Abstract
The authors aimed to document prescriptions and clinical outcomes in routine homeopathic practice to short list promising areas of targeted research and efficacy trials of homeopathy in obstetrics and gynecology (O&G).
Three homeopathic physicians participated in methodical data collection over a 3-month period in the O&G outpatient setting of The Calcutta Homeopathic Medical College and Hospital, West Bengal, India. A specifically designed Excel spreadsheet was used to record data on consecutive appointments, including date, patient identity, socioeconomic status, place of abode, religion, medical condition/complaint, whether chronic/acute, new/follow-up case, patient-assessed outcome (7-point Likert scale: −3 to +3), prescribed homeopathic medication, and whether other medication/s was being taken for the condition. These spreadsheets were submitted monthly for data synthesis and analysis.
Data on 878 appointments (429 patients) were collected, of which 61% were positive, 20.8% negative, and 18.2% showed no change. Chronic conditions (93.2%) were chiefly encountered. A total of 434 medical conditions and 52 varieties were reported overall. The most frequently treated conditions were leucorrhea (20.5%), irregular menses (13.3%), dysmenorrhea (10%), menorrhagia (7.5%), and hypomenorrhea (6.3%). Strongly positive outcomes (+3/+2) were mostly recorded in oligomenorrhea (41.7%), leucorrhea (34.1%), polycystic ovary (33.3%), dysmenorrhea (28%), and irregular menses (22.2%). Individualized prescriptions predominated (95.6%). A total of 122 different medicines were prescribed in decimal (2.9%), centesimal (87.9%), and 50 millesimal potencies (4.9%). Mother tinctures and placebo were prescribed in 3.4% and 30.4% instances, respectively. Several instances of medicine-condition pairings were detected.
This systematic recording cataloged the frequency and success rate of treating O&G conditions using homeopathy.
Keywords: homeopathy, India, obstetrics and gynecology, patient-reported outcomes, systematic data collection
1. Introduction
Until 2014, clinical research in homeopathy has grown to a considerable extent of 1113 studies, of which, 86 were diseases/conditions related to obstetrics and gynecology (O&G).1 These O&G studies have chiefly focused on childbirth and/or dystocia (23.2%), menopause (20.9%), infertility and premenstrual syndrome (13.9% each), vaginal candidiasis/infection/discharge (4.7%), dysmenorrhea and mastopathy/mastodynia (3.5% each), uterine fibroid (2.3%), and other miscellaneous cases (13.9%, including lactation disorder, posthysterectomy, postpartum hemorrhage, ovarian cyst, pregnancy-related complaints, breast fibroadenoma, menorrhagia, etc.). A total of 40.7% of the studies were double-blind, randomized, controlled trials, 11.6% were open observational studies, and the remaining 47.7% were case series and case reports. Although experimenting with individualized homeopathy predominated (32.5%), other forms were also prevailing—complex (23.2%), nonindividualized and standardized (25.6%), and unknown (18.6%).
To perform targeted research in homeopathy, the necessity for documentation of prescriptions and clinical outcomes in routine practice and critical inspection with systematic analysis of relevant data has been highlighted.2 These documentation studies were initiated in multipractitioner homeopathic settings,2 including dentistry,3, 4 in the last decade. Earlier, similar projects were also successfully accomplished in a homeopathic hospital setting in West Bengal, India, short listing probable future research.5, 6 For the purpose of carrying out efficacy trials of homeopathy in the field of O&G, the homeopathic doctors attending the O&G outpatient department of The Calcutta Homeopathic Medical College and Hospital were engaged to accumulate outcome data over a 3-month period. The objectives of such an initiative were to recognize the complaints that homeopathic doctors treat in the O&G outpatient setting, to determine patient-assessed change in the severity of the treated condition/complaint, and thus to identify promising areas of future research in homeopathy.
2. Materials and methods
This prospective and observational study was of 3-months' duration (June to August, 2014). Three homeopathic doctors willing to contribute to the study were provided with a specially designed spreadsheet (Microsoft Excel).2 The doctors had >10 years of practice experience in outpatient settings. Detailed instructions on how to use the spreadsheet format and how to ask patients questions about their clinical outcome were provided on separate pages of the file. The spreadsheet allowed for the recording of consecutive appointments, row by row, under the following column headings: appointment date (day, month), unique (anonymized) patient identity number, age and sex of the patient, religion, occupation, socioeconomic status, living environment, the condition/complaint treated, whether the condition/complaint is “chronic” or “acute” in relation to the previous 12 months, whether that was a new or a follow-up (FU) appointment for the same complaint, patient-assessed change in the treated complaint at the current FU compared with the initial homeopathic consultation, using a 7-point Likert scale (no change or unsure: 0; mild: ±1; moderate: ±2; major: ±3), homeopathic medicine/s prescribed, any other medication/s (conventional) being taken for the condition/complaint, and comments, if any.
The participating doctors submitted data reliably. Upon receipt of the final spreadsheets for each month for 3 consecutive months, the original data were rechecked and scrutinized for obvious missing data and typographical errors. These errors were flagged, and rectified where possible. A new master copy of the complete appointments page was then created, into which new columns were added to indicate: (1) the appointment number per patient per condition/symptom; and (2) whether or not an appointment was the final one for a given condition/symptom in a given patient during the 3-month study period. These procedures enabled analysis based on final appointments, that is, on the number of individual patient conditions treated, irrespective of whether they were treated by the doctor once, twice, or more often. The term individual patient condition was used because a given patient could present with different conditions on a different, or even the same occasion.
The following principal analyses were carried out: (1) final outcome score by acute/chronic conditions; (2) final outcome score by medical conditions/complaints; and (3) enlisting the most frequently used homeopathic medicines.
3. Results
The mean age of the patients was 30.7 years (standard deviation 12.7). Most patients were in the 18–30 (n = 186; 43.4%) years and 31–45 (n = 125; 29.1%) years age group range. The religion distribution ratio (Hindu:Islam) was 5:4. The patients were chiefly homemakers (n = 194; 45.2%) and students (n = 106; 24.7%); mostly (n = 210; 49%) from middle-income group families; and resided in an airy/ventilated environment (n = 275; 64.1%; Table 1).
Table 1.
Sociodemographic profile of the patients (n = 429).
| Characteristics | n (%) |
|---|---|
| Age groups (y) | |
| <18 | 63 (14.7) |
| 18–30 | 186 (43.4) |
| 31–45 | 125 (29.1) |
| 46–60 | 45 (10.5) |
| 61–75 | 10 (2.3) |
| Religion | |
| Hindu | 237 (55.2) |
| Islam | 192 (44.8) |
| Occupation | |
| Homemaker | 194 (45.2) |
| Student | 106 (24.7) |
| Service | 47 (11.0) |
| Labor | 19 (4.4) |
| Teacher | 19 (4.4) |
| Tailor | 17 (4.0) |
| Business | 15 (3.5) |
| Others | 12 (2.8) |
| Socioeconomic status | |
| Poor | 85 (19.8) |
| Middle class | 210 (49.0) |
| Affluent | 134 (31.2) |
| Living environment | |
| Airy | 275 (64.1) |
| Damp | 77 (17.9) |
| Slum | 77 (17.9) |
A total of 434 medical conditions and 52 varieties were reported overall. The most frequently treated conditions were leucorrhea (n = 88; 20.5%), irregular menses (n = 57; 13.3%), dysmenorrhea (n = 43; 10%), menorrhagia (n = 32; 7.5%), hypomenorrhea (n = 27; 6.3%), menopausal syndrome (n = 23; 5.4%), and genital prolapsed and pruritus vulvae (n = 20; 4.7% each; Table 2).
Table 2.
Most frequently treated medical conditions/complaints.
| Rank | Condition/complaint | Total no. (%) of cases |
|---|---|---|
| 1 | Leucorrhea | 88 (20.5) |
| 2 | Irregular menses | 57 (13.3) |
| 3 | Dysmenorrhea | 43 (10.0) |
| 4 | Menorrhagia | 32 (7.5) |
| 5 | Hypomenorrhea | 27 (6.3) |
| 6 | Menopausal syndrome | 23 (5.4) |
| 7 | Genital prolapse | 20 (4.7) |
| 8 | Pruritus vulvae | 20 (4.7) |
| 9 | Low back pain | 18 (4.2) |
| 10 | Breast fibroadenoma | 17 (3.9) |
| 11 | Secondary amenorrhea | 17 (3.9) |
| 12 | Uterine fibroid | 13 (3.0) |
| 13 | Urinary tract infection | 9 (2.1) |
| 14 | Polycystic ovary | 8 (1.9) |
| 15 | Delayed menarche | 7 (1.6) |
| 16 | Metrorrhagia | 7 (1.6) |
| 17 | Oligomenorrhea | 7 (1.6) |
| 18 | Abdominal pain | 6 (1.4) |
| 19 | Genital boils/eruptions | 5 (1.2) |
| 20 | Urinary incontinence | 5 (1.2) |
| 21 | Breast fibroadenosis | 4 (0.9) |
| 22 | Delayed menses | 4 (0.9) |
| 23 | Infertility | 4 (0.9) |
| 24 | Dysfunctional uterine bleeding | 3 (0.7) |
| 25 | Dyspareunia | 3 (0.7) |
| 26 | Primary amenorrhea | 3 (0.7) |
A total of 434 conditions and 52 varieties were reported overall; the tabulation pick-lists only those 26 comprising at least three cases in each.
Acute conditions were deficient in number (n = 44; 6.8%). While treating chronic cases, strongly positive outcomes (+3/+2) were recorded in 148 (23%), strongly negative (−2/−3) in 32 (5%), and mild/no changes (±1/0) in 420 (65.2%) encounters (Table 3).
Table 3.
Outcome scores by percentage of 644 follow ups of acute and chronic cases.
| Outcomes | Percentage of follow-up patients |
||
|---|---|---|---|
| Acute | Chronic | Overall | |
| −3 | 0.2 | 0.2 | 0.3 |
| −2 | 2.3 | 4.8 | 7.1 |
| −1 | 2.0 | 11.3 | 13.4 |
| 0 | 0.6 | 17.5 | 18.2 |
| +1 | 0.9 | 36.3 | 37.3 |
| +2 | 0.8 | 21.1 | 21.9 |
| +3 | 0.0 | 1.9 | 1.9 |
Data on 878 appointments (429 patients) were generated, of which 393 (61%) were positive, 134 (20.8%) were negative, and 117 (18.2%) showed no change. Strongly positive changes (+2/+3) were noted in 143 (22.2%) FUs, strongly negative outcomes (−2/−3) in 48 (7.5%) encounters, and mild changes (±1) or no changes (0) in 443 (68.8%) appointments. Among the medical conditions, strongly positive outcomes (+2/+3) were mostly recorded in oligomenorrhea (41.7%), leucorrhea (34.1%), polycystic ovary (33.3%), dysmenorrhea (28%), and irregular menses (22.2%; Table 4).
Table 4.
Summary of outcome scores of follow-up patients by medical conditions/complaints.
| Rank | Conditions/complaints | No. final follow ups | % +2/+3 | % ±1/0 | % −2/−3 |
|---|---|---|---|---|---|
| 1 | Leucorrhea | 41 | 34.1 | 61.0 | 4.9 |
| 2 | Irregular menses | 36 | 22.2 | 66.7 | 11.1 |
| 3 | Dysmenorrhea | 25 | 28.0 | 64.0 | 8.0 |
| 4 | Breast fibroadenoma | 12 | 8.3 | 91.7 | 0.0 |
| 5 | Genital prolapse | 12 | 16.7 | 75.0 | 8.3 |
| 6 | Oligomenorrhea | 12 | 41.7 | 58.3 | 0.0 |
| 7 | Low back pain | 10 | 10.0 | 90.0 | 0.0 |
| 8 | Menopausal syndrome | 10 | 20.0 | 80.0 | 0.0 |
| 9 | Menorrhagia | 9 | 11.1 | 77.8 | 11.1 |
| 10 | Pruritus vulvae | 9 | 11.1 | 55.6 | 33.3 |
| 11 | Polycystic ovary | 6 | 33.3 | 66.7 | 0.0 |
| 12 | Uterine fibroid | 6 | 16.7 | 66.7 | 16.7 |
| 13 | Metrorrhagia | 6 | 0.0 | 83.3 | 16.7 |
| 14 | Breast fibroadenosis | 4 | 0.0 | 75.0 | 25.0 |
| 15 | Hypomenorrhea | 3 | 0.0 | 66.7 | 33.3 |
| 16 | Secondary amenorrhea | 3 | 33.3 | 66.7 | 0.0 |
The tabulation pick-lists only those 16 most frequently treated medical conditions/complaints comprising at least three cases in each.
The presence of other (conventional) medication/s taken for the condition/complaint (including “none”) was reported in just 37 appointments (4.2%). The participating physicians used the column “comments, if any” for additional notes sparingly—only on 30 occasions (3.4%) for advice (regarding management and investigations), important treatment histories, and referrals to specialty and higher centers.
Medicines were prescribed in 611 (69.6%) encounters and placebo in 267 (30.4%). Individualized approach predominated in the prescriptions (95.6%), but polypharmacy was found on five (0.8%) occasions to encounter the following conditions: (1) leucorrhea and pruritus vulvae in a patient with cervical dysplasia and filariasis; (2) sudden respiratory distress arising in a diabetic and perimenopausal patient; (3) low back pain; (4) sudden mucoid stool and colic in a patient with irregular menses; and (5) acute exacerbation of pruritus vulvae in a diabetic patient. Local application was advised in a single case—Calendula officinalis mother tincture for local dressing. Mother tinctures were used in 21 (3.4%) instances—two acute conditions, six acute exacerbation of chronic conditions, and 13 chronic conditions. Potentized medicines were used in all the three available scales, namely, decimal (n = 18; 2.9%), centesimal (n = 537; 87.9%), and 50 millesimal (n = 30; 4.9%) scales. A total of 122 different medicines were prescribed. The most frequently used five medicines were Pulsatilla (8.0%), natrum muriaticum (6.2%), medorrhinum (4.9%), Sepia succus (4.9%), and sulfur (4.7%; Table 5).
Table 5.
Most frequently used medicines.
| Rank | Medicines | Total no. (%) of prescriptions |
|---|---|---|
| 1 | Pulsatilla nigricans | 49 (8.0) |
| 2 | Natrum muriaticum | 38 (6.2) |
| 3 | Medorrhinum | 30 (4.9) |
| 4 | Sepia succus | 30 (4.9) |
| 5 | Sulfur | 29 (4.7) |
| 6 | Calcarea phosphorica | 23 (3.8) |
| 7 | Thuja occidentalis | 21 (3.4) |
| 8 | Rhus toxicodendron | 20 (3.3) |
| 9 | Nux vomica | 18 (2.9) |
| 10 | Calcarea fluorica | 16 (2.6) |
| 11 | Causticum | 13 (2.1) |
| 12 | Calcarea carbonica | 12 (2.0) |
| 13 | Carbo vegetabilis | 12 (2.0) |
| 14 | Magnesia phosphorica | 11 (1.8) |
| 15 | Natrum sulphuricum | 11 (1.8) |
| 16 | Bryonia alba | 10 (1.6) |
A total of 122 different medicines were prescribed; the tabulation pick-lists only those 16 most frequently used in at least 10 instances each.
Several instances of matching between a specific medical condition and a particular homeopathic medicine were found. Some of the following medicine–condition pairings were most noticeable: Pulsatilla nigricans (11.4%), natrum muriaticum (9.1%), and calcarea phosphorica and sulfur (5.7% each) for leucorrhea; P. nigricans (15.8%), natrum muriaticum (8.8%), and medorrhinum (7.0%) for irregular menses; P. nigricans (11.6%), calcarea phosphorica (9.3%), and magnesia phosphorica (7.0%) for dysmenorrhea; carbo vegetabilis, Thlaspi bursa pastoris, and Trillium pendulum (9.4% each) for menorrhagia; natrum muriaticum (11.1%) for hypomenorrhea; medorrhinum (21.7%) for menopausal syndrome; S. succus (25%) for genital prolapse; sulfur (25%) for pruritus vulvae, etc.
4. Discussion
This methodical and meaningful documentation of clinical outcomes of homeopathic appointments in the O&G outpatient setting identified promising areas of future clinical research in the relevant field. In spite of its inherent limitations, such as recall bias, selection bias, interaction bias, empathy bias, central tendency bias, and acquiescence bias arising from the use of Likert-scale responses, etc., and according to protocol analysis, this study laid the groundwork for conducting targeted research. On account of the absence of controls, these observations cannot offer evidence of an effect that can be causally attributed to the homeopathic intervention; however, the study can be considered a valuable evidence-seeking activity by pointing out probable associations between treatment and outcome.7 Pick-listing the most frequently used medicines and the conditions/complaints treated most often, has helped identify the areas where initiation of efficacy trials seems to be reasonably feasible, by both predefining probable medicines and imposing no restrictions on the physicians, thereby allowing them to choose from a wide range of remedies. It would be a practical input that could be made toward an evidence base, without undertaking the rigorous demands of experimental studies. The outcomes research progresses beyond mere unstructured observations, and yet still represents clinical findings in the “real-world” setting of homeopathic medical care. Although individualized prescribing was the norm, it was equally apparent that few homeopathic medicines tended to be selectively used for specific medical conditions.
The overall rate of positive outcome in 61% of FU patients in this study is quite lower than that reported in other homeopathy outcome studies in primary care2, 8, 9 and in hospital settings.10, 11, 12 In a pragmatic documentation study in Germany, of >900 patients availing homeopathic treatment, 77% perceived subjective benefits on improvement rating scales (“better,” “somewhat better,” “unchanged”, and “worse”).13 Although the use of the 7-point Likert scale was previously validated in homeopathy outcome audits, and was expedient to use, it would be more acceptable to have validated outcome scales for specific medical conditions. In this study, 95.6% of the prescriptions were individualized, a finding quite similar to earlier studies in which 100%, 85.6%, and 97.4% were recorded in another Indian homeopathic hospital.6, 14, 15 The predominating use of centesimal potencies (87.9%) and minimal (almost nonexistent) use of external application were also similar to earlier studies.6, 14, 15 Similarly, the use of other conventional medications was reported sparingly. Most frequently reported medical conditions/complaints also varied to some extent.
5. Conclusion
Data from this clinical outcomes study may act as fundamental data for performing well-targeted and controlled future research on homeopathy in O&G, feasible in the hospital outpatient setting.
Conflicts of interest
The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Acknowledgments
The authors would like to acknowledge Dr Kajal Bhattacharyya, Principal-in-Charge, The Calcutta Homeopathic Medical College and Hospital for allowing us to carry out the project successfully in his institution. The authors are also grateful to Dr Manisha Singh and Dr Sudipta Chakraborty, House Staff, Department of O&G, The Calcutta Homeopathic Medical College and Hospital for their sincere cooperation in data collection. Subhranil Saha and M. Koley worked on the concept, design, literature search, data analysis and interpretation, statistical analysis, and manuscript preparation; Sangita Saha, R. Singh, Md. M. Hossain, and I. Pramanik were involved in the clinical study and data acquisition. All the authors reviewed and approved the final manuscript.
Footnotes
Peer review under responsibility of The Center for Food and Biomolecules, National Taiwan University.
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