THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE

Volume 17, Number 10, 2011, pp. 923930

Mary Ann Liebert, Inc.
DOI: 10.1089/acm.2010.0380

The Effect of Acupuncture on Psychosocial

Outcomes for Women Experiencing Infertility:
A Pilot Randomized Controlled Trial
Caroline A. Smith, PhD,1 Jane M. Ussher, PhD,2 Janette Perz, PhD,2
Bridget Carmady, BNat,1 and Sheryl de Lacey, PhD 3

Abstract

Objectives: The study objectives were to examine the effectiveness of acupuncture for reducing infertility-related stress.
Design: The study design was a randomized controlled trial of acupuncture compared with a wait-list control.
Setting: The study was conducted at The University of Western Sydney.
Subjects: Thirty-two (32) women aged 2045 years, with a diagnosis of infertility, or a history of unsuccessfully
trying to conceive for 12 months or more, were the subjects of the study.
Interventions: Women received six sessions of acupuncture over 8 weeks.
Outcome measures: The primary outcomes were infertility self-efficacy, anxiety, and infertility-related stress. The
womens experience of infertility and acupuncture is also reported.
Results: At the end of the 8-week intervention, women in the acupuncture group reported significant changes on
two domains on the Fertility Problem Inventory with less social concern (mean difference [MD] - 3.75, 95%
confidence interval [CI] - 7.58 to 0.84, p = 0.05), and less relationship concern (MD - 3.66, 95% CI - 6.80 to
- 0.052, p = 0.02). There were also trends toward a reduction of infertility stress on other domains, and a trend
toward improved self-efficacy (MD 11.9, 95% CI - 2.20 to 26.0, p = 0.09) and less anxiety (MD - 2.54, 95% CI
- 5.95 to 0.86, p = 0.08) in the acupuncture group compared with the wait-list control. Women described the
experience and impact of acupuncture as positive relating to a sense of relaxation and time out, the engagement
with the practitioner, and an intervention that had very few negative side-effects. Changes were also perceived
after treatment with women describing a physical and psychologic sense of relaxation and calmness, and a
changed perspective in relation to coping.
Conclusions: Acupuncture may be a useful intervention to assist with the reduction of infertility-related stress.
Further research is justified.

Introduction

here are now a greater number of women attempting

pregnancy at an older age when they are less fertile,1 and
this has contributed to the increase in the use of assisted
reproductive technologies (ART). Womens responses to unsuccessful attempts to achieve a pregnancy include disappointment, frustration, or significant psychologic distress.
Emotional responses to infertility have been linked to grief,2
depression,3 anxiety, or chronic stress,4 which may have effects
on the hypothalamic pituitary axis,5 and impact negatively on
the chances of a successful pregnancy outcome following IVF.6

Various types of psychological interventions already exist

for individuals struggling with their response to their infertility or subfertility. These interventions focus on specific
therapeutic approaches such as psychodynamicanalytic
interventions, mindbody-oriented relaxation, cognitive
behavioral therapies, education, and online counseling interventions.7 However, although traditional psychological
support is available at many IVF clinics, only a minority of
couples utilize these services,8 as some individuals do not
perceive the need for counseling, particularly in the early
stages of treatment, and frequently these services are not
offered except as a last resort.

Centre for Complementary Medicine Research, The University of Western Sydney, Sydney, Australia.
Health Services and Outcomes Research Group, The University of Western Sydney, Sydney, Australia.
School of Nursing and Midwifery, Flinders University, Flinders, Australia.

2
3

923

924
There has been increasing interest by women in the use of
complementary therapies (CM) alongside infertility treatments. Five (5) studies in particular have reported on the use
of CM by men and women while attending for ART.913 Two
(2) qualitative studies undertaken in Australia of womens
experiences of using CM to enhance their fertility have
highlighted benefits to their general well-being and fertility
enhancement. Rayner and colleagues described womens
experiences with complementary therapies as being affirming and empowering.14 Similar themes were reported from a
qualitative study examining womens experiences following
a course of acupuncture.15 These study findings suggest that
acupuncture may increase confidence, clarity, and wellbeing, enhance coping and adaptation, and encourage positive emotion and provide social support. Women also
reported feeling relaxed, less stressed, and an increased capacity to cope. These benefits can be described as increasing
self-efficacy, a term describing an ability and confidence to
engage in particular health-promoting activities, or to harbor
attitudes proximal to these behaviors. Preliminary data also
suggest that acupuncture may improve self-efficacy for
women experiencing delays with becoming pregnant.16 In
this observational study, a significant increase in infertility
self-efficacy (ISE) scores was found after four consecutive
acupuncture treatments.
These emerging data indicating that acupuncture may
have a role with improving infertility self-efficacy warrant further research. This article reports on the outcomes
from a pilot randomized controlled trial. The authors
examined the hypothesis that acupuncture compared to a
wait-list control would demonstrate improvements in infertility self-efficacy, and reductions in anxiety and infertilityrelated stress. Womens experience of acupuncture is also
reported.
Materials and Methods
Study design
A mixed-methods, randomized controlled trial, comparing acupuncture with a wait-list control, was conducted.
Subjects and setting
The ethics committee of the University of Western Sydney
approved the research. The recruitment strategy used a press
release, advertisements in local papers, and online forums.
Women were eligible to join the study if they were aged 20
45 years, with a diagnosis of infertility and/or a history of
unsuccessfully trying to conceive for 12 months or more.
Women planning ART were required to enroll in the study 1
month before commencing their first treatment. Exclusion
criteria included women currently involved in a professionally led infertility support group or workshop, or planning to
use acupuncture in the next 4 months.
Intervention
Following written consent from participants, and the collection of baseline outcome measures and demographic data,
women were randomized to acupuncture or the wait-list
control. An independent researcher was responsible for the
computer-generated randomization schedule, and the allocation of the randomization sequence was concealed using

SMITH ET AL.
sealed envelopes. The randomized treatment allocation was
known only to the acupuncturist administering the study
intervention.
The acupuncture diagnosis and treatment combined the
five-element style with a diagnostic focus on individual
causative factors, and the Traditional Chinese Medicine
(TCM) style with diagnosis primarily based on syndrome
patterns.17 Both styles of acupuncture are based on traditional acupuncture theory. TCM is widely practiced in
Australia, and a five-element style is practiced among some
United Kingdomtrained acupuncturists, and Australiantrained acupuncturists undertaking postprimary qualification training. The acupuncture needling and treatment parameters were based on the findings from an initial study
undertaken in clinical practice,16 and acupuncture points
selected in response to emotional complaints.18 The specific
points for each individual were defined at each treatment
session, depending on the participants feedback and needs
in relation to their stress. Each treatment followed an individualized protocol addressing the Causative Factor, and
TCM diagnosis. Common points used included the Kidney
Chest points and points, Neiguan (PC6), Jiansi (PC5), Tongli
(HT5), and Shenmen (HT7).
Six (6) acupuncture treatments were performed over 8
weeks, commencing with weekly treatments, and subsequent tapering in the second month. An average of 6.8
needles were administered per participant (range 311) (insertions were reduced for the 4 women diagnosed with a
pregnancy during the study). The research practitioner (CS)
undertook the treatment consultation at the start of each
session, she administered the needling, and left the room for
a short period midway through the treatment while the
participant lay quietly. Treatment sessions lasted 45 minutes,
with mostly bilateral needle retention over 2030 minutes for
evens techniques, and dependent on pulse change response
to treatment. Needles were withdrawn immediately for tonification. Seirin 0.2- 30-mm acupuncture needles were
used. Needle stimulation was administered until de qi was
obtained and detected by a needle grasp, or reporting of a
needle sensation by the participant (tingling, warmth). The
depth of the needle insertion varied with the thickness of
skin and fatty tissue at the site of the acupuncture points.19 A
proportional method of point location was used (ACI locator). Moxa, cupping, and herbs were not used, relaxation
advice was provided with a focus on using the breath to
achieve a relaxation response.
A qualified United Kingdomtrained and licensed acupuncturist (CS) registered with the Australian Acupuncture
and Chinese Medicine Association, and with 14 years clinical
experience of womens health, was responsible for administering acupuncture. Due to the limited financial resources
available to this pilot study, a study investigator (CS) undertook this role.
Women who were randomized to the wait-list control
condition completed all assessments but did not receive any
active intervention during the 2-month trial. They were offered acupuncture after this time period. The decision to use
a wait-list design was based on a lack of previous research in
this area, and to systematically examine and build on the
evidence from the authors two earlier studies. The first
priority was to establish whether there was evidence of some
benefit from acupuncture in a controlled setting.15,16

ACUPUNCTURE FOR INFERTILITY DISTRESS

Instruments
Primary endpoints were measured at baseline and at 8
weeks following completion of the intervention. Outcome
measures included the Fertility Problem Inventory (FPI),20
the Infertility Self-Efficacy Scale21 (ISE), and the StateTrait
Anxiety Inventory (STAI).22 The FPI is a 46-item validated
questionnaire that assesses infertility-related stress, and
shows good reliability and validity. Scores are summated
into five domains: social concern, sexual concern, relationship concern, rejection of childfree lifestyle, and need for
parenthood. The shortened 10-item version of the 20-item
STAI was used to measure state anxiety. The STAI has good
psychometric properties and has been used extensively in
evaluation research. The ISE is a self-report questionnaire
consisting of 16 items that probe into the respondents perceptions about their ability to deal with various aspects
of fertility treatment. The ISE has been specifically validated
with infertility patients and has demonstrated excellent
reliability.
The sample size was based on prior analyses.16 It was
estimated that a moderate to strong effect size would be
obtained (i.e., Cohen g = 0.7) from acupuncture on the outcomes. With a set at 0.05, and power at 0.8 (80% chance that
the expected effect size would be significant), a minimum
sample of 32 participants was required (N = 16 per group).
The analyses used an intention-to-treat approach, and the
initial analysis examined the reproductive, demographic,
and baseline characteristics of women randomized to the
trial. For differences between groups and over time, analysis
of covariance testing difference was undertaken between
post-treatment scores on the relevant outcome variable while
controlling for pretreatment scores, controlling for previous
use of acupuncture. Levels of significance were reported at
p < 0.05. A study statistician performed the analysis blind to
study group.
Qualitative data
Funding received for the pilot study allowed for 10 indepth interviews. A sample size was expected to produce
thematic saturation, with no additional information forthcoming in successive interviews.23 Women were consecutively invited to participate in the interviews following the
completion of their 8-week acupuncture intervention. Two
(2) women declined, and invitations were made until the
tenth interview had been completed. Interviews were conducted by BC, a junior researcher with the Research Centre.
BC received training with conducting in-depth interviews
and data analysis from JU and JP, who are researchers experienced in qualitative data collection and analysis. Interviews typically explored the womens experience of infertility,
its psychologic impact, and the perceived impact of acupuncture on cognitive control. Women were first asked an
open-ended question about their fertility treatment and how it
affects them, with prompt questions including reasons for
joining the trial, previous experience of fertility treatment, and
expectations of treatment. They were then asked about their
sessions with the acupuncturist, including what happened,
how they felt, whether it made them feel differently, and
whether their feelings about it changed over time. Finally,
women were asked about the effects of acupuncture, including problems and difficulties and feelings for the future.

925
Interview data were digitally recorded and transcribed verbatim by a professional transcriber. Transcripts of the interviews were de-identified and checked for transcription
accuracy. Three (3) researchers (BC, JU, and JP) read the transcripts independently and subjected the data to a process of
coding and thematic analysis, based on notions of consistency,
commonality, and the function and effects of specific themes,
following established protocols for thematic analysis.24 The research was largely inductive, where the concepts and categories
came from the data, rather than being deductive or informed by
existing preconceptions about acupuncture and fertility.25 To
begin, the data were subject to open coding, involving a close
reading of each transcript to identify first-order concepts,
such as relationship conflict, anger, love, anxiety, or
increased responsibility segment by segment.26 Axial coding was employed to develop categories that subsumed
many of the first-order concepts, including expectations
of acupuncture: invoking change, positive experiences of
acupuncture, and changes achieved after acupuncture. In the
final stage of selective coding, a core category of Expectations and psychologic experiences of acupuncture was developed, which essentially linked all of the concepts and categories.
Results
Recruitment and baseline data
Women were recruited to the trial between April and
September 2009. Promotion of the study led to 124 women
making contact with the study center (Fig. 1). All women in
the acupuncture group received a minimum of six treatments. One (1) woman withdrew from the wait-list control
following allocation to this group. Outcome data were
available from 30 women randomized to the study.
Baseline data of participants at trial entry is presented
in Table 1. Most women were in their mid-30s, had been
trying for a baby for the previous 3 years, employed, and
had completed high school education. Women presented
with mild to moderate levels of anxiety, moderate levels of
self-efficacy, and infertility-related stress. The randomized
groups were comparable on most baseline characteristics
except for greater previous use of acupuncture in the acupuncture group (56% versus 25%). This was controlled for in
the analysis of primary outcomes.
Outcome data
Adjusted analyses are presented in Table 2. At the end of
the 8-week intervention, women in the acupuncture group
reported significant changes on two domains on the FPI,
with less social concern defined as sensitivity to comments,
reminders of infertility, feelings of social isolation, and
alienation from family or peers (MD - 3.75, 95% CI - 7.58 to
0.84, p = 0.05). Women receiving acupuncture also reported
significantly less relationship concern, defined as difficulty
talking about infertility, understanding/accepting sex differences, and concerns about the impact infertility on their
relationship (MD - 3.66, 95% CI - 6.80 to - 0.052, p = 0.02).
There were also trends toward a reduction of infertility stress
on other domains, and a trend toward improved self-efficacy
(MD 11.9, 95% CI - 2.20 to 26.0, p = 0.09) and less anxiety
(MD - 2.54, 95% CI - 5.95 to 0.86, p = 0.08) in the acupuncture group compared with the wait-list control.

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SMITH ET AL.

FIG. 1. Recruitment and

participant flow through the
trial.

Expectations of acupuncture: Invoking change. A number of women initially spoke of having few or unclear expectations, but as having an open mind about acupuncture.

This participant also said that acupuncture provided a

sense of purpose: At least it feels as though youre doing
something. Several women spoke about their expectation
that participation in the trial would provide an opportunity
to regain some control of their fertility, and a perceived need
to try something new. Many women came to the trial at a
point of despair with lack of success in achieving a pregnancy, but also an awareness that their fertility was declining
with increasing age. It was starting to get really desperate
(S1), and for the older women I turned 41 and I thought, Im
running out of time (S1). For women who expressed a sense
of their options running out, the trial was seen as an opportunity for change.

I was fairly open-minded about it. Ive never had acupuncture

ever before, so I had no expectations of what it would be like.
(S5)

I just thought it would be a good opportunity just to look into

another avenue of trying to find out, or trying to help me in
order to probablynot solve my fertility problems, because I

Qualitative analysis
Expectations and psychological experiences of acupuncture. The mean age of women participating in the interviews
was 36 years, the duration of their infertility was 5.2 years,
50% had used acupuncture previously, and 4 women had a
diagnosis of unexplained infertility. Womens responses are
organized under three themes: expectations of acupuncture:
invoking change, positive experiences of acupuncture, and
changes achieved after acupuncture.

ACUPUNCTURE FOR INFERTILITY DISTRESS

927

think Im asking for a miracle therejust help guide me a bit

as to what my next step mightve been and where do I go
from here. (S10)

An opportunity to try something new was also associated

with an expectation that acupuncture carried little risk.
I thought, yeah, like I fit the criteria very well and it definitely
wont hurt to just to do it, like I could get benefit out of it and
even if I dont, nothing bad will happen, so its worth it to
have a go. (S3)

Some women expressed hopefulness but not expectation

that this change would help them to become pregnant.
Well, I mean there was always a hope that Id get pregnant
somewhere along the line, but no, not really, like I didnt
really have any too great expectations about it. (S2)

Table 1. Baseline Characteristics of Participants

Acupuncture
(n = 16)
Mean SD

Control
(n = 16)
Mean SD

Age
35.1 (4.2)
34.1 (5.2)
BMI
21.6 (14.2) 25.7 (7.9)
Parity 0
68.8
75.0
Duration of infertility
4.50 (3.5)
3.57 (2.4)
Reason for infertility (%)
Male factor
6.3
18.8
Female factor
43.8
18.8
Unexplained
25.0
46.8
Unknown (not investigated)
25.0
18.8
Number of IVF cycles
1.38 (1.7)
1.13 (1.9)
Fertility Problem Inventory
Social concern
29.4 (8.7)
26.4 (8.0)
Sexual concern
23.9 (6.6)
21.1 (8.0)
Relationship concern
23.9 (6.7)
22.9 (4.7)
Rejection of childfree lifestyle
26.3 (6.7)
26.4 (5.2)
Need for parenthood
35.5 (7.2)
33.4 (7.2)
Infertility self-efficacy
75.3 (20.2) 73.5 (22.1)
StaitTrait Anxiety
20.4 (6.3)
20.4 (5.7)
Previous use of acupuncture
56.3
25.0
(% yes)
Ever sought psychologic support
12.5
18.8
services before re: infertility
(% yes)
Previous use CM as psychosocial 37.5
31.3
support (% yes)
Current CM use re: psychosocial
25.0
31.3
support (% yes)
Employment status
Full time
68.8
62.5
Part time
18.8
18.8
Home duties
12.5
12.5
Student
0.0
6.3
Education
Finish high school (% yes)
100
87.5
Tertiary education (% yes)
87.5
87.5
University (% yes)
56.3
31.3
Race
White
93.8
100
Other
6.3
0.0
Marital situation
Single
0.0
6.3
Married/de facto
100
93.8
SD, standard deviation; BMI, bodymass index; IVF, in vitro
fertilization; CM, complementary therapies.

For others, acupuncture invoked expectations that the trial

would assist with achieving relaxation.
I think I thought it would be more physical stress relief rather
than anything emotional. I just really didnt know what to
expect, so I thought it would be a relaxation thing, kind of like
getting a massage for an hour but it would be acupuncture.
(S4)

Positive experiences of acupuncture. All 10 women described the experience of the acupuncture sessions as positive. The positive effects of acupuncture were related to a
sense of relaxation and time out, engagement with the
practitioner, and an intervention that had very few negative
side-effects.
Nine (9) women reported that they found the acupuncture
relaxing during the session, that it had immediate benefits,
and that the effects were sustained.
It was half an hour of nothing. Not having to think about it,
half an hour of just lying there and having nothing, if that
makes any sense. (S4)
It was a real chance to switch off for a change. I remember
when I left the first session, I walked out feeling lighter,
feeling less stressed, feeling really positive for a change. (S4)
Women also described positive physical sensations from
acupuncture. I remember getting outside and I felt a bit buzzy
and I thought, jeez, I dont know if Im actually relaxed or Im
actuallylike shes obviously got it so the bloods racing
around my body; does that mean Im relaxed? (S9).
I had a sense of warmth and it lasted for like 1 week. (S3)
Well it was a very warm fuzzy feeling.very relaxed, warm,
and feeling like it had made a big difference. (S5)

Half of the women described a positive surprise with the

level of engagement they experienced with the research
acupuncturist, in particular with the trust invoked in the
therapeutic relationship, as this was occurring with someone
new and disconnected from mainstream services.
It was just somebody outside of everyone else who was
poking or prodding me, or friends and family that were
asking questions and not understanding it. (S4)
I found her really easy to talk to in that regard, so that was
good. What I found really positive was talking to [her].before the treatment; that was really great. (S2)
I think there is a benefit in having someone to talk to as well
as the actual acupuncture. It was an unexpected opportunity
to talk to someone about the situation who you knew was
going to be private. (S5)

Five (5) women mentioned some negative side-effects such

as minor pain, or feeling light headed after the treatment. For
example, one woman said Sometimes you would get a
point that was sore (S3). I dont know if pain is the right
word, or just strange (S4). However, no women indicated
that the risks outweighed the benefits from acupuncture.
Changes achieved after acupuncture. Several different
impacts of acupuncture were described, with the effects
commencing soon after the treatment and being sustained.
The majority of women described a physical and psychologic
sense of relaxation and calmness, and a changed perspective
in relation to coping. Over the course of the intervention,

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SMITH ET AL.
Table 2. Primary and Secondary Endpoints by Group

STAI
Fertility problem inventory
Social concern
Sexual concern
Relationship concern
Rejection of childfree lifestyle
Need for parenthood
Infertility self- efficacy

Acupuncture (n = 16)

Control (n = 14)

MD

18.1 (1.1)

20.7 (1.2)

- 2.54

( - 5.95 to 0.86)

0.083

24.8
20.3
22.1
24.9
32.5
85.9

28.6
22.8
25.8
24.9
33.9
74.0

- 3.75
- 2.50
- 3.66
- 0.26
- 1.38
11.9

( - 7.58
( - 6.32
( - 6.80
( - 3.14
( - 5.47
( - 2.20

0.055
0.190
0.024
0.987
0.495
0.095

(1.2)
(1.2)
(1.0)
(1.0)
(1.3)
(4.6)

(1.3)
(1.3)
(1.1)
(1.1)
(1.4)
(4.9)

95% CI

to
to
to
to
to
to

0.84)
1.32)
- 0.052)
3.09)
2.71)
26.0)

Raw data n, %, or mean standard error and effect size with 95% CI.
MD, mean difference; CI, confidence interval; STAI, StateTrait Anxiety Inventory.

several women spoke of a change in their focus toward

pregnancy, coping, a reduction in anxiety, a change in attitude, and a change in communication with others.
It just took a lot of the anxiety off, the anxiety of what if I
dont, what if I cant, what if Im too old. That sort of panic
was left..Each visit that got less and less, which is a good
thing. (S1)
Whereas now I do care (about getting pregnant), but there is a
limit to how much I am willing to do for it. Now I can just see
things, yeah, a bit more clearly and in a bit more balanced
way, which is good..I am just going to live my life and do
what I do..Now I want to have a happy life inside myself.
(S3)
Some women also attributed improved relationships with
their partner to the intervention.
Its opened up communication between myself and my husband, a big thing between us. I think that was one of the most
positive things to come out of me agreeing to be [in the study]
in the first place..By taking part, yeah, it has opened up
communication between us so that together were resolved
that, okay, well we will start trying a bit more fervently than
before. (S2)

The womens comments reflected a change in their sense

of control and a changed perspective and clarity.
I think at the beginning of the trial I was probably more focused on, oh yeah, like I just want to get pregnant and this
study might help me and then I am going to do IVF. Whereas
now I do care, but there is a limit to how much I am willing to
do for it. I am just focusing on some other things because it is
very time consuming, and I have wasted a lot of time and
energy thinking about it and you dont want your whole life
to be about one topic. (S3)

For other women, the treatment had a positive benefit as

they prepared for a future IVF cycle, providing an opportunity to relax, and some time out for themselves.
I think the acupuncture gave me time in the lead up to [IVF]
it, just to physically relax and physically sort of shut down.
(S4)

For most women, however, acupuncture was associated

with a general feeling of positivity, regeneration, and improved well-being.
I guess the best way I could put it is that I left here in a
positive frame of mind. Apart from being relaxed and calm
throughout it all, when I walked out that door, I thought to

myself, you knowI felt good. I felt good and I felt that
whatever I was getting from the actual acupuncture session
lasted more than just that hour that I was here. (S10)

Discussion
This study provides preliminary data suggesting that
acupuncture may be a useful intervention to assist with the
reduction of infertility-related stress. The data also show
promising trends in relation to improved self-efficacy and
reduced anxiety. These outcomes were complemented by
findings from the in-depth interviews that highlighted a
changed perception for women with regard to coping, feeling less anxious, feeling physically calm, relaxed, and overall
having achieved a greater sense of well-being. To the authors knowledge, this is the first controlled clinical trial to
examine the effects from acupuncture on psychologic outcomes for women experiencing infertility. The study also
demonstrated feasibility with timely recruitment, the use of
appropriate outcome measures, acceptability, and compliance with the acupuncture.
Womens experiences of the intervention highlighted their
surprise at the engagement with the study practitioner. The
development of a therapeutic relationship between the participant and practitioner is acknowledged as an important
part of the acupuncture in clinical practice. Kelley and colleagues have suggested that such interaction can reduce stress
and increase expectancies for improvement.27 The aim of this
research was not to explore efficacy of how and why acupuncture may have worked in this setting. However, womens
responses from the interviews highlight the importance of
practitioner factors, and these may have contributed to some
womens positive experience. The authors acknowledge the
experience of CS working with this client group, or she may
have been highly motivated to developing a strong therapeutic alliance. This requires further study within a larger
resourced study with additional study practitioners, and collection of data describing practitioner characteristics.
Some women spoke of a changed perspective toward the
urgency to achieve a pregnancy using assisted fertility. This
finding has clinical implications for the older womans potential fertility, and highlights a need for the acupuncturist to
encourage the women to discuss her treatment plans with
her specialist. It is unclear how applicable this finding is to a
wider population of women using acupuncture to reduce
infertility-related stress, and this finding warrants further
exploration in future research.

ACUPUNCTURE FOR INFERTILITY DISTRESS

The pilot study has several strengths. The trial was randomized, thereby reducing selection bias. Second, the fertility profile of women participating in the study includes a
cohort of women with subfertility, not of all whom may have
sought fertility investigation and treatment. This may reflect
one group of women using acupuncture. However, it is also
possible that this group of women with unknown fertility
issues may be less emotionally or psychologically affected
than women who have or are seeking fertility treatment.
However, the baseline fertility-related stress scores (using the
FPI) of our population are similar to the baseline FPI scores
of 190 women undergoing treatment at three fertility centers
in the United States28 suggesting similar levels of stress, although women in the current study may have slightly
greater coping skills. This studys findings are also consistent
with the authors earlier observational and qualitative research suggesting improvements from acupuncture with
self-efficacy and resilience,15,16 with data from both studies
showing similar mean post-treatment scores of 83.3 and 85.9.
The similarity of scores from different geographical and
socioeconomic study populations increases the generalizability of the findings to a wider population. Although the
study was of a short duration, encouraging improvements in
self-efficacy and anxiety were observed, and inclusion of
interviews provided data that supported the quantitative
findings from the trial. Altogether, this study demonstrated
real, tangible, and most importantly, positive physical and
emotional effects following acupuncture.
The study does have some limitations. First, the pilot results should be interpreted with caution due to the small
sample size and the lack of participant blinding. The authors
demonstrated statistical differences on two domains of the
FPI and trends toward significance on the STAI and ISE scales.
This effect was smaller than the clinical observational study.
However, the findings from the qualitative study suggest that
the effects from acupuncture were clinically significant to
women. Although the number of study participants participating in the qualitative study was small, it was able to
provide a preliminary understanding of the subjective experiences of the acupuncture. It was also possible that the outcomes from acupuncture may differ according to womens
duration of infertility or subfertility. This study was too small
to examine this. Future research should use a larger sample,
and a follow-up assessment to see whether changes and
positive perceptions of acupuncture are maintained over time.
Second, the study question and design aimed to evaluate the
effect of acupuncture used in clinical practice, but the design
used did not aim to control for other confounders such as the
therapeutic relationship, the role of patient expectations, or
practitioner intent. Third, it is possible that the dose of acupuncture was inadequate; for example, more frequent treatments, or using a team of acupuncture researchers, or a
different treatment protocol may have generated different results. Fourth, womens expectations or thoughts about what
might happen as a result of treatment may have differed following group allocation by randomization, and these expectations may have influenced treatment outcomes. The influence
of expectations on the current study outcomes is unclear, although interview data suggest that women expressing expectations were mostly unrelated to the experiences and impacts as
reported by women. A positive effect on treatment outcome
from self-initiated help-seeking behavior on outcomes has been

929
demonstrated in one study with a population of women receiving IVF.29 To address some of these limitations, an appropriately powered study examining treatment effectiveness is
now planned. A trial using mixed methods with qualitative
methods used to explore participants expectations, and practitioner factors in both groups at various stages of the study
may contribute to increasing our understanding of the contribution of expectancy and treatment outcomes.
Conclusions
Psychologic interventions providing patient preparation
and psychologic support for infertile patients have been shown
to produce beneficial outcomes including a reduction in distress.30,31 While women seek out acupuncturists to provide
fertility support, acupuncture may provide an opportunity for
adjunctive support to women struggling with their infertility.
The current findings suggest a need for further research; evaluating the role of acupuncture is now feasible and justified.
Acknowledgments
The authors thank Ben Colagiuri for statistical
This study was funded by a research grant from
versity of Western Sydney.
Clinical Trial Registration: Australian New
Clinical Trials Registry, www.anzctr.org.au
ACTRN12609000288224.

support.
the UniZealand
ACTRN

Disclosure Statement
No competing financial interests exist.
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Address correspondence to:

Caroline A. Smith, PhD
Centre for Complementary Medicine Research
The University of Western Sydney
Penrith South, New South Wales
Sydney 1797
Australia
E-mail: Caroline.smith@uws.edu.au

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