Acupuncture for menopausal hot flushes
Abstract
Background
Hot flushes are the most common menopausal vasomotor symptom. Hormone therapy (HT) has frequently been recommended for relief of hot flushes, but concerns about the health risks of HT have encouraged women to seek alternative treatments. It has been suggested that acupuncture may reduce hot flush frequency and severity.
Objectives
To determine whether acupuncture is effective and safe for reducing hot flushes and improving the quality of life of menopausal women with vasomotor symptoms.
Search methods
We searched the following databases in January 2013: the Cochrane Menstrual Disorders and Subfertility Group Specialised Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, CINAHL, PsycINFO, Chinese Biomedical Literature Database (CBM), Chinese Medical Current Content (CMCC), China National Knowledge Infrastructure (CNKI), VIP database, Dissertation Abstracts International, Current Controlled Trials, Clinicaltrials.gov, National Center for Complementary and Alternative Medicine (NCCAM), BIOSIS, AMED, Acubriefs, and Acubase.
Selection criteria
Randomized controlled trials comparing any type of acupuncture to no treatment/control or other treatments for reducing menopausal hot flushes and improving the quality of life of symptomatic perimenopausal/postmenopausal women were eligible for inclusion.
Data collection and analysis
Sixteen studies, with 1155 women, were eligible for inclusion. Three review authors independently assessed trial eligibility and quality, and extracted data. We pooled data where appropriate and calculated mean differences (MDs) and standardized mean differences (SMDs) with 95% confidence intervals (CI). We evaluated the overall quality of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria.
Main results
Eight studies compared acupuncture versus sham acupuncture. No significant difference was found between the groups for hot flush frequency (MD ‐1.13 flushes per day, 95% CI ‐2.55 to 0.29, 8 RCTs, 414 women, I2 = 70%, low‐quality evidence) but flushes were significantly less severe in the acupuncture group, with a small effect size (SMD ‐0.45, 95% CI ‐0.84 to ‐0.05, 6 RCTs, 297 women, I2 = 62%, very‐low‐quality evidence). There was substantial heterogeneity for both these outcomes. In a post hoc sensitivity analysis excluding studies of women with breast cancer, heterogeneity was reduced to 0% for hot flush frequency and 34% for hot flush severity and there was no significant difference between the groups for either outcome.
Three studies compared acupuncture versus HT. Acupuncture was associated with significantly more frequent hot flushes than HT (MD 3.18 flushes per day, 95% CI 2.06 to 4.29, 3 RCTs, 114 women, I2 = 0%, low‐quality evidence). There was no significant difference between the groups for hot flush severity (SMD 0.53, 95% CI ‐0.14 to 1.20, 2 RCTs, 84 women, I2 = 57%, low‐quality evidence).
One study compared electroacupuncture versus relaxation. There was no significant difference between the groups for either hot flush frequency (MD ‐0.40 flushes per day, 95% CI ‐2.18 to 1.38, 1 RCT, 38 women, very‐low‐quality evidence) or hot flush severity (MD 0.20, 95% CI ‐0.85 to 1.25, 1 RCT, 38 women, very‐low‐quality evidence).
Four studies compared acupuncture versus waiting list or no intervention. Traditional acupuncture was significantly more effective in reducing hot flush frequency from baseline (SMD ‐0.50, 95% CI ‐0.69 to ‐0.31, 3 RCTs, 463 women, I2 = 0%, low‐quality evidence), and was also significantly more effective in reducing hot flush severity (SMD ‐0.54, 95% CI ‐0.73 to ‐0.35, 3 RCTs, 463 women, I2 = 0%, low‐quality evidence). The effect size was moderate in both cases.
For quality of life measures, acupuncture was significantly less effective than HT, but traditional acupuncture was significantly more effective than no intervention. There was no significant difference between acupuncture and other comparators for quality of life. Data on adverse effects were lacking.
Authors' conclusions
We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.
Plain language summary
Acupuncture for menopausal hot flushes
Review question: Is acupuncture safe and effective for reducing hot flushes and improving the quality of life of menopausal women with hot flushes?
Background: Hot flushes are the most common symptoms related to perimenopause and menopause. Hormone therapy (HT) is considered to be the most effective treatment for symptoms. However, studies have reported that hormone therapies may have some negative health effects and many women are now choosing not to use these and are looking for alternatives such as acupuncture. Cochrane review authors examined the evidence, which is current to January 2013.
Study characteristics: Sixteen randomized controlled trials, with 1155 women, were included in the review. Most were small and of short duration. 15 of the 16 included studies reported their funding sources.
Key findings: When acupuncture was compared with sham acupuncture, there was no evidence of any difference in their effect on hot flushes. When acupuncture was compared with no treatment, there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT.
Quality of the evidence: These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture with no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.
Authors' conclusions
Summary of findings
| Acupuncture versus sham acupuncture for menopausal hot flushes | ||||
| Population: women with menopausal hot flushes | ||||
| Outcomes | Illustrative comparative risks* (95% CI) | No of Participants | Quality of the evidence | Comments |
| Acupuncture versus sham acupuncture | ||||
| Hot flush frequency (number/day) | The mean hot flush frequency in the intervention groups was | 414 | ⊕⊕⊝⊝ | There was no significant difference between the groups in the mean number of hot flushes per day |
| Hot flush severity | The mean hot flush severity in the intervention groups was | 297 | ⊕⊝⊝⊝ | Hot flushes were significantly less severe in the acupuncture group. The size of the effect was small. SMD ‐0.45 (‐0.84 to ‐0.05) |
| *The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||
| GRADE Working Group grades of evidence | ||||
| 1 Only 2/8 studies described appropriate methods of randomization and allocation concealment, one of which had very high attrition. | ||||
| Acupuncture versus hormone therapy for menopausal hot flushes | ||||
| Population: women with menopausal hot flushes | ||||
| Outcomes | Illustrative comparative risks* (95% CI) | No of Participants | Quality of the evidence | Comments |
| Acupuncture versus hormone therapy | ||||
| Hot flush frequency (number/day) | The mean hot flush frequency in the intervention groups was | 114 | ⊕⊕⊝⊝ | Hot flushes were significantly more common in the acupuncture group than in the hormone therapy group |
| Hot flush severity | The mean hot flush severity in the intervention groups was | 84 | ⊕⊕⊝⊝ | There was no significant difference between the groups in the mean severity of hot flushes SMD 0.53 (‐0.14 to 1.2) |
| *The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||
| GRADE Working Group grades of evidence | ||||
| 1 None of studies described method of allocation concealment. | ||||
| Electroacupuncture versus relaxation for menopausal hot flushes | ||||
| Population: women with menopausal hot flushes | ||||
| Outcomes | Illustrative comparative risks* (95% CI) | No of Participants | Quality of the evidence | Comments |
| Electroacupuncture versus relaxation | ||||
| Hot flush frequency (number/day) | The mean hot flush frequency in the intervention groups was | 38 | ⊕⊝⊝⊝ | There was no significant difference between the groups in the frequency or severity of hot flushes |
| Hot flush severity | The mean hot flush severity in the intervention groups was | 38 | ⊕⊝⊝⊝ | |
| *The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||
| GRADE Working Group grades of evidence | ||||
| 1 Methods of randomization and allocation concealment not described in sufficient detail. | ||||
| Acupuncture versus waitlist or no intervention for menopausal hot flushes | ||||
| Population: women with menopausal hot flushes | ||||
| Outcomes | Illustrative comparative risks* (95% CI) | No of Participants | Quality of the evidence | Comments |
| Acupuncture versus wait listing or no intervention | ||||
| Change in frequency of hot flushes from baseline to end of study | The mean change in frequency of hot flushes from baseline to end of study in the intervention groups was | 463 | ⊕⊕⊝⊝ | Acupuncture significantly reduced the frequency and severity of hot flushes compared to waiting list or no intervention The effect size was moderate in both cases Frequency: SMD ‐0.5 (‐0.69 to ‐0.31) Severity: SMD ‐0.54 (‐0.73 to ‐0.35) |
| Change in hot flush severity from baseline to end of study | The mean change in hot flush severity from baseline to end of study in the intervention groups was | 463 | ⊕⊕⊝⊝ | |
| *The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||
| GRADE Working Group grades of evidence | ||||
| 1 Only 1/3 studies described satisfactory methods of randomization and allocation concealment; 2/3 unblinded. | ||||
Background
Menopause is said to have occurred once a period of 12 months of amenorrhoea (no menstrual periods) has elapsed. Perimenopause is the time period prior to menopause and ends 12 months after the final menstrual period (Soules 2001). This menopausal transition reflects a period of changing ovarian function, which may precede the final menstrual period by between two and eight years (Greendale 1999). Postmenopause is defined as all the years after the last menstrual period (Soules 2001). The menopause is brought about by a decrease in ovarian hormone secretion (Soules 2001). It can occur naturally as the result of aging or from surgical removal of the ovaries, radiotherapy, or chemotherapy. Most women experience natural menopause between 40 and 58 years of age (NIH 2005).
From perimenopause to late postmenopause, some women experience problems such as vasomotor and vaginal symptoms, urinary stress incontinence, sexual dysfunction, impaired quality of life, mood disturbance, depression, and cognitive difficulties (NAMS 2012). Vasomotor symptoms are highly prevalent across menopausal stages in most societies (Freeman 2007).
Description of the condition
Hot flushes (or hot flashes) are the most common vasomotor symptom related to menopause and perimenopause. Hot flushes are thought to result from the brain's response to diminished hormones and hormonal fluctuations during the menopause transition, with instability of the thermoregulatory mechanisms that regulate temperature homeostasis in the hypothalamus (Freeman 2007).
They are characterized by a sensation of intense heat in the face, neck, or chest accompanied by objective signs of cutaneous vasodilation and a subsequent drop in core temperature (Stearns 2002). Women may also experience sweating, flushing, palpitations, anxiety, irritability, and night sweats (Stearns 2002). The reported prevalence of hot flushes varies from 13% to 79% (median 41%) among perimenopausal women and from 8% to 80% (median 41.5%) in postmenopausal women.
It is reported that almost two‐thirds of postmenopausal women experience hot flushes, and 10% to 20% of these find them very distressing (Borud 2009). They are often accompanied by sweating, and can cause disruption of sleep patterns, irritability, and disturbance of daily activity.
Description of the intervention
Hormone therapy (HT) (oestrogen or combined oestrogen‐progestogen therapy) is the most common treatment for hot flushes, and the North American Menopause Society (NAMS 2012) supports its use for treating moderate‐to‐severe vasomotor symptoms. However, an increased risk of cardiovascular disease and breast cancer has been observed in healthy menopausal women treated with HT (Marjoribanks 2012). The publication of the Women's Health Initiative study, which highlighted these risks, has resulted in reduced use of HT. Among French‐speaking women in Quebec, the total number of women on long‐term HT and new users has declined by 28% and 50%, respectively (Guay 2007).
Due to lack of confidence in pharmacological interventions, many menopausal women are trying complementary and alternative medicines (CAM). More than half of peri‐ and postmenopausal women use some type of CAM, including dietary and herbal therapies, stress management, acupuncture, and massage therapy (Newton 2002; Wathen 2006; Gold 2007).
Acupuncture has been proposed for various indications including dental pain, fibromyalgia, nausea, vomiting, knee osteoarthritis, insomnia, epicondylitis, chronic back pain, idiopathic headache, resolution of breech presentation, and as an aid during gastrointestinal endoscopy (Ernst 2006). Estimates of the prevalence of acupuncture use by mid‐life women ranges from 1% to 10.4% (Newton 2002; Wathen 2006; Gold 2007).
Acupuncture is defined as the practice of inserting a needle or needles into certain points in the body for therapeutic purposes (Nasir 2002). Manual pressure (acupressure), small electric currents through the inserted needles (electroacupuncture), and lasers can also stimulate these points. Laser acupuncture is defined as the stimulation of traditional acupuncture points with low‐intensity, non‐thermal laser irradiation (Whittaker 2004).
Types of acupuncture include the following:
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traditional Chinese medicine (TCM) acupuncture involves the insertion of needles into body acupoints for therapeutic purposes;
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electroacupuncture involves passing small electric currents through the inserted acupuncture needles;
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acupressure is a technique that involves manual pressure on the acupoints;
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laser acupuncture is defined as the stimulation of traditional acupuncture points with low‐intensity, non‐thermal laser irradiation;
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ear acupuncture uses acupuncture needles, seeds, or magnetic pearls to stimulate the acupoints located on the ear;
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moxibustion uses the heat generated by burning herbal preparation to stimulate acupuncture points;
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scalp acupuncture involves the use of acupuncture needles along the surface of the head.
It has been suggested that acupuncture may have the potential to reduce hot flush frequency and severity.
How the intervention might work
The mechanism by which acupuncture might affect health or menopausal symptoms is not completely understood. Two explanations (Western and Eastern) have been proposed. According to the Western view, luteinizing hormone (LH) pulsatility indicates that β‐endorphin activity is low after the menopause and is increased by oestrogen therapy. Nappi and colleagues found a lower concentration of β‐endorphin in the cerebrospinal fluid of postmenopausal women than in women of fertile age (Nappi 1990). Low levels of central β‐endorphin activity after menopause may contribute to elevated levels of LH and lability in thermoregulation. During oestrogen treatment, increased central opioid activity may account for a decrease in vasomotor symptoms. Acupuncture may act in the same way as HT, by increasing the activity of hypothalamic β‐endorphin (Wyon 2004). It has also been observed that acupuncture may affect the nervous system by modulating the levels of several neurotransmitters and neuropeptides and may also have an immunomodulatory effect (Cabyoglu 2006).
The Eastern view of acupuncture is based on Chinese medical philosophy. Through the stimulation of specific points, acupuncture tries to re‐establish the energy balance in order to treat disease. According to Chinese medicine theory, energy (qi) flows through the body along meridians and the disruption of this flow causes disease (Pearl 1999). TCM acupuncture stimulates the qi at points along the body meridians that pass through major organs. It effectively opens blocked gates to increase energy flow and balance Yin and Yang. This enables the person to achieve optimal health. Acupuncture specific to menopausal symptoms is designed to correct a condition known as deficient heat. This condition is a deficiency in Yin energy and is characterized by "five palm sweats", night sweats, and a general mental agitation. Acupuncture points specific to menopausal symptoms balance the kidney qi by subduing kidney Yang, nourish the heart, and quieten the spirit (Cohen 2003).
Acupuncture treatment might also have additional physical and mental health benefits for perimenopausal and menopausal women, such as improving quality of sleep and decreasing feelings of fatigue.
Why it is important to do this review
If shown to be effective, acupuncture could be used to treat menopausal hot flushes and improve quality of life, offering an alternative to HT. A systematic review is required to determine whether acupuncture is effective and safe for reducing menopausal vasomotor symptoms.
Objectives
To determine whether acupuncture is effective and safe for reducing hot flushes and improving the quality of life of menopausal women with vasomotor symptoms.
Methods
Criteria for considering studies for this review
Types of studies
We included only randomized controlled trials (RCTs) in the review. Studies using cross‐over designs were included only if pre‐cross‐over data were available. We excluded quasi‐RCTs.
Types of participants
We included perimenopausal, menopausal, and postmenopausal women of any age recruited from any healthcare setting in the review. Only women experiencing hot flushes at baseline were included.
We defined menopausal status according to the Stages of Reproductive Aging Workshop (STRAW) criteria (Soules 2001). We defined menopause as occurring after 12 months of amenorrhoea; perimenopause as the time period prior to menopause, ending 12 months after the final menstrual period; and postmenopause as all the years beyond the last menstrual period. Trials that included women with menopause due to surgical removal of ovaries, radiation, or chemotherapy were eligible.
Types of interventions
Trials of any type of acupuncture were eligible, including TCM acupuncture, electroacupuncture, acupressure, laser acupuncture, ear acupuncture, moxibustion, and scalp acupuncture, regardless of the duration of treatment.
Control groups could receive no intervention (e.g. wait list), placebo acupuncture, sham acupuncture, HT, or any other active therapy. We defined placebo acupuncture as a needle not penetrating the skin but placed over the same acupuncture points and sham acupuncture as a needle located outside of acupuncture points, or shallow needling.
We considered acupuncture interventions combined with other interventions, provided both interventions were given to both comparison groups.
Types of outcome measures
Primary outcomes
Hot flush
Change in hot flushes (with or without night sweats): change in frequency or severity, evaluated subjectively by participants, using daily diaries, any validated objective scoring system, or other generic measures of vasomotor symptoms.
Secondary outcomes
Quality of life
Evaluated with any validated quality of life instrument (e.g. the Menopause‐Specific Quality of Life (Hilditch 1996), Women's Health Questionnaire (WHQ) (Hunter 1992), or other generic measures of quality of life.
Adverse events
All adverse events (e.g. needling pain, bleeding at the site of needling, trauma to internal organs).
Search methods for identification of studies
We searched for all published and unpublished RCTs of acupuncture for hot flushes, without language restriction and in consultation with the Menstrual Disorders and Subfertility Group (MDSG) Trials Search Co‐ordinator. Searches were first conducted in 2008 and then again in January 2013.
Electronic searches
We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, CINAHL, PsycINFO, Chinese Biomedical Literature Database (CBM), Chinese Medical Current Content (CMCC) (www.cmcc.org.cn), China National Knowledge Infrastructure (CNKI), VIP database, Dissertation Abstracts International, Current Controlled Trials (controlled‐trials.com), Clinicaltrials.gov (clinicaltrials.gov), National Center for Complementary and Alternative Medicine (NCCAM) (nccam.nih.gov/clinicaltrials/alltrials.htm), BIOSIS, AMED (The Allied and Complementary Medicine Database), Acubriefs, and Acubase (see the Appendix 1; Appendix 2; Appendix 3; Appendix 4; Appendix 5; Appendix 6; Appendix 7; and Appendix 8 for search strategies).
We searched the following clinical trial registries for ongoing trials:
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Australian and New Zealand Clinical Registry (www.anzctr.org.au/);
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Chinese Clinical Trial Register (www.chictr.org);
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Current Controlled Trials (controlled‐trials.com);
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Clinical trials.gov (clinicaltrials.gov);
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ISRCTN (www.isrctn.org/);
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WHO International Clinical Trial Registration Platform search portal (www.who.int/trialsearch/).
Searching other resources
We handsearched relevant journals, conference abstracts, and the reference lists of studies identified.
Data collection and analysis
We conducted data collection and analysis in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
Selection of studies
Three review authors (SD, GA, and CB) undertook trial selection. One review author (WT) searched the Chinese databases. GA and CB screened the titles and abstracts of articles found in the search and discarded trials that were clearly ineligible.
SD, GA, and CB independently assessed whether the trials met the inclusion criteria, with disagreements resolved by discussion. When articles contained insufficient information to make a decision about eligibility, CB attempted to contact authors of the original reports to obtain further details; if there was no response, CB sent a reminder.
Data extraction and management
Two review authors (GA and CB) independently extracted data using a form designed by the review authors for this purpose. We resolved discrepancies by discussion or in consultation with a third review author (SD). For each included trial, we collected information regarding the location of the trial, methods of the trial, risk of bias, participants (age range, eligibility criteria), type of interventions, and effect of interventions.
Assessment of risk of bias in included studies
Two review authors (CV and JP) independently assessed risk of bias using The Cochrane Collaboration's 'Risk of Bias' tool (Higgins 2011). We resolved any disagreements between review authors by discussion or with a third party. For each study, the seven domain‐based criteria were: random sequence generation, quality of allocation concealment, blinding of participants and personnel, blinding of outcome assessors, completeness of outcome data, risk of selective outcome reporting, and other potential bias. The review authors assessed each domain as at high, low, or unclear risk of bias. See Characteristics of included studies.
Measures of treatment effect
All data were continuous. If all studies reported exactly the same outcomes we calculated mean difference (MDs) between treatment groups. If similar outcomes were reported on different scales, we calculated the standardized mean difference (SMD). We presented 95% confidence intervals (CI) for all estimates.
Unit of analysis issues
We planned to use only first‐phase data from cross‐over studies, had any cross‐over studies been eligible.
Dealing with missing data
We analyzed the data on an intention‐to‐treat basis as far as possible and we attempted to obtain missing data from the original trialists. Where these were unobtainable, we analyzed only the available data.
Assessment of heterogeneity
We considered whether the clinical and methodological characteristics of the included studies were sufficiently similar for meta‐analysis to provide a clinically meaningful summary.
We examined heterogeneity between the results of different trials informally by the overlap in their CIs. Poor overlap generally indicates the presence of statistical heterogeneity. In additon, more formally, we employed the results of the Chi2 test to determine the strength of evidence that heterogeneity was genuine. A low P value (or a large Chi2 statistic relative to the degree of freedom) suggests heterogeneity of effects (variation in effect estimates beyond chance).
An I2 statistic was also calculated and interpreted as:
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0% to 40% might not be important;
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30% to 60% represents moderate heterogeneity;
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50% to 90%, represents substantial heterogeneity;
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75% to 100%, represents considerable heterogeneity (Higgins 2011).
Assessment of reporting biases
In view of the difficulty of detecting and correcting for publication bias and other reporting biases, the review authors aimed to minimize the potential impact of reporting bias by ensuring a comprehensive search for eligible studies and by being alert for duplication of data.
Data synthesis
We combined data from included studies using random‐effects models in the following comparisons:
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acupuncture versus sham‐acupuncture;
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acupuncture versus HT;
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electroacupuncture versus relaxation;
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acupuncture versus waitlist or no intervention.
We stratified analyses by type of acupuncture.
Subgroup analysis and investigation of heterogeneity
We performed subgroup analyses for the primary outcome to determine the separate evidence for:
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acupuncture in cancer trials;
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acupuncture in trial less of 12 weeks duration;
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acupuncture in trial of 12 weeks and more.
Sensitivity analysis
We conducted sensitivity analyses for the primary outcome, to investigate the impact of:
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restricting eligibility to studies without high risk of bias;
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adopting a fixed‐effect model.
Overall quality of the body of evidence: 'Summary of findings' table
Summary of findings tables were generated using GRADEPRO software. These tables evaluated the overall quality of the body of evidence for primary review outcomes for comparisons of acupuncture versus sham acupuncture, using GRADE criteria (study limitations (i.e. risk of bias), consistency of effect, imprecision, indirectness, and publication bias).
Results
Description of studies
See: Characteristics of included studies; Characteristics of excluded studies.
Results of the search
We identified and screened 384 references. We excluded 322 references based on the title and abstract, and retrieved 62 references for more detailed evaluation. From these, we excluded 46 publications, and included 16 publications (Figure 1).
Study flow diagram.
Included studies
Sixteen RCTs with 1155 participants met the inclusion criteria. Ten studies compared acupuncture versus sham acupuncture (Avis 2008; Bokmand 2013; Deng 2007; Hervik 2009; Kim 2011; Nir 2007; Painovich 2012; Venzke 2010; Vincent 2007; Wyon 2004). Two RCTs compared acupuncture versus HT (Frisk 2008; Zhou 2011). One RCT compared acupuncture versus relaxation (Nedstrand 2006). Five RCTs compared acupuncture versus wait list or no intervention (Bokmand 2013; Borud 2009; Kim 2010; Painovich 2012; Park 2009). We presented full descriptions of the studies in the Characteristics of included studies table.
Study design
All of the trials were parallel‐group RCTs.
Trials took place in China (Zhou 2011), Korea (Kim 2010; Kim 2011; Park 2009), Norway (Borud 2009; Hervik 2009), Sweden (Frisk 2008; Nedstrand 2006; Wyon 2004), Denmark (Bokmand 2013), and the US (Avis 2008; Deng 2007; Nir 2007; Painovich 2012; Venzke 2010; Vincent 2007). Five of the studies were multicentred Avis 2008; Borud 2009; Frisk 2008; Kim 2010; (Nedstrand 2006).
Only four studies reported the use of intention‐to‐treat analysis Borud 2009; Kim 2010; Kim 2011; (Vincent 2007). Five studies reported use of power calculations for estimating their sample size (Bokmand 2013; Borud 2009; Deng 2007; Kim 2011; Vincent 2007).
Participants
The range of mean participant age was 51 to 57 years. In seven studies, participants were recruited through newspaper advertisements (Borud 2009; Kim 2011; Nir 2007; Park 2009; Venzke 2010; Wyon 2004; Zhou 2011); in one study they were recruited through local newspaper advertisements, hospital posting, and notifications in the community meeting (Kim 2010); in seven studies via cancer centres or clinic centres (Avis 2008; Bokmand 2013; Deng 2007; Frisk 2008; Hervik 2009; Nedstrand 2006; Vincent 2007), and in one study by mailing advertisements near the medical centre and via the medical centre intranet (Painovich 2012).
All studies included perimenopausal or postmenopausal women, or both. Six studies used follicle‐stimulating hormone or serum oestradiol levels (or both) for confirming the menopausal status of participants (Borud 2009; Kim 2010; Nir 2007; Park 2009; Venzke 2010; Wyon 2004). Six studies determined menopausal status by self reported levels of hot flushes (Avis 2008; Hervik 2009; Kim 2011; Nedstrand 2006; Painovich 2012; Vincent 2007). Three studies did not state how menopausal status was determined (Bokmand 2013; Deng 2007; Frisk 2008). One study included women who had received a bilateral ovariectomy (Zhou 2011).
All women had vasomotor symptoms at baseline. Seven studies did not specify a minimum number of hot flushes as an inclusion criterion (Bokmand 2013; Frisk 2008; Hervik 2009; Kim 2011; Nedstrand 2006; Wyon 2004; Zhou 2011). Other studies required had 3 to 15 hot flushes daily as an inclusion criterion.
Only one study did not report the demographic characteristics of participants at baseline (Nedstrand 2006). In all others, the study groups were well balanced and no significant differences in demographic characteristics were reported at baseline.
Five trials enrolled women with breast cancer who had previously completed their treatment and experienced hot flushes (Bokmand 2013; Deng 2007; Frisk 2008; Hervik 2009; Nedstrand 2006). In one study, women were treated with the oestrogen antagonist, tamoxifen (Hervik 2009).
Interventions
The duration of acupuncture treatment varied considerably between studies. It ranged from four to five weeks (Bokmand 2013; Deng 2007; Kim 2010; Park 2009; Vincent 2007), seven to eight weeks (Avis 2008; Kim 2011; Nir 2007), 10 weeks (Hervik 2009; Vincent 2007), and 12 weeks (Borud 2009; Frisk 2008; Nedstrand 2006; Painovich 2012; Venzke 2010; Zhou 2011).
Traditional acupuncture was performed in 11 trials (Avis 2008; Bokmand 2013; Borud 2009; Deng 2007; Hervik 2009; Kim 2010; Kim 2011; Nir 2007; Painovich 2012; Venzke 2010; Vincent 2007), electroacupuncture in three trials (Frisk 2008; Nedstrand 2006; Wyon 2004), acupuncture and auricular acupressure (Zhou 2011), and moxibustion in one trial (Park 2009). The acupuncture points used differed across studies. In three trials, the acupuncturists administered individualized acupuncture treatment for each participant (Borud 2009; Nir 2007; Venzke 2010) and 13 trials used a standardized formula with the number of acupuncture points selected ranging from 4 to 13 points (Avis 2008; Bokmand 2013; Deng 2007; Frisk 2008; Hervik 2009; Kim 2010; Kim 2011; Painovich 2012; Nedstrand 2006; Park 2009; Vincent 2007; Wyon 2004; Zhou 2011).
All trials provided data on compliance with the intervention(s).
Outcomes
Vasomotor symptoms
All studies assessed vasomotor symptoms by self report. Five assessed only vasomotor symptoms such as hot flush frequency and severity ( Avis 2008; Deng 2007; Kim 2011; Vincent 2007;Zhou 2011). Climacteric symptoms were assessed by the Menopause Rating Scale (MRS) (Kim 2010; Kim 2011), WHQ (Borud 2009), Greene Climateric Scale (Venzke 2010), Modified Kupperman's Index (Frisk 2008; Hervik 2009; Nedstrand 2006; Wyon 2004), visual analogue scale (VAS) (Bokmand 2013; Nedstrand 2006; Park 2009; Wyon 2004), and Hot Flash Related Daily Interference Scale (HFRDIS) (Avis 2008).
The diary of vasomotor symptoms was the most commonly used tool to quantify hot flush frequency and severity. For all RCTs, the frequency of hot flushes was based on the number of hot flushes recorded by day. Few authors calculated a mean daily hot flush score from seven days of values. More recent studies evaluated the mean reduction in average 24‐hour hot flush frequency and severity from baseline to the end of the study. The different hot flush severity scores used and results of frequency and severity recalls by women complicated the comparison among trials in regards of the severity results. Severity was evaluated according to different rating scales ranging from 1 to 3 (mild to severe symptoms), 1 to 4 (mild to very severe symptoms), by VAS of 1 to 10, and according to log transformation of the severity scores obtained.
Quality of life
Quality of life was assessed in three studies, which used the Menopausal‐Specific Quality of Life Scale (MENQoL) (Nir 2007; Park 2009; Painovich 2012).
Excluded studies
We excluded 46 trials (see Characteristics of excluded studies). The most common reason for exclusion was that participants did not meet the inclusion criteria for the intervention studies; for example, qualitative and observational research, case history and abstract of annual meeting with no further scientific publication of their results (Mingling 1991; Ji 1998; Towlerton 1999; Gui‐e 2000; Cummins 2000; Tukmachi 2000; Zhenya 2001; De Valois 2003; Xu 2004; Hu 2005; Perez 2005; Xiaoming 2005; Zhou 2006; Walker 2007; Huazhang 2008; Walker 2008; Guévin 2009; Hervik 2010; Borud 2010; De Valois 2010; Otte 2011; Castelo Branco 2011; Azizi 2011; Spetz Holm 2012; Kao 2012; Lesi 2012). We excluded eight studies due to insufficient data information related to vasomotor symptoms in order to meet the review inclusion criteria (Wyon 1995; Cohen 2003; Huo 2004; Li 2005; Jin 2007; Xia 2008; O'Brien 2010; Walker 2010). One study did not assess hot flushes outcome in their psychological distress study (Sandberg 2002). Two studies assessed only acupuncture techniques (Facchinetti 1989; Grilli 1989). Four studies were a duplicate of an included trial (Nedstrand 2005; Huang 2006; Zaborowska 2007; Frisk 2012). We excluded five studies because they were not randomized (Davies 2001; Harris 2002; Porzio 2002; Zhang 2006; Sunay 2011).
Risk of bias in included studies
For further details, see the methodological quality summary (Figure 2) and methodological quality graph (Figure 3).
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Allocation
Generation of random sequence
We rated 12 studies as at low risk of bias related to sequence generation; these studies used computer‐generated randomization, randomization tables, or fully‐described drawing of lots. We rated the other four studies as at unclear risk of this bias.
Allocation concealment
We rated three studies as at low risk of bias related to allocation concealment; these studies used remote allocation. We rated the other 13 studies as at unclear risk of bias because they did not describe an acceptable method of allocation concealment; this included several studies that used envelopes for allocation concealment but did not state whether the envelopes were sealed, opaque and sequentially numbered.
Blinding
As our primary review outcome was self assessed, we considered that lack of participant blinding could influence outcome measures. We rated 11 studies as at low risk of bias because participants (at least) were blinded. We rated five as at high risk of bias because participants were not blinded.
Incomplete outcome data
We assessed 12 of the 16 studies as at low risk of attrition bias. We considered four studies to be at high risk of attrition bias due to high dropout rates.
Selective reporting
We evaluated each study for the possible risk of selective reporting bias. We considered all studies to have a low risk of selective reporting bias.
Other potential sources of bias
We considered 13 of the studies to be free of other potential sources of bias. One study was at unclear risk of bias due to lack of information about the baseline characteristics of participants (Nedstrand 2006), one study was at high risk due to reported differences in the baseline characteristics of the two groups of women (Nir 2007), and one was at unclear risk because during the project period some women received another type of treatment (which had no effect on the acupuncture according to the authors) (Bokmand 2013).
Effects of interventions
See: Summary of findings for the main comparison Acupuncture versus sham acupuncture for menopausal hot flushes; Summary of findings 2 Acupuncture compared to hormone therapy for menopausal hot flushes; Summary of findings 3 Electroacupuncture versus relaxation for menopausal hot flushes; Summary of findings 4 Acupuncture versus waitlist or no intervention for menopausal hot flushes
1. Acupuncture versus sham acupuncture
Primary outcome
Hot flushes
Eight studies compared traditional acupuncture (Avis 2008; Deng 2007; Hervik 2009; Kim 2011; Nir 2007; Vincent 2007) or electroacupuncture (Wyon 2004) versus sham acupuncture, and reported hot flush frequency or severity.
No significant difference was found between the groups for hot flush frequency (MD ‐1.13 flushes per day, 95% CI ‐2.55 to 0.29, 8 RCTs, 414 women, I2 = 70%) (Figure 4), but flushes were significantly less severe in the acupuncture group, with a small effect size (SMD ‐0.45, 95% CI ‐0.84 to ‐0.05, 6 RCTs, 297 women, I2 = 62%) (Figure 5).
Forest plot of comparison: 1 Acupuncture versus sham acupuncture, outcome: 1.1 Hot flush frequency (number/day).
Forest plot of comparison: 1 Acupuncture versus sham acupuncture, outcome: 1.2 Hot flush severity.
There was substantial heterogeneity for both these outcomes. We considered clinical and methodological differences between the studies that might explain the heterogeneity and noted that a post‐hoc analysis excluding studies of women with cancer eliminated heterogeneity for hot flush frequency (MD 0.15 flushes per day, 95% CI 0.61 to 0.91, 6 studies, 188 women, I2 = 0%) and reduced heterogeneity for the analysis of hot flush severity (MD ‐0.29, 95% CI ‐0.62 to 0.04, 5 studies, 237 women, I2 = 34%). There was no longer a significant difference between the groups for hot flush severity when we excluded the single study of women with cancer.
No significant difference was found between the groups in subgroup or sensitivity analysis of hot flush frequency (Analysis 1.3; Analysis 1.4; Analysis 1.5; Analysis 1.8), but acupuncture significantly reduced hot flush severity compared to sham acupuncture in a study of women with cancer (Analysis 1.6) and in studies of less than 12 weeks' duration (Analysis 1.7).
Secondary outcomes
Quality of life
Two studies compared traditional acupuncture versus sham acupuncture and reported quality of life. No significant difference was found between the groups (SMD 0.11, 95% CI ‐0.33 to 0.55, 2 RCTs, 80 women, I2 = 0%) (Analysis 1.9).
No significant difference was found between the groups for any of subgroup analyses (Analysis 1.10; Analysis 1.11).
Adverse events
Three studies reported no adverse events (Venzke 2010; Vincent 2007; Wyon 2004), and three noted some minor adverse effects, such as slight bruising at the needle site (Deng 2007; Kim 2011; Nir 2007). Three trials did not report this outcome (Avis 2008; Hervik 2009; Painovich 2012).
2. Acupuncture versus hormone therapy
Primary outcome
Hot flushes
Three studies compared electroacupuncture (Frisk 2008; Wyon 2004), or acupuncture plus auricular acupressure (Zhou 2011), versus HT and reported hot flush frequency or severity. When these studies were pooled, acupuncture was associated with significantly more hot flushes per day than HT (MD 3.18 flushes per day, 95% CI 2.06 to 4.29, 3 RCTs, 114 women, I2 = 0%) (Figure 6). No significant difference was found between the groups for hot flush severity (SMD 0.53, 95% CI ‐0.14 to 1.20, 2 RCTs, 84 women, I2 = 57%) (Figure 7). There was moderate heterogeneity for hot flush severity: the study of electroacupuncture found a significant difference between the groups (Frisk 2008), while the study of acupuncture plus auricular acupressure found no significant difference (Zhou 2011).
Forest plot of comparison: 2 Acupuncture versus hormone therapy, outcome: 2.1 Hot flush frequency (number/day).
Forest plot of comparison: 2 Acupuncture versus hormone therapy, outcome: 2.2 Hot flush severity.
Subgroup and sensitivity analyses did not affect the main findings (Analysis 2.3).
Secondary outcomes
Quality of life
One study compared electroacupuncture versus HT and reported quality of life (Frisk 2008). Quality of life was significantly higher in the HT group (MD 0.11, 95% CI 0.01 to 0.21, 1 RCT, 41 women) (Analysis 2.4).
Adverse events
No serious adverse events were reported in the two studies.
3. Acupuncture versus relaxation
Primary outcome
Hot flushes
One study compared electroacupuncture versus relaxation and reported hot flush frequency and severity (Nedstrand 2006). There was no significant difference between the groups for either hot flush frequency (MD ‐0.40 flushes per day, 95% CI ‐2.18 to 1.38, 1 RCT, 38 women) (Analysis 3.1) or hot flush severity (MD 0.20, 95% CI ‐0.85 to 1.25, 1 RCT, 38 women) (Analysis 3.3).
Secondary outcomes
Quality of life
One study compared electroacupuncture versus relaxation and reported quality of life (Nedstrand 2006). There was no significant difference between the groups (MD 8.30, 95% CI ‐4.23 to 20.83, 1 RCT, 38 women) (Analysis 3.4).
Adverse events
No adverse events were mentioned in the study.
4. Acupuncture versus wait list or no intervention
Primary outcome
Hot flushes
Four studies compared traditional acupuncture (Borud 2009; Kim 2010; Painovich 2012), or moxibustion (Park 2009), versus wait list or no intervention and reported hot flush frequency or severity.
Traditional acupuncture was significantly more effective than wait list or no intervention in reducing hot flush frequency from baseline (SMD ‐0.50, 95 CI ‐0.69 to ‐0.31, 3 RCTs, 463 women, I2 = 0%) (Analysis 4.1). The effect size was moderate. Moxibustion was significantly more effective than wait list or no intervention in reducing the number of hot flushes per week (MD ‐5.27, 95% CI ‐8.06 to ‐2.48, 1 RCT, 28 women) (Analysis 4.2).
Traditional acupuncture was significantly more effective than wait list or no intervention in reducing hot flush severity from baseline (SMD ‐0.54, 95% CI ‐0.73 to ‐ 0.35, 3 RCTs, 463 women, I2 = 0%) (Analysis 4.3). The effect size was moderate. Similarly, acupuncture and moxibustion were significantly more effective than wait list or no intervention in reducing hot flush severity (SMD ‐1.35, 95% CI ‐1.81 to ‐0.89, 2 RCTs, 93 women, I2 = 0%) (Analysis 4.4).
Subgroup and sensitivity analyses did not affect the main findings.
Secondary outcomes
Quality of life
Four studies compared traditional acupuncture (Borud 2009; Kim 2010; Painovich 2012), or moxibustion (Park 2009), versus wait list or no intervention and reported quality of life.
Traditional acupuncture improved quality of life from baseline significantly more than wait list or no intervention (SMD ‐0.93, 95% CI ‐1.20 to ‐0.67, 3 RCTs, 463 women, I2 = 32%) (Analysis 4.5). There was no significant difference between the moxibustion and controls groups for quality of life (MD ‐0.46, 95% CI ‐5.98 to 5.06, 1 RCT, 30 women) (Analysis 4.6).
Adverse events
Two studies reported mild side effects, including skin burns related to moxibustion and bruising around the needle site (Park 2009; Kim 2010). One trial reported no adverse effects (Borud 2009), and one did not report adverse effects (Painovich 2012).
Discussion
Summary of main results
This review assessed the effectiveness of acupuncture on vasomotor symptoms in RCTs.
Studies that compared acupuncture versus sham acupuncture did not provide sufficient evidence to show whether acupuncture is an effective treatment for vasomotor symptoms. It is debatable as to whether sham acupuncture is a suitable placebo intervention due to the possibility that sham acupuncture has an active effect related to peripheral sensory stimulation.
Three small studies comparing acupuncture with HT indicated that HT was superior to acupuncture for reducing the frequency of hot flushes.
One small study compared acupuncture with relaxation and showed no significant difference between the groups.
However, comparisons of acupuncture with wait list or no treatment or control groups indicated that acupuncture reduced the frequency and severity of hot flushes from baseline to end of study and also improved quality of life.
Currently there is insufficient evidence to determine whether acupuncture is effective as a treatment for hot flushes, as there are still few studies comparing acupuncture to other treatments and the quality of some of the studies is poor. Further high‐quality studies are needed to determine the effect of acupuncture on vasomotor symptoms.
Overall completeness and applicability of evidence
Most of the included studies reported hot flush frequency, hot flush severity and quality of life, but data on adverse events were poorly reported or lacking.
Interventions were usually well described but were of limited applicability as they often used protocols requiring the acupuncturist to select acupuncture points during the intervention, based on their past experience.
There was some indication that effects may differ in studies of women with cancer, but this was unclear.
Quality of the evidence
The 16 studies included in this systematic review were published from 2004 to 2012. This suggests that acupuncture has been the subject of more studies in the last decade than previously. However, most had small sample sizes and questionable methodological quality. Many had an inadequate level of blinding and no intention‐to‐treat analysis. Meta‐analyses were generally underpowered and there was moderate‐to‐high heterogeneity in some cases. We graded the overall quality of the evidence for the primary outcomes as low to very low, using GRADE criteria (summary of findings Table for the main comparison; summary of findings Table 2; summary of findings Table 3; summary of findings Table 4). There was some indication that effects may differ in studies of women with cancer, but this was unclear.
Potential biases in the review process
This review was limited by methodological heterogeneity between the included studies, which used a variety of measures for hot flush frequency and severity. This meant that we were unable to pool some of the data. In most cases, we had no access to the original data, and some studies reported their results in tabular form. Many primary study authors failed to respond to our requests for missing data.
A strength of the review was that we made strong efforts to retrieve all RCTs on acupuncture.
Agreements and disagreements with other studies or reviews
Our results and those presented in recent reviews support our conclusion that there is currently insufficient randomized evidence to show whether acupuncture is an effective treatment for menopausal hot flushes and that further evaluation of the effects of acupuncture on vasomotor symptoms in placebo‐controlled trials is justified.
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Forest plot of comparison: 1 Acupuncture versus sham acupuncture, outcome: 1.1 Hot flush frequency (number/day).
Forest plot of comparison: 1 Acupuncture versus sham acupuncture, outcome: 1.2 Hot flush severity.
Forest plot of comparison: 2 Acupuncture versus hormone therapy, outcome: 2.1 Hot flush frequency (number/day).
Forest plot of comparison: 2 Acupuncture versus hormone therapy, outcome: 2.2 Hot flush severity.
Comparison 1 Acupuncture versus sham acupuncture, Outcome 1 Hot flush frequency (number/day).
Comparison 1 Acupuncture versus sham acupuncture, Outcome 2 Hot flush severity.
Comparison 1 Acupuncture versus sham acupuncture, Outcome 3 Hot flush frequency in trials less than 12 weeks.
Comparison 1 Acupuncture versus sham acupuncture, Outcome 4 Hot flush frequency in trials of 12 weeks and more.
Comparison 1 Acupuncture versus sham acupuncture, Outcome 5 Hot flush frequency in cancer trials.
Comparison 1 Acupuncture versus sham acupuncture, Outcome 6 Hot flush severity in cancer trials.
Comparison 1 Acupuncture versus sham acupuncture, Outcome 7 Hot flush severity in trials less than 12 weeks.
Comparison 1 Acupuncture versus sham acupuncture, Outcome 8 Hot flush severity in trials of 12 weeks and more.
Comparison 1 Acupuncture versus sham acupuncture, Outcome 9 Quality of life.
Comparison 1 Acupuncture versus sham acupuncture, Outcome 10 Quality of life in trials less than 12 weeks.
Comparison 1 Acupuncture versus sham acupuncture, Outcome 11 Quality of life in trials of 12 weeks and more.
Comparison 2 Acupuncture versus hormone therapy, Outcome 1 Hot flush frequency (number/day).
Comparison 2 Acupuncture versus hormone therapy, Outcome 2 Hot flush severity.
Comparison 2 Acupuncture versus hormone therapy, Outcome 3 Hot flush severity in cancer trials.
Comparison 2 Acupuncture versus hormone therapy, Outcome 4 Quality of life.
Comparison 3 Electroacupuncture versus relaxation, Outcome 1 Hot flush frequency (number/day).
Comparison 3 Electroacupuncture versus relaxation, Outcome 2 Hot flush frequency in cancer trials.
Comparison 3 Electroacupuncture versus relaxation, Outcome 3 Hot flush severity.
Comparison 3 Electroacupuncture versus relaxation, Outcome 4 Quality of life.
Comparison 4 Acupuncture versus waiting list or no intervention, Outcome 1 Change in frequency of hot flushes from baseline to end of study.
Comparison 4 Acupuncture versus waiting list or no intervention, Outcome 2 Hot flush frequency.
Comparison 4 Acupuncture versus waiting list or no intervention, Outcome 3 Change in hot flush severity from baseline to end of study.
Comparison 4 Acupuncture versus waiting list or no intervention, Outcome 4 Hot flush severity (end score).
Comparison 4 Acupuncture versus waiting list or no intervention, Outcome 5 Quality of life ‐ change from baseline to end of study.
Comparison 4 Acupuncture versus waiting list or no intervention, Outcome 6 Quality of life (end score).
| Acupuncture versus sham acupuncture for menopausal hot flushes | ||||
| Population: women with menopausal hot flushes | ||||
| Outcomes | Illustrative comparative risks* (95% CI) | No of Participants | Quality of the evidence | Comments |
| Acupuncture versus sham acupuncture | ||||
| Hot flush frequency (number/day) | The mean hot flush frequency in the intervention groups was | 414 | ⊕⊕⊝⊝ | There was no significant difference between the groups in the mean number of hot flushes per day |
| Hot flush severity | The mean hot flush severity in the intervention groups was | 297 | ⊕⊝⊝⊝ | Hot flushes were significantly less severe in the acupuncture group. The size of the effect was small. SMD ‐0.45 (‐0.84 to ‐0.05) |
| *The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||
| GRADE Working Group grades of evidence | ||||
| 1 Only 2/8 studies described appropriate methods of randomization and allocation concealment, one of which had very high attrition. | ||||
| Acupuncture versus hormone therapy for menopausal hot flushes | ||||
| Population: women with menopausal hot flushes | ||||
| Outcomes | Illustrative comparative risks* (95% CI) | No of Participants | Quality of the evidence | Comments |
| Acupuncture versus hormone therapy | ||||
| Hot flush frequency (number/day) | The mean hot flush frequency in the intervention groups was | 114 | ⊕⊕⊝⊝ | Hot flushes were significantly more common in the acupuncture group than in the hormone therapy group |
| Hot flush severity | The mean hot flush severity in the intervention groups was | 84 | ⊕⊕⊝⊝ | There was no significant difference between the groups in the mean severity of hot flushes SMD 0.53 (‐0.14 to 1.2) |
| *The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||
| GRADE Working Group grades of evidence | ||||
| 1 None of studies described method of allocation concealment. | ||||
| Electroacupuncture versus relaxation for menopausal hot flushes | ||||
| Population: women with menopausal hot flushes | ||||
| Outcomes | Illustrative comparative risks* (95% CI) | No of Participants | Quality of the evidence | Comments |
| Electroacupuncture versus relaxation | ||||
| Hot flush frequency (number/day) | The mean hot flush frequency in the intervention groups was | 38 | ⊕⊝⊝⊝ | There was no significant difference between the groups in the frequency or severity of hot flushes |
| Hot flush severity | The mean hot flush severity in the intervention groups was | 38 | ⊕⊝⊝⊝ | |
| *The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||
| GRADE Working Group grades of evidence | ||||
| 1 Methods of randomization and allocation concealment not described in sufficient detail. | ||||
| Acupuncture versus waitlist or no intervention for menopausal hot flushes | ||||
| Population: women with menopausal hot flushes | ||||
| Outcomes | Illustrative comparative risks* (95% CI) | No of Participants | Quality of the evidence | Comments |
| Acupuncture versus wait listing or no intervention | ||||
| Change in frequency of hot flushes from baseline to end of study | The mean change in frequency of hot flushes from baseline to end of study in the intervention groups was | 463 | ⊕⊕⊝⊝ | Acupuncture significantly reduced the frequency and severity of hot flushes compared to waiting list or no intervention The effect size was moderate in both cases Frequency: SMD ‐0.5 (‐0.69 to ‐0.31) Severity: SMD ‐0.54 (‐0.73 to ‐0.35) |
| Change in hot flush severity from baseline to end of study | The mean change in hot flush severity from baseline to end of study in the intervention groups was | 463 | ⊕⊕⊝⊝ | |
| *The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||
| GRADE Working Group grades of evidence | ||||
| 1 Only 1/3 studies described satisfactory methods of randomization and allocation concealment; 2/3 unblinded. | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Hot flush frequency (number/day) Show forest plot | 8 | 414 | Mean Difference (IV, Random, 95% CI) | ‐1.13 [‐2.55, 0.29] |
| 1.1 Traditional vs. sham acupuncture | 6 | 332 | Mean Difference (IV, Random, 95% CI) | ‐1.65 [‐3.62, 0.32] |
| 1.2 Electroacupuncture vs. sham acupuncture | 1 | 28 | Mean Difference (IV, Random, 95% CI) | ‐0.30 [‐3.60, 3.00] |
| 1.3 Changes in frequency of hot flushes from baseline to end of study | 1 | 54 | Mean Difference (IV, Random, 95% CI) | ‐0.20 [‐1.68, 1.28] |
| 2 Hot flush severity Show forest plot | 6 | 297 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.45 [‐0.84, ‐0.05] |
| 2.1 Traditional vs. sham acupuncture | 4 | 215 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.44 [‐0.98, 0.10] |
| 2.2 Electroacupuncture vs. sham acupuncture | 1 | 28 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.09 [‐0.83, 0.66] |
| 2.3 Changes in severity of hot flushes from baseline to end of study | 1 | 54 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.77 [‐1.33, ‐0.22] |
| 3 Hot flush frequency in trials less than 12 weeks Show forest plot | 6 | 335 | Mean Difference (IV, Random, 95% CI) | ‐1.68 [‐3.61, 0.24] |
| 3.1 Traditional vs. sham acupuncture | 5 | 281 | Mean Difference (IV, Random, 95% CI) | ‐2.29 [‐4.88, 0.31] |
| 3.2 Changes in frequency of hot flushes from baseline to end of study | 1 | 54 | Mean Difference (IV, Random, 95% CI) | ‐0.20 [‐1.68, 1.28] |
| 4 Hot flush frequency in trials of 12 weeks and more Show forest plot | 3 | 103 | Mean Difference (IV, Random, 95% CI) | 0.15 [‐1.11, 1.40] |
| 4.1 Traditional vs. sham acupuncture | 1 | 51 | Mean Difference (IV, Random, 95% CI) | 0.10 [‐1.47, 1.67] |
| 4.2 Electroacupuncture vs. sham acupuncture | 1 | 28 | Mean Difference (IV, Random, 95% CI) | ‐0.30 [‐3.60, 3.00] |
| 4.3 Changes in frequency of hot flushes from baseline to end of study | 1 | 24 | Mean Difference (IV, Random, 95% CI) | 0.60 [‐2.13, 3.33] |
| 5 Hot flush frequency in cancer trials Show forest plot | 2 | 126 | Mean Difference (IV, Random, 95% CI) | ‐6.20 [‐16.03, 3.64] |
| 5.1 Traditional vs. sham acupuncture | 2 | 126 | Mean Difference (IV, Random, 95% CI) | ‐6.20 [‐16.03, 3.64] |
| 6 Hot flush severity in cancer trials Show forest plot | 1 | 60 | Mean Difference (IV, Fixed, 95% CI) | ‐2.40 [‐3.50, ‐1.30] |
| 7 Hot flush severity in trials less than 12 weeks Show forest plot | 5 | 269 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.50 [‐0.95, ‐0.06] |
| 7.1 Traditional vs. sham acupuncture | 4 | 215 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.44 [‐0.98, 0.10] |
| 7.2 Changes in severity of hot flushes from baseline to end of study | 1 | 54 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.77 [‐1.33, ‐0.22] |
| 8 Hot flush severity in trials of 12 weeks and more Show forest plot | 2 | 52 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.09 [‐0.63, 0.46] |
| 8.1 Electroacupuncture vs. sham acupuncture | 1 | 28 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.09 [‐0.83, 0.66] |
| 8.2 Changes in severity of hot flushes from baseline to end of study | 1 | 24 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.09 [‐0.89, 0.72] |
| 9 Quality of life Show forest plot | 3 | 104 | Std. Mean Difference (IV, Random, 95% CI) | 0.12 [‐0.26, 0.51] |
| 9.1 Traditional vs. sham acupuncture | 2 | 80 | Std. Mean Difference (IV, Random, 95% CI) | 0.11 [‐0.33, 0.55] |
| 9.2 Changes in quality of life from baseline to end of study | 1 | 24 | Std. Mean Difference (IV, Random, 95% CI) | 0.16 [‐0.64, 0.96] |
| 10 Quality of life in trials less than 12 weeks Show forest plot | 1 | 29 | Std. Mean Difference (IV, Random, 95% CI) | 0.13 [‐0.61, 0.87] |
| 10.1 Traditional vs. sham acupuncture | 1 | 29 | Std. Mean Difference (IV, Random, 95% CI) | 0.13 [‐0.61, 0.87] |
| 11 Quality of life in trials of 12 weeks and more Show forest plot | 1 | 51 | Std. Mean Difference (IV, Random, 95% CI) | 0.10 [‐0.45, 0.66] |
| 11.1 Traditional acupuncture vs. sham acupuncture | 1 | 51 | Std. Mean Difference (IV, Random, 95% CI) | 0.10 [‐0.45, 0.66] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Hot flush frequency (number/day) Show forest plot | 3 | 114 | Mean Difference (IV, Random, 95% CI) | 3.18 [2.06, 4.29] |
| 1.1 Electroacupuncture vs. HT | 2 | 71 | Mean Difference (IV, Random, 95% CI) | 3.40 [1.96, 4.84] |
| 1.2 Acupuncture + auricular acupressure vs. HT | 1 | 43 | Mean Difference (IV, Random, 95% CI) | 2.84 [1.07, 4.61] |
| 2 Hot flush severity Show forest plot | 2 | 84 | Std. Mean Difference (IV, Random, 95% CI) | 0.53 [‐0.14, 1.20] |
| 2.1 Electroacupuncture vs. HT | 1 | 41 | Std. Mean Difference (IV, Random, 95% CI) | 0.89 [0.24, 1.53] |
| 2.2 Acupuncture + auricular acupressure vs. HT | 1 | 43 | Std. Mean Difference (IV, Random, 95% CI) | 0.20 [‐0.40, 0.80] |
| 3 Hot flush severity in cancer trials Show forest plot | 1 | 41 | Std. Mean Difference (IV, Random, 95% CI) | 0.89 [0.24, 1.53] |
| 3.1 Electroacupuncture vs. HT | 1 | 41 | Std. Mean Difference (IV, Random, 95% CI) | 0.89 [0.24, 1.53] |
| 4 Quality of life Show forest plot | 1 | 41 | Mean Difference (IV, Random, 95% CI) | 0.11 [0.01, 0.21] |
| 4.1 Electroacupuncture vs. HT | 1 | 41 | Mean Difference (IV, Random, 95% CI) | 0.11 [0.01, 0.21] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Hot flush frequency (number/day) Show forest plot | 1 | 38 | Mean Difference (IV, Random, 95% CI) | ‐0.40 [‐2.18, 1.38] |
| 1.1 Electroacupuncture vs. relaxation | 1 | 38 | Mean Difference (IV, Random, 95% CI) | ‐0.40 [‐2.18, 1.38] |
| 2 Hot flush frequency in cancer trials Show forest plot | 1 | 38 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.14 [‐0.78, 0.50] |
| 2.1 Electroacupuncture vs. relaxation | 1 | 38 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.14 [‐0.78, 0.50] |
| 3 Hot flush severity Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 3.1 Electroacupuncture vs. relaxation | 1 | 38 | Mean Difference (IV, Random, 95% CI) | 0.20 [‐0.85, 1.25] |
| 4 Quality of life Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 4.1 Electroacupuncture vs. relaxation | 1 | 38 | Mean Difference (IV, Random, 95% CI) | 8.3 [‐4.23, 20.83] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Change in frequency of hot flushes from baseline to end of study Show forest plot | 3 | 463 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.50 [‐0.69, ‐0.31] |
| 1.1 Traditional acupuncture vs. waiting list/no intervention | 3 | 463 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.50 [‐0.69, ‐0.31] |
| 2 Hot flush frequency Show forest plot | 1 | 28 | Mean Difference (IV, Random, 95% CI) | ‐5.27 [‐8.06, ‐2.48] |
| 2.1 Moxibustion vs. waiting list/no intervention | 1 | 28 | Mean Difference (IV, Random, 95% CI) | ‐5.27 [‐8.06, ‐2.48] |
| 3 Change in hot flush severity from baseline to end of study Show forest plot | 3 | 463 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.54 [‐0.73, ‐0.35] |
| 3.1 Traditional acupuncture vs. waiting list/no intervention | 3 | 463 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.54 [‐0.73, ‐0.35] |
| 4 Hot flush severity (end score) Show forest plot | 2 | 93 | Std. Mean Difference (IV, Random, 95% CI) | ‐1.35 [‐1.81, ‐0.89] |
| 4.1 Acupuncture vs. waiting list/no treatment | 1 | 65 | Std. Mean Difference (IV, Random, 95% CI) | ‐1.27 [‐1.81, ‐0.74] |
| 4.2 Moxibustion vs. waiting list/no treatment | 1 | 28 | Std. Mean Difference (IV, Random, 95% CI) | ‐1.55 [‐2.43, ‐0.66] |
| 5 Quality of life ‐ change from baseline to end of study Show forest plot | 3 | 463 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.93 [‐1.20, ‐0.67] |
| 5.1 Traditional acupuncture vs. waiting list/no intervention | 3 | 463 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.93 [‐1.20, ‐0.67] |
| 6 Quality of life (end score) Show forest plot | 1 | 30 | Mean Difference (IV, Random, 95% CI) | ‐0.46 [‐5.98, 5.06] |
| 6.1 Moxibustion vs. waiting list/no intervention | 1 | 30 | Mean Difference (IV, Random, 95% CI) | ‐0.46 [‐5.98, 5.06] |
