Bachelor Thesis, 15 credits
Physiotherapy Programme 180 credits
Vt 2020
USAGE OF
NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS
IN A SAMPLE OF NEW
ZEALANDERS WITH
OSTEOARTHRITIS
A cross-sectional study
Physiotherapy Programme 180 credits
Title English:
Usage of Non-steroidal anti-inflammatory drugs in a sample of New Zealanders with osteoarthritis
Year:
2020
Title Swedish:
Användning av icke-steroida antiinflammatoriska läkemedel i ett stickprov av Nya Zeeländare med artros
Year:
2020
Author:
Victor Swenson, Tvistevägen 1E 90729 Umeå Mattias Ekberg, Tvistevägen 1E 90729 Umeå
Tutor:
Dr Cathy Chapple, School of physiotherapy, University of Otago, Dunedin, New Zealand
Keywords:
NSAID, Oesteoarthritis, Survey, Cross-sectional study, Comorbidities, Adverse events, Clinical guidelines, New Zealand
External collaboration:
Yes
School of physiotherapy, University of Otago
Part of ongoing project:
Yes
Abstract:
Introduction
Oral Non-steroidal anti-inflammatory drugs (NSAID) is an analgesia and is commonly used by people with osteoarthritis (OA). Oral NSAID is currently recommended as the second level of treatment for OA, and could be considered if physical activity, topical NSAID or paracetamol do not supply sufficient pain relief.
Aim
To investigate how frequently oral NSAID is used in a sample of New Zealanders with OA and also to investigate the exposure to heightened risk of adverse events while using oral NSAID.
Method
A cross-sectional survey was conducted to collect information about the use of oral NSAID by people with self-reported OA. The survey included 75 participants who were over the age of 45 with an average age of 70.6 years.
Results
While having OA, 57,3% of the sample reported oral NSAID use. The results also show that 52% of the participants with cardiovascular (CV), gastrointestinal (GI) or renal comorbidities used oral NSAID, and 17,3% of them also combined that NSAID with medication for their comorbidity. Concerning the heightened risks of adverse events, 21% of the participants did acquire the analgesia over the counter (OTC), and 76,6% stated that they were over the age of 65.
Conclusion
A majority of the participants in the study with self-reported OA take NSAID as an analgesia. Also, the study shows that NSAID is commonly used among participants with co-morbidity, which is similar to figures presented in previous studies in the area. However, the small sample size limits its generalizability to a larger population.
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Svensk sammanfattning:
Introduktion
Orala icke-steroida antiinflammatoriska läkemedel (NSAID) är en grupp smärtstillande mediciner som är vanligt använt av personer mer artros. Orala NSAID-preparat rekommenderas idag som en andrahandsbehandling och kan övervägas om fysisk aktivitet, topikala NSAID-preparat eller paracetamol inte ger tillräcklig smärtlindrande effekt.
Syfte
Att undersöka hur vanligt användandet av orala NSAID-preparat är i ett stickprov av personer med artros i Nya Zeeland samt att undersöka exponering av orala NSAID-preparat i subgrupper med ökad risk för biverkningar vid användande av orala NSAID-preparat.
Metod
En tvärsnittsstudie genomfördes för att samla in information kring användning av orala NSAID-preparat av personer med självrapporterad artros. Studiepopulationen bestod av 75 personer över 45 års ålder med en medelålder på 70,6 år.
Resultat
57,3% av deltagarna använder orala NSAID-preparat som behandling för sin självrapporterad artros. Gällande subgrupper med ökad risk för biverkning av NSAID användning visar studien att 52% av deltagare med kardiovaskulära, gastrointestinala eller njurpåverkade sjukdomar använder orala NSAID-preparat och av dessa kombinerar 17,3% NSAID-preparaten med medicin för sin samsjuklighet. Av deltagarna som uppgav att de använder orala NSAID-preparat erhåller 21% av dessa NSAID-preparaten receptfritt över disk. Av deltagare som var 65 år eller äldre uppgav 76,6% att de använder orala NSAID-preparat för behandling av artros.
Slutsats
Introduction
Osteoarthritis (OA) is a chronic degenerative condition which is clinically characterized as pain and functional limitation in one or multiple joints (1). OA is a heterogeneous disease which means that the disease has several aetiologies. Certain factors increase the risks of developing OA, such as, previous joint injury, surgery, obesity, hard demanding physical activity and a genetic influence (2). Muscle weakness is also considered to be a risk factor (3). A systematic review and meta-analysis showed that there is a correlation between increased risk of developing knee-OA and muscle weakness in the knee- extensors (3). OA is most common in the knee, hip and hand (1) and it affects 50% of New Zealand’s adults over the age of 60 years (4) and is estimated to affect 10-15% of the population world-wide who are over the age of 60 years (5). This makes OA the most common cause of disability for elderly people and because of the increasing rates of ageing and related factors such as obesity, it is estimated 20% of the world’s population over the age of 60 will be affected by 2050 (5).
Pathology
OA occurs when the articular cartilage has impaired healing in relation to the strain the joint is exposed to, resulting in gradual cartilage breakdown (6). OA is therefore a dynamic process with an imbalance between the active repair and destruction of joint tissue (6). The structural alterations occur in the joint as a whole, which includes the degradation of the articular cartilage, subchondral bone thickening, ligament and capsule degeneration and synovium inflammation (7). The articular cartilage changes its composition during the OA-process and is partly associated with increased impact from mechanical forces (6). These forces can cause a degradation of cartilage, and later on create fissures deep in the cartilage. The cartilage attempts to repair the fissures through hypertrophic-chondrocytes which grow until they go into apoptosis (programmed cell death) (6). This leads to breakdown of the articular cartilage matrix and a pro-inflammatory reaction becomes active in the synovium, resulting in calcification and degradation of the cartilage (6). The inflammatory reaction also affects the subchondral bone and results in an endochondral ossification and the bone gets thicker. This highlights the importance of inflammation as part of the pathological process in the joint (6).
Obesity is as previously stated a risk factor for OA (2), not just from the biomechanical load but also from metabolic and low-grade inflammatory reactions that are associated with having a body mass index (BMI) >30 (8). Having a body composition with a larger amount of fat mass is associated with having pre-clinical OA (9). The explanation for this is that fat mass is recognized to be a highly metabolically active tissue that produces inflammatory molecules such as cytokines and adipokines (9). These inflammatory molecules have been shown to contribute to the OA process by causing a low-grade inflammation in the synovium, which is associated with cartilage loss (9). This inflammation caused by the metabolic fat tissue explains why obesity is a risk factor for hand-OA, since it is not a typically loaded joint (9).
International treatment guideline recommendations
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recommended in the managing of the disease. The third level should be recommended only if the first two steps make no difference in the disease development (12, 13). These levels for treating people with OA are common in international treatment guidelines as they show direct steps on how best to manage the disease from a low-level intervention and how to gradually step up the management to minimize the risk of having to undergo surgery for the OA (11, 12). Recent research suggests that only 10-15% of the population with OA should be recommended treatment that involves surgery (12).
Within the different levels of care there are many different treatment methods and approaches for OA. Initially core treatments are recommended, which include providing information, exercise and weight loss (13-17). Through provision of information the patient will learn more about OA, how to manage the disease and how to develop self-efficacy, or confidence in their own ability to self-manage the disease. Recommendations for exercise include an individualized, physiotherapist supervised program that includes a combination of muscle strength, aerobic exercise and mobility (11). To manage and reduce pain arising from a joint with OA, weight control is an important consideration, especially for individuals with a BMI >25 kg/m2 (18).
When considering pharmacological interventions in the first level of care, core treatments commonly recommended are paracetamol or topical non-steroidal anti-inflammatory drugs (NSAID) (16, 17). The second level treatments recommended if the core treatment is insufficient to reduce pain and increase quality of life, are alternative physical treatments or different pharmacological solutions (11, 18). The non-pharmacological treatments include aquatic training, tai chi/yoga, manual therapy, thermotherapy, transcutaneous electrical nerve stimulation (TENS) and supportive devices such as canes (4, 10-20). The benefits of these interventions are primarily that they reduce pain and stiffness and increase mobility, and do not have any serious side effects (11, 19).
A New Zealand report shows that physical activity and physiotherapeutic interventions, in addition to not causing any serious side effects, also have positive effects on obesity, balance, quality of life and reduce risks of comorbidities, such as cardiovascular diseases (CV) (20). Furthermore, exercise and alternative physical treatment have also been shown to provide at least the same pain relief as topical and oral NSAID medications (18). Further evidence from a meta-epidemiological study supports this finding with combined data from six Cochrane reviews showing that exercise and use of analgesic had the same effect (21). A Danish-developed model of care (GLA:D), today used in several places around the world makes use of a combination of standardized education and standardized exercise programs delivered by physiotherapists. The aim of this model of care is to increase physical function, physical activity and quality of life, primarily in people with OA (22). This model is based on recommendations from international treatment guidelines and has proven that education and exercise will reduce joint pain by 25% on average, reduce sick days by 25%, and is associated with a 33% reduction in use of analgesia (paracetamol, NSAID medication and opioids) in a 3-month period (23). These results indicate that education in combination with standardized, supervised training programs is a good alternative to the use of medication in relieving pain and improving physical activity, physical function and quality of life (22).
Pharmacological treatment basis
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The risks of oral NSAID use increases with age, other comorbidities, prolonged or excessive use (25, 26). Long-term usage of all oral NSAID is associated with developing CV, gastrointestinal (GI) ulceration and bleeding and renal impairment (25). There is medication available to reduce risks of adverse events for some comorbidities. In cases of GI co-morbidity, proton pump inhibitors (PPI) are commonly used as preventive treatment (27). The analgesic effect that comes with short-term usage of oral NSAID is well established. According to a systematic review and meta-analysis analgesic effect peaks at two weeks and then decreases over time (24). Additionally, the incidence of minor CV and GI rises consistently with long-term usage of oral NSAID (24). However, the evidence can be contradictory. Another meta-analysis suggests that risks of developing myocardial infarction is greatest during the first four weeks of usage (28). Risks of adverse events are said to increase even more if you are over the age of 65 years or if you already suffer from co-morbidity before starting with NSAID, in particular CV, GI or renal diseases (29). International treatment guidelines suggest that if patients have to use oral NSAID despite involved risks, it should be taken in the lowest dose and for the shortest possible amount of time (13-17).Despite the risks, topical and oral NSAIDs are widely available, and can be acquired by more or less controlled forms. prescription from a medical practitioner, over the counter (OTC) or bought online (30). This comes with differing levels of screening and monitoring for adverse events (29). Regardless of how the NSAID medications are purchased or the presence of risk factors such as certain comorbidities or increasing age, care should be taken regarding dosing and interaction with other medication (31). When purchasing OTC NSAID risks are increased if there is no consideration of comorbidities, suitable dose, or drug interactions, and no medical monitoring of side effects (29). OTC purchase of NSAID may lead to people exceeding the recommended dose, or combining NSAID with other medication causing an adverse medical reaction (31). In particular, concurrent use of NSAID and medications for prevention of CV events such as angiotensin-converting enzyme inhibitors (ACEI) and diuretics should be done with extra caution due to the risks of adverse events (31). Findings from a small study conducted in Italy showed that 47% of participants with OA acquired extra NSAID in addition to their original prescription, which were used to treat conditions other than OA itself, such as headache or fever (26). In addition, the general public’s knowledge of side effects that can arise from overuse of NSAID has been found to be deficient (32). According to a Danish study it was concluded that 54% of a small sample of rheumatological-care patients did not know what the side effects were from overuse of NSAID and were therefore more likely to overuse by combining prescribed and OTC-bought NSAID (32).
Research aims and questions
To the best of our knowledge there are no studies done in New Zealand investigating the use of NSAID as an analgesic for OA. The primary aim of this research was therefore to estimate the frequency of use of oral NSAID for OA in a New Zealand sample. Secondary aims were to investigate exposure to heightened risk of adverse events while using oral NSAID from factors such as comorbidities, other medications and increasing age. Furthermore, no studies were found investigating OTC use of oral NSAID in New Zealand. This cross-sectional study will therefore examine these aims in a small community-based sample as a possible basis for future research about use of oral NSAID by people with OA in New Zealand. Our research questions were:
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Primary
• In what frequency are oral NSAID used as analgesia by people with OA?
Secondary
• In a sample of people with OA taking NSAID, how many reports a comorbidity of CV, GI or renal disease, and use medication for their condition?
• What is the age distribution in a sample of people with OA taking NSAID?
• In a sample of people with OA are their oral NSAID prescribed by a doctor or purchased as an OTC medication?
Methods
Study Design
A cross-sectional survey was conducted to collect information about the use of oral NSAID by people with OA.
Settings
The data collection took place in Dunedin which is a small city in the south of New Zealand. The recruitment was conducted in two settings, the first being the New Zealand's Master's Games which is the largest multi-sport event in New Zealand and was held between 1st - 9th
of February 2020. At the Master's Games the research team attended various sports venues asking people if they wanted to participate in the study. The second recruitment setting was in a shopping mall outside a supermarket where passers-by were asked if they wanted to participate. Data collection at the shopping mall took place between 1st – 11th of March
2020.
Procedures
The data collection was conducted using iPads which had the survey uploaded onto the Qualtrics platform, or by printed surveys which could be filled out by hand. A QR-code and an URL link were also provided, to facilitate completion of the survey at a later time. The online version of the survey was available to answer until the 31st of March. Informed
consent was obtained from participants before conducting the survey by ticking a box on the consent form. The form included the ethical requirements for the study´s approach. The research team who collected the data consisted of two undergraduate physiotherapy students from Umeå University, Sweden, a physiotherapy lecturer from the University of Otago in Dunedin, New Zealand, and a PhD student from the University of Sydney, Australia.
Participants
The eligible participants were adults over 45 years of age, in the city of Dunedin in New Zealand. To be included in the study, participants had to be able to understand the information sheet, understand and fill in the consent form and understand the study questions. They also had to have self-reported joint pain and/or OA.
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The recruitment settings were selected in preference to medical centres or health care providers as the sample of interest were a sample of the general population, rather than people with comorbidities and prescribed medication seeking formal healthcare.Data sources and measurement
The Otago research team designed the survey to answer the primary research questions. The questions were structured to make the study as specific as possible, while limiting participant burden by making the survey concise and easy to answer. Demographic questions were included to characterise the sample. In addition, asking about comorbidities was considered useful, as use of NSAIDs is not recommended for people with CV, GI or renal diseases. The study sheet was designed not to be too long as this could increase the risk of people not completing the entire survey.
The New Zealand OA research survey (Appendix A) contained five questions about demographics (age, ethnicity, sex, weight and height). Questions about self-reported OA ensured inclusion criteria were met, and that the sample contained the main group of interest for answering the research questions. To clarify the location of pain, a question was asked about which joint was affected by OA. The survey also contained questions about whether the participant was using oral NSAID medication, and if so, how frequently the medication was used, and if it was acquired by prescription from a medical practitioner, purchased as an OTC medication (bought at a supermarket, pharmacy or online) or both. Questions were also asked about participants comorbidities and use of medication for diseases other than OA. These questions were included to assess risk of adverse events from using oral NSAID that are:
i. Contraindicated by comorbidities
ii. Used in combination with other medications likely to cause adverse interactions iii. Exceeding recommended dose
Order of questions was constructed using flow logic, with drop down options on the iPad, or secondary questions asked as follow-up to initial questions in the printed survey. There were also free text options when answering questions concerning medication. The estimated time to complete the survey was 5-10 minutes.
During the Master´s Games, questions from the Otago survey were included in a larger survey created by University of Sydney researchers. The University of Sidney research was investigating dietary and training behaviours of Master´s Games athletes. This survey took approximately 25-30 minutes to answer. Combining the two projects allowed for ease of access to potential participants, while decreasing participant burden.
Sample size
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Data management and statistical analysis
Electronic data was downloaded and transferred to an excel sheet. Printed survey data was transferred to the same excel sheet manually and every 10th answer was double-checked by
a second researcher to check for accuracy. The data is presented as descriptive statistics and in contingency tables which were created with Jamovi version 1.2.
Age data is divided into groups 45-64, 65-79 and 80+ according to the MeSH terms for age groups; Middle age, Aged and Aged, 80 and over. BMI was calculated using the formula BMI=weight(kg)/[height(m)]2 and reported as kg/m2 BMI is divided into ranges of <18.5,
18.5-24.9, 25-29.9 and > 30, classified as underweight, healthy weight, overweight and obese(34). If the participants did not report their weight or height, they were presented as “No data” and excluded from calculations of mean and standard deviation for BMI. Other demographic variables did not require further calculations.
Participants reported their medications by their pharmaceutical name in the survey. These were categorized as: extra oral NSAID (besides the one already reported), paracetamol, CV, GI or renal medication. Medications for other conditions are not reported.
Ethics
This study has received ethical approval from the University of Otago Ethics Committees (Health): (SoP/EC/2020/01) and from the University of Sydney (2019/960). Additional approval was sought from all data collection venues. The study was submitted for consultation with Māori via Ngāi Tahu Research Consultation Committee of the University of Otago.
By ticking the box on the consent form, participants agreed that their participation in the study was completely voluntary and, as participants, they were entitled to withdraw from the study at any time until the study sheet was completed and submitted. It was possible to withdraw for whatever reason and the data collected up to the point of withdrawal would be destroyed. Study participation was completely anonymous and no identification data was collected. The collected data will be stored in secure storage for ten years.
Results
Participants
A total of 148 data survey responses were collected, 43 of these online via Qualtrics from the Master´s Games, and 105 paper-based from the shopping mall. Of these, 13 participants were excluded due to young age (<45) and 4 participants were excluded due to unspecified
age. The remaining 131 surveys were screened and another 57 participants were thereafter
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Figure 1. Flow chart of participants in the study
Descriptive data
Table 1 describes the demographics of the study participants. Out of 131 screened surveys, 75 participants stated that they had some form of OA. The average age of participants was 70,6 years and most people were overweight. Of those who stated that they suffered from OA, a majority were women with New Zealand European ethnicity. Slightly less than 10 % of the participants indicated having another ethnicity.
Table 1. Demographics of participants with osteoarthritis
OA (n=75)Male (%) 20 (26,7)
Female (%) 55 (73,3)
Age, years (mean ± SD) 70,6 (± 10,6) Age category years (%)
45-64 15 (20,0)
65-79 46 (61,3)
80+ 14 (18,7)
Ethnicity (%)
New Zealand Europeana 71 ( 91,0)
Māoria 4 (5,1)
Chinese 1 (1,3)
Indian 1 (1,3)
Cook Island Māori, Samoan, Niuean, Tongan 0 (0,0)
Other 1 (1,3) BMI, (mean ± SD) 28,0 (± 6,48) BMI category (%) <18,5 1 (1,3) 18,5-24,9 24 (32,0) 25-29,9 25 (33,3) >30 20 (26,7) No data 5 (6,7)
Key: BMI= Body mass index, SD= Standard deviation,
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Table 2 reports how frequently oral NSAID are used by the participants with OA. In total, 43 participants used oral NSAIDs and almost half of them had used NSAIDs every day for more than a month. More than half of the NSAID users used NSAIDs less frequently or for shorter periods of time.
Table 2. Frequencies of oral non-steroidal anti-inflammatory drugs use for people with
osteoarthritis
NSAID use N (%)
No 32 (42,7) a
Yes 43 (57,3) a
Frequency of NSAID use
Occasionally (single dose) 10 (23,6) b
Sometimes (for a few days) 13 (30,2) b
Every day (< a month) 1 (2,3) b
Every day (> a month) 19 (44,2) b
NSAID= Non-steroidal anti-inflammatory drugs, OA= Osteoarthritis
a Based on total number of participants with OA (n=75) b Based on number reporting NSAID use (n=43)
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medication with oral NSAID. In total 17,3% of the participants combined their CV, GI or renal medication with oral NSAID, and 52% of the participants with comorbidities used oral NSAID.Table 3. Comorbidities and combinations with medication
Table 4 reports on how the use of oral NSAID is distributed between the different age groups. Of the people with OA who used oral NSAID a clear majority was over the age of 65 years.
Self-reported
comorbidities N (%) Medication for comorbidity, N (%) Oral NSAID for OA Use, N (%) Medication for comorbidity + oral NSAID for OA, N (%)
Paracetamol, N (%)
CV 33 (67,3) 19a (57,6) b 27a (81,8) b 11 (33,3) b 1 (3,0) b
(2 combined with
renal medication) (9 reported use of two different prescribed NSAIDs) GI 6 (12,3) 0 (0,0) c 3a (50,0) c 0 (0,0) c 1 (16,7) c (1 reported use of two different prescribed NSAIDs) Renal 10 (20,4) 3a (30,0) d 9a (90,0) d 2 (20,0) d 1 (10,0) d (2 combined with CV
medication) (5 reported use of two different prescribed NSAIDs)
Total 49 (100) 22a (29,3) e 39a (52,0) e 13 (17,3) e 3 (4,0) e
OA= osteoarthritis, NSAID= Non-steroidal anti-inflammatory drugs, CV= cardiovascular, GI= Gastrointestinal
a Some participants are on several medications b Calculations based on n=33
c Calculations based on n=6 d Calculations based on n=10
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Table 4. Age distribution between the oral non-steroidal anti-inflammatory drugs
users
NSAID use (n=43) Age N (%) 45-64 10 (23,3) 65-79 26 (60,5) 80+ 7 (16,2) Total 43 (100)NSAID= Non-steroidal anti-inflammatory drugs
Table 5 reports on how the oral NSAIDs were acquired by the participants with OA. Most of the participants acquired their Oral NSAID through a prescription from a doctor.
Table 5. Sources of the oral non-steroidal anti-inflammatory drugs
NSAID use (n=43) Source N (%) Prescribed by doctor 34 (79,1) OTC 7 (16,3) Prescribed + OTC 2 (4,7) Total 43 (100)
NSAID= Non-steroidal anti-inflammatory drugs, OTC= Over the counter
Discussion
This study demonstrated that oral NSAID-use is common, with 57.3% of the sample reporting the use of oral NSAID as treatment for OA. With regards to the increased risks for adverse events when using oral NSAID, our results show that more than half (52%) of the participants with CV, GI or renal comorbidities used oral NSAID, and 17,3% of them also combined that NSAID with other medication for their comorbidity. Out of the participants with OA who were recommended to use oral NSAIDs more cautiously because of their age, 76,7% over the age 65 state that they used oral NSAID. However, the study demonstrates a positive indication that a relatively small proportion (21%) of NSAID users acquire their oral NSAID OTC.
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reasons for these results, either the sample coincidentally had a lot of people who already had found the first line treatment insufficient, or opposed to guideline recommendations, people are choosing oral NSAID as a first approach to manage their condition. A recent review states that 50% of the population in the US with OA and 47% of the population in Europe with OA use prescribed NSAID, which is similar to findings in this study (45,3%) (25). According to participants in another US study, 63% reported use of oral NSAID and 19% of them exceeded the daily-dose recommendation (35). The recommended daily intake maximum for some of the most commonly used oral NSAIDs is 1200 mg for Ibuprofen, 1000 mg for Naproxen and 150 mg for Diclofenac (36). To exceed the recommendations for the use of oral NSAID does not seem to be unusual. A quantitative study reports that 11% of 1326 participants exceeded the daily dosage recommendations for oral NSAID (30). A reason explaining why so many choose to use oral NSAID might be because many feels that it provides them with better pain relief than paracetamol (37).The overuse of oral NSAIDs can also be explained by how uncontrolled it can become when it is acquired OTC. OTC use of oral NSAID can contribute to increased risks of adverse events when the use of it is not prescribed or supervised by a medical practitioner as it easily results in the consumer exceeding the recommended dosage. Common reasons for this are because people do not read or follow the instructions on the package (38) or if they don’t realize that they are using a double dose of oral NSAID (30). It is easy to acquire oral NSAID OTC in many countries, including NZ (39, 40). According to a study on Ibuprofen users from the US, 90% of its participants state that they used OTC Ibuprofen and 37% of them also used a second oral NSAID without recognizing they were doubling the dose (30). However, in our study a much lower percentage of participants state that they were using oral NSAIDs OTC (21%) than reported in the literature, when it is compared to other studies (30, 32, 39).
Another part of the explanation could be inadequate consumer knowledge. A study investigating what consumers know about the recommendations for the usage of oral NSAID showed that more than 50% of the participants did not know what the side effects of it could be and a third of the participants in the study did not know what the maximal dosage was and did not know what the contraindications for it was (41). This New Zealand study emphasizes that most oral NSAID users acquire their medication through prescription from a doctor (79,1%) and research from other countries indicates a high use of OTC medication (30, 32, 39). The higher rate of prescription NSAID in New Zealand suggests medical practitioners would have greater capacity to screen for safe use and monitor possible adverse events, thus increasing its safety when compared to other countries. Risk assessments and monitoring from medical practitioners provides a certain level of security form adverse events for the patients (27). Medical practitioners can prescribe either non-selective or selective NSAID depending on the risk factors of patients (27). Non-selective NSAIDs, such as naproxen, are preferred if a patient has a higher risk for a CV adverse event, and selective NSAID, such as celecoxib, are preferred if a GI adverse event is more likely (27).
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Old age is also mentioned as a risk factor for adverse events when using oral NSAIDs. In our study almost 80% of the 75 people with self-reported OA over the age of 65 (60.5% aged 65-79 years, 16.2% aged 80 years or over) used oral NSAID. This might be due to the fact that a larger percentage of elderly people have OA and require a higher level of care (5). Older people also tend to have more comorbidities than the average population (29). This brings a higher risk of adverse events when using oral NSAID since it comes with risks in itself and is likely to be combined with other medication, and should therefore be used with great caution (14).
Comparing use of oral NSAIDs and paracetamol in this study shows that oral NSAIDs are more commonly used than paracetamol as an analgesia. Only 9,3% of the people with OA in this study used prescribed paracetamol to manage their condition, while 52% used oral NSAID. An explanation to why oral NSAID are used so much in contrast to paracetamol is that paracetamol might not be as effective as an analgesic. According to a meta-analysis paracetamol does not provide any statistically significant or clinically important benefit for knee-OA when compared to placebo (42). Another study suggests that as paracetamol have only shown minimal benefit compared to placebo, other treatment approaches should be tried, such as physical activity (23).
Physical activity has been shown to have a comparable effect to oral analgesics on pain relief without the risks of side effects (21). Although the two treatment methods seem to provide the same effects on pain-relief initially, the effects of oral NSAID peaks within the first 2 weeks of usage, and decrease over time, while physical activity has a longer retained effect (24). Some of the pain-relieving mechanisms from physical activity occur by unloading the joint through muscle strengthening and weight loss. Home based quadriceps training has been shown to provide the same pain-relieving effects as oral NSAID for knee-OA (18). Weight loss has been shown to decrease pain and low-grade inflammation by getting rid of metabolic fat-tissue which affects the local inflammation in the joint (8). Even though a significant proportion of the participants in our study chose to manage their OA through the use of oral NSAID, 42,7% still chose to not use any medication at all. Instead participants may have chosen an alternative non-pharmaceutical way to manage their condition or ignore the disease and choose not to undergo treatment at all.
Ethical reflection
To make the participants feel confident that the data for the survey was being collected for a scientific study, and also to reduce the risk of not being perceived as unserious, the research collectors wore uniforms with logos from the University of Otago. During the data collection outside the shopping mall, a showcase was set up with a banner stating collaboration with the School of Physiotherapy in order to provide the same impression of seriousness. Prior to every conducted survey the research collector handed out the information sheet and consent form to the participants and explained the purpose of the study, who it was for and what they agreed to if they accepted to participate in the survey. The objective of this procedure was to reduce the risks of misinterpretation on the ethical aspects of the survey, that the participation was voluntary, withdrawal was possible at any time and that the participation was anonymous.
Limitations
The study had some limitations regarding the data collection, the participants interpretation of the questions and bias.
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survey, with the Otago survey nested within it. was estimated to take about 30 minutes to complete. This could be an explanation why only approximately 40 responses were gathered from that venue. By contrast, the shorter survey conducted in the mall took only 5-10 minutes to complete and gathered many more responses. Additionally, Master´s Games athletes were focused on their sports participation and enjoying themselves and were not keen to take the time to complete a lengthy survey.
Different methods of data collection (electronic or paper-based) could have influenced participant responses. In the electronic version participants only got the opportunity to answer questions about NSAID use if they reported having OA, as the subsequent question was hidden. In the paper-based surveys a few participants stated that they used oral NSAIDs for OA, even though they did not state that they had OA in the initial question. However, the degree to which this affected our overall findings would be small, due to the low amount of people completing the survey electronically.
Participant bias can also be considered a limitation when all answers provided were self-reported. For example, participants perceptions of illnesses and use of medications can give misleading answers. For instance, several people described that they experienced pain and other joint symptoms that would qualify as OA symptoms but did not state that they had the condition in the survey. This was evident because it was possible to note that the participant had OA in two places of the survey, one in a section about other comorbidities and one in a section concerning injuries. This interpretation of the questions may have affected the number of survey respondents who were included in the study.
The study shows preliminary findings in a small sample from the population of the Otago region, which limits its generalizability to the entire NZ population or internationally. Other factors that could have influenced generalizability were insufficient diversity in the sample as the majority of the participants in the study were women, with New Zealand European ethnicity, and in the age range of 65-79 years.
However, there were some interesting trends in the results, which would support a similar study in a larger sample. A larger sample size with increased diversity would increase confidence in the findings, as well as generalizability and give possibility to permitting subgroup analyses (43).
Conclusion
The findings from this small-scale cross-sectional study support previous research in the area. The results from this survey show that 57,3% of participants with self-reported OA take NSAID medications, which is similar to figures presented in other studies from both America and Europe. Several guidelines around the world clearly indicate that NSAID treatment is a secondary alternative for OA. As at least 50% of all OA participants in this and other studies use NSAID, further research should be considered to examine if there needs to be any changes in the current treatment recommendations of OA.
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Appendices
Appendix A : Survey form
Landing page:
Research study to investigate the use of anti-inflammatory medication by adults with
self-reported osteoarthritis in a New Zealand sample
You are invited to participate in a research study which aims to collect information on use of anti-inflammatory medication by adults in New Zealand. Any adult over 45 years may take part. Please read this information carefully before deciding whether or not to participate. If you decide to participate, we thank you. If you decide not to take part, we thank you for considering our request. You may withdraw at any point.
The study involves completing an anonymous online survey that asks about demographics, health-related information, and use of anti-inflammatory medication. The survey takes
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What is the Aim of the Project? We know that people take anti-inflammatory medication for lots
of reasons, including joint injury, and osteoarthritis. Sometimes this is prescribed by a Doctor, other times people acquire the medication themselves. However, we have very limited information about how people in New Zealand take anti-inflammatory medication. The aim of this research is to survey adults to find out about presence of joint injury, or osteoarthritis, and their use of oral anti-inflammatory medication, using an online survey. Findings will contribute to the design of information about the safe consumption of anti-inflammatory medication for people with osteoarthritis and other musculoskeletal pain.
What Data or Information will be collected and what use will be made of it? The data will be
collected via the Qualtrics platform, stored securely with password protection, and analysed by the research team. The results of the survey will likely be shared in presentations and published reports. It will also be used in future to support grant applications, and provide context for the research. When sharing results, we will make every attempt to preserve anonymity of individuals. If you have any questions about our project, either now or in the future, please feel free to contact the lead researcher:
Dr Cathy Chapple, School of Physiotherapy, University of Otago
cathy.chapple@otago.ac.nz
Phone: +643 479 5235
This study has received ethical approval from the University of Otago Ethics Committees (Health): (SoP/EC/2020/01). If you have any concerns about the ethical conduct of the research you may contact the University of Otago Human Ethics Committee through the Human Ethics Committee Administrator (Phone: +643 479 8256 or email gary.witte@otago.ac.nz ). Any issues you raise will be treated in confidence and investigated and you will be informed of the outcome.
[SoP/EC/2020/01]
[20/12/2019]
Research study to investigate the use of anti-inflammatory medication by adults with
self-reported osteoarthritis in a New Zealand sample
CONSENT FORM FOR
PARTICIPANTS
I have read the information concerning this project and understand what it is about. All my questions have been answered to my satisfaction. I understand that I am free to request further information at any stage.
I know that:-
1. My participation in the project is entirely voluntary;
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3. No personal identifying information will be collected. Raw data on which the results of theproject depend will be retained in secure storage for at least ten years;
4. If I am uncomfortable with answering any questions in the survey I can withdraw from the project or decline to complete the survey. Data from all incomplete surveys will be destroyed. 5. The results of the project may be published, and every attempt will be made to preserve my
anonymity.
o By ticking the box, I acknowledge that I have read the participant information sheet, asked any questions I need to, and consent to being in the study.
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Online survey
Personal information
1. What is your gender?
o Male o Female o Other
2. What is your age in years? ___________________________ 3. Which ethnic group do you belong to? (check all that apply to you) o New Zealand European
o Māori o Samoan
o Cook Islands Maori o Tongan
o Niuean o Chinese o Indian
o Other: Please state ____________________________________________________________
4. What is your height (cm)? __________________ 5. What is your weight (kg)? __________________ 6. Do you have a chronic illness or medical condition? o Yes
o No
6.1. Please select from the list below:
o Insulin or non-insulin dependent diabetes mellitus (i.e. type 1 or type 2 diabetes) o High cholesterol or high blood lipids
o Hypertension (i.e. high blood pressure)
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o Inflammatory bowel condition(e.g. Crohn’s disease, ulcerative colitis, coeliac disease) o Heart, kidney or liver condition
o Osteoarthritis
Please specify which joints it affects ______________________________________
o Asthma
o Food allergy or intolerance
o Other (please specify) ____________________________________________ 7. If you have osteoarthritis, do you take anti-inflammatory medication (e.g. Ibuprofen,
Nurofen, Brufen, Diclofenac, Voltaren, Naproxen, Naprosyn, Celebrex) o Yes
o No
7.1. How often do you take anti-inflammatory medication? o Every day (for period > 1 month) o Every day (for period < 1 month) o Sometimes (for a few days) o Occasionally (single dose) 7.2. Is your anti-inflammatory medication
o Prescribed by a Doctor
o Purchased by yourself with no prescription (e.g. from supermarket/pharmacy/on-line)
8. Are you currently taking any other medication that has been prescribed by a doctor? o Yes: Please specify
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9. Do you currently have any injuries that limit your ability to perform your usual activities, train or compete in your chosen sport?
o Yes o No
9.1. What best describes your current injury: o Fracture
o Over-use injury (e.g. tendonitis)
o Soft tissue injury (e.g. muscle, tendon, or ligament damage) o Osteoarthritis
o Other
Thank you end of survey page:
Thank you for your participation in this study. The study investigators value your time and willingness to participate in this important study.
