Role of homoeopathic treatment in women suffering from post-caesarean backache: an open observational clinical trial

Arunava nath1*, mahadeb de1, subhas singh1, nivedita kundu1, james michael1, satarupa sadhukhan1, deepak kumar2, munmun koley3, subhranil saha4

Introduction
In caesarean section, the foetuses after 28th week are delivered through abdominal route. the caesarean delivery rate in the united states in 2010 was 32.8%. the estimate for caesarean section rates in india is rising. the who report suggests that a higher rate of caesarean section was associated with greater risk of maternal and perinatal mortality and morbidity. Although the who has recommended since 1985 that the rate is not to exceed 10%–15%, a study conducted by sarkar et al. Showed the rate to be around 32%. literature review shows homoeopathic medicines to be effective in injury to spine.Low back pain also restricts mobility, interferes with normal functioning and results in lifelong pain and permanent disability.Back pains after surgery may result from a multitude of causes that include posture during surgery, aggravation of an existing medical condition Or needle trauma during central neuraxial blocks.Although caesarean section is one of the most commonly performed operations, chronic pain after caesarean section has not been well studied. The prevalence of chronic pain after caesarean section is usually observed in retrospective studies and varies considerably from one study to another.

Methods
Trial design-This open-label, prospective, observational, non-controlled clinical trial of pre–post comparison design was conducted at the outpatient department of national institute of homoeopathy (nih), kolkata, india. The study protocol was approved by the institutional ethical committee (ref. No. 5-023/nih/pg/ethical comm. 2009/vol. Iii/1970 [a/s]; dated 27 march 2017) and was registered prospectively in the clinical trials registry – india (trial registration: ctri/2017/06/008849). The trial protocol and full dissertation was submitted as a post-graduate thesis of the corresponding author to the west bengal university of health sciences.

Participants
Inclusion criteria were female subjects suffering from backache over 3 months following caesarean section (2019 icd 10 diagnosis code g89.28, other chronic post-procedural pain), aged between 18 and 45 years and willing to participate in the study by giving written consent. Exclusion criteria were the cases too sick for consultation, unable to read patient information sheets and not giving consent to take part, post-menopausal women, female subjects presenting with confounding variables such as backache existing before caesarean section, with immediate complications after caesarean section, diagnosed cases of unstable psychiatric illness or other systemic disease affecting quality of life, currently receiving homoeopathic treatment for chronic condition(s), pregnant and lactating women, self-reported immune-compromised state, substance abuse and/or dependence.

Intervention
The intervention was planned as the administration of indicated homoeopathic medicines in centesimal or 50 millesimal potencies and in individualised dosage, as decided appropriate to the case or condition. In centesimal potencies, each dose consisted of four 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 marked on the vial, each dose of 5 ml was directed 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. Patients were instructed to take each dose orally on clean tongue with empty stomach. Duration of such therapy was 3 months.Single individualised medicine was prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorisation using  radar® software  (version 10.0.028 (ck), archibel 2007, belgium) when required with due consultation with materia medica. Subsequent prescriptions were generated as per kent’s observations and hering’s law

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) and consider alternative positions or ways to minimise pain, rest when needed. They were advised to be present for monthly follow-ups.

Outcome
Primary outcome measure – short form mcgill pain questionnaire (sf-mpq).[14] the sf-mpq, the shorter version of the mpq, is a multidimensional valid and reliable measure of perceived chronic pain in adults. It is comprised of 15 words (first 11 sensory and last 4 affective), which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. The sf-mpq also includes one item for present pain intensity (ppi; 0–5) and one item for a 10-cm visual analogue scale (vas) for average pain. The total pain rating index (pri) score is obtained by summing the item scores (range 0–45). There are no established critical cut points. As for the mpq, a higher score indicates worse pain. The sf-mpq takes 2–5 min to complete. A mean improvement in total scores >5 on the 0–45 scale demonstrated a clinically important change. It was administered at baseline and after 3 months of treatment

Secondary outcome measure – Oswestry low back pain disability questionnaire (odq), it is one of the most commonly used outcome measures for individuals with low back pain and considered to be gold standard in the assessment of patient-rated outcome. It is a valid, reliable and responsive condition-specific assessment tool that is suited for use in clinical practice. It is easy to administer and score, objectifies clients’ complaints and monitors effects of therapy. For each section, the total possible score is 5, the first statement is marked = 0, the last statement is marked = 5. Total section = 10; total possible score = 50. Minimum detectable change (90% confidence) was 10% points (change of less than this may be attributable to error in the measurement). It was administered at baseline and after 3 months of treatment

Sample size
No relevant data were available on the reduction of sf-mpq and odq scores by individualised homoeopathic treatment using an open observational study design over 3 months of intervention.Thus, assuming a medium effect size (d) of 0.5, alpha = 0.05 and power of 90%, to detect a significant difference between two dependent means of pri% (mean pre- and post-scores) by wilcoxon signed rank test (matched pairs), we would have required a sample size of 47. Keeping a provision for about 5% drop-outs, the target sample was 50.

Statistical methods
The analysis was carried out with intention-to-treat approach; i.e., every included patient entered into the final analysis. Missing values were replaced by the last observation carried forward method. Data distribution was examined by histograms, q–q plots, kolmogorov–smirnov test and shapiro–wilk test. The baseline descriptive data (categorical and continuous) were presented in terms of absolute values, percentages, means, standard deviations, medians, and inter-quartile ranges.Non-parametric wilcoxon signed rank tests were planned to be used as inferential statistics comparing non-normally distributed dependent observation of continuous outcomes at baseline and after 3 months. P < 0.05 was considered statistically significant.

Results
Participant flow as per the pre-specified inclusion and exclusion criteria, 120 female subjects suffering from backache with obstetrical history of caesarean section were screened; 70 were excluded on account of various reasons; 50 met the eligibility criteria and were enrolled into the trial. Following that, baseline socio-demographic and outcome data were obtained. After 3 months of intervention, outcome data were recorded again. During the course of treatment, five dropped out; 45 completed the trial.

Recruitment  : Starting from may 2017, follow-up of the last enrolled patient was completed by the end of august 2018.

Baseline data
Eleven variables were studied for the baseline socio-demographic features of the female subjects – age, residence, religion, duration of suffering, treatment taken, body mass index, systolic blood pressure, diastolic blood pressure, educational status, employment status and family income status.

Numbers analysed  – outcomes from 45 female subjects were complete; therefore, all the enrolled subjects (n = 50) entered into the final analyses.

Data distribution
Data distribution seemed to be inconclusive from the histograms and q-q plots; however, the kolmogorov–smirnov test and the shapiro–wilk test revealed p values much less than α (=0.05), thus indicating stronger evidence against normal distribution. Thus, non-parametric wilcoxon signed rank test was planned to be performed.

Outcome
Statistically significant reductions were achieved on three individual components of the mpq – the pri% score (p < 0.001, wilcoxon signed-rank test), vas score (p < 0.001), ppi score (p = 0.019) and odq% score (p < 0.001) [table “” not found /]
. An 11.1% point reduction in total pri% score is considered as minimal detectable change (vide a mean improvement in total scores more than 5 on the 0–45 scale demonstrated a clinically important change).[14] after 3 months of treatment, minimum 11.1% score reduction was achieved in 28 subjects. A 10% point reduction in total odq% score is considered as minimal detectable change at 90% confidence level.[16,17] after 3 months of treatment, minimum 10% score reduction was achieved in 15 subjects

Medicines used
Sixteen different individualised medicines were prescribed in the study – natrum muriaticum (n = 11, 22%), staphysagria (n = 8, 16%), bryonia alba and rhus toxicodendron (n = 6 each, 12%), pulsatilla nigricans (n = 4, 8%), calcarea carbonicum (n = 3, 6%), ruta graveolens and sulphur (n = 2 each, 4%), arnica montana, causticum, hypericum perforatum, ignatia amara, lachesis mutus, medorrhinum, natrum sulphuricum and sepia officinalis (n = 1 each, 2%

Strengths of the study
The possible effects of homoeopathic treatment in individuals suffering from backache following caesarean section were explored using the bengali translated version of sf-mpq score, a multidimensional measure of perceived pain in adults with chronic pain. It helped to discriminate among different pain syndromes and evaluate the responsiveness of different symptoms to treatment. The oswestry disability index was a self-administered questionnaire that required 5 min to complete and 1 min to score. Scores were associated with degree of disability, ranging from minimal to bedbound. Homoeopathic treatment was based on the principles of individualisation.

Formal validity and reliability of the bengali versions of sf-mpq and odq have also been addressed before enrolment in this study but will be reported elsewhere and beyond the scope of this paper. Another important strength was the participation of qualified and experienced homoeopathic physicians schooled in and practicing individualised homoeopathy. Our study was representative of individualised (‘classical’) homoeopathy only. In a broader interpretation of the law of similar, medicines were selected for symptoms both typical of the diagnosis and outside the pre-dominating pathologies (‘constitutional’).

Limitations
The potential explanatory power of a one-armed observational trial is very limited. Although the trial was adequately powered to detect significant change in the specified outcome measures over 3 months, still the sample size was inadequate to make a definite conclusion regarding the effectiveness of homoeopathic treatment in individuals suffering from backache following caesarean section. The time period for the study was of short duration. The study was open and observational in design and hence did not involve any blinding, randomisation or control. Thus, efficacy data could not be generated and the effect sizes might have been overestimated

The duration of suffering was more than 5 years on average, thus indicating other confounders playing important role such as increasing age, multiple gestation, diabetes mellitus, obesity, pregnancy-related hypertension, complicated obstetric conditions (including pre-eclampsia and eclampsia), urinary tract infection and urinary tract stone (including renal stone and ureteral stone); however, our study design could not address this issue and controlled trials are warranted for the purpose.

Conclusion
In this open-label, prospective, observational, clinical trial of pre–post comparison design conducted on 50 female subjects suffering from post-caesarean backache revealed statistically significant improvement in both sf-mpq and odq scores after 3 months of individualised homoeopathic treatment. Further explorations by adequately powered randomised trials and independent replications are warranted.

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