Efficacy of individualized homeopathic treatment of insomnia: Double-blind, randomized, placebo-controlled clinical trial

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Highlights

  • We evaluated whether individualized homeopathy (IH) could produce significant effect beyond placebo in treatment of insomnia.

  • In this double-blind, randomized, placebo-controlled, two parallel arms trial, 60 patients were randomized in 1:1 ratio to receive either IH or placebo.

  • Patient-administered sleep diary (6 items) and Insomnia Severity Index (ISI) were taken as the primary and secondary outcomes respectively, measured at baseline, and after 3 months.

  • Group differences were significant for sleep diary items 4, 5 and 6 (P < 0.01) and just significant (P =  0.014) for ISI score with moderate to large effect sizes; but non-significant for rest of the outcomes.

  • IH seemed to produce significantly better effect than placebo in treatment of insomnia.

Abstract

Background

Insomnia is the most common sleep-related complaint associated with impaired day-time functioning, reduced quality of life, increased morbidity and substantial societal cost. We evaluated whether individualized homeopathy (IH) could produce significant effect beyond placebo in treatment of insomnia.

Methods

In this double-blind, randomized, placebo-controlled, two parallel arms trial, 60 patients were randomized to receive either IH/verum or control/placebo (1:1). Patient-administered sleep diary (6 items; 1: latency to fall asleep, 2: minutes awake in middle of night, 3: minutes awake too early, 4: hours spent in bed, 5: total sleep time in hours, and 6: sleep efficiency) and Insomnia Severity Index (ISI) were taken as the primary and secondary outcomes respectively, measured at baseline, and after 3 months.

Results

Five patients dropped out (verum: 2, control: 3). Intention to treat sample (n = 60) was analyzed. Trial arms were comparable at baseline. In the verum group, except sleep diary item 3 (P =  0.371), rest of the outcomes improved significantly (all P < 0.01). In the control group, there were significant improvements in diary item 6 and ISI score (P < 0.01) and just significant improvement in item 5 (P =  0.018). Group differences were significant for items 4, 5 and 6 (P < 0.01) and just significant (P =  0.014) for ISI score with moderate to large effect sizes; but non-significant (P > 0.01) for rest of the outcomes.

Conclusion

IH seemed to produce significantly better effect than placebo. Rigorous trials and independent replications are warranted.

Introduction

Insomnia is a very common sleep disorder and is defined as the difficulty in initiating sleep or maintaining sleep, sleep difficulty at least 3 nights a week, or sleep difficulty that causes impairment of daytime functioning.1 A number of factors can cause or contribute to insomnia, ranging from psychological disorders, over-the-counter medications to end-stage conditions such as Acquired Immunodeficiency Syndrome (AIDS), heart diseases, obstructive airway diseases, and renal diseases.1 Besides, aging,2 genetics3 and traumatic brain injuries4 too have been found to contribute significantly to sleep quality. Conversely, insomnia can also be considered as a contributing factor to a multitude of diseases such as diabetes,5 hypertension,6 fibromyalgia,7 coronary heart disease8 and an increased risk of mental disorders.9 It is a significant risk factor especially for the development of depression10,11 and anxiety.12 However, even when there are no symptoms of psychological disorders, a degree of disability in the performance of daily activities and social roles do occur in persons with sleep disorders.13 Insomnia is the most common sleep-related complaint with a prevalence of 6–18% in the general population.14 It is associated with impaired day-time functioning, reduced quality of life, increased risk of morbidity and substantial societal cost.15, 16, 17 Numerous pharmacological and non-pharmacological therapeutic interventions (such as cognitive behavioral therapy) exist for the treatment of insomnia18,19. However, the cycle of drug dependent insomnia can also result from commonly prescribed pharmacological agents even when used intermittently.20 These treatments are not always fully effective and some have marked adverse effects. For these reasons, many patients suffering from insomnia try alternative therapies such as homeopathy.21 There are a number of placebo controlled trials supporting the efficacy of homeopathic medicines in insomnia.22, 23, 24

The outpatient department of National Institute of Homoeopathy (NIH) is often consulted by many patients suffering from sleep disorders. Hence, it provided a promising setting to conduct an efficacy trial of IH in insomnia. A systematic review of randomized trials of homeopathy for insomnia and sleep related disorders recommended that the future trials of homeopathy for insomnia should be conducted using adequate and rigorous designs.25 It also pointed out the lack of intention to treat (ITT) analysis as a common shortcoming on the part of RCTs selected for review. Hence, the present work sought to assess the efficacy of IH in the patients suffering from insomnia and included ITT analysis.

We hypothesized that there might (alternative; Ha) or might not be (null; H0) any significant difference between the groups receiving IH and placebo in the treatment of insomnia. We aimed to evaluate the efficacy of IH treatment against placebo in treatment of insomnia by detecting group differences, if any. We also intended to shortlist the most frequently indicated homeopathic medicines in insomnia.

Section snippets

Trial design

This double-blind, randomized, prospective, placebo controlled, two parallel arms clinical trial was conducted at the out-patient departments of National Institute of Homoeopathy (NIH). The study protocol was approved by the Institutional Ethical Committee (IEC) [Ref. No. 5-023/NIH/PG/Ethical Comm. 2009/Vol. III/ 1957 (A/S); dated March 27, 2017] and was registered prospectively in the Clinical Trials Registry – India [CTRI/2017/05/008450] and had a secondary identifier – UTN of

Participant flow

As per the pre-specified inclusion and exclusion criteria, 174 patients suffering from insomnia were screened; 114 were excluded on account of various reasons; 60 met the eligibility criteria and were enrolled into the trial. Following that, baseline socio-demographic and outcome data was obtained and were randomized to either IH (verum) or placebo (control). After 3 months of intervention, outcome data was recorded again. During course of treatment, 5 dropped out (2 in verum and 3 in control);

Principal findings

This double blind, placebo-controlled, prospective, randomized, two parallel arms trial was carried out at National Institute of Homoeopathy on 60 patients suffering from insomnia and were treated with either individualized homeopathic medicines (n = 30) or identical placebo (n = 30). Sleep Diary and ISI were taken as primary and secondary outcome measures respectively, measured at baseline and after 3 months. Five patients had dropped out (verum: 2, control: 3). Intention to treat (ITT) sample

Conclusion

In thisdouble-blind, randomized, prospective, placebo-controlled, two parallel arms clinical trial conducted on 60 patients suffering from insomnia, there was statistically significant difference measured in sleep efficiency, total sleep time, time in bed, and ISI score in favor of homeopathy over placebo with moderate to large effect sizes. Group differences were non-significant for rest of the outcomes (i.e. latency to fall asleep, minutes awake in middle of night and minutes awake too

Authors’ contribution

JM and S. Singh: concept, literature search, clinical study, data acquisition, data interpretation, and preparation of the article; S. Sadhukhan, AN, NK, NM, SD and MP: clinical study and data acquisition; MK and S. Saha: design, data interpretation, statistical analysis, preparation of the article. All the authors reviewed and approved the final article.

Conflict of interest statement

We declare no conflict of interest. The trial was carried out as the postgraduate thesis of the corresponding author. Prof. (Dr.) S. Singh was the Head, Dept. of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy and guide of the corresponding author. S. Sadhukhan, AN, NK, NM, SD and MP were the postgraduate trainees at National Institute of Homoeopathy. MK and S. Saha were independent researchers.

Funding

We received no funding for the project. The institution has no role to play in analysis of the study results and publication of the paper.

Acknowledgement

The authors are grateful to institutional heads, both academic and hospital section for allowing us to conduct the trial. We sincerely thank the fellow postgraduate trainees, staff, pharmacists and the patients for their sincere participation in the study.

References (45)

  • S. Saha et al.

    Developing the criteria for evaluating quality of individualization in homeopathic clinical trial reporting: A preliminary study

    J Integr Med

    (2014)
  • D. Kasper et al.

    Harrison’s principles of internal medicine

    (2015)
  • M. Vitiello

    Sleep disorders and aging: Understanding the causes

    J Gerontol A Biol Sci Med Sci

    (1997)
  • A.C. Heath et al.

    Evidence for genetic influences on sleep disturbance and sleep pattern in twins

    Sleep

    (1990)
  • M.C. Ouellet et al.

    Insomnia in patients with traumatic brain injury

    J Head Trauma Rehabil

    (2006)
  • Y. Hayashino et al.

    Relation between sleep quality and quantity, quality of life, and risk of developing diabetes in healthy workers in Japan: the high-risk and population strategy for occupational health promotion (HIPOP-OHP) study

    BMC Public Health

    (2007)
  • A.N. Vgontzas et al.

    Insomnia with objective short sleep duration is associated with a high risk for hypertension

    Sleep

    (2009)
  • T. Chandola et al.

    The effect of short sleep duration on coronary heart disease risk is greatest among those with sleep disturbance: A prospective study from the Whitehall II cohort

    Sleep

    (2010)
  • P. Salo et al.

    Sleep disturbances as a predictor of cause-specific work disability and delayed return to work

    Sleep

    (2010)
  • B. Sivertsen et al.

    The bidirectional association between depression and insomnia

    Psychosom Med

    (2012)
  • D. Neckelmann et al.

    Chronic insomnia as a risk factor for developing anxiety and depression

    Sleep

    (2007)
  • T.B. Üstün et al.

    Form, frequency and burden of sleep problems in general health care: A report from the WHO collaborative study on psychological problems in general health care

    Eur Psychol

    (1996)
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