- Email: [email protected]
Patients’ decisions regarding the treatment of primary dysmenorrhoea
Complementary Therapies in Medicine 45 (2019) 1–6
Contents lists available at ScienceDirect
Complementary Therapies in Medicine journal homepage: www.elsevier.com/locate/ctim
Patients’ decisions regarding the treatment of primary dysmenorrhoea a,⁎
T
b
Karsten Münstedt , Thomas Riepen a b
Ortenau Klinikum Offenburg, Ebertplatz 12, 77654, Offenburg, Germany Konrad-Adenauer-Str. 2, 35781, Weilburg, Germany
A R T I C LE I N FO
A B S T R A C T
Keywords: Complementary and alternative medicine Primary dysmenorrhoea Patients’ choice Counselling Integrative medicine
Objectives: To assess earlier experiences and likelihood for use of methods used for the treatment of primary dysmenorrhoea, a very common problem in women. Design: A consecutive group of patients (n = 205) visiting a private gynaecological practice in Weilburg, Germany, received an assessment form on which they were asked to provide earlier experiences with various methods for the treatment of primary dysmenorrhoea. They were also asked to rate the likelihood for use of various methods from conventional medicine as well as from complementary and alternative medicine. Half of them received information on efficacy, safety and costs based on the American Cancer Society Working Group grading system. Results: Only 5.5% reported no experience with contraceptives or pain relievers and 26.7% had no experience with complementary and alternative medicine. The remaining patients had experience with a median of two (mean = 3.7, SD = 4.8) methods. Diet and homeopathy were the most frequently used methods from complementary and alternative medicine. In spite of the provision of information on efficacy, safety and costs, patients chose the methods based on earlier experience. Patients familiar with complementary and alternative medicine also did not see which areas belong together, e.g. homeopathy, Schüssler’s salts and anthroposophy. Conclusions: In spite of the provision of information, patients preferred to use those methods they were already acquainted with. In order to allow patients to make better decisions, different ways should be gone in order to help patients make better decisions.
1. Introduction Primary dysmenorrhoea is defined as cramping pain in the lower abdomen that occurs just before or during menstruation, in the absence of other causes such as uterine fibroids, cysts, adenomyosis, cervical stenoses and polyps, endometriosis or intrauterine devices. It is a very common problem, with 16–91% of all women suffering from it and 2–29% suffering from it to a high degree. 1 Primary dysmenorrhoea is frequently associated with other symptoms such as headache, nausea, vomiting, bloating, diarrhoea and cramping abdominal pain. These symptoms are believed to be due to the disintegration of endometrial tissue, which releases PGF2 (prostaglandin) and leads to cramps of the myometrium, ischaemia in the muscular tissue and irritation of the nerve endings. Symptoms may improve over time, after pregnancies, with the use of contraceptives or with better stress management. Smoking, diet, obesity and depression do not seem to have any influence on the incidence and severity of complaints. 1 Primary dysmenorrhoea leads to some economic problems, since it is associated with an inability to work. Treatment concepts of
⁎
conventional medicine include the inhibition of prostaglandin production by non-steroidal anti-inflammatory drugs, such as aspirin, naproxen and ibuprofen, and reduction of the volume of menstrual fluid by oral contraceptives or progestins (e.g. levonorgestrel-releasing intrauterine system, etonogestrel-releasing subdermal implant, depot medroxyprogesterone). If necessary, non-steroidal anti-inflammatory drugs may be combined with oral contraceptives or progestins.2 The success rates of these approaches range between 64% and 100%. 1 Contraindications to the use of the above-mentioned drugs include a history of thrombosis or digestive problems; also, about 10–18% of all affected women do not respond to conventional treatments whereas others have an aversion to academic medicine. In all these cases women seek alternatives, 3 which include surgical procedures, vasodilators (sildenafil, nifedipine), vasopressin and oxytocin receptor antagonists, antispasmodics and non-pharmacological medical treatments, as well as a wide spectrum of methods from a different field of medicine called complementary, alternative or integrative medicine. The terms ‘complementary’, ‘alternative’ or ‘integrative’ medicine are very poorly defined 3 and are often used interchangeably. The National Center of
Corresponding author. E-mail address: [email protected] (K. Münstedt).
https://doi.org/10.1016/j.ctim.2019.05.016 Received 31 January 2019; Received in revised form 11 May 2019; Accepted 13 May 2019 Available online 14 May 2019 0965-2299/ © 2019 Elsevier Ltd. All rights reserved.
Complementary Therapies in Medicine 45 (2019) 1–6
K. Münstedt and T. Riepen
Table 1 Demographic characteristics of the patients in the study. Entire group n = 205
Group with information n = 100
Group without information n = 105
Age [years] Mean (SD) Range
35.7 (11.4) 18 – 68
37.4 (11.7) 18 – 68
34.1 (10.9) 18 – 68
Type of patient (%) Acute disease Chronic disease Routine check-up Follow-up visit Others Missing
29 (14.1) 10 (4.9) 137 (66.8) 5 (2.4) 21 (10.2) 2 (1.0)
13 4 67 4 11
(13.0) (4.0) (67.0) (4.0) (11.0) 0
16 (15.2) 6 (5.7) 70 (66.7) 1 (1.0) 10 (9.5) 2 (1.9)
School leaving certificate (%) None Secondary modern school (years 5 to 9) Secondary modern school (years 5 to 10) Vocational diploma University entrance diploma University degree Others Missing
2 (1.0) 30 (14.) 91 (44.4) 38 (18.7) 19 (9.3) 22 (10.7) 1 (.5) 2 (1.0)
2 13 46 17 9 10 1 2
(2.0) (13.0) (46.0) (17.0) (9.0) (10.0) (1.0) (2.0)
17 (16.2) 45 (42.9) 21 (20.0) 10 (9.5) 12 (11.4) 0 0
statistical analyses. In order to determine the influence that information on efficacy, safety and costs of the method might have on patients’ decisions, half of the assessment forms had ratings regarding these aspects based on a systematic review and a recent review [5, 6.]. The ratings were provided in the form of smileys as a translation of the American Cancer Society Working Group grading system. 7 For example ☺☺☺ symbolized a very positive rating whereas ☹☹ symbolized a negative rating. Aspects of a method which could not be elaluated because of lack of date were marked with a question mark. The two different questionnaires were issued randomly on a weekly basis to ensure that patients could not gather information on a method by looking at another patient’s assessment form. Comparison of assessment forms with and without smileys was to find out how far patients’ decisions could be influenced by providing information. Criteria for inclusion into the study were age > 18 years and ability to read and write the German language. We excluded patients with severe diseases (e.g. active cancer). Patients were asked to complete the questionnaire while waiting for the physician or to take it home and return it later. All patients were informed that participation in the study was welcomed and they would not face any problems if they chose not to participate. The survey was anonymous and approved by the ethical review committee of the University Clinic Giessen, Germany (AZ 204/ 17). PSPP software was used for data management and statistical analysis. Descriptive statistics, Spearman’s bivariate correlation (twosided), cross-tabulation and Pearson’s χ2 test were used for statistical analysis and a probability of error of < 5% was regarded as significant.
Complementary and Integrative Health (NCCIH, USA) has issued definitions that seem to be appropriate (https://nccih.nih.gov/health/ integrative-health#term; accessed January 26th, 2019):
• ‘complementary medicine’ – a non-mainstream practice used together with conventional medicine; • ‘alternative medicine’ – a non-mainstream practice used in place of conventional medicine; • ‘integrative medicine’ – approaches from complementary and alternative medicine incorporated into mainstream health care after rigorous scientific investigation.
There are few epidemiologic data on the use of complementary and alternative medicine (CAM) for dysmenorrhoea. A Turkish study showed that 70% of 428 study participants (students) used CAM for primary dysmenorrhoea. 4 However, we know little about the general population. In order to understand patients’ decisions better, we analysed a group of women visiting a gynaecological practice and asked them about earlier experiences and likelihood for use of various methods for to dysmenorrhoea.
2. Patients and methods In order to analyse patients’ complaints and preferences, we developed an assessment form for recording:
• demographic data; • complaints related to primary dysmenorrhoea; • earlier experience with several methods used for primary dysmenorrhoea (rating possibilities yes = 1; no = 0); • patient-rated likelihood for using these methods (rating possibilities
3. Results In the given time period we issued 229 assessment forms and 205 were received back; however, several were returned not fully completed. Patient characteristics are given in Table 1 and patient complaints with respect to dysmenorrhoea are presented in Table 2. Almost all patients were familiar with conventional medicine, only 5.5% reported no experience with contraceptives or pain relievers and 26.7% had no experience with CAM. The remaining patients had experience of a median of two (mean = 3.7, SD = 4.8) methods. Fig. 1 shows patients’ earlier experience with the various methods. It can be seen that patients had the most experience with contraceptives and pain relievers, followed by diet and homeopathy. Contraceptives were frequently used primarily for the treatment of dysmenorrhoea. Patients had least experience with royal jelly, anthroposophy and biophotons.
were 1 = very likely; 2 = likely; 3 = possibly; 4 = unlikely).
Selection of the various methods that patients had to rate was based on an earlier analysis of methods used for dysmenorrhoea in Germany. 5 The various methods were listed alphabetically and patients asked to note earlier experience and the likelihood of using the named method. A copy of the assessment form can be obtained from KM (German version only). The assessment form was distributed as a paper version between May 2018 and July 2018 to a consecutive group of patients in a private gynaecological practice in Weilburg, Germany. It was intended to receive 200 assessment forms back to allow appropriate 2
Complementary Therapies in Medicine 45 (2019) 1–6
K. Münstedt and T. Riepen
Furthermore, patients were asked to rate the probability of using the different methods for dysmenorrhoea, the results of which are shown in Fig. 2. Fig. 2 does not differentiate between women who received information on efficacy and safety because it was found using Pearson’s χ² test that the provided information had no influence on patients’ decision. Due to the necessity for a Bonferroni correction, only the decision regarding the use of enzymes might have been influenced by the provided information on efficacy, safety and costs (χ² = 15.5; df = 3; p = 0.001). Fig. 2 shows that the likelihood of using a certain method is quite similar to earlier experience. Pearson’s χ² test confirmed that earlier experience was a significant factor that influenced patients’ decision for or against a certain method (all p < 0.01). The results were analysed to see whether there are strong correlations between the likelihood of using one method over another. Correlation analysis using a high number of patients gave many statistically significant results but only the results with correlation coefficients of ≥ 0.5 are given (p < 0.001):
Table 2 Severity of complaints of patients related to dysmenorrhea on a scale from 0 (no complaints) to 10 (severe complaints). Entire group n = 205
Group with information n = 100
Group without information n = 105
Headache Mean (SD) Range
2.3 (2.7) 0 – 10
2.5 (2.9) 0 – 10
2.1 (2.6) 0–8
Malaise Mean (SD) Range
2.9 (2.6) 0 – 10
3.3 (2.7) 0 – 10
2.5 (2.6) 0–8
Bloating Mean (SD) Range
2.1 (2.5) 0–9
2.4 (2.6) 0–8
1.7 (2.4) 0–9
Nausea Mean (SD) Range
.7 (1.7) 0 – 10
0.9 (1.9) 0–8
.6 (1.6) 0 – 10
Vomiting Mean (SD) Range
.2 (.6) 0–4
.3 (.7) 0–3
0.1 (.5) 0–4
Diarrhoea Mean (SD) Range
.8 (1.9) 0 – 10
1.1 (2.3) 0 – 10
.6 (1.6) 0–8
Abdominal cramps Mean (SD) Range
4.6 (3.2) 0 – 10
4.7 (3.2) 0 – 10
4.4 (3.2) 0 – 10
• Oral contraceptives: no correlations • Acupressure: acupuncture (.609), honey (.552), royal jelly (.588) • Acupuncture: acupressure (.609) • Anthroposophy: honey (.534), royal jelly (.644), apipuncture (.581), biophotons (.570) • Honey: acupressure (.552), anthroposophy (.534), royal jelly (.855), •
apipuncture (.595), biophotons (.578), neural therapy (.588), orthomolecular medicine (.537) Royal jelly: acupressure (.588), anthroposophy (.644), honey (.855),
Fig. 1. Patients’ earlier experiences with various methods for dysmenorrhoea. Contraceptives were frequently used primarily for the treatment of dysmenorrhoea. Colours indicate whether a method may be considered a part of conventional medicine (blue = conventional medicine; red = complementary, alternative or integrative medicine) (For interpretation of the references to colour in this figure legend, the reader is referred to the web version of this article). 3
Complementary Therapies in Medicine 45 (2019) 1–6
K. Münstedt and T. Riepen
Fig. 2. Patient rated likelihood for using the various methods for dysmenorrhoea.
• • • • • • • • • • • • •
• Orthomolecular medicine: honey (.537), royal jelly (.612), biopho-
apipuncture (.686), biophotons (.701), leeches (.510), magnets (.573), neural therapy (.564), orthomolecular medicine (.612) Apipuncture (bee venom acupuncture): anthroposophy (.581), honey (.595), royal jelly (.686), biophotons (0.714), leeches (.548), neural therapy (.731), orthomolecular medicine (.571) Aromatherapy: Bach flowers (.574), biophotons (.529) Bach flowers: aromatherapy (.574), biophotons (.574), diet (.608), omega-3 fatty acids (.554), phytotherapy (.512) Biophotons: anthroposophy (.570), honey (.578), royal jelly (.701), apipuncture (.714), aromatherapy (.529), Bach flowers (.574), leeches (.717), magnets (.605), neural therapy (.525), orthomolecular medicine (.597), phytotherapy (.572) Leeches: royal jelly (.510), apipuncture (.548), biophotons (.717), magnets (.520) Diet: Bach flowers (.608) Homeopathy: no correlations Ginger: no correlations Magnets: royal jelly (.573), biophotons (.574), leeches (.520), manual therapy (.560), neural therapy (.534), phytotherapy (.524) Manual therapy: magnets (.560), phytotherapy (.512) Moxibustion: neural therapy (.571), omega-3 fatty acids (.502), orthomolecular medicine (.678), phytotherapy (.521) Neural therapy: honey (.588), royal jelly (.564), apipuncture (.731), biophotons (.525), magnets (.534), moxibustion (.571), omega-3 fatty acids (.581), orthomolecular medicine (.700) Omega-3 fatty acids: Bach flowers (.554), moxibustion (.502), neural therapy (.581), orthomolecular medicine (.553), order therapy (.515), vitamin B1 (.502)
• • • • • • • • •
tons (.597), moxibustion (.678), neural therapy (.700), omega-3 fatty acids (.553), phytotherapy (.514) Order therapy (includes exercise and relaxation): omega-3 fatty acids (.515), physical therapy (.588) Physical therapy: phytotherapy (.555) Phytotherapy: Bach flowers (.525), biophotons (.572), magnets (.524), manual therapy (.512), moxibustion (.521), orthomolecular medicine (.514), physical therapy (.555) Pain relievers: no correlations Schüssler cell salts (homoeopathically potentised doses of essential minerals): Traditional Chinese Medicine (.602) Traditional Chinese Medicine: Schüssler cell salts (.602), osteopathy (.603), cinnamon (.517) Vitamin B1: omega-3 fatty acids (.502), osteopathy (.566), cinnamon (.521) Osteopathy: Traditional Chinese Medicine (.603), vitamin B1 (.566), cinnamon (.518) Cinnamon: Traditional Chinese Medicine (.517), vitamin B1 (.521), osteopathy (.518)
No correlation between age, total pain score (sum of all complaints), degree of education and the likelihood of using a certain method was found.
4. Discussion This study provides some insight regarding the use of various 4
Complementary Therapies in Medicine 45 (2019) 1–6
K. Münstedt and T. Riepen
patients. 12 From the physicians perspective, efficacy is one of the key issues. In this respect patients should not only have a choice but should also receive education in this field. It was hypothesized that the method of delivery of information is critical and that patients prefer exact information on what to expect from treatment. 14 Other research in the field suggests that costs play an important role in patients from lowincome groups and that safety seems to be a major concern. 15 In order to allow patients to make the right choice it seems important that physicians are aware of patients’ preferences and the background to their decision. Based on this study it seems important that physicians who want to give the patient good advice should inform them in greater detail and with personal dialogue. Holistic treatment in the literal and true sense should include the therapist being familiar with all the treatment options in order to counsel patients appropriately. This study should also be interesting for protagonists of very special types of therapies, for example apitherapists. Apitherapists claim that all diseases can be cured with bee products and thus they promote bee products. 10,16 As shown for primary dysmenorrhoea, the evidence for apitherapy is scarce. This study shows that patients’ interest in these methods is low and that patients might be better off with other CAM methods. There are some limitations to this study. This study comprises a convenience sample of patients who visited a physician advocating conventional medicine in a small town in Hesse, Germany. Thus it cannot be said that our sample is representative of the female population of Germany. It must also be assumed that patients with disrespect for conventional medicine will not visit a physician. These factors might have created biases. However, about 80% of all women visit physicians for early cancer diagnosis and screening. 17 In combination with the excellent response rate, we should have reached a good proportion of females living in the specified area. Furthermore, the results show that we reached many patients with manifold experiences in the field of CAM. In summary this study provides some insight regarding patients’ decisions on a very common problem in the field of obstetrics and gynaecology. It shows that the factor “earlier treatment experiences” is of great importance and that brief information on efficacy, safety and costs are not sufficient to influence treatment decisions. In this respect homoeopathy and diet seem to be of greatest relevance. Since both do not seem to be of greatest efficacy, is seems important to develop effective means to inform patients on most appropriate methods. According to the deficit model effective science communication should include findings from social science research and engage community members around scientific issues.
methods from conventional and from complementary, alternative and integrative medicine for primary dysmenorrhoea. In contrast to our prior beliefs, patients did not consider the given information on efficacy, safety and costs when asked whether they would use a particular method. Earlier experience with a method was the most important reason why patients chose that method. The study also shows that patients have different conceptions of which methods are associated with each other. Interestingly, patients associated the various concepts of apitherapy (honey, royal jelly, apipuncture) with each other, whereas the various parts of Traditional Chinese Medicine were not associated (acupuncture, moxibustion). Also, no association was found between Schüssler’s salts, homeopathy and anthroposophy, which also have a common background. This means that patients have differing views of the different fields of CAM. Also, there are no associations between the methods of conventional medicine (oral contraceptives, pain relievers) and any CAM treatment. Use of CAM is a mainly patient-driven field of medicine. As stated by Fotaki, choice policies do not lead to more efficiency or higher quality in health care. 8 While highly educated and well-informed patients may benefit from personalized and high-quality service arrangements that are closely adapted to their needs, in contrast to largescale and standardized health care there is a great possibility that patients receive worse-quality treatment if users’ literacy concerning health and/or the health care system is low. 8 This problem may be even more pronounced when the multitude of methods from alternative, complementary and integrative medicine come into consideration. Since there is limited information on efficacy and safety for many of these methods, the chances to make the wrong choices are even greater. In this respect it is important that patients receive information on what to expect from treatment. This seems to be true for the problem of primary dysmenorrhoea as well. Apart from the concepts from conventional medicine, local heat applications (hot water bottles), the use of aromatherapy, aroma oil massage, ginger and moxibustion can be considered efficacious and may thus be considered candidates for integrative medicine. 5,6 Although this information was provided to the patients, it was not used. Instead, many chose homeopathy, which was not reported to be helpful based on a randomized controlled trial. 9 Recent reviews on the efficacy and safety of CAM for dysmenorrhoea conclude that some methods can be efficacious whereas there is no information on the suitability or even the risks of others. 3,5,6,10 However, it seems to take more than a little information on efficacy, safety and costs to make patients consider new treatment options. As patients are not familiar with the interrelationship between various types of medicine, they seem to choose on the basis of what they already know. It was shown in this study that providing information on efficacy, safety and costs does not mean that they make better choices. If they had considered the given information on efficacy, safety and costs based on the studies in the field, patients would have chosen the already mentioned methods (local heat applications, exercise or physical therapy, aromatherapy including lavender oil massage, ginger) and perhaps vitamin B1, omega-3 fatty acids and acupressure, all of which have proved to be effective, fairly safe and highly cost effective. 5,6,10 Thus, the treatment decisions of the patients in this study were not influenced by our way of providing information and are not rationally founded. These findings are well in line with the “deficit model” which hypothesizes that effective science communication should be based on social science research and use approaches that engage community members around scientific issues. 11 However, earlier studies showed that other factors are considered regarding treatment decisions for dysmenorrhoea. These include the mode of administration, chances of irregular bleedings, chances of nausea, and chances of symptoms becoming “improved”. 12 As it has been shown that patients can be influenced by the physician’s opinion, it seems necessary that patients require more information than just a few smileys. 13 On the basis of the work by Akiyama et al. it may be concluded that efficacy is not the primary concern of the
Funding None. Conflict of interest None. Acknowledgement The authors thank Rosemarie Badaczewski for preparing the questionnaires for statistical analysis. References 1. Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea. Epidemiol Rev. 2014;36:104–113. 2. Bernardi M, Lazzeri L, Perelli F, Reis FM, Petraglia F. Dysmenorrhea and related disorders. F1000Research. 2017;6:1645. https://doi.org/10.12688/f1000research. 11682.1. 3. Oladosu FA, Tu FF, Hellman KM. Nonsteroidal antiinflammatory drug resistance in
5
Complementary Therapies in Medicine 45 (2019) 1–6
K. Münstedt and T. Riepen
4.
5. 6. 7. 8. 9.
10. 11.
12.
dysmenorrhea: Epidemiology, causes, and treatment. Am J Obstet Gynecol. 2018;218:390–400. Midilli TS, Yasar E, Baysal E. Dysmenorrhea characteristics of female students of health school and affecting factors and their knowledge and use of complementary and alternative medicine methods. Holist Nurs Pract. 2015;29:194–204. Münstedt K. Rationale naturheilkundliche Ansätze zur Behandlung der primären Dysmenorrhoe. Gyne. 2016;37(2):7–14. Latthe PM, Champaneria R, Khan KS. Dysmenorrhoea. BMJ Clin Evid. 2011;21(February 2011) pii: 0813. Münstedt K. Komplementäre und alternative Krebstherapien. 3rd edition Germany: Landsberg am Lech; 2012. Fotaki M. Is patient choice the future of health care systems? Int J Health Policy Manag. 2013;1:121–123. Alizadeh Charandabi SM, Biglu MH, Yousefi Rad K. Effect of homeopathy on pain intensity and quality of life of students with primary dysmenorrhea: A randomized controlled trial. Iran Red Crescent Med J. 2016;18:e30902. Münstedt K. Meaningfulness of apitherapeutic approaches using the example of primary dysmenorrhoea. J Apitherapy. 2018;3:9–16. Simis MJ, Madden H, Cacciatore MA, Yeo SK. The lure of rationality: Why does the deficit model persist in science communication? Public Underst Sci. 2016;25:400–414. https://doi.org/10.1177/0963662516629749. Akiyama S, Goren A, Basurto E, Komori T, Harada T. Treatment preferences among
13. 14.
15.
16.
17.
6
Japanese women with dysmenorrhea: Results from a discrete choice experiment study. Patient Prefer Adherence. 2018;12:1627–1640. https://doi.org/10.2147/PPA. S166332. Rozenberg S, Ham H. Effect of physicians’ opinion on patients’ choice of treatment. Eur J Obstet Gynecol Reprod Biol. 2001;96:215–217. Harmsen CG, Støvring H, Jarbøl DE, et al. Medication effectiveness may not be the major reason for accepting cardiovascular preventive medication: A populationbased survey. BMC Med Inform Decis Mak. 2012;12:89. https://doi.org/10.1186/ 1472-6947-12-89. Bo NJ, Ejg JD, Dorte GH, Lind BB, Veldt LP. Determinants for acceptance of preventive treatment against heart disease – A web-based population survey. BMC Public Health. 2014;14:783. https://doi.org/10.1186/1471-2458-14-783. Hellner M, Winter D, von Georgi R, Münstedt K. Apitherapy: Usage and experience in German beekeepers. Evidence Based Complementary and Alternative Medicine. 2008;5:475–479. https://doi.org/10.1093/ecam/nem052. Starker A, Bertz J, Saß A-C. Inanspruchnahme von krebsfrüherkennungsuntersuchungen. Daten und fakten: Ergebnisse Der Studie “gesundheit in deutschland aktuell 2010”. Beiträge Zur Gesundheitsberichterstattung Des Bundes. RKI, Berlin: Robert Koch Institute; 2012https://www.rki.de/DE/Content/Gesundheitsmonitoring/ Gesundheitsberichterstattung/GBEDownloadsB/Geda2010/kapitel_ krebsfrueherkennung.pdf?__blob=publicationFile).
Contents lists available at ScienceDirect
Complementary Therapies in Medicine journal homepage: www.elsevier.com/locate/ctim
Patients’ decisions regarding the treatment of primary dysmenorrhoea a,⁎
T
b
Karsten Münstedt , Thomas Riepen a b
Ortenau Klinikum Offenburg, Ebertplatz 12, 77654, Offenburg, Germany Konrad-Adenauer-Str. 2, 35781, Weilburg, Germany
A R T I C LE I N FO
A B S T R A C T
Keywords: Complementary and alternative medicine Primary dysmenorrhoea Patients’ choice Counselling Integrative medicine
Objectives: To assess earlier experiences and likelihood for use of methods used for the treatment of primary dysmenorrhoea, a very common problem in women. Design: A consecutive group of patients (n = 205) visiting a private gynaecological practice in Weilburg, Germany, received an assessment form on which they were asked to provide earlier experiences with various methods for the treatment of primary dysmenorrhoea. They were also asked to rate the likelihood for use of various methods from conventional medicine as well as from complementary and alternative medicine. Half of them received information on efficacy, safety and costs based on the American Cancer Society Working Group grading system. Results: Only 5.5% reported no experience with contraceptives or pain relievers and 26.7% had no experience with complementary and alternative medicine. The remaining patients had experience with a median of two (mean = 3.7, SD = 4.8) methods. Diet and homeopathy were the most frequently used methods from complementary and alternative medicine. In spite of the provision of information on efficacy, safety and costs, patients chose the methods based on earlier experience. Patients familiar with complementary and alternative medicine also did not see which areas belong together, e.g. homeopathy, Schüssler’s salts and anthroposophy. Conclusions: In spite of the provision of information, patients preferred to use those methods they were already acquainted with. In order to allow patients to make better decisions, different ways should be gone in order to help patients make better decisions.
1. Introduction Primary dysmenorrhoea is defined as cramping pain in the lower abdomen that occurs just before or during menstruation, in the absence of other causes such as uterine fibroids, cysts, adenomyosis, cervical stenoses and polyps, endometriosis or intrauterine devices. It is a very common problem, with 16–91% of all women suffering from it and 2–29% suffering from it to a high degree. 1 Primary dysmenorrhoea is frequently associated with other symptoms such as headache, nausea, vomiting, bloating, diarrhoea and cramping abdominal pain. These symptoms are believed to be due to the disintegration of endometrial tissue, which releases PGF2 (prostaglandin) and leads to cramps of the myometrium, ischaemia in the muscular tissue and irritation of the nerve endings. Symptoms may improve over time, after pregnancies, with the use of contraceptives or with better stress management. Smoking, diet, obesity and depression do not seem to have any influence on the incidence and severity of complaints. 1 Primary dysmenorrhoea leads to some economic problems, since it is associated with an inability to work. Treatment concepts of
⁎
conventional medicine include the inhibition of prostaglandin production by non-steroidal anti-inflammatory drugs, such as aspirin, naproxen and ibuprofen, and reduction of the volume of menstrual fluid by oral contraceptives or progestins (e.g. levonorgestrel-releasing intrauterine system, etonogestrel-releasing subdermal implant, depot medroxyprogesterone). If necessary, non-steroidal anti-inflammatory drugs may be combined with oral contraceptives or progestins.2 The success rates of these approaches range between 64% and 100%. 1 Contraindications to the use of the above-mentioned drugs include a history of thrombosis or digestive problems; also, about 10–18% of all affected women do not respond to conventional treatments whereas others have an aversion to academic medicine. In all these cases women seek alternatives, 3 which include surgical procedures, vasodilators (sildenafil, nifedipine), vasopressin and oxytocin receptor antagonists, antispasmodics and non-pharmacological medical treatments, as well as a wide spectrum of methods from a different field of medicine called complementary, alternative or integrative medicine. The terms ‘complementary’, ‘alternative’ or ‘integrative’ medicine are very poorly defined 3 and are often used interchangeably. The National Center of
Corresponding author. E-mail address: [email protected] (K. Münstedt).
https://doi.org/10.1016/j.ctim.2019.05.016 Received 31 January 2019; Received in revised form 11 May 2019; Accepted 13 May 2019 Available online 14 May 2019 0965-2299/ © 2019 Elsevier Ltd. All rights reserved.
Complementary Therapies in Medicine 45 (2019) 1–6
K. Münstedt and T. Riepen
Table 1 Demographic characteristics of the patients in the study. Entire group n = 205
Group with information n = 100
Group without information n = 105
Age [years] Mean (SD) Range
35.7 (11.4) 18 – 68
37.4 (11.7) 18 – 68
34.1 (10.9) 18 – 68
Type of patient (%) Acute disease Chronic disease Routine check-up Follow-up visit Others Missing
29 (14.1) 10 (4.9) 137 (66.8) 5 (2.4) 21 (10.2) 2 (1.0)
13 4 67 4 11
(13.0) (4.0) (67.0) (4.0) (11.0) 0
16 (15.2) 6 (5.7) 70 (66.7) 1 (1.0) 10 (9.5) 2 (1.9)
School leaving certificate (%) None Secondary modern school (years 5 to 9) Secondary modern school (years 5 to 10) Vocational diploma University entrance diploma University degree Others Missing
2 (1.0) 30 (14.) 91 (44.4) 38 (18.7) 19 (9.3) 22 (10.7) 1 (.5) 2 (1.0)
2 13 46 17 9 10 1 2
(2.0) (13.0) (46.0) (17.0) (9.0) (10.0) (1.0) (2.0)
17 (16.2) 45 (42.9) 21 (20.0) 10 (9.5) 12 (11.4) 0 0
statistical analyses. In order to determine the influence that information on efficacy, safety and costs of the method might have on patients’ decisions, half of the assessment forms had ratings regarding these aspects based on a systematic review and a recent review [5, 6.]. The ratings were provided in the form of smileys as a translation of the American Cancer Society Working Group grading system. 7 For example ☺☺☺ symbolized a very positive rating whereas ☹☹ symbolized a negative rating. Aspects of a method which could not be elaluated because of lack of date were marked with a question mark. The two different questionnaires were issued randomly on a weekly basis to ensure that patients could not gather information on a method by looking at another patient’s assessment form. Comparison of assessment forms with and without smileys was to find out how far patients’ decisions could be influenced by providing information. Criteria for inclusion into the study were age > 18 years and ability to read and write the German language. We excluded patients with severe diseases (e.g. active cancer). Patients were asked to complete the questionnaire while waiting for the physician or to take it home and return it later. All patients were informed that participation in the study was welcomed and they would not face any problems if they chose not to participate. The survey was anonymous and approved by the ethical review committee of the University Clinic Giessen, Germany (AZ 204/ 17). PSPP software was used for data management and statistical analysis. Descriptive statistics, Spearman’s bivariate correlation (twosided), cross-tabulation and Pearson’s χ2 test were used for statistical analysis and a probability of error of < 5% was regarded as significant.
Complementary and Integrative Health (NCCIH, USA) has issued definitions that seem to be appropriate (https://nccih.nih.gov/health/ integrative-health#term; accessed January 26th, 2019):
• ‘complementary medicine’ – a non-mainstream practice used together with conventional medicine; • ‘alternative medicine’ – a non-mainstream practice used in place of conventional medicine; • ‘integrative medicine’ – approaches from complementary and alternative medicine incorporated into mainstream health care after rigorous scientific investigation.
There are few epidemiologic data on the use of complementary and alternative medicine (CAM) for dysmenorrhoea. A Turkish study showed that 70% of 428 study participants (students) used CAM for primary dysmenorrhoea. 4 However, we know little about the general population. In order to understand patients’ decisions better, we analysed a group of women visiting a gynaecological practice and asked them about earlier experiences and likelihood for use of various methods for to dysmenorrhoea.
2. Patients and methods In order to analyse patients’ complaints and preferences, we developed an assessment form for recording:
• demographic data; • complaints related to primary dysmenorrhoea; • earlier experience with several methods used for primary dysmenorrhoea (rating possibilities yes = 1; no = 0); • patient-rated likelihood for using these methods (rating possibilities
3. Results In the given time period we issued 229 assessment forms and 205 were received back; however, several were returned not fully completed. Patient characteristics are given in Table 1 and patient complaints with respect to dysmenorrhoea are presented in Table 2. Almost all patients were familiar with conventional medicine, only 5.5% reported no experience with contraceptives or pain relievers and 26.7% had no experience with CAM. The remaining patients had experience of a median of two (mean = 3.7, SD = 4.8) methods. Fig. 1 shows patients’ earlier experience with the various methods. It can be seen that patients had the most experience with contraceptives and pain relievers, followed by diet and homeopathy. Contraceptives were frequently used primarily for the treatment of dysmenorrhoea. Patients had least experience with royal jelly, anthroposophy and biophotons.
were 1 = very likely; 2 = likely; 3 = possibly; 4 = unlikely).
Selection of the various methods that patients had to rate was based on an earlier analysis of methods used for dysmenorrhoea in Germany. 5 The various methods were listed alphabetically and patients asked to note earlier experience and the likelihood of using the named method. A copy of the assessment form can be obtained from KM (German version only). The assessment form was distributed as a paper version between May 2018 and July 2018 to a consecutive group of patients in a private gynaecological practice in Weilburg, Germany. It was intended to receive 200 assessment forms back to allow appropriate 2
Complementary Therapies in Medicine 45 (2019) 1–6
K. Münstedt and T. Riepen
Furthermore, patients were asked to rate the probability of using the different methods for dysmenorrhoea, the results of which are shown in Fig. 2. Fig. 2 does not differentiate between women who received information on efficacy and safety because it was found using Pearson’s χ² test that the provided information had no influence on patients’ decision. Due to the necessity for a Bonferroni correction, only the decision regarding the use of enzymes might have been influenced by the provided information on efficacy, safety and costs (χ² = 15.5; df = 3; p = 0.001). Fig. 2 shows that the likelihood of using a certain method is quite similar to earlier experience. Pearson’s χ² test confirmed that earlier experience was a significant factor that influenced patients’ decision for or against a certain method (all p < 0.01). The results were analysed to see whether there are strong correlations between the likelihood of using one method over another. Correlation analysis using a high number of patients gave many statistically significant results but only the results with correlation coefficients of ≥ 0.5 are given (p < 0.001):
Table 2 Severity of complaints of patients related to dysmenorrhea on a scale from 0 (no complaints) to 10 (severe complaints). Entire group n = 205
Group with information n = 100
Group without information n = 105
Headache Mean (SD) Range
2.3 (2.7) 0 – 10
2.5 (2.9) 0 – 10
2.1 (2.6) 0–8
Malaise Mean (SD) Range
2.9 (2.6) 0 – 10
3.3 (2.7) 0 – 10
2.5 (2.6) 0–8
Bloating Mean (SD) Range
2.1 (2.5) 0–9
2.4 (2.6) 0–8
1.7 (2.4) 0–9
Nausea Mean (SD) Range
.7 (1.7) 0 – 10
0.9 (1.9) 0–8
.6 (1.6) 0 – 10
Vomiting Mean (SD) Range
.2 (.6) 0–4
.3 (.7) 0–3
0.1 (.5) 0–4
Diarrhoea Mean (SD) Range
.8 (1.9) 0 – 10
1.1 (2.3) 0 – 10
.6 (1.6) 0–8
Abdominal cramps Mean (SD) Range
4.6 (3.2) 0 – 10
4.7 (3.2) 0 – 10
4.4 (3.2) 0 – 10
• Oral contraceptives: no correlations • Acupressure: acupuncture (.609), honey (.552), royal jelly (.588) • Acupuncture: acupressure (.609) • Anthroposophy: honey (.534), royal jelly (.644), apipuncture (.581), biophotons (.570) • Honey: acupressure (.552), anthroposophy (.534), royal jelly (.855), •
apipuncture (.595), biophotons (.578), neural therapy (.588), orthomolecular medicine (.537) Royal jelly: acupressure (.588), anthroposophy (.644), honey (.855),
Fig. 1. Patients’ earlier experiences with various methods for dysmenorrhoea. Contraceptives were frequently used primarily for the treatment of dysmenorrhoea. Colours indicate whether a method may be considered a part of conventional medicine (blue = conventional medicine; red = complementary, alternative or integrative medicine) (For interpretation of the references to colour in this figure legend, the reader is referred to the web version of this article). 3
Complementary Therapies in Medicine 45 (2019) 1–6
K. Münstedt and T. Riepen
Fig. 2. Patient rated likelihood for using the various methods for dysmenorrhoea.
• • • • • • • • • • • • •
• Orthomolecular medicine: honey (.537), royal jelly (.612), biopho-
apipuncture (.686), biophotons (.701), leeches (.510), magnets (.573), neural therapy (.564), orthomolecular medicine (.612) Apipuncture (bee venom acupuncture): anthroposophy (.581), honey (.595), royal jelly (.686), biophotons (0.714), leeches (.548), neural therapy (.731), orthomolecular medicine (.571) Aromatherapy: Bach flowers (.574), biophotons (.529) Bach flowers: aromatherapy (.574), biophotons (.574), diet (.608), omega-3 fatty acids (.554), phytotherapy (.512) Biophotons: anthroposophy (.570), honey (.578), royal jelly (.701), apipuncture (.714), aromatherapy (.529), Bach flowers (.574), leeches (.717), magnets (.605), neural therapy (.525), orthomolecular medicine (.597), phytotherapy (.572) Leeches: royal jelly (.510), apipuncture (.548), biophotons (.717), magnets (.520) Diet: Bach flowers (.608) Homeopathy: no correlations Ginger: no correlations Magnets: royal jelly (.573), biophotons (.574), leeches (.520), manual therapy (.560), neural therapy (.534), phytotherapy (.524) Manual therapy: magnets (.560), phytotherapy (.512) Moxibustion: neural therapy (.571), omega-3 fatty acids (.502), orthomolecular medicine (.678), phytotherapy (.521) Neural therapy: honey (.588), royal jelly (.564), apipuncture (.731), biophotons (.525), magnets (.534), moxibustion (.571), omega-3 fatty acids (.581), orthomolecular medicine (.700) Omega-3 fatty acids: Bach flowers (.554), moxibustion (.502), neural therapy (.581), orthomolecular medicine (.553), order therapy (.515), vitamin B1 (.502)
• • • • • • • • •
tons (.597), moxibustion (.678), neural therapy (.700), omega-3 fatty acids (.553), phytotherapy (.514) Order therapy (includes exercise and relaxation): omega-3 fatty acids (.515), physical therapy (.588) Physical therapy: phytotherapy (.555) Phytotherapy: Bach flowers (.525), biophotons (.572), magnets (.524), manual therapy (.512), moxibustion (.521), orthomolecular medicine (.514), physical therapy (.555) Pain relievers: no correlations Schüssler cell salts (homoeopathically potentised doses of essential minerals): Traditional Chinese Medicine (.602) Traditional Chinese Medicine: Schüssler cell salts (.602), osteopathy (.603), cinnamon (.517) Vitamin B1: omega-3 fatty acids (.502), osteopathy (.566), cinnamon (.521) Osteopathy: Traditional Chinese Medicine (.603), vitamin B1 (.566), cinnamon (.518) Cinnamon: Traditional Chinese Medicine (.517), vitamin B1 (.521), osteopathy (.518)
No correlation between age, total pain score (sum of all complaints), degree of education and the likelihood of using a certain method was found.
4. Discussion This study provides some insight regarding the use of various 4
Complementary Therapies in Medicine 45 (2019) 1–6
K. Münstedt and T. Riepen
patients. 12 From the physicians perspective, efficacy is one of the key issues. In this respect patients should not only have a choice but should also receive education in this field. It was hypothesized that the method of delivery of information is critical and that patients prefer exact information on what to expect from treatment. 14 Other research in the field suggests that costs play an important role in patients from lowincome groups and that safety seems to be a major concern. 15 In order to allow patients to make the right choice it seems important that physicians are aware of patients’ preferences and the background to their decision. Based on this study it seems important that physicians who want to give the patient good advice should inform them in greater detail and with personal dialogue. Holistic treatment in the literal and true sense should include the therapist being familiar with all the treatment options in order to counsel patients appropriately. This study should also be interesting for protagonists of very special types of therapies, for example apitherapists. Apitherapists claim that all diseases can be cured with bee products and thus they promote bee products. 10,16 As shown for primary dysmenorrhoea, the evidence for apitherapy is scarce. This study shows that patients’ interest in these methods is low and that patients might be better off with other CAM methods. There are some limitations to this study. This study comprises a convenience sample of patients who visited a physician advocating conventional medicine in a small town in Hesse, Germany. Thus it cannot be said that our sample is representative of the female population of Germany. It must also be assumed that patients with disrespect for conventional medicine will not visit a physician. These factors might have created biases. However, about 80% of all women visit physicians for early cancer diagnosis and screening. 17 In combination with the excellent response rate, we should have reached a good proportion of females living in the specified area. Furthermore, the results show that we reached many patients with manifold experiences in the field of CAM. In summary this study provides some insight regarding patients’ decisions on a very common problem in the field of obstetrics and gynaecology. It shows that the factor “earlier treatment experiences” is of great importance and that brief information on efficacy, safety and costs are not sufficient to influence treatment decisions. In this respect homoeopathy and diet seem to be of greatest relevance. Since both do not seem to be of greatest efficacy, is seems important to develop effective means to inform patients on most appropriate methods. According to the deficit model effective science communication should include findings from social science research and engage community members around scientific issues.
methods from conventional and from complementary, alternative and integrative medicine for primary dysmenorrhoea. In contrast to our prior beliefs, patients did not consider the given information on efficacy, safety and costs when asked whether they would use a particular method. Earlier experience with a method was the most important reason why patients chose that method. The study also shows that patients have different conceptions of which methods are associated with each other. Interestingly, patients associated the various concepts of apitherapy (honey, royal jelly, apipuncture) with each other, whereas the various parts of Traditional Chinese Medicine were not associated (acupuncture, moxibustion). Also, no association was found between Schüssler’s salts, homeopathy and anthroposophy, which also have a common background. This means that patients have differing views of the different fields of CAM. Also, there are no associations between the methods of conventional medicine (oral contraceptives, pain relievers) and any CAM treatment. Use of CAM is a mainly patient-driven field of medicine. As stated by Fotaki, choice policies do not lead to more efficiency or higher quality in health care. 8 While highly educated and well-informed patients may benefit from personalized and high-quality service arrangements that are closely adapted to their needs, in contrast to largescale and standardized health care there is a great possibility that patients receive worse-quality treatment if users’ literacy concerning health and/or the health care system is low. 8 This problem may be even more pronounced when the multitude of methods from alternative, complementary and integrative medicine come into consideration. Since there is limited information on efficacy and safety for many of these methods, the chances to make the wrong choices are even greater. In this respect it is important that patients receive information on what to expect from treatment. This seems to be true for the problem of primary dysmenorrhoea as well. Apart from the concepts from conventional medicine, local heat applications (hot water bottles), the use of aromatherapy, aroma oil massage, ginger and moxibustion can be considered efficacious and may thus be considered candidates for integrative medicine. 5,6 Although this information was provided to the patients, it was not used. Instead, many chose homeopathy, which was not reported to be helpful based on a randomized controlled trial. 9 Recent reviews on the efficacy and safety of CAM for dysmenorrhoea conclude that some methods can be efficacious whereas there is no information on the suitability or even the risks of others. 3,5,6,10 However, it seems to take more than a little information on efficacy, safety and costs to make patients consider new treatment options. As patients are not familiar with the interrelationship between various types of medicine, they seem to choose on the basis of what they already know. It was shown in this study that providing information on efficacy, safety and costs does not mean that they make better choices. If they had considered the given information on efficacy, safety and costs based on the studies in the field, patients would have chosen the already mentioned methods (local heat applications, exercise or physical therapy, aromatherapy including lavender oil massage, ginger) and perhaps vitamin B1, omega-3 fatty acids and acupressure, all of which have proved to be effective, fairly safe and highly cost effective. 5,6,10 Thus, the treatment decisions of the patients in this study were not influenced by our way of providing information and are not rationally founded. These findings are well in line with the “deficit model” which hypothesizes that effective science communication should be based on social science research and use approaches that engage community members around scientific issues. 11 However, earlier studies showed that other factors are considered regarding treatment decisions for dysmenorrhoea. These include the mode of administration, chances of irregular bleedings, chances of nausea, and chances of symptoms becoming “improved”. 12 As it has been shown that patients can be influenced by the physician’s opinion, it seems necessary that patients require more information than just a few smileys. 13 On the basis of the work by Akiyama et al. it may be concluded that efficacy is not the primary concern of the
Funding None. Conflict of interest None. Acknowledgement The authors thank Rosemarie Badaczewski for preparing the questionnaires for statistical analysis. References 1. Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea. Epidemiol Rev. 2014;36:104–113. 2. Bernardi M, Lazzeri L, Perelli F, Reis FM, Petraglia F. Dysmenorrhea and related disorders. F1000Research. 2017;6:1645. https://doi.org/10.12688/f1000research. 11682.1. 3. Oladosu FA, Tu FF, Hellman KM. Nonsteroidal antiinflammatory drug resistance in
5
Complementary Therapies in Medicine 45 (2019) 1–6
K. Münstedt and T. Riepen
4.
5. 6. 7. 8. 9.
10. 11.
12.
dysmenorrhea: Epidemiology, causes, and treatment. Am J Obstet Gynecol. 2018;218:390–400. Midilli TS, Yasar E, Baysal E. Dysmenorrhea characteristics of female students of health school and affecting factors and their knowledge and use of complementary and alternative medicine methods. Holist Nurs Pract. 2015;29:194–204. Münstedt K. Rationale naturheilkundliche Ansätze zur Behandlung der primären Dysmenorrhoe. Gyne. 2016;37(2):7–14. Latthe PM, Champaneria R, Khan KS. Dysmenorrhoea. BMJ Clin Evid. 2011;21(February 2011) pii: 0813. Münstedt K. Komplementäre und alternative Krebstherapien. 3rd edition Germany: Landsberg am Lech; 2012. Fotaki M. Is patient choice the future of health care systems? Int J Health Policy Manag. 2013;1:121–123. Alizadeh Charandabi SM, Biglu MH, Yousefi Rad K. Effect of homeopathy on pain intensity and quality of life of students with primary dysmenorrhea: A randomized controlled trial. Iran Red Crescent Med J. 2016;18:e30902. Münstedt K. Meaningfulness of apitherapeutic approaches using the example of primary dysmenorrhoea. J Apitherapy. 2018;3:9–16. Simis MJ, Madden H, Cacciatore MA, Yeo SK. The lure of rationality: Why does the deficit model persist in science communication? Public Underst Sci. 2016;25:400–414. https://doi.org/10.1177/0963662516629749. Akiyama S, Goren A, Basurto E, Komori T, Harada T. Treatment preferences among
13. 14.
15.
16.
17.
6
Japanese women with dysmenorrhea: Results from a discrete choice experiment study. Patient Prefer Adherence. 2018;12:1627–1640. https://doi.org/10.2147/PPA. S166332. Rozenberg S, Ham H. Effect of physicians’ opinion on patients’ choice of treatment. Eur J Obstet Gynecol Reprod Biol. 2001;96:215–217. Harmsen CG, Støvring H, Jarbøl DE, et al. Medication effectiveness may not be the major reason for accepting cardiovascular preventive medication: A populationbased survey. BMC Med Inform Decis Mak. 2012;12:89. https://doi.org/10.1186/ 1472-6947-12-89. Bo NJ, Ejg JD, Dorte GH, Lind BB, Veldt LP. Determinants for acceptance of preventive treatment against heart disease – A web-based population survey. BMC Public Health. 2014;14:783. https://doi.org/10.1186/1471-2458-14-783. Hellner M, Winter D, von Georgi R, Münstedt K. Apitherapy: Usage and experience in German beekeepers. Evidence Based Complementary and Alternative Medicine. 2008;5:475–479. https://doi.org/10.1093/ecam/nem052. Starker A, Bertz J, Saß A-C. Inanspruchnahme von krebsfrüherkennungsuntersuchungen. Daten und fakten: Ergebnisse Der Studie “gesundheit in deutschland aktuell 2010”. Beiträge Zur Gesundheitsberichterstattung Des Bundes. RKI, Berlin: Robert Koch Institute; 2012https://www.rki.de/DE/Content/Gesundheitsmonitoring/ Gesundheitsberichterstattung/GBEDownloadsB/Geda2010/kapitel_ krebsfrueherkennung.pdf?__blob=publicationFile).