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EVIDENCE BASED PRACTICE 2
Assessment 2, Written Assignment 

Abstract

Robert, male and 62 years old, has osteoarthritis of his knees and obsessed with the constant pain. He was confused whether he should try homeopathy for his osteoarthritis. Thus, research question whether homeopathy cost effective to treat osteoarthritis of knees compared to no or any other strategy on the alleviation of constant pain should be answered by searching databases and appraising related papers. Two paper (paper 3 and paper 4) were regarded to provide the strongest evidence, and critical appraisal skills programme (CASP) was applied to them. The results showed that homeopathy had similar efficacy as other therapy. Given that it costs less, Robert should try homeopathy to treat his for his knee osteoarthritis.

The Case Introduction

Robert, male, is a 62-year-old retired bus driver. He has osteoarthritis of his knees due to years of bus driving. He is obsessed with the constant pain. Moreover, due to limitation on savings, he need cost effective therapy for his osteoarthritis. After watching a program about homeopathy, he wanted to know whether he should try homeopathy for his knee osteoarthritis.
10% of populations over 65 and 2% of adults suffer osteoarthritis of the knee, which is a painful, degenerative joint disease. Unfortunately, there is still no effective therapy to treat osteoarthritis totally. But several medications can result in good therapeutic results, such as anti-inflammatories, corticosteroids, organ lysates, hyaluronic acid and homeopathy (Nahler, Metelmann&Sperber, 1998). In homeopathic therapy, extracts of Rhustoxicodendron, Solanumdulcamara and Sanguinvaria Canadensis are used to relieve the pain and inflammation of rheumatic conditions (Birnesser, Klein & Weiser, 2003).
Combining the above information, a clinical question was developed: is homeopathy cost effective to treat osteoarthritis of knees compared to no or any other strategy on the alleviation of constant pain?
To search the databases, the clinical question should be converted to a research question. The research question of PICO format is listed in the Table 1.

Search Strategy and results

Using the above research question, four databases are searched. The databases are PubMed (http://www.ncbi.nlm.nih.gov/pubmed), OvidSP (https://ovidsp.ovid.com/), CINAHL http://www.cinahl.com/‎) and ProQuest (http://search.proquest.com/‎), which are all widely used clinical databases.
Both of “Homeopathy” and “osteoarthritis” were used as keywords to search the databases.
Only 35 results were displayed in PubMed, 16 in OvidSP, 179 results in CINAHL and 914 in ProQuest. Due to the large amount of results, “knee osteoarthritis” was replaced the keyword “osteoarthritis”.
After that, there were 8 results in PubMed, 6 results in OvidSP, 59 results in CINAHL and 473 results in ProQuest. In ProQuest, many results were from newspapers, trade journals and other resources, so the sources were limited in scholarly journals (248)‎, reports (17)‎ and books (4)‎.
Word “pain” was tried to be added as a keyword. There are 6 results in PubMed, 2 results in OvidSP, 53 results in CINAHL and 241 results in ProQuest.
Though there were still many results left, it was necessary to read the title and abstract to decide whether they were related to the research question.
The search strategy was summarized in Table 2.
Among searching results of these four databases, some results were repetitive. For example, the two results from OvidSP were both displayed in the PubMed. However, to preventing omit of important articles, all of the databases were required.
Though most of the searching results were related to the research questions to some extent, some articles could not be used. For example, one of the two results from OvidSP was about the preparation of homeopathy to treat osteoarthritis (Anderson, 2006). Some articles compared the difference efficacy of homeopathy to treat osteoarthritis among different populations (Lapane, Yang, Jawahar, McAlindon& Eaton, 2013; Yang, Jawahar, McAlindon, Eaton &Lapane, 2012). However, these results were hard to exclude by simple searching, but required us to figure them out.

Analysis of Eleven Articles

The details of the articles, study design and levels of evidence are listed in the Table 3.
Among the selected eleven articles, one article is retrospective cohort study, one is prospective cohort study, two are case series and another seven articles are randomized controlled trial. Criteria from Centre for Evidence-based Medicine (CEBM) and National Health and Medical Research Council (NHMRC) are used to appraise the level of evidence.

Further Analysis of Two Articles

Overview

Most of above eleven articles is not suitable for the research question. For example, in paper 1, the research studied outcome of mobility and functioning of knee; in paper 7, pain reduction was not considered as a primary parameter, whereas only overall assessment was considered; in paper 8, the study was based on dogs but not human beings. Removing articles with lower level of evidence, only paper 3, 4, 6 and 8 were left. And paper 6 and paper 8 had very limited samples with 36 and 19, respectively.
Therefore, paper 3 and paper 4 provide strongest evidence to answer the research question. The reasons why these two articles were selected are that they had relatively high level of evidences, studied the therapy on osteoarthritis of the knee, took pain relief as the outcome, were based on human beings and had a relatively large samples. And also, paper 3 is an experimental study, and paper 4 is an observational study, so the results may complement with each other. (The reasons underlined are the strongest reasons in my opinion, if only two reasons are allowed to answer question 5)
In paper 3, it compared the efficacy and tolerance of Zeel comp., which is a combination homeopathic preparation, and hyaluronic acid in patients with osteoarthritis of the knee. This study is a single-blind, randomized controlled trial with data on 114 patients used for statistical analysis. The result showed that Zeel comp. have similar effect with hyaluronic acid (Nahler, Metelmann&Sperber, 1998).
In paper 4, it compared efficacy and tolerance of Zeel comp. N with COX 2 inhibitors in osteoarthritis of the knee. It is a prospective cohort study with data on 592 patients. The study proved that Zeel comp. N and COX 2 inhibitor had similar efficacy, and Zeelcomp.N is better tolerated (Birnesser, Klein & Weiser, 2003).
To appraise this two articles, critical appraisal tool (CAT) is used. Critical appraisal skills programme (CASP) was an appropriate CAT here, because paper 3 is experimental study and paper 4 is observational studies, while CASP can be used in both studies.

CASP CAT

For the paper 3, the CASP results are shown in the BOX 1 (Critical Appraisal Skills Programme (CASP), 2014).
This study addressed a clearly focused issue that whether the efficacy and tolerance of Zeel comp. and hyaluronic acid were the same in patients with osteoarthritis of the knee. And this is a randomized, single-blind trial. So the study personnel was not blind to treatment, which might led to bias. Another shortcoming was that the article did not tell the readers which drop-outs belonged to, though it displayed the reason and the number. Generally speaking, Zeel comp. and hyaluronic acid groups had similar samples at the start of the trial, except for the criteria of knee joint(s) affected. In Zeel comp. group, 42 patients had knee joints affected on both sides, while 27 in hyaluronic acid group.Aside from the experimental intervention, the two groups were treated equally. In sum, some bias were existed in the study design and execution, but it might be still believable.
In this paper, many outcomes were considered. The primary outcomes contained subjective experience of pain during active movement and assessment of tolerance. Secondary parameters included pain during night, duration of morning stiffness, maximum walking distance and so forth. The results showed that two therapies had similar efficacy and tolerance. The p-values with null hypothesis that two therapies have the same therapeutic effect are 0.4298, 0.3077, 0.9211 for pain during movement, during night and morning stiffness, respectively. When it comes to tolerance, chi-square test for the percentage of patients who developed adverse effects was 0.079, bigger than 0.05. In sum, there were no significant difference between two therapies with p-values above 0.05.
The results can be applied to this research questions. One reason is that Robert does not accord with the criteria for exclusion. Also, the article had considered all clinically important outcomes and the benefit worth the costs. No harms happened.
For paper 4, the CASP results are shown in the BOX 2 (CASP, 2014).
This article addressed an issue whether efficacy and tolerance of Zeel comp. N are the same as COX 2 inhibitors in osteoarthritis of the knee. The cohort recruited through the hospital in an acceptable way. But the exposure was not measured accurately to minimize bias, considering that some patients took more Zeel comp. N tablets than others. Outcome was accurately measured. No confounding factors were identified. The follow up of subjects complete enough and long enough with 592 patients and 2 months.
Several outcomes were considered, including severity of symptoms, the WOMAC osteoarthritis index, onset of efficacy, overall ratings, tolerability and adverse drug events.In the section of onset of efficacy, results of therapy and tolerability, rates between the exposed/unexposed were reported. Takenseverity, WOMAC index, onset of efficacy and overall ratings into consideration, Zeel comp. N had similar effect as COX 2 inhibitors. In the section overall ratings, the p-value was between 0.1 and 0.2 showing no significant difference between two therapies; and in tolerability, the p-value was less than 0.0001. The results of these two sections were relatively precise. But in other sections, it is hard to determine the precision because the author just said that the difference lay inside the confidence interval.
Totally, I am not really believe the results due to bias and lack of confidence in some parts. But the results can be applied to this research question and they fit with other available evidence.
Both of articles considered various aspects of outcomes. From my perspective, pain relief, stiffness, disability, overall assessment and side effect are five outcomes measuring the effectiveness of homeopathy. First, pain, stiffness and disability are all the adverse influence of knee osteoarthritis. Given that there is no effective therapy to treat osteoarthritis thoroughly, diminishing the bad influence is the first and most important matter. Thus these three outcomes should be considered on effectiveness of homeopathy for osteoarthritis. Second, overall assessment shows which therapy patients prefer, and hints the most effective therapy in general. And last, side effect must be considered when any medication is used. High rate of side effect or severe adverse effect can disable the application of therapy. (Question 8)
Generally speaking, the two articles can provide evidence for the research question.

Bias of articles

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Besides CASP, other bias wereappeared in this two article.
In paper 3, selection bias appeared. The criteria for exclusion included population less than 35 or more than 85 years. Though Robert accords with the criteria, it is not necessary to exclude population under 35, considering risk for patients above 85 might be high. Besides, allocation bias and attrition bias had been discussed in the above.Proficiency bias and measurement might be caused by 12 different physicians from two countries. They might give slightly different measurements and diagnosis due to the difference between countries. Data from two countries could have been separated and found out whether there were difference between countries.
In paper 4, measurement biasand proficiency biasmay exist. 127 physicians measured the degree of severity of osteoarthritis on a four-point scale and the time of onset of symptomatic improvement. Though the 127 participating physicians were separated into two groups at random, no information about physicians in this two groups was available. The researchers could have provided the information of physicians in the two groups, like gender, age, education level and so forth. They should guarantee that physicians in Zeel comp. and in hyaluronic acid groups were similar at the start of the trial.

Conclusion

Generally speaking, the two articles can provide evidence for the research question, except for methodological bias and other shortcomings. And the results of two articles fit with each other.
The results showed that Zeel comp. had similar efficacy as COX II inhibitors or hyaluronic acid. And the tolerance was better than COX II inhibitors. Even though homeopathy is not better than other treatment, the cost of homeopathic therapy is lower than COX II inhibitors or hyaluronic acid. Lack of savings, Robert should try homeopathy to treat his for his knee osteoarthritis if he does not have a history of allergic reactions to any component of homeopathic medication.
However, this advice is limited, because it only referred to the results of eleven articles, and summarized and appraised two articles. Moreover, only two medications were compared with homeopathy. Whether there is more cost effective therapy is still unknown. Actually, there are 241 articles in the searching results in the database ProQuest. In order to get the most accurate conclusion, more articles should be used in the research question.

Reference

Anderson, K. (2006) ‘A complex homeopathic preparation for the treatment of osteoarthritis’, Explore: The Journal of Science and Healing, vol.2, no.3, pp.234.
Birnesser, H., Klein, P., & Weiser, M. (2003) ‘A modern homeopathic medication works as well as COX 2 Inhibitors’, Der Allgemeinarzt, vol.25, no.4, pp.261-264.
Critical Appraisal Skills Programme (CASP) (2014) CASP Checklists, [Online], Available:http://www.casp-uk.net/#!casp-tools-checklists/c18f8 [April 4, 2014].
Lapane, K. L., Yang, S., Jawahar, R., McAlindon, T., & Eaton, C. B. (2013) ‘CAM use among overweight and obese persons with radiographic knee osteoarthritis’, BMC complementary and alternative medicine, vol.13, no.1, pp.241.
Nahler, G., Metelmann, H., &Sperber, H. (1998) ‘Treating osteoarthritis of the knee with a homeopathic preparation’, Biomedical Therapy, vol.16, pp.186-191.
Yang, S., Jawahar, R., McAlindon, T. E., Eaton, C. B., &Lapane, K. L. (2012) ‘Racial differences in symptom management approaches among persons with radiographic knee osteoarthritis’, BMC complementary and alternative medicine, vol.12, no.1, pp.86.

Appendix

Table 1Research question of PICO format
Population People with osteoarthritis of knee
Intervention / Exposure Homeopathy
Comparison No or any other strategy
Outcome Alleviation of constant pain
 
Table 2Search Stratergy
Search Terms Databases searched
1.      Homeopathy + osteoarthritis
2.      Homeopathy + knee osteoarthritis
3.      Homeopathy + knee osteoarthritis (source limitation of scholarly journals, reports and books)
4.      Homeopathy + knee osteoarthritis + pain
5.      Homeopathy + knee osteoarthritis + pain (source limitation of scholarly journals, reports and books)
PubMed, OvidSP, CINAHL, ProQuest
PubMed, OvidSP, CINAHL, ProQuest
ProQuest
 
 
PubMed, OvidSP, CINAHL
 
ProQuest
 
 
Table 3Analysis of selected articles
Study Study Design Level of Evidence
CEBM NHMRC
1 The research compared the efficacy of Zeel comp. to that of diclofenac in patients with osteoarthritis of the knee. Both therapies are similar but significant improvements in mobility and functionality of the knee joint. Double-blind, randomized controlled trial Level 2 II
2 The research evaluated loidative stress in osteoarthritis before and after homeopathy treatment Case series, descriptive study Level 4 IV
3 The research compared the efficacy and tolerance of Zeel comp. and Hyalart brand of hyaluronic acid in patients with osteoarthritis of the knee. Single-blind, randomized controlled trial Level 2 II
4  The research compared the efficacy and tolerance of Zeelcomp.N and COX 2 inhibitors celecoxib and rofecoxib Cohort study – Prospective Level 2 II
5 The research report the outcome of patients treatment with homeopathic medicines Case series, descriptive study Level 4 IV
6 The research compare the efficacy of an herbal ointment and a sham ointment in patients with osteoarthritis of the hand and knee Single-blind, randomized controlled trial Level 2 II
7 The research compare the efficacy and safety of a homeopathic gel and an NSAID gel in patients with osteoarthritis of the knee Double-blind, randomized controlled trial Level 2 II
8 The paper compared the efficacy of an herbal ointment and a placebo in relieving the pain and stiffness of osteoarthritis Double-blind, randomized controlled trial Level 2 II
9 The paper compared the efficacy of Marhame-Mafasel and placebo in pain relief of osteoarthritis Double-blind, randomized controlled trial Level 2 III-1
10 The paper evaluated the efficacy of Zeel for canine osteoarthritis Double-blinded, randomized clinical trial Level 2 II
11  The paper evaluated a private homoeopathic medical practice in rheumatological dogs Cohort study – retrospective Level 3 III-3
 
Table 4CASP of randomised controlled trial for paper 3
文本框: 1.	Did the trial address a clearly focused issue?
Yes
2.	Was the assignment of patients to treatments randomised?
Yes
3.	Were all of the patients who entered the trial properly accounted for at its conclusion?
No (The article did not tell which group the left patients belonged to.)
4.	Were patients, health workers and study personnel ‘blind’ to treatment?
No (It is single-blind)
5.	Were the groups similar at the start of the trial?
Can’t tell (Criteria of age, gender etc. were similar between two groups. Only knee joints affected seemed different from two two groups.)
6.	Aside from the experimental intervention, were the groups treated equally?
Yes
7.	How large was the treatment effect?
The primary outcomes contained subjective experience of pain during active movement and assessment of tolerance. Secondary parameters included pain during night, duration of morning stiffness, maximum walking distance and so forth. The primary outcomes showed that two therapies had similar efficacy and tolerance. 
8.	How precise was the estimate of the treatment effect? (What are the confidence limits?)
Can’t tell. There were no significant difference between two therapies with p-value above 0.01. 
9.	Can the results be applied in your context? (or to the local population?)
Yes (Robert does not accord with the criteria for exclusion)
10.	 Were all clinically important outcomes considered?
Yes
11.	 Are the benefits worth the harms and costs?
Yes
Table 5CASP of cohort for paper 4
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