Efficacy of individualized homeopathic medicines in treatment of post-stroke hemiparesis: A randomized trial

Stroke or cerebrovascular accident (CVA) is a major global public health concern. It is becoming a significant cause of early death and disability, especially, in low- and middle-income countries like India.1 This scenario is mostly influenced by demographic changes and the increasing prevalence of the key modifiable risk factors.2 Disability and recovery after stroke are getting punitive attention due to its poor understandability and therapeutic limitations. Recovery following a stroke is often divided into two categories: neurological recovery and functional recovery. Neurological recovery varies according to stroke pathophysiology, time since stroke, affected cerebral hemisphere and lesion etiology,3 while functional recovery is determined by the external environment, continuity of rehabilitation, and motivation.4 About 88% of people who have had a stroke have some degree of trouble moving one side or suffering from weakness on one side of their body, which we call hemiparesis.5 Other than weakness, spasticity is another concern prevalent in around 30% to 80% of stroke survivors due to upper motor neuron involvement. The incidence of spasticity among paretic patients has been reported to be 27% at 1 month, 28% at 3 months, 23% and 43% at 6 months, and 34% at 18 months after stroke.6,7 The first 3–6 months following a stroke are very crucial because most of the functional and motor recovery occurs at this time.8 This is why an extensive therapeutic strategy must be targeted during this period to ensure maximum recovery. However, in spite of this fact, most of the patients continue suffering with disability.

Currently, Physical rehabilitation strategies are considered to be the mainstay of treatment. So far, no drug or medicine has been shown to work well enough to be recommended in these situations.9 Most of the focus of rehabilitation is reflected in improving the safety and performance of motor activities.10,11 Improving the movement or walking safety and speed is the primary goal for gait rehabilitation to prevent falls and, subsequently, to enhance the activities of daily living. A multi-disciplinary approach is usually employed and encouraged to achieve the maximum clinical outcomes for stroke survivors.12 But continuous employment and maintenance of such strategies are costly and often not feasible for the poor socioeconomic class, which results in low adherence to the treatment.13 A better approach of therapy is warranted for post-stroke hemiparesis (PSH) to complement or replace the ongoing therapeutic modalities in terms of feasibility, cost-effectiveness, chance of recovery, and patient satisfaction.

Various trials have been conducted previously in homeopathy related to stroke and its aftermaths. An open-label pilot study was carried out on 50 patients to evaluate the role of adjuvant homeopathic medications in post-stroke sequels, and it showed significant improvement in several parameters.14 However, the study did not evaluate the efficacy and was not focused strictly on hemiparesis. A double-blind, randomized trial revealed the efficacy of homeopathic medicines in treatment of Broca's aphasia, but did not report other consequences of stroke.15 Another trial was carried out to see whether Arnica montana 30cH, given in the first seven days following a stroke, was able to improve the prognosis concerning mortality and functional ability.16 A further study was conducted to evaluate the role of Arnica montana 1000cH potency in various parameters of stroke outcomes.17 It included the level of consciousness, mobility, incontinence, social performance, and mental state. In this series of forty patients, no significant benefit of Arnica could be demonstrated. There is only a single trial strictly conducted on hemiparetic patients.18 The study evaluated the effectiveness of Curare 30cH against individualized homeopathic medicines (IHMs), which further concluded that the effect of Curare 30cH was non-inferior to the IHMs. But the efficacy statement from those studies cannot be established as none of them had a placebo-controlled arm to compare the possible benefit from treatment.

Therefore, this trial was aimed at evaluating the efficacy of IHMs in PSH using a randomized placebo-controlled design. In this study, the important consequences after stroke, i.e., weakness, spasticity, and quality of life after stroke, were evaluated as outcome measures.

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