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| ORIGINAL ARTICLE |
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| Year : 2018 | Volume
: 12
| Issue : 3 | Page : 139-148 |
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Assessment of the effectiveness of homoeopathic remedies in improving quality of life of chronic urticaria patients in a typical clinical setting
Rashmi Sharma1, Shailendra Kumar2, VK Vimal3, Raj K Manchanda4
1 Medical Officer Incharge, State Homoeopathic Dispensary, Ahmadpur, India
2 Mechanical Engineering Section, Faculty of Engineering and Technology, Aligarh Muslim University, Aligarh, Uttar Pradesh, India
3 Director (Homeopathy), Government of Uttar Pradesh, Uttar Pradesh, India
4 Director General, Central Council for Research in Homeopathy, New Delhi, India
| Date of Submission | 12-Mar-2018 |
| Date of Acceptance | 04-Sep-2018 |
| Date of Web Publication | 27-Sep-2018 |
Correspondence Address:
Dr. Rashmi Sharma
State Homoeopathic Dispensary, Ahmadpur, Aligarh, Uttar Pradesh
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/ijrh.ijrh_20_18
Objective: To evaluate the effectiveness of homoeopathic remedies in improving quality of life (QoL) of chronic urticaria (CU) patients. Methods: Setting: The study population included patients attending the Outpatient Department of State Homoeopathic Dispensary, Ahmadpur, Aligarh, Uttar Pradesh, India. CU-QoL questionnaire (CU-Q2oL) and average Urticaria Activity Score for 7 days (UAS7) questionnaires were filled questionnaires were filled at baseline and 3rd, 6th, 9th and 12th months. The study included both male and female patients clinically diagnosed with CU, screened from January 2015 to June 2016. Eighteen homoeopathic remedies were used. The individualised prescription was based on the totality of each patient's symptoms. Scores were analysed using one-way repeated measures ANOVA with SPSS version 19. Results: A total of 134 patients were screened and 70 were diagnosed with CU and enrolled in the study were analysed under modified intention-to-treat approach. Significant difference was found in baseline and 12th month CU-Q2oL score (mean difference 34.14 with standard error of 1.65, 95% confidence interval, lower bound 29.31, upper limit 38.94, P < 0.001). A one-way repeated measures ANOVA was calculated for comparing CU-Q2oL scores (F [2.45, 169.46] = 260.89, P ≤ 0.000, effect size = 0.791). Apis mellifica (n = 10), Natrum muriaticum (n = 9), Rhus toxicodendron (n = 8) and Sulphur (n = 8) were the most frequently used remedies. Conclusions: Homoeopathic medicines have potential to improve QoL of CU patients by reducing pruritus, intensity of wheals, swelling, nervousness, and improve sleep, mood and concentration. Further studies with more sample size are desirable.
Keywords: Chronic urticaria quality of life questionnaire, Chronic urticaria, Homoeopathy, Quality of life
How to cite this article:
Sharma R, Kumar S, Vimal V K, Manchanda RK. Assessment of the effectiveness of homoeopathic remedies in improving quality of life of chronic urticaria patients in a typical clinical setting. Indian J Res Homoeopathy 2018;12:139-48 |
How to cite this URL:
Sharma R, Kumar S, Vimal V K, Manchanda RK. Assessment of the effectiveness of homoeopathic remedies in improving quality of life of chronic urticaria patients in a typical clinical setting. Indian J Res Homoeopathy [serial online] 2018 [cited 2023 Mar 22];12:139-48. Available from: https://www.ijrh.org/text.asp?2018/12/3/139/242276 |
| Introduction | |  |
Urticaria is one of the frequent presenting complaints in dermatology with lifetime prevalence of 8.8%.[1] It is a disease characterised by the development of wheals (hives), angioedema or both. Chronic urticaria (CU), defined as episodic or daily wheals lasting for at least 6 weeks, occurs in approximately 1.8% of the adult population with predominance of females.[1],[2],[3] Despite low mortality, it can have devastating effects on the quality of life (QoL) of those who are suffering from it.[4] Due to its chronic nature, many patients suffer from significant detrimental effects on their QoL and experience symptoms of depression or anxiety. CU can interfere with subjective well-being and daily life. Several studies over the last decade have shown that its effect on QoL is comparable to that experienced by patients suffering from ischaemic heart disease with considerable loss of energy, sleep disturbance and emotional upset. Compared to QoL in patients with respiratory allergy, CU patients were more affected in physical functioning, pain perception and perceived health.[5],[6],[7] Patients with CU are highly affected by disease, and impairment of QoL should be assessed routinely. It causes inconvenience in family structures, compromising performance at work, school and negatively impact leisure activities. The disease interferes with subjective well-being and daily life, but the treatment is often focused on skin symptoms rather than the effects; these symptoms can have on the individual's QoL. This often leads to unsatisfactory management of the disease. Patient-related outcomes are important to be looked at in the treatment for urticaria.[8]
Homoeopathic treatment focuses on patient as a person, at the same time take into consideration his/her pathological condition. There has been growing interest in the use of Homoeopathy in various dermatological disorders.[9],[10] In homoeopathic literature, Kent repertory has 101 drugs under rubric– Skin, eruptions, urticaria,[11] Boger-Boeninghausen repertory has 75 drugs under rubric– Skin, eruptions, urticarious (nettle rash),[12] Boger's Synoptic Key presented 11 drugs under– Skin, eruptions, urticarious, hives, wheals, etc.,[13] Boericke's Repertory under urticaria (hives, nettle rash) has 54 drugs,[14] Knerr Repertory of Hering Guiding Symptoms has 61 drugs under– Skin eruptions, urticaria (nettle rash, hives),[15] Clarke in 'The Prescriber' under nettle rash (urticaria) has given 10 drugs.[16] Despite the promising results with Homoeopathy, scientific evidence of its effectiveness for CU is scarce. In the present study, the authors performed a clinical observational study to evaluate the effects of homoeopathy in patients suffering from chronic urticaria.
Primary objective
To evaluate the effectiveness of homoeopathic remedies in improving QoL of CU patients.
Secondary objectives
- To verify the characteristic symptoms of useful medicines
- To prevent the progression and relapse of CU
- To identify the relationship between QoL of patients and activity of CU, if any.
| Methods | | |
Study design
This was a clinical observational study on 70 patients in the treatment of chronic urticaria. The patients were screened from January 2015 to June 2016. SPSS verison 19 IBM SPSS Statistics, United States.
Setting
The study population consists of patients attending the Outpatient Department of State Homoeopathic Dispensary, Ahmadpur, Aligarh, Uttar Pradesh, India.
Participants
The study comprised both male and female patients clinically diagnosed with CU, characterised by erythema and itchy lesions occurring for a period of 6. The study excluded patients with acute urticaria, angioedema with no urticaria, urticarial vasculitis and associated psychiatric diseases. All patients provided written informed consent.
Selection of medicine
Patients were interviewed and examined for matching patients' symptoms with the homoeopathic medicines. Each individual patient was prescribed a single homoeopathic medicine (selected considering mental generals, physical generals and particulars) at a time in three doses a day (one dose comprises four globules medicated with indicated medicine) and documented in case recording format.
Intervention
Each medicine was first given in 30C potency. Patients were followed up at an interval of a week or early if required. To avoid the 'rebound effect' (body's exaggerated response to removal of drug), the same conservative regime was continued for 1st week or till improvement starts. If the condition improves, patients were advised to take drugs on alternate days from the 2nd week and twice a week from the 3rd week, followed by once a week before stopping the medicine. Tapering varies from patient to patient and is tailored as per the individual needs, or lengthening of amount of time for reducing of dose depends on the patient's response. If any obvious triggering factor was identified from the history, it was eliminated wherever possible, e.g. specific food. Treatment with aspirin, non-steroidal anti-inflammatory drugs and codeine were stopped, and physical triggers such as cold and heat were avoided wherever possible. Thyroid disorders and underlying infections were treated. Patients were advised to keep a symptom diary, and were advised to note any triggering factor (physical) for rash to identify a physical trigger for rash. Patients were assured that in most of the cases, there is no serious underlying medical problem causing rash. There was no adjunctive therapy given (e.g. counselling and psychotherapy); however, the authors discussed the problem faced by the patients during the follow-up, if required.
Treatment and follow-up
Follow-up visits were carried out weekly for first few months, fortnightly in cases of well controlled and monthly in urticaria-free cases. In case of acute condition, the consultations are made at 3–5 days of interval or early if required. Patients were followed up for a minimum period of 12 months. Effect and outcome of urticaria were noted and evaluated on the following criteria: eruptions (frequency, duration and intensity), itching (frequency, duration and intensity), burning sensation, heat of the part and provoked by causative factor or not.
Outcome
Health-related QoL of CU patients was calculated by CU-Q2 oL (CU QoL Questionnaire), a questionnaire developed by Baiardini et al,[17],[18] It is a validated specific questionnaire to evaluate health-related QoL in CU. It is a self-administered 23-item questionnaire, where patients have to indicate, on a Likert scale with multiple options (1: not at all, 2: a little, 3: somewhat, 4: a lot and 5: very much), how much they have been troubled by each problem, with higher scores indicating worse QoL. It has 23 items, grouped into six QoL categories associated with urticaria: pruritus (2 questions), swelling (2 questions), life activities (6 questions), sleep (5 questions), limits (3 questions) and looks (5 questions). The CU-Q2 oL was filled by patients on the first appointment (within a week) and then again at 3, 6, 9 and 12 months. The changes in variable from one category to the subsequent lower one was considered as significant. Disease activity was calculated using average UAS7.[19],[20] It is based on the assessment of key urticaria symptoms (wheals and pruritus). It is suitable for the evaluation of disease activity by urticaria patients and their treating physicians. The activity of CU was further classified as urticaria free (0), well controlled (1–6), mild (6–17), moderate (18–28) or severe (28–42) based on the UAS7 score.[21]
To summarise, CU-Q2 oL measures impact of disease on patients' QoL, and UAS7 measures activity and severity of disease, both were recommended by EAACI/GA2 LEN/EDF/WAO urticaria guideline.[7] The data related to these questionnaires were collected at baseline and 3rd, 6th, 9th and 12th months.
Study size
As this was a clinical observational study, the sample size was not calculated. Patients who reported under the screening period and fulfilled the inclusion criteria were enrolled.
Statistical methods
Statistical analysis was performed through SPSS version 19. Descriptive analysis were used in the clinical and demographic characterisation of patients enrolled. Missing data were replaced by the last assessed value as per the last observation carried forward method under intention-to-treat (ITT) principle. One-way repeated measures ANOVA was applied to compare the CU-Q2 oL and UAS7 means at 3-month interval, Effect size was also calculated to assess the effects; P < 0.05 was considered statistically significant.
| Results | | |
A total of 134 patients were evaluated and 70 were diagnosed with CU. Of these, 62 patients completed the follow-up of 1 year. Eight patients did not complete the follow-up. Flowchart of the study is provided in [Figure 1].
Descriptive features of participants
Out of 70 patients analysed under ITT, 26 were male and 44 were female. 62% of CU cases were females; the reason for this could be that women are likely to have more sensitive skin and mental consciousness towards the symptoms of urticaria and more influenced by alteration in appearance. 44.25% patients were from 21 to 30 years of age and thus prone to decreased productivity because of illness. The baseline information of all patients along with duration of illness, activity, kind, duration and activity of CU are summarised in [Table 1]. Thirty-two (45.71%) patients had chronic spontaneous urticaria (CSU), 20 (28.57%) patients had inducible urticaria (CIU) and 18 (25.71%) patients had urticaria which was spontaneous and inducible both (CSU and CIU). The mean CU-Q2 oL score at baseline was 65.71 (12.28). UAS7 scores at baseline reflected, 24.28% patients had CU of mild activity, 52.85% had CU of moderate activity and 22.85% had CU of severe activity. The activity of disease during treatment is presented in [Table 2]. Associated complaints along with urticaria symptoms are listed in [Table 3]. Headache, joints pain and gastrointestinal problems such as constipation were most common associated complaints found, followed by upper respiratory distress, uterine complaints and urinary tract infections. | Table 2: Activity of chronic urticaria at various time intervals (as per urticaria activity score for 7 days score) and number of patients in each category
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 | Table 3: Associated complaints with chronic urticaria in enrolled patients (n=70)
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A one-way repeated measures ANOVA was calculated, comparing CU-Q2 oL scores with the Greenhouse–Geisser correction determined at 3-month intervals and a significant effect was found (F {2.45, 169.46} = 260.89, P ≤ 0.000, partial eta squared = 0.791). The mean CU-Q2 oL score at baseline was 65.71 (standard error [SE] 12.28), which was reduced to 47.46 (10.11) at 3 months and 38.17 (9.81), 34.15 (8.91) and 31.50 (7.32) at 6th, 9th and 12th months, respectively (P < 0.001).
The maximum impact on CU-Q2 oL was seen in first 3 months (mean difference between baseline and 3 months = 18.25, standard error [SE] = 1.13, 95% confidence interval [CI], P < 0.0001). The minimum difference in means was seen in CU-Q2 oL scores of 9th and 12th months (mean difference = 2.92, SE = 0.80, P < 0.005). Repeated measures ANOVA result for 3rd, 6th, 9th and 12th months for UAS7 score is F (1.95, 135.16) = 127.03, partial eta squared = 0.740, P < 0.0001. The mean UAS7 score at baseline was 25.23 (SD 10.09), which was reduced to 14.27 (5.56) at 3 months and 10.24 (4.90), 8.77 (4.87) and 7.16 (5.02) at 6th, 9th and 12th months, respectively (P < 0.001). A correlation coefficient and P value has to be mentioned. Patients with higher UAS7 score were found to have a higher CU-Q2 oL score. The declining trend of CU-Q2 oL corresponds with a decline in UAS7 scores [Figure 2]. Changes in various items under CU-Q2 oL questionnaire are summarised in [Table 4]. | Figure 2: Decreasing trend of chronic urticaria quality of life questionnaire and UAS7 mean scores at 3, 6, 9 and 12 months
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 | Table 4: Mean chronic urticaria-quality of life questionnaire items at various time intervals
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[Table 5] shows a list of of homoeopathic medicines prescribed for patients in the study. Apis mellifica was given to highest number of patients (n = 10), followed by Natrum muriaticum (n = 9), Rhus toxicodendron (n = 8), Sulphur (n = 8) and Dulcumara (n = 7). Change of medicine with reasons thereof is given in [Table 6]. Two patients who were prescribed Dulcamara at baseline required a change to Pulsatilla at the 7th month and Rhus toxicodendron at 9th month, respectively, while two patients who were prescribed Apis mellifica at baseline required a change to Natrum muriaticum after 6th and 10th months, respectively. These patients required a change of medicine at various time points because either they remained status quo of their symptoms or presented with different symptom picture. The same remedy was continued for the entire course of the study in 58 patients (eight did not complete the follow-up of 1 year). Medicines were prescribed as per mental general symptoms, physical general symptoms, particulars and other symptoms. There was no significant sign of deterioration or homoeopathic aggravation. Two patients who had urticarial eruptions only on lower limbs, both of them were given Ledum palustre, showed remarkable improvement with this remedy. [Table 7] presents symptoms of indicated medicine in patients. After 12 months, 13 (18.57%) patients were urticaria free. In 21 (30%) patients, disease was well controlled; only 2 (2.8%) patients had moderate and 34 (48.58%) had mild symptoms.
| Discussion | | |
The main results surfaced from this study are:
- QoL of CU patients was correlated with the activity of disease; more is the activity of disease, worse the QoL
- There was a significant improvement in QoL, in patients treated with homoeopathic remedies
- The objective to prevent the progression of CU was achieved in all patients
- There were least side effects with homoeopathic medicines; drug side effect mean as per CU-Q2 oL questionnaire was 2.44 (1.05) at baseline, which was reduced to 1.24 (0.65).
Individualised homoeopathic treatment was associated with significant alleviation of urticaria symptoms, enabling the reduction in the use of conventional treatment. There was a significant reduction in the activity of CU after the treatment.
This study, to the best of our knowledge, is the first clinical observational study to assess the QoL of CU patients with homoeopathic treatment. Here, the study is based on the patient-related outcomes, rather than biomarkers. The results from the study supplement rather challenge the findings of previous studies on CU. CU was once considered as manifestation of idiosyncratic reaction to food, food preservatives or dyes. The authors did not find any support to this theory in their study, which is consistent with the works of Kaplan [22] and Perera and Sinclair.[23] Another dictum that detailed history is usually sufficient to establish diagnosis and type of urticarial [7],[23],[24] was found effective.
Itamura,[25] in his work on chronic skin diseases on sixty patients, reported about six CU patients and evaluated them on Glasgow Homoeopathic Hospital Outcome Score (GHHOS), now renamed as Overall impact in daily living (ORIDL). The results of the two studies cannot be compared, but our study is consistent with the work, where 88.3% of patients reported over 50% improvement after individualised homoeopathic treatment. This reaffirms the significance of individualization and the concept of totality of symptoms described by Dr. Hahnemann in Aphorism 18 of Organon of Medicine.
Limitations
One major problem that arose in the study was related to completion of the questionnaire, for example, sporting activities was not regarded as relevant by patients, because >90% of patients involved in this study were not practicing sports. As it is an 'in-clinic' study and is not a blinded randomised clinical trial, there was no control group to allow assessing the change in CU-Q2 oL scores over time in the absence of therapy, and hence, placebo and therapeutic effects could not be separated.
| Conclusions | | |
Homoeopathic medicines improved QoL of CU patients by reducing pruritus, intensity of wheals, swelling, nervousness, sleep, mood and concentration besides drug side effects if any. CU-Q2 oL and UAS7 scores differed statistically significantly every 3-month time interval with homoeopathic treatment. Significant difference was found in baseline and 12th month CU-Q2 oL score (mean difference = 34.14, SE = 1.65, 95% Confidence Interval, lower bound 29.31, upper limit 38.94, P < 0.001). As it was an 'in-clinic' study, there was no control group to allow assessing the change in CU-Q2 oL and UAS7 scores over time in the absence of therapy, and hence, placebo and therapeutic effects could not be separated. The results presented in this study can be considered as a step towards a randomised control trial, which would include a larger number of patients.
Acknowledgement
The authors are thankful to Dr Varanasi Roja, Research Officer (H)/Scientist-2, CCRH, New Delhi, for providing valuable inputs in analysis and for her support in this study.
Financial support and sponsorship
Nil.
Conflicts of interest
None declared.
| References | | |
| 1. | Zuberbier T, Balke M, Worm M, Edenharter G, Maurer M. Epidemiology of urticaria: A representative cross-sectional population survey. Clin Exp Dermatol 2010;35:869-73.  |
| 2. | Sánchez-Borges M, Asero R, Ansotegui IJ, Baiardini I, Bernstein JA, Canonica GW, et al. Diagnosis and treatment of urticaria and angioedema: A worldwide perspective. World Allergy Organ J 2012;5:125-47. |
| 3. | Zuberbier T, Asero R, Bindslev-Jensen C, Walter Canonica G, Church MK, Giménez-Arnau A, et al. EAACI/GA(2)LEN/EDF/WAO guideline: Definition, classification and diagnosis of urticaria. Allergy 2009;64:1417-26. |
| 4. | Jáuregui I, Ortiz de Frutos FJ, Ferrer M, Giménez-Arnau A, Sastre J, Bartra J, et al. Assessment of severity and quality of life in chronic urticaria. J Investig Allergol Clin Immunol 2014;24:80-6. |
| 5. | O'Donnell BF, Lawlor F, Simpson J, Morgan M, Greaves MW. The impact of chronic urticaria on the quality of life. Br J Dermatol 1997;136:197-201. |
| 6. | Baiardini I, Giardini A, Pasquali M, Dignetti P, Guerra L, Specchia C, et al. Quality of life and patients' satisfaction in chronic urticaria and respiratory allergy. Allergy 2003;58:621-3. |
| 7. | Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, et al. Methods report on the development of the 2013 revision and update of the EAACI/GA2 LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of urticaria. Allergy 2014;69:e1-29. |
| 8. | Baiardini I, Braido F, Bindslev-Jensen C, Bousquet PJ, Brzoza Z, Canonica GW, et al. Recommendations for assessing patient-reported outcomes and health-related quality of life in patients with urticaria: A GA(2) LEN taskforce position paper. Allergy 2011;66:840-4. |
| 9. | Waisse-Priven S, Jurj G, Lima Thomaz LC, Tierno SA, Filho WL, Sos A, et al. Individualized homeopathic treatment of dermatological complaints in a public outpatient clinic. Homeopathy 2009;98:149-53. |
| 10. | Anelli M, Scheepers L, Sermeus G, Van Wassenhoven M. Homeopathy and health related quality of life: A survey in six European countries. Homeopathy 2002;91:18-21. |
| 11. | Kent JT. Repertory of Homeopathic Materia Medica. Reprint Edition. New Delhi: B. Jain Publishers (P) Ltd.; 2007. |
| 12. | Boger CM. Bœnninghausen's Characteristics Materia Medica and Repertory. New Delhi, B. Jain Publishers, 2004. |
| 13. | Boger CM. Synoptic Key of the Materia Medica. New Delhi, B. Jain Publishers, 2004. |
| 14. | |
| 15. | Knerr CB. Repertory of Hering's Guiding Symptoms of our Materia Medica. New Delhi, B. Jain Publishers, 2002. |
| 16. | |
| 17. | Baiardini I, Pasquali M, Braido F, Fumagalli F, Guerra L, Compalati E, et al. Anew tool to evaluate the impact of chronic urticaria on quality of life: Chronic urticaria quality of life questionnaire (CU-qoL). Allergy 2005;60:1073-8. |
| 18. | |
| 19. | |
| 20. | Młynek A, Zalewska-Janowska A, Martus P, Staubach P, Zuberbier T, Maurer M, et al. How to assess disease activity in patients with chronic urticaria? Allergy 2008;63:777-80. |
| 21. | Khalil S, McBride D, Ana Gimenez-Arnau, Grattan C, Magdalena Balp M, Stull D, et al. Weekly urticaria activity score (UAS 7) and dermatology life quality index (DLQI) in validation of chronic spontaneous/idiopathic urticaria (CSU/CIU) health states. J Allergy Clin Immunol 2015;135:AB131. |
| 22. | Kaplan AP. Chronic urticaria: Pathogenesis and treatment. J Allergy Clin Immunol 2004;114:465-74. |
| 23. | Perera E, Sinclair R. Evaluation, diagnosis and management of chronic urticaria. Aust Fam Physician 2014;43:621-5. |
| 24. | Moolani Y, Lynde C, Sussman G. Advances in understanding and managing chronic urticaria. 2016;5: F1000 Faculty Rev-177. Published online 2016 Feb 16. |
| 25. | Itamura R. Effect of homeopathic treatment of 60 Japanese patients with chronic skin disease. Complement Ther Med 2007;15:115-20. |
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]
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