Sleep disorders are commonly observed among postmenopausal women, with negative effects on their quality of life. The search for complementary therapies for sleep disorders during postmenopausal period is of high importance, and acupuncture stands out as an appropriate possibility. The present review intended to systematically evaluate the available literature, compiling studies that have employed acupuncture as treatment to sleep disorders in postmenopausal women. A bibliographic search was performed in PubMed/Medline and Scopus. Articles which had acupuncture as intervention, sleep related measurements as outcomes, and postmenopausal women as target population were included and evaluated according to the Cochrane risk of bias tool and to the STRICTA guidelines. Out of 89 search results, 12 articles composed our final sample. A high heterogeneity was observed among these articles, which prevented us from performing a meta-analysis. Selected articles did not present high risk of bias and had a satisfactory compliance rate with STRICTA guidelines. In general, these studies presented improvements in sleep-related variables. Despite the overall positive effects, acupuncture still cannot be stated as a reliable treatment for sleep-related complaints, not due to inefficacy, but rather limited evidence. Nevertheless, results are promising and new comprehensive and controlled studies in the field are encouraged.
Considering the current increase in life expectancy in the worldwide population [
The most prevalent sleep disorder during this phase is insomnia, being characterized by a difficulty in initiating or sustaining sleep [
The treatments for menopausal symptoms have been discussed for many years, and hormonal therapy is always an important issue, due to its well-known positive effects upon certain complaints, such as on vasomotor symptoms and on vaginal atrophy. However, since the release of Women’s Health Initiative (WHI), which has associated hormonal therapy with an increased risk for breast cancer and thromboembolism [
Several alternative and complementary therapies have emerged as potential treatments for sleep disorders in postmenopausal women, such as lifestyle alterations and physical exercise, homeopathy, phytotherapy (e.g.,
The systematic review protocol detailed below had the aim of selecting articles evaluating the effect of acupuncture on sleep-related complaints and disorders in postmenopausal women and was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) [
In order to identify the studies that have addressed the potential therapeutic effects of acupuncture in postmenopausal sleep disorders, a systematic bibliographic search was conducted concurrently in PubMed/Medline and in Scopus. Primary search strategy was the following: [acupuncture AND menopause AND (sleep OR insomnia OR apnea)]. Articles were selected in a two-step process: in the first step, titles and abstracts were screened in accordance with their suitability with the purposes of this review. Second step included full text evaluations for eligibility and data extractions. Secondly, articles that were not found in primary search but that were cited by these studies and that were relevant according to the aims of this research were also considered eligible. Inclusion and exclusion criteria were applied in both steps and two authors (AGB and GNP) performed articles selection concurrently.
Articles were included or excluded according to the evaluation of five different items: type of article, language, population, acupuncture technique, and sleep evaluation.
Only original, interventional, and longitudinal articles were included; no additional limitations regarding study designs were applied. Thus, since case reports to randomized controlled clinical trials were considered eligible, observational or transversal articles were excluded, as well as reviews and other theoretical articles.
To be included, articles should have presented an abstract in English; articles that failed to present an abstract or that presented it in any other language were excluded during the first phase of our selection process (title and abstract screening). No language restriction was applied in the second phase of our selection process (full texts evaluation).
The current review considered only articles in which population was composed by postmenopausal women. Thus, any study conducted in male individuals or in women in pre- or perimenopausal periods was excluded. Specially, articles conducted in breast cancer patients or survivors, in which menopause may have been induced by chemotherapy and hormonal suppression, were excluded in order to avoid heterogeneity within the sample.
Only articles that have employed traditional/body acupuncture and/or ear acupuncture/auriculotherapy as intervention were included. Articles in which main intervention was based on correlated techniques, such as moxibustion, scraping therapy, and cupping therapy, were excluded. There were no restrictions regarding treatment duration, therapy session duration, or number of sessions until outcome assessment.
Controlled trials presenting parallel intervention and control groups were included. Additional study designs (case reports and cohorts) presenting sleep evaluations in at least two time points, one before and another after acupuncture interventions, were also included. No restriction was applied regarding the type of sleep evaluation, being eligible both objective measurements (polysomnography, actigraphy, etc.) and subjective scales (questionnaires, indexes, scores, etc.).
Potential methodological biases affecting the selected articles were evaluated using the Cochrane risk of bias tool [
The STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) [
We used the STRICTA guidelines to assess the methodological completeness of the articles selected in this systematic review. It is worth to mention that these guidelines were not designed to be applied as an evaluative tool of prepublished studies (as are the Cochrane risk of bias tool, the Jadad scale, and others [
Of note, subitems rated as “no” are not conditionally indicative of low methodological quality or of incompleteness, as some of STRICTA subitems do not refer to mandatory practices in clinical acupuncture trials. As an example, a “no” attribution to subitems such as “response sought” (2d) or “needle stimulation” (2e) does not refer to lack of quality but rather may indicate that these practices were not employed in a given protocol. Thus, the use of STRICTA in the present review and the raised data should be interpreted carefully; overgeneralizations and the use of STRICTA to generate quality indexes should be avoided. The evaluation of selected articles according to the STRICTA guidelines was performed by two authors concurrently (AGB and GNP).
A total of 89 articles returned as a result of our bibliographic search. Among them, 33 were obtained in PubMed/Medline search and the remaining 56 were found exclusively in Scopus. After title and abstract screening, 73 articles were excluded due to different reasons and 16 articles remained eligible. From these, four more articles were excluded in the second step of the selection process, and the remaining 12 articles composed our final sample, among which 11 were published in English and one in Spanish language [
Flowchart of articles selection of the current study.
Most of the screened articles were published in the last two decades, showing that, despite being a millenary technique, reports of the use of acupuncture for postmenopausal sleep-related complaints are very recent. The first report was published in 1994 and since then, a clear temporal growth tendency can be observed. Some few erratic dynamics can be noted, such as the decreases in publication in the years of 2004, 2010, and 2013; however, they can be understood as artifacts of the still reduced total number of articles. As this is a very recent publication field, as well as due to its steady growth, almost 50% of the total output was published in the last five years (Figure
Time analysis of publication on the use of acupuncture for postmenopausal sleep-related complaints.
Among the 12 articles that composed our sample, three are case reports and the remaining nine articles are proper comparative studies. A full description of these articles and their main features is available in Table
List and description of selected studies.
Article | Article type | Sample description |
|
|
Treatment condition | Type of treatment | Acupoints, exp | Acupoints, ctrl | Sleep assessment | Main results |
---|---|---|---|---|---|---|---|---|---|---|
Hammes et al., 2014 [ |
Case report | 49-y postmenopausal woman | 1 | NA | 22 sessions, weekly or biweekly | Body and auricular acupuncture | Sessions 1–6: LI-4, LR-3, CV-6, CV-17, HT-6, KI-6, KI-2, GV-20, auricular: ShenMen, kidney Sessions 7–22: LI-4, LR-3, CV-4, CV-6, CV-17, HT-6, KI-6, GB-41, GV-20, auricular: ShenMen, kidney | NA | Insomnia self-report | Improvement |
|
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Baccetti et al., 2014 [ |
Randomized controlled trial | Postmenopausal women, ≥3 hot flushes episodes/day | 47 | 49 | Twice a week, during four weeks | B |
Stimulation with star needles in dorsal region C7-T5. Electrostimulation: dispersion (100 cycles/s) on GV-23, CV-22, BL-2, LI-11, and LI-4; tonification (40 cycles/s) on SP-10 and SP-6; and tonification with GV-20, CV-4, CV-6, ST-37, and LR-3 | None | 1–4 scale about sleep disorders severity | Improvement |
|
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Hachul et al., 2013 [ |
Randomized controlled trial | Postmenopausal women, insomnia | 9 | 9 | Twice a week, during five weeks | Body acupuncture | Not reported | Sham acupoints | PSQI and PSG | Improvements in SWS at PSG and in PSQI score |
|
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Painovich et al., 2012 [ |
Randomized controlled trial | Peri- and postmenopausal women, at least seven VMS/day | 12 | 9/12 | Three times a week, during 12 weeks | Body acupuncture | GV-20, PC-6, HT-7, LV-3, LI-4, LI-11, KI-3, SP-6, ST-36, CV-17, CV-6, GV-14, GB-15, GB-18, GB-20, GB-23, GB-34, and KI-3 | Sham or none | PSQI | Nonsignificant |
|
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Kung et al., 2011 [ |
Cohort | Postmenopausal women, insomnia | 45 | NA | Daily before sleep, during four weeks | Auricular acupuncture | ShenMen, kidney, heart, brainstem, and subcortex | NA | PSQI | Improvements in PSQI score, sleep latency, total sleep duration, and sleep efficiency |
|
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Borud et al., 2009 [ |
Multicentric randomized controlled trial | Postmenopausal women, at least seven hot flushes/day | 134 | 133 | 10 sessions over 12 weeks | Body acupuncture (elective additional moxibustion) | Individualized and customized treatment | None | Sleep logs and WHQ | Improvement in total sleep time |
|
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Borud et al., 2010 [ |
Follow-up on Borud et al., 2009 [ |
Postmenopausal women, at least seven hot flushes/day | 134 | 133 | NA | NA | NA | NA | WHQ | Maintenance of results, as in Borud et al., 2009 [ |
|
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Avis et al., 2008 [ |
Randomized controlled trial | Peri- or postmenopausal women, at least four hot flushes/day | 19 | 18 | Twice a week, during eight weeks | Body acupuncture | CV-4, KI-3, SP-6, BL-23, HT-6, KI-7 (possible additional points depending on diagnostic: KI-6, KI-10, GV-4, CV-6, BL-52, LR-3, LR-8, GB-20, BL-18, PC-7, GB-13, GV-20, taiyang, HT-7, HT-8, Yintang, CV-15, BL-15) | Sham acupoints | Women's Health Initiative Insomnia Rating Scale | Nonsignificant |
|
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Huang et al., 2006 [ |
Randomized controlled trial | Postmenopausal women, at least 7 moderate or severe hot flushes/day | 12 | 17 | Nine sessions, during seven weeks | Body acupuncture | 5–7 acupoints from a previously defined list | Sham acupoints | PSQI | Nonsignificant |
|
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Hu, 2005 [ |
Case report | 51-y postmenopausal woman | 1 | NA | Three times a week, duration not clear | Body and auricular acupuncture | BL-23, BL-15, PC-7, HT-7, Anmian (extra), SP-6, LR-3, KI-3, BL-18, BL-20, GV-20, GV-24, EX-HN 3 Auricular: subcortex, sympathesis, ear-ShenMen, endocrine, ovary, kidney, spleen, and heart | NA | Insomnia self-report | Improvement |
|
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Cohen et al., 2003 [ |
Randomized controlled trial | Postmenopausal woman, self- identification of menopausal hot flashes | 8 | 9 | Irregular schedule, total six sessions | Body acupuncture | BL-15, BL-23, BL-32, GV-20, HT-7, PC-6, SP-6, SP-9, LI-3 | Standard treatment, not related to menopause | 0–3 scale about sleep disorders severity | Nonsignificant between groups comparison Improvement in within-group comparison |
|
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Bijak, 2009 [ |
Case report | 59-y postmenopausal woman | 1 | NA | Once a week, ten weeks | Body and auricular acupuncture | BL-17 (until the 4th session), BL-43 (5th until the 10th session), KI-3, BL-31, HT-3, LI-3, auricular: Jerome's point and sleep point (until the 4th session) | NA | Insomnia self-report | Improvement |
Exp: experimental group; ctrl: control group;
Among the 12 selected articles, nine (75%) presented improvements in sleep complaints following acupuncture, while only three (25%) showed nonsignificant effects [
About treatment conditions, a wide range of protocols was used in what regards theoretical background, type of acupuncture intervention, treatment duration, number of sessions, and chosen acupoints. Among the 12 articles, eight have employed exclusively body acupuncture, all of them based on Traditional Chinese Medicine (TCM) background. One article has employed ear acupuncture only, and the remaining two articles employed a mixed protocol, composed of both body and ear acupuncture. Regarding number of sessions, data ranged from nine to 36 sessions, in frequencies ranging from weekly to three times a week. Acupoints ranged enormously among the experiments and no specific pattern or preferable treatment option was observed.
For sleep assessment tools, some degree of variability was also observed. Six experiments (50%) employed self-reported scales related to sleep, which are the most unspecific and least reliable way to measure sleep disorders or related complaints. Sleep logs, which are still a kind of self-report but with a bigger reliability, were employed in one article (8.3%). Then, standardized and validated questionnaires were used in seven articles: the Pittsburgh Sleep Quality Index (PSQI) was used in four articles (25%), Women’s Health Questionnaires (WHQ) in two (16.6%), and Women’s Health Initiative Insomnia Rating Scale in a single experiment (8.3%). Lastly, polysomnography, which is the gold standard method for sleep evaluation, was used in only one article (8.3%). Of note, only two articles took sleep-related complaints as primary outcomes or aims [
Regarding article types, we could identify three case reports (25%), one cohort (8.3%) and eight randomized controlled trials (encompassing one multicentric study and a follow-up—66.6%). As these different study designs involve different methodological details and different levels of evidence, results are presented in detail below.
Hu [
These three reports observed positive effects of acupuncture on sleep-related postmenopausal symptoms. However, the case reports represent the lowest degree of scientific evidence. This type of articles is markedly prone to be affected by publication bias, as negative case reports are completely unlikely to be published. Thus, these cases are useful to disclose the plausibility of the use of acupuncture as an adjuvant on the treatment of the refereed sleep complaints; but the extent of this usefulness and the likelihood to extrapolate these results to a wider sample is questionable. Another caveat relies on the fact that all the reports have employed unreliable sleep measurement tools and failed to provide further details on sleep evaluation. Conversely, as a positive feature of these case reports, this type of article allows an individualized and customized treatment, which is extremely valuable under the concepts of TCM.
A single cohort article was included in our systematic review, which encompassed a group of 45 postmenopausal women with insomnia complaints. In this case, the treatment consisted of auricular acupuncture, with acupressure being recommended daily before sleep. Results showed a reduced latency to sleep and an increased total sleep time and sleep efficiency, measured by means of the PSQI [
Out of the 12 selected articles, eight were categorized as randomized controlled trials [
Regarding the main results of the randomized controlled trials, five of them presented improvements in sleep-related complaints after acupuncture, one of them addressing it in a 6–12-month follow-up. Additionally, one of these articles presented improvement only in within-group analysis, when comparing pre- and posttreatment values within the experimental group, but failed to show significant results in between-group comparisons. Other three articles failed to show significant results of acupuncture on sleep complaints.
Randomized controlled trials are among the methodological designs that provide the greatest levels of scientific evidence, usually providing data with increased external validity. In this sense, the observation of positive results in only 62.5% of the trials (reduced to 50% if considered only between-group analysis) is a fact that should be observed carefully. There is no obvious reason that distinguishes randomized trials that demonstrate significant effects from those that do not, among the studies that composed our sample. However, as a positive consideration, the studies that presented the most appropriate and detailed protocols and analysis were concordant in showing positive effects. Both Borud et al. [
The evaluation of risk of bias considered eight articles due to the exclusion of three case reports [
In general, there was a low risk of bias among the evaluated items. The only item that presented a potential high risk of bias was “blinding of participants and personnel” (28.6%). This is a consequence of the presence of some articles that did not use any kind of placebo or sham group, but rather employed waiting list or no treatment groups as controls. In these cases, as only one group has received acupuncture, it would be impossible to make the participants blinded to the treatment. Other than that, no item displayed concerning increased levels of biases. An overview about the risk of bias in our sample can be found in Table
Risk of bias assessment.
Low risk | Unclear risk | High risk | |
---|---|---|---|
Sequence generation ( |
100.0% | 0.0% | 0.0% |
Allocation concealment ( |
85.7% | 14.3% | 0.0% |
Blinding of participants and personnel ( |
71.4% | 0.0% | 28.6% |
Blinding of outcome assessors ( |
57.1% | 42.9% | 0.0% |
Incomplete outcome data ( |
100.0% | 0.0% | 0.0% |
Selective outcome reporting ( |
100.0% | 0.0% | 0.0% |
Other sources of bias ( |
100.0% | 0.0% | 0.0% |
Evaluation according to the Cochrane risk of bias tool.
As with the risk of bias assessment, the follow-up by Borud et al. [
Evaluation of the selected articles based on STRICTA criteria.
Hammes et al., 2014 [ |
Baccetti et al., 2014 [ |
Hachul et al., 2013 [ |
Painovich et al., 2012 [ |
Kung et al., 2011 [ |
Borud et al., 2009 [ |
Avis et al., 2008 [ |
Huang et al., 2006 [ |
Hu, 2005 [ |
Cohen et al., 2003 [ |
Bijak, 2009 [ | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|
( |
(1a) Style of acupuncture | Yes, TCM | Yes, TCM, five elements | Yes, TCM | Yes, TCM | Yes, ear acupuncture | Yes, TCM | Yes, TCM | Yes, TCM | Yes, TCM, ear acupuncture | Yes, TCM | Yes,TCM, ear acupuncture |
(1b) Reasoning for treatment provided | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
(1c) Extent to which treatment was varied | N/A, case report | Yes, partially individualized | Yes, no individualization | Yes, no individualization | Yes, no individualization | Yes, individualized treatment | Yes, partially individualized | Yes, partially individualized | N/A, case report | Yes, No individualization | N/A, case report | |
|
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( |
(2a) Number of needle insertions per subject per session | No | Yes for common protocol; No for individualized treatment | No | Yes, 28 points | Yes, 5 auricular points | No | Yes, 11 to 16 needle insertions per subject per section | Yes, 5–7 points | Yes, 21 points + 9 ear points | Yes, 9 points | Yes, 5 points + 2 ear points |
(2b) Names or location of points used | Yes |
Partially, Yes |
No | Yes |
Yes |
No | Partially, Yes |
Yes |
Yes |
Yes |
Yes | |
(2c) Depth of insertion | No | No | No | Yes, 0.5 to 1.5 in | No | No | Yes, 0.5 to 3 cm | No | No | No | No | |
(2d) Response sought | Yes, needles inserted until deqi sensation was obtained | No | No | Yes, manually stimulated until reaching |
No | Yes, deqi obtained, if possible | Yes, deqi obtained, if possible | No | No | No | No | |
(2e) Needle stimulation | Yes, needling with tonifying technique | Yes |
No | Yes, manually stimulated until reaching |
No | Partially, needle manipulation allowed | No | No | No | No | Yes, superficial tonification | |
(2f) Needle retention time | Yes, 20 min | Yes, 30 min | Yes, 30 min | Yes, 30 min | No | No | Yes, 20 min for anterior points; 10 min for posterior points | No | No | No | No | |
(2g) Needle type | Yes, DBC Spring-Ten sterile and disposable needles 0.20 × 0.30 mm | No | Yes, disposable 0.25 × 40 mm acupuncture needles | No | Yes, 0.2 cm sized magnetic pellet on a 1 cm sized sticky patch (Ching-Ming Co., Taiwan) | No | Yes, Sterile, single-use, Vinco 34-gauge, 1-inch (0.22 25 mm) and 30-gauge, 1.5-inch (0.30 40 mm) | No | No | No | Yes, disposable 0.3 mm needles and ASP needles for auriculotherapy | |
|
||||||||||||
( |
(3a) Number of treatment sessions | Yes |
Yes |
Yes |
Yes |
No | Yes |
Yes |
Yes |
No | Yes |
Yes |
(3b) Frequency and duration of treatment sessions | Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes | |
|
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( |
(4a) Details of other interventions administered to the acupuncture group | Yes, description about medicines | Yes, diet (according to TCM) and self-massage (TuiNa) | No | No | No | Yes, moxibustion was allowed | No | No | No | No | No |
(4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients | No | Yes, participants received instructions about diet and self-massage Practitioners received specific training before the beginning of the study | No | No | No | Yes, participants free to use self-provided care. |
Yes, all study participants were instructed not to take hormonal medications or initiate other treatments for their hot flashes during treatment | Yes, acupuncturists were instructed to limit verbal contact to the most pertinent clinical information and to refrain from counseling and offering advice | Yes, take light food, more fruits and vegetables, and avoid greasy and spicy food, do appropriate physical exercises to strengthen the body constitution (among others) | No | No | |
|
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( |
(5a) Description of participating acupuncturists | No | Yes, sessions were conducted by MDs trained at the TCM with at least 400 h of experience Practitioners received training and were supervised by the director of the study | No | No | Yes, licensed acupuncturist | Yes, the study acupuncturists met the current membership criteria of the Norwegian Acupuncture Society (2,500 h) and had at least 3 years of experience | Yes, treatments were performed by experienced acupuncturists trained in TCM | No | No | Yes, licensed acupuncturist | No |
|
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( |
(6a) Rationale for the control or comparator in the context of the research question | N/A, case report | Yes, control group were given diet and self-massage training, but no acupuncture | Yes, Sham group | Yes, Sham group | No | Yes, control group with no intervention | Yes, Sham group | Yes, Sham group | N/A, case report | Yes, comparison acupuncture treatment | N/A, case report |
(6b) Precise description of the control or comparator | N/A, case report | Yes, TuiNa massage (30 min massage for the areas in which acupuncture points are present) and diet (food choice based on the energetic balance of the individual) | Yes, needles in different acupoints | Yes, Sham points were proximate to the treatment points site, but not considered active | No | Yes, no medical treatment, but free to use self-provided nonpharmaceutical interventions | Yes, needling at sites thought to have minimal effects on hot flashes. Six needles in each side, shallowly needled, no attempt to reach deqi | Yes, Streitberger placebo needles in 4-5 points | N/A, case report | Yes, general treatment: LV4, KI7, ShenMen sympathetic, kidney, liver, and lung points | N/A, case report |
STRICTA: Standards for Reporting Interventions in Clinical Trials of Acupuncture; N/A: nonapplicable;
STRICTA guidelines work as checklist of items that should preferably be reported in all clinical acupuncture trials, rather than as a methodological quality evaluation tool. Thus, more than evaluating the techniques and methods employed, this tool has helped us to evaluate the proportion of articles that have properly addressed these items. In this sense, several items had a good reporting rate, ranging from 80% to 100%, mainly on items related to acupuncture rationale (item 1), treatment regimen (item 3), and control intervention. Conversely, an increased omission rate (i.e., “no” responses) was observed in several items, but mainly on those related to needling details and acupuncturists background, such as in “depth of insertion” (2c; 81.2%), “response sought” (2d; 63.6%), “needle stimulation” (2e; 54.5%), “needle retention time” (2f; 54.5%), “needle type” (2g; 54.5%), and “description of acupuncturists” (5a; 54.5%). When evaluating reporting and omissions rates individually for each article, results are satisfactory: articles presented an average reporting rate of 62.1%, while the average omission rate was of 35.8%. The trial that presented the highest reporting rate (82.4%) and consequently the lowest omission rate (11.8%) was Avis et al. [
A full description of how each selected article addressed the items of STRICTA checklist can be checked in Table
Simplified evaluation according to STRICTA criteria and reporting and omission rates.
Hammes et al., 2014 [ |
Baccetti et al., 2014 [ |
Hachul et al., 2013 [ |
Painovich et al., 2012 [ |
Kung et al., 2011 [ |
Borud et al., 2009 [ |
Avis et al., 2008 [ |
Huang et al., 2006 [ |
Hu, 2005 [ |
Cohen et al., 2003 [ |
Bijak, 2009 [ |
Reporting rate per subitem | Omission rate per subitem | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
( |
(1a) Style of acupuncture | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 100.0% | 0.0% |
(1b) Reasoning for treatment provided | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 90.9% | 9.1% | |
(1c) Extent to which treatment was varied | N/A | Yes | Yes | Yes | Yes | Yes | Yes | Yes | N/A | Yes | N/A | 100.0% | 0.0% | |
|
||||||||||||||
( |
(2a) Number of needle insertions per subject per session | No | Yes | No | Yes | Yes | No | Yes | Yes | Yes | Yes | Yes | 72.7% | 27.3% |
(2b) Names or location of points used | Yes | Partially | No | Yes | Yes | No | Partially | Yes | Yes | Yes | Yes | 63.6% | 18.2% | |
(2c) Depth of insertion | No | No | No | Yes | No | No | Yes | No | No | No | No | 18.2% | 81.8% | |
(2d) Response sought | Yes | No | No | Yes | No | Yes | Yes | No | No | No | No | 36.4% | 63.6% | |
(2e) Needle stimulation | Yes | Yes | No | Yes | No | Partially | No | No | No | No | Yes | 36.4% | 54.5% | |
(2f) Needle retention time | Yes | Yes | Yes | Yes | No | No | Yes | No | No | No | No | 45.5% | 45.5% | |
(2g) Needle type | Yes | No | Yes | No | Yes | No | Yes | No | No | No | Yes | 45.5% | 54.5% | |
|
||||||||||||||
( |
(3a) Number of treatment sessions | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | No | Yes | Yes | 81.8% | 18.2% |
(3b) Frequency and duration of treatment sessions | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 100.0% | 0.0% | |
|
||||||||||||||
( |
(4a) Details of other interventions administered to the acupuncture group | Yes | Yes | No | No | No | Yes | No | No | No | No | No | 27.3% | 72.7% |
(4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients | No | Yes | No | No | No | Yes | Yes | Yes | Yes | No | No | 45.5% | 54.5% | |
|
||||||||||||||
( |
(5a) Description of participating acupuncturists | No | Yes | No | No | Yes | Yes | Yes | No | No | Yes | No | 45.5% | 54.5% |
|
||||||||||||||
( |
(6a) Rationale for the control or comparator in the context of the research question | N/A | Yes | Yes | Yes | No | Yes | Yes | Yes | N/A | Yes | N/A | 87.5% | 12.5% |
(6b) Precise description of the control or comparator | N/A | Yes | Yes | Yes | No | Yes | Yes | Yes | N/A | Yes | N/A | 87.5% | 12.5% | |
|
||||||||||||||
Reporting rate per article | 71.4% | 76.5% | 47.1% | 76.5% | 47.1% | 64.7% | 82.4% | 58.8% | 42.9% | 58.8% | 57.1% | |||
Average reporting rate among articles | 62.1% | |||||||||||||
Omission rate per article | 28.6% | 17.6% | 52.9% | 23.5% | 52.9% | 29.4% | 11.8% | 41.2% | 57.1% | 35.3% | 42.9% | |||
Average omission rate among articles | 35.8% |
STRICTA: Standards for Reporting Interventions in Clinical Trials of Acupuncture; N/A: nonapplicable.
The current article presents a systematic literature review about the therapeutic effects of acupuncture on sleep-related complaints in postmenopausal women. Here we highlight one of the biggest challenges of the current review: to join the need of synthesis of general evidences by systematic methods, which is paramount in western medicine, with the patient-focused and customized treatment professed by acupuncture and TCM in general. This discrepancy between western and eastern medicines becomes clear in the way each of them approach sleep complaints observed in postmenopausal women. In western medicine, insomnia and other sleep disorders and complaints may be consequences or symptoms of the postmenopausal period, which are primarily caused by a hormonal imbalance. In this case, the focus of treatment is on the symptoms (as the sleep complaints, aside from hot flushes and behavioral consequences). On the other hand, according to the perspective of TCM, the postmenopausal period can be classified as a syndrome, in which sleep disorder may or may not be present, being explained as a consequence of an energetic imbalance. More specifically, in postmenopause there is a marked deficiency of
An important tool in the standardization of acupuncture trial was the development of STRICTA, which in some extent is an attempt to synchronize both eastern and western scientific methods. This tool was first published in 2001 [
Despite the satisfactory compliance rate with STRICTA items, the selected articles present a high and marked level of heterogeneity, mainly in what regards acupuncture related variables (type of intervention, type of control group, needling procedures, etc.), which reinforces the patient-focused principles of acupuncture. Such a conclusion sets high heterogeneity as a virtually conditional feature of acupuncture trials. Moreover, some degree of variation was also observed on outcome-related variables, such as on time between intervention and outcome measurement and type of evaluation of sleep-related features. Information about the heterogeneity on these items can be checked in Tables
In a wider perspective, Attarian et al. [
Some more specific methodological issues deserve special attention, as they lead to additional heterogeneity and cannot be easily overcome. One of them regards the proper development of a sham group with no therapeutic effect [
Considering the selected articles, it can be noted that the majority of them are directed only to the approach and treatment of vasomotor symptoms caused by hormonal decay in this life period, being the sleep-related complaints often neglected or considered as a secondary measure. In general, insomnia is strongly associated with the severity and quantity of hot flushes [
To a proper understanding of the above presented results and discussion, some limitations and methodological caveats should be taken into consideration. The most evident of them have already been presented, which are the increased heterogeneity and limited number of articles. These both conditions are indeed important limitations and the most important reason to invest in new and better-designed acupuncture trials in the future, thus allowing better conclusions based on bigger and more homogeneous data samples. Another class of previously discussed methodological caveats is the acupuncture-related limitations, among which we highlight the potential bias of sham control groups in acupuncture trials and the variability among interventions. Additionally, some other methodological drawbacks should be discussed. Firstly, one may wonder that in a bibliographic search of articles about acupuncture, a higher proportion of articles in Chinese, or eventually in other western languages such as Japanese or Korean, would be expected. However, only three articles in Chinese were present among the 89 included in our primary samples. From these, one was excluded due to incompatible design at the first step of selection process, while the other two were excluded because full texts were not available, leading us to a final sample composed only by articles in eastern languages (11 in English, one in Spanish). It is highly possible that articles in Chinese and other languages should have been published, but it seems that they are being published in nonindexed or nonsearchable sources, which suggests a case of publication bias. Another important point relates to the fact that only two databases were used for bibliographic search. In this case, further reviews on the topic should include more databases. However, more than including traditional global databases (such as the employed PubMed/Medline and Scopus, as well as Embase and Web of Science), local and specific databases should also be considered, in order to include a bigger amount of articles in general, specifically those in western languages.
A primary conclusion regards the limited number of articles included. Few studies have addressed the therapeutic effects of acupuncture on sleep-related complaints in postmenopausal women, most of them with reduced sample size. In this sense, it is surprising how this millenary technique has been the focus of scientific reports only in the last few years. Additionally, heterogeneity was an important finding of the current review, both in what regards acupuncture intervention and studies design, which have varied since case reports until multicentric randomized controlled trials. Case reports on the field describe interesting data and controlled clinical trials address the possible effects in larger samples. Controlled trials usually corroborated these effects, but some studies have failed to address beneficial effects of acupuncture. In spite of that, data are still not sufficient to allow concluding that acupuncture is a reliable therapeutic alternative for the treatment of postmenopausal sleep disorders. However, this observation is not due to the lack of efficacy, but rather due to the limited evidences raised so far. Previous results are promising and the tendency is that, as new randomized controlled trials on the field are published, acupuncture can be suggested as a reliable treatment to sleep complaints in postmenopausal women. New researches, duly controlled and scientifically sound, should be encouraged. Additionally, studies not only on general sleep complaints, but also on more specific diseases, such as in insomnia and OSAS, should be performed. Regarding acupuncture intervention, both studies applying fully individualized interventions and standardized treatments are welcome, as both serve for acquisition of evidences, considering that the acupuncture protocol is fully described and replicable. Additionally, as most of the current studies have been performed according to the TCM, other traditional acupuncture techniques (such as Japanese, Korean, Western, French ear acupuncture, etc.) should be encouraged. Finally, the use of STRICTA guidelines is highly recommended for future studies.
Regardless of the still limited evidence about the effects of acupuncture for postmenopausal sleep disorders, none of the selected articles described side or deleterious effects. Thus, acupuncture can be safely applied in clinical practice for this population as an alternative treatment, but not as primary or single conduct.
G. N. Pires is a current employee of Springer Science + Business Media; this position has no relation with the present paper nor with any of this author’s academic activities. Other authors have no conflict of interests to disclose.
All of the listed authors have approved the final paper.
Funding for our studies is provided by AFIP, CNPq, and CAPES.