David Francis Naude ́*, Ingrid Marcelline Stephanie Couchman and Ashnie Maharaj
Department of Homoeopathy, Faculty of Health Sciences, Durban University of Technology, P.O. Box 1334,

Durban 4000, South Africa

Introduction

Chronic primary insomnia is defined as difficulty in initiating or maintain- ing sleep or of non-restorative sleep that lasts for at least 1 month and causes significant distress or impairment in social, occupational or other important areas of functioning. The homeopathic simillimum is that remedy which most closely corresponds to the total- ity of symptoms; remedy selection is based on a full evaluation of the patient’s physical, emotional and mental characteristics.

Aim/Purpose

The purpose of this randomised, double-blind, placebo-controlled study was to evaluate the efficacy of homeopathic simillimum in the treatment of chronic primary insomnia.
Method: 30 participants were selected in accordance with DSM-IV TR (2000)1 criterion 307.42 Primary Insomnia and then randomly divided between treatment and placebo groups. The measurement tools used were a Sleep Diary (SD) and the Sleep Impairment Index (SII).2

After an initial consultation, 2 follow-up consultations at 2-week intervals took place. Homeopathic medication was prescribed at the first and second consultations. The SII was completed at each consultation and participants were instructed at the first consul- tation to start the SD.

Results

SD data revealed that verum treatment resulted in a significant increase in duration of sleep throughout the study, compared to the placebo treatment which resulted in no significant increase in duration of sleep. A significant improvement in SII summary scores and number of improved individual questions were found in the verum group, responses to all 11 questions having improved significantly upon completion of the study. An initial improvement occurred in the placebo group, but was not sustained. Comparison of results between the groups revealed a statistically significant difference.

Conclusion

The homeopathic simillimum treatment of primary insomnia was effective, compared to placebo. Homeopathy is a viable treatment modality for this condition and further research is justified. Homeopathy (2010) 99, 63–68.

Keywords:

Insomnia; Simillimum; Homeopathy; homeopathic treatment for insomnia; homeopathic research; natural treatment for insomnia; drug free treatment for insomnia

Introduction

Chronic primary insomnia is defined as difficulty in initiating or maintaining sleep or of non-restorative sleep that lasts for at least 1 month and causes significant distress or impairment in social, occupational or other important areas of functioning.1 It is a prevalent and distressing problem reportedly affecting 9%–10% of the population in the United States.3 Chronic insomnia, if untreated, can have social, economic and occupational impacts on the individual.2

Insomnia is the most commonly reported sleep problem in industrialized nations, leading to emotional distress, day- time fatigue and loss of productivity. The enormity of this problem indicates that routine clinical assessment and

Homeopathy (2010) 99, 63–68 Ó 2009 The Faculty of Homeopathy

doi:10.1016/j.homp.2009.11.001, available online at http://www.sciencedirect.com

ORIGINAL PAPER

64

Chronic primary insomnia

DF Naude ́ et al

treatment of insomniacs may have important health benefits for the individual.4

Commonly prescribed pharmacological agents such as anxiolytics and hypnotics even when used intermittently (to prevent tolerance) can result in a cycle of drug- dependent insomnia.5 The use of non-prescription drugs such as antihistamines is not recommended for more than 7–10 days due to the risk of adverse effects.6 Besides the risk of adverse effects, chronic use of sleep medication may undermine the development of self-management skills to cope with insomnia.5

These factors contribute to the need to conduct clinical studies investigating other treatment modalities.5

There is much literature regarding the use of homeo- pathic remedies in the treatment of insomnia. Unfortu- nately, there is a paucity of controlled clinical trials evaluating the efficacy of homeopathic treatment of chronic primary insomnia. A literature search revealed only two related studies. The first study assessed the effectiveness of homeopathic simillimum in the form of 50 Millesimal (LM) potencies in the treatment of secondary insomnia in peri- and post-menopausal women.6 The second study tested the efficacy of a commercially available homeopathic complex in secondary insomnia.7 Although both studies produced statistically significant results in favour of the homeopathic interventions, both suffered from number of methodological weaknesses. No studies assessing the effectiveness of homeopathic simillimum in chronic primary insomnia were found.

The purpose of this double-blind, placebo-controlled study was to evaluate the efficacy of homeopathic similli- mum in the treatment of chronic primary insomnia in terms of the patient’s perception of the treatment, using a Sleep Diary (SD) and the Sleep Impairment Index (SII).2

Material and methods

Ethical approval for the conduct of this study was granted by the Faculty of Health Sciences Research Committee at Durban University of Technology (DUT) in Durban, South Africa. The study was conducted at the DUT Homeopathic Day Clinic.

Recruitment and sampling

Following a series of advertisements placed in the local press, the first thirty consenting participants were recruited via convenience sampling (a form of non-probability sam- pling utilising the most conveniently available participants to the researcher).8 Participants were considered suitable if they met diagnostic criterion 307.42 Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th edition and were not using additional sleep aids, interventions or medication.1 Informed consent was obtained from all participants who were free to with- draw from the study at any stage.

The sample size was set at 30 participants, with an addi- tional three participants being recruited to allow for poten- tial patient exclusions or withdrawals. Each participant was assigned a number sequentially as they entered the study.

These numbers had previously been randomly allocated into two groups by the research supervisor (by means of drawing numbers from a hat) to form a randomisation list. Of the 33 participants recruited, 30 completed the study. Three participants were excluded either due to scheduling difficulties resulting in non-attendance of their follow-up consultations or poor compliance with medication instruc- tions. Of the remaining 30 participants, 14 comprised the treatment group and 16 the placebo group. During the study, neither the participant nor the researcher was aware of which group the participant belonged to. Dispensing of medication was performed by an independent dispenser at the DUT Homeopathic Day Clinic, according to the ran- domisation list. Unblinding took place only once all partic- ipants had completed the study (see Figure 1).

Measurement tools

Two outcome measures were used: in this study: SD and SII.

A SD is a daily, written record of an individual’s sleep- wake pattern containing such information as time of retiring and arising, time in bed, estimated total sleep period, num- ber and duration of sleep interruptions, quality of sleep, and daytime naps.9 Sleep diaries can provide clinically useful information in the initial assessment of the complaint, particularly as it relates to the patient’s perception of the problem.10 The SD format used in this study has been used by Bakea (2003) as a subjective measurement against polysomnograph readings and was designed by a patient of the sleep laboratory where she is based.11

The SII is a 7-item measurement tool that yields a quanti- tative index of sleep impairment. It is a brief and global self- report instrument which provides valuable information on the patient’s perception of his or her insomnia, its severity, level of distress and impairment of daytime functioning.2 The SII has been found to be sensitive to changes in insom- nia research. It is a reliable and valid measure for the assess- ment of insomnia severity in a clinical population. It instrument is a cost-efficient method to quantify perceived insomnia severity and may be used either as a screening device or as a measure of treatment outcome.12

Case management

At the first consultation, a full homeopathic case history was taken and a physical examination was performed. Participants completed the SII which provided a baseline measurement for statistical purposes. Each participant was instructed to record data in a SD related to the hours slept for 1 week before taking the medication prescribed, so as to provide a baseline measurement for statistical purposes. Recordings in a SD were continued throughout the trial.

Medicines

Limitations were not set as to the potency of the similli- mum prescribed but rather the most suitable potency(s) was determined for each case. The dosage form however was limited to the prescription of three single dose lactose pow- der sachets per consultation, one of which was dissolved sublingually each night consecutively before going to sleep.