|Year : 2018 | Volume
| Issue : 4 | Page : 194-201
An open-label pilot study to identify the usefulness of adjuvant homoeopathic medicines in the treatment of cerebral stroke patients
Aslam Abbas1, Md Shahid Ali1, Hima Bindu Ponnam1, Divya Taneja2, Anil Khurana2, Chaturbhuja Nayak3, Anil Santapur1
1 Extension Homoeopathic Clinical Research Unit of CCRH, Princess Durru Shehvar Children's and General Hospital, Hyderabad, Telangana, India
2 Central Council for Research in Homoeopathy (CCRH), New Delhi, India
3 Homoeopathy University, Jaipur, Rajasthan, India
|Date of Submission||06-Nov-2018|
|Date of Acceptance||12-Nov-2018|
|Date of Web Publication||08-Feb-2019|
Dr. Hima Bindu Ponnam
Scientist II, Extension Clinical Research Unit of CCRH, Princess Durru Shehvar Children's and General Hospital, Purani Haveli, Hyderabad - 500 002, Telangana
Source of Support: None, Conflict of Interest: None
Background: Stroke, the third leading cause for neurological morbidity and mortality has a global annual incidence of 0.2–2.5/1000 population. The clinical sequelae of stroke are often devastating with hemiparesis, depression, walking difficulties and aphasia. It is essential to take measures halting the progression of stroke. Homoeopathic literature mentions many medicines for stroke. Till a pilot study was undertaken to study the usefulness of Homoeopathy as an adjuvant therapy to standard conventional care in stroke patients. Materials and Methods: An open-label pilot study was conducted at Princess Durru Shehvar Children's and General Hospital, Hyderabad, in coordination with Extension Clinical Research Unit of Central Council for Research in Homoeopathy. Fifty patients presenting with episodes of cerebral stroke of the different period were assessed by the National Institute of Health Stroke Scale (NIHSS) Score, prior homoeopathic treatment and after 6 months of treatment. Results: Of 50 patients, 10 patients had stroke more than 1 year and suffering with sequelae, 27 patients had stroke episode between 1 month and 1 year and 13 patients had a stroke episode within 4 weeks. The reduction in NIHSS score after 6 months of treatment was statistically significant in all three groups. The useful medicines found were Causticum (n = 11), Arnica montana (n = 7), Nux vomica (n = 6), Lycopodium (n = 6) and Lachesis (n = 3). Neither patient had worsening signs nor any new infarcts during the study. Conclusion: This pilot study showed encouraging results. Further randomised control trials are suggested to evaluate the efficacy of homoeopathic medicines in stroke.
Keywords: Adjuvant therapy, Arnica, Causticum, Cerebral infarct, Homoeopathy, National Institute of Health Stroke Scale, Pilot study
|How to cite this article:|
Abbas A, Ali MS, Ponnam HB, Taneja D, Khurana A, Nayak C, Santapur A. An open-label pilot study to identify the usefulness of adjuvant homoeopathic medicines in the treatment of cerebral stroke patients. Indian J Res Homoeopathy 2018;12:194-201
|How to cite this URL:|
Abbas A, Ali MS, Ponnam HB, Taneja D, Khurana A, Nayak C, Santapur A. An open-label pilot study to identify the usefulness of adjuvant homoeopathic medicines in the treatment of cerebral stroke patients. Indian J Res Homoeopathy [serial online] 2018 [cited 2019 Jun 26];12:194-201. Available from: http://www.ijrh.org/text.asp?2018/12/4/194/251918
| Introduction|| |
Stroke is a phenomenon of rapidly developing clinical symptoms and/or signs of focal disturbance of cerebral function, with symptoms lasting for more than 24 h or leading to death. Stroke continues to remain a common neurologic problem in India constituting an important cause of death and hazardous long-term disability. The ageing of our population will undoubtedly result in an increased incidence of stroke and a rapid rise in health-care economic burden. Thus, the reduction of the incidence of stroke is a high priority objective for India. About 80% of strokes are ischaemic, 10% are intracerebral haemorrhage and 5% are subarachnoid haemorrhage. Clinically, stroke can be classified as follows: (a) transient, if the deficit recovers within 24 h, (b) complete if the focal deficit is persistent and not worsening and (c) evolving, if the focal deficit continues to worsen after about 6 h from onset. The risk factors for stroke are classified into Irreversible (age, gender, race, heredity and previous vascular event) and modifiable (hypertension, heart disease, diabetes, hyperlipidaemia, smoking, excess alcohol consumption, polycythaemia and oral contraceptives).
The clinical sequelae of stroke survivors are often devastating with one half having hemiparesis, one-third clinically depressed, approximately one-third unable to walk and one-sixth aphasic. It is essential to take rapid measures that can halt the progression of the cerebrovascular disease to prevent complications. In homoeopathic literature, a number of medicines are mentioned for the management of stroke and its related symptomatology. However, no systematic studies could be identified in Homoeopathy for the treatment of stroke and related symptomatology. As such, a pilot study was undertaken to identify the usefulness of homoeopathic medicines adjuvant to the conventional care in patients affected with cerebral stroke where all the patients were assessed for clinical status by using the National Institute of Health Stroke Scale (NIHSS).
| Materials and Methods|| |
Princess Durru Shehvar Children's and General Hospital, Hyderabad, Telangana, is a tertiary care hospital with inpatient and outpatient services. The extension clinical research unit of the Central Council for Research in Homoeopathy (CCRH) is located in the hospital premises wherein the outpatient homoeopathic treatment is provided. The study was conducted in the Neurology department of the hospital in collaboration with the Extension Clinical Research Unit of the CCRH. Three conventional medicine doctors including a neurologist and physician along with three Homoeopathy experts were involved in the study.
Total study duration was 3 years (2006–2009) with two and a half year's enrollment period. Each case was followed for 6 months.
This was an open-label observational pilot study to evaluate the usefulness of homoeopathic medicines as adjuvant to conventional care in treating patients affected with cerebral stroke.
Selection of patients
Patients presenting with stroke-related sequelae reporting in the neurology department of the hospital were screened for inclusion in the study as per the following inclusion/exclusion criteria:
- Patients aged between 30 and 65 years, of both the sexes, suffering from post-stroke sequelae and patients of stroke not improved after conventional treatment
- Patients that were conclusively diagnosed by investigations such as CT scan, of having cerebral infarcts as an eventuality after a stroke with score <20 on NIHSS.
- Patients with uncontrolled hypertension leading to haemorrhagic stroke, and patients with uncontrolled diabetes which are on insulin therapy for the maintenance
- Patients of stroke presenting with seizures
- Patients that need continuous administration of drugs such as tissue plasminogen activator (TPA), anticoagulants and clot-busters
- Patients with polycythaemia/uncontrolled hyperlipidaemia which were attributed as risk factors for the stroke
- Patients with infections such as HIV and other systemic disorders like malignancies
- Patients with evolving pattern of stroke and also which were of <3 h duration showing signs of worsening
- Patients with severe stroke manifestations i.e., where the NIHSS score is more than 20.
Initially, all patients were screened for cerebral infarct clinically and by computed tomographic scan of the brain and further evaluated through certain essential clinical laboratory tests (haematology, blood chemistry including glucose, lipid profile, electrolytes, renal function tests and electrocardiography) for enrolment into the study as per the inclusion criteria. All the patients were required to give voluntary consent, by signing the Informed Consent Format, for participation in the study. A detailed case history of each patient was recorded in a predesigned case taking proforma.
Each case was analysed, evaluated and totality of symptoms was built on. The symptoms were repertorised using the Complete Repertory in Hompath Version 8 Classic software (Jawahar Shah, 2005, Mind Technologies, Mumbai). However, the final selection of the remedy was done using the Materia Medica., The Homoeopathic medicine was prescribed adjuvant to the standard conventional care (TPA and anticoagulants). The patients were asked to continue their regular oral hypoglycaemic drugs, antihypertensives and lipid-lowering medicines as per their routine schedule. The selected Homoeopathic medicine was initially prescribed in 6C potency and repeated doses. Subsequently, the potency was raised in sequential manner if the case showed amelioration with one potency and then got stand still with no further improvement.
Data collection and assessment
Patients were assessed clinically at 7 days, 14 days, 1 month after starting the treatment and then at monthly intervals up to 6 months. NIHSS score was taken at baseline and subsequently at the completion of 6-month treatment. CT scan of the brain was also done at baseline and after completion of 6 months of treatment. Improvement assessment by a neurologist based on the NIHSS score reduction (more than 75% reduction in score was considered as marked improvement, 50%–75% reduction as moderate improvement, 25%–50% reduction as mild improvement, increase in score as worse and no change as static). Clinically, all the patients were assessed by a neurologist basing on the NIHSS Score. This scale (NIHSS) was developed by the investigators at the University of Cincinnati Stroke Center to quantify neurologic status in stroke patients. The NIHSS is a 24-point scale (11 items – level of consciousness, gaze, visual fields, facial palsy, motor arm, motor leg, ataxia, sensory, language, dysarthria and extinction), with zero being a normal score and the maximum possible score is 42. Patients receive points depending on different areas of deficit. The test takes approximately 5 min to administer and another 5 min to record the proper scores.
Statistical analysis was done using Statistical Package for the Social Sciences Software (IBM SPSS 20.0 version, India). Mean values of NIHSS score before and after treatment were compared using paired t-test. All values were expressed as n (%), mean ± standard deviation, and P < 0.05 was considered statistically significant.
Necessary ethical approval has been obtained from the Institutional Ethical Committee of the hospital where the study has been conducted.
| Results|| |
During the 3-year study, 118 patients with cerebral infarct were screened, out of whom 31 were excluded, 87 patients were enrolled out of whom 27 patients dropped out and 10 patients were withdrawn. Data of 50 patients have been analysed. Of these 50 patients, 10 patients had stroke episodes more than 1 year back, 27 patients had stroke episode for more than 1 month but <1 year back while 13 patients had stroke episodes <1 month. The data of these three groups have been analysed separately as shown in [Table 1].
Of 50 patients, whose data were analysed, 36 (72%) of the patients were above the age of 50 years, whereas 14 (28%) patients were 30–50 years old. Twenty-three (46%) of patients presented with the involvement of left cerebral artery lesion, 18 (36%) with right cerebral artery lesion and 9 (18%) showed both cerebral arteries involvement as given in [Table 1]. Seventeen (34%) patients showed a sudden onset of symptoms and 33 (66%) showed a gradual onset of symptoms as shown in [Table 1].
Thirty-six (72%) patients presented with a duration of more than 3 weeks of illness (chronic) and among them 27 (75%) patients showed signs of improvement. Eight (16%) patients were with a duration of 3 days–3 weeks (subacute) of illness, and among them, 5 (62.5%) patients showed signs of improvement. Five (10%) patients were with a duration of 6 h–3 days (acute) of illness and among them 5 (100%) patients showed signs of improvement and only 1 case (2%) was enrolled with a duration of <6 h of illness and showed signs of improvement, when symptomatically assessed. Various risk factors identified in stroke patients such as smoking, alcohol, family history of hypertension and diabetes are given in [Table 1]. Among those, eight patients reported both smoking and alcohol intake. Significant reduction in NIHSS score was seen in all three groups of patients as given in [Table 2]. The changes in individual symptomatology and the time of initiation of improvement [Figure 1] are given in [Table 3] and [Table 4], respectively.
|Table 2: Change in NIHSS score from baseline to 6 months after treatment|
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|Figure 1: Initiation of improvement in stroke patients with different duration of onset|
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Eleven homoeopathic medicines which were used as adjuvant to the conventional care (which included medicines such as blood thinners and TPA) showed no drug interactions or adverse events during the treatment period. Causticum (n = 14, 28%) was the most frequently used medicine followed by Arnica montana(n = 9, 18%), Nux vomica (n = 9, 18%), Lycopodium (n = 7, 14%) and Lachesis (n = 4, 8%). Other medicines used were Conium maculatum (n = 1, 2%), Arsenic album (n = 1, 2%), Baryta carb (n = 1, 2%), Bothrops (n = 1, 2%), Calcarea carbonica (n = 1, 2%), Phosphorus (n = 1, 2%) and Ignatia (n = 1, 2%) as given in [Table 5]. The characteristic indications of the medicines found useful in four or more patients are given in [Table 6].
| Discussion|| |
The present open-label pilot study was conducted to explore the usefulness of homoeopathic medicines in the treatment of stroke-related symptoms and stroke sequelae given adjuvant to conventional care in a hospital setting. Among 50 patients, who fulfilled the study protocol, 38 patients showed a marked reduction in the NIHSS score showing various stages of improvement as marked, moderate and mild, whereas in the remaining 12 patients the overall score remained the same.
Most of the patients (n = 23, 46%) in this study showed lesion in the left middle cerebral artery which corroborates with the classical presentation of stroke, 18 (36%) patients showed lesions in right cerebral artery, 9 (18%) patients showed lesions in both right and left cerebral artery. The onset of complaints in 17 (34%) patients was found to be of sudden nature, whereas 33 (66%) patients showed a gradual onset.
Forty-nine out of 50 (98%) patients presented with a history of hypertension, 80% (n = 40) with a family history of hypertension and 60% (n = 30) of patients were having irregular treatment for hypertension. Previous studies established that uncontrolled hypertension plays a major role in stroke manifestation, which corroborates with the patients enroled in the present study. Twenty-two (44%) patients presented with a habit of smoking and 8 (16%) patients presented with a combination of alcohol and smoking habits.
No change in these risk factors was observed during the study. The effect of these factors on change in the NIHSS score could not be ascertained in this pilot study.
The medicines found useful in this observational study were Arnica, Causticum, Lachesis, Lycopodium, Nux vomica. The results were found to be encouraging. In spite of many controversial statements on the efficacy of Arnica in the treatment of cerebral stroke patients, it was found beneficial in this study showing positive results. The positive role of Arnica has been ascertained in middle cerebral artery occlusion in rat model in a previous study. Our study also emphasises the same clinically. Further, the symptoms given in the homoeopathic literature for the above medicines have been clinically verified albeit in a small number of patients highlighting the importance of the holistic approach.
The homoeopathic medicines were used adjuvant to the conventional care (which included medicines such as blood thinners and TPA). No drug interactions or adverse events were reported during the study.
The computed tomography of the brain was conducted for all the cerebral infarct patients at screening level, and the same was repeated for the patients complying the protocol at the end of the study. In a few patients, where the duration of illness was within 4 weeks, it was observed that the infarct size markedly reduced showing good clinical improvement, which corroborates with the findings of a previous study. Another significant observation of our study was that no new infarcts appeared during the trial period.
The strength of this study is that it represents a pragmatic setting of homoeopathic practice which reflects the day-to-day clinical practice. However, the study did not have any control group, randomisation and blinding. For authentication of findings, the diffuse weighted image scan of the brain could not be conducted. These were the limitations of this study.
| Conclusion|| |
This was an open-label pilot study where a marked reduction in the NIHSS score with good recovery was found after adjuvant homoeopathic treatment in 76% patients. The NIHSS score predicts the patient's recovery after stroke. The results of the study emphasise a positive impact of homoeopathic treatment in stroke-affected patients. For further validation of the results, the following suggestions are given:
- Multicentric study with a bigger sample size
- The study to be based on randomised control trial study design
- Diffuse weighted imaging scan to be conducted for the patients for authentication of findings which gives exact size and involvement of the lesion
- To ascertain effects of the risk factors on NIHSS score.
The authors acknowledge the Medical Superintendent and the hospital authorities of Princess Durru Shehvar Children's and General Hospital, Hyderabad for their constant support throughout the study. Special thanks to Dr. Syed Ateeq Ahmed Jafri, Research Associate, for his counselling skills in motivating the patients to comply for regular follow-ups and other protocol guidelines. Lastly, authors extend their heartfelt thanks to the patients enrolled in the study for their co-operation.
Financial support and sponsorship
The study was conducted under the Extra-Mural Research Scheme of the Department of AYUSH, Ministry of Health and Family Welfare (now called as Ministry of AYUSH), Government of India. The authors acknowledge the support received under the scheme.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]