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TAASS
Claims
Contents
TAASS claims summary
Traumeel ointment and gel are as effective as diclofenac gel in the treatment of pain
in acute ankle sprain
Traumeel ointment and gel are as effective as diclofenac gel in function
improvement in acute ankle sprain
Traumeel ointment and gel are as effective as diclofenac gel in reducing ankle
swelling in acute ankle sprain in all secondary endpoint variables
Traumeel ointment and gel are as effective as diclofenac gel for global efficacy in
acute ankle sprain
Traumeel ointment and gel are as effective as diclofenac gel for time to normal
function in acute ankle sprain
In the TAASS study, all treatment arms were well tolerated
Traumeel ointment and gel are both well tolerated and effective alternatives
to diclofenac gel for the treatment of pain and function in patients with acute ankle
sprain
TAASS in perspective
Traumeel – evidence base
Appendix
TAASS claims summary
The Significance of TAASS
Traumeel has been shown to be as effective as diclofenac in a
randomized controlled study (TAASS study), which is a ‘gold
standard’ study design
The TAASS study is a significant and robust addition to the evidence
base comparing a natural medicine with a conventional medicine
(diclofenac)
The TAASS study complements the existing data from double-blind
and/or randomized placebo controlled trials with Traumeel1
The TAASS study confirms that Traumeel ointment and gel is
as effective as diclofenac
The TAASS study provides confirmatory evidence that Traumeel
provides an effective alternative to diclofenac for the treatment of
musculoskeletal disorders and inflammation
Therefore, being as effective as diclofenac is THE major claim!
NSAID, non-steroidal anti-inflammatory drug; 1. Linde K et al. Lancet 1997;350:834–43
Claims Summary – TAASS Study
Traumeel ointment and Traumeel gel are as effective as
diclofenac gel 1% for the treatment of pain and restoration
of function associated with acute mild to moderate ankle
sprain
By day 7, patients reported over 60% reduction in pain
Reductions in VAS pain score were over 93% on day 14 and total
pain relief (100%) was reported by all patients at 6 weeks
By day 7, patients’ function was improved by about 35% from
baseline taking function to about 80% of what patients considered
to be normal
Function was improved by about 45% from baseline taking ankle
function to about 95% of what patients considered to be normal
on day 14; normal function was restored in all patients by 6 weeks
Claims Summary – TAASS Study
Both Traumeel ointment and gel were also proven to be as
effective as diclofenac gel for secondary endpoint variables
including:
 FAAM sports subscale
 current level of function during daily living activity
 current level of function during sports-related activities
 swelling
 assessment of normal function
 global efficacy
All secondary parameters returned to normal by 6 weeks
Time to normal function was about 19 days for all groups
All treatments were equally well tolerated: Traumeel ointment,
Traumeel gel and diclofenac gel 1%
Claims
Traumeel ointment and gel are
as effective as diclofenac gel in the
treatment of pain in acute ankle sprain
Efficacy Claim – Reducing Pain
Claim
 Traumeel ointment and Traumeel gel are both as effective as
diclofenac gel for reducing ankle pain at day 7 of treatment
and, after 6 weeks from injury, all patients are pain free
Key Note
 Diclofenac is a marker of efficacy
 Traumeel is now proven to be an equally effective agent
 This effect holds true for the different topical formulations
Efficacy Claim – Reducing Pain
Key Messages
 Traumeel gel and ointment performed as well as diclofenac gel
 Significant reductions in ankle pain were seen by all agents on
day 4
 All patients had negligible pain after 14 days
 Traumeel has been shown to be an equally effective agent to
diclofenac
 Because this claim holds for the primary efficacy variable, pain
reduction, this study is positive for Traumeel
Efficacy Claim – Reducing Pain
Traumeel is as effective as NSAIDs in reducing pain
Traumeel ointment (O) N = 143
% median change in VAS score
of ankle pain
0
Day 4
Traumeel gel (G) N = 140
Day 7
Diclofenac gel (D) N = 137
Day 14
Day 42
-20
-40
O vs. D: p=0.5069
G vs. D: p=0.1131
-60
-80
-100
O vs. D: p=0.8205
G vs. D: p=0.3422
Primary efficacy
endpoint: percentage
change from baseline
at day 7
O vs. D: p=0.7312
G vs. D: p=0.7640
O vs. D: p=0.9267
G vs. D: p=0.8314
Efficacy Claim – Reducing Pain
Traumeel is as effective as NSAIDs in reducing pain
Traumeel ointment
N = 143
Traumeel gel
N = 140
Diclofenac gel
N = 137
Median VAS score of ankle pain
60
50
40
30
20
10
0
Baseline
Day 4
Day 7
Day 14
A patient’s assessment of ankle pain was performed using a
100 mm VAS (0=no pain; 100=worst pain imaginable)
Day 42
Efficacy Claim – Reducing Pain
At each level of pain reduction (i.e. 100%, ≥ 80%, ≥ 50% and
≥ 20%), a similar proportion of patients reported pain reduction in
the three treatment groups at day 7 (see table below and next
slide)
Further evidence that Traumeel is an equally effective
agent to diclofenac
Traumeel
ointment
Traumeel gel
Diclofenac gel
8.5%
5.0%
5.9%
at least 80% reduction in pain
34.5%
36.4%
33.8%
at least 50% reduction in pain
62.7%
74.3%
74.3%
at least 20% reduction in pain
93.0%
94.3%
94.9%
total pain relief
Efficacy Claim – Reducing Pain on Day 7
This again shows that, however you look at the data, Traumeel’s performance matches that of diclofenac
Traumeel ointment N = 143
Traumeel gel N = 140
Diclofenac gel N = 137
100
Patients (%)
80
60
40
20
0
≥20%
≥50%
≥80%
At each level of pain reduction (i.e. 100%, ≥ 80%, ≥ 50%
and ≥ 20%), a similar proportion of patients reported pain
reduction in the three treatment groups at day 7
100%
Claims
Traumeel ointment and gel are
as effective as diclofenac gel in function
improvement in acute ankle sprain
Efficacy Claim – Improving Function
Claim
 Traumeel ointment and Traumeel gel are both as effective as
diclofenac gel for improving function during daily activities of
living at day 7 of treatment and, after 6 weeks from injury, all
patients are back to normal function
Key Note
 It is the lack of function - apart from the pain - that causes
the most distress for patients and necessitates early and
effective treatment
 This ensures that patients are returned to normal daily life as
soon as possible
 Importantly, Traumeel will do this as effectively as
diclofenac
Efficacy Claim – Improving Function
Claim
 The improvement in function during daily activities of living at
day 7 of treatment with Traumeel ointment (score 26.2) or
with Traumeel gel (score 26.2) is comparable to that of
diclofenac gel (score 25)
Note
 This is a key measure of efficacy and relates to the improved
quality of life that patients can expect after using Traumeel
 That this efficacy is equivalent to that of diclofenac
should give both patients and doctors confidence
Efficacy Claim – Improving Function
Key Messages
 Traumeel is as effective as diclofenac in enabling
patients to return to their normal daily life
 Traumeel has been shown to be an equally effective agent to
diclofenac
 Because this claim holds for the primary efficacy variable,
improvement in function, this study is positive for
Traumeel
Efficacy Claim – Improving Function
Traumeel is as effective as NSAIDs in improving function
Traumeel ointment N = 143
Traumeel gel N = 140
Diclofenac gel N = 137
Median change from baseline in
ADL subscale score
60
O vs. D: p=0.4030
G vs. D: p=0.7588
50
O vs. D: p=0.4963
G vs. D: p=0.6665
40
O vs. D: p=0.3155
G vs. D: p=0.1584
30
20
O vs. D: p=0.6234
G vs. D: p=0.5350
10
0
Day 4
Day 7
Day 14
Higher scores represent higher levels of physical function
Day 42
Efficacy Claim – Improving Function
Traumeel is as effective as NSAIDs in improving function
Traumeel ointment N = 143
Traumeel gel N = 140
Diclofenac gel N = 137
Median ADL subscale score
100
80
60
40
20
0
Baseline
Day 4
0=worst level of physical function,
100=highest level of physical function
Day 7
Day 14
Day 42
Claims
Traumeel ointment and gel are as
effective as diclofenac gel in reducing
ankle swelling in acute ankle sprain in
all secondary endpoint variables
Secondary Efficacy Variables
The treatment groups were also proven as effective as
diclofenac for secondary endpoint variables:
Secondary endpoint variable
Description
FAAM sports subscale
Measuring patients’ sports performance
Current level of function during daily living
activity
Measuring how patients function going about their daily
activities
Current level of function during sports-related
activities
Measuring how patients function during sports
Current level of function
Measuring how patients function overall
Swelling
Measuring reduction in ankle swelling
Assessment of normal function
Measuring if patients function as normal
Global efficacy assessment
Patients rating of overall treatment efficacy
Time to normal function: training and sports
Measuring the time taken for patients to resume training and
to resume sports
All secondary parameters returned to normal by 6 weeks for all three groups: Traumeel ointment,
Traumeel gel, diclofenac gel
Efficacy Claim – Secondary Endpoint Variables
A comparable reduction in swelling (as demonstrated by reduction
in circumference) was seen in all groups at day 7
Baseline
median cm
Day 7
median cm
(change from baseline)
Traumeel ointment
55.1
53.9(-0.5)
Traumeel gel
54.1
53.0 (-0.5)
Diclofenac
54.0
53.1(-0.5)
Efficacy Claim – Secondary Endpoint Variable:
Swelling
Claim
 Traumeel ointment and Traumeel gel are each as effective as
diclofenac gel for reducing ankle swelling at day 7 of treatment
 The reduction in ankle swelling at day 7 of treatment with
Traumeel ointment (0.5 cm) or with Traumeel gel (0.5 cm) is
comparable to that of diclofenac gel (0.485 cm)
Key Note
 Swelling, along with stiffness, is a key symptom in soft tissue
injury. Reducing it is a mark of effectiveness for any agent
 Further evidence that Traumeel is an equally effective
agent to diclofenac
Efficacy Claim – Secondary Efficacy Variable:
Swelling
Swelling was reduced from baseline in all groups at all time points
0
Day 4
Day 7
Day 14
Median changes in swelling
‘figure-of-eight’ (cm)
-0.1
-0.2
-0.3
-0.4
O vs.. D: p=0.5096
G vs. D: p=0.2236
-0.5
-0.6
O vs. D: p=0.3895
G vs. D: p=0.2000
-0.7
O vs. D: p=0.1454
G vs. D: p=0.1295
-0.8
Traumeel ointment (O) N = 143
Traumeel gel (G) N = 140
Diclofenac gel (D) N = 137
Greater changes represent greater improvement (reduced swelling)
Claims
Traumeel ointment and gel are as
effective as diclofenac gel for global
efficacy in acute ankle sprain
Efficacy Claim – Secondary Endpoint Variable:
Global Efficacy
At day 14 treatments were rated as ‘very good’/’good’ by the vast
majority of patients:
 Traumeel ointment: 92.25% of patients
 Traumeel gel: 92.09% of patients
 Diclofenac gel: 92.70% of patients
Over 92% of patients in each group rated the treatment as “very
good” or “good”
Comparable efficacy was demonstrated for Traumeel vs.
diclofenac
Treatment
Very good
Good
Satisfactory
No
improvement
Worse
Traumeel
ointment
72 (50.7%)
59 (41.6%)
10 (7.0%)
1 (0.7%)
0
Traumeel gel
69 (49.6%)
59 (42.5%)
11 (7.9%)
0
0
Diclofenac gel
74 (54.0%)
53 (38.7%)
10 (7.3%)
0
0
Claims
Traumeel ointment and gel are as
effective as diclofenac gel for time to
normal function in acute ankle sprain
Efficacy Claim – Secondary Endpoint Variable:
Time to Normal Function
All groups were equally comparable for time to training and time
to sports
Treatment
Time to training (days)
Time to sports (days)
Traumeel ointment
14.30
19.09
Traumeel gel
14.32
19.35
Diclofenac gel
14.61
19.39
Efficacy Claim – Secondary Endpoint Variable:
Time to Normal Function
Claims
 The ultimate clinical objective must be the return to normal daily living.
Returning to sports activities is probably the most extreme test of that.
 Further evidence that Traumeel is an equally effective agent to
diclofenac
In the TAASS study, all treatment arms
were well tolerated
TAASS Safety
The key claim is that both Traumeel gel and ointment and diclofenac
gel had similar tolerability profiles
 this is to be expected for topical preparations, especially when
used acutely (i.e. for a short time)
The majority of events were mild or moderate in severity; none was
serious
 At 6 weeks, most (41/43) adverse events had resolved
Traumeel has previously been reported to be well tolerated and
without treatment-related adverse effects, including in:
 patients with other indications, e.g. various musculoskeletal sports
injuries, post-traumatic hemarthrosis, epicondylitis
 other studies using ointment, and other routes of administration,
e.g. injection, tablets and gel
TAASS Claims Summary
In general, good safety and tolerability can be
assessed for all three study treatments
This topical study is a robust addition to the
Traumeel evidence base and ensures that the
product can be seen as an effective treatment
option for musculoskeletal disorders
Claims
Traumeel ointment and gel are both
well tolerated and effective alternatives
to diclofenac gel for the treatment of
pain and function in patients with
acute ankle sprain
TAASS Efficacy Summary
Efficacy
Evidence from a ‘gold’ standard design trial in patients with acute ankle
sprain, that Traumeel ointment and gel are as effective as diclofenac gel in:

reducing pain

improving function

reducing swelling

time to return to normal function
All secondary parameters returned to normal by 6 weeks
Median time to normal function was about 19 days for all groups
TAASS Safety Summary
Safety
The majority of events were mild or moderate in severity; none was
serious

9/152 patients (5.9%) in the Traumeel ointment group

14/148 patients (9.5%) in the Traumeel gel group

8/147 patients (5.4%) in the diclofenac gel group
There were no findings of clinical relevance
At 6 weeks, most (41/43) adverse events had resolved
Traumeel is as well tolerated as diclofenac gel 1%
This topical study is a robust addition to the Traumeel
evidence base and ensures that the product can be seen as an
effective treatment option for musculoskeletal disorders
TAASS in Perspective
This topical study is a robust addition to the Traumeel
evidence base and ensures that the product can be seen as
an effective treatment option for musculoskeletal disorders
Evidence from in vitro and pre clinical studies show that the
mechanism of action of Traumeel has a beneficial effect on both
tissue repair and accelerated wound healing1-5
 It can be concluded that components of Traumeel may promote
recovery and may speed up the healing process
 Traumeel provides a multitargeted, synergistic action to address
multiple aspects of the inflammatory process and may promote healing
Evidence from previous studies with Traumeel demonstrate a
better tolerability profile compared to NSAIDs 6,7
Another reason to switch to Traumeel – better tolerability
with the added benefit of accelerated healing
1.Heine H, Schmolz M. Biomed Ther. 1998;XVI(3):224–226. 2. Heine H, Andrä F. Ärztezeit
f Naturheilverfahrenn. 2002;43(2):96–104. 3. Lussignoli S et al. Complement Ther Med.
1999;7(4):225–230. 4. Porozov et al. Clin Dev Immunol. 2004;11(2):143–149. 5. Conforti
A et al. Biomed Ther. 1997;XV(1):28–31. 6. Birnesser H et al. J Musculoskel Res.
2004;2/3:119–128;7 Schneider C. Complement Ther Med 2008; 16(1):22–27
TAASS in Perspective
Safety
In a 4 week study it was concluded that Traumeel is safe and welltolerated in healthy subjects, and should be considered as a safer
alternative to NSAIDs, particularly in patients with conditions or
receiving medications that affect normal coagulation.1
Traumeel has previously been reported to be well tolerated and
without treatment-related adverse effects 2-9
1.Arora S, Harris T, Scherer C. Biomed Ther. 2000;XVIII(2):222–225. 2. Schneider C et al. Explore. 2005;1:446–452;
3. Böhmer D & Ambrus P. Biol Ther. 1992;10:290–300; 4. Thiel W. Biol Ther. 1994;XII:242–248; 5. Birnesser H et al.
J Musculoskel Res. 2004;2/3:119–128; 6. Zenner S & Metelmann H. Biol Ther. 1992;X:301–310; 7. Zenner S &
Metelmann H. 1994;XII:204–211; 8. Zenner S & Weiser M. Biomed Ther.1997;XV:22–26; 9. Schneider C et al
Complement Ther Med. 2008;16:22–27
Traumeel in Perspective
Safety
The long-term efficacy of topical NSAIDs is controversial.1
Topical NSAIDs - often recommended for patients who are unable
to tolerate the GI side effects of systemic NSAIDs.
 a systematic review of topical NSAIDs in older patients with
osteoarthritis OA found that while topical application is
associated with lower incidence of GI side effects2
 up to 15% of patients experienced a GI-related side effect
 up to 39.3% reported application site side effects, including
local skin sensitivity, contact dermatitis, and
photodermatitis.
1. Lin J BMJ, doi:10.1136/bmj.38159.639028.7C. 2. Makris UE AJ Rheumatol. 2010 June ; 37(6): 1236–1243.
Traumeel in Perspective
Safety
Despite favorable evidence of safety and tolerability, the FDAapproved topical NSAIDs carry the same black box warnings as
oral diclofenac concerning the risk of gastrointestinal and
cardiovascular AEs, as well as hepatic abnormalities.1,2
1.Barkin RL Drugs Aging 2010. 2. Roth HS. The Physician and Sportsmedicine. Vol 39. 2011.
Traumeel – Previous Studies
Traumeel has previously been reported to be well tolerated and
without treatment-related adverse effects, including in:
 patients with other indications, e.g. various musculoskeletal sports
injuries, post-traumatic hemarthrosis, epicondylitis
 other studies using ointment, and other routes of administration, e.g.
injection and tablets
Traumeel has shown that is as effective as diclofenac with a better
tolerability profile
 Tolerability assessed as “very good” by 88% of Traumeel patients and
45% NSAIDs patients1
 Physician-rated tolerability was “very good” for 90% of Traumeel cases
vs. 50% of conventional cases (P = 0.01)2
This topical study is a robust addition to the Traumeel evidence base
and ensures that the product can be seen as an effective treatment
option for musculoskeletal disorders
1. Birnesser H, et al. J Musculoskel Res 2004;8(2–3):119–128. 2. Schneider C, et al. Complement Ther Med.
2008,16(1):22–27.
Traumeel’s Evidence Base of Efficacy and Safety in
Various Musculoskeletal Conditions - Summary
Study
Musculoskeletal
Conditions
Study type
RCT
Observational
study
√
Efficacy better vs.
placebo
Pain
Mobility
√
√
Efficacy equal vs.
NSAIDs
Pain
Zell et al.
19891
Ankle sprain
Birnesser et
al. 20042
Epicondylitis
√
Schneider
et al. 20053
Tendinopathy
√
√
Schneider
et al. 20084
Musculoskelet
al injuries
√
√
Orizola &
Vargas
20075
Tendinopathy
√
√
√
Mobility
Efficacy better vs.
NSAIDs
Safety vs. NSAIDs
Pain
Mobility
Equal
√
√
√
Better
√
√
√
√
1. Zell J et al. Biol Ther. 1989;VII(1):1–6; 2. Birnesser H et al. J Musculoskel Res. 2004;2/3:119–128;
3. Schneider C et al. Explore. 2005;1:446–452; 4. Schneider C, et al. Complement Ther Med.
2008;16:22–27; 5. Orizola AJ, et al. Med & Sci Sports & Exercise 2007;39 (suppl):S79.
√
√
Summary - Traumeel
Traumeel has fewer side effects than NSAIDs
Traumeel can be used in all age groups
Traumeel is better tolerated than NSAIDs
Traumeel is available in tablets, ointment, gel and ampoules,
thereby enabling flexibility of administration
Traumeel’s unique multitargeted, synergistic action addresses
multiple aspects of the inflammatory process.
This unique mechanism of action may promote both tissue repair
and healing, whereas NSAIDs have been proven to have
deleterious effect on healing process in soft tissues
Traumeel is better tolerated than NSAIDs. Another reason to
switch to Traumeel – better tolerability with the added
benefit of a multi-targeted mechanism of action.
Appendix
Figures for
Traumeel ointment vs diclofenac gel
Traumeel gel vs diclofenac gel
Efficacy Claim – Reducing Pain
Traumeel Ointment vs. Diclofenac
Traumeel is as effective as NSAIDs in reducing pain
Traumeel ointment (O) N = 143
% median change in VAS score
of ankle pain
0
Day 4
Day 7
Diclofenac gel (D) N = 137
Day 14
Day 42
-20
-40
O vs. D: p=0.5069
G vs. D: p=0.1131
-60
-80
-100
O vs. D: p=0.8205
G vs. D: p=0.3422
Primary efficacy
endpoint: percentage
change from baseline
at day 7
O vs. D: p=0.7312
G vs. D: p=0.7640
O vs. D: p=0.9267
G vs. D: p=0.8314
Efficacy Claim – Reducing Pain
Traumeel Gel vs. Diclofenac
Traumeel is as effective as NSAIDs in reducing pain
Traumeel gel (G) N = 140
% median change in VAS score
of ankle pain
0
Day 4
Diclofenac gel (D) N = 137
Day 7
Day 14
Day 42
-20
-40
O vs. D: p=0.5069
G vs. D: p=0.1131
-60
-80
-100
O vs. D: p=0.8205
G vs. D: p=0.3422
Primary efficacy
endpoint: percentage
change from baseline
at day 7
O vs. D: p=0.7312
G vs. D: p=0.7640
O vs. D: p=0.9267
G vs. D: p=0.8314
Efficacy Claim – Reducing Pain
Traumeel Ointment vs. Diclofenac
Traumeel is as effective as NSAIDs in reducing pain
Traumeel ointment
N = 143
Diclofenac gel
N = 137
Median VAS score of ankle pain
60
50
40
30
20
10
0
Baseline
Day 4
Day 7
Day 14
A patient’s assessment of ankle pain was performed using a
100 mm VAS (0=no pain; 100=worst pain imaginable)
Day 42
Efficacy Claim – Reducing Pain
Traumeel Gel vs. Diclofenac
Traumeel is as effective as NSAIDs in reducing pain
Traumeel gel
N = 140
Diclofenac gel
N = 137
Median VAS score of ankle pain
60
50
40
30
20
10
0
Baseline
Day 4
Day 7
Day 14
A patient’s assessment of ankle pain was performed using a
100 mm VAS (0=no pain; 100=worst pain imaginable)
Day 42
Efficacy Claim – Improving Function
Traumeel Ointment vs. Diclofenac
Traumeel is as effective as NSAIDs in improving function
Traumeel ointment N = 143
Diclofenac gel N = 137
Median change from baseline in
ADL subscale score
60
O vs. D: p=0.4030
G vs. D: p=0.7588
50
O vs. D: p=0.4963
G vs. D: p=0.6665
40
O vs. D: p=0.3155
G vs. D: p=0.1584
30
20
O vs. D: p=0.6234
G vs. D: p=0.5350
10
0
Day 4
Day 7
Day 14
Higher scores represent higher levels of physical function
Day 42
Efficacy Claim – Improving Function
Traumeel Gel vs. Diclofenac
Traumeel is as effective as NSAIDs in improving function
Traumeel gel N = 140
Diclofenac gel N = 137
Median change from baseline in
ADL subscale score
60
O vs. D: p=0.4030
G vs. D: p=0.7588
50
O vs. D: p=0.4963
G vs. D: p=0.6665
40
O vs. D: p=0.3155
G vs. D: p=0.1584
30
20
O vs. D: p=0.6234
G vs. D: p=0.5350
10
0
Day 4
Day 7
Day 14
Higher scores represent higher levels of physical function
Day 42
Efficacy Claim – Improving Function
Traumeel Ointment vs. Diclofenac
Traumeel is as effective as NSAIDs in improving function
Traumeel ointment N = 143
Diclofenac gel N = 137
Median ADL subscale score
100
80
60
40
20
0
Baseline
Day 4
0=worst level of physical function,
100=highest level of physical function
Day 7
Day 14
Day 42
Efficacy Claim – Improving Function
Traumeel Gel vs. Diclofenac
Traumeel is as effective as NSAIDs in improving function
Traumeel gel N = 140
Diclofenac gel N = 137
Median ADL subscale score
100
80
60
40
20
0
Baseline
Day 4
0=worst level of physical function,
100=highest level of physical function
Day 7
Day 14
Day 42
Efficacy Claim – Secondary Efficacy Variable:
Swelling – Traumeel Ointment vs. Diclofenac
Swelling was reduced from baseline in all groups at all time points
0
Day 7
Day 14
Day 14
Median changes in swelling
‘figure-of-eight’ (cm)
-0.1
-0.2
-0.3
O vs.. D: p=0.5096
G vs. D: p=0.2236
-0.4
-0.5
O vs. D: p=0.3895
G vs. D: p=0.2000
-0.6
-0.7
O vs. D: p=0.1454
G vs. D: p=0.1295
-0.8
Traumeel ointment (O) N = 143
Diclofenac gel (D) N = 137
Greater changes represent greater improvement (reduced swelling
Efficacy Claim – Secondary Efficacy Variable:
Swelling – Traumeel Gel vs. Diclofenac
Swelling was reduced from baseline in all groups at all time points
0
Day 7
Day 14
Day 14
Median changes in swelling
‘figure-of-eight’ (cm)
-0.1
-0.2
-0.3
O vs.. D: p=0.5096
G vs. D: p=0.2236
-0.4
-0.5
O vs. D: p=0.3895
G vs. D: p=0.2000
-0.6
-0.7
O vs. D: p=0.1454
G vs. D: p=0.1295
-0.8
Traumeel gel (G) N = 140
Diclofenac gel (D) N = 137
Greater changes represent greater improvement (reduced swelling