The efficacy of a homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helleborus niger D6, Opium D30) in management of excessive daytime sleepiness

Abstract

Background : Excessive daytime sleepiness (EDS) is the inclination or compulsion to fall asleep whilst intending to stay awake; it is believed to negatively affect occupational and social functioning and may be a predisposition towards accidents (Hayley et al. 2014), low productivity and interpersonal problems (Fong et al. 2005). Excessive daytime sleepiness is one of the most common sleep-related symptoms and it affects an estimated 20% of the population (Pagel .2009). The causes of EDS are numerous and include intrinsic sleep disorders (e.g. narcolepsy, obstructive apnoea/ hypopnea syndrome, idiopathic hypersomnia), and extrinsic disorders (Banerjee et al. 2004). Sleep deprivation is probably the most common cause of excessive daytime sleepiness. This clinic trial intended to evaluate the effectiveness of a homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helliborus niger D6, Opium D30) in the management of EDS in terms of the Epworth Sleepiness Scale (Johns, 1991) and Stanford Sleepiness Scale (Hoddes et al. 1973). And this randomised, double-blind placebo controlled study also aimed to provide a safe and effective alternative therapy for EDS. Aim of the study : The objective of this study was to determine the efficacy of a homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helliborus niger D6, Opium D30) and placebo in the management of EDS in terms of the Epworth Sleepiness Scale (ESS) and the Stanford Sleepiness Scale (SSS). Materials and Methodology : A sample group of 35 participants was selected voluntarily to conduct the study on basis of the inclusion and exclusion criteria. The participants were than randomly divided into two groups; a treatment group consisting of 23 participants and a placebo group consisting of 12 participants. Each participant had to attend three consultations in total with the researcher over a period of four weeks at the Durban University of Technology (DUT) Homoeopathic Day Clinic. At the first consultation a comprehensive case history (appendix F) was taken and physical examination (appendix E) was performed by the researcher but no medication was handed at that point. At each consultation the participants with the help of the researcher completed the Epworth Sleepiness Scale (ESS), and the seven days’ baseline Stanford Sleepiness Scale (SSS) was handed to the participants at the first and second consultation which the participants completed without the help of the researcher throughout the trial till their last consultation. Results : Results from the two measuring tools were statistically analysed with SPSS version 24.0. the participant’s level of sleepiness improved in both the treatment group and the placebo group. Intra-group analyses of ESS means revealed that both groups improved significantly over time, intergroup ANOVA analysis however revealed no significant differences between the groups. Section analyses however using the Fisher’s Exact Tests did reveal statistically significant differences within certain variables at some points of the study. Intra-group analyses of SSS data revealed no statistically significant change in SSS scores over the three weeks in both the Homoeopathic Complex and the Placebo Groups, as well as the Inter-group Fischer’s Exact tests revealed no statistically significant differences between the groups. Conclusion : Barring a few exceptions described in Chapter 4 & 5 it can be concluded from the results of the study that statistically the Homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helliborus niger D6, Opium D30) was not superior to placebo in the treatment of EDS. The data shows that both the Homoeopathic Complex and the placebo interventions had a positive effect on EDS and were effective in improving the level of excessive daytime Sleepiness. Irrespective of the general lack of statistical significance between groups a closer analysis of the intragroup and inter-group data does reveal a trend suggesting clinical significance in support of the effectiveness of the homoeopathic complex in the treatment of EDS however this needs to be further explored and confirmed in subsequent studies.