International Journal of Current Research and Review
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IJCRR - vol 05 issue 19, October, 2013

Pages: 103-109

Date of Publication: 19-Oct-2013


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AN INTERVENTIONAL TRIAL TO EVALUATE EFFICACY OF NUTOOL THERAPY IN CONTROL OF PRIMARY INSOMNIA AMONG ELDERLY USING INSOMNIA SEVERITY INDEX

Author: Muhib J., Arish M. K. Shervani, Najeeb J., Kouser F. F., A. Nasir Ansari, Muneeb J.

Category: Healthcare

Abstract:Background and objectives: Insomnia is a unique and complex problem in geriatric population. As many as half of the elderly population between 60 to 79 years of age complain of disturbed sleep, which includes increased sleep latency, decreased quality of sleep, awaking symptoms, excessive daytime sleepiness, mental stress / depression which may result in disturbed intellect, impaired cognition, confusion, psychomotor retardation the whole syndrome of complaints can compromise patient's quality of life and create social and economic burden for caregiver. Considering the wide spread prevalence of insomnia in geriatrics, compounded with lack of wholesome drugs in the treatment, an interventional study was carried out with the objectives to evaluate the efficacy and safety of Nutool therapy in control of geriatric insomnia. Methods: A total of 30 elderly primary insomniacs, diagnosed for primary insomnia by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, were randomly assigned to test and control groups, comprising 15 patients in each group, respectively. In the test group, Nutool was performed with Roghan e Banafsha (500ml) and Roghan e Gul (500ml), both mixed in equal ratio while Nutool was done with liquid paraffin in control group. The therapy was scheduled on alternate days for one month. The change in the severity of insomnia was evaluated on the basis of scores of Insomnia severity index. Statistical analysis was done using student t-test (paired) for comparison in intra group and t-test (unpaired) for inter-group comparison. Results: Nutool therapy showed statistically significant improvement in all the parameters of Insomnia Severity Index, when pre and post interventional values of the parameters were assessed in intra as well as inter group comparisons. Interpretation and conclusion: This intervention proves the efficacy and safety of Nutool therapy in control of insomnia among elderly.

Keywords: Insomnia, geriatrics, Nutool therapy, Insomnia severity index.

Full Text:

INTRODUCTION

Insomnia is a common complaint throughout the world, and is characterized by difficulty in initiating or maintaining sleep or non-restorative sleep, associated with significant morbidity1. Insomnia in the geriatric patients is commonest among sleep complaints reported by population more than 60 years of age. It is consistently associated with significant reduction in the quality of life, higher risk of depression, and increased use 

of health care services3. An epidemiological study reports that individuals with insomnia have a 4.5 folds higher probability of presenting with depression compared with those with normal sleep pattern. In addition, primary insomniacs have an elevated risk of manifesting depression within 3.5 years after onset, even in absence of psychological disturbances4.

Primary insomnia is a specific disorder, defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) as a condition of at least 1 month’s duration, not caused by a medical or psychiatric disorder. In addition, a symptom of insomnia (disturbed sleep initiation or sleep maintenance, or early morning awaking) must present and be associated with complaints of daytime dysfunction.

Pharmacological treatment is the most practical approach to insomnia management; however, adverse events most commonly perceived by the insomniacs include alteration in cognitive function, memory and psychomotor activity, with negative effect on routine daily activities, the so-called hangover is a common manifestation. Moreover, rebound insomnia can occur after abrupt withdrawal of hypnotic therapy. National Institute of Health and Clinical Excellence recommends that doctor should consider using non-drug therapy before starting hypnotic drugs5, as side effects and risks associated with long-term use of the drugs are often major reasons for abetting the patients to discontinue their use despite their perception of continued efficacy4. With these limitations in pharmacotherapy there is a growing interest in non-pharmacological interventions for older adults6. Considering this unconvincing scenario regarding the use of drugs and their side effects, researchers are turning to the nature and the traditional pathies. Unani medicine axiomatically comes to the fore as Seher (Insomnia) has successfully been treated since ancient times without considerable obnoxious side effects on the body.

MATERIAL AND METHODS

The study was designed as Single blind, randomized, placebo-controlled, concurrent parallel group interventional trial, conducted at National Institute of Unani Medicine Hospital, Bangalore. Ethical clearance was obtained from the Institutional Ethical Committee, NIUM, Bangalore. The study spanned from March 2009 to February 2010. Thirty eligible cases of either sex, above 60 years of age, with primary insomnia and ISI higher than 7, were selected and randomly assigned to Group A (Control Group) and Group B (Test Group), each comprising 15 patients. Group A had been administered liquid paraffin, a placebo drug, under identical conditions as those for test group. Group B was treated with Roghan Banafshan and Roghan gul, mixed in equal quantity of 500 ml each. Efficacy of the drug was evaluated with a Score of Insomnia severity index. Nutool therapy was performed on every alternate day for one month divided in fifteen sittings. Pre and post treatment values of the parameter were assessed statistically.

Patients were advised to observe abstinence from all sorts of hypnotic drugs or measures one week prior to starting the therapy, and no concomitant treatment for insomnia was allowed during the treatment.

Patients were selected on the basis of DSM-IV-TR- Diagnostic criteria for primary insomnia which includes the predominant complaint of difficulty in initiating or maintaining sleep, or non restorative sleep, for at least one month and this sleep disturbance is associated with day time fatigue and may cause clinically significant distress or impairment in social, occupational or other important area of functioning.

Insomniacs associated with secondary medical problems such as Acute fevers or painful conditions, known cases of chronic obstructive pulmonary disease, patients with Obstructive sleep apnea syndrome, Central sleep apnea syndrome, known cases of Restless leg syndrome, Periodic Limb Movement Disorders, Idiopathic Insomnias 

or lifelong insomnia, known cases of narcolepsy, sleep disorders associated with diagnosed mental, neurologic and other medical disorders, history of glucocorticoids consumption, known cases of Parkinson, chorea, epilepsy, dementia, Huntington disease, poor mental health, alcohol or drug abuse with in past six months, patients who do not agree to give consent and adhere to protocol were excluded from the study. Ancient Unani physicians used Nutool as an efficient regimen in the treatment of insomnia, as Nutool produces Tarteeb (moistness) in the organ.7, 8

The test drugs, Roghan e banafshan (oil of Viola odorata) and Roghan e gul (oil of Rosa centifolia), used for the Nutool possess properties like Munnawim, Murattib and Muqavvi etc.

Administration of oil: Before starting the therapy, clean gauze was tied just behind the eye brows to avoid spilling of oil over the face. Eyes were protected by keeping a cotton swab soaked in plain water over the closed eye lids. Oil was sterilized and cooled to luke warm to start the therapy. The oil was continuously poured in a rhythmic stream from a distance of half feet 7over the fore head of a patient lying in supine position. The oil flowing down the head was collected in a container placed beneath the outlet of the nutool table. The collected oil was reused to maintain an uninterrupted flow of oil over head for duration of 30 minutes.

Statistical analysis

Results on continuous measurements are presented on Mean ± SD (Min-Max) and results on categorical measurements are presented in Number (%). Significance is assessed at 5 % level of significance, unpaired Student t test ( two tailed, independent) has been used to find the significance of study parameters on continuous scale between two groups (Inter group analysis) and paired Student t test (two tailed, dependent) has been used to find the significance of study parameters on continuous scale within each group.


DISCUSSION

The purpose of test drug in one group and liquid paraffin in other group is to assess the efficacy of Nutool therapy, because Roghan banafshan with Roghan gul being sedative may relieve insomnia and with liquid paraffin, it would not relieve the symptom. But the present study is the first of its kind evaluating the efficacy of procedure of Nutool therapy, as no satisfactory data is available, suggesting Nutool is effective therapy in management of insomnia. This trial had also been studied in a manner of psychological/behavioral studies, multimodal therapies like cognitive and behavioral studies, where  studies had been evaluated the pre and post changes and thus p values were observed within group (intra group comparison as opposed to between groups) by comparing p value of two groups (inter group) we had evaluated the variation of therapy in those groups, furthermore, if inter group comparison showed any significant improvement in outcome, this can be considered as the superiority of the test oil  over pharmacological inert liquid in improving the variable, sleep latency, mental depression and day time somnolence. Hence pre and post interventional changes within both the groups are evaluated to prove the efficacy of Nutool therapy as a whole.

The Intra group comparisons were made and findings were significant in both the groups with p value<0.001. These changes from base line data for the subjective sleep variable mentioning current sleep pattern, daily functioning (e.g. Day time fatigue, ability to function at work, concentration, mood, memory), impairment of quality of life, current sleep problems, sleep initiation, sleep maintenance and interruptions indicated that Nutool therapy significantly reduces insomnia severity in both the groups as insomnia severity index evaluated insomnia severity, and findings come as an outcome in consonance with the improvement observed in pre and post intervention with p<0.001. This also proves the efficacy of Nutool therapy as a whole. Effect size was 2.97 in group A and effect size of group B as 4.54 with d>1.20 considered as very large effect statistically.

In group A, of 7 patients of moderate severity 6 were relieved to no clinically significant and one patient to sub threshold insomnia. All the 3 patients of sub threshold insomnia were relieved to normal. Among 5 patients having severe insomnia, the severity after treatment decreased to normal in 2 patients and to sub threshold in 3 patients.

In group B, 8 patients of moderate severity 7 were relieved to normal and 1 to sub threshold insomnia. 1 patients of sub threshold insomnia was relieved to normal, and among 6 patients having severe insomnia, the severity after treatment decreased to normal in 5 patients and to sub threshold in 1 patients.

Effect size 2.97 in group A and effect size of group B as 4.54 with d>1.20 considered as very large effect statistically.

However, variation in pre intervention and post intervention values was significant in

both groups (P<0.001). This also proves the efficacy of Nutool therapy, in which any

medicated oil or  non medicated liquid if poured have significant effect.

CONCLUSION

  • Nutool therapy showed comparable effect in both test and control group after analysis of post interventional values of various parameters of insomnia severity index; it suggests that Nutool therapy irrespective of use of any kind liquid exerts its own effect by the virtue of its sheer streaming effect on the forehead.
  • In addition to the inherent effect of Nutool therapy the efficacy was further enhanced by using Roghan e Banafsha and Roghan e Gul.

Nutool therapy can be used as more widely and to a greater effectiveness in the clinical settings to reduce severities and manifestations of various types of insomnia without side effects that are associated with other pharmacological treatments.

Annexure-I

Insomnia Questionnaire for primary insomnia among geriatric population

                                                                                       Part-A

              S. NO. ………………       OPD/ IPD  NO. ………….

  1. Name: ………………………………Age /Sex:………
  2. Religion…
  3. Marital status : married/ unmarried/divorced/widow/widower

Life style and behavioural pattern:

1. Appetite              Good     ………            Fair ……….           Poor ……………………

2. Diet          Veg.      ............           Non Veg........        Mixed ……………………

3. Addiction ……..Smoking …….Alcoholism ……Tobacco Chewing …………. Others………

Concurrent Known illness:

High blood pressure                  Diabetes        

Heart disease                                Lung disease                     Liver disease 

Abnormal heart rhythm          Kidney disease                      

Head trauma or concussion     Seizure disorder                     Immune disorder                     Kidney disease             Thyroid disease                  Arthritis                 Stroke                  

Depression       Anxiety/ panic disorder           Drug abuse/dependence     Alcoholism   

Treatment history:

  Allopathic /Unani /Ayurvedic / homeopathic……………………………………………

  Duration……………………………..Response………………………………......

Physical examination:

      Eye redness…yes/no            Fatigue………….yes/no

                                                            

                                               Part –B

Inclusion criteria:

DSM-IV-TR- Diagnostic criteria for primary insomnia,

Exclusion criteria for ruling out secondary Insomnia:

                                                  

                                                          Part-C

Insomnia severity index

  1. Please rate the current (i.e., last 2 weeks) severity of your insomnia problem(s).

   None mild     Moderate         Severe      Very severe

  1. Difficulty falling asleep 0          1              2                   3              4
  2. Difficulty staying asleep 0         1              2                   3                4
  3. Problem waking up too

Early  __ampersandsig

References:

  1. Roth T, Hajak G, Ustun TB. Consensus for the pharmacological management of insomnia in the new millennium.   Int J Clin Practic 2001; 55(1): 42-52.
  2. Avidan AY. Insomnia in geriatric patients. Clin  Cornerstone 2003; 5(3): 51-60
  3. Belanger L, Belleville G, Morin MC. Management of hypnotic dyscontinuation in chronic insomnia. Sleep Med Clin 2009; 4: 583-592.
  4. Breslau N, Roth T, Rosenthal L et al. Sleep disturbances and psychiatric disorders: a longitudinal epidemiological study in young adults. Biol psychiatry 1996; 39(6): 411-8)
  5. Insomnia newer hypnotic drugs. http://www.nice.org.ku/guidance/index.jsp?action=byIDando=11530. cited on 3-4- 2010
  6. Krishnan P,  Hawranik P. Diagnosis and management of geriatric insomnia: A guide for nurse practitioners. Journal of the American Academy of Nurse Practitioners  2008; 20(12):590.
  7. Ghani MN. Khazainul Advia. New Delhi: Idarae kitabul shifa; YNM: 120-122,741-742, 802,805, 813,814, 999-1003, 1235-1236. 397-398, 1133-1135,
  8. Ibn sena. Kulliyat e qanoon. (Urdu translation by Kabir uddin.). vol 1,2 New Delhi: Eijaz Publication House; 2003:156-156.
  9. Khan A. Qarabadein e Azam, Maqzanul mujarribat. New Delhi: Aijaz publications1996: 609.
  10. Baghdadi IH. Kitabul mukhtarat fil tib. Vol II. New Delhi: CCRUM; 2005: 429-30
  11. Sleep disorders In: Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Text Revision American Psychiatric Association. Washington, DC; 2000:533-557. 
  12. Buscemi N, Vandermeer B, Friesen C. Manifestations and management of chronic insomnia in adults.  Evid Rep Technol Assess (Summ) 2005 ;( 125):1–10.
  13. Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age.  Health Psychol 2006; 25(1):3–14

Research Incentive Schemes

Awards, Research and Publication incentive Schemes by IJCRR

Best Article Award: 

One article from every issue is selected for the ‘Best Article Award’. Authors of selected ‘Best Article’ are rewarded with a certificate. IJCRR Editorial Board members select one ‘Best Article’ from the published issue based on originality, novelty, social usefulness of the work. The corresponding author of selected ‘Best Article Award’ is communicated and information of award is displayed on IJCRR’s website. Drop a mail to editor@ijcrr.com for more details.

Women Researcher Award:

This award is instituted to encourage women researchers to publish her work in IJCRR. Women researcher, who intends to publish her research work in IJCRR as the first author is eligible to apply for this award. Editorial Board members decide on the selection of women researchers based on the originality, novelty, and social contribution of the research work. The corresponding author of the selected manuscript is communicated and information is displayed on IJCRR’s website. Under this award selected women, the author is eligible for publication incentives. Drop a mail to editor@ijcrr.com for more details.

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Best Article Award

A Study by Juna Byun et al. entitled "Study on Difference in Coronavirus-19 Related Anxiety between Face-to-face and Non-face-to-face Classes among University Students in South Korea" is awarded Best Article for Vol 12 issue 16
A Study by Sudha Ramachandra & Vinay Chavan entitled "Enhanced-Hybrid-Age Layered Population Structure (E-Hybrid-ALPS): A Genetic Algorithm with Adaptive Crossover for Molecular Docking Studies of Drug Discovery Process" is awarded Best article for Vol 12 issue 15
A Study by Varsha M. Shindhe et al. entitled "A Study on Effect of Smokeless Tobacco on Pulmonary Function Tests in Class IV Workers of USM-KLE (Universiti Sains Malaysia-Karnataka Lingayat Education Society) International Medical Programme, Belagavi" is awarded Best article of Vol 12 issue 14, July 2020
A study by Amruta Choudhary et al. entitled "Family Planning Knowledge, Attitude and Practice Among Women of Reproductive Age from Rural Area of Central India" is awarded Best Article for special issue "Modern Therapeutics Applications"
A study by Raunak Das entitled "Study of Cardiovascular Dysfunctions in Interstitial Lung Diseas epatients by Correlating the Levels of Serum NT PRO BNP and Microalbuminuria (Biomarkers of Cardiovascular Dysfunction) with Echocardiographic, Bronchoscopic and HighResolution Computed Tomography Findings of These ILD Patients" is awarded Best Article of Vol 12 issue 13 
A Study by Kannamani Ramasamy et al. entitled "COVID-19 Situation at Chennai City – Forecasting for the Better Pandemic Management" is awarded best article for  Vol 12 issue 12
A Study by Muhammet Lutfi SELCUK and Fatma COLAKOGLU entitled "Distinction of Gray and White Matter for Some Histological Staining Methods in New Zealand Rabbit's Brain" is awarded best article for  Vol 12 issue 11
A Study by Anamul Haq et al. entitled "Etiology of Abnormal Uterine Bleeding in Adolescents – Emphasis Upon Polycystic Ovarian Syndrome" is awarded best article for  Vol 12 issue 10
A Study by Arpita M. et al entitled "Estimation of Reference Interval of Serum Progesterone During Three Trimesters of Normal Pregnancy in a Tertiary Care Hospital of Kolkata" is awarded best article for  Vol 12 issue 09
A Study by Ilona Gracie De Souza & Pavan Kumar G. entitled "Effect of Releasing Myofascial Chain in Patients with Patellofemoral Pain Syndrome - A Randomized Clinical Trial" is awarded best article for  Vol 12 issue 08
A Study by Virendra Atam et. al. entitled "Clinical Profile and Short - Term Mortality Predictors in Acute Stroke with Emphasis on Stress Hyperglycemia and THRIVE Score : An Observational Study" is awarded best article for  Vol 12 issue 07
A Study by K. Krupashree et. al. entitled "Protective Effects of Picrorhizakurroa Against Fumonisin B1 Induced Hepatotoxicity in Mice" is awarded best article for issue Vol 10 issue 20
A study by Mithun K.P. et al "Larvicidal Activity of Crude Solanum Nigrum Leaf and Berries Extract Against Dengue Vector-Aedesaegypti" is awarded Best Article for Vol 10 issue 14 of IJCRR
A study by Asha Menon "Women in Child Care and Early Education: Truly Nontraditional Work" is awarded Best Article for Vol 10 issue 13
A study by Deep J. M. "Prevalence of Molar-Incisor Hypomineralization in 7-13 Years Old Children of Biratnagar, Nepal: A Cross Sectional Study" is awarded Best Article for Vol 10 issue 11 of IJCRR
A review by Chitra et al to analyse relation between Obesity and Type 2 diabetes is awarded 'Best Article' for Vol 10 issue 10 by IJCRR. 
A study by Karanpreet et al "Pregnancy Induced Hypertension: A Study on Its Multisystem Involvement" is given Best Paper Award for Vol 10 issue 09
Late to bed everyday? You may die early, get depression
Egg a day tied to lower risk of heart disease
88 Percent Of Delhi Population Has Vitamin D Deficiency: ASSOCHAM Report

List of Awardees

Awardees of COVID-19 Research

Woman Researcher Award

A Study by Neha Garg et al. entitled "Optimization of the Response to nCOVID-19 Pandemic in Pregnant Women – An Urgent Appeal in Indian Scenario" published in Vol 12 issue 09

A Study by Sana Parveen and Shraddha Jain entitled "Pathophysiologic Enigma of COVID-19 Pandemic with Clinical Correlates" published in Vol 12 issue 13

A Study by Rashmi Jain et al. entitled "Current Consensus Review Article on Drugs and Biologics against nCOVID-19 – A Systematic Review" published in Vol 12 issue 09

Emerging Researcher Award

A Study by Madhan Jeyaraman et al. entitled "Vitamin-D: An Immune Shield Against nCOVID-19" published in Vol 12 issue 09

Study by Dheeraj Kumar Chopra et al. entitled "Lipid-Based Solid Dispersions of Azilsartan Medoxomil with Improved Oral Bioavailability: In Vitro and In Vivo Evaluation" published in Vol 12 issue 19


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