|Year : 2019 | Volume
| Issue : 1 | Page : 14-21
Appraisal of core therapy, supportive therapy, and alternative therapy in a tertiary care rural hospital of vidarbha region in correlation to plethora of menopausal problems
Priyanka Bharat Aglawe1, Rajesh K Jha1, Vedprakash Mishra2, Kamini M Sakore3, Aditya Chetan4, Deepti S Shrivastava5
1 Department of Pharmacology, Jawaharlal Nehru Medical College, DMIMS (DU), Wardha, Maharashtra, India
2 Department of Physiology, Jawaharlal Nehru Medical College, DMIMS (DU), Wardha, Maharashtra, India
3 Intern, MBBS, Jawaharlal Nehru Medical College, DMIMS (DU), Wardha, Maharashtra, India
4 Computer Science and Applied Mathematics, Indian Institute of Information Technology, Delhi, India
5 OBGY, Jawaharlal Nehru Medical College, Wardha, Maharashtra, India
|Date of Web Publication||29-Mar-2019|
Priyanka Bharat Aglawe
Department of Pharmacology, Jawaharlal Nehru Medical College, DMIMS (DU), Sawangi (M), Wardha, Maharashtra
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Context: Menopause is a crucial phase of the women fraternity which marks the end of reproductive age. Mostly it is physiological; however, certain conditions may lead to premature menopause. Menopause has an extensive spectrum of symptoms which are extremely bothersome. An effective, empathetic, and rational treatment strategy is necessary. Aim: The present study was carried out to appraise the treatment strategies to tackle menopausal problems in Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha – a tertiary care hospital in rural Vidarbha. Materials and Methods: This monocentric hospital-based qualitative study was carried out on 330 menopausal women. Data were collected from in-depth interview of the health-care professionals of obstetrics and gynecology department and patients. Results: Of 330 participants, the incidence of natural menopause was 90.96% (2016) and 85.36% (2017); surgical menopause was 09.03% (2016) and 14.63% (2017). There was no incidence of chemotherapy-induced and pelvic radiation-induced menopause during the study. Pharmacotherapy (85.45%) and surgery (19.09%) were the mainstay treatments. The most common route of drug administration was oral (92.20%), followed by intravaginal (15.60%), topical (09.57%), and injectables (0.35%). Pharmacotherapy was categorized into core therapy (84.75%), supportive therapy (47.52%), and alternative therapy (03.19%). Conclusion: The present study concludes that there is a decline in the use of hormone replacement therapy for the management of menopausal complaints. There is lack of awareness of the complexity of menopausal symptoms and available treatment strategies in this rural population, and therefore, it is recommended to organize various awareness camps, so that a prompt and most suitable treatment can be provided.
Keywords: Menopause, spectrum of symptoms, treatment strategies
|How to cite this article:|
Aglawe PB, Jha RK, Mishra V, Sakore KM, Chetan A, Shrivastava DS. Appraisal of core therapy, supportive therapy, and alternative therapy in a tertiary care rural hospital of vidarbha region in correlation to plethora of menopausal problems. J Mid-life Health 2019;10:14-21
|How to cite this URL:|
Aglawe PB, Jha RK, Mishra V, Sakore KM, Chetan A, Shrivastava DS. Appraisal of core therapy, supportive therapy, and alternative therapy in a tertiary care rural hospital of vidarbha region in correlation to plethora of menopausal problems. J Mid-life Health [serial online] 2019 [cited 2019 Jun 17];10:14-21. Available from: http://www.jmidlifehealth.org/text.asp?2019/10/1/14/255274
| Introduction|| |
Menopause marks the end of reproductive age of the women fraternity. It is defined as the cessation of menstrual cycles for 12 consecutive months.
The history of menopause has several wayposts with regard to the development of treatment strategies. Testicular extract, crude ovaries, ovarian juice, and powdered ovarian tablets were used in the previous era, which followed the use of tranquilizers. The use of hormone replacement therapy (HRT) was only after medicalization of menopause. Premarin was the first marketed estrogen as a treatment of menopause in the 1940s.
At present, HRT is the mainstay treatment.
Nonhormonal treatments such as selective serotonin reuptake inhibitors, serotonin, and noradrenaline reuptake inhibitors, gabapentin, pregabalin, clonidine; phytoestrogens;, herbal, products; and various other nonpharmacological strategies are now in use.
Due to the availability of a wide range of treatment strategies, an in-depth study was required to appraise the recent prescribing trends in menopause.
The present study was carried out to assess the status of core therapy, supportive therapy, and alternative therapy in our tertiary care rural hospital of Vidarbha region – Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi (Meghe), Wardha, in correlation to plethora of menopausal problems.
| Materials and Methods|| |
- Type of study: A monocentric hospital-based qualitative study
- Locus of administrative control: Department of Pharmacology, Jawaharlal Nehru Medical College, Sawangi (Meghe), Wardha
- Locus of study: AVBRH, Sawangi (Meghe), Wardha
- Study population: Females with menopausal symptoms coming to Obstetrics and Gynecology (OBGY) Outpatient department (OPD)/Inpatient department (IPD) of AVBRH, Sawangi (Meghe), Wardha
- Duration of the study: October 01, 2016–August 31, 2018
- Period of enrolment: October 01, 2016–December 31, 2017
- Period of analysis: January 01, 2018–August 31, 2018
- Sample size: 330.
The sample size of the study was calculated with reference to the parameter menstrual complaints, using the following formula:
Sample size formula for the difference between two proportions:
- 2α/2 is the critical value of normal distribution at α/2= 1.96
- 2 β is the critical value of the normal distribution at β = 0.84 (80% power)
- P1 is the expected sample proportion of 1st group = 42.5%
- P2 is the expected sample proportion of 2nd group = 44%.
n = 322.80
The research protocol was approved in the meeting held on July 9, 2016, by the Institutional Ethics Committee and the Letter of Approval was received on July 11, 2016 (Ref. No. DMIMS (DU)/IEC/2016-17/3016).
- Women above 35 years of age who has been diagnosed with:
- Natural menopause
- Chemotherapy-induced menopause
- Pelvic radiation-induced menopause
- Surgical menopause.
Menopausal women are presenting with menopausal complaintsMenopausal women who are willing to participate in the study.
- Women below 35 years of age
- Women with a complaint of amenorrhea associated with polycystic ovarian syndrome
- Women with a history of malignancy.
- Psychiatric disorder
- Musculoskeletal disorder
- Urogenital disorder.
The identity and personal information of all the patients enrolled in the study was kept strictly confidential.
With the help of the statistician working in the Department of Community Medicine, JNMC, Sawangi (Meghe), Wardha, the collected data were statistically analyzed using descriptive and inferential statistics using Chi-square test to ascertain the clinical significance of the present study. The software used in the analysis was SPSS 22.0 version and GraphPad Prism 6.0 version (Armonk, NY: IBM Corp.) and P < 0.05 is considered as the level of statistical significance.
| Results|| |
Incidence of different types of menopause
The incidence of natural menopause was found to be maximum which was followed by surgical menopause. In comparison to the year 2016, the incidence of natural menopause was decreased, whereas surgical menopause was increased in the year 2017 [Table 1].
|Table 1: Incidence of natural menopause, chemotherapy-induced menopause, pelvic radiation-induced menopause, and surgical menopause|
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Pharmacotherapy and surgery were the main treatment modalities used to treat menopausal complaints of the patients visiting OBGY OPD of AVBRH, Sawangi (Meghe), Wardha [Graph 1].
Routes of drug administration
Drug administration in maximum number of patients was Oral, followed by Vaginal, Topical and Injectables [Graph 2].
Types of pharmacotherapy
Pharmacotherapy was further divided into core therapy, supportive therapy, and alternative therapy according to the type of drug. Drugs for treating the primary menopausal complaint were included in the core therapy; vitamins, supplements, and those drugs used to prevent the side effects of core drugs were included in the supportive therapy; whereas drugs other than allopathic were included under alternative therapy [Graph 3].
Core drugs (n – 239, % - 84.75)
The drugs used in core therapy were further classified according to the Anatomical Therapeutic Chemical (ATC) classification system [Table 2].
- Imidazole and triazole derivatives of topical antifungals: Candid cream (Clotrimazole) was used topically in 2.09% of menopausal women on core therapy
- Combination of topical corticosteroid with antibiotics: Candid B cream (Clotrimazole + Beclometasone) was used topically in 8.37% of menopausal women on core therapy
- Imidazole derivative of gynecological anti-infectives and antiseptics: Tablet Candid V pessary (Clotrimazole) was used intravaginally in 3.77% of menopausal women on core therapy
- Gynecological anti-infective drugs: Tablet Clid V pessary (Clindamycin + Metronidazole + Clotrimazole + Lactobacillus sporogens) was used intravaginally in 14.23% of menopausal women on core therapy
- Plain preparation of natural and semisynthetic estrogens: Estrogen cream (Estradiol) was used topically in 0.84% of menopausal women on core therapy
- Progesterone and estrogen fixed combinations: OC pills (Levonorgestrel + Ethinylestradiol) were taken orally by 1.67% of menopausal women on core therapy
- Progesterone derivatives: Tablet Primolut – N (Norethisterone) was taken orally by 0.42% of menopausal women on core therapy
- Triazole derivative of systemic antimycotics: Tablet Flucos (Fluconazole) was used orally in 0.84% of menopausal women on core therapy
- Fluoroquinolone group of antibacterial drugs: Tablet Norflox (Norfloxacin) was used orally in 6.28% of menopausal women on core therapy
- Tetracycline group of antibacterial drugs: Tablet Doxy (Doxycycline) was used orally in 39.33% of menopausal women on core therapy
- Other antibacterial drugs: Tablet Metro (Metronidazole) was used orally in 35.56% of menopausal women on core therapy
- Third-generation cephalosporins: Tablet C Tax–O (Cefixime) was used orally in 3.77% of menopausal women on core therapy
- Combinations of antibacterials: FAS 3 kit tablets (Fluconazole + Azithromycin + Secnidazole) were used orally in 0.42% of menopausal women on core therapy
- Nitrofuran derivative of antibacterial drugs: Tablet Nitrofur (Nitrofurantoin) was used orally in 1.26% of menopausal women on core therapy
Tablet Norflox TZ (Norfloxacin + Tinidazole) was used orally in 1.67% of menopausal women
- Urologic drugs: Syrup Cital and Syrup Citralka (Disodium hydrogen citrate) were used orally in 17.57% of menopausal women on core therapy
- Belladonna alkaloids, semisynthetic, quaternary ammonium compounds: Tablet Buscopan and Tablet Hyocimax (Hyoscine butylbromide) were used orally in 13.39% of menopausal women on core therapy
- Propionic acid derivatives of nonsteroidal anti-inflammatory and antirheumatic products: Tablet Brufen (Ibuprofen) was used orally in 1.67% of menopausal women on core therapy
- Opioid group of analgesic drugs: Tablet Tramadol was used orally in 2.09% of menopausal women on core therapy
- Combination of antispasmodic with analgesic drugs: Tablet Meftal spas (Dicyclomine + Mefenamic acid) were used orally in 2.51% of menopausal women on core therapy
- Analgesic and antipyretic drugs: Tablet PCM (Paracetamol) was used orally in 0.42% of menopausal women on core therapy
- Antifibrinolytic drugs: Tablet Pause (Tranexamic acid) was used orally in 10.04% of menopausal women on core therapy
- Piperazine derivative of antihistaminics for systemic use: Tablet Ceriz (Cetirizine) was used orally in 0.84% of menopausal women on core therapy
- Gynecological antiseptics: Tablet Betadine pessary (Povidone iodine) was used intravaginally in 0.42% of menopausal women on core therapy.
Supportive therapy (n – 134, % - 47.52)
The drugs used in supportive therapy were further classified according to the ATC classification system [Table 3].
Multivitamin with minerals
Multivitamin tablets and injections (Vitamin A, B1, B2, B3, B5, B6, B7, B12, C, D3, E, Calcium, Iron, Cu, Mn, Zn, Magnesium oxide, P, Sodium molybdate, and Boron) were used in 5.97% of the menopausal women who were on supportive therapy to improve their general health.
Multivitamin with other combinations
B-colen NS syrup (Pine bark extract, carbohydrates, sugar, Vitamin C, B3, B5, B1, B2, B12, and B6, lysine, zinc sulfur, and copper sulfate) was used orally in 16.42% of patients on supportive therapy.
Drugs for peptic ulcer and gastroesophageal reflux disease
Rantac (Ranitidine) was prescribed to 63.43% of menopausal women on supportive therapy.
Iron tablets were used in 10.45% of menopausal women on supportive therapy.
Calcium tablets were used in 18.66% of menopausal women on supportive therapy.
Vitamin D preparation
Vitamin D granules (Cholecalciferol) were used in 04.48% of menopausal women on supportive therapy.
Alternative therapy (n – 9, % - 3.19)
- Herbal preparation: Evening primrose oil in the form of tablets and capsules were used orally in 66.67% of patients on alternative medicine
- Ayurvedic preparation: Syrup M2 Tone is an Ayurvedic medicine which contains Ashoka, Ashwagandha, Cedrus Deodara, Kasisa Bhasma, Lodhra, Mesua Ferrea, Nardostachys Jatamansi, and Shatavari as active ingredients. It was used Orally in 33.33% of patients on alternative medicine [Graph 4].
The incidence of natural menopause decreased in the year 2017 as compared to 2016, which can be explained by the finding of increased incidence of surgical menopause.
During the literature search, no studies with similar results were found as the number of studies evaluating the incidence of various types of menopause has not been conducted yet. However, a research conducted by the Study of Women's Health Across the Nation roughly estimated that 5% of women belonging to the age group of 40–45 years, whereas 25% of women in 45–55 years' experience natural menopause.
Unni and Syamala and Sivakami also showed similar finding that the incidence and prevalence of premature menopause including surgical menopause is increasing at an alarming rate in India, especially in the states such as Andhra Pradesh, Gujarat, and Karnataka.
During the study, there was no incidence of chemotherapy or pelvic radiation-induced menopause. However, the study by Shuster et al. is suggestive of an increased incidence of chemotherapy and pelvic radiation-induced menopause, which they associated it to the increased and better treatment strategies of cancer in all the age groups of women, and exposure to higher doses of alkylating agents and higher doses of radiation to the ovaries during cancer therapy makes women more likely to experience ovarian failure.
Pharmacotherapy and surgery were the main treatment modalities used for menopausal complaints of the patients visiting OBGY OPD of AVBRH, Sawangi (Meghe), Wardha.
During the study, the use of hormonal therapy was very less; Estradiol cream 0.84%, Levonorgestrel + Ethinyl estradiol oral contraceptive pills 01.67%, and Norethisterone 0.42%. Estradiol cream was used as monotherapy and in combination for urogenital symptoms such as increased frequency of micturition, burning micturition, and itching in the vulva region. Levonorgestrel + Ethinyl estradiol oral contraceptive pills were used for abnormal uterine bleeding and dysfunctional uterine bleeding as a monotherapy; whereas norethisterone was used for dysfunctional uterine bleeding as a monotherapy.
These findings are in contrast to the findings by Hackley and Rousseau, Santoro et al., and Panay et al., which showed the maximum use of HRT to manage various urogenital symptoms such as hot flashes and musculoskeletal symptoms. However, Rousseau in her study revealed that the primary care physicians showed a lower rate of hormonal therapy recommendations.
Similarly, Hersh et al. in their study revealed that the use of HRT has considerably declined.
During the study, the maximum drugs used in core therapy had a symptomatic cure approach with an effort to minimize the use of HRT. Maximum drugs used were antibiotics of various groups.
Multivitamin, Iron, Calcium, and Vitamin D were used for pain in the abdomen, white discharge, backache, dysfunctional uterine bleeding, abnormal uterine bleeding, uterine prolapse, vaginal erosions, and menorrhagia as a supportive therapy. Ranitidine was prescribed as a supportive drug along with antibiotics and pain killers, so as to reduce the gastrointestinal side effects of these drugs.
A herbal preparation of evening primrose oil (66.67%) in the form of tablets and capsules; and an Ayurvedic preparation Syrup M2 Tone (33.33%) was used as alternative medicines for the treatment of menopausal symptoms.
Evening primrose oil was used in combination with calcium and Vitamin D supplements for hot flush, mastalgia, white discharge, and pain abdomen.
Syrup M2 Tone was used as a monotherapy for abnormal uterine bleeding in two patients and in combination with tablet Pause (Tranexamic acid) in one patient.
Ohn Mar et al. in their study on the use of alternative medications showed a similar finding that evening primrose oil is the most used alternative medication (18.1%) which is followed by use of soy-based products (12.3%), green tea (6.8%), and gingko (5.8%).
Mehrpooya et al. in their study concluded that herbs such as black cohosh and evening primrose oil are effective in reducing the severity of hot flashes, but black cohosh is more effective than evening primrose oil.
Limitation of the study
- As the present study was carried out in a rural setup, there was lack of awareness in females about the various clinical manifestations of menopause, and therefore, there was underreporting of few categories of symptoms in our study
- Due to time constraint, no follow-ups were conducted in the present study. Therefore, assessment of the status outcome after the treatment was out of scope
- As the data of the present study were collected only from the OBGY Department of AVB Rural Hospital, Sawangi (Meghe) Wardha, patients bypassing the OBGY department to other department according to the type of menopausal complaint could not be addressed.
The authors are very much thankful to Dr. Swanand S. Pathak, (Professor and Head), Department of Pharmacology, all the unit heads, associate professors, assistant professors, and J.R. III, J.R. II and J.R. I of OBGY Department for their cooperation, support, and help at various levels. Our sincere thanks to Dr. Vijay Babar, Assistant professor in Statistics, Department of Community Medicine for his help in statistical analysis. The authors are inundate to the Staff Resource Society of DMIMS (DU), for financial assistance required for this project. We express our sense of gratitude to Professor Arvind Bhake, Co-ordinator, Staff Research Society, DMIMS (DU). The authors are highly obliged for the need-based contributions of Dr. Rupali Sarode and Brihi Joshi.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Nappi RE, Lachowsky M. Menopause and sexuality: Prevalence of symptoms and impact on quality of life. Maturitas 2009;63:138-41.
Singh A, Kaur S, Walia I. A historical perspective on menopause and menopausal age. Bull Indian Inst Hist Med Hyderabad 2002;32:121-35.
Austin PC, Mamdani MM, Tu K, Jaakkimainen L. Prescriptions for estrogen replacement therapy in Ontario before and after publication of the women's health initiative study. JAMA 2003;289:3241-2.
Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ 2017;359:j5101.
Farrell E. Medical choices available for management of menopause. Best Pract Res Clin Endocrinol Metab 2003;17:1-16.
Remport J, Blázovics A. Phytoestrogens in the treatment of menopause. Orv Hetil 2017;158:1243-51.
Low Dog T. Menopause: A review of botanical dietary supplements. Am J Med 2005;118 Suppl 12B:98-108.
Klein S, Rister R. The complete German commission E monographs. In: Riggins C, editor. Therapeutic Guide to Herbal Medicines. 1st
ed. Austin, Texas, Boston: American Botanical Council; 1998. p. 684.
North American Menopause Society. Treatment of menopause-associated vasomotor symptoms: Position statement of the North American Menopause Society. Menopause 2004;11:11-33.
Dennerstein L, Dudley EC, Hopper JL, Guthrie JR, Burger HG. A prospective population-based study of menopausal symptoms. Obstet Gynecol 2000;96:351-8.
Johnston JM, Colvin A, Johnson BD, Santoro N, Harlow SD, Bairey Merz CN, et al.
Comparison of SWAN and WISE menopausal status classification algorithms. J Womens Health (Larchmt) 2006;15:1184-94.
Unni J. Third consensus meeting of Indian menopause society (2008): A summary. J Midlife Health 2010;1:43-7.
Syamala T, Sivakami M. Menopause: An Emerging issue in India. Journal of Economic & Political Weekly 2005;40:1-36.
Shuster LT, Rhodes DJ, Gostout BS, Grossardt BR, Rocca WA. Premature menopause or early menopause: Long-term health consequences. Maturitas 2010;65:161-6.
Hackley B, Rousseau ME. CEU: Managing menopausal symptoms after the women's health initiative. J Midwifery Womens Health 2004;49:87-95.
Santoro N, Epperson CN, Mathews SB. Menopausal symptoms and their management. Endocrinol Metab Clin North Am 2015;44:497-515.
Panay N, Hamoda H, Arya R, Savvas M, British Menopause Society and Women's Health Concern. The 2013 British Menopause Society & Women's Health Concern recommendations on hormone replacement therapy. Menopause Int 2013;19:59-68.
Rousseau ME. Evidence-based practice in women's health: Hormone therapy for women at menopause. J Midwifery Womens Health 2001;46:167-80.
Hersh AL, Stefanick ML, Stafford RS. National use of postmenopausal hormone therapy: Annual trends and response to recent evidence. JAMA 2004;291:47-53.
Ohn Mar S, Malhi F, Syed Rahim SH, Chua CT, Sidhu SS, Sandheep S, et al.
Use of alternative medications for menopause-related symptoms in three major ethnic groups of Ipoh, Perak, Malaysia. Asia Pac J Public Health 2015;27:19S-25S.
Mehrpooya M, Rabiee S, Larki-Harchegani A, Fallahian AM, Moradi A, Ataei S, et al.
A comparative study on the effect of “black cohosh” and “evening primrose oil” on menopausal hot flashes. J Educ Health Promot 2018;7:36.
[Table 1], [Table 2], [Table 3]