

Plantar warts: These are found on any part of the sole. The lesions are occasionally painful. The warts present as skin colored well defined areas in the sole with irregular surface.

Genital warts: These warts are usually transmitted through sexual contact. These are present as fungating masses of verucous tissue. They usually present on glans penis, corona, mucosal surface of prepuce and occasionally on the urinary meatus in males and the vulva and vaginal openings in the females.

Molluscum Contagiosum: Large virus belonging to the pox group of viruses causes it. It gets implanted on the skin by contact with an infected individual. Auto - inoculation after infection is very common which causes the spread of the disease to the different parts of the body. The disease is common in children. When it is present on the genitals of an adult male or female transmission is usually through sexual exposure. It manifests in the form of asymptomatic, pearly white or pink papules with well-defined depressed centers known as umbilication. After trauma or spontaneously after a few months, inflammatory changes result in suppuration and crusting leading to destruction and disappearance of the lesions.

       The course of warts and Molluscum Contagiosum is unpredictable, peculiar and inconsistent therefore it is often difficult to evaluate the results of any treatment. The various modalities are available for the treatment of warts in various systems of medicine include electrocoagulation, cryosurgery 1, curetage 2, trichloracetic acid, silver nitrate, poddophyllin urea 3, formalin soaks 4, vitamin A acid application 5, calcium hydroxide solution soaks 3, bleomycin local injection 6 and hypnosis 3,7. It is known that Homoeopathic drugs are very effective for the treatment of Warts/Molluscum contagiosa. Many cases and reports are available confirming the efficacy but no report is based on double blind study 8,9,10. In the study undertaken during 1986-88 it was revealed that some of the homoeopathic medicines were found effective 75-90% in the treatment of different types of warts. Keeping in view the possibility of spontaneous remissions in warts it is desirable that a double blind placebo control trailed is conducted with the drugs found very useful in the treatment of warts/molluscum.

Aims & Objectives

  • To evaluate the efficacy of selected homeopathic drugs found useful in the treatment of warts in open clinical trials using control trials.
  • To evaluate the efficacy of Calcarea carb in the treatment of Mollusum contagiosum.

Material & Methods

       A problem oriented Performa having provision of recording all the symptoms pertaining to warts and the person as a whole was designed and used in the trials. The duration, size, number, sensations in the warts in respect of each case was recorded on this Performa. All the cases were diagnosed and assessed clinically.

Study Designs

Two types of placebo controlled double blind clinical trials were undertaken.

Cross over design

:

The subjects were given both drug and the placebo. This study was carried out during 1995-96.

Parallel design

:

One group received the drug and other group received placebo. This trial was carried out during 1996-97.

Both the trials were carried out at Nehru Homoeopathic Medical College & Hospital.

Inclusion Criteria

  • Any age group
  • Cases of Verruca Vulgaris, Verucca Plana, Verruca filiformis, Verucca plantaris and Verruca genitalis.
  • Cases of Molluscum Contagiosum.

Exclusion Criteria

  • Cases on immunosuppressive drugs
  • Cases having active treatment for other diseases.

Project Report 1:

       The study was started in the month May 95 and was concluded on 30th April 96 and 60 cases [35 Males, 25 Females] having different types of warts were registered. Results of 43 Cases [25 Males, 18 Females] were analyzed and 17 cases were dropped out.

       All the cases were given pre-coded (Thuja, Ruta, Calcarea carb, Dulcamara, Nitric acid, Causticum) drugs or pre-coded placebo at random for a period of 15 days. The pre-coded drugs of 30 potency were given in TDS dose, 200 potency was used in BD doses and 1M potency was used in OD doses.

Prescribing indication used:

Calcerea carbonicum was given to all the cases of Mollusum contagiosum.

Ruta was used for smooth warts on face and palms and plantar warts having soreness.

Nitric acid was used for common warts having cauliflower like appearance, hard, large and bleeding easily.

Dulcamara was given for plain fleshy warts on face and hands.

Causticum was used for small as well big warts over hands and peri ungual region.

Thuja was used in all other cases of warts having different types and locations, irrespective of any constitutional indications.

After decoding the experiment the details of the responses received are as under:

Results after decoding the treatment

Results after decoding the treatment

Cases

Total

100%

Active
Drug
Group

Resp.
in %

Placebo
Group

Resp.
in %

Drug-
Plac.
Group

Resp.
in %

Only
Plac.

Resp.
in %

Verruca
Vulgaris

21

18

10

55.56

8

44.44

7

38.89

1

5.56

Verruca
Vulgaris

07

04

03

75.00

1

25.00

1

25.00

0

0.00

Verruca
Vulgaris

05

03

02

66.67

1

33.33

0

0.00

1

33.33

Molluscum
cont.

10

08

06

75.00

2

25.00

2

25.00

0

0.00

Total

43

33

21

63.64

12

36.36

10

30.30

2

6.06

Observations:

  1. 63.6% cases improved with active drug and 36.36% cases improved with placebo in our study. The improvement indices of active drug group are far better than the placebo group which clearly indicates that the homoeopathic drugs definitely possess power to cure warts and Molluscum contagiosum.
  2. In this research study design, each case was initially given a drug code in 30 potency which could be either active drug or placebo. If the case did not improve with this code, the next code of 200 potency was given which could again be either active drug or placebo. Therefore it was found after decoding, that some cases who were initially on active drug code in 30 potency received placebo in the next drug code of 200 or 1 M potency or vice a versa.
  3. Among 36.36% improved cases under the placebo group, it was found that 30.30% received an active drug in the preceding drug code and therefore this could be attributed to carry over effects of active drug. Only 6 % improved cases under placebo group were found to be only on Placebo throughout the trial period. This observation is very significant.

Project 2

      The study was started in the month May 96 and was concluded on 30th April 97 and 124 cases [81 Males, 43 Females] having different types of warts and Molluscum contagiosum were registered. Results of 104 Cases [71 Males, 33 Females] were analyzed and 20 cases were dropped out.

All the cases were given pre-coded drugs Thuja, Ruta, Calcarea carb and Causticum following double blind placebo controlled study, parallel design for a period of 15 days. The pre-coded drugs of 30 potency were given in TDS doses, 200 potency was used in BD doses and 1M potency was used in OD doses.

This study had much larger size than the previous one and care was taken to avoid carry over effects of homoeopathic medicines adopting different research design.

The data pertaining to reporting cases is as follows:

DRUG WISE RESPONSE AFTER DECODING

Drug

Total

Res
ponse

%

Drug

Res
ponse

%

Placebo

Res
ponse

%

Thuja

42

24

57

27

22

81

15

05

33

Caust.

29

17

58

19

13

68

10

04

40

Ruta

19

09

69

10

07

70

03

02

66

Cal.carb

20

14

70

13

13

100

07

01

14


Type of Warts Response

Type

Total

Improved
100%

Improved
with drug

%

Improved
with placebo

%

Total cases

104

64

52

81

12

19

V.Vulgaris

39

17

12

70

05

30

V.Plana

20

16

12

75

04

25

V.Plantar

12

10

08

80

02

20

V.Filiform

12

06

06

-

-

-

V.Genitalis

01

01

01

-

-

-

Molluscum

20

14

13

93

01

07

Observations

  • The results of active drug group are far better than the placebo group. This again reconfirms the observation made in previous project report that homoeopathic medicines are quite effective in the treatment of warts and Molluscum contagiosum.
  • The improvement results of placebo group (19%) in this study under project 2 are significant as compared to those of 33.4% in the project 1. This clarifies the doubtful observation of carry over effects of homoeopathic treatment and signifies that probably homoeopathic medicines have no carry over effects in the treatment of warts and Molluscum contagiosum. Hence the effectively of the indicated medicine can be perceived with in few days of its intake.
  • Among results of individual medicine, Thuja was found most useful drug for warts and Calcarea carbonicum in Molluscum contagiosum. The sample sizes of active drug group and placebo group in respect of Ruta and Causticum are insufficient to comment on the efficacy of these medicines in the treatment of warts.

Conclusion

          The findings of earlier open studies and common belief that homoeopathy has a curative role in the treatment of warts and molluscum contagiosum is re-established in these two studies.

References:

  1. Limmer Bl, Louis BT. Cryosurgery of plantar wart. J Am Pod Asoc 1979; 69:713
  2. Davidson MR. Skin crettage and the treatment of plantar verruca. J Am Pod Assoc 1976; 66: 331-6
  3. Clinton WL. Verruca, a Dermatologic problem. JAMA 1950, 44 : 1361-5.
  4. McKnight AG. Assessment of treatment of plantar warts. Ulster Med 1968; 40: 40-53.
  5. Bersaqures JD. Vitamin A acid in the topical treatment of plantar wart. Dermatologica 1975; 150: 369-71.
  6. Hudson AL. Treatment of plantar warts with Bleomycin. Arch Derm 1976; 112: 1179.
  7. Moorris Brians AP. Hypnotherapy of warts using The Simonton visualization technique. Am J Clin Hypnosis 1985; 27: 237-40.
  8. Sehgal V.N. Thuja, an antibacterial agent in the management of wart. Indian J Derm and Ven 1967; 33:37-39.
  9. Chand DH, Verucca. Br. Hom J 1986; 175: 18-26.
  10. Boericke W. Pocket Manual of Homoeopathic Materia Medica with Repertory. Pp. 55-918. New Delhi: B. Jain 1987
  11. Gupta Ramji, Bhardwaj O.P. & Manchnda R.K. Homoeopathy in the treatment of warts. Br. Hom. J 1991; 80: 108-11


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