NHR Jan-Mar 2019: Original Research: Clinical adaptability of Kent’s repertory in the homoeopathic treatment of sciatica pain: An open, observational trial

Clinical adaptability of Kent’s repertory in the homoeopathic treatment of sciatica pain: An open, observational trial


Deepak Pandey*1, Amitava Samanta2

  1. Former Postgraduate Trainee, Dept. of Repertory, National Institute of Homoeopathy, Govt. of India
  2. Professor, Dept. of Repertory, National Institute of Homoeopathy, Govt. of India

*Correspondence: deepak.nihkolkata@gmail.com


ABSTRACT:

Background: Sciatica is neuralgia along the course of the sciatic nerve, most often with pain radiating into the buttock and lower limb, most commonly due to herniation of a lumbar disc. The prevalence of sciatica is 1-10% in the population. As per the homoeopathic literature, homoeopathic medicines play a promising role in relieving the symptom severity and improving the quality of life in sciatica patients, but scarcely subjected to systemic research.

Methods: An open, non-randomized, prospective, observational clinical study was undertaken at the National Institute of Homoeopathy, in which 30 patients suffering from sciatica pain, fulfilling the eligibility criteria were enrolled and followed up periodically at minimum of one month interval. Pain intensity measuring 0-10 numeric rating scale (NRS) and the translated Bengali version of Roland-Morris Low Back Pain and Disability Questionnaire (RMQ) were used as primary and secondary outcomes respectively, measured at baseline, and after 3 and 6 months. Medicines were prescribed on the basis of individualization and repertorial totality using Kent’s repertory. Changes over time were checked by paired t test and one way repeated measure ANOVA.

Results: Out of 40 enrolled patients, 10 were dropped out and 30 completed the study. Mean age was 40.5 years (SD7.5), majority was male (57%). Reduction in pain NRS and improvement in RMQ score, both were statistically significant (p<0.001) from baseline over 3 and 6 months. Rhus toxicodendron (33.3%), Lycopodium clavatum (13.3%), and Bryonia alba (10%) were the most frequently prescribed medicines.

Conclusion: The overall response of homoeopathic medicines selected on the basis of totality of symptoms using Kent’s repertory in the treatment of sciatica pain was promising. Further rigorous controlled trials with large sample size are warranted.

Keywords: Sciatica, Roland Morris questionnaire, Numeric rating scale, Kent’s Repertory, Homoeopathy


INTRODUCTION 

The physician must be able to tell the antecedents, know the present, and foretell the future must mediate these things, and have two special objects in view with regard to disease, namely to do good or to do no harm.” … Hippocrates.

Although low back pain is a common condition that affects as many as 80-90% of people during their lifetime, prevalence of true sciatica occurs in about 1-10% of population [1-5]. Sciatica is more common between 30-50 years of age [1]. Men are more frequently affected than women [1]; individuals engaged in occupations that require heavy physical labor are more often affected [3]. In western countries like US, about 40-50% of population experience sciatica at some times during their life [3]. Most common cause of sciatica includes lumbar spinal stenosis, lumbar disc herniation directly pressing on the nerve, degenerative disc disease, spondylolisthesis, pregnancy, muscle spasm and wearing high heels [2].

Homoeopathy is a holistic system of medicine and considers the human being as a single unit, as an individual, who consists of body, mind and soul. Homoeopathy treats the patient and not the disease. Every patient with the same nosological disease differs from each other. Individualizing features of a patient differentiate him from other patients. Repertory is very essential in homoeopathy to find out a group of similar remedies in an easy way and one of the most frequently referred is Kent’s Repertory. An alarming rise in the incidence of sciatica pain has created an impetus for further research in the light of homoeopathic knowledge. So, this study was undertaken to analyze the effects of homoeopathic medicines in the management of sciatica pain and improving the quality of life of patients. The aim was also to identify a group of medicines with the help of Kent’s repertory.

METHODS

Trial design: This open label, prospective, observational, non-randomized, non-controlled clinical trial of pre-post comparison design was conducted at the Repertory out-patient department of National Institute of Homoeopathy, Kolkata, India. The study protocol was approved by the Institutional Ethical Committee (IEC) [Ref. No. 5-023/NIH/PG/Ethical Comm. 2009/Vol. III/ 1954 (A/S); dated March 27, 2017]. The trial protocol (unpublished) and full dissertation was submitted as postgraduate thesis of the corresponding author to The West Bengal University of Health Sciences.

Participants: Inclusion criteria were the patients suffering from sciatica pain for more than 3 months (2018/19 ICD-10-CM diagnosis code M54.31), both sexes, aged 30-50 years, and the patients willing to give written consent to participate in the trial. Exclusion criteria were the patients suffering from any life threatening illness or other systemic disease affecting quality of life or any vital organ failure, patients suffering from disc prolapse, psoriatic arthritis and gout, cases willing for or requiring immediate surgical intervention or already underwent any major spinal or hip surgery in last 6 months, undergoing homoeopathic treatment for chronic disease within last 6 months, diagnosed cases of unstable psychiatric illness, pregnant and lactating women, self-reported immune-compromised state, substance abuse and/or dependence, and the patients not willing to participate. Patients already taking any standard or other alternative therapy for sciatica pain were included if agreed to discontinue for at least 1 month.

Intervention: Intervention was planned as administration of indicated homoeopathic medicines in centesimal or 50 millesimal potencies and in individualized dosage, as decided appropriate to the case or condition. In centesimal potencies, each dose consisted of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 90% v/v ethanol. In 50 millesimal potencies, a single medicated cane sugar globules medicated with a single drop of the indicated medicine, preserved in 90% v/v ethanol. In 50 millesimal potencies, a single medicated cane sugar globule of poppy seed size (no.10) was dissolved in 50 ml distilled water with addition of 2 drops of 90% v/v ethanol, 10 doses were marked on the vial, each dose of 5 ml was instructed to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid in the cup. Each dose was directed to be taken orally on clean tongue with empty stomach. Duration of such therapy was 6 months. Medicines were obtained from SBL Pvt. Ltd. and Homoeopathy International® – Good Manufacturing Practice certified firms. Single individualized medicine was prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization by Kent’s  repertory using RADAR® software with due consultation with Materia Medica. Participants were assessed by two homoeopaths at a time. Medicine was selected on each occasion by two homoeopaths. All the homoeopaths involved were affiliated with respective state councils with experience and expertise of practicing classical homoeopathy.

General management: All the participants were given general guidelines to remain active within the limits of pain, avoid activities which would make the pain worse (e.g. lifting heavy weights), consider alternative positions or ways to minimise pain, rest when needed, spinal extension exercises and reassurance. They were advised to be present for monthly follow-ups.

Outcomes:

  • Primary outcome measure: Pain 0-10 numeric rating scale, administered at baseline, after 3 months and 6 months. Numeric rating scales (NRS; 0-10) measuring intensity of pain [0: no pain; 10: worst possible pain]. Degrees of improvement are defined a priori as per the below defined percentage reduction of pain NRS (i.e. the minimally clinically important difference) [6, 7]

35% reduction: “minimal relief”

67% reduction: “moderate relief”

70% reduction: “much relief”

94% reduction: “complete relief”

  • Secondary outcome measure: Bengali version of Ronald- Morris Low Back Pain and Disability (RMQ) Questionnaire [8] administered at base line, after 3 months and 6 months

Sample size: No relevant data was available on reduction of pain NRS scores by individualized homoeopathic treatment using an open observational study design over 6 months of intervention. Thus assuming a medium effect size (d) of 0.5, alpha = 0.05 and power of 85%, to detect a significant difference between two dependent means of NRS scores by paired t test, we would have required a sample size of 38. Keeping a provision for 5% drop-outs, target sample was 40.

Statistical methods: The analysis was carried out with per protocol approach; i.e. only the protocol-compliant sample entered into the final analysis. The baseline descriptive data (categorical and continuous) were presented in terms of absolute values, percentages, means, and standard deviations. Parametric tests (Student’s t test and post hoc one way repeated measure ANOVA) were planned to be used as inferential statistics comparing dependent observation of continuous outcomes at baseline and after 3 and 6 months. P values less than 0.05 were considered as statistically significant. No interim and subgroup analyses were planned. SPSS®-IBM® v.20 for Windows was used for analysis of data. Reporting adhered to the CONSORT [9] and RedHot [10] guidelines for reporting trials, Mathie’s criteria for model validity of homoeopathic treatment [11, 12] (MVHT) and Saha’s criteria for reporting quality of homoeopathic individualization in clinical trials [13].

RESULTS

Participant flow: As per the pre-specified inclusion and exclusion criteria, 68 subjects suffering from frozen shoulder were screened; 28 were excluded on account of various reasons; 40 met the eligibility criteria and were enrolled into the trial. Following that, baseline socio-demographic and outcome data was obtained. After 3 and 6 months of intervention, outcome data was recorded again. During intervention, 10 dropped out; 30 completed the trial.

Recruitment: Starting from April 2017, follow up of the last enrolled patient was completed by the end of June 2018.

Baseline data: The following variables were studied for the baseline socio-demographic features of the subjects – age, gender, residence, religion, history of injury, duration of suffering, treatment taken, marital status, educational status, employment status, and family income status. (Table 1)

Numbers analyzed: Outcomes from 30 out of 40 subjects were complete and only those entered into the final analyses.

Outcomes and estimation:

  • Pain NRS scores: Patient assessed severity of pain on NRS was reduced from 8.3 (sd 0.8) to 5.8 (sd 0.8) over 3 months of Homoeopathic treatment. The reduction [mean 2.5, 95% CI 2.2 to 2.8, t29 = 16.490, p < 0.001] was statistically significant. Similarly after 6 months of treatment the NRS Pain intensity score was reduced to 2.9 (sd 0.7) and the reduction [mean 5.4, 95% CI 5.1 to 5.7, t29 = 13.445, p < 0.001] was also statistically significant. According to the a priori definition of degrees of improvement, complete, much, moderate and minimal relief was obtained in none (0%), 11 (37%), 5 (17%), 14 (46%) patients respectively. Post hoc one way repeated measure ANOVA also revealed statistically significant reductions [Wilks’ lambda 0.028, Partial η2 = 0.972, F2, 28 = 486.017, p < 0.001]. (Tables 2, 3)
  • RMQ scores: Patient assessed severity of RMQ score was reduced from 16.6 (sd 2.8) to 8.8 (sd 2.7) over 3 months of homoeopathic treatment. The reduction [mean 7.8, 95% CI 6.6 to 9.0, t29 = 9.611, p < 0.001] was statistically significant. Similarly after 6 months of treatment the RMQ intensity score was reduced to 5.4 (sd 1.9) and the reduction [mean 11.2, 95% CI 10.1 to 12.3, t29 = 20.149, p < 0.001] was also statistically significant. Post hoc one way repeated measure ANOVA also revealed statistically significant reductions [Wilks’ lambda 0.067, Partial η2 = 0.933, F2, 28= 196.018, p < 0.001]. (Tables 2, 3)
  • The box and whisker plots reveal the changes in median pain intensity NRS scores over 3 months [median change 2.0, inter-quartile range 2.0 to 3.0, min 1.0, max 4.0] and 6 months [median change 5.0, IQR 5.0 to 6.0, min 3.0, max 7.0] of treatment and RMQ pain intensity scores over 3 months [median change 7.0, inter-quartile range 6.0 to 9.0, min 2.0, max 17.0] and 6 months [median change 11.0, IQR 9.0 to 13.0, min 5.0, max 19.0] of treatment. (Figures 1, 2)

Prescribed medicines:

Rhus tox (n=10, 33.3%), Lycopodium (n= 4, 13.3 %) and Bryonia (n=3, 10%) were the most frequently prescribed medicines,

 

followed by Lachesis, Sulphur, Thuja (n=2 each, 6.66%), Valeriana, Pulsatilla, Natrum mur, Lyssin, Hypericum, Calcarea carb, and Ars alb (n=1 each, 3.33%).

Prescribed potencies: Medicines were prescribed in centesimal potencies to 5 (16.7%) and in 50 millesimal potencies to 25 (83.3%) patients depending upon the susceptibility of the patients.

Baseline socio-demographic features (N=30)

Features N (%)
Age (yrs; mean ± sd) ¥ 40.5 ± 7.5
Age groups (yrs) §

§  30 – 40

§  41 – 50

17 (57)

13 (43)

Gender§

§  Male

§  Female

17 (57)

13 (43)

Residence§

§  Rural

§  Urban

14 (47)

16 (53)

Religion§

§  Hinduism

§  Islam

16 (53)

14 (47)

History of injury§ 6 (20)
Duration of suffering (yrs) ¥ 3.0 ± 3.3
Treatment taken§

§  Allopathy

§  Homoeopathy

25 (83)

5 (17)

Marital status§

§  Married

§  Single

27 (90)

3 (10)

Education§

§  8th std. or below

§  9th to 12th std

§  Above 12th std

10 (34)

7 (23)

13 (43)

Employment status§

§  Farmer

§  Business

§  Others

6 (20)

13 (43)

11 (37)

Family income status§

§  Low

§  Medium

§  Affluent

10 (33)

18 (60)

2 (7)

¥Continuous data presented as means ± standard deviations; §Categorical data presented as absolute values (%)

 

Table 2: Changes in outcomes over 3 and 6 months: pair-wise analysis (N=30)

Outcome measures Baseline After 3 months After

6 months

Change (0-3);

mean ± sd (95% CI)

Change (0-6);

mean ± sd (95% CI)

NRS 8.3 ± 0.8 5.8 ± 0.8 2.9 ± 0.7 2.5 ± 0.8 (2.2 to 2.8)¥ 5.4 ± 0.9 (5.1 to 5.7) ¥¥
RMQ 16.6 ± 2.8 8.8 ± 2.7 5.4 ± 1.9 7.8 ± 3.2 (6.6 to 9.0)* 11.2 ± 3.0 (10.1 to 12.3)**

¥ t29 = 16.490, P < 0.001 (significant); * t29 = 13.445, P < 0.001 (significant); ¥¥ t29 = 9.611, P < 0.001 (significant); ** t29 = 20.149, P < 0.001 (significant)

Table 3: Changes in outcomes over 3 and 6 months: one-way repeated measure ANOVA (N=30)

Outcome measures Baseline After 3 months After 6 months P value
NRS 8.3 ± 0.8 5.8 ± 0.8 2.9 ± 0.7 < 0.001¥
RMQ 16.6 ± 2.8 8.8 ± 2.7 5.4 ± 1.9 < 0.001*

¥ Wilks’ lambda 0.028, Partial η2=0.972, F2, 28 = 486.017, P< 0.001 (significant); *Wilks’ lambda 0.067, Partial η2=0.933, F2, 28 = 196.018, P< 0.001 (significant)

Figures 1 and 2: Box and whisker plots showing changes in outcomes over 3 and 6 months

DISCUSSION

Principal findings: There were significant reductions achieved in the pain NRS and RMQ scores over 3 and 6 months of treatment with individualized homeopathic medicines selected with the help of Kent’s repertory. Individualized homoeopathic medicines selected using Kent’s repertory seemed to produce promising treatment effect for sciatica pain.

Main strength of the study: The study was the very first of its kind in homoeopathy; hence exploratory in nature. The methodological strengths of the study include the use of standardized and already validated outcome scales- pain intensity measuring 0-10 NRS and RMQ questionnaire. This study is representative of individualizing (“classical”) homoeopathic treatment of sciatica pain. Being an observational study, it was important for conceptualization of hypothesis. It might also offer help in calculation of effect size and sample size for controlled trials in future. Though the sample size of this study was small, still was adequately powered to detect changes in the specified outcome measure over 3 and 6 months. Actually the sample size was small keeping in mind the feasibility issues and stipulated time frame of postgraduate thesis. All the collected data (hard form) was converted into an analyzable and reproducible master chart (soft copy) where all data was extracted systematically and underwent statistical analysis subsequently. We presented the results using sufficient numbers of both tabular forms and pictorials for easy understanding. Enrolment into the study was prospective; i.e. the protocol was drafted prior enrolment of the first patient. The study was transparent in terms of declaration of protocol, ethical conduct and reporting. There was no placebo control and no new drug was experimented; thus ethically less vulnerable. There was no violation of routine homoeopathy practice and the outcome data was gathered at baseline, 3 months and after 6 months of treatment. In all the cases, medicines were prescribed only after due repertorization with Kent’s repertory and after referring standard Materia Medica books to treat the patient as a whole. The medicines were prescribed in both centesimal and fifty millesimal potencies. Advices on lifestyle modification were also given as adjunctive to homoeopathic treatment. Prior to enrolment, each patient was provided with a patient information sheet in local vernacular Bengali detailing the study aims and objectives, methods, risks and benefits of participating and confidentiality issues. Subsequent to that, written informed consent was obtained. Thus the study conformed to the every possible ethical standard. Clearance was obtained from the Institutional Ethical Committee (IEC).The statistically significant results were obtained as there was marked reduction in the scores before and after treatment along with reduction in the symptom severity of the patient with marked improvement in pain of majority of patients.

Weakness of the study: Duration of follow-up was one of the major limitations of the study. It could have been enhanced and/or the outcomes could have been measured repeatedly to enhance the rigor of the study. This study did not support conclusions as to the efficacy or effectiveness of the homeopathic medicines because no methodology for this purpose (control group, randomization, blinding, multi-center study design, etc.) was built into its design.  Also, simultaneous advices on lifestyle modifications could have overestimated the effect size. Besides, the trial was open; no blinding was used. Thus patient selection bias, evaluation bias, and data analysis bias might have affected the outcomes of the study. The study was done on a small sample of 30 patients only.  In order to come to any conclusion it needs regular follow up of patients for longer duration. The data may also be helpful in the planning of further research projects on homoeopathy.

Comparison with other studies: There are very few scientific research works done in this field. Homeopathic research database on treatment of Low back pain is compromised. A comprehensive search into electronic databases (CORE-Hom, Pub Med, Science Direct, Wiley Online Library, CHIRO-Access, and Cochrane) revealed seven published papers [14-20]. In two similar double-blind, randomized, placebo-controlled, parallel, arm, trials, efficacy of a complex remedy Disci/Rhus toxicodendron compositum was tested on 150 patients suffering from chronic LBP; but no significant differences between homoeopathy and placebo was elicited  In another double-blind, randomized, placebo-controlled, parallel arm trials, efficacy of a complex rememdy Lymphdiaral was tested on 228 patients suffering from chronic LBP; the outcome improved by trend in the intention-to-treat analysis and significantly in the per-protocol analysis. In an open, randomized, parallel arm trial, efficacy of individualized homeopathy was tested vs. standard physiotherapy on 43 patients suffering from LBP; Oswestry score over 8 weeks improved by 6.3 in homeopathy patients and -0.5 in standard patients. In another single-blind, randomized, parallel arm trial, efficacy of a complex remedy Chirofossat was tested vs. unconventional treatment (details unclear) on patients suffering from degenerative joint and vertebral diseases; patients rated significant relief in 80/98 homeopathy group and 58/91 in unconventional group. Efficacy of another complex remedy Spiroflor SRL was tested against Cremor Capsici Compositus on patients suffering from LBP in a double-blind, randomized, parallel arm trial; no significant difference was obtained –mean pain (VAS) was reduced by 37.2 mm in homeopathy patients and 37.7 mm in standard patients. In a single, open, non-randomized study, role of individualized homeopathy was examined in 129 patients suffering from chronic LBP; treatment was found to be effective; it improved health related QoL and reduced the use of other healthcare services.

In contrast to the mentioned trial, this study was open and observational in design, used valid outcomes measuring pain intensity and quality of life, and intervened with individualized homoeopathic medicines selected with the help of Kent’s repertory, instead of empirically. This may have caused difference in results; however, the results should not be compared. Rather randomized trials should be designed on individualized homoeopathy and only after that, the study results should be matched up to.

Unanswered questions and future research: Future research is warranted with larger sample for longer duration of time. The data is also helpful in the planning of RCTs of individualized homoeopathic treatment of Sciatica pain in future.

CONCLUSION

In this prospective observational clinical study carried out at National Institute of Homoeopathy on 30 patients suffering from sciatica pain, there were statistically significant reductions in pain severity measuring 0-10 NRS and improvement in the RMQ questionnaire score after 3 and 6 months of individualized homoeopathic treatment using Kent’s repertory. Thus Kent’s repertory seemed to be a useful aid in individualized homoeopathic treatment of Sciatica pain. Finally null hypothesis of no effect was discarded and the alternative hypothesis of probable treatment effect was accepted. Further explorations by randomized trials with enhanced methodological rigor are warranted.

 

Conflict of interest statement: The authors declare that they have no competing interests. The trial was carried out as the postgraduate thesis of the corresponding author under guidance of Prof. (Dr.) Amitava Samanta, MD(Hom) who was a teaching faculty of the institute.

Funding: We received no funding for the study. Funding required for the project was borne by the authors themselves.

Authors’ contributions: DP conceived and designed the study. Data was collected by DP and AS. DP prepared the manuscript. Both the authors reviewed and approved the final manuscript.

Acknowledgements: We thank Dr. Subhranil Saha for statistical analysis. The authors are grateful to the institutional heads of both academic and hospital section for their cooperation. We thank the fellow postgraduate trainees, staff, pharmacists, and the patients for their sincere cooperation and participation in the study.

 

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Cite this article as: Pandey D, Samanta A. Clinical adaptability of Kent’s repertory in the management of sciatica pain: An open, observational trial. National Homoeo Recorder 2019;15(1):24-33.

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