Journal of Traditional Medicine & Clinical Naturopathy
Open Access

Clinical trial; Infantile colic; Homeopathic

Introduction

Infantile colic is a developmental behavioral syndrome characterized by excessive crying and symptoms like flatulence. It was at that point referenced in the absolute first pediatric course readings of Rhazes, Roelans von Mecheln, and Thomas Phaer (ninth, fifteenth and sixteenth century respectively). A first conventional depiction given by Wessel in 1954, known as the "rule of three", characterizes puerile colic as a harmless cycle happening in any case solid newborn children under 90 days old enough portrayed by miserable weeping for multiple h each day, over 3 days of the week, for longer than 3 weeks [1-3]. The cause of infantile colic is still unknown, despite the existence of a number of hypotheses regarding the underlying mechanisms, such as an increase in the production of gas in the intestines, changes in the microflora of the gastrointestinal tract, or sensitivity to cow's milk protein.

A recent systematic review found that the prevalence of infantile colic ranges from 3 to 73%, with a likely prevalence of 20%. Even though infantile colic is typically a self-limiting condition that goes away after six months, it has a significant impact on the child's environment, resulting in high levels of parental distress and maternal depression. This is made possible by the fact that the symptoms have no underlying cause. Additionally, clinical evidence suggests that children with early crying issues are more likely to suffer from behavioral issues, such as attention deficit hyperactivity disorder (ADHD), shaken baby syndrome (SBS), or even abuse. The issue of prescribing treatments for infantile colic is up for debate. One of the earliest and most common treatments for bloating is the anti-foaming agent Simethicone [4]. Although it is widely accepted for treating infantile colic, there is limited evidence to support its use; its effect could be due to the calming effect of its sweet taste. Dicyclomine has been shown to be effective for treating infantile colic, but it is not recommended for use in infants because of its side effects. Also, the use of the anticholinergic agent.

The situation necessitates safe and effective approaches to treating infantile colic. Homeopathic preparations have been considered as a potentially safe and effective treatment in the field of integrative pediatrics, but there is a lack of literature on this topic. Despite the fact that parents and physicians indicate frequent use of homeopathic medicines to treat infantile colic, and homeopathic preparations have been considered as a potentially safe and effective treatment in the field of integrative pediatrics, the most recent meta-analysis on the use of the probiotic dietary supplement Lactobacillus reuteri Aside from a non-controlled cohort study on the use of the complex homeopathic medicine Enterokind in children with functional gastrointestinal disorders23, only one RCT has been described on this subject: 30 infants were given the complex homeopathic medicine Magen, which contains ten single remedies for conditions like colic, cramping, abdominal pain, and/or flatulence. Compared to a placebo, Magen significantly reduced colic symptoms.

Materials and Method

A prospective, multi-center, randomized, open-label, controlled clinical trial with two parallel groups that was conducted in three Moscow medical centers in 2009 yielded the data presented here. It was acted as per the regulation of the RF and its public guidelines of Good Clinical Practice. Moral endorsement was given by the Morals Advisory group of the Russian Government Organization for Medical care and Social Advancement on 20 May 2008 (convention No. 9). In May 2010, the data were analyzed for the first time in the Russian Federation, and they were then sent to the Russian Ministry of Health and Social Development and published in a Russian-language journal [5-7]. With the new data that were processed in 2018, a sub-group analysis was done to look at the results for babies younger than six months.

The Biostatistics Laboratory, State Research Center for Preventative Medicine, and Federal Agency for Health Care and Social Development of the RF used electronic block randomization with a block size of 4. In accordance with the plan for the randomization, half of the patients were assigned to the Enterokind group and half to the control group, which received Simethicone. More information about the interventions can be found below. Envelopes with random numbers and sealed seals contained medication information for the patients [8]. The investigator opened the envelope with the lowest available number for treatment group allocation after patients' parents gave informed consent. This meant that the patient's parents and the investigator knew which medication the patient would receive. By comparing the effective amount of medication taken, as determined by the weight differences between the dispensed and returned medication bottles, with the amount of medication that was to be taken in accordance with the protocol, the patients' compliance with the study medication intake was calculated separately for each visit interval. Patients with a medicine consumption consistence of fewer than 70% for no less than 1 stretch, or a consistence that was not assessable for something like 2 spans, were considered as "rebellious". Both agreeable and resistant patients entered the goal to-treat (ITT) investigation. The IMOS scale was used by the researchers and the parents of patients to assess the overall treatment outcome in addition to the objective findings. Overall, patients' parents' assessments performed slightly better than the investigators'. At day 10, both the investigators (45.2% vs. 21.3%) and the patients' parents (75.3% vs. 21.3%) assessed that more patients in the homeopathically treated group had "no complaints" than in the control group.

Discussion

As a subspecialty of integrative medicine, pediatric integrative medicine is a growing field with a lot of potential and increasing academic recognition in recent decades. One of its goals is to outline which treatment methods are appropriate for children in terms of effectiveness and safety criteria. However homeopathy has been displayed to satisfy these criteria, there is as yet a hole in the field of clinical examination. The present study aims to contribute to the core of evidence-based clinical research in homeopathy in the field of gastroenterology by providing data about homeopathic treatment in infantile colic, a syndrome for which there is still a lack of consensus regarding management and treatment. In particular, there is a demand for condition-specific firm evidence to provide reliable effect estimates of homeopathic treatment. Additionally, the investigators and patients' parents were aware of the patient's medication regimen thanks to the open-label design. Therefore, it is impossible to rule out the possibility that the parents of the patients and the researchers overestimated the effects in the group that received homeopathic treatment. The chosen design, on the other hand, closely resembles typical clinical practice, providing the study with external validity-an important requirement for comparative effectiveness research in integrative pediatrics [9-10]. It also aligns with the roadmap for complementary and alternative medicine, which emphasizes comparative effectiveness and safety research, typically conducted in a “real world” setting. Finally, a limitation that may have affected the outcome is the high number of patients who violated the concomitant medication use protocol during the study (13 in the Enterokind group and 7 in the control group). However, the fact that the results of the primary outcome analysis in the per-protocol population, which represent the "ideal" population without protocol violations (results not shown), were comparable to those in the ITT population suggests that the use of prohibited concurrent medications had no effect on the outcome.

Conclusion

Enterokind was found to be a safe and effective treatment for infantile colic in babies younger than six months. It could be a new option for treating this condition. The use of validated scales and quantitative data collection as part of additional comparative effectiveness research should be carried out. In the field of pediatric gastroenterology, this would consolidate the evidence base for homeopathy and raise Enterokind's profile.

Declaration of competing interest

The authors declared that there is no conflict of intrest

Acknowledgment

None

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