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Using acupuncture to treat depression: A feasibility study

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To establish the feasibility of conducting a randomised controlled trial to evaluate the efficacy of acupuncture in the treatment of mild-to-moderate depression. Control group intervention, blinding of treatment, outcome measures and the acceptability of such a trial amongst participants were key factors to be addressed. The findings from this study will be used to determine the design of a phase III randomised controlled trial. Nineteen participants were recruited through general practices in London, UK. Participants were randomly assigned on a 2:1 basis to either 12 sessions of verum acupuncture or 12 sessions of sham acupuncture (control). Sham acupuncture involved actual needling but at sites considered to be unrelated to depression. The Beck's Depression Inventory (BDI) and the RAND 36 Item Health Survey 1.0 (RAND) were completed at baseline and at the end of treatment or at treatment dropout. All participants also attended a brief qualitative interview at the end of the study. Treatment dropout was low and there were high levels of patient enthusiasm for a study of acupuncture. Referrals from General Practitioners (GPs) were lower than expected. The sham control method successfully maintained participant blinding to treatment and enabled the specific (or active) component of an acupuncture intervention to be isolated and its efficacy assessed. The outcome measures were sensitive enough to record changes in depressive symptoms and quality of life and are appropriate for use in a larger trial. This feasibility study has provided important information that can be used to guide the design and methodology of a full-randomised controlled trial.
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Complementary Therapies in Medicine (2008) 16, 87—91
available at www.sciencedirect.com
journal homepage: www.elsevierhealth.com/journals/ctim
SHORT COMMUNICATION
Using acupuncture to treat depression:
A feasibility study
M. Whitinga, G. Leaveyb,c,, A. Scammella,S.Au
d, M. Kingc
aWandsworth Primary Care Research Centre, Wandsworth PCT, London, UK
bR&D Department, Barnet, Enfield and Haringey Mental Health Trust, London, UK
cDepartment of Mental Health Sciences, University College London, London, UK
dTCM Healthcare, Middlesex, UK
Available online 29 September 2007
KEYWORDS
Depression;
Acupuncture;
Sham control
Summary
Objectives: To establish the feasibility of conducting a randomised controlled trial to evaluate
the efficacy of acupuncture in the treatment of mild-to-moderate depression. Control group
intervention, blinding of treatment, outcome measures and the acceptability of such a trial
amongst participants were key factors to be addressed. The findings from this study will be
used to determine the design of a phase III randomised controlled trial.
Design: Nineteen participants were recruited through general practices in London, UK. Partici-
pants were randomly assigned on a 2:1 basis to either 12 sessions of verum acupuncture or 12
sessions of sham acupuncture (control). Sham acupuncture involved actual needling but at sites
considered to be unrelated to depression.
Main outcome measures: The Beck’s Depression Inventory (BDI) and the RAND 36 Item Health
Survey 1.0 (RAND) were completed at baseline and at the end of treatment or at treatment
dropout. All participants also attended a brief qualitative interview at the end of the study.
Results: Treatment dropout was low and there were high levels of patient enthusiasm
for a study of acupuncture. Referrals from General Practitioners (GPs) were lower than
expected. The sham control method successfully maintained participant blinding to treat-
ment and enabled the specific (or active) component of an acupuncture intervention to be
isolated and its efficacy assessed. The outcome measures were sensitive enough to record
changes in depressive symptoms and quality of life and are appropriate for use in a larger
trial.
Conclusions: This feasibility study has provided important information that can be used to guide
the design and methodology of a full-randomised controlled trial.
© 2007 Elsevier Ltd. All rights reserved.
Corresponding author. Tel.: +44 208 442 6972.
E-mail address: Gerard.Leavey@beh-mht.nhs.uk (G. Leavey).
Introduction
Depressive disorders are expected to become the second
highest cause of disease burden worldwide by 2020.1Around
70% of all primary care consultations are reported to involve
individuals with depressive disorder.2
0965-2299/$ — see front matter © 2007 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ctim.2007.07.005
88 M. Whiting et al.
Acupuncture may be a promising treatment in primary
care for individuals with depressive disorders3—5; however,
the evidence for use of this technique in such cases is incon-
sistent or inconclusive, and further trials are required.5—7
The objective of this study was to establish the feasibil-
ity of conducting a randomised controlled trial to evaluate
the efficacy of acupuncture in the treatment of mild-
to-moderate depression. Previous report has highlighted
the need for greater methodological rigour in acupuncture
trials6; therefore, this feasibility study was designed to focus
on patient recruitment, to identify a suitable control group
intervention, to explore treatment blinding, and to ascer-
tain suitable outcome measures.
Materials and methods
Accrual of participants
Participants were recruited in seven general practices in
North London, UK. General Practitioners (GPs) provided
information to eligible participants during routine consul-
tations and posters and leaflets describing the study (and
inviting contact) were displayed in practice waiting rooms.
Participants were screened using a self-completion Beck’s
Depression Inventory (BDI) and those who scored at least 14
were contacted.
Following referral or expression of interest, the partici-
pants were screened for eligibility.
Inclusion criteria
(1) Aged at least 18 years; (2) ‘‘mixed anxiety and depres-
sion’’ or ‘‘mild-to-moderate depressive episode with or
without somatic syndrome’’8as diagnosed using the Clinical
Interview Schedule—–Revised.9
Exclusion criteria
(1) Pregnancy; (2) history of substance abuse or brain dam-
age; (3) other psychiatric disorder preceding the onset of
depression; (4) in receipt of concurrent alternative treat-
ments or a talking therapy for repression; (5) in receipt of
pharmacological treatments for more than 3 months in the
past year.
Randomisation and treatment blinding
Participants with confirmed eligibility attended a diagnostic
session with the acupuncturist and were then randomised.
The acupuncturist elicited the underlying imbalances of the
participants without reference to ‘depression’. A member
of the research team (S.A.) was independently responsible
for randomisation off-site, and used a block method on a
2:1 ratio with two-thirds of participants receiving verum
acupuncture.
The member of the research team responsible for ran-
domisation informed the acupuncturist by telephone of
each patient’s randomisation after they had completed
their diagnostic session. All other researchers, including
assessors, and the participants were blinded to treatment.
The acupuncturist received training from a member of
the research team who has extensive clinical trial expe-
rience. The training included advice on how to maintain
professionalism and confidentiality about assignment of
treatment.
Intervention
Participants were randomised to receive either 12 sessions
of manual verum acupuncture or 12 sessions of manual
sham acupuncture (control). Each session lasted 40 min
and was provided during usual clinic hours by an accred-
ited TCM Healthcare practitioner with 10 years’ clinical
experience.
Verum acupuncture—–rationale and method
A formula combined with two additional discretionary points
was used in the acupuncture treatment. Box 1 (pub-
lished in online version at http://sciencedirect.com/ as
supplementary data) shows the points used in the verum
group, the range of needling depth, and the dimensions of
the needles used. Choice of points and needling depth was
individualised according to TCM Healthcare principles10 and
body mass of the participant.
Sham acupuncture—–rationale and method
Sham acupuncture involves actual needling but at sites con-
sidered to be unrelated to depression. The same sham points
were used on all participants in the sham group (Box 1,
published in online version at http://sciencedirect.com/ as
supplementary data). In addition, only shallow needling was
undertaken, there was no needle stimulation after insertion
and de-qi was avoided.
Needle retention time was 20 min for both verum and
sham control treatments.
Outcome assessment
The primary outcome measure was the BDI.11 The secondary
outcome measure was the RAND 36 Item Health Survey
1.0 (RAND).12 Both the BDI and the RAND were completed
at baseline and at the end of treatment or at treatment
dropout. All participants also attended a brief qualita-
tive interview at the end of the study. The interview was
designed to explore the participant’s experiences of the
study. The participants were also asked to indicate to which
study group they believed they had been assigned. All base-
line outcome measures were assessed face-to-face at the
participant’s general practice. Where possible, end point
assessments were also conducted face-to-face. In cases
where this was not possible, end point assessments were
conducted by telephone.
Analysis
Brief descriptive analysis of the BDI and the RAND was used
to examine changes in mean scores. Qualitative data were
coded into the categories ‘acupuncture treatment had a
positive impact’, ‘acupuncture treatment had a negative
impact’ and ‘acupuncture treatment was ineffective’.
Using acupuncture to treat depression: A feasibility study 89
Ethical approval was obtained from Barnet, Enfield and
Haringey Local Research EthicsCommittee. All participants
provided signed informed consent.
Results
Enrolment
Twenty patients were recruited into the study over a period
of 15 months. One patient withdrew from the study before
randomisation. Thirteen participants were randomised into
the verum group and six into the sham-control group. End-
point data were available for all 13 participants in the verum
group and for four of the six participants in the sham-
control group. The flow of participants through each stage
of the study is shown in Fig. 1. Most participants were self-
referred.
Baseline characteristics
The mean age of participants was 39.9 years (S.D. = 12.1) in
the verum group (nine female, four male) and 48.5 years
(S.D. = 10.2) in the sham-control group (five female, one
male). Participants in the verum group had slightly higher
depression scores on the BDI and slightly lower wellbeing
scores on the RAND than participants in the sham-control
group (Table 1). The TCM Healthcare diagnosis of each
participant’s condition at enrolment is given in Box 2 (pub-
lished in online version at http://sciencedirect.com/ as
supplementary data).
Adherence to treatment
Treatment adherence was good: 11 of 19 participants (58%)
completed all 13 study sessions and 16 of 19 participants
(84%) completed at least 6 study sessions (Table S1, pub-
lished in online version at http://sciencedirect.com/ as
supplementary data). There was no correlation between
early treatment dropout of participants and the treatment
they were receiving.
Outcome scores
There was a decrease in mean scores on the BDI in both study
groups, which indicates a reduction in depressive symptoms.
There was also a slight increase in mean scores on the RAND
in both study groups, which indicates an improvement in
quality of life; however, a reduction in mean scores for the
RAND categories of ‘physical functioning’ and ‘pain’ was
seen in the sham-control group only.
Qualitative interviews
All participants welcomed the opportunity to participate
in the current study. There were no differences between
the verum and sham-control groups with regard to self-
Figure 1 Flow of participants through the trial.
90 M. Whiting et al.
Table 1 Mean scores (S.D.) in BDI and RAND 36 Item Health Survey 1.0 at baseline and end point
Verum baseline (n=13) Verum end point (n=13) Sham baseline (n= 6) Sham end point (n=4)
BDI 30.7 (5.3) 21.3 (10.5) 24.7 (8.4) 13.5 (11.6)
RAND 36 Item Health Survey
Physical functioning 63.2 (27.8) 64.6 (33.9) 73.5 (24.2) 61.1 (41.8)
Role limitations physical 26.9 (29.8) 50.7 (48.5) 54.2 (40.1) 75.0 (35.4)
Role limitations emotional 2.6 (9.6) 47.2 (43.7) 27.8 (39.0) 73.3 (43.5)
Energy/fatigue 21.0 (12.5) 35.3 (22.9) 25.3 (33.2) 62.3 (23.0)
Emotional well-being 29.8 (11.1) 50.2 (23.7) 30.7 (13.5) 55.2 (29.3)
Social functioning 25.0 (15.3) 46.9 (23.9) 31.3 (29.5) 55.0 (36.0)
Pain 51.7 (32.3) 63.3 (35.5) 63.3 (29.3) 56.0 (21.0)
General health 34.2 (16.1) 46.3 (15.8) 50.8 (28.9) 60.0 (12.4)
reported positive or negative impacts of acupuncture.
Eleven participants (eight verum, three sham) reported
that the acupuncture treatment had a positive impact on
their wellbeing, particularly on levels of stress and energy.
One participant in the verum group reported that nee-
dle insertion caused pain, and two participants in the
verum group reported that the acupuncture process had
made their depressive symptoms worse. Three other partic-
ipants (two verum, one sham) considered acupuncture to be
ineffective.
Treatment blinding
There was no correlation between a participant’s ability to
judge correctly their study group and the treatment they
were receiving.
Discussion
This feasibility study has increased our understanding of the
challenges associated with conducting a full trial of the effi-
cacy of acupuncture in the treatment of depression, and
has provided important guidance on how to proceed. The
study has been particularly useful in providing information
about recruitment, control group design and outcome mea-
sures. The outcome measures used in this study appear to
be suitable for use in a larger trial. In such a trial, the
BDI and RAND will be completed following an extended
follow-up period to clarify the long-term efficacy of verum
acupuncture. The main purpose of this feasibility study was
to provide methodological guidance for future work. The
study comprised only a small population; therefore, the
findings of the study need to be treated with caution and
no definitive conclusions about the efficacy of acupuncture
in the treatment of depression can be drawn. The number
of GP referrals into this study was lower than expected,
which is consistent with other trials,13 and may be a prob-
lem related to time pressures and workload priorities14,15
rather than a lack of commitment to the study. Most partic-
ipants were self-referred after seeing an advertisement for
the study in their practice waiting rooms. More consistent
referral channels will need to be established for recruitment
of participants into a full trial. Retrospective recruitment
methods have been used successfully in Complementary and
Alternative Medicine (CAM) trials16; however, these meth-
ods were not used in the current study because many
recorded patients may be on alternative treatments that
would exclude them from the study, and retrospective
recruitment would exclude patients who have not yet been
diagnosed with depression by the GP. Recruitment of partic-
ipants into a large phase III trial is recommended to occur
through a combination of patient screening in general prac-
tice waiting rooms and targeted advertising in primary care
settings.
The use of a sham control method is recommended
in a definitive randomised controlled trial. However, non-
acupuncture points should also be used to show that the
sham control needling sites are completely ineffective in
the treatment of depression.
There are several concerns about the use of sham control
interventions in acupuncture studies. For example, sham
control methods may be perceived to reduce the experi-
ence of acupuncture solely to needling, rather than enabling
the holistic nature of acupuncture to be assessed.17 Also,
the possibility that ‘expectation’ of treatment has a phys-
iological effect on the brain, thus mediating a potentially
powerful non-specific clinical response to acupuncture, has
been suggested during pain trials.18
The study described here was designed to separate the
non-specific effects of the intervention from the effects of
needling at the correct depth in the correct place and with
manual stimulation, all of which are specific to acupunc-
ture treatment. Furthermore, the study showed that the
sham method was a plausible intervention for the control
group and successfully maintained participant blinding to
treatment, an issue that is central to improving the method-
ological quality of trials assessing the effects of acupuncture
in individuals with depression.6
The use of a sham-control group also enabled the specific
(or active) component of an acupuncture intervention to be
isolated and its efficacy assessed.
Although practitioner engagement is an essential part
of acupuncture,19 correct needling must be considered
the most important factor. Examination of the impact of
inserting needles into specific energy points in the body
is imperative and will provide valuable evidence about the
efficacy of acupuncture.
Using acupuncture to treat depression: A feasibility study 91
Conclusion
This feasibility study has provided important information
that can be used to guide the design and methodology of
a full-randomised controlled trial.
Acknowledgements
The authors would like to thank the acupuncturist, study
participants and GPs. The North Central London Community
Research Consortium funded this study.
Appendix A. Supplementary data
Supplementary data associated with this arti-
cle can be found, in the online version, at
doi:10.1016/j.ctim.2007.07.005.
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... Sixteen trials [35,[37][38][39][40][41][42][43][44][45][46][47][48][49][50][51] used SSRI or SNRI medication alone as the control. Twelve trials used an acupuncture control, with nine trials using sham acupuncture [52][53][54][55][56][57][58][59][60][61] and two trials [62,63] using an invasive control. One trial [36] of acupuncture plus usual care had two control groups, one of counseling plus usual care and one usual care alone. ...
... Sample sizes of trials included in this review ranged from 19 [59] to 755 [36], with an overall median of 60. Trials undertaken in Chinese speaking countries had a median sample size of 61, while those in English speaking countries had a median sample size of 37. ...
... Overall, 19 trials used acupuncture treatment three times a week or more, three trials used acupuncture treatment twice per week [52,55,56], five trials used acupuncture treatment once a week on average [36,57,58,62,63]. The frequency of acupuncture treatment was unclear in two trials [54,59]. In English speaking countries, the median frequency of treatments was once per week, while in Chinese speaking countries, the median frequency was treatment every second day (3.5 treatments per week). ...
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Background: Depression is commonly treated with anti-depressant medication and/or psychological interventions. Patients with depression are common users of complementary therapies, such as acupuncture, either as a replacement for, or adjunct to, their conventional treatments. This systematic review and meta-analysis examined the effectiveness of acupuncture in major depressive disorder. Methods: A search of English (Medline, PsychINFO, Google Scholar, and CINAL), Chinese (China National Knowledge Infrastructure Database (CNKI) and Wanfang Database), and Korean databases was undertaken from 1980 to November 2018 for clinical trials using manual, electro, or laser acupuncture. Results: Twenty-nine studies including 2268 participants were eligible and included in the meta-analysis. Twenty-two trials were undertaken in China and seven outside of China. Acupuncture showed clinically significant reductions in the severity of depression compared to usual care (Hedges (g) = 0.41, 95% confidence interval (CI) 0.18 to 0.63), sham acupuncture (g = 0.55, 95% CI 0.31 to 0.79), and as an adjunct to anti-depressant medication (g = 0.84, 95% CI 0.61 to 1.07). A significant correlation between an increase in the number of acupuncture treatments delivered and reduction in the severity of depression (p = 0.015) was found. Limitations: The majority of the included trials were at a high risk of bias for performance blinding. The applicability of findings in Chinese populations to other populations is unclear, due to the use of a higher treatment frequency and number of treatments in China. The majority of trials did not report any post-trial follow-up and safety reporting was poor. Conclusions: Acupuncture may be a suitable adjunct to usual care and standard anti-depressant medication.
... RCTs that satisfied the inclusion criteria were retrieved and read in full text. All 26 RCTs included in this review satisfied the specifications in the revised CONSORT and STRICTA guidelines (Allen et al. 2006;Andreescu et al. 2011;Chen et al. 2014;Chung et al. 2012;Gallagher et al. 2001;He et al. 2007;Luo et al. 1998;MacPherson et al. 2013;Man et al. 2014;Manber et al. 2004Manber et al. , 2010Mischoulon et al. 2012;Qu et al. 2013;Quah-Smith et al. 2005, 2013aRöschke et al. 2000;Song et al. 2007;Whiting et al. 2008;Yeung et al. 2011;Zhang 2005;Zhang et al. 2009Zhang et al. , 2013. ...
... Two different study designs were used in the RCTs to compare verum and sham acupuncture. In the first design, six trials compared acupuncture using specific versus non-specific acupoints for treatment of depression; five used MA (Allen et al. 2006;Gallagher et al. 2001;Manber et al. 2004Manber et al. , 2010Whiting et al. 2008) and one used EA (Andreescu et al. 2011). Only one study differentiated between the types of acupuncture and demonstrated the effectiveness of verum acupuncture (Manber et al. 2010). ...
Chapter
Clinical evidence increasingly supports acupuncture treatment for depression. However, efficacy evaluations are beset by many critical challenges relating to the limited range of study designs and important conceptual differences between Chinese and Western medical systems. Recently, clinical researchers have attempted to overcome these problems by using a standard research approach for acupuncture designed to be appropriate for use in randomized controlled trials (RCTs) and also within the conceptual framework that is used in traditional Chinese medicine (TCM). This review summarizes and discusses the existing evidence-based medicine. The analysis examined data from 26 RCTs (involving a total of 2618 patients) that investigated the effectiveness of manual, laser or electroacupuncture treatment, used as monotherapy or as augmentation therapy in patients with depression. The evidence supports the use of acupuncture as a safe and promising therapy. The antidepressant effects of acupuncture can be explained biologically in terms of regulating functions and effects upon monoamine neurotransmitters, anti-inflammation, and neuroplasticity. However, significant placebo effects exist in all of the included studies. In order to decrease the placebo effect, a more appropriate study design for comparing verum and sham acupunctures might be to compare active and inactive stimulation with laser acupuncture and with electroacupuncture. Depression is a heterogeneous disorder. For future research, it is important that clinical trials include TCM personalized medicine and that they identify subtypes of depressed patients that would best suit specific styles and techniques of acupuncture.
... The study did not focus on depression. Whiting et al. (2008) The authors aimed to establish the feasibility of conducting a randomised controlled trial to evaluate the efficacy of acupuncture in the treatment of mild-to-moderate depression. While they undertook some qualitative interviews with participants, there was very little reporting of it, with no discussion of themes and no presentation of quotations. ...
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... When considering the possibility of incorporating further evidence into the analyses, only one previous trial of 59 patients with depression has been undertaken in the UK [27]. Patients received 12 sessions of acupuncture or sham acupuncture and outcomes were measured on the Beck Depression Index (BDI). ...
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... The study did not focus on depression. Whiting et al. (2008) The authors aimed to establish the feasibility of conducting a randomised controlled trial to evaluate the efficacy of acupuncture in the treatment of mild-to-moderate depression. While they undertook some qualitative interviews with participants, there was very little reporting of it, with no discussion of themes and no presentation of quotations. ...
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Depression is a common psychiatric disease. At present, psychometric scales are the main methods for detecting depression in patients and evaluating the clinical treatment effect of depression. However, accuracy of the scales is influenced by the subjective factors of patients and doctors. This study explored the construction of a depression detection model based on task-state heart rate variability (HRV) parameters and the effect of therapy on the related HRV parameters. The candidate HRV parameters were first extracted from the task-state electrocardiogram (ECG) collected before treatment and at three observation points during treatment. Then a statistical t-test was used to screen those characteristic HRV parameters with a significant difference between the depressed and normal groups before treatment. The characteristic HRV parameters and a support-vector machine (SVM) were combined to construct the detection model. Finally, a score model was designed to reveal dynamic changes of the HRV parameters during the treatment process. This study constructed an automatic, simple and efficient depression detection model: peakHF+SVM. Detection accuracy reached 89.66% and this model had comprehensive advantages compared with other related methods. During the entire treatment process, the change in the scores and the time to achieve the maximal scores were different among patients. The type and number of HRV parameters related to the maximal score of each patient also were different. The depression detection model has good application prospects in objective, quantitative and automatic detection of depression. The same curative method produced different effects on each patient with depression. The proposed score model may be helpful for quantitative assessment of the therapeutic effect.
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Background: Depression is recognised as a major public health problem that has a substantial impact on individuals and on society. People with depression may consider using complementary therapies such as acupuncture, and an increasing body of research has been undertaken to assess the effectiveness of acupuncture for treatment of individuals with depression. This is the second update of this review. Objectives: To examine the effectiveness and adverse effects of acupuncture for treatment of individuals with depression.To determine:• Whether acupuncture is more effective than treatment as usual/no treatment/wait list control for treating and improving quality of life for individuals with depression.• Whether acupuncture is more effective than control acupuncture for treating and improving quality of life for individuals with depression.• Whether acupuncture is more effective than pharmacological therapies for treating and improving quality of life for individuals with depression.• Whether acupuncture plus pharmacological therapy is more effective than pharmacological therapy alone for treating and improving quality of life for individuals with depression.• Whether acupuncture is more effective than psychological therapies for treating and improving quality of life for individuals with depression.• Adverse effects of acupuncture compared with treatment as usual/no treatment/wait list control, control acupuncture, pharmacological therapies, and psychological therapies for treatment of individuals with depression. Search methods: We searched the following databases to June 2016: Cochrane Common Mental Disorders Group Controlled Trials Register (CCMD-CTR), Korean Studies Information Service System (KISS), DBPIA (Korean article database website), Korea Institute of Science and Technology Information, Research Information Service System (RISS), Korea Med, Korean Medical Database (KM base), and Oriental Medicine Advanced Searching Integrated System (OASIS), as well as several Korean medical journals. Selection criteria: Review criteria called for inclusion of all published and unpublished randomised controlled trials comparing acupuncture versus control acupuncture, no treatment, medication, other structured psychotherapies (cognitive-behavioural therapy, psychotherapy, or counselling), or standard care. Modes of treatment included acupuncture, electro-acupuncture, and laser acupuncture. Participants included adult men and women with depression diagnosed by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV), Research Diagnostic Criteria (RDC), International Statistical Classification of Diseases and Related Health Problems (ICD), or Chinese Classification of Mental Disorders Third Edition Revised (CCMD-3-R). If necessary, we used trial authors' definitions of depressive disorder. Data collection and analysis: We performed meta-analyses using risk ratios (RRs) for dichotomous outcomes and standardised mean differences (SMDs) for continuous outcomes, with 95% confidence intervals (CIs). Primary outcomes were reduction in the severity of depression, measured by self-rating scales or by clinician-rated scales, and improvement in depression, defined as remission versus no remission. We assessed evidence quality using the GRADE method. Main results: This review is an update of previous versions and includes 64 studies (7104 participants). Most studies were at high risk of performance bias, at high or unclear risk of detection bias, and at low or unclear risk of selection bias, attrition bias, reporting bias, and other bias.Acupuncture versus no treatment/wait list/treatment as usualWe found low-quality evidence suggesting that acupuncture (manual and electro-) may moderately reduce the severity of depression by end of treatment (SMD -0.66, 95% CI -1.06 to -0.25, five trials, 488 participants). It is unclear whether data show differences between groups in the risk of adverse events (RR 0.89, 95% CI 0.35 to 2.24, one trial, 302 participants; low-quality evidence).Acupuncture versus control acupuncture (invasive, non-invasive sham controls)Acupuncture may be associated with a small reduction in the severity of depression of 1.69 points on the Hamilton Depression Rating Scale (HAMD) by end of treatment (95% CI -3.33 to -0.05, 14 trials, 841 participants; low-quality evidence). It is unclear whether data show differences between groups in the risk of adverse events (RR 1.63, 95% CI 0.93 to 2.86, five trials, 300 participants; moderate-quality evidence).Acupuncture versus medicationWe found very low-quality evidence suggesting that acupuncture may confer small benefit in reducing the severity of depression by end of treatment (SMD -0.23, 95% CI -0.40 to -0.05, 31 trials, 3127 participants). Studies show substantial variation resulting from use of different classes of medications and different modes of acupuncture stimulation. Very low-quality evidence suggests lower ratings of adverse events following acupuncture compared with medication alone, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) (mean difference (MD) -4.32, 95% CI -7.41 to -1.23, three trials, 481 participants).Acupuncture plus medication versus medication aloneWe found very low-quality evidence suggesting that acupuncture is highly beneficial in reducing the severity of depression by end of treatment (SMD -1.15, 95% CI -1.63 to -0.66, 11 trials, 775 participants). Studies show substantial variation resulting from use of different modes of acupuncture stimulation. It is unclear whether differences in adverse events are associated with different modes of acupuncture (SMD -1.32, 95% CI -2.86 to 0.23, three trials, 200 participants; very low-quality evidence).Acupuncture versus psychological therapyIt is unclear whether data show differences between acupuncture and psychological therapy in the severity of depression by end of treatment (SMD -0.5, 95% CI -1.33 to 0.33, two trials, 497 participants; low-quality evidence). Low-quality evidence suggests no differences between groups in rates of adverse events (RR 0.62, 95% CI 0.29 to 1.33, one trial, 452 participants). Authors' conclusions: The reduction in severity of depression was less when acupuncture was compared with control acupuncture than when acupuncture was compared with no treatment control, although in both cases, results were rated as providing low-quality evidence. The reduction in severity of depression with acupuncture given alone or in conjunction with medication versus medication alone is uncertain owing to the very low quality of evidence. The effect of acupuncture compared with psychological therapy is unclear. The risk of adverse events with acupuncture is also unclear, as most trials did not report adverse events adequately. Few studies included follow-up periods or assessed important outcomes such as quality of life. High-quality randomised controlled trials are urgently needed to examine the clinical efficacy and acceptability of acupuncture, as well as its effectiveness, compared with acupuncture controls, medication, or psychological therapies.
Background Menopausal period is accompanied by numerous disorders and complications. Nowadays, hormone therapy is the most effective existing method to treat these complications, but many women cannot undergo that due to the known potentiality of risk. So, the present study aimed to investigate the effect of acupressure on early complications of menopause. Materials and Methods This is a blind random clinical trial conducted on 70 menopaused women referring to selected health care centers in Tehran who were qualified to enter the study. The subjects were randomly assigned to study (wearing a special acupressure wrist brace, three times a week for 15 min, in both bands on Shenmen and Sanyinjiao acupoints, in addition to receiving conventional menopausal care) and placebo (wearing a special acupressure wrist brace, three times a week for 15 min, but in a counter wise way, in addition to receiving conventional menopausal care) groups. Length of intervention was 4 weeks. Early complications of menopause were evaluated before intervention and 2 and 4 weeks after intervention in both groups. Data were analyzed by descriptive and inferential statistical methods. Results The findings revealed a significant reduction in the number and severity of hot flashes, the number of night sweats, and state–trait anxiety severity (P < 0.001), but with regard to the severity of night sweats and trait anxiety, there was no significant difference between groups. Conclusions With regard to the obtained results on the effect of acupressure on reduction of early menopausal complications, acupressure along with conventional menopausal care is suggested as one of the complementary medicine methods to improve the complications of this period.
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Major depressive disorder (MDD) is a prevalent condition associated with significant burden in terms of reduced quality of life, lower productivity, increased prevalence of other conditions and increased health care costs. We conducted a systematic review and qualitative summary of randomized controlled trials (RCTs) that assessed the effectiveness and safety of acupuncture for the treatment of MDD. We searched the databases PubMed, CINAHL, PsycINFO, Web of Science, Embase, CDSR, CENTRAL, clinicaltrials.gov, DARE, and PILOTS for English-language RCTs published through January 2015. Two independent reviewers screened the identified literature against inclusion and exclusion criteria, abstracted study level data, and assessed the risk of bias and methodological quality of included studies. The quality of the evidence was assessed using GRADE. Eighteen studies met inclusion criteria. Eleven assessed acupuncture as monotherapy, seven as adjunct depression treatment. Intervention approaches and comparators varied. Evidence on the effectiveness and comparative effectiveness of acupuncture to treat MDD for the outcomes depression improvement, measured as scale score differences and the number of responders, is very weak. Acupuncture may be superior to waitlist (low quality of evidence) but findings for effect estimates compared to other comparators are inconclusive. Few studies reported on patients achieving remission. The effect of acupuncture on relapse rates could not be determined. Too few studies assessed quality of life to estimate treatment effects. Reported adverse events were typically mild in nature, but the assessment lacked rigor and studies were not designed to detect rare events.
Article
Depressed patients with scores of 17 or more on the 17 items of the Hamilton Depression Rating Scale were treated with the antidepressant drug paroxetine. They also underwent verum acupuncture or electroacupuncture at Baihui (GV20) and Yintang (GV29). The World Health Organization Quality of Life Scale Brief Version showed a significant increase in the total scores of patients who underwent verum acupuncture and electroacupuncture for 6 weeks compared with those who were given paroxetine only; significantly increased physical domain and social relationship scores in verum acupuncture patients compared with paroxetine only; and significantly elevated psychological domain scores with electroacupuncture compared with paroxetine only. These results indicate that both verum acupuncture and electroacupuncture can improve quality of life in depressed patients undergoing paroxetine treatment.
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Recently, Ware and Sherbourne published a new short-form health survey, the MOS 36-Item Short-Form Health Survey (SF-36), consisting of 36 items included in long-form measures developed for the Medical Outcomes Study. The SF-36 taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. The SF-36 items and scoring rules are distributed by MOS Trust, Inc. Strict adherence to item wording and scoring recommendations is required in order to use the SF-36 trademark. The RAND 36-Item Health Survey 1.0 (distributed by RAND) includes the same items as those in the SF-36, but the recommended scoring algorithm is somewhat different from that of the SF-36. Scoring differences are discussed here and new T-scores are presented for the 8 multi-item scales and two factor analytically-derived physical and mental health composite scores.
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To determine patients' experience of outcomes after acupuncture treatment. A patient questionnaire followed by semistructured interviews. Acupuncture practices in York, England. Questionnaires were distributed by 4 acupuncturists to all 132 of their patients over a 2-week period, 72 (55%) of whom responded. Of these, 11 patients were interviewed. Patients received normal care from their acupuncturists, all of whom were members of the British Acupuncture Council. Patients reported on physical symptoms, emotional/mental symptoms, lifestyle changes, major life changes and inner life changes affecting outlook and attitudes to health. Patients also reported on the extent they attributed change to acupuncture and what they valued about attending for treatment. Primary reasons for attending were categorized by patients as physical symptoms (90%), mental and emotional problems (9%) and general health and well-being (1%). For physical symptoms, 75% of patients reported definite change; for emotional and mental symptoms, 67%; lifestyle changes, 40%, major life changes, 27%; and for inner life changes, 54%. Over time, many of the patients (42%) changed their primary reason for attending from their initial physical concerns, half of whom describing their new focus as related to general health and well-being. Some emotional changes were experienced by 83% of patients, irrespective of the initial reason for attending. For all these changes, 58% of patients reported that they "substantially" attributed the changes to acupuncture, and 25% "totally". The interviews provided additional data on the depth of the changes particularly for the longer term patients and on what they valued about treatment. Treatment with acupuncture results in a broad range of outcomes from physical and emotional change through to wider benefits involving the patients' lifestyle, outlook, and attitude toward their health. Existing outcome measures are not adequate to assess these wider benefits. The results suggest that patients experienced holistic benefits from acupuncture, an outcome that could be described as holism-in-action.
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The difficulties inherent in obtaining consistent and adequate diagnoses for the purposes of research and therapy have been pointed out by a number of authors. Pasamanick12 in a recent article viewed the low interclinician agreement on diagnosis as an indictment of the present state of psychiatry and called for "the development of objective, measurable and verifiable criteria of classification based not on personal or parochial considerations, but on behavioral and other objectively measurable manifestations."Attempts by other investigators to subject clinical observations and judgments to objective measurement have resulted in a wide variety of psychiatric rating scales.4,15 These have been well summarized in a review article by Lorr11 on "Rating Scales and Check Lists for the Evaluation of Psychopathology." In the area of psychological testing, a variety of paper-and-pencil tests have been devised for the purpose of measuring specific
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Background: There is interest from the community in the use of self help and complementary therapies for depression. This review examined the currently available evidence supporting the use of acupuncture to treat depression. Objectives: To examine the effectiveness and adverse effects of acupuncture in the treatment for depression. Search strategy: The following databases were searched: CCDAN-CTR, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to Dec 2008), EMBASE (1980 to Dec 2008), PSYCINFO (1874 to Dec 2008), the Database of Abstracts of Reviews of Effectiveness (DARE), CINAHL (1980 to Dec 2008), Wan Fang database (to Dec 2008). The following terms were used: depression, depressive disorder, dysthymic disorder and acupuncture. Selection criteria: Inclusion criteria included all published and unpublished randomised controlled trials comparing acupuncture with sham acupuncture, no treatment, pharmacological treatment, other structured psychotherapies (cognitive behavioural therapy, psychotherapy or counselling), or standard care. The following modes of treatment were included: acupuncture, electro acupuncture or laser acupuncture. The participants included adult men and women with depression defined by clinical state description, or diagnosed by the Diagnostic and Statistical Manual (DSM-IV), Research Diagnostic Criteria (RDC), International Classification of Disease (ICD) or the Criteria for Classification and Diagnosis of Mental Diseases CCMD-3-R. Data collection and analysis: Meta-analyses were performed using relative risk for dichotomous outcomes and standard mean differences for continuous outcomes, with 95% confidence intervals. Primary outcomes were reduction in the severity of depression, measured by self rating scales, or by clinician rated scales and an improvement in depression defined as remission versus no remission. Main results: This review is an update and now contains data from 30 studies. Following recent searches, 23 new studies have been added and a further 11 trials were excluded (due to suboptimal doses of medication, no clinical outcomes, insufficient reporting). Thirty trials with 2,812 participants are included in the meta-analysis.There was a high risk of bias in the majority of trials. There was insufficient evidence of a consistent beneficial effect from acupuncture compared with a wait list control or sham acupuncture control. Two trials found acupuncture may have an additive benefit when combined with medication compared with medication alone. A subgroup of participants with depression as a co-morbidity experienced a reduction in depression with manual acupuncture compared with SSRIs (RR 1.66, 95%CI 1.03, 2.68) (three trials, 94 participants). The majority of trials compared manual and electro acupuncture with medication and found no effect between groups. Authors' conclusions: We found insufficient evidence to recommend the use of acupuncture for people with depression. The results are limited by the high risk of bias in the majority of trials meeting inclusion criteria.
Article
Background: There are many factors affecting recruitment to trials in primary care, and trials are often jeopardized due to the inability to enter sufficient patient numbers. It is generally agreed that the interest in and commitment of GPs to the project are important, and their forgetfulness and time pressures are major factors which mitigate against maximal recruitment. Objectives: The aim of this study is to focus on maximizing recruitment of patients to a randomized controlled trial of exercise classes for back pain patients. Methods: Two distinct methods of recruitment were used. One practice provided a computerized list of names and asked patients' permission, by letter, to be contacted by the researchers. The other 18 practices manually recorded referrals after the consultation by the GP. Results: Referral rates were slower than expected. Many patients either did not fit the inclusion criteria or excluded themselves due to domestic commitments or work. During 24 months, 1588 patients were referred. A total of 187 patients (12%) met the criteria and could be included in the study. The practice which referred patients through a computerized listing contributed 44% of the patients successfully included in the study. Conclusions: Recruitment rates depended on the method and rate of GP referrals, the proportion of referrals meeting the entry criteria and the proportion of patients available to attend the exercise classes.
Article
SYNOPSIS Many of the standardized interviews currently used in psychiatry require the interviewer to use expert psychiatric judgements in deciding upon the presence or absence of psychopathology. However, when case definitions are standardized it is customary for clinical judgements to be replaced with rules. The Clinical Interview Schedule was therefore revised, in order to increase standardization, and to make it suitable for use by ‘lay’ interviewers in assessing minor psychiatric disorder in community, general hospital, occupational and primary care research. Two reliability studies of the revised Clinical Interview Schedule (CIS-R) were conducted in primary health care clinics in London and Santiago, Chile. Both studies compared psychiatrically trained interviewer(s) with lay interviewer(s). Estimates of the reliability of the CIS-R compared favourably with the results of studies of other standardized interviews. In addition, the lay interviewers were as reliable as the psychiatrists and did not show any bias in their use of the CIS-R. Confirmatory factor analysis models were also used to estimate the reliabilities of the CIS-R and self-administered questionnaires and indicated that traditional measures of reliability are probably overestimates.
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Depression is one of the most common reasons for using complementary and alternative therapies. The aim of this article is to provide an overview of the evidence available on the treatment of depression with complementary therapies. Systematic literature searches were performed using several databases, reference list searching, and inquiry to colleagues. Data extraction followed a predefined protocol. The amount of rigorous scientific data to support the efficacy of complementary therapies in the treatment of depression is extremely limited. The areas with the most evidence for beneficial effects are exercise, herbal therapy (Hypericum perforatum), and, to a lesser extent, acupuncture and relaxation therapies. There is a need for further research involving randomized controlled trials into the efficacy of complementary and alternative therapies in the treatment of depression.