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944 Original article

Osteopathy improves the severity of irritable bowel


syndrome: a pilot randomized sham-controlled study
Blanche-Maëlle Florancea, Gregory Frinb, Raffaella Daineseb,
Marie-Hélène Nébot-Vivinusc, Eugénia Marine Barjoand, Sophie Marjouxb,
Jean-Pierre Laurensa, Jean-Luc Payrousea, Xavier Hébuterneb
and Thierry Picheb,c

Background Effective therapies for irritable bowel Both anxiety and depression scores decreased without
syndrome (IBS) are disappointing. Therefore, IBS patients difference between groups. Stool frequency and
have a growing interest for alternative medicines including consistency were not significantly modified.
osteopathy.
Conclusion Osteopathy improves the severity of IBS
Aim We aimed to evaluate the effect of osteopathy on the symptoms and its impact on quality of life. Osteopathy
severity of IBS in a randomized sham-controlled trial. should therefore be considered for future research
as an effective complementary alternative medicine
Methods We prospectively assigned 30 patients with IBS
in the management of IBS symptoms. Eur J Gastroenterol
(23F, 7M, mean age 45.8±16.4 years) fulfilling the Rome III
Hepatol 24:944–949 c 2012 Wolters Kluwer Health |
criteria in a 2/1 ratio to receive either osteopathy or sham
Lippincott Williams & Wilkins.
osteopathy. Two separate sessions were performed at
a 7-day interval (days 0 and 7) with a further 3 weeks European Journal of Gastroenterology & Hepatology 2012, 24:944–949
of follow-up (day 28). The primary outcome included at Keywords: irritable bowel syndrome, irritable bowel syndrome severity
least a 25% improvement in the IBS severity score at day 7. score, osteopathy
The secondary outcomes included the impact of IBS on a
Osteopathic Center ATMAN, Sophia-Antipolis, bGastroenterology Department,
quality of life, psychological factors, and bowel habits. Archet 2 Hospital, cInserm 576, Immunology Department, Archet 1 Hospital and
d
Epidemiology Department, Archet 1 Hospital, CHU of Nice, University of Nice
Results The severity of IBS decreased in both groups Sophia-Antipolis, France

at days 7 and 28. At day 7, this decrease was significantly Correspondence to Thierry Piche, MD, PhD, Gastroenterology and Inserm 576,
more marked in patients receiving osteopathy compared Archet 2 Hospital, CHU of Nice, France
Tel: + 33 492 036 399; fax: + 33 492 036 575;
with those receiving the sham procedure (– 32.2±29.1 vs. e-mail: piche.t@chu-nice.fr
– 9.0±16.0, mean difference normalized to the baseline
Received 25 January 2012 Accepted 29 March 2012
P = 0.01). This difference did not persist at day 28 (P = 0.4).

Introduction based practices based on reflexology have been proposed


The irritable bowel syndrome (IBS) affects 10–20% of the to IBS patients with various benefits [4]. The osteopathic
adult population worldwide and causes significant morbid- treatment could be of specific interest in IBS patients.
ity, quality-of-life impairment, and burden on the health- Treatment consists of gentle stretching, mobilizing, and
care system [1,2]. Although IBS has a high prevalence, manipulating procedures applicable to various tissues and
its underlying mechanism is not fully understood, being of parts of the body, including the musculoskeletal and vis-
multifactorial origin, including abnormalities in gut motility ceral systems [5]. One of its main principles is the inter-
and sensitivity, activated gut immunity, and disturbances relationship of structure and function, the goal being to
in brain–gut interactions, with psychological disorders [3]. restore movement within the environment of an abdominal
Because of the wide range of symptoms that may be expe- organ or article. The concept of osteopathy is appealing
rienced, the pharmacological treatments available for IBS now that there is greater appreciation of the role of the
are mainly targeted at symptom reduction. brain–gut axis in functional gastrointestinal disorders such
as IBS. Interestingly, an osteopathic approach such as
As conventional IBS treatments provide only minor clini- vertebral and abdominal manipulations may affect the
cal benefit, a growing number of complementary alter- sympathetic tone [6], which is shown to be altered in IBS
native medicine modalities are becoming attractive options patients [7]. To date, only one controlled study from the
for many patients. Therefore, natural products including Netherlands has been carried out in IBS patients with
herbal medicine, peppermint oil, exclusion diet, probiotics a 6-month follow-up. In this study, in the osteopathic
and prebiotics, and mind–body medicines including hyp- group, 68% of patients experienced a definite overall
nosis, acupuncture, meditation, manipulative, and body- improvement in symptoms and 27% experienced a slight
0954-691X
c 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins DOI: 10.1097/MEG.0b013e3283543eb7

Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Osteopathy is effective in IBS Florance et al. 945

improvement, whereas only 18% experienced an overall frequency corresponded to the average number of bowel
improvement and 59% experienced a slight improvement movements per day assessed on the diary. The stool form
while on standard care [8]. was evaluated through the mean of numbers associated
with the stool picture from the Bristol Stool Form Scale
Therefore, the primary aim of this study was to evaluate
(1, separate hard lumps like nuts; 2, sausage shaped but
the effect of osteopathy on the severity of IBS. The
lumpy; 3, like a sausage but with cracks on its surface; 4,
secondary outcomes were to assess the efficacy of oste-
like a sausage or a snake, smooth and soft; 5, soft blobs
opathy on quality of life, psychological factors, and bowel
with clear-cut edges; 6, fluffy pieces with ragged edges,
habits in these patients. We performed a randomized
a mushy stool). All participants were evaluated under the
sham-controlled single-blind trial testing two sessions of
same conditions in the morning at the inclusion visit (day
standardized osteopathy at a 7-day interval, followed by a
0), on days 7 and 28. Each participant completed the
3-week follow-up period.
French validated IBS severity scoring system [9]. Quality
of life and psychological variables were also assessed
Methods through a set of questionnaires including the fatigue im-
Participants pact scale (FIS), the Beck Depression Inventory (BDI),
Consecutive patients who fulfilled the Rome III criteria [1] and the Hospital Anxiety and Depression Scale. All
for the diagnosis of IBS were seen in the Department patients gave their written informed consent.
of Gastroenterology of the Centre Hospitalier Universitaire
The osteopathic procedure was performed by a single
de Nice between March 2009 and February 2011.
osteopath and standardized as follows: the focus in treat-
Symptoms of IBS (e.g. abdominal pain and/or discomfort,
ment, therefore, went beyond simple spinal alignment, to
change in stool frequency) had to be present more than
dealing directly with the abnormal body physiology using
25% of the time, being evaluated by means of daily diaries
an array of direct and indirect techniques [10]. By def-
completed during 10 days including a Bristol Stool Form
inition, direct techniques produce a change in the body
Scale. IBS subtypes were divided as predominance of con-
by working against a barrier of resistance in the tissue,
stipation (IBS-C) or diarrhea (IBS-D). We did not include
and indirect techniques produce a change in the body by
patients with mixed symptoms because of the inherent
moving tissue away from a barrier, allowing the vectors of
variability in symptoms in this IBS subtype. Patients were
force within the tissue to reach a new point of balance.
examined thoroughly and were subjected to biological tests
to exclude an organic disease: celiac disease, inflammatory Each session began with a physical examination and inter-
vention, paying special attention to the spine and the
bowel diseases, lactose intolerance, severe depression and
anxiety, and thyroid and renal dysfunction. Patients with abdomen. The direct technique included pressure on
each segment of the spine with the hands for 90 s. This
rheumatologic disease or symptoms were not included.
Patients were instructed to continue their usual treatment was completed by an indirect technique, during which
the patient was properly positioned and the osteopath
for IBS including antispasmodics, laxatives, or loperamide
without modifying the doses during the entire study. manipulated in all directions. In the indirect method,
pressure was applied to the manipulated segment with
Dietary habits were also unchanged during the 3 previous
the help of the hand, knee, or the chest. Each session was
months before inclusion and during the entire study. None
completed by visceral osteopathy to relieve imbalances
were taking antidepressants, anti-inflammatory drugs
and restrictions in the interconnections between the
(steroids), or analgesic (paracetamol, aspirin). None were
motions of all the organs. Each session was performed for
smokers or alcohol consumers. Patients were not included
60 min. The sham procedure consisted only of a gentle
if they were well aware and/or had previously been treated
massage of the same part of the body including both the
with osteopathy to ensure an optimal blinding.
spine and the abdomen at the same time.
Study protocol
Thirty eligible IBS patients fulfilling the Rome III Irritable bowel syndrome severity and impact
criteria [1] were randomly assigned in a 2/1 ratio to on quality of life
receive either osteopathy (treatment group) or sham Each individual was asked to complete the French vali-
osteopathy (control group). A 2 : 1 unequal allocation was dated IBS severity scoring system initially developed by
used to increase patient acceptability and for maximizing Francis et al. [9] and subsequently used in cohorts of IBS
participants’ exposure to treatment. Two sessions of patients in France [11,12]. The questionnaire is com-
manipulative procedures were performed at a 7-day posed of 1–2 items assessing the presence of abdominal
interval with a further 3-week period of follow-up. The pain and bloating (answer yes or no), 2–4 visual analog
osteopath was not aware of the IBS subtype and was not scales measuring the intensity of pain, bloating, relief
involved in data analysis to optimize the blinding of the following defecation, and the impact of symptoms on the
study. Patients were instructed to complete a stool diary general quality of life, 3– an item on the number of days
each day during 10 days before the study (diary 1) and 10 of suffering during the preceding 10 days. The total score
days before ending the follow-up (diary 2). The stool of the questionnaire ranges from 0 to 500 and provides

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946 European Journal of Gastroenterology & Hepatology 2012, Vol 24 No 8

a qualitative assessment of severity(< 75 = remission; risk a. The maximum attrition rate was assumed to be
75–175 = mild IBS; 175–300 = moderate IBS; and >300 10%. Parameters of the study population were compared
= severe IBS). using w2 for qualitative variables and Kruskall–Wallis and
Mann–Whitney nonparametric tests for quantitative
The severity of abdominal pain/discomfort was scored 0–4 variables. Paired tests were also used for the comparison
according to its impact on patients’ daily activities [11]: of quantitative data in the same group at different times.
0, absent; 1, mild (not influencing activities); 2, relevant Data are expressed as means and SD.
(diverting from, but not urging modification of activities);
3, severe (influencing activities markedly enough to urge Results
modifications); and 4, extremely severe (precluding daily Baseline characteristics of irritable bowel syndrome
activities). patients
Thirty patients were included and completed the entire
Fatigue protocol; 20 received osteopathy and 10 received the
Fatigue was measured using the French version of the FIS sham procedure. None of the patients were lost to follow-
questionnaire, which was initially translated into French up. There were no significant differences at baseline
and validated in a cohort of healthy blood donors in between the osteopathy and the sham procedure groups
Montreal and subsequently in patients with IBS [13]. FIS with respect to age, sex, duration of disease, the severity
is a self-report questionnaire consisting of 40 statements of IBS, and its impact on quality of life, fatigue, anxiety,
that describes possible manifestations of fatigue; these depression, and the proportion of IBS subtypes (Table 1).
statements are divided into three categories [cognitive
(n = 10), physical (n = 10), and psychosocial (n = 20)]. Severity of irritable bowel syndrome and quality of life
Each item is rated on a five-point scale of distress, ranging On day 0, the severity of IBS was 300±71 in the
from 0 (‘no problem’) to 4 (‘extreme problem’), with a osteopathy group and 275±92 in the sham procedure
maximum of 160 points. group (NS). Treatment with osteopathy significantly
reduced the severity of IBS at day 7 (196±88, P < 0.01)
Depression and day 28 (224±102, P < 0.01), corresponding to a 33.7
Depression was assessed using the short version of the and 25.5% improvement, respectively. The sham proce-
BDI, a well-standardized 13-item measure of the cognitive, dure also reduced the severity of IBS, with a 16%
affective, and somatic symptoms of depression available improvement at day 7 (244±75, P = 0.04) and an almost
in French [14]. The short 13-item BDI contains only significant 24% improvement at day 28 (228±119, P =
a pertinent item that correlates significantly with both the 0.07) (Fig. 1). When normalized to baseline, the reduc-
global score of the original 21-item form and the clinical tion in the severity of IBS at day 7 was significantly more
evaluation of depression by physicians [14]. Four sentences pronounced in patients treated with osteopathy com-
are included in each item, rating from 0 to 3 in function of pared with the sham procedure (P = 0.01), whereas no
the severity of a symptom. significant difference was observed at day 28 (P = 0.8)
(Fig. 1 and Table 2). No significant difference was also
Anxiety observed between IBS subtypes.
The Hospital Anxiety and Depression Scale is a reliable
Similar to the variation in the severity of IBS, the
instrument with a ‘cutoff ’ score for screening for clinically
improvement in quality of life normalized to baseline was
significant anxiety and depression and has also been
shown to be a valid measure of the severity of these dis-
orders of mood [15]. This self-assessment scale consists Table 1 Clinical characteristics of irritable bowel syndrome
of 14 items, each using a four-grade Likert scale (0–3), patients at baseline
with subscales for anxiety including seven items. The Osteopathy Sham procedure P
score varies with the severity of anxiety and depression.
Sex (male/female) 5M/15F 2M/8F 0.7
Age (years) 47.5±15.8 47.5±17.8 0.5
Level of satisfaction IBS severity score 300±71 275±92 0.2
Impact of abdominal pain severity 2.2±0.7 1.6±0.9 0.06
The level of satisfaction was assessed at the end of the on quality of life
study by asking patients their global appreciation of oste- Impact of abdominal pain frequency 2.8±0.9 2.9±1.1 0.7
opathy and whether they would agree to pay for sub- on quality of life
FIS score 61.8±31.9 53.1±43.4 0.8
sequent manipulative procedures. HAD score 15.6±7.4 17.2±7.8 0.5
Beck score 8.5±4.4 9.2±6.3 0.8
Duration of IBS (years) 11.3±9.8 11.4±17.9 0.1
Statistical analysis
IBS-D, IBS-C 11/9 3/7 0.2
The sample size was calculated at 24 and 12 evaluable
patients, respectively, in each group for an expected sig- Data are means and SD.
FIS, fatigue impact scale; HAD, Hospital Anxiety and Depression Scale; IBS,
nificant reduction in the IBS severity score of 25% with irritable bowel syndrome; IBS-C, irritable bowel syndrome with constipation;
osteopathy versus sham osteopathy with a 5% adjusted IBS-D, irritable bowel syndrome with diarrhea.

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Osteopathy is effective in IBS Florance et al. 947

significantly more marked at day 7 in patients treated at day 28, NS). There was no significant difference at any
with osteopathy compared with the sham procedure (P = time between the groups.
0.03), whereas there was no significant difference
At day 0, the BDI score was 8.5±4.4 in the osteopathy
between groups at day 28 (P = 0.6) (Table 2).
group and 9.2±6.3 in the sham procedure group (NS). In
Data of stool frequency and consistency are detailed patients treated with osteopathy, the BDI score did not
in Table 3 for IBS-D and IBS-C. In both subtypes, the change significantly at day 7 (7.7±5.5, P = 0.2 vs. day 0),
average frequency and form of bowel movement were not but decreased significantly at day 28 (4.9±1.8, P < 0.01
significantly different between osteopathy and the sham vs. day 0 and P = 0.05 vs. day 7). In patients receiving
procedure. In IBS-D, a statistical trend favoring greater the sham procedure, the BDI score remained unchanged
improvement in stool frequency was observed with oste- at day 7 (7.6±4.8, P = 0.07 vs. day 0) and decreased sig-
opathy compared with the sham procedure (– 0.1±0.2 vs. nificantly at day 28 (4.4±2.2, P = 0.01 vs. day 0 and
0.5±1.2 bowel movements/day, P = 0.067). Moreover, P = 0.04 vs. day 7). There was no significant difference at
there was no change in the IBS phenotype throughout any time between the groups.
the study.
At day 0, the HAD score was 15.6±7.4 in patients treated
with osteopathy and 17.2±7.8 in patients receiving the
Psychological variables
sham procedure (NS). In patients treated with osteo-
The total score of fatigue was not significantly reduced
pathy, the HAD score remained unchanged at day 7
over time either in patients receiving osteopathy (61.8±
(15.7±7.8, P = 0.7 vs. day 0), but decreased significantly
31.9 at day 0, 57.2±33.3 at day 7, and 51.3±31.0 at day
at day 28 (6.7±4.7, P < 0.01 vs. day 0 and P < 0.01 vs. day
28, NS) or in patients treated with the sham procedure
7). In patients receiving the sham procedure, the HAD
(53.1±43.4 at day 0, 51.2±47.2 at day 7, and 45.1±44.0
score was not significantly changed at day 7 (16.4±7.2,
P = 0.5 vs. day 0) and decreased significantly at day 28
Fig. 1
(6.2±5.5, P < 0.001 vs. day 0 and P < 0.001 vs. day 7).
There was no significant difference at any time between
IBS severity score the groups.
(mean±SD)
320 Satisfaction of the patients
Severe
300 At the end of the study, the level of satisfaction was
Moderate
280 significantly higher in the group of IBS patients treated
with osteopathy (14/20, 70%) compared with those treated
260
with the sham procedure (4/10, 40%, P = 0.03).
240
220 Safety and tolerance
200 Both osteopathy and sham procedures were well toler-
180 P = 0.01 ated, without any significant side-effects.
Mild
160
Day 0 Day 7 Day 28 Discussion
In this study, we have shown that a standardized oste-
Sham osteopathy Osteopathy opathic technique was effective in decreasing the severity
of IBS, in particular abdominal pain, for a short-term
Evolution of the severity of irritable bowel syndrome (mean±SD) in duration. Our data indicate a specific effect of osteopathy
patients receiving osteopathy (dark) or sham osteopathy (white) at days
0, 7, and 28. P = 0.01 between osteopathy and sham osteopathy at day as the clinical improvement with the sham procedure was
7. IBS, irritable bowel syndrome. significantly less pronounced. Anxiety and depression
scores improved at the end of follow-up but at similar

Table 2 Severity of irritable bowel syndrome and psychological outcomes normalized to baseline after osteopathy or the sham procedure
Variation between days 7 and 0 Variation between days 28 and 0

Osteopathy Sham procedure P Osteopathy Sham procedure P

IBS severity score – 32.2±29.1 – 9.0±16.0 0.01 – 22.9±34.3 – 18.9±24.4 0.7


Impact of abdominal pain severity on quality of life – 24.1±45.0 12.5±35.8 0.03 – 6.6±50.8 – 2.5±41.0 0.6
FIS score – 6.9±30.4 – 7.9±44.6 0.9 – 7.4±62.3 – 19.0±44.6 0.9
HAD score – 45.0±83.4 – 62.9±26.4 0.5 1.1±18.7 1.6±23.1 0.5
Beck score – 15.3±38.1 – 14.1±24.0 0.9 – 23.8±61.3 – 36.5±65.5 0.6

Data are variations normalized to baseline and expressed as means and SD.
FIS, fatigue impact scale; HAD, Hospital Anxiety and Depression Scale; IBS, irritable bowel syndrome.

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948 European Journal of Gastroenterology & Hepatology 2012, Vol 24 No 8

Table 3 Changes in the bowel habits of irritable bowel syndrome duced a significant improvement in the severity of IBS, in
patients particular, abdominal pain and bloating. Finally, similar
Diary 1 Diary 2 clinical improvements in IBS-C and IBS-D subtypes
Stool frequency Stool Stool frequency Stool
suggest that manual treatment should be proposed to IBS
(BM/day) form (BM/day) form patients irrespective of their predominant gut motility
IBS-D
dysfunction.
Osteopathy 1.9±0.5 5.0±0.6 1.5±0.4 5.0±0.4
Sham 1.1±0.5 5.0±0.0 1.3±0.2 5.3±0.5
Beside abdominal pain and altered bowel habits, IBS
procedure patients are likely to complain of a variety of other
IBS-C nongastrointestinal somatic disorders, increasing their
Osteopathy 0.3±0.1 1.6±0.7 0.5±0.2 1.8±0.6
Sham 0.2±0.0 1.4±0.5 0.4±0.1 1.7±0.7 healthcare utilization, including fatigue, depression, and
procedure anxiety [19,20]. In the present study, depression and
Stool frequency corresponds to the average number of bowel movements per day
anxiety scores were equally reduced, without any differ-
assessed in 10 days diary before entering (diary 1) and ending (diary 2) the study. ence between osteopathy or the sham procedure. Interest-
Stool form was assessed by meaning numbers of stool pictures from the Bristol ingly, the improvement in anxiety and depression occurred
Stool Form Scale. Data are means and SD.
BM, bowel movement; IBS, irritable bowel syndrome; IBS-C, irritable bowel only after relief of gut symptoms was achieved, suggesting
syndrome with constipation; IBS-D, irritable bowel syndrome with diarrhea. that psychological factors were mostly a consequence of
chronic abdominal pain.
levels in both groups. However, osteopathy had no effect In this study, we did not evaluate the underlying mecha-
on the bowel habits of IBS patients (e.g. stool frequency nisms of osteopathy on gut function. Both central and
and consistency). Finally, the clinical benefit of osteo- peripheral factors contribute to a biopsychosocial con-
pathy was not sustained over 28 days of follow-up. ceptualization of the pathogenesis and clinical expression
A number of factors are likely to explain the increasing of IBS [21,22]. In theory, there are a number of ways
interest in complementary alternative therapies that is to promote an osteopathic approach in IBS. Obviously,
considered by up to 30% of IBS patients [8]. First, treatment of patients with osteopathy can be compared
traditional medical therapies for IBS only offer limited with a behavioral therapy. However, our findings suggest
therapeutic gains over placebo [16,17]. Further, in many a specific effect of osteopathy as the sham procedure was
countries, prescription medication insurance coverage for less effective. In fact, osteopathic techniques, such as
IBS and other ‘quality-of-life’ conditions is decreasing. articulation manipulation and soft tissue massage to these
Finally, perhaps related to concerns regarding the safety areas, may affect the sympathetic tone [6], which was
of prescription medications, there appears to be a growing shown to be altered in IBS patients [7]. This effect on
desire among patients for more holistic and ‘natural’ autonomic function may be one explanation for the supe-
treatment options with certain benefits [18]. However, riority of osteopathy compared with soft massage of the
further data on the efficacy and safety of alternative same areas (e.g. sham procedure). Whether vertebral and/
therapies are urgently needed. or visceral manipulation should be preferred to treat IBS
is currently unknown. Our findings also suggest that oste-
Surprisingly, there has been very little research into the opathy sessions should be repeated with less than a 1-month
treatment of IBS using manual therapy techniques, in interval to sustain the clinical benefit. Finally, osteopathy
particular osteopathy. In a pilot open randomized study has also been shown to improve cardiac indices [23] and
including 39 individuals, Hundscheid et al. [8] reported lymph flow rates through the thoracic duct [24].
that five osteopathic procedures during 2–3 weeks con-
ferred a sustained 6-month clinical benefit compared Our study also has some drawbacks that need to be
with the standard care option (e.g. medical care) on mentioned. Clearly, the sample size was estimated to assess
overall symptom, quality of life, and IBS severity. How- the effect of one session of a manipulative technique
ever, this interesting and encouraging study was flawed by assuming that a 25% decrease in the severity of IBS could
the absence of a true control group and the inherent be significantly more marked compared with the sham
variations in the osteopathic black box method, the indi- procedure. We used unequal 2/1 randomization to increase
vidual approach to osteopathic treatment depending on patient acceptability and the recruitment rate. However,
the diagnostic findings of the osteopath. In the present the small sample size may have underpowered the findings
study, each patient was treated with a similar manual pro- on bowel habits. Moreover, we did not plan a cross-over
cedure irrespective of the diagnosis findings of the oste- design because IBS is likely to be prone to a carry-over
opath. We also used a sham procedure, being conscious of effect. In this study, the follow-up of symptoms was short,
the limitation of blinding because of possible patient being restricted to 15 days after the treatment was stopped.
knowledge of the osteopathic technique. Finally, the Finally, it is not clear whether the benefits of real and sham
severity of IBS was assessed soon after (e.g. 7 days) each osteopathy over ‘usual care’ are a consequence of the in-
session to avoid inherent variations in IBS symptoms over teraction between the complementary alternative medicine
long time periods. Thus, one session of osteopathy in- provider and IBS patients.

Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Osteopathy is effective in IBS Florance et al. 949

Conclusion 9 Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring
This pilot study has identified a clinical benefit of oste- system: a simple method of monitoring irritable bowel syndrome and its
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