Stener 2013
Stener 2013
Stener 2013
RESEARCH ARTICLE
Open Access
Abstract
Background: Women with polycystic ovary syndrome (PCOS) have symptoms of depression and anxiety and
impaired health related quality of life (HRQoL). Here we test the post-hoc hypothesis that acupuncture and exercise
improve depression and anxiety symptoms and HRQoL in PCOS women.
Methods: Seventy-two PCOS women were randomly assigned to 16 weeks of 1) acupuncture (n = 28); 2) exercise
(n = 29); or 3) no intervention (control) (n = 15). Outcome measures included: change in Montgomery sberg
Depression Rating Scale (MADRS-S), Brief Scale for Anxiety (BSA-S), Swedish Short-Form 36 (SF-36), and PCOS
Questionnaire (PCOSQ) scores from baseline to after 16-week intervention, and to 16-week post-intervention
follow-up.
Results: A reduction in MADRS-S and BSA-S from baseline to 16-weeks post-intervention follow-up was observed
for the acupuncture group. The SF-36 domains role physical, energy/vitality, general health perception and the
mental component of summary scores improved in the acupuncture group after intervention and at follow-up.
Within the exercise group the role physical decreased after treatment, while physical functioning and general
health perception scores increased at follow-up. The emotion domain in the PCOSQ improved after 16-weeks of
intervention within all three groups, and at follow-up in acupuncture and exercise groups. At follow-up,
improvement in the infertility domain was observed within the exercise group.
Conclusion: There was a modest improvement in depression and anxiety scores in women treated with
acupuncture, and improved HRQoL scores were noted in both intervention groups. While not a primary focus of
the trial, these data suggest continued investigation of mental health outcomes in women treated for PCOS.
Trial registration number: ClinicalTrials.gov Identifier: NCT00484705
Keywords: Acupuncture, Anxiety, Depression, Exercise, Health-related quality of life, Polycystic ovary syndrome
Background
Polycystic ovary syndrome (PCOS) is a complex endocrine
and metabolic disorder with an estimated prevalence of 8
18% depending on diagnostic criteria [1]. The characteristics of PCOS include polycystic ovaries, hyperandrogenism,
irregular menstrual cycles, and metabolic abnormalities
* Correspondence: [email protected]
1
Institute of Neuroscience and Physiology, Department of Physiology,
Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
2
Department of Obstetrics and Gynecology, First Affiliated Hospital,
Heilongjiang University of Chinese Medicine, Harbin, China
Full list of author information is available at the end of the article
2013 Stener-Victorin et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the
Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly cited.
PCOS is lifestyle intervention focusing on diet and exercise. In two studies, HRQoL measured by the polycystic
ovary syndrome questionnaire (PCOSQ) improved across
all domains after a lifestyle modification program [15,16].
In obese and overweight PCOS women, diet plus exercise
and diet alone decreased depression scores and improved
the PCOSQ domains of emotion, body weight, and
menstrual problems [17].
Acupuncture with manual stimulation [18,19] and electrical stimulation of low-frequency, i.e. electro-acupuncture
has been shown to be effective in the treatment of major
depression disorder in women without PCOS [20-23], and
in women with depression during pregnancy [24,25] and
post partum [26]. In women with PCOS, both a standardized acupuncture protocol with manual and electrical
stimulation of low-frequency and physical exercise has
been demonstrated to result in more regular menses and
decrease hyperandrogenemia [27]. Whether acupuncture
also improves symptoms of anxiety and depression and/or
HRQoL in these women has not been investigated. In
women with breast cancer, 12 weeks of acupuncture improved HRQoL and sleep assessed with the Womens
Health Questionnaire [28], general well-being assessed with
the Symptom Checklist and mood assessed with the Mood
Scale [29]. Similarly, acupuncture improved HRQoL
assessed by the short-form 36 (SF-36) in patients with
chronic pain conditions, such as dysmenorrhea [30] and
pain from osteoarthritis [31].
Trials of physical exercise for the treatment of depression
suggest that exercise is effective for decreasing depressive
symptoms, although one recent large randomized controlled trials (RCT) reported no significant effect on
depressive symptoms [32,33].
Because PCOS is a chronic disease that is often
accompanied by symptoms of anxiety and depression
and impaired HRQoL, with health implications across
the lifespan, there is a need to evaluate treatment
options that have few negative side effects, such as
acupuncture and physical exercise. In this study, we
tested the secondary hypothesis that affective symptoms
and impaired HRQoL can be improved by acupuncture
and physical exercise in women with PCOS.
Methods
Study design
The study is a secondary analysis of a prospective randomized clinical trial (RCT) [27] in women with PCOS. All
participants were Swedish women living in Gothenburg.
The study was conducted at Sahlgrenska Academy at
the University of Gothenburg, performed in accordance
with Declaration of Helsinki, and approved by the Ethics
Committee at the University of Gothenburg. The Clinical
Trials Government Identifier number is NCT00484705.
Page 2 of 8
Questionnaires were completed at baseline, after the 16week treatment, and 16 weeks after the last treatment.
The outcome measure assessing symptoms of depression
and anxiety was the CPRS-S-A [35], from which the
subscales Montgomery sberg Depression Rating Scale
(MADRS-S) [36] and the Brief Scale for Anxiety (BSA-S)
[37] were extracted. MADRS-S and BSA-S each include
9 items, of which two are present in both scales. All
items are rated on a 7-point Likert scale, where 0
indicates no symptoms and 6 an extremely pathological
condition. Item ratings are summed, yielding a maximum value of 54 for each scale. A symptom burden
Interventions
The acupuncture treatment and physical exercise interventions have been described in detail [27]. In brief, all
participants received general information about the benefits of regular exercise and were instructed to complete
a physical exercise diary during weeks 132 of the study.
Acupuncture intervention
Page 3 of 8
Like the other participants, women in the no intervention group received oral information about the benefits
of regular physical exercise. All participants could call
the study coordinator at any time.
Statistical analyses
Results
Table 1 shows anthropometry and scores on PCOSQ
domains for all participants. There were no differences
in anthropometric measurements before and after
treatment, as reported [27].
Symptoms of depression and anxiety. There were no
baseline differences between the groups regarding
anxiety and depression scores; MADRS-S and BSA-S
(Table 2). Over the 16 week intervention, there was
neither within group differences nor between group
differences regarding change in MADRS-S or BSA-S
29.9 4.4
BMI (kg/m )
28.1 7.4
WHR
0.84 0.07
PCOSQ
Emotions
4.4 1.2
Body hair
3.4 2.0
Body weight
3.6 2.0
Infertility
4.0 1.7
Menstruation
4.0 1.1
Values are mean SD. BMI, body mass index; WHR, waist hip ratio; PCOSQ,
polycystic ovary syndrome questionnaire.
Page 4 of 8
Control (n = 15)
P Between group
10.7 6.2
10.8 9.0
13.8 9.4
ns
13.1 6.4
11.3 6.0
14.6 5.7
ns
Physical functioning
88.6 16.4
87.9 15.0
92.3 10.0
ns
Role physical
67.9 33.9
86.2 22.7
76.7 30.6
ns
Role emotional
52.4 43.9
47.1 42.3
37.8 41.5
ns
Social functioning
74.6 21.6
67.2 26.2
67.5 31.3
ns
Mental health
60.3 19.5
60.3 19.9
56.0 23.1
ns
Energy/vitality
44.3 22.0
48.8 23.9
46.6 19.2
ns
Bodily pain
73.4 19.4
71.9 32.6
72.9 23.5
ns
56.6 25.2
63.7 18.0
64.6 18.6
ns
50.1 9.8
53.1 7.4
54.4 6.1
ns
35.7 14.2
33.8 12.9
30.8 15.2
ns
Emotions
4.7 1.2
4.2 1.1
4.2 1.2
ns
Body hair
4.0 2.2
2.9 1.9
3.3 1.9
ns
Body weight
4.1 2.2
3.3 2.0
3.1 1.7
ns
Infertility
4.2 1.7
3.6 1.6
4.5 1.6
ns
Menstruation
4.1 0.9
3.9 1.2
4.0 1.4
ns
SF36 domains
PCOSQ
Values are mean SD. Between-group differences at baseline were determined with the Kruskal-Wallis test.
Page 5 of 8
Table 3 Changes in outcome measures from baseline to week 16 directly after treatment
Acupuncture (n = 28)
Mean SD
Mean SD
0.96 5.25
9.0
0.52 7.62
1.61 4.72
12.3
0.41 5.62
1.7 12.9
1.9
0.9 10.2
P*
Control (n = 15)
Mean SD
4.8
1.53 5.33
11.1
ns
3.6
0.13 3.96
0.9
ns
1.0
4.0 8.1
4.3
ns
SF-36 domains
Physical functioning
Role physical
8.0 31.2
11.8
16.4 36.8
19.0
6.7 27.5
8.7
0.046
Role emotional
6.5 35.8
12.4
5.7 45.5
12.1
15.6 35.3
41.3
ns
10.7
3.0 23.1
4.5
3.3 18.0
4.9
ns
9.5
1.1 19.8
1.8
4.5 13.7
8.0
ns
19.0
0.7 16.8
1.4
1.2 16.4
2.6
ns
3.0
1.3 30.2
1.8
3.0 19.7
4.1
ns
10.4
1.2 11.6
1.9
5.5 16.8
8.5
ns
A,a
Social functioning
8.0 17.7
Mental health
5.7 16.0
Energy/vitality
8.4 16.9
Bodily pain
2.2 21.2
5.9 13.6
0.4 6.4
0.8
1.6 6.2
3.0
3.2 4.6
5.9
ns
Mental component
4.3 9.7b
12.0
1.6 10.5
4.7
1.5 9.2
4.9
ns
Emotions
0.8 0.8c
17.0
0.8 1.2e
19.0
0.7 0.7g
16.7
ns
Body hair
0.1 0.8
2.5
0.1 0.6
3.4
0.2 1.1
Body weight
0.2 0.5
4.9
0.1 1.1
3.0
0.6 1.0
Infertility
0.3 1.0
7.1
0.4 1.0d
11.1
Menstruation
0.4 1.0
9.8
0.4 1.0
10.3
PCOSQ domains
6.1
ns
19.4
ns
0.0 0.7
0.0
ns
0.4 0.8f
10.0
ns
*Intergroup differences for the changes from baseline to week 16 were determined by the Kruskal-Wallis test followed by MannWhitney U-test: P < 0.05 vs
physical exercise. Within group changes were determined by Wilcoxon rank-sum test: aP < 0.05 (acupuncture group); bP < 0.01 (acupuncture group); cP < 0.001
(acupuncture group); dP < 0.05 (exercise group); eP < 0.001 (exercise group); fP < 0.05 (control group); gP < 0.001 (control group).
Discussion
This is the first study to evaluate the effect of acupuncture
on affective symptoms and HRQoL in women with PCOS.
We demonstrated a within group reduction in depression
and anxiety scores at follow up 16 weeks after the last
treatment. HRQoL was greater in the acupuncture group,
as reflected by increased scores in the SF-36 domain role
physical after a 16 week intervention. In addition, the SF36 domains social functioning, energy/vitality, and general
health perception and the mental component of SF-36
summary scores improved within the acupuncture group
although there were no between-group differences. The
effect remained at 32 weeks follow-up in the domain roles
physical, energy/vitality, and general health perception and
in the mental component of SF-36 summary scores. The
emotion domain in the PCOSQ also improved significantly after the 16 week acupuncture intervention, which
persisted at 32 weeks.
The results in the present study are in line with previous
reports indicating that acupuncture can reduce symptoms
of anxiety [42] and depression [22,23,25] and improve
HRQoL [28,30,31] in other conditions than PCOS. The
effect of acupuncture was more pronounced on anxiety
symptoms and there was a clear tendency of decrease
within the acupuncture group immediately after the treatment period but it did not reach statistical significance. At
the follow up, the decrease was even larger and decreased
symptoms of anxiety as compared to the exercise group.
This may reflect that the effect of treatment last at least
4 months after the treatment period.
Page 6 of 8
Acupuncture (n = 28)
P*
Control (n = 15)
Mean SD
Mean SD
Mean SD
1.00 8.07 a
9.3
0.55 8.00
5.1
1.00 6.94
7.2
ns
13.3
1.41 6.86 B
12.5
1.53 3.78
10.5
0.027
2.5 17.4
2.8
3.8 6.7
4.3
3.7 7.4
4.0
0.008
SF-36 domains
Physical functioning
C,d
Role physical
12.5 33.7
18.4
0.9 19.5
1.0
6.7 27.5
8.7
ns
Role emotional
11.9 40.8
22.7
17.2 42.4
36.5
22.2 34.9 f
58.7
ns
Social functioning
5.8 20.5
7.8
5.2 25.3
7.7
2.5 21.2
3.7
ns
Mental health
6.3 19.5
10.4
4.1 20.0
6.8
4.3 21.9
7.7
ns
Energy/vitality
11.3 17.0
25.5
5.5 20.5
11.3
4.2 18.3
9.0
ns
Bodily pain
2.8 20.6
3.8
3.6 30.0
5.0
0.3 15.8
0.4
ns
6.8 16.0a
12.0
5.3 10.0 c
8.3
4.6 19.2
7.1
ns
0.5 7.9
1.0
0.2 5.2
0.4
1.7 5.1
3.1
ns
5.1 12.4a
14.3
4.3 11.6
12.7
1.8 11.6
5.8
ns
Emotions
0.4 0.8a
8.5
0.6 1.0
14.3
0.1 0.7
2.4
ns
Body hair
0.1 0.9
2.5
0.1 0.8
3.4
0.2 0.8
6.1
ns
Body weight
0.2 0.8
4.9
0.2 1.2
6.1
0.4 0.8
12.9
ns
16.7
0.1 0.8
2.2
0.014
2.6
0.5 1.0
12.5
ns
PCOSQ domains
d
B,d
Infertility
0.2 1.1
4.8
0.6 1.2
Menstruation
0.3 1.0
7.3
0.1 1.0
*Intergroup differences for the changes from baseline to week 16 were determined by the Kruskal-Wallis test followed by MannWhitney U-test: P < 0.05 vs
physical exercise; BP < 0.05 vs control group; CP < 0.05 vs EA and control group. Within group changes were determined by Wilcoxon rank-sum test: aP < 0.05
(acupuncture group); bP < 0.01 (acupuncture group); cP < 0.05 (exercise group); dP < 0.01 (exercise group); eP < 0.001 (exercise group); fP < 0.05 (control group).
A strength of this study is the randomized design. However, it was also limited by the multiple comparisons and
characteristics of the study design, as extensively discussed
elsewhere [27,46]. Importantly, the results presented in
this paper stem from a secondary analysis; the study was
not designed or powered to specifically address these
research questions. We suggest that future RCTs for
women with PCOS include assessments of anxiety and
depression symptoms and HRQoL to elucidate the impact
of any intervention on these variables.
Conclusions
In conclusion, there was a modest improvement in
depression and anxiety scores in women treated with
acupuncture, and improved HRQoL scores were noted
in both intervention groups. Acupuncture and physical
exercise are well-tolerated and safe. While not a primary
focus of the clinical trial, these data suggest continued
investigation of mental health outcomes in women
treated for PCOS.
Competing interests
The authors have nothing to disclose and no competing financial interest exist.
Authors contributions
Conceived and designed the trial: ESV, GH, and POJ. Performed the trial: ESV,
GH, and POJ. Analyzed the data: ESV, MW, and DG. Manuscript drafting and
critical discussion: ESV, GH, POJ, DG, and MW. All authors read and approved
the final manuscript.
Acknowledgement
We thank Elizabeth Jedel for carrying out the clinical trial and Professor
Anders Odn for excellent statistical advice. The study was supported by
grants from the Swedish Medical Research Council (K2012-55X-15276-08-3),
the Swedish Federal Government under the LUA/ALF (ALFGBG-136481), and
the Regional Research and Development agreement (VGFOUREG-5171, 11296, and 7861). No competing interest declared.
Page 7 of 8
Author details
1
Institute of Neuroscience and Physiology, Department of Physiology,
Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
2
Department of Obstetrics and Gynecology, First Affiliated Hospital,
Heilongjiang University of Chinese Medicine, Harbin, China. 3Institute of
Medicine, Department of Metabolism and Cardiovascular Research,
Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
4
Institute of Clinical Science, Department of Obstetrics and Gynaecology,
Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
5
Institute of Neuroscience and Physiology, Department of Psychiatry and
Neurochemistry, Sahlgrenska Academy, University of Gothenburg,
Gothenburg, Sweden. 6State University of New York Downstate Medical
Center, Brooklyn, NY, USA.
Received: 7 February 2013 Accepted: 11 June 2013
Published: 13 June 2013
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