Effectiveness of Homoeopathic Treatments for Sleep Disorders in Children and Adolescents: A Systematic Review According to the Principles of Evidence-Based Medicine
Highlights
- For the first time, a critical systematic review based on evidence-based medicine criteria has been presented on the effects of individualised homoeopathy on sleep disorders in children and adolescents.
- For the following conditions, there are currently four placebo-controlled studies and one observational study with transparently declared treatment regimens available in the English-language specialist literature: bruxism, insomnia, and nocturnal enuresis.
- The findings highlight areas where evidence-based homoeopathic research exists and where further studies are needed to strengthen clinical understanding.
- This systematic review may serve as a valuable reference for clinicians and researchers exploring complementary approaches for paediatric sleep disorders.
Abstract
1. Introduction
1.1. Concept of Homoeopathy
1.2. Dosage in Homoeopathy
2. Materials and Methods
2.1. Study Design
2.2. Data Sources and Search Strategy
2.3. Search Strings Used
2.4. Eligibility Criteria
2.4.1. Inclusion Criteria
2.4.2. Exclusion Criteria
2.4.3. Bias (Quality) Assessment
2.4.4. Data Synthesis
2.4.5. PRISMA Flow and Study Count
3. Results
3.1. Study Selection Flow
3.2. Study Characteristics and Populations
3.3. Outcome Measures
3.4. Homoeopathic Interventions and Comparators
- Complex remedy (ZinCyp-3-02): In Jong et al. 2016, the intervention was a fixed combination product “ZinCyp-3-02,” containing three homoeopathic ingredients: Cypripedium pubescens D4, Magnesium carbonicum D10, and Zincum valerianicum D12 [1,32]. This product was formulated specifically for paediatric sleep troubles and restlessness. The dosage regimen was 1 tablet four times daily for 28 days [1]. The comparator was glycine (an amino acid) 100 mg tablets, given on the same schedule [1], as glycine is sometimes used as a mild sedative in Eastern Europe. Glycine served as an active control to benchmark efficacy.
- Individualised single remedies: In the Indian trials on enuresis [29,30], children received individualised homoeopathic medicines. In these, a qualified homoeopathic practitioner evaluated each child and prescribed a remedy tailored to that child’s constitution and symptoms. For instance, in the observational enuresis study, Kreosotum was the most frequently chosen remedy (in ~26% of cases) [30], with others like Calcarea salts and Sulphur also used. The potencies were not explicitly stated but were likely in centesimal (commonly 30C or 200C), and dosing was adjusted per clinical response at monthly follow-ups. The RCT by Akram et al. similarly used individualised prescriptions (with Sulphur 30C being the single most common remedy, given to 18.6% of children) [29]. The control arm in that RCT received identical-looking placebo globules, with all children also receiving standard enuresis advice (routine behavioural strategies). The individualised approach means each child’s dosage schedule could differ, but generally remedies were given one to two times daily and changed or repeated as needed over the 3-month period.
- Specific single remedies in a standardised crossover: Tavares-Silva et al. 2019 tested two specific single remedies for bruxism: Melissa officinalis 12C and Phytolacca decandra 12C [28]. These were chosen based on a prior hypothesis or pilot that they might help bruxism. The trial had four arms (in crossover form): Melissa alone, Phytolacca alone, Melissa + Phytolacca in combination, and placebo. Each treatment was given for 30 days. The dosing was reported as 5 globules once every night at bedtime (common practice in such trials, though the abstract did not detail it). There was a 15-day washout between each phase [28]. All participants eventually received each treatment in randomised order. No conventional treatment was given concurrently, and parents were advised to maintain regular bedtime routines.
- homoeopathic complexes vs. placebo: (No included study used an over-the-counter complex like Hyland’s Calming Tablets or Sedatif-PC vs. placebo in the last 10 years, although older studies like Cialdella 2001 did that [32]. One open-label French study in 2016 observed Passiflora Compose use, but it was in adults, so not in our table.)
3.5. Outcomes and Efficacy Results
3.5.1. Paediatric Insomnia/General Sleep Disturbance
3.5.2. Sleep Bruxism
3.5.3. Nocturnal Enuresis (Bedwetting)
3.5.4. Summary of Efficacy
- A well-formulated homoeopathic complex can alleviate general bedtime struggles in toddlers/preschoolers (possibly reducing the need for sedatives).
- A specific remedy (Melissa 12C) may help reduce bruxism severity in children.
3.5.5. Safety Profile
3.5.6. Results Summary
4. Discussion
4.1. Principal Findings
4.2. Consistency with Previous Work
4.3. Biological Plausibility
4.4. Clinical Significance
4.5. Limitations of Current Evidence
4.6. Comparative Effectiveness and Integrative Approach
4.7. Implications for Future Research
4.8. Limitations of This Review
5. Conclusions and Future Research Directions
5.1. Conclusions
5.2. Future Research Directions
- (1)
- Formulating questions
- (2)
- Researching to gather relevant information
- (3)
- Evaluating existing external findings
- (4)
- Combining external findings with one’s own experiences and the values of the patients concerned
- (5)
- Evaluating the process initiated).” [54].
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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| Author(s) (Year) | Country | Study Design | Sample Size | Age Range | Sleep Disorder Type | Outcome Measures (Key) |
|---|---|---|---|---|---|---|
| Jong et al. (2016) [1] | Russia (multi-centre) | RCT (open- Label and active control) | N = 179 (89 vs. 90) | 1–6 years (52 m/37 f verum; 51 m/39 f placebo) ** | Insomnia and restlessness (≥1 month) | Total complaints severity score; time to sleep onset; night awakenings; Integrative Medicine Outcome Scale (IMOS); patient/parent satisfaction (IMPSS) |
| Tavares- Silva et al. (2019) [28] | Brazil | RCT (crossover, triple-blind, and placebo-controlled) *** | N = 52 (crossover) | Mean 6.6 ±1.8 years (range 5–12; 27 m/25 f in these 4 groups) ** | Possible sleep bruxism (teeth grinding) | Parental VAS for bruxism severity; sleep diary (sleep quality); Trait Anxiety Scale for Children (TAS); side effects log |
| Akram et al. (2025) [29] | India | RCT (parallel, double-blind, and placebo-controlled) | N = 140 (70 vs. 70) | 5–16 years (33 m/37 f verum; 28 m/42 f placebo) ** | Nocturnal enuresis (bedwetting) | Frequency of bedwetting (episodes/week); Paediatric Quality of Life (PedsQL) child and parent report; cure rate (dry nights); adverse events |
| Saha et al. (2018) [30] | India | Observational (pre–post single-arm) | N = 34 | 5–18 years (17 m/17 f) ** | Nocturnal enuresis (bedwetting) | Nocturnal enuresis severity score (custom 0–15 scale counting nights and intensity); measured at baseline, 2 months, and 4 months |
| Harrison et al. (2013) [31] (Excluded from final) | UK (for context) | RCT (double-blind and placebo-controlled) | N = 46 | 7–12 years (all male) | Psychophysiological insomnia (PI) | Pre-Sleep Arousal Scale (PSAS); sleep diaries; global improvement (note: older study, outside 10-year range) |
| Author(s) (Year) | Homoeopathic Medicine Name(s) | Potency & Dosage/Regimen | Treatment Duration | Control/Comparator (If Any) |
|---|---|---|---|---|
| Jong et al. (2016) [1] | ZinCyp-3-02 (complex of Cypripedium D4, Magnesia carb. D10, Zincum valerianicum D12) | 1 tablet 4 times daily (dissolved in water for <3 yrs.) | 4 weeks (28 days) | Glycine 100 mg tablet, 4× daily (active comparator) |
| Tavares-Silva et al. (2019) [28] | Melissa officinalis 12C; Phytolacca decandra 12C; (also combined MO + PD) | 5 globules once nightly (implied); crossover: each child received 30 days of each regimen, with 15-day washouts | 4 × 30-day phases (crossover, total ~5 months) | Placebo (matching globules) during one phase of crossover |
| Akram et al. (2025) [29] | Individualised homoeopathic remedy (e.g., Sulphur, Calc. phosphorica, Calc. carbonica, etc., chosen per case) | Potency varied (commonly 30C/200C); given typically once or twice daily; the remedy could be adjusted at monthly visits | 3 months (with monthly follow-ups) | Placebo globules (identical look/taste) + standard care advice (fluid restriction, alarms, etc.) |
| Saha et al. (2018) [30] | Individualised homoeopathic medicine (most common: Kreosotum in 26% of cases, others like Sulphur, Nux vomica, etc.) | Potency 30C or 200C (typical), dosage individualised (e.g., one dose nightly); adjustments made at 2-month and 4 month visits if needed | 4 months total (evaluation at 2 and 4 months) | None (no control group in this single-arm trial) |
| Harrison et al. (2013) [31] (not in final synthesis) | Complex homoeopathic blend for insomnia (included Coffea 30C, etc.) | 2 tablets at bedtime (per author’s report) | 4 weeks | Placebo tablets (double-blind) |
| Author(s) (Year) | Domain Assessed | Bias Assessment Method (Narrative) | Judgement/Concerns |
|---|---|---|---|
| Jong et al. (2016) [1] | Blinding (Performance/Detection) | Evaluated as an open-label design; the outcome (symptom score) was rated by investigators/parents aware of the treatment | High risk—lack of blinding could inflate perceived improvements in the homoeopathy arm (observer expectancy bias). |
| Tavares-Silva et al. (2019) [28] | Selection Bias (Randomisation) | Reviewed the randomisation procedure in the triple-blind RCT; assignment was random and crossover counterbalanced (each child as their own control) | Low risk—proper random sequence and allocation; crossover design with each child receiving all treatments reduces between-group differences. |
| Tavares-Silva et al. (2019) [28] | Carryover Effect (Crossover) | Analysed washout adequacy (15 days) and period effect; no significant period/order effects reported by authors | Some concerns—a 15-day washout may not fully prevent carryover, but it is unlikely to be a major issue given that homoeopathic 12C likely has a transient effect; overall design is robust. |
| Akram et al. (2025) [29] | Performance/Detection Bias | Double-blind RCT: patients, prescribers, and evaluators blinded; outcomes (bedwetting frequency) objectively counted by parents, likely unbiased by group | Low risk—blinding was maintained; the placebo was identical to the verum, minimising expectation bias. (Slight risk if parents guessed treatment due to improvement, but unlikely). |
| Akram et al. (2025) [29] | Attrition Bias | Monitored dropouts (only 4 total dropouts, evenly split); used intention-to-treat analysis for primary outcome | Low risk—minimal attrition and no differential loss between groups; results robust. |
| Saha et al. (2018) [30] | Confounding (Study Design) | Observational one-group pre-post; no control for placebo effect or maturation; baseline to outcome comparison only | High risk—improvement could partly reflect spontaneous resolution or parent perception changes; positive results must be interpreted cautiously without a control group. |
| All studies (general) | Reporting Bias | Checked outcomes vs. methods for each study; all predefined outcomes reported, no selective omission noted (e.g., no significant diaries in Tavares’s study were acknowledged) | Low risk—no evident selective reporting. Publication bias in the field is possible (negative trials may be unpublished), but within the included studies, reporting was transparent. |
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Upreti, K.; Frass, M. Effectiveness of Homoeopathic Treatments for Sleep Disorders in Children and Adolescents: A Systematic Review According to the Principles of Evidence-Based Medicine. Children 2026, 13, 45. https://doi.org/10.3390/children13010045
Upreti K, Frass M. Effectiveness of Homoeopathic Treatments for Sleep Disorders in Children and Adolescents: A Systematic Review According to the Principles of Evidence-Based Medicine. Children. 2026; 13(1):45. https://doi.org/10.3390/children13010045
Chicago/Turabian StyleUpreti, Kanchan, and Michael Frass. 2026. "Effectiveness of Homoeopathic Treatments for Sleep Disorders in Children and Adolescents: A Systematic Review According to the Principles of Evidence-Based Medicine" Children 13, no. 1: 45. https://doi.org/10.3390/children13010045
APA StyleUpreti, K., & Frass, M. (2026). Effectiveness of Homoeopathic Treatments for Sleep Disorders in Children and Adolescents: A Systematic Review According to the Principles of Evidence-Based Medicine. Children, 13(1), 45. https://doi.org/10.3390/children13010045

