|Year : 2019 | Volume
| Issue : 2 | Page : 81-90
The 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
1 Department of Organon of Medicine, Homoeopathic Philosophy, Chronic Diseases and Psychology, National Institute of Homoeopathy, Kolkata, West Bengal, India
2 Department of Practice of Medicine, National Institute of Homoeopathy, Kolkata, West Bengal, India
3 Postgraduate Trainee, National Homoeopathic Medical College, Lucknow, Uttar Pradesh, India
4 Postgraduate Trainee, National Institute of Homoeopathy, Kolkata, West Bengal, India
|Date of Submission||24-Feb-2019|
|Date of Acceptance||20-May-2019|
|Date of Web Publication||27-Jun-2019|
Dr. Arunava Nath
Department of Organon of Medicine, Homoeopathic Philosophy, Chronic Diseases and Psychology, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata - 700 106, West Bengal
Source of Support: None, Conflict of Interest: None
Context: An open observational trial was carried out at National Institute of Homoeopathy, India, to assess the possible effects of individualised Homoeopathy in individuals suffering from post-caesarean backache. Aim: The aim of the study was to find the role of homoeopathic treatment in individuals suffering from post-caesarean backache. Methods: Fifty subjects were enrolled. The Short-Form McGill Pain Questionnaire (SF-MPQ) and Oswestry Low Back Pain Disability Questionnaire (ODQ) were used as the outcome measures, assessed at baseline and after 3 months of treatment. Medicines prescribed followed homoeopathic principles. Non-parametric Wilcoxon signed rank test was applied to compare the dependent observations. P < 0.05 two-tailed was considered statistically significant. Results: Five subjects dropped out and 45 completed the trial. Intention-to-treat sample (n = 50) was analysed. There were statistically significant reductions in pain rating index percentage score (median 83.3 (IQR 66.7 to 100) vs. median 66.7 (IQR 33.3 to 71.1), P < 0.001); visual analogue scale score (median 7.0 (IQR 6.0 to 8.0) vs. median 6.0 (IQR 4.8 to 7.0), P < 0.001); present pain index score (median 3.0 (IQR 2.0 to 3.0) vs. median 2.0 (IQR 2.0 to 3.0), P = 0.019) and ODQ% score (median 44.0 (IQR 39.5 to 50.0) vs. median 39.0 (IQR 31.9 to 44.0), P < 0.001) over 3 months of treatment. Natrum muriaticum (n = 11, 22%); Staphysagria (n = 8, 16%); Bryonia alba and Rhus toxicodendron (n = 6 each, 12%) and Pulsatilla nigricans (n = 4, 8%) were prescribed frequently. Conclusion: Indicated homoeopathic medicines reduced SF-MPQ and ODQ scores. Further randomised trials are warranted with enhanced methodological rigour.
Keywords: Backache, Caesarean section, Homoeopathy, Oswestry Low Back Pain Disability Questionnaire, Short-Form McGill Pain Questionnaire
|How to cite this article:|
Nath A, De M, Singh S, Kundu N, Michael J, Sadhukhan S, Kumar D, Koley M, Saha S. The role of homoeopathic treatment in women suffering from post-caesarean backache: An open observational clinical trial. Indian J Res Homoeopathy 2019;13:81-90
|How to cite this URL:|
Nath A, De M, Singh S, Kundu N, Michael J, Sadhukhan S, Kumar D, Koley M, Saha S. The role of homoeopathic treatment in women suffering from post-caesarean backache: An open observational clinical trial. Indian J Res Homoeopathy [serial online] 2019 [cited 2019 Nov 22];13:81-90. Available from: http://www.ijrh.org/text.asp?2019/13/2/81/261633
| 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. Moreover, the number of studies that have examined the risk factors of chronic post-surgical pain after caesarean section is limited.
| Methods|| |
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.
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 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. Medicines were obtained from good manufacturing practice-certified firms of India. 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. Participants were assessed by three homoeopaths at a time. Medicine was selected on each occasion by two homoeopaths, and in case of any differences in opinion, it was resolved by involvement of another homoeopath.
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.
- Primary outcome measure – Short Form McGill Pain Questionnaire (SF-MPQ). 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.,,
Before this trial was initiated, the questionnaires underwent standardised translation into local vernacular Bengali after obtaining permission from the developer of the questionnaire via e-mail, which was checked for face-and-content validity, and subjected to pilot testing and thereafter formal psychometric validity and reliability testing.
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.
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. No interim and subgroup analyses were planned. SPSS®-IBM® version 20 (IBM Corp., IBM SPSS Statistics for Windows, Armonk, NY: USA) for Windows was used for the analysis of data.
| Results|| |
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 [Figure 1].
Starting from May 2017, follow-up of the last enrolled patient was completed by the end of August 2018.
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 [Table 1].
|Table 1: Baseline socio-demographic features of the female subjects (n=50)|
Click here to view
Outcomes from 45 female subjects were complete; therefore, all the enrolled subjects (n = 50) entered into the final analyses.
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.
Outcomes and estimation
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 2]. 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). 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., After 3 months of treatment, minimum 10% score reduction was achieved in 15 subjects.
|Table 2: Changes in outcomes over 3 months; non-parametric Wilcoxon signed-rank test (n=50)|
Click here to view
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%). Percentages were calculated by dividing the number of prescriptions of each medicine by total number of prescriptions (i.e., 50) multiplied with 100. Indications of the prescribed medicines are given in [Table 3].
Patients were instructed to report any harms, unintended effects, serious adverse events and undue aggravations either directly in the outpatients or over phone, but not a single incidence was reported from either group.
| Discussion|| |
This open observational clinical trial found statistically significant improvement in both the outcomes after homoeopathic treatment, suggesting Homoeopathy as a promising treatment option for women suffering from backache following caesarean section and suggesting further substantiation using methodologically sound trials.
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').
Weaknesses of the study
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. This might be partly explained by placebo and/or regression to the mean effects that our study was not designed to control. We also could not rule out the undisclosed use of concurrent therapeutic modalities, if any. 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.
Strength and weakness in relation to other studies
Controversies exist whether caesarean section is associated with chronic low backache or not;,,,, however, a recent meta-analysis finds a clinically relevant incidence of chronic post-surgical pain after caesarean section ranging from 15% at 3 months to 11% at 12 months or longer that has been largely stable in recent years. Recent large-scale cohort studies also support the claim,,, with evidence of impaired quality of life. Dexamethasone local pre-treatment was found to significantly reduce the incidence of post-operative acute low back pain and the degree of pain after epidural delivery analgesia. However, the Complementary and Alternative medicine (CAM) modalities remained under-researched and were examined for efficacy mostly in short-term backache following caesarean section, but not for chronic low back pain. Thus, we intended to compare the treatment effect sizes of Homoeopathy with that of other CAM, physiotherapy or usual treatment, but scarcity of trials in the relevant subject area did not allow for such comparisons. A prospective, randomised, double-blind placebo-controlled clinical trial was conducted under the official title “Effect of Homeopathic Drugs Bellis perennis, Staphysagria on the Post-Operative Recovery, of Women Undergoing Cesarean Section – (An exploratory) Double Blind, Placebo Controlled Study” with 90 participants from August 2008 to April 2009 (ClinicalTrials.gov identifier: NCT00725569). It was anticipated that homoeopathic treatment proved to be both safe and effective in shortening the duration of post-operative healing, with respect to both healthcare costs and patient suffering. It is supposed to open the door for further research in the field of trauma medicine, as well as other stress-related illnesses. A randomised, double-blind, placebo-controlled trial was conducted from December 2003 to May 2007 on 248 patients with a homoeopathic drug combination Lymphdiaral basistropfen, which was established in the treatment of oedema and swellings. It was for the first time the effectiveness and safety of the drug were investigated in the treatment of chronic low back pain. This trial showed that the homoeopathic drug combination could improve the treatment of chronic low back pain. A prospective, multicentre cohort study was conducted in 2005 with 3981 patients suffering from long-term chronic diseases. According to both physician and patient assessments, the severity of complaints decreased markedly over the 24-month observation period. Younger patients and those with more severe disease appeared to benefit most from homoeopathic treatment. Amongst adults and children, an improvement in quality of life was observed. The findings indicated that homoeopathic medical therapy might play a beneficial role in the long-term care of patients with chronic diseases. A placebo-controlled study was conducted on 144 women with an average age of 23.5 years, who had undergone surgical childbirth by comparably trained obstetricians. The sample was divided into a treatment group receiving an ointment of St. John's-Wort (Hypericum perforatum) 24-h post-operation, a placebo group who received a placebo ointment 24-h post-operation and a control group who received no treatment. Assessment was done for redness, oedema, ecchymosis, discharge, approximation scale and VAS. The study found a significant difference in the St. John's-Wort group's wound healing and scar formation, while there was little difference in wound healing and scar formation in the placebo or control group.
Unanswered questions and future research
The role of homoeopathic treatment on the radiological changes including bony and soft tissue changes could not be studied. The assessment for the same can be done in future. The trial would have been methodologically better if randomisation and blinding techniques could have been included. Role of few medicines such as Bellis perennis and Kalium carbonicum in post-traumatic backache which is mentioned in available Homoeopathic literature could not be assessed in the present trial. Further investigations can be undertaken to study the efficacy or effectiveness of the above-stated medicines in the management of post-traumatic complications, especially in backache following caesarean section. A comparative study can be carried out to assess whether treatment results vary with individualised medicines or with specific medicines for a clinical condition. Further studies can be carried out to assess the magnitude of back pain in primary and repeat caesarean section as well as on the type of anaesthetic technique used during deliveries so that necessary treatment protocol can be framed accordingly. In an observational study of 64 healthy, singleton, new-born infants (33 boys) born at term, cord blood was sampled after elective caesarean section and vaginal delivery. The study concluded that there was increasing evidence for epigenetic changes with caesarean section, suggesting that it might not be just the mother and infant who were affected by surgical deliveries, but there might be transgenerational effects. It can be deduced from the above facts that there is ample scope for doing further methodical research in Homoeopathy in the management of post-caesarean complications.
| 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.
We deeply acknowledge the Former Directors Dr. Samir Kumar Nanda, Dr. Gautam Ash and Present Director Dr. Abhijit Chattopadhyay of NIH for allowing us to conduct the trial. We gratefully acknowledge the active co-operation and participation made towards the study by the patients and the supporting staff.
Financial support and sponsorship
Conflicts of interest
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[Table 1], [Table 2], [Table 3]