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Bengali questionnaire validation among geriatric population visiting homeopathic hospital and subsequent open observational trial evaluating effectiveness of homeopathic treatment
Accepted Manuscript Title: Bengali questionnaire validation among geriatric population visiting homeopathic hospital and subsequent open observational trial evaluating effectiveness of homeopathic treatment Author: Kaushik Deb Das Sutanu Patra Munmun Koley Subhranil Saha PII: DOI: Reference:
S2212-9588(16)30079-9 http://dx.doi.org/doi:10.1016/j.aimed.2017.06.001 AIMED 119
To appear in: Received date: Revised date: Accepted date:
5-10-2016 9-5-2017 6-6-2017
Please cite this article as: Das KD, Patra S, Koley M, Saha S, Bengali questionnaire validation among geriatric population visiting homeopathic hospital and subsequent open observational trial evaluating effectiveness of homeopathic treatment, Adv. Integr. Med. (2017), http://dx.doi.org/10.1016/j.aimed.2017.06.001 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Article type: Original Research Paper TITLE PAGE Article title: Bengali questionnaire validation among geriatric population visiting homeopathic hospital and subsequent open observational trial evaluating effectiveness of homeopathic treatment
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Running title: Geriatric Bengali Questionnaire Validation and Homeopathy Treatment
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List of authors: Kaushik Deb Das, Sutanu Patra, Munmun Koley, Subhranil Saha
Corresponding author: Kaushik Deb Das; MD(Hom); Lecturer and Head, Dept. of Homoeopathic
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Pharmacy, Midnapore Homoeopathic Medical College and Hospital, Govt. of West Bengal, PO: Midnapore, Dist: Paschim Medinipur, Pin code 721101, West Bengal, India; Mobile: 09932298682;
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E-mail: [email protected]
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Author affiliations:
Kaushik Deb Das; MD(Hom); Lecturer and Head, Dept. of Homoeopathic Pharmacy, Midnapore
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Homoeopathic Medical College and Hospital, Govt. of West Bengal, PO: Midnapore, Dist: Paschim Medinipur, Pin code 721101, West Bengal, India; E-mail: [email protected] Sutanu Patra; undergraduate BHMS student, 3rd yr; Midnapore Homoeopathic Medical College
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and Hospital, Govt. of West Bengal, PO: Midnapore, Dist: Paschim Medinipur, Pin code 721101, West Bengal, India; E-mail: [email protected] Munmun Koley; BHMS, MSc; Independent Researcher, affiliated to Central Council of
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Homoeopathy; Vill: Champsara, PO: Baidyabati, Hooghly, Pin code: 712222, West Bengal, India; E-mail: [email protected] 4.
Subhranil Saha; BHMS, MSc; Independent Researcher, affiliated to Central Council of Homoeopathy; 93/2/1, Shibpur Road, PO and PS: Shibpur, Howrah, Pin code 711102, West Bengal, India; E-mail: [email protected]
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ACKNOWLEDGEMENT The authors are grateful to Dr. Chapal Kanti Bhattacharjee, Principal (Acting) and Administrator, MHMC&H for allowing us to conduct the study successfully in his institution. The authors will also remain grateful to Dr. Soumitra Sain and Dr. Sanjukta Mandal, House Staffs, and Ms. (Dr.) Sumana Das, Internee, MHMC&H for their sincere contributions and to the patients for their participation in
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this study.
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AUTHOR CONTRIBUTIONS
KDD: concept, design, literature search, clinical study, data acquisition and interpretation, manuscript
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preparation. SP: clinical study and data acquisition. MK, SS: statistical analysis. All the authors
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edited, reviewed, and approved the final article.
DECLARATION OF CONFLICTING INTERESTS
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The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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FUNDING
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The authors received no funding for the project.
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Title: Bengali questionnaire validation among geriatric population visiting homeopathic hospital and subsequent open observational trial evaluating effectiveness of homeopathic treatment
ABSTRACT Aims: The authors intend to develop translated Bengali questionnaires measuring depression, stress, mindfulness and quality of life among geriatric population seeking homeopathic care and to examine
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effectiveness of homeopathic treatment subsequently in the said conditions by an open, observational trial. Methods: A mixed method bi-phasic study – a cross-sectional validation study in the first phase, followed by open, observational trial in the second phase was conducted using 4 translated questionnaires – Geriatric Depression Scale, Perceived Stress Questionnaire, Mindfulness Attention
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Awareness Scale, and Quality of Life Scale. Hamilton‟s Anxiety Scale was physician-administered;
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hence translation, further validation and testing cross-cultural adaptability was unnecessary.
Results: Total 110 geriatric patients were enrolled; 60 suffered from depression, 86 from stress, 59
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from anxiety. Exploratory principal component analysis using varimax rotation provided indications for construct validity. Questionnaires were internally consistent (Cronbach‟s α 0.745-0.926); with
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acceptable concurrent validity (Pearson‟s r 0.552-0.884). After the questionnaires were found valid by psychometric evaluation, the subsequent open observational trial for 3 months demonstrated
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individualized homeopathic treatment to be effective for the said conditions by changing the questionnaire scores significantly (P<0.00001; Cohen‟s d 0.568-1.499).
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Conclusion: The questionnaires appeared valid and reliable. Effect sizes were promising, forming basis of up-taking efficacy trials. Limited generalizability of treatment effects necessitates cautious
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interpretation. Trial registration: CTRI/2015/06/005927. KEYWORDS
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Aging, Depression, Stress, Anxiety, Quality of life
INTRODUCTION
Regardless of physician's preference, the use of Complementary and Alternative Medicine (CAM) is predominantly more popular in older adults [1-3], especially for depression, and late-life mood and cognitive disorders [4]. However, homeopathy research on geriatric population was seriously compromised until the 90‟s, and our search in different electronic databases up to then revealed only 9 old published papers [5-13]. But gradually, until December 2014, homeopathy total clinical research
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grew substantially to 1136 studies, of which, 98 (8.6%) are mental disorders/conditions. These studies have chiefly focussed on attention deficit hyperactivity disorder (ADHD) (18, 18.4%); insomnia (14, 14.3%); depression (10; 10.2%); anxiety (6; 6.1%); chronic fatigue syndrome (CFS) (5; 5.1%); behavioural disorder, autism spectrum disorder (ASD) and nervous disorder (4 each; 4.1% each); depression with anxiety, schizophrenia, and stress (3 each; 3.1% each); and others. Though
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experimenting with individualized homeopathy predominated (44; 44.9%), other forms are also
prevailing – complex (21; 21.4%), non-individualized and standardized (17; 17.3%), isopathy (3;
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3.1%), and unknown (13; 13.3%) [14]. Twelve studies have been conducted in India, of which only 3
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(25%) have been published in peer-reviewed journals. These studies have concentrated on schizophrenia, ADHD, and behavioural disorder (2 each); and opium withdrawal, ASD, insomnia,
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heroin detoxification, drug addiction, and borderline personality disorder (1 each). Seven studies were open and observational, 4 were parallel arm, and study design was unclear in one [14]. Apart from
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methodological shortcomings, the major and common problem underlying these Indian studies was the use of non-validated outcomes, thus questioning the interpretation of the study results. In a
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subgroup analysis of 83 elderly patients from a prospective, multicentre, observational, cohort study in primary care practices in Germany and Switzerland, the severity of diseases showed significant
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improvement (both physician and patient rated numeric rating scales) under homeopathic treatment, but not in SF-36 quality of life over 24 months [15]. Although a number of studies have suggested positive effects of mindfulness-based training on
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psychological wellbeing [16-18], no studies have evaluated the role of homeopathy in mindfulness, and emotional well-being in the geriatric population. In this project, we intend to develop translated Bengali versions of these available outcome measures through standardized forward-backward translation method and to validate it in a homeopathic hospital setting. This project is the initial work before conducting a prospective, double-blind, randomized, placebo-controlled study evaluating the efficacy of individualized homeopathic treatment in reducing depression, stress, and anxiety; and improving mindfulness and quality of life among the geriatric population seeking homeopathic care and to examine utility of individualized homeopathic treatment in the said conditions. Apart from
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being a psychometric validation study of the Bengali questionnaires, this study is also designed to estimate homeopathy treatment effect in observational study design at the same time, thereby evaluating the justification of up taking controlled efficacy trials in future. Thus two research questions were dealt with at the same time:
attention-awareness, and quality of life are valid and reliable?
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1. Whether the translated Bengali versions measuring geriatric depression, stress, mindfulness-
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2. Are the homeopathy treatment effects observed in the said conditions in pre-post
METHODOLOGY
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observational trial design statistically significant enough to conduct controlled trials in future?
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Ethical issues: Clearance was obtained from the institutional ethics committee (Ref. No. MHMCH/18/2015; April 22, 2015) prior to conducting the study. All participants were provided with
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patient information sheets in local vernacular Bengali and informed consents were obtained. The study matter and questions were also explained verbally to the participants for easy understanding. No
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identifiable patient information was required, ensuring anonymity and protection of patient privacy. Study registration: The study was registered with Clinical Trials Registry, India vide
1169-7929.
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CTRI/2015/06/005927; June 17, 2015. The study has a unique Universal Trial No. (UTN) of U1111-
Selected outcomes:
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1. Geriatric Depression Scale (GDS): It is used to measure depressive symptoms [19]. It has demonstrated 92% sensitivity, 89% specificity, and a good capacity for discriminating between depressed and non-depressed elderly people [20]. Scores range from 0-15; 0-4 considered as normal; 5-8 indicates mild depression; 9-11 moderate depression; and 12-15 severe depression. It is a useful screening tool in the clinical setting to facilitate assessment of depression in older adults especially when baseline measurements are compared to subsequent scores.
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2. Perceived Stress Scale (PSS): It measures the degree to which situations in one‟s life are appraised as stressful [21]. The scale includes items designed to measure how often individuals find their lives unpredictable, uncontrollable, and overloaded during the last month. Internal consistency is good (0.85), and the stability of the test-retest coefficients ranges from 0.75 to 0.86. This scale has been used among older adult populations [22] and is used in the current
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study to assess the mediating role of perceived stress in the relationship between mindfulness
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and cognitive outcome. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing
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across all scale items. Scores around 13 are considered average; scores of 20 or are considered as high stress.
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3. Hamilton’s Anxiety Scale (HAS): It is a physician-administered psychological scale used to
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rate the severity of patients‟ anxiety [23]. Though often criticized for its poor ability to discriminate between anxiolytic and antidepressant effects, and somatic anxiety versus somatic side effects, the reported levels of inter-rater reliability for the scale appear to be
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acceptable [24]. The scale consists of 14 items, each defined by a series of symptoms, and
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measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where less than 17 indicates mild
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severity, 18-24 mild to moderate severity, and 25-30 moderate to severe.
4. Mindfulness Attention Awareness Scale (MAAS): It is used as a dispositional measure of mindfulness [25]. It has been used previously to measure mindfulness in older adults and has a Cronbach‟s alpha level of 0.87 among the general adult population in the United States [26]. To score the scale, mean of the 15 items is computed. Higher scores reflect higher levels of dispositional mindfulness. 5. Quality of Life Scale (QoLS): It measures satisfaction with needs met [27]. It contains 16 items representing 6 domains of quality of life: physical and material well-being, relationships
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with other people, social and civic activities, personal development, and independence. Cronbach‟s coefficient has been documented at 0.87 for the general adult population [28]. The instrument is scored by summing the items to make a total score. Higher scores reflect better quality of life.
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6. Numeric Rating Scale (NRS): One 0-10 point scale assessing patients‟ self-reported intensity of complaints has been provided at the end of each outcome questionnaire [except
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Hamilton‟s Anxiety Questionnaire that is clinician-rated; NRS provided with HAS were
marked by the clinician himself]. This NRS is helpful in examining the concurrent validity of
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each outcome.
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The used questionnaires in this study are available from the corresponding author on request. Questionnaire translation: The process consisted of 6 steps – (1) Forward translation by two
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independent native Bengali speakers; (2) Synthesis of the two translations into one; (3) Back translation of the synthesised version into English by two English language translators; (4) Review of
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the translated versions and development of the pre-final version; (5) Face validation on 5 randomly selected geriatric patients visiting outpatients of MHMC&H; and (6) Appraisal. Thus the translated
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Bengali versions of GDS, RSS, MAAS, and QoLS questionnaire were obtained. The Hamilton‟s Anxiety Scale (HAS) was physician-administered; hence translation, validation and testing crosscultural adaptability was unnecessary. Then the questionnaires were pilot tested on 15 randomly
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selected geriatric patients. After little modification, the questionnaires were finalized.
Eligibility criteria: Inclusion criteria were the patients visiting out-patient clinics of Midnapore Homoeopathic Medical College & Hospital (MHMC&H), aged 60 years and above and both sexes; exclusion criteria were patients who were too sick for consultation, unwilling to stay after the doctor‟s visit, unable to read patient information sheets, and not giving consent to join the study, diagnosed cases of unstable mental or psychiatric illness or other systemic disease affecting QoL, currently receiving standard psychiatric therapy (conventional medication), self-reported immune-compromised state, and substance abuse.
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Methods: The adopted study design was bi-phasic and mixed method; i.e. cross-sectional validation study in first phase, followed by open, observational trial in second phase. Data gathered in the first phase (validation) of the study also served as baseline data of the second phase observational trial. In the validation/baseline phase, the questionnaire psychometric statistics were examined whether it was appropriate to be used in clinical trial. In the next phase, data was gathered again after 3 months using
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the same questionnaires and was compared with baseline for significant difference and determining
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treatment effect, if any (pre-post comparison).
We intended to achieve the maximum possible sample size within the stipulated timeframe of one
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year – May 2015 to April 2016. All the patients of geriatric age group underwent preliminary
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screening using the translated questionnaires, followed by detailed screening by the specified eligibility criteria. Seventeen patients refused to participate in the study. Effect size was measured by requesting the patients to fill in the questionnaire again 3 months after treatment. Concurrent validity
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(Pearson‟s r correlation coefficient) was tested by comparing the questionnaire scores with the NRS
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responses. The filled-in questionnaires were put inside opaque envelops and sealed at the study site. These were sent for data extraction in a specially designed Microsoft Excel spread sheet that was
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subjected to statistical analysis. Adverse or serious adverse event(s), if any, was planned to be treated accordingly as per homeopathic principles, or if non-responding, then the patient were referred for conventional treatment.
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Intervention and treatment plan: Interventions were planned as administering indicated remedies in centesimal or 50 millesimal potencies as appropriate. In centesimal scale, each dose consisted of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 88% v/v ethanol. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no.10) dissolved in 50 ml distilled water with addition of 2 drops of 88% v/v ethanol, 10 doses marked on the vial, each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid in the cup. Repetition 24, 12 or 8 hourly or even oftener, depended upon the individual requirement of the case. All medicines were procured from a Good Manufacturing Practice (GMP)8 Page 8 of 22
certified firm. Following recruitment, selection of the single individualized medicine was based on the presenting symptom totality, repertorization (RADAR® software, Archibel, Belgium) and consultation with materia medica, and individualized dose, based on the judgment of susceptibility of the patients and as per individual requirement of the cases. Subsequent prescriptions were generated according to Kent‟s observations and second prescription. Thus results of this study adhered to the criteria for
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reporting individualization in homeopathy [29].
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Statistical analysis: Statistical analysis followed the intention-to-treat (ITT) approach; i.e. every
included patient entered final analyses. The missing values were imputed by the means of the normal
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distribution fitted against specified data series and performed by the Maximum-likelihood method.
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Descriptive statistics was presented as means, standard deviations, variance, skewness and kurtosis. Exploratory factor analysis (EFA) using principal component analysis (PCA) was run to ensure that
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the questions asked relate to the construct that was intended to measure and to identify underlying variables that explain the pattern of correlations within a set of observed variables. Subsequently,
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internal consistency and concurrent validity of the used questionnaires was examined. Paired t test was run comparing values obtained at baseline and after 3 months. Effect size was calculated in terms of Cohen‟s d. To do this, correlations (Pearson‟s r) between the two means was calculated first and
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then Cohen‟s d was estimated by the Morris and DeShon's (2002) equation 8 [30]. Effect sizes were classified: as |d|>0.8, large; |d|>0.5, medium; and |d|>0.2, small [31]. The commonly accepted rule of thumb was applied to interpret Cronbach‟s alpha: α≥0.9 excellent; 0.9>α≥0.8 good; 0.8>α≥7
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acceptable; 0.7>α≥0.6 questionable; 0.6>α≥5 poor; and 0.5>α unacceptable [32]. Lastly, univariate analysis was run to test any significant influence of the suspected variables on the outcome scores. P values less than 0.05 two-tailed were considered as statistically significant. All these analyses were carried out using IBM® Statistical Package for Social Sciences (SPSS)® software, version 20.0. RESULTS Baseline sample characteristics: Total 110 responses were obtained from the geriatric sample approached; 60 (54.55%) suffered from depression, 86 (78.18%) from stress, and 59 (53.64%) from anxiety. The participants had a mean age of 66.78 years (sd 5.95; 95% CI 65.66, 67.91). The majority 9 Page 9 of 22
of the respondents were men (n=68; 61.82%; 95% CI 52.49, 70.35), belonged to the age group 61-70 years (n=84; 76.36%; 95% CI 67.62, 83.33). Most frequently reported condition was rheumatologic complaints (n=62; 56.36%; 95% CI 47.03, 65.26), including osteoarthritis, rheumatoid arthritis, low backache, cervical and lumbar spondylosis, sciatica, gout, and frozen shoulder. Mean duration of suffering from rheumatologic condition was 7.32 yrs (sd 4.74; 95% CI 6.42, 8.22). Other reported
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conditions were gastro-intestinal disorders (constipation, diarrhea, dyspepsia, gastritis, indigestion,
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etc.; 11.82%), prostatic complaints (benign hyperplasia; 10%), diabetes, hypertension and bronchial asthma (9.09% each), skin diseases (eczema, scabies; 6.36%), insomnia (4.55%), sebaceous cysts
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(2.72%), piles and respiratory tract infections (1.82%), and chronic suppurative otitis media, chronic debility, facial paralysis, and anal fistula (0.91% each). Homeopathic treatment was perceived to be
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effective to majority (n=51; 46.36%; 95% CI 37.32, 55.64) of the patients, while most of the patients
Exploratory factor analysis (EFA):
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(n=70; 63.64%; 95% CI 54.33, 72.03) expected marked improvement from it. (Table 1)
1. GDS: Though the achieved sample size of 110 was pretty less than the recommended 300 for
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carrying out psychometric validation [33], still it seemed adequate for factor analysis as the
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average communalities after extraction was 0.708, much above the preferred cut-off of 0.5. Also, the Kaiser-Meyer-Olkin (KMO) measure was 0.857 [chi-square: 1137.456, df=105], much greater than the minimum Kaiser criterion of 0.5, indicating adequacy of the sample and compactness of correlation patterns. A significant Bartlett‟s test of sphericity (P<0.0001)
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also indicated that the R-matrix was not an identity matrix. Next, the correlation matrix was scanned for values greater than 0.9 for identifying multi-co-linearity and singularity, but when cross-checked, no questionnaire item showed values greater than 0.05. Then using PCA, factors with eigenvalues more than 1 were extracted and were listed before extraction, after extraction, and after rotation. Rotation had the effect of optimizing the factor structure and equalization of relative importance of the selected factors. We expected the factors to be independent, and chose one of the orthogonal rotations – i.e. varimax. The rotated component matrix is a matrix of factor loadings for each variable onto each factor. By selecting „Sorted
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by size‟, the variables were ordered by their factor loadings. The absolute values less than a specified value of 0.1 were suppressed, ensuring that factor loadings within ±0.1 were not displayed in the output. After conducting factor rotation, the content of questions was looked for that loaded onto the same factor. Four sub-components of the main construct were identified. These are probable, and needs to be substantiated further, but beyond the scope of
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this paper.
2. PSS: The average communalities after extraction was 0.605 and the KMO measure was 0.912
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[chi-square: 726.774, df=45], indicating adequacy of the sample. A significant Bartlett‟s test
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of sphericity (P<0.0001) also indicated that the R-matrix was not an identity matrix. In the correlation matrix, there were no values greater than 0.9 and all the items showed significance
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values less than 0.05. Then using PCA, factors with eigenvalues more than 1 were extracted and were listed before extraction, after extraction, and after varimax rotation. As only one
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component was extracted, the solution could not be rotated.
3. MAAS: The average communalities after extraction was 0.649, the KMO measure was 0.843
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[chi-square: 685.459, df=105], and Bartlett‟s test of sphericity was significant (P<0.0001), thus indicating adequacy of sample. In the correlation matrix, no values greater than 0.9 were
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identified. Then using PCA, factors with eigenvalues more than 1 were extracted and were listed before extraction, after extraction, and after varimax rotation. Factor loading was done after selecting „Sorted by size‟ and after suppressing absolute values less than 0.1. After
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conducting factor rotation, the content of questions was looked for that loaded onto the same factor. Four sub-components of the main construct were identified.
4. QoLS: The average communalities after extraction was 0.657, the KMO measure was 0.847 [chi-square: 1034.970, df=120], and Bartlett‟s test of sphericity was significant (P<0.0001), thus indicating that the achieved sample size was sufficient for EFA. In the correlation matrix, no values greater than 0.9 were identified. Then using PCA, factors with eigenvalues more than 1 were extracted and were listed before extraction, after extraction, and after varimax rotation. Factor loading was done after selecting „Sorted by size‟ and after suppressing absolute values less than 0.1. After conducting factor rotation, the content of questions was 11 Page 11 of 22
looked for that loaded onto the same factor. Three sub-components of the main construct were identified. Further details of EFA and questionnaire descriptive statistics (means, standard deviations, variance, skewness and kurtosis) are available from the corresponding author on request.
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Internal consistency: The measure of internal consistency, i.e. the Cronbach‟s alpha is presented in table 2. The questionnaires showed good (MAAS α=0.813) to excellent (PSS α=0.926) internal
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consistency with agreeable inter-item and item-total statistics. Single measure intra-class correlation coefficients were 0.364 (95% CI 0.299, 0.442), 0.557 (95% CI 0.485, 0.633), 0.225 (95% CI 0.172,
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0.291), and 0.319 (95% CI 0.257, 0.393) for the GDS, PSS, MAAS, and QoLS questionnaires
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respectively (Table 2). Further details are available from the corresponding author on request. Concurrent validity: It was tested by comparing the total score of each questionnaire with that of
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NRS score. The correlation measure Pearson‟s r showed positive correlation, moderate to strong (0.552-0.884), indicating acceptable concurrent validity. (Table 3)
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Changes in outcomes: After 3 months of homeopathic treatment, the GDS, PSS, and HAS scores reduced significantly (P<0.00001) with moderate to large effect size (Cohen‟s d 0.712-1.499).
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Increase in MAAS and QoLS scores, showing large and moderate effect sizes of 1.002 and 0.568 respectively, were also statistically significant (P<0.00001). Simultaneously, the NRS scores also confirmed significant change (P<0.05) over time with moderate to large effect sizes (0.300-0.988).
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(Table 4)
Influence of suspected variables on outcome scores: GDS score appeared to be significantly high (P<0.05) in females, semi-urban patients, unmarried patients, and economically dependent patients. Also, assumed effectiveness of homeopathic treatment was considered to the patients showing higher GDS and PSS scores (P<0.05); still they had expectations of marked improvement from treatment. Higher HAS scores were found in females and semi-urban patients; and they had significantly high (P<0.05) expectations of marked improvement. Higher MAAS scores were noted in urban patients, those who are married, having education of 10th standard or less, and having high expectation of cure 12 Page 12 of 22
(P<0.05). Higher QoLS scores were (P<0.05) found in urban and married patients, and those who were economically dependent. (Table 5) Medicines used: Total 38 different medicines were used in varied centesimal and 50 millesimal scale potencies. The most frequently used medicines are listed with their indications in Table 6.
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DISCUSSION
In this study, we first aimed at examining psychometric properties of the translated Bengali
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questionnaires measuring depression, anxiety, stress, mindfulness-attention-awareness, and quality of
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life in the geriatric population seeking homeopathic care in West Bengal, India. When this validity statistics appeared satisfactory, then we examined homeopathy treatment effects in pre-post
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observational trial design. The estimated effect sizes were quite promising, ranging from moderate to large, over a treatment period of 3 months with statistically significant changes in the questionnaire
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scores. Thus this project served as the initial work before up taking controlled efficacy trials of individualized homeopathic treatment in comparison with placebo. Univariate analyses detected some
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potential variables having significant influence on the outcomes. Assessments of intensity of depression, stress and anxiety consistently showed substantial reductions
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and mindfulness-attention and quality of life revealing significant increase that may be partly attributable to regression to the mean effects, that our study was not designed to control. We also cannot rule out overestimation of the treatment effect and undisclosed use of concurrent therapeutic
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modalities, if any. We used „classical‟ (individualized) form of homeopathic treatment. In contrast to randomized controlled trials, our study describes patients from everyday practice with multiple morbidities and a large variety of life styles. This ensures a high degree of external validity that allows extrapolation to usual medical care. We used numeric rating scales that are validated and often used. NRS scales were used to examine the concurrent validity of the questionnaires measuring the same construct. However, no other valid instrument, except for NRS, was used for cross-validation, and it has been a limitation. As the data gathered from the sample in the validation phase also served as the baseline data for estimating treatment effect, the authors opted for reporting the results of the
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two phases in a single paper. This might be considered sub-optimal, but probably quite rationalistic from feasibility point of view, i.e. in a hospital exclusively providing a single complementary and alternative healthcare namely homeopathy and suffering from various infrastructural constraints [34]. However, our findings are considerably similar to the instruments in other languages, i.e. factor structures, validity, and reliability. Further specific factor analyses are warranted using Rasch rating
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models or different stoichiometric models to confirm the uni-dimensionality of the scales.
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Confirmatory factor analysis (CFA) and structural equation modelling (SEM) may be run to confirm correlations and infer causal relationships among factors.
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Research into the homeopathic consultation has identified several contextual factors such as empathy,
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empowerment, hopefulness, enablement and narrative competence, which are not the active components of the treatment but are inherent within the whole package of care. Homeopathy
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consultations involve a complete exploration of the patient‟s emotional, spiritual, and physical wellbeing to enable treatment of the whole person, not just the illness. Thus, highly individualized
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homeopathy consultations and „case taking‟ necessitate a very detailed understanding of the patient in a unique and personalized approach in order to identify a homeopathic remedy. Such consultations
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elicited the sufferings of the mental sphere of the patients enrolled and reflected the state of depression, stress, and anxiety present in them. At the same time, there were a few other patients who declared themselves free from such kinds of mental states and expected their physical sufferings only to be cured. Some of the common causes behind such mental states in the elderly patients as disclosed
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from their end were events of death of spouse, sudden demise of grown up son or daughter, broken families, acts of irresponsibility on the part of son, son-in-law, daughter or daughter-in-law, humiliation from near relatives etc. Anxiety over career, marriage of grown up son or daughter and too deep anxious thoughts of the future were few other concerns elicited in some of the patients. During the course of treatment, alongside homeopathic medication, all the subjects were infused with positive mental thoughts in their first visit and subsequent follow ups. After the three month period, it was observed that the chief one or two physical ailments from which the patient had been suffering had reduced from moderate to remarkable degree. Among the subjects, a few patients reported of 14 Page 14 of 22
reduction in both mental and physical sufferings to some extent. However in some instances, it was found that the mental suffering which was improving with passage of time with homeopathic medication as reported by the patients suddenly aggravated at some points of time in the three month period. Events of any untoward incidents, misfortune or a quarrel in the family might have affected the score in such cases. The authors also observed that the patients suffering from depression, stress,
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or anxiety of comparatively shorter duration reported improvement earlier than the patients suffering
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from the similar mental complaints of longer duration. So, it can be assumed that the latter group
might have required a little more time for reduction of their mental symptoms, which although was
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not the aim of the study. To study whether and to what extent the homoeopathic medicines are useful in reducing depression, stress etc. of longer duration in geriatric population, a similar study of longer
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observation period can be designed in future.
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In spite of some inherent problems of observational trial designs and cross-sectional validation studies, our study puts the first light on homeopathic treatment of geriatric population in West Bengal,
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India. As already stated, the major hindrance of conducting well-planned research in the said population is the absence of validated translated versions of different outcome measure questionnaires
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in Bengali language. Naturally, our first intention was to develop such psychometrically valid tools; thus enabling conduct of meaningful efficacy research in near future satisfying the internal validity issues related to observational research. Our study also detected moderate to large effect sizes, but may be subject to some serious and unresolved biases, like inadequate sample size and in-built
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psychological effects of homeopathic consultation processes. These issues are to be addressed in welldesigned placebo-controlled RCTs in near future. Thus the study offers some promising tools, but the treatment effects obtained demand cautious interpretation. The main strength of this type of observational studies is their greater proximity to “real life situations” by capturing large amount of uneven data, since RCTs have stricter inclusion criteria and rigid protocols that may not reflect clinical practice. Other advantages include cheaper cost than RCTs, ease to perform, and help in creating new hypotheses. CONCLUSION 15 Page 15 of 22
The cross-sectional validation study generated valid translated Bengali versions of questionnaires measuring depression, anxiety, stress, mindfulness-attention-awareness, and quality of life in the geriatric population seeking homeopathic care in West Bengal, India. Subsequently, the observational trial detected moderate to large treatment effect sizes with statistically significant changes. This project sufficiently justifies conduct of placebo-controlled efficacy trials of individualized
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homeopathic treatment to evaluate how far the treatment effects are different from placebo effect and
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Age (yrs.)¥ Age groups (yrs.): 61-70 71 and above Gender: Male Female Residence: Urban Semi-urban Rural Marital status: Married Unmarried and others Education: 10th std. or less 12th std. Graduate or above Employment status: Service Business Dependent Others Income status: Poor Middle class Affluent BMI¥ BMI groups: <18.5 (underweight) 18.5-24.9 (normal) 25.0 and above (overweight, obese) Blood pressure: SBP¥
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Table 1: Baseline socio-demographics (N=110) Features N (%) 66.78 ± 5.95
95% CI 65.66, 67.91
84 (76.36) 26 (23.64)
67.62, 83.33 16.67, 32.38
68 (61.82) 42 (38.18)
52.49, 70.35 29.65, 47.51
33 (30) 39 (35.45) 38 (34.55)
22.23, 39.12 27.14, 44.74 26.32, 43.82
102 (92.73) 8 (7.27)
86.31, 96.27 3.73, 13.69
87 (79.09) 12 (10.91) 11 (10)
70.57, 85.64 6.35, 18.11 5.68, 17.02
3 (2.73) 16 (14.55) 65 (59.09) 26 (23.64)
0.93, 7.72 9.16, 22.33 49.75, 67.82 16.67, 32.38
54 (49.09) 47 (42.73) 9 (8.18) 22.90 ± 3.14
39.94, 58.3 33.88, 52.07 4.36, 14.82 22.31, 23.49
7 (6.36) 79 (71.82) 24 (21.82)
3.11, 12.55 62.79, 79.38 15.12, 30.42
139.44 ± 17.60
136.11, 142.76
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79.95, 83.14
62 (56.36) 13 (11.82) 11 (10) 10 (9.09) 10 (9.09) 10 (9.09)
47.03, 65.26 7.04, 19.18 5.68, 17.02 5.01, 15.93 5.01, 15.93 5.01, 15.93
7.32 ± 4.74 7.46 ± 6.92 6.64 ± 5.66 8.77 ± 7.2 6 ± 4.20 6 ± 3.16
6.42, 8.22 6.15, 8.77 5.57, 7.71 7.41, 10.13 2.99, 9.00 3.74, 8.26
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10 (9.09) 51 (46.36) 16 (14.55) 2 (1.82)
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81.55 ± 8.45
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DBP¥ Conditions suffering from§: Rheumatic complaints Gastro-intestinal disorders Prostatic complaints Diabetes Hypertension Bronchial asthma Duration of illness (yrs.): Rheumatic complaints Gastro-intestinal disorders Prostatic complaints Diabetes Hypertension Bronchial asthma Assumed effectiveness of homeopathy (n=79): Very effective Effective Less effective Ineffective Expectations: Cure Marked improvement
27.97, 45.67 54.33, 72.03
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40 (36.36) 70 (63.64)
5.01, 15.93 37.32, 55.64 9.16, 22.33 0.5, 6.39
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Abbreviations: BMI = Body Mass Index; SBP = Systolic blood pressure; DBP = Diastolic blood pressure; CI = Confidence Interval; ¥Continuous data presented as mean ± sd and other categorical data as N (%); §Total 15 varieties of clinical conditions were reported overall; here we tabulated only those conditions (with duration of suffering) reporting minimum absolute frequency of n=10. For the rest of the conditions, please see text.
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Table 2: Internal consistency of the outcome measures (N=110) Outcomes Cronbach‟s alpha 95% CI Acceptability GDS 0.896 0.865, 0.922 Good PSS 0.926 0.904, 0.945 Excellent MAAS 0.813 0.757, 0.860 Good QoLS 0.882 0.847, 0.912 Good
Abbreviations: GDS = Geriatric Depression Scale; PSS = Perceived Stress Scale; MAAS = Mindfulness Attention Awareness Scale; QoLS = Quality of Life Scale; NRS = Numeric Rating Scale; CI = Confidence Interval
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Table 3: Concurrent validity of the outcomes (N=110) Questionnaire scores NRS scores Significance Outcomes Pearson‟s r Correlation (mean ± sd) (mean ± sd) (2-tailed) GDS 6.2 ± 4.5 4.0 ± 3.0 0.854 Strongly positive <0.0001* PSS 19.8 ± 6.6 4.0 ± 2.9 0.884 Strongly positive <0.0001* MAAS 67.2 ± 6.4 5.6 ± 2.1 0.552 Moderately positive <0.0001* QoLS 72.5 ± 9.4 6.1 ± 1.5 0.832 Strongly positive <0.0001* Abbreviations: GDS = Geriatric Depression Scale; PSS = Perceived Stress Scale; MAAS = Mindfulness Attention Awareness Scale; QoLS = Quality of Life Scale; NRS = Numeric Rating Scale; *P<0.05 two-tailed considered as statistically significant
Outcomes GDS GDS-NRS
Baseline; mean (sd) 9.73 (2.85) 6.17 (1.81)
Table 4: Changes in outcomes after 3 months After 3 months; Change; Cohen‟s d mean (sd) mean (95% CI) 7.85 (3.21) -1.88 (-2.56, -1.19) 0.712 4.77 (1.72) -1.40 (-1.77, -1.02) 0.970
t score¥
P value
-5.428 -7.424
P<0.00001* P<0.00001*
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PSS 22.39 (4.60) 19.36 (4.77) -3.03 (-3.89, -2.16) 0.751 -6.912 P<0.00001* PSS-NRS 5.13 (2.20) 3.92 (2.02) -1.212 (-1.55, -0.87) 0.767 -7.042 P<0.00001* HAS 23.62 (4.08) 15.99 (5.58) -7.63 (-8.99, -6.26) 1.499 -11.080 P<0.00001* HAS-NRS 5.86 (1.63) 4.02 (1.83) -1.84 (-2.33, -1.36) 0.988 -7.514 P<0.00001* MAAS 4.48 (0.43) 4.61 (0.34) 0.13 (0.07, 0.18) 1.002 4.723 P<0.00001* MAAS-NRS 5.65 (2.05) 6.01 (1.67) 0.37 (0.13, 0.60) 0.300 3.048 P=0.003* QoLS 72.51 (9.41) 75.64 (7.83) 3.13 (2.05, 4.21) 0.568 5.727 P<0.00001* QoLS-NRS 6.09 (1.54) 6.41 (1.22) 0.32 (0.13, 0.50) 0.342 3.398 P=0.001* Abbreviations: GDS = Geriatric Depression Scale; PSS = Perceived Stress Scale; HAS = Hamilton Anxiety Scale; MAAS = Mindfulness Attention Awareness Scale; QoLS = Quality of Life Scale; NRS = Numeric Rating Scale; CI = Confidence Interval; sd = standard deviations; ¥Paired t test; *P<0.05 two-tailed considered statistically significant
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Table 5: Influence of baseline variables on the outcomes (N=110) P value
PSS score
P value
HAS score
P value
MAAS score
P value
QoLS score
P value
6.07 (4.54) 6.49 (4.47)
0.689
19.57 (6.68) 20.49 (6.31)
0.270
18.11 (7.11) 19.04 (5.54)
0.544
4.50 (0.43) 4.43 (0.42)
0.482
72.63 (9.44) 72.13 (9.27)
0.814
5.14 (4.42) 7.83 (4.20)
0.001*
18.83 (6.92) 21.35 (5.74)
0.053
17.03 (6.40) 20.42 (6.86)
0.010*
4.54 (0.44) 4.39 (0.39)
0.061
72.55 (9.28) 72.44 (9.61)
0.950
4.56 (3.37) 7.72 (4.55) 5.98 (4.85)
0.01*
18.59 (5.59) 21.14 (7.38) 19.47 (6.34)
0.242
15.64 (5.46) 20.21 (6.51) 18.73 (7.33)
0.013*
4.64 (0.30) 4.35 (0.43) 4.47 (0.47)
0.013*
77.48 (7.02) 68.41 (10.73) 72.41 (7.52)
<0.001*
5.85 (4.41) 10.25 (4.02)
0.004*
19.46 (6.37) 23.93 (8.07)
0.067
17.99 (6.81) 22.63 (4.53)
0.063
4.52 (0.41) 4.04 (0.36)
0.002*
73.36 (8.69) 61.72 (11.32)
0.001*
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GDS score
6.03 (4.51) 6.75 (4.34) 6.65 (4.74)
0.817
19.31 (6.48) 21.65 (7.24) 21.53 (6.19)
0.333
18.49 (6.80) 17.75 (6.66) 17.64 (6.68)
0.882
4.52 (0.37) 4.20 (0.65) 4.49 (0.39)
0.341
72.83 (8.22) 69.83 (13.34) 72.91 (12.15)
0.573
4 (3.56) 5.85 (5.07) 7.09 (4.44) 4.31 (3.74)
0.043*
21.32 (4.92) 18.77 (7.92) 20.63 (6.75) 18.13 (4.90)
0.350
16 (4.97) 16.75 (7.22) 19.71 (6.89) 16.12 (5.40)
0.076
4.65 (0.32) 4.26 (0.62) 4.45 (0.40) 4.68 (0.23)
0.010*
70.93 (5.72) 68.61 (13.13) 71.89 (8.87) 76.66 (6.32)
0.036*
7.04 (4.64) 5.10 (4.09) 6.56 (4.86)
0.091
20.41 (6.49) 18.97 (6.37) 20.32 (7.96)
0.531
19.40 (7.00) 17.34 (6.28) 17 (6.96)
0.256
4.50 (0.38) 4.50 (0.36) 4.24 (0.80)
0.205
71.13 (7.88) 73.87 (9.09) 73.72 (15.93)
0.308
6.71 (4.77) 6.07 (4.57) 6.33 (4.29)
0.919
22.01 (5.13) 19.41 (6.93) 20.41 (5.67)
0.532
19.43 (7.96) 18.05 (6.72) 18.92 (6.55)
0.778
4.56 (0.41) 4.50 (0.37) 4.41 (0.58)
0.612
73.53 (5.94) 72.21 (8.88) 73.19 (11.60)
0.866
5.94 (4.21) 6.25 (4.44) 6.15 (3.95) 7.8 (5.19) 6.25 (4.02) 5.75 (4.82)
0.890
18.91 (6.35) 18 (0) 19.62 (4.75) 23.59 (6.67) 21.27 (7.41) 18.24 (6.64)
0.212
17.67 (6.30) 17.33 (3.73) 19.91 (5.07) 21.9 (6.99) 19.33 (7.78) 18.75 (7.68)
0.406
4.48 (0.40) 4.56 (0.39) 4.57 (0.45) 4.34 (0.51) 4.41 (0.42) 4.68 (0.23)
0.528
73.23 (7.51) 75.05 (6.62) 72.99 (6.01) 67.57 (10.99) 72.55 (13.01) 76.19 (6.86)
0.293
7.41 (4.37) 4.71 (4.19) 8.56 (4.75)
0.004*
23.50 (6.98) 18.16 (6.78) 21.81 (5.66)
0.022*
17.7 (7.52) 17.09 (6.44) 19.28 (6.53)
0.484
4.31 (0.52) 4.52 (0.45) 4.39 (0.37)
0.298
69.28 (15.92) 74.53 (9.4) 70.01 (7.84)
0.137
4.63 (4.10) 7.05 (4.53)
0.003*
17.73 (6.58) 20.97 (6.33)
0.013*
16.4 (7.08) 19.43 (6.35)
0.024*
4.6 (0.36) 4.41 (0.45)
0.028*
74.28 (8.61) 71.50 (9.69)
0.138
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Variables Age groups (yrs):§ 61-70 71 and above Gender:§ Male Female Residence:¥ Urban Semi-urban Rural Marital status:§ Married Unmarried, others Education:¥ 10th std. or less 12th std. Graduate or above Employment status:¥ Service Business Dependent Others Income status:¥ Poor Middle class Affluent BMI groups:¥ <18.5 18.5-24.9 25.0 and above Conditions suffering from: ¥ Rheumatologic Gastro-intestinal Prostatic Diabetes Hypertension Bronchial asthma Assumed effectiveness of homeopathy (n=79):¥ Very effective Effective Less effective or ineffective Expectations:§ Cure Marked improvement §
Independent t test; ¥One way ANOVA; Outcome scores presented as mean (standard deviations); *P<0.05 twotailed considered as statistically significant
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3. Causticum 4. Natrum muriaticum
5. Sulphur 6. Thuja occidentalis
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7. Aurum metallicum 8. Gelsemium sempervirens 9. Medorrhinum
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2. Arsenicum album
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1. Ignatia amara
Table 6: Most frequently used medicines with indications No. of Indications prescriptions 10 Suppressed grief, sensation of heaviness in chest, defensive, deep sighing, bursting into tears, sense of lump in the throat 8 Fastidious, sense of insecurity, worried about health, general aggravation at midnight 7 Old event of grief, mentally sympathetic to others suffering, strong sense of justice 7 Reserved outside, angry when consoled, tiredness and aggravation from exposure to sun heat, sense of responsibility, hides strong inner feelings 6 Hot patient, feels too hungry at 11-12 noon, prefers sweet and meat, aversion to milk, burning of palms and soles 6 Talks slowly, general worsening in rainy season, prefers salt, intolerance tea and onion 4 Suicidal thoughts, complete hopelessness 4 Anxiety, trembling of muscles, heaviness of head, aggravation from sun heat 4 Hot patient, burning of palms and soles, prefers hot application in affected parts, forgetful, forgetting names, difficulty in recollection, craving everything cold
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Name of the medicines
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S2212-9588(16)30079-9 http://dx.doi.org/doi:10.1016/j.aimed.2017.06.001 AIMED 119
To appear in: Received date: Revised date: Accepted date:
5-10-2016 9-5-2017 6-6-2017
Please cite this article as: Das KD, Patra S, Koley M, Saha S, Bengali questionnaire validation among geriatric population visiting homeopathic hospital and subsequent open observational trial evaluating effectiveness of homeopathic treatment, Adv. Integr. Med. (2017), http://dx.doi.org/10.1016/j.aimed.2017.06.001 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Article type: Original Research Paper TITLE PAGE Article title: Bengali questionnaire validation among geriatric population visiting homeopathic hospital and subsequent open observational trial evaluating effectiveness of homeopathic treatment
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Running title: Geriatric Bengali Questionnaire Validation and Homeopathy Treatment
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List of authors: Kaushik Deb Das, Sutanu Patra, Munmun Koley, Subhranil Saha
Corresponding author: Kaushik Deb Das; MD(Hom); Lecturer and Head, Dept. of Homoeopathic
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Pharmacy, Midnapore Homoeopathic Medical College and Hospital, Govt. of West Bengal, PO: Midnapore, Dist: Paschim Medinipur, Pin code 721101, West Bengal, India; Mobile: 09932298682;
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E-mail: [email protected]
1.
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Author affiliations:
Kaushik Deb Das; MD(Hom); Lecturer and Head, Dept. of Homoeopathic Pharmacy, Midnapore
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Homoeopathic Medical College and Hospital, Govt. of West Bengal, PO: Midnapore, Dist: Paschim Medinipur, Pin code 721101, West Bengal, India; E-mail: [email protected] Sutanu Patra; undergraduate BHMS student, 3rd yr; Midnapore Homoeopathic Medical College
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2.
and Hospital, Govt. of West Bengal, PO: Midnapore, Dist: Paschim Medinipur, Pin code 721101, West Bengal, India; E-mail: [email protected] Munmun Koley; BHMS, MSc; Independent Researcher, affiliated to Central Council of
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3.
Homoeopathy; Vill: Champsara, PO: Baidyabati, Hooghly, Pin code: 712222, West Bengal, India; E-mail: [email protected] 4.
Subhranil Saha; BHMS, MSc; Independent Researcher, affiliated to Central Council of Homoeopathy; 93/2/1, Shibpur Road, PO and PS: Shibpur, Howrah, Pin code 711102, West Bengal, India; E-mail: [email protected]
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ACKNOWLEDGEMENT The authors are grateful to Dr. Chapal Kanti Bhattacharjee, Principal (Acting) and Administrator, MHMC&H for allowing us to conduct the study successfully in his institution. The authors will also remain grateful to Dr. Soumitra Sain and Dr. Sanjukta Mandal, House Staffs, and Ms. (Dr.) Sumana Das, Internee, MHMC&H for their sincere contributions and to the patients for their participation in
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this study.
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AUTHOR CONTRIBUTIONS
KDD: concept, design, literature search, clinical study, data acquisition and interpretation, manuscript
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preparation. SP: clinical study and data acquisition. MK, SS: statistical analysis. All the authors
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edited, reviewed, and approved the final article.
DECLARATION OF CONFLICTING INTERESTS
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The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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FUNDING
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The authors received no funding for the project.
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Title: Bengali questionnaire validation among geriatric population visiting homeopathic hospital and subsequent open observational trial evaluating effectiveness of homeopathic treatment
ABSTRACT Aims: The authors intend to develop translated Bengali questionnaires measuring depression, stress, mindfulness and quality of life among geriatric population seeking homeopathic care and to examine
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effectiveness of homeopathic treatment subsequently in the said conditions by an open, observational trial. Methods: A mixed method bi-phasic study – a cross-sectional validation study in the first phase, followed by open, observational trial in the second phase was conducted using 4 translated questionnaires – Geriatric Depression Scale, Perceived Stress Questionnaire, Mindfulness Attention
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Awareness Scale, and Quality of Life Scale. Hamilton‟s Anxiety Scale was physician-administered;
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hence translation, further validation and testing cross-cultural adaptability was unnecessary.
Results: Total 110 geriatric patients were enrolled; 60 suffered from depression, 86 from stress, 59
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from anxiety. Exploratory principal component analysis using varimax rotation provided indications for construct validity. Questionnaires were internally consistent (Cronbach‟s α 0.745-0.926); with
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acceptable concurrent validity (Pearson‟s r 0.552-0.884). After the questionnaires were found valid by psychometric evaluation, the subsequent open observational trial for 3 months demonstrated
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individualized homeopathic treatment to be effective for the said conditions by changing the questionnaire scores significantly (P<0.00001; Cohen‟s d 0.568-1.499).
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Conclusion: The questionnaires appeared valid and reliable. Effect sizes were promising, forming basis of up-taking efficacy trials. Limited generalizability of treatment effects necessitates cautious
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interpretation. Trial registration: CTRI/2015/06/005927. KEYWORDS
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Aging, Depression, Stress, Anxiety, Quality of life
INTRODUCTION
Regardless of physician's preference, the use of Complementary and Alternative Medicine (CAM) is predominantly more popular in older adults [1-3], especially for depression, and late-life mood and cognitive disorders [4]. However, homeopathy research on geriatric population was seriously compromised until the 90‟s, and our search in different electronic databases up to then revealed only 9 old published papers [5-13]. But gradually, until December 2014, homeopathy total clinical research
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grew substantially to 1136 studies, of which, 98 (8.6%) are mental disorders/conditions. These studies have chiefly focussed on attention deficit hyperactivity disorder (ADHD) (18, 18.4%); insomnia (14, 14.3%); depression (10; 10.2%); anxiety (6; 6.1%); chronic fatigue syndrome (CFS) (5; 5.1%); behavioural disorder, autism spectrum disorder (ASD) and nervous disorder (4 each; 4.1% each); depression with anxiety, schizophrenia, and stress (3 each; 3.1% each); and others. Though
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experimenting with individualized homeopathy predominated (44; 44.9%), other forms are also
prevailing – complex (21; 21.4%), non-individualized and standardized (17; 17.3%), isopathy (3;
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3.1%), and unknown (13; 13.3%) [14]. Twelve studies have been conducted in India, of which only 3
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(25%) have been published in peer-reviewed journals. These studies have concentrated on schizophrenia, ADHD, and behavioural disorder (2 each); and opium withdrawal, ASD, insomnia,
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heroin detoxification, drug addiction, and borderline personality disorder (1 each). Seven studies were open and observational, 4 were parallel arm, and study design was unclear in one [14]. Apart from
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methodological shortcomings, the major and common problem underlying these Indian studies was the use of non-validated outcomes, thus questioning the interpretation of the study results. In a
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subgroup analysis of 83 elderly patients from a prospective, multicentre, observational, cohort study in primary care practices in Germany and Switzerland, the severity of diseases showed significant
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improvement (both physician and patient rated numeric rating scales) under homeopathic treatment, but not in SF-36 quality of life over 24 months [15]. Although a number of studies have suggested positive effects of mindfulness-based training on
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psychological wellbeing [16-18], no studies have evaluated the role of homeopathy in mindfulness, and emotional well-being in the geriatric population. In this project, we intend to develop translated Bengali versions of these available outcome measures through standardized forward-backward translation method and to validate it in a homeopathic hospital setting. This project is the initial work before conducting a prospective, double-blind, randomized, placebo-controlled study evaluating the efficacy of individualized homeopathic treatment in reducing depression, stress, and anxiety; and improving mindfulness and quality of life among the geriatric population seeking homeopathic care and to examine utility of individualized homeopathic treatment in the said conditions. Apart from
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being a psychometric validation study of the Bengali questionnaires, this study is also designed to estimate homeopathy treatment effect in observational study design at the same time, thereby evaluating the justification of up taking controlled efficacy trials in future. Thus two research questions were dealt with at the same time:
attention-awareness, and quality of life are valid and reliable?
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1. Whether the translated Bengali versions measuring geriatric depression, stress, mindfulness-
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2. Are the homeopathy treatment effects observed in the said conditions in pre-post
METHODOLOGY
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observational trial design statistically significant enough to conduct controlled trials in future?
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Ethical issues: Clearance was obtained from the institutional ethics committee (Ref. No. MHMCH/18/2015; April 22, 2015) prior to conducting the study. All participants were provided with
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patient information sheets in local vernacular Bengali and informed consents were obtained. The study matter and questions were also explained verbally to the participants for easy understanding. No
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identifiable patient information was required, ensuring anonymity and protection of patient privacy. Study registration: The study was registered with Clinical Trials Registry, India vide
1169-7929.
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CTRI/2015/06/005927; June 17, 2015. The study has a unique Universal Trial No. (UTN) of U1111-
Selected outcomes:
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1. Geriatric Depression Scale (GDS): It is used to measure depressive symptoms [19]. It has demonstrated 92% sensitivity, 89% specificity, and a good capacity for discriminating between depressed and non-depressed elderly people [20]. Scores range from 0-15; 0-4 considered as normal; 5-8 indicates mild depression; 9-11 moderate depression; and 12-15 severe depression. It is a useful screening tool in the clinical setting to facilitate assessment of depression in older adults especially when baseline measurements are compared to subsequent scores.
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2. Perceived Stress Scale (PSS): It measures the degree to which situations in one‟s life are appraised as stressful [21]. The scale includes items designed to measure how often individuals find their lives unpredictable, uncontrollable, and overloaded during the last month. Internal consistency is good (0.85), and the stability of the test-retest coefficients ranges from 0.75 to 0.86. This scale has been used among older adult populations [22] and is used in the current
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study to assess the mediating role of perceived stress in the relationship between mindfulness
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and cognitive outcome. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing
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across all scale items. Scores around 13 are considered average; scores of 20 or are considered as high stress.
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3. Hamilton’s Anxiety Scale (HAS): It is a physician-administered psychological scale used to
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rate the severity of patients‟ anxiety [23]. Though often criticized for its poor ability to discriminate between anxiolytic and antidepressant effects, and somatic anxiety versus somatic side effects, the reported levels of inter-rater reliability for the scale appear to be
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acceptable [24]. The scale consists of 14 items, each defined by a series of symptoms, and
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measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where less than 17 indicates mild
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severity, 18-24 mild to moderate severity, and 25-30 moderate to severe.
4. Mindfulness Attention Awareness Scale (MAAS): It is used as a dispositional measure of mindfulness [25]. It has been used previously to measure mindfulness in older adults and has a Cronbach‟s alpha level of 0.87 among the general adult population in the United States [26]. To score the scale, mean of the 15 items is computed. Higher scores reflect higher levels of dispositional mindfulness. 5. Quality of Life Scale (QoLS): It measures satisfaction with needs met [27]. It contains 16 items representing 6 domains of quality of life: physical and material well-being, relationships
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with other people, social and civic activities, personal development, and independence. Cronbach‟s coefficient has been documented at 0.87 for the general adult population [28]. The instrument is scored by summing the items to make a total score. Higher scores reflect better quality of life.
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6. Numeric Rating Scale (NRS): One 0-10 point scale assessing patients‟ self-reported intensity of complaints has been provided at the end of each outcome questionnaire [except
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Hamilton‟s Anxiety Questionnaire that is clinician-rated; NRS provided with HAS were
marked by the clinician himself]. This NRS is helpful in examining the concurrent validity of
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each outcome.
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The used questionnaires in this study are available from the corresponding author on request. Questionnaire translation: The process consisted of 6 steps – (1) Forward translation by two
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independent native Bengali speakers; (2) Synthesis of the two translations into one; (3) Back translation of the synthesised version into English by two English language translators; (4) Review of
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the translated versions and development of the pre-final version; (5) Face validation on 5 randomly selected geriatric patients visiting outpatients of MHMC&H; and (6) Appraisal. Thus the translated
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Bengali versions of GDS, RSS, MAAS, and QoLS questionnaire were obtained. The Hamilton‟s Anxiety Scale (HAS) was physician-administered; hence translation, validation and testing crosscultural adaptability was unnecessary. Then the questionnaires were pilot tested on 15 randomly
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selected geriatric patients. After little modification, the questionnaires were finalized.
Eligibility criteria: Inclusion criteria were the patients visiting out-patient clinics of Midnapore Homoeopathic Medical College & Hospital (MHMC&H), aged 60 years and above and both sexes; exclusion criteria were patients who were too sick for consultation, unwilling to stay after the doctor‟s visit, unable to read patient information sheets, and not giving consent to join the study, diagnosed cases of unstable mental or psychiatric illness or other systemic disease affecting QoL, currently receiving standard psychiatric therapy (conventional medication), self-reported immune-compromised state, and substance abuse.
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Methods: The adopted study design was bi-phasic and mixed method; i.e. cross-sectional validation study in first phase, followed by open, observational trial in second phase. Data gathered in the first phase (validation) of the study also served as baseline data of the second phase observational trial. In the validation/baseline phase, the questionnaire psychometric statistics were examined whether it was appropriate to be used in clinical trial. In the next phase, data was gathered again after 3 months using
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the same questionnaires and was compared with baseline for significant difference and determining
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treatment effect, if any (pre-post comparison).
We intended to achieve the maximum possible sample size within the stipulated timeframe of one
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year – May 2015 to April 2016. All the patients of geriatric age group underwent preliminary
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screening using the translated questionnaires, followed by detailed screening by the specified eligibility criteria. Seventeen patients refused to participate in the study. Effect size was measured by requesting the patients to fill in the questionnaire again 3 months after treatment. Concurrent validity
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(Pearson‟s r correlation coefficient) was tested by comparing the questionnaire scores with the NRS
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responses. The filled-in questionnaires were put inside opaque envelops and sealed at the study site. These were sent for data extraction in a specially designed Microsoft Excel spread sheet that was
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subjected to statistical analysis. Adverse or serious adverse event(s), if any, was planned to be treated accordingly as per homeopathic principles, or if non-responding, then the patient were referred for conventional treatment.
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Intervention and treatment plan: Interventions were planned as administering indicated remedies in centesimal or 50 millesimal potencies as appropriate. In centesimal scale, each dose consisted of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 88% v/v ethanol. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no.10) dissolved in 50 ml distilled water with addition of 2 drops of 88% v/v ethanol, 10 doses marked on the vial, each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid in the cup. Repetition 24, 12 or 8 hourly or even oftener, depended upon the individual requirement of the case. All medicines were procured from a Good Manufacturing Practice (GMP)8 Page 8 of 22
certified firm. Following recruitment, selection of the single individualized medicine was based on the presenting symptom totality, repertorization (RADAR® software, Archibel, Belgium) and consultation with materia medica, and individualized dose, based on the judgment of susceptibility of the patients and as per individual requirement of the cases. Subsequent prescriptions were generated according to Kent‟s observations and second prescription. Thus results of this study adhered to the criteria for
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reporting individualization in homeopathy [29].
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Statistical analysis: Statistical analysis followed the intention-to-treat (ITT) approach; i.e. every
included patient entered final analyses. The missing values were imputed by the means of the normal
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distribution fitted against specified data series and performed by the Maximum-likelihood method.
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Descriptive statistics was presented as means, standard deviations, variance, skewness and kurtosis. Exploratory factor analysis (EFA) using principal component analysis (PCA) was run to ensure that
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the questions asked relate to the construct that was intended to measure and to identify underlying variables that explain the pattern of correlations within a set of observed variables. Subsequently,
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internal consistency and concurrent validity of the used questionnaires was examined. Paired t test was run comparing values obtained at baseline and after 3 months. Effect size was calculated in terms of Cohen‟s d. To do this, correlations (Pearson‟s r) between the two means was calculated first and
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then Cohen‟s d was estimated by the Morris and DeShon's (2002) equation 8 [30]. Effect sizes were classified: as |d|>0.8, large; |d|>0.5, medium; and |d|>0.2, small [31]. The commonly accepted rule of thumb was applied to interpret Cronbach‟s alpha: α≥0.9 excellent; 0.9>α≥0.8 good; 0.8>α≥7
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acceptable; 0.7>α≥0.6 questionable; 0.6>α≥5 poor; and 0.5>α unacceptable [32]. Lastly, univariate analysis was run to test any significant influence of the suspected variables on the outcome scores. P values less than 0.05 two-tailed were considered as statistically significant. All these analyses were carried out using IBM® Statistical Package for Social Sciences (SPSS)® software, version 20.0. RESULTS Baseline sample characteristics: Total 110 responses were obtained from the geriatric sample approached; 60 (54.55%) suffered from depression, 86 (78.18%) from stress, and 59 (53.64%) from anxiety. The participants had a mean age of 66.78 years (sd 5.95; 95% CI 65.66, 67.91). The majority 9 Page 9 of 22
of the respondents were men (n=68; 61.82%; 95% CI 52.49, 70.35), belonged to the age group 61-70 years (n=84; 76.36%; 95% CI 67.62, 83.33). Most frequently reported condition was rheumatologic complaints (n=62; 56.36%; 95% CI 47.03, 65.26), including osteoarthritis, rheumatoid arthritis, low backache, cervical and lumbar spondylosis, sciatica, gout, and frozen shoulder. Mean duration of suffering from rheumatologic condition was 7.32 yrs (sd 4.74; 95% CI 6.42, 8.22). Other reported
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conditions were gastro-intestinal disorders (constipation, diarrhea, dyspepsia, gastritis, indigestion,
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etc.; 11.82%), prostatic complaints (benign hyperplasia; 10%), diabetes, hypertension and bronchial asthma (9.09% each), skin diseases (eczema, scabies; 6.36%), insomnia (4.55%), sebaceous cysts
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(2.72%), piles and respiratory tract infections (1.82%), and chronic suppurative otitis media, chronic debility, facial paralysis, and anal fistula (0.91% each). Homeopathic treatment was perceived to be
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effective to majority (n=51; 46.36%; 95% CI 37.32, 55.64) of the patients, while most of the patients
Exploratory factor analysis (EFA):
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(n=70; 63.64%; 95% CI 54.33, 72.03) expected marked improvement from it. (Table 1)
1. GDS: Though the achieved sample size of 110 was pretty less than the recommended 300 for
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carrying out psychometric validation [33], still it seemed adequate for factor analysis as the
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average communalities after extraction was 0.708, much above the preferred cut-off of 0.5. Also, the Kaiser-Meyer-Olkin (KMO) measure was 0.857 [chi-square: 1137.456, df=105], much greater than the minimum Kaiser criterion of 0.5, indicating adequacy of the sample and compactness of correlation patterns. A significant Bartlett‟s test of sphericity (P<0.0001)
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also indicated that the R-matrix was not an identity matrix. Next, the correlation matrix was scanned for values greater than 0.9 for identifying multi-co-linearity and singularity, but when cross-checked, no questionnaire item showed values greater than 0.05. Then using PCA, factors with eigenvalues more than 1 were extracted and were listed before extraction, after extraction, and after rotation. Rotation had the effect of optimizing the factor structure and equalization of relative importance of the selected factors. We expected the factors to be independent, and chose one of the orthogonal rotations – i.e. varimax. The rotated component matrix is a matrix of factor loadings for each variable onto each factor. By selecting „Sorted
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by size‟, the variables were ordered by their factor loadings. The absolute values less than a specified value of 0.1 were suppressed, ensuring that factor loadings within ±0.1 were not displayed in the output. After conducting factor rotation, the content of questions was looked for that loaded onto the same factor. Four sub-components of the main construct were identified. These are probable, and needs to be substantiated further, but beyond the scope of
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this paper.
2. PSS: The average communalities after extraction was 0.605 and the KMO measure was 0.912
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[chi-square: 726.774, df=45], indicating adequacy of the sample. A significant Bartlett‟s test
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of sphericity (P<0.0001) also indicated that the R-matrix was not an identity matrix. In the correlation matrix, there were no values greater than 0.9 and all the items showed significance
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values less than 0.05. Then using PCA, factors with eigenvalues more than 1 were extracted and were listed before extraction, after extraction, and after varimax rotation. As only one
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component was extracted, the solution could not be rotated.
3. MAAS: The average communalities after extraction was 0.649, the KMO measure was 0.843
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[chi-square: 685.459, df=105], and Bartlett‟s test of sphericity was significant (P<0.0001), thus indicating adequacy of sample. In the correlation matrix, no values greater than 0.9 were
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identified. Then using PCA, factors with eigenvalues more than 1 were extracted and were listed before extraction, after extraction, and after varimax rotation. Factor loading was done after selecting „Sorted by size‟ and after suppressing absolute values less than 0.1. After
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conducting factor rotation, the content of questions was looked for that loaded onto the same factor. Four sub-components of the main construct were identified.
4. QoLS: The average communalities after extraction was 0.657, the KMO measure was 0.847 [chi-square: 1034.970, df=120], and Bartlett‟s test of sphericity was significant (P<0.0001), thus indicating that the achieved sample size was sufficient for EFA. In the correlation matrix, no values greater than 0.9 were identified. Then using PCA, factors with eigenvalues more than 1 were extracted and were listed before extraction, after extraction, and after varimax rotation. Factor loading was done after selecting „Sorted by size‟ and after suppressing absolute values less than 0.1. After conducting factor rotation, the content of questions was 11 Page 11 of 22
looked for that loaded onto the same factor. Three sub-components of the main construct were identified. Further details of EFA and questionnaire descriptive statistics (means, standard deviations, variance, skewness and kurtosis) are available from the corresponding author on request.
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Internal consistency: The measure of internal consistency, i.e. the Cronbach‟s alpha is presented in table 2. The questionnaires showed good (MAAS α=0.813) to excellent (PSS α=0.926) internal
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consistency with agreeable inter-item and item-total statistics. Single measure intra-class correlation coefficients were 0.364 (95% CI 0.299, 0.442), 0.557 (95% CI 0.485, 0.633), 0.225 (95% CI 0.172,
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0.291), and 0.319 (95% CI 0.257, 0.393) for the GDS, PSS, MAAS, and QoLS questionnaires
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respectively (Table 2). Further details are available from the corresponding author on request. Concurrent validity: It was tested by comparing the total score of each questionnaire with that of
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NRS score. The correlation measure Pearson‟s r showed positive correlation, moderate to strong (0.552-0.884), indicating acceptable concurrent validity. (Table 3)
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Changes in outcomes: After 3 months of homeopathic treatment, the GDS, PSS, and HAS scores reduced significantly (P<0.00001) with moderate to large effect size (Cohen‟s d 0.712-1.499).
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Increase in MAAS and QoLS scores, showing large and moderate effect sizes of 1.002 and 0.568 respectively, were also statistically significant (P<0.00001). Simultaneously, the NRS scores also confirmed significant change (P<0.05) over time with moderate to large effect sizes (0.300-0.988).
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(Table 4)
Influence of suspected variables on outcome scores: GDS score appeared to be significantly high (P<0.05) in females, semi-urban patients, unmarried patients, and economically dependent patients. Also, assumed effectiveness of homeopathic treatment was considered to the patients showing higher GDS and PSS scores (P<0.05); still they had expectations of marked improvement from treatment. Higher HAS scores were found in females and semi-urban patients; and they had significantly high (P<0.05) expectations of marked improvement. Higher MAAS scores were noted in urban patients, those who are married, having education of 10th standard or less, and having high expectation of cure 12 Page 12 of 22
(P<0.05). Higher QoLS scores were (P<0.05) found in urban and married patients, and those who were economically dependent. (Table 5) Medicines used: Total 38 different medicines were used in varied centesimal and 50 millesimal scale potencies. The most frequently used medicines are listed with their indications in Table 6.
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DISCUSSION
In this study, we first aimed at examining psychometric properties of the translated Bengali
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questionnaires measuring depression, anxiety, stress, mindfulness-attention-awareness, and quality of
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life in the geriatric population seeking homeopathic care in West Bengal, India. When this validity statistics appeared satisfactory, then we examined homeopathy treatment effects in pre-post
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observational trial design. The estimated effect sizes were quite promising, ranging from moderate to large, over a treatment period of 3 months with statistically significant changes in the questionnaire
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scores. Thus this project served as the initial work before up taking controlled efficacy trials of individualized homeopathic treatment in comparison with placebo. Univariate analyses detected some
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potential variables having significant influence on the outcomes. Assessments of intensity of depression, stress and anxiety consistently showed substantial reductions
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and mindfulness-attention and quality of life revealing significant increase that may be partly attributable to regression to the mean effects, that our study was not designed to control. We also cannot rule out overestimation of the treatment effect and undisclosed use of concurrent therapeutic
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modalities, if any. We used „classical‟ (individualized) form of homeopathic treatment. In contrast to randomized controlled trials, our study describes patients from everyday practice with multiple morbidities and a large variety of life styles. This ensures a high degree of external validity that allows extrapolation to usual medical care. We used numeric rating scales that are validated and often used. NRS scales were used to examine the concurrent validity of the questionnaires measuring the same construct. However, no other valid instrument, except for NRS, was used for cross-validation, and it has been a limitation. As the data gathered from the sample in the validation phase also served as the baseline data for estimating treatment effect, the authors opted for reporting the results of the
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two phases in a single paper. This might be considered sub-optimal, but probably quite rationalistic from feasibility point of view, i.e. in a hospital exclusively providing a single complementary and alternative healthcare namely homeopathy and suffering from various infrastructural constraints [34]. However, our findings are considerably similar to the instruments in other languages, i.e. factor structures, validity, and reliability. Further specific factor analyses are warranted using Rasch rating
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models or different stoichiometric models to confirm the uni-dimensionality of the scales.
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Confirmatory factor analysis (CFA) and structural equation modelling (SEM) may be run to confirm correlations and infer causal relationships among factors.
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Research into the homeopathic consultation has identified several contextual factors such as empathy,
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empowerment, hopefulness, enablement and narrative competence, which are not the active components of the treatment but are inherent within the whole package of care. Homeopathy
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consultations involve a complete exploration of the patient‟s emotional, spiritual, and physical wellbeing to enable treatment of the whole person, not just the illness. Thus, highly individualized
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homeopathy consultations and „case taking‟ necessitate a very detailed understanding of the patient in a unique and personalized approach in order to identify a homeopathic remedy. Such consultations
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elicited the sufferings of the mental sphere of the patients enrolled and reflected the state of depression, stress, and anxiety present in them. At the same time, there were a few other patients who declared themselves free from such kinds of mental states and expected their physical sufferings only to be cured. Some of the common causes behind such mental states in the elderly patients as disclosed
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from their end were events of death of spouse, sudden demise of grown up son or daughter, broken families, acts of irresponsibility on the part of son, son-in-law, daughter or daughter-in-law, humiliation from near relatives etc. Anxiety over career, marriage of grown up son or daughter and too deep anxious thoughts of the future were few other concerns elicited in some of the patients. During the course of treatment, alongside homeopathic medication, all the subjects were infused with positive mental thoughts in their first visit and subsequent follow ups. After the three month period, it was observed that the chief one or two physical ailments from which the patient had been suffering had reduced from moderate to remarkable degree. Among the subjects, a few patients reported of 14 Page 14 of 22
reduction in both mental and physical sufferings to some extent. However in some instances, it was found that the mental suffering which was improving with passage of time with homeopathic medication as reported by the patients suddenly aggravated at some points of time in the three month period. Events of any untoward incidents, misfortune or a quarrel in the family might have affected the score in such cases. The authors also observed that the patients suffering from depression, stress,
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or anxiety of comparatively shorter duration reported improvement earlier than the patients suffering
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from the similar mental complaints of longer duration. So, it can be assumed that the latter group
might have required a little more time for reduction of their mental symptoms, which although was
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not the aim of the study. To study whether and to what extent the homoeopathic medicines are useful in reducing depression, stress etc. of longer duration in geriatric population, a similar study of longer
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observation period can be designed in future.
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In spite of some inherent problems of observational trial designs and cross-sectional validation studies, our study puts the first light on homeopathic treatment of geriatric population in West Bengal,
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India. As already stated, the major hindrance of conducting well-planned research in the said population is the absence of validated translated versions of different outcome measure questionnaires
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in Bengali language. Naturally, our first intention was to develop such psychometrically valid tools; thus enabling conduct of meaningful efficacy research in near future satisfying the internal validity issues related to observational research. Our study also detected moderate to large effect sizes, but may be subject to some serious and unresolved biases, like inadequate sample size and in-built
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psychological effects of homeopathic consultation processes. These issues are to be addressed in welldesigned placebo-controlled RCTs in near future. Thus the study offers some promising tools, but the treatment effects obtained demand cautious interpretation. The main strength of this type of observational studies is their greater proximity to “real life situations” by capturing large amount of uneven data, since RCTs have stricter inclusion criteria and rigid protocols that may not reflect clinical practice. Other advantages include cheaper cost than RCTs, ease to perform, and help in creating new hypotheses. CONCLUSION 15 Page 15 of 22
The cross-sectional validation study generated valid translated Bengali versions of questionnaires measuring depression, anxiety, stress, mindfulness-attention-awareness, and quality of life in the geriatric population seeking homeopathic care in West Bengal, India. Subsequently, the observational trial detected moderate to large treatment effect sizes with statistically significant changes. This project sufficiently justifies conduct of placebo-controlled efficacy trials of individualized
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homeopathic treatment to evaluate how far the treatment effects are different from placebo effect and
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Age (yrs.)¥ Age groups (yrs.): 61-70 71 and above Gender: Male Female Residence: Urban Semi-urban Rural Marital status: Married Unmarried and others Education: 10th std. or less 12th std. Graduate or above Employment status: Service Business Dependent Others Income status: Poor Middle class Affluent BMI¥ BMI groups: <18.5 (underweight) 18.5-24.9 (normal) 25.0 and above (overweight, obese) Blood pressure: SBP¥
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Table 1: Baseline socio-demographics (N=110) Features N (%) 66.78 ± 5.95
95% CI 65.66, 67.91
84 (76.36) 26 (23.64)
67.62, 83.33 16.67, 32.38
68 (61.82) 42 (38.18)
52.49, 70.35 29.65, 47.51
33 (30) 39 (35.45) 38 (34.55)
22.23, 39.12 27.14, 44.74 26.32, 43.82
102 (92.73) 8 (7.27)
86.31, 96.27 3.73, 13.69
87 (79.09) 12 (10.91) 11 (10)
70.57, 85.64 6.35, 18.11 5.68, 17.02
3 (2.73) 16 (14.55) 65 (59.09) 26 (23.64)
0.93, 7.72 9.16, 22.33 49.75, 67.82 16.67, 32.38
54 (49.09) 47 (42.73) 9 (8.18) 22.90 ± 3.14
39.94, 58.3 33.88, 52.07 4.36, 14.82 22.31, 23.49
7 (6.36) 79 (71.82) 24 (21.82)
3.11, 12.55 62.79, 79.38 15.12, 30.42
139.44 ± 17.60
136.11, 142.76
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79.95, 83.14
62 (56.36) 13 (11.82) 11 (10) 10 (9.09) 10 (9.09) 10 (9.09)
47.03, 65.26 7.04, 19.18 5.68, 17.02 5.01, 15.93 5.01, 15.93 5.01, 15.93
7.32 ± 4.74 7.46 ± 6.92 6.64 ± 5.66 8.77 ± 7.2 6 ± 4.20 6 ± 3.16
6.42, 8.22 6.15, 8.77 5.57, 7.71 7.41, 10.13 2.99, 9.00 3.74, 8.26
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10 (9.09) 51 (46.36) 16 (14.55) 2 (1.82)
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81.55 ± 8.45
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DBP¥ Conditions suffering from§: Rheumatic complaints Gastro-intestinal disorders Prostatic complaints Diabetes Hypertension Bronchial asthma Duration of illness (yrs.): Rheumatic complaints Gastro-intestinal disorders Prostatic complaints Diabetes Hypertension Bronchial asthma Assumed effectiveness of homeopathy (n=79): Very effective Effective Less effective Ineffective Expectations: Cure Marked improvement
27.97, 45.67 54.33, 72.03
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40 (36.36) 70 (63.64)
5.01, 15.93 37.32, 55.64 9.16, 22.33 0.5, 6.39
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Abbreviations: BMI = Body Mass Index; SBP = Systolic blood pressure; DBP = Diastolic blood pressure; CI = Confidence Interval; ¥Continuous data presented as mean ± sd and other categorical data as N (%); §Total 15 varieties of clinical conditions were reported overall; here we tabulated only those conditions (with duration of suffering) reporting minimum absolute frequency of n=10. For the rest of the conditions, please see text.
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Table 2: Internal consistency of the outcome measures (N=110) Outcomes Cronbach‟s alpha 95% CI Acceptability GDS 0.896 0.865, 0.922 Good PSS 0.926 0.904, 0.945 Excellent MAAS 0.813 0.757, 0.860 Good QoLS 0.882 0.847, 0.912 Good
Abbreviations: GDS = Geriatric Depression Scale; PSS = Perceived Stress Scale; MAAS = Mindfulness Attention Awareness Scale; QoLS = Quality of Life Scale; NRS = Numeric Rating Scale; CI = Confidence Interval
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Table 3: Concurrent validity of the outcomes (N=110) Questionnaire scores NRS scores Significance Outcomes Pearson‟s r Correlation (mean ± sd) (mean ± sd) (2-tailed) GDS 6.2 ± 4.5 4.0 ± 3.0 0.854 Strongly positive <0.0001* PSS 19.8 ± 6.6 4.0 ± 2.9 0.884 Strongly positive <0.0001* MAAS 67.2 ± 6.4 5.6 ± 2.1 0.552 Moderately positive <0.0001* QoLS 72.5 ± 9.4 6.1 ± 1.5 0.832 Strongly positive <0.0001* Abbreviations: GDS = Geriatric Depression Scale; PSS = Perceived Stress Scale; MAAS = Mindfulness Attention Awareness Scale; QoLS = Quality of Life Scale; NRS = Numeric Rating Scale; *P<0.05 two-tailed considered as statistically significant
Outcomes GDS GDS-NRS
Baseline; mean (sd) 9.73 (2.85) 6.17 (1.81)
Table 4: Changes in outcomes after 3 months After 3 months; Change; Cohen‟s d mean (sd) mean (95% CI) 7.85 (3.21) -1.88 (-2.56, -1.19) 0.712 4.77 (1.72) -1.40 (-1.77, -1.02) 0.970
t score¥
P value
-5.428 -7.424
P<0.00001* P<0.00001*
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PSS 22.39 (4.60) 19.36 (4.77) -3.03 (-3.89, -2.16) 0.751 -6.912 P<0.00001* PSS-NRS 5.13 (2.20) 3.92 (2.02) -1.212 (-1.55, -0.87) 0.767 -7.042 P<0.00001* HAS 23.62 (4.08) 15.99 (5.58) -7.63 (-8.99, -6.26) 1.499 -11.080 P<0.00001* HAS-NRS 5.86 (1.63) 4.02 (1.83) -1.84 (-2.33, -1.36) 0.988 -7.514 P<0.00001* MAAS 4.48 (0.43) 4.61 (0.34) 0.13 (0.07, 0.18) 1.002 4.723 P<0.00001* MAAS-NRS 5.65 (2.05) 6.01 (1.67) 0.37 (0.13, 0.60) 0.300 3.048 P=0.003* QoLS 72.51 (9.41) 75.64 (7.83) 3.13 (2.05, 4.21) 0.568 5.727 P<0.00001* QoLS-NRS 6.09 (1.54) 6.41 (1.22) 0.32 (0.13, 0.50) 0.342 3.398 P=0.001* Abbreviations: GDS = Geriatric Depression Scale; PSS = Perceived Stress Scale; HAS = Hamilton Anxiety Scale; MAAS = Mindfulness Attention Awareness Scale; QoLS = Quality of Life Scale; NRS = Numeric Rating Scale; CI = Confidence Interval; sd = standard deviations; ¥Paired t test; *P<0.05 two-tailed considered statistically significant
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Table 5: Influence of baseline variables on the outcomes (N=110) P value
PSS score
P value
HAS score
P value
MAAS score
P value
QoLS score
P value
6.07 (4.54) 6.49 (4.47)
0.689
19.57 (6.68) 20.49 (6.31)
0.270
18.11 (7.11) 19.04 (5.54)
0.544
4.50 (0.43) 4.43 (0.42)
0.482
72.63 (9.44) 72.13 (9.27)
0.814
5.14 (4.42) 7.83 (4.20)
0.001*
18.83 (6.92) 21.35 (5.74)
0.053
17.03 (6.40) 20.42 (6.86)
0.010*
4.54 (0.44) 4.39 (0.39)
0.061
72.55 (9.28) 72.44 (9.61)
0.950
4.56 (3.37) 7.72 (4.55) 5.98 (4.85)
0.01*
18.59 (5.59) 21.14 (7.38) 19.47 (6.34)
0.242
15.64 (5.46) 20.21 (6.51) 18.73 (7.33)
0.013*
4.64 (0.30) 4.35 (0.43) 4.47 (0.47)
0.013*
77.48 (7.02) 68.41 (10.73) 72.41 (7.52)
<0.001*
5.85 (4.41) 10.25 (4.02)
0.004*
19.46 (6.37) 23.93 (8.07)
0.067
17.99 (6.81) 22.63 (4.53)
0.063
4.52 (0.41) 4.04 (0.36)
0.002*
73.36 (8.69) 61.72 (11.32)
0.001*
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GDS score
6.03 (4.51) 6.75 (4.34) 6.65 (4.74)
0.817
19.31 (6.48) 21.65 (7.24) 21.53 (6.19)
0.333
18.49 (6.80) 17.75 (6.66) 17.64 (6.68)
0.882
4.52 (0.37) 4.20 (0.65) 4.49 (0.39)
0.341
72.83 (8.22) 69.83 (13.34) 72.91 (12.15)
0.573
4 (3.56) 5.85 (5.07) 7.09 (4.44) 4.31 (3.74)
0.043*
21.32 (4.92) 18.77 (7.92) 20.63 (6.75) 18.13 (4.90)
0.350
16 (4.97) 16.75 (7.22) 19.71 (6.89) 16.12 (5.40)
0.076
4.65 (0.32) 4.26 (0.62) 4.45 (0.40) 4.68 (0.23)
0.010*
70.93 (5.72) 68.61 (13.13) 71.89 (8.87) 76.66 (6.32)
0.036*
7.04 (4.64) 5.10 (4.09) 6.56 (4.86)
0.091
20.41 (6.49) 18.97 (6.37) 20.32 (7.96)
0.531
19.40 (7.00) 17.34 (6.28) 17 (6.96)
0.256
4.50 (0.38) 4.50 (0.36) 4.24 (0.80)
0.205
71.13 (7.88) 73.87 (9.09) 73.72 (15.93)
0.308
6.71 (4.77) 6.07 (4.57) 6.33 (4.29)
0.919
22.01 (5.13) 19.41 (6.93) 20.41 (5.67)
0.532
19.43 (7.96) 18.05 (6.72) 18.92 (6.55)
0.778
4.56 (0.41) 4.50 (0.37) 4.41 (0.58)
0.612
73.53 (5.94) 72.21 (8.88) 73.19 (11.60)
0.866
5.94 (4.21) 6.25 (4.44) 6.15 (3.95) 7.8 (5.19) 6.25 (4.02) 5.75 (4.82)
0.890
18.91 (6.35) 18 (0) 19.62 (4.75) 23.59 (6.67) 21.27 (7.41) 18.24 (6.64)
0.212
17.67 (6.30) 17.33 (3.73) 19.91 (5.07) 21.9 (6.99) 19.33 (7.78) 18.75 (7.68)
0.406
4.48 (0.40) 4.56 (0.39) 4.57 (0.45) 4.34 (0.51) 4.41 (0.42) 4.68 (0.23)
0.528
73.23 (7.51) 75.05 (6.62) 72.99 (6.01) 67.57 (10.99) 72.55 (13.01) 76.19 (6.86)
0.293
7.41 (4.37) 4.71 (4.19) 8.56 (4.75)
0.004*
23.50 (6.98) 18.16 (6.78) 21.81 (5.66)
0.022*
17.7 (7.52) 17.09 (6.44) 19.28 (6.53)
0.484
4.31 (0.52) 4.52 (0.45) 4.39 (0.37)
0.298
69.28 (15.92) 74.53 (9.4) 70.01 (7.84)
0.137
4.63 (4.10) 7.05 (4.53)
0.003*
17.73 (6.58) 20.97 (6.33)
0.013*
16.4 (7.08) 19.43 (6.35)
0.024*
4.6 (0.36) 4.41 (0.45)
0.028*
74.28 (8.61) 71.50 (9.69)
0.138
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Variables Age groups (yrs):§ 61-70 71 and above Gender:§ Male Female Residence:¥ Urban Semi-urban Rural Marital status:§ Married Unmarried, others Education:¥ 10th std. or less 12th std. Graduate or above Employment status:¥ Service Business Dependent Others Income status:¥ Poor Middle class Affluent BMI groups:¥ <18.5 18.5-24.9 25.0 and above Conditions suffering from: ¥ Rheumatologic Gastro-intestinal Prostatic Diabetes Hypertension Bronchial asthma Assumed effectiveness of homeopathy (n=79):¥ Very effective Effective Less effective or ineffective Expectations:§ Cure Marked improvement §
Independent t test; ¥One way ANOVA; Outcome scores presented as mean (standard deviations); *P<0.05 twotailed considered as statistically significant
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3. Causticum 4. Natrum muriaticum
5. Sulphur 6. Thuja occidentalis
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7. Aurum metallicum 8. Gelsemium sempervirens 9. Medorrhinum
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2. Arsenicum album
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1. Ignatia amara
Table 6: Most frequently used medicines with indications No. of Indications prescriptions 10 Suppressed grief, sensation of heaviness in chest, defensive, deep sighing, bursting into tears, sense of lump in the throat 8 Fastidious, sense of insecurity, worried about health, general aggravation at midnight 7 Old event of grief, mentally sympathetic to others suffering, strong sense of justice 7 Reserved outside, angry when consoled, tiredness and aggravation from exposure to sun heat, sense of responsibility, hides strong inner feelings 6 Hot patient, feels too hungry at 11-12 noon, prefers sweet and meat, aversion to milk, burning of palms and soles 6 Talks slowly, general worsening in rainy season, prefers salt, intolerance tea and onion 4 Suicidal thoughts, complete hopelessness 4 Anxiety, trembling of muscles, heaviness of head, aggravation from sun heat 4 Hot patient, burning of palms and soles, prefers hot application in affected parts, forgetful, forgetting names, difficulty in recollection, craving everything cold
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Name of the medicines
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