Download Ibuprofen and tension-type headache – exploring the evidence

Ibuprofen and tension-type headache
– exploring the evidence
An evidence-based summary
Essential information can be found on the back page
1
These materials have been developed by RB | UK/N/0614/0052a | August 2014
Introduction
The symptoms of common headaches
Each of these types of headache has marked characteristics.
Despite its high, global prevalence, headache
still remains an under-recognised and undertreated condition.1 Around half of all headache
sufferers self-manage without seeking medical
advice, making headache a key area for
pharmacy intervention.1
Tension-type headache (TTH) is the most common
type of headache,2 accounting for around 80% of
all headaches.3
Recommended first-line drug treatment of episodic TTH
(≤2 days/week) is OTC analgesics.2,4–8 This presents
pharmacy with a critical role in effective TTH management.
However, it is very important that medication-overuse
headaches (MOH) are avoided, and these treatments are
therefore not recommended for chronic TTH.2,4,6
As pharmacists weigh the balance between efficacy and
safety when recommending OTC analgesics for episodic
TTH, this document evaluates the available clinical data and
expert evidence to aid decision-making.
Evidence in summary
•
•
TTH is the most common of the headache disorders
and it places a significant burden to society2
The exact mechanism of TTH is not known, but
referred pain from the peripheral muscles in the
head and neck are believed to play a significant
role,9 while tenderness in these muscles is also
important in TTH development9–11
•
Guidelines recommend NSAIDs, such as
ibuprofen and aspirin, and paracetamol
as a first-line drug treatment for
episodic TTH4–8,12
•
Ibuprofen provides effective and fastacting pain relief in TTH13–19 and is
more effective than paracetamol as
acute therapy for TTH14,15
•
Ibuprofen is as well tolerated as
paracetamol.20 Ibuprofen, at OTC
doses, does not need to be taken with food21
Understanding tension-type headache (TTH)
Identifying TTH
Also known as Tension headache,
muscle-contraction
headache, stress
headache,
ordinary headache
Migraine
MOH
Cluster
Common migraine
(without aura),
classic migraine
(with aura)
Rebound headache,
Ciliary neuralgia, Horton’s headache
drug-induced headache,
medication-misuse
headache
Area of head
affected
Generally both
sides, across the
forehead, around
the back of the
head, the temples
Can be one side or
both sides; most
often one side in
adults and both
sides in children
and adolescents
Can be one side or
both sides
One side, in and around the eye
and/or temple
Pain severity
Mild-to-moderate
Moderate-to-severe
Varies through the day
Severe-to-very severe
Pain
description
Pressing or
tightening,
non-pulsating
Pulsating (throbbing
or banging in young
people aged
12−17 years)
Dull pain, present
and often worse
on wakening
Excruciating
Pain duration
30 minutes –
7 days
4–72 hours (adults),
1−72 hours (children
and young people
aged 12−17 years)
Not stated
15–180 minutes
Frequency of
headache
<15 days/month
(episodic TTH) or
≥15 days/month
for ≥3 months
(chronic TTH)
<15 days/month
(episodic migraine)
or ≥15 days/month
for ≥3 months
(chronic migraine)
Headache present
on >15 days per
month in a patient
with pre-existing
headache disorder
Typically, clusters of 6−12 weeks duration
1 every other day to 8 per day, with remission
>1/month (episodic cluster headache)
or 1 every other day to 8 per day, with a
continuous remission
<1 month in a 12-month period (chronic
cluster headache)
Aura
None
Some sufferers
experience aura
symptoms (visual,
sensory, speech/
language, motor)
for 5–60 minutes,
with or up to
an hour before
headache onset
None
None
Other
features
None, not
aggravated
by routine
physical activity
At least one of the
following: nausea,
vomiting, aversion to
light or sound.
May be aggravated
by routine activities
of daily living
Regular overuse of
one or more headache
treatments for
>3 months.
Can be accompanied
by tiredness, irritability,
feeling sick and/or
difficulty sleeping
At least one of the following on the same
side as the headache: watering eyes, nasal
congestion/runny nose, swollen or drooping
eyelid, forehead and facial sweating/flushing.
Individual may also be restless/agitated
Table 1: International Headache Society primary headache classification2,7,11
Headache is among the most common of all health conditions1
The main types of headache are TTH, migraine, cluster and medication-overuse headache (MOH).
the most common globally, with more than 80% of people affected at some time.2
1,22
2
TTH
Of all these types, TTH is
EVALUATE: What percentage of your patients purchases OTC
analgesics for TTH and how does this disorder impact on their lives?
3
The implications of sensitisation of the
central nervous system
The source of TTH
What triggers TTH?
The physiological mechanisms of TTH are not fully understood,11 but musculoskeletal factors play a role.23 Recent guidance
from the International Headache Society (IHS) confirms that muscles and peripheral pain mechanisms are involved in
acute, episodic TTH.11
What role does peripheral pain play?
Evidence suggests that there are peripheral pain
mechanisms that originate in the muscles of the head and
neck, resulting in a referred pain that is felt as headache.24
In TTH, muscle fibres in the head and face (the pericranial
myofascial tissues) become increasingly painful and tender
to the touch.10 Tender muscle knots can develop hyperirritable areas called myofascial trigger points.9 Research has
shown that patients with TTH have greater tenderness in
the muscles of the head and neck and an increased number
of myofascial trigger points.24
When activated, myofascial trigger points release
inflammatory mediators such as prostaglandins,9 that
make the nerves more sensitive to painful stimuli.9 These
Too much or
pain signals are then sent from the trigger points
tosleep
the
too little
brain, which are felt as TTH.9 So, even though the muscles
are actually the source of the pain, the pain is felt in
the head – this is called referred pain.9 As the muscle
tenderness increases, the frequency of headaches can
also increase.24
The International Headache Society (IHS) states that
peripheral mechanisms are associated with infrequent episodic
TTH and that central mechanisms are more prominent in the
development of chronic TTH.11 It has been shown that the
central nervous system is sensitised in patients with chronic
TTH.24 This is believed to be due to prolonged firing of the
nerves in the head and neck muscles, causing sensitisation of
the central pain pathways and reduction of the pain threshold,
meaning normal stimuli are regarded as painful.24 This is
thought to play a part in patients converting from an acute
TTH to a chronic TTH.24 In short, muscles can play a role in the
development of both acute and chronic TTH.24
People with episodic TTH experiencing frequent headaches
are at increased risk of developing chronic TTH.24 It is
therefore important to intervene and treat TTH as early
as possible before acute headaches evolve into a chronic
headache disorder.
JAN
12
Knowing when to refer
Dehydration
Stress
Caffeine – too
much or
too little
Irregular
meals
Exercise – not
Menstruation
Muscle
Bad posture
enough or theIt is important to identify the
tension
symptoms that need referral
wrong kind
•
A new headache, especially in patients who:
•
•
•
When activated, the
trigger points release
inflammatory mediators,
such as prostaglandins
When inflammatory
mediators reach a threshold,
they cause the nerve endings
to send signals, which are
interpreted as pain
Referred pain from the
head and neck muscles is
felt as pain in the head
The patient
perceives this
referred pain as TTH
Figure 1: Referred pain from the neck and shoulder muscles can cause acute TTH9,24
What does this mean for patients?
For patients with TTH, the involvement of the peripheral
head and neck muscles can also cause:23
•
•
4
Increased muscular tenderness
Decreased neck muscle strength
•
•
•
Reduced range of motion in the neck muscles
A more severe forward head posture (in both
sitting and standing positions) compared with
healthy subjects
A higher number of trigger points and lower pain
threshold in the head and neck muscles.
Are aged >50 years or <10 years
Have a history of cancer known to metastasise to the brain
Are <20 years old with a history of any type
of cancer
•
Not previously experienced symptoms suggestive
of migraine
•
•
A worsening headache with fever
•
eadache that comes on suddenly, like a
H
thunderclap, reaching maximum pain in 5 minutes
Headache that develops after a head injury in the
past 3 months
Diary
Red Flag
A headache which differs from the normal
headache experienced by the customer – i.e. is new
or unexpected
•
•
History of, or risk factors for, HIV or cancer
•
•
Headache that changes with posture
•
•
•
•
Headaches that cause waking during sleep
•
•
Persistent morning headache with nausea
Have a compromised immune system (e.g. HIV positive patients)
Are vomiting for no reason
Certain foods
•
and further investigation in any individual, especially if
patients have:4,7
•
•
Trigger points develop
due to muscle overuse,
mechanical overload
or stress
Alcohol
Headache with other symptoms like muscle
weakness, change in personality, reduced
consciousness, difficulty concentrating
or remembering
Headache triggered by coughing, sneezing,
exercising or breathing out with the nose and
mouth blocked
Headaches with jaw pain plus visual disturbances
Headache with a painful red eye or misty vision
Headache with aura for the first time in a customer
on combined oral contraceptives
Progressive headache that gets worse over weeks
or longer
EVALUATE: How does this knowledge change your
understanding of the source of TTH?
5
Understanding treatments
Pain intensity difference (mm)
70
Choosing effective treatment for TTH
How do analgesics work in relieving TTH?
Ibuprofen, and other NSAIDs, work by inhibiting
prostaglandin synthesis in the peripheral and central pain
pathways. Prostaglandins are one of the inflammatory
mediators that are the source of pain in TTH.9 Due to their
action on the peripheral pain pathways, NSAIDs, such as
ibuprofen, are able to act on the muscular sources of TTH,
in addition to their central action.25
30
Ibuprofen 400 mg (n=153)
Paracetamol 1000 mg (n=151)
*p<0.01
20
10
1
2
3
Time (hours)
4
Adapted from Schachtel et al., 1996
Figure 2: Ibuprofen reduced mean headache pain intensity significantly more than paracetamol in patients with
episodic TTH
Ibuprofen
Paracetamol
Acts centrally to inhibit prostaglandin production
✓
✓
✓
✓
✘
✓
25
20
Has anti-inflammatory action
20
Acts via the central nociceptive pathway
...a single dose of ibuprofen at 400 mg is significantly more effective than
paracetamol at 1000 mg in the treatment of TTH
26
Schachtel – 1996
27
26
Table 2: Mode of action of ibuprofen and paracetamol
How does ibuprofen compare with
paracetamol?
Ibuprofen provides superior pain relief to
paracetamol in TTH14,15
In clinical studies, ibuprofen has demonstrated
superior efficacy to paracetamol in relieving the pain of
episodic TTH.14,15
A double-blind, randomised trial compared single doses
of ibuprofen (400 mg, n=153) to paracetamol (1000 mg,
n=151) and placebo (n=151) (see Figure 2):14
6
40
0
Action
Several clinical studies have confirmed the efficacy of
NSAIDs and paracetamol in relieving the pain associated
with TTH.20 Head-to-head clinical trials have also been
performed to compare the safety, time to onset of action
and efficacy of common pain relievers with placebo.
50
0
In contrast, paracetamol is believed to act primarily
on prostaglandin production only in the central
nervous system.26
What treatments are effective for TTH?
60
•
Significantly more patients experienced complete
headache relief with ibuprofen than with paracetamol
or placebo
•
In addition, patients randomised to ibuprofen achieved
complete headache relief significantly faster than those
taking paracetamol or placebo
The European Headache Federation (EHF) and the British Association
for the Study of Headache (BASH) have stated that paracetamol may be
less effective than ibuprofen or other NSAIDs.2,4
How does ibuprofen compare with
other OTC NSAIDs?
The EFNS have stated that the clinical data show
little difference in efficacy between ibuprofen and
other OTC NSAIDs in TTH.16–19 The EFNS have stated
that it has not been possible to clearly demonstrate
the superiority of any one NSAID in treating TTH.6
Ibuprofen vs aspirin
Although there is limited evidence comparing aspirin
with ibuprofen, some evidence suggests that they have
comparable efficacy. A study compared ibuprofen 200 mg
and aspirin 500 mg with placebo in 95 patients with mildto-moderate migraine, episodic TTH, or both, who usually
self-medicated with OTC analgesics.19
In this double-blind, double-dummy trial:
•
Ibuprofen was at least as effective after 150 minutes
in the 65 patients who completed the study (see
Figure 3)19
Another randomised, double-blind trial of 108 patients
with TTH compared ibuprofen 400 mg, ibuprofen
800 mg, aspirin 650 mg and placebo for 4 successive
headaches, when a single dose was taken at the onset of
the headache:18
•
Patients taking either ibuprofen dose or aspirin reported
significant improvement in their pain scores 3 hours
after taking the drug compared to placebo
•
The physician’s global assessment of overall efficacy
of the trial medication based on responses to all 4
headaches indicated that both doses of ibuprofen were
significantly superior to placebo
7
This also impacts on pain relief. As fast-acting
formulations are absorbed into the bloodstream
quicker, they provide faster onset of pain relief than
standard ibuprofen.30
Mean visual analogue scale (VAS)
reduction (mm)
30
25
20
Ibuprofen 200 mg (n=65)
Aspirin 500 mg (n=65)
Placebo (n=65)
*p<0.0001 vs placebo
**p<0.05 vs aspirin
**
15
*
10
5
0
0
30
60
90
120
Arrow indicates the time when the
main response criterion (decrease
of headache intensity by ≥50% at
60 minutes) was evaluated.
Significance for time points before
and after 60 minutes were not
calculated or displayed.
Minutes
A systematic review published in 2014 compared singledoses of fast-acting formulations with standard ibuprofen
tablets for acute pain. Results indicated that the fastacting formulations:30
•
•
Achieved a faster onset of pain relief after dosing
•
Did not result in an increase in the number of patients
reporting side-effects
Ensured fewer patients needed additional pain relief
within 6 hours of dosing
Adapted from Nebe et al., 1996
Figure 3: Ibuprofen is as effective as aspirin in relieving migraine, TTH, or both headache types for up to 2 hours (as measured
by patient-rated visual analogue scale)
Fast-acting formulations
Is a rapid onset of action important when
treating TTH?
There are two reasons to consider time to onset of action
when recommending an OTC analgesic for TTH:
•
•
Moore – 2014
Treatment should be taken at the first sign of
symptoms of an acute headache episode to
gain relief as early as possible.8 Second only to
efficacy, a fast-acting treatment is one of the
most important functional benefits that patients
want from their analgesics when treating
headache (n=2000)28
Treating an acute TTH early may also help prevent
prolonged sensitisation of the central nervous
system,29 which is thought to play a key role in the
development of chronic TTH11
What are the benefits of
fast-acting formulations?
Fast-acting ibuprofen formulations, e.g. sodium ibuprofen
and liquid-filled capsules, enhance ibuprofen absorption with
earlier peak concentrations than standard formulations.30
This is due to the ibuprofen salts having a faster solubility
than standard ibuprofen in studies of healthy individuals,
increasing the rate of absorption into the bloodstream.31 Data
show fast-acting ibuprofen formulations are absorbed twice
as fast as standard ibuprofen.31,32
8
Fast-acting formulations
of ibuprofen demonstrated
more rapid absorption,
faster initial pain reduction,
but with no higher rate
of patients reporting
adverse events
Standard 200 mg (n=1883)
Standard 400 mg (n=4772)
Colour density change indicates the
point estimate. Width of the bar
indicates the 95% confidence interval
(CI) of the NNT.
Fast-acting 200 mg (n=828)
Fast-acting 400 mg (n=1199)
NNT = Number needed to treat,
where 1 is the ideal analgesic
1
2
3
4
NNT for ≥50% max total pain relief
over 6 hours (95% CI)
Adapted from Moore et al., 2014
Figure 4: A meta-analysis indicated NNTs for fast-acting ibuprofen formulations are lower than with standard ibuprofen
when compared with placebo in dental pain
9
Ibuprofen liquid capsules
Ibuprofen safety profile
In a TTH study, ibuprofen liquid capsules showed faster onset of
relief and superior efficacy to paracetamol.15 This randomised,
double-blind, parallel group trial compared a single dose of
ibuprofen liquid capsules 400 mg (n=60) to paracetamol 1000 mg
(n=62) or placebo (n=32) in patients with episodic TTH.15
•
Time from dosing to perceptible pain relief and meaningful
pain relief was faster with ibuprofen liquid capsules
than either paracetamol or placebo (perceptible pain
relief median: 39 min, 47 min, and 113 min respectively,
p<0.001 for both ibuprofen vs paracetamol or placebo;
Meaningful Relief by 30 minutes
80
•
•
meaningful pain relief median: 39 min, 53 min, and >180
min respectively, p≤0.02 for ibuprofen vs paracetamol and
p<0.001 for ibuprofen vs placebo)15
How does ibuprofen’s safety profile compare
to other analgesics?
A single ibuprofen liquid capsule 400 mg dose
demonstrated significantly superior overall analgesic
efficacy compared with paracetamol when treating
TTH, with more subjects achieving complete relief (see
Figure 5)15
Some clinical studies also show that the gastrointestinal
(GI) effects of ibuprofen are comparable to paracetamol at
OTC doses.20,33,34
No subjects reported any adverse effects15
Complete Relief at 3 hours
75*
Subjects achieving complete relief (%)
70
*p<0.01 vs paracetamol
60
Ibuprofen has the lowest risk of GI side effects
compared with all other OTC NSAIDs.34 At OTC doses
up to 1200 mg/day, ibuprofen has a good GI safety
profile and is better tolerated than aspirin, naproxen
and diclofenac.20,35,36
In terms of cardiovascular (CV) effects, OTC dose ibuprofen
and naproxen are least likely to increase CV risk among the
widely used NSAIDs.37
Ibuprofen, as well as other NSAIDs, is recommended by
headache experts based on its efficacy and favourable
safety profile.2,4,6
50
40
The overall tolerability of
ibuprofen in this large-scale
study was equivalent to that of
paracetamol and better than
that of aspirin
32
30
20
20*
10
2
Moore et al. – 1999
0
Ibuprofen
Paracetamol
Ibuprofen
Paracetamol
Adapted from Packman et al., 2000
Figure 5: Percentage of subjects obtaining meaningful relief by 30 min and complete relief by 3 hours is superior with ibuprofen
liquid-filled capsules than paracetamol in episodic TTH
...several other studies have demonstrated the overall analgesic superiority of
ibuprofen to paracetamol [in TTH]…the liquigel formulation also provides a
clinically relevant advantage for time to analgesic effects
Packman – 2000
In practice, this means that recommending a fast-acting ibuprofen
formulation can deliver faster overall pain relief, compared to standard
ibuprofen at the same dose.30
10
It can be recommended to customers suffering with
acute TTH at the OTC dose – up to 400 mg up to
3 times a day, as required in adults and children over
12 years old. Note: there are some special warnings
and contraindications regarding GI and CV safety of
ibuprofen (including patients with hypersensitivity to
ibuprofen or other NSAIDs and those with pre-existing GI
or CV conditions) – please see the Summary of Product
Characteristics for full details.
Amongst the NSAIDs [for TTH],
ibuprofen seems to have the most
favourable side-effect profile
EFNS – 2010
EVALUATE: How does this information alter your
perception of the safety of ibuprofen compared to
paracetamol at OTC doses?
11
Understanding patients
Guideline recommendations for TTH
What is the recommended treatment for TTH
How do patients manage their TTH?
Simple analgesics are recommended as the first-line
treatment choice in international and UK guidelines for
acute TTH.2,4–8,12 Analgesic options available OTC include:38
•
NSAIDs
• ibuprofen
• aspirin
• naproxen
• diclofenac
• ketoprofen
•
Paracetamol
The impact of TTH?
TTH affects both adults and children and
although there is limited data and estimates vary
with the latter, one 2007 review suggested that 1 in
3 children/adolescents suffer from TTH.22 Episodes
commonly start in children at 7 years of age.39 Peak
prevalence is between the age of 30–39 years and
decreases slightly with age.6 Females are marginally
more affected than men.6
What do the UK guidelines recommend?
Organisation
Recommendation
Key quote
The British Association for the
Study of Headache (BASH)
Ibuprofen 400 mg
Aspirin 600–900 mg
“Symptomatic treatment is
appropriate for TTH occurring on
less than 2 days per week”
The UK National Institute for
Health and Care Excellence (NICE)
NSAIDs
Aspirin
Paracetamol
“..taking into account the person’s
preference, comorbidities and risk of
adverse events”
Table 3: UK guideline recommendations for first-line treatment of TTH
What do the European guidelines recommend?
The European Headache Federation (EHF) and the
European Federation of Neurological Societies (EFNS)
state that paracetamol may be less effective than
NSAIDs.2,6 Data show that a 400 mg dose of
standard ibuprofen tablets can start relieving TTH
from 15 minutes.13 Ibuprofen 200–400 mg should be
considered as a treatment of choice for TTH, provided
NSAIDs are not contraindicated.
Combination treatments for TTH
A combination of aspirin + paracetamol + caffeine
is recommended in some guidelines.6,12 Combination
analgesics plus caffeine have been shown to increase the
efficacy of analgesics.38
However, European guidance advises it is used only as a
second-line option as caffeine-containing combinations
are believed to be more likely to induce MOH than single
OTC analgesics.6 These guidelines also state that codeine
12
combinations should also be avoided for TTH for the
same reason.2,6
The UK BASH guidelines consider analgesics containing
caffeine and codeine to have an increased risk for the
development of MOH.4
Simple analgesics and NSAIDs
are the mainstays in the acute
therapy of TTH. Paracetamol
1000 mg is probably less effective
than the NSAIDs...
Ibuprofen 400 mg may be
recommended as drug of choice
amongst the NSAIDs
EFNS – 2010
TTH is estimated to exert a greater global burden
with much larger disability worldwide compared
with migraine.22 TTH, like other headaches, has a
significant impact on quality of life; affecting family
and social life and reducing productivity at work.1
A study showed that depression and anxiety have also
been shown to be associated with migraine and
non-migraine headaches, compared with headache
free individuals.40
Delaying treatment:
Many patients want fast and effective pain relief for their
TTH.28 In spite of this, a survey of 961 customers with
headache, demonstrated that more than half of customers
with headache delay taking analgesics until the pain is
unbearable.42 In a UK survey of 2000 adults, 84% wait at
least 20 minutes before taking any medication.43
Taking analgesics with food:
Ibuprofen is a pain reliever that can be taken with or
without food, even on an empty stomach.20,44 Paracetamol
can also be taken without food. However, other NSAIDs (e.g.
diclofenac) do require administration with food.45,46
What do patients believe about
TTH management?
RB global market research has found that some
individuals who suffer from TTH believe that
medication should only be used when it affects their
ability to concentrate, or that treating a headache may
make them reliant on analgesics or negate their efficacy
for more serious pain.41 Understanding more about
patient behaviours can help pharmacy staff intervene
more effectively.
Common mistakes patients make when
treating their TTH
Since half of those who suffer from headache will opt to
self-treat their headache without any consultation with a
healthcare professional,1 it is important to consider what
treatment decisions they may be making.
Treatment choice:
A survey of 2000 UK patients shows that twice as many
people use paracetamol over ibuprofen as their TTHrelieving analgesic.28
13
Alleviating the burden
There is also a broader socioeconomic and healthcare burden
associated with TTH. European data found that the mean per
person annual costs for TTH were €303.47 Indirect costs, such
as reduced productivity and absenteeism from work, accounts
for 92% of the cost of TTH.47
The management of TTH also places a large burden
on healthcare systems. In Europe, outpatient care was
listed as the top contributor to the direct costs of this type
of headache.47
Can pharmacy play a pivotal role in the management of TTH?
The majority of customers with headache have a positive
attitude towards OTC medications and feel that they
are more adequate for acute headache than prescription
medication.42 Ultimately, half of headache suffers will opt
to self-treat their headache without any consultation with
a healthcare professional.1
Although the pharmacist is well-placed to provide
first-line advice on the management of the different
types of headache, recent UK research (involving
2000 adults) revealed around half of sufferers have
rarely or never sought advice from a pharmacist.43
Better communication, through specific techniques,
such as motivational interviewing, may increase patient
engagement and encourage patients to seek advice from
the pharmacy in the future. Pharmacy has a key role in
improving patient care and reducing healthcare costs
associated with TTH.
The role of the pharmacy
How can pharmacy make a difference?
A UK survey of 2000 adults revealed 86% of
patients may be influenced by advice from
their pharmacist.43 Furthermore, around threequarters of people said they would change their
treatments if they understood more about their
headache.43 This allows the pharmacy team the
opportunity to work with patients to optimise
TTH management.
Explaining about the role of muscles in headache can
help, as well as identifying likely trigger factors. These
can include:6
•
•
•
•
•
•
14
Mental or physical stress
Irregular or inappropriate meals
Pharmacists can suggest non-pharmacological options
that can help reduce the likelihood of future headaches
(e.g. avoiding triggers,2 relaxation techniques,6
improving posture2).
Another key part of the pharmacist’s role in helping patients
manage their TTH is to enquire about their current analgesic
usage and emphasise the importance of avoiding MOH,
i.e. ensuring the safe and appropriate use of any medications.
It is important to be aware of MOH and refer any customer
you suspect might be affected to the pharmacist or their GP
for further help. MOH is a chronic headache which results
from taking too many analgesics routinely for a period of
time.4 Customers regularly taking simple OTC pain relievers
on 15 or more days per month or codeine-containing
analgesics on 10 or more days per month are at risk of
developing MOH.4
In addition, pharmacists can signpost patients to their GP
if there is evidence of any ‘red-flag’ symptoms that require
further investigation (see page 5).
Helping patients choose appropriate
treatment
In addition to gaining an accurate picture of the patient’s
symptoms and concerns, another aspect is to understand
what is motivating patient behaviours. Using motivational
interviewing skills can help. This uses open-ended questions
based around the following key principles:
•
Expressing empathy with the patient’s suffering –
this will require the pharmacy team to first determine
that the analgesic being purchased is for TTH
•
Identifying behaviours that may explain why relief is
not optimal e.g. analgesic choice, delaying treatment
(taking effective analgesics early in the course of a
headache is important to relieve the pain before it
becomes established)
•
Not all patients will be happy to implement
behaviour change at the pharmacist’s initial
suggestion, but this can be discussed further in
later consultations
•
Supporting self-care
High intake or withdrawal of caffeine
Dehydration
Too much or too little sleep
Reduced or inappropriate exercise
15
Essential information:
Nurofen Express 400 mg Liquid Capsules: Each capsule contains Ibuprofen 400 mg. Nurofen Express Soluble
400mg Oral Powder: Each sachet contains 400mg ibuprofen as ibuprofen lysinate. Indications: Nurofen
Express Liquid Capsules: for symptomatic relief of non-serious arthritic conditions, rheumatic or muscular pain,
backache, neuralgia , migraine, headaches, dental pain, dysmenorrhoea, feverishness, colds and influenza. Nurofen
Express Soluble Oral Powder: For the relief of mild to moderate pain associated with headache, migraine,
backache, period pain, dental pain, rheumatic and muscular pain, cold and flu symptoms such as sore throat and
fever. Dosage and Administration: Nurofen Express Liquid Capsules: Adults and children over 12 years: Take 1
capsule with water, up to three times a day as required. Leave at least 4 hours between doses. Do not take more
than 3 capsules in any 24 hour period. Not for use by children under 12 years. of age. Nurofen Express Soluble
Oral Powder: Adults, the elderly and children over 12 years: Initial dose – one sachet. Then, if necessary, one
sachet up to three times a day as required. Dissolve the contents of the sachet in a glass of water, stir, and then
drink immediately. Leave at least six hours between doses. Do not exceed more than 3 sachets (1200mg) in any
24 hour period. The patient should consult a doctor if symptoms persist or worsen, or if the product is required
for more than 5 days when treating pain and 3 days when treating fever. Not for use by children under 12 years
of age. Contraindications: Known hypersensitivity to ibuprofen or other ingredients. History of bronchospasm,
asthma, rhinitis, or urticaria, associated with aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
History of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs.
Severe hepatic failure, severe renal failure or severe heart failure. Concomitant NSAIDs, including COX-2
inhibitors. Last trimester of pregnancy. Special warnings and precautions for use: SLE and mixed connective
tissue disease. Gastrointestinal disorders and chronic inflammatory intestinal disease. Hypertension and/or
cardiac impairment. Renal impairment. Hepatic dysfunction. Bronchial asthma or allergic disease. GI bleeding,
ulceration or perforation, which can be fatal has been reported with all NSAIDs at anytime during treatment, with
or without warning symptoms or a previous history of GI events. Caution with concomitant medications which
could increase the risk of gastrotoxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin
or anti-platelet agents such as aspirin. Withdraw treatment if GI bleeding or ulceration occurs. Possible reversible
effects on fertility. Avoid use during the first 6 months of pregnancy if possible. Patients with rare hereditary
problems of fructose intolerance should not take Nurofen Express Liquid Capsules. Side effects: Hypersensitivity
reactions including: (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity e.g. asthma,
aggravated asthma, bronchospasm, dyspnoea, (c) various skin reactions e.g. pruritus, urticaria, angiodema and
more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Gastrointestinal disturbance including: peptic ulcer, perforation or GI haemorrhage, headache, acute renal failure,
liver disorders, haematopoietic disorders including anaemia. Product Licence Number: Nurofen Express Liquid
Capsules PL 00063/0653. Nurofen Express Soluble Oral Powder PL 00063/0611 Licence Holder: Reckitt Benckiser
Healthcare (UK) Ltd, SL1 4AQ. Legal category: P MRRP: Nurofen Express Liquid Capsules £8.19 (20 capsules)
Nurofen Express Soluble Oral Powder £4.99 (10 sachets) Date: August 2014 – For full information refer to SPC
(http://www.medicines.org.uk/emc/).
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Reckitt Benckiser Healthcare (UK) ltd on: 0500 455 456
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These materials have been developed by RB | UK/N/0614/0052a | August 2014