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Table of Contents
REVIEW ARTICLE
Year : 2022  |  Volume : 8  |  Issue : 2  |  Page : 199-209

Effectiveness and safety of moxibustion for poststroke insomnia: A systematic review and meta-analysis


School of Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China

Date of Submission20-Feb-2021
Date of Decision31-Mar-2021
Date of Acceptance31-Mar-2021
Date of Web Publication07-Jan-2022

Correspondence Address:
Lu Tian
Tianjin University of Traditional Chinese Medicine, Tianjin 301617
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2311-8571.335136

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  Abstract 


Objective: This study aimed to systematically evaluate the clinical efficiency and safety of moxibustion for the treatment of poststroke insomnia (PSI). Methods: We searched PubMed, the Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service platform (Wanfang Data), Chinese Scientific Journal Database (VIP), and clinical rial for trandomized controlled trials on moxibustion as a treatment for PSI, including results from the creation of all databases until December 12, 2020. The functional languages used were Chinese and English. Two reviewers independently performed the literature search, data extraction, and quality evaluation. The primary and secondary outcome measures were the effective rate and adverse events, respectively. The meta-analysis was carried out using RevMan5.4 software and Stata15. Results: Of the 11 trials, 996 patients in mainland China were included. Compared to the control group, the combination of single moxibustion therapy or moxibustion combined with acupuncture in the treatment of DN could reduce the sleep quality score (SQS) (mean difference [MD] = −0.50, 95% confidence interval [CI] [ − 0.89, −0.11], Z = 2.51, P = 0.01), time to falling asleep score (MD = −0.39, 95% CI [−0.49, −0.29], Z = 7.79, P < 0.00001), sleep time score (MD = −0.34, 95% CI [−0.59, −0.09], Z = 2.64, P = 0.008), sleep efficiency score (MD = −0.30, 95% CI [−0.52, −0.08], Z = 2.69, P = 0.007), sleep disorder score (MD = −0.29, 95% CI [−0.49, −0.09], Z = 2.85, P = 0.004), daily function disturbance score (MD = −0.54, 95% CI [−0.82, −0.26], Z = 3.78, P = 0.0002), Pittsburgh Sleep Quality Index aggregate score (MD = −2.30, 95% CI [−2.97, −1.63], Z = 6.71, P < 0.00001), SPIEGEL aggregate score (MD = −7.62, 95% CI [−8.12, −7.12], Z = 29.75, P < 0.00001), and stroke-specific quality of life aggregate score (MD = 12.68, 95% CI [0.92, 24.44], Z = 2.11, P = 0.03). Conclusion: This study indicates that moxibustion contributes to the treatment of PSI. Nevertheless, more extensive trials are required to validate the results due to the small sample sizes, few reports on adverse effects, and high risk of bias in the included studies.

Keywords: Insomnia, meta-analysis, moxibustion, poststroke insomnia, traditional Chinese medicine


How to cite this article:
Ren JJ, Tian HC, Wang YF, Li YT, Xu Q, Tian L. Effectiveness and safety of moxibustion for poststroke insomnia: A systematic review and meta-analysis. World J Tradit Chin Med 2022;8:199-209

How to cite this URL:
Ren JJ, Tian HC, Wang YF, Li YT, Xu Q, Tian L. Effectiveness and safety of moxibustion for poststroke insomnia: A systematic review and meta-analysis. World J Tradit Chin Med [serial online] 2022 [cited 2022 Aug 8];8:199-209. Available from: https://www.wjtcm.net/text.asp?2022/8/2/199/335136




  Introduction Top


Poststroke insomnia (PSI) is a common complication of cerebrovascular diseases. Epidemiological investigations have shown that 90% of stroke patients have sleep disorders, and the incidence of insomnia in these patients is as high as 56.7%–66.7%,[1] which is much higher than the incidence in the general population (15%).[2] PSI is a mental disease caused by damage to the brain tissue.[3] The main manifestations include difficulty in falling asleep, difficulty in staying asleep,[4] poor sleep quality, and early awakening in the morning.[5] PSI could have significant detrimental effects on patients. Some studies have indicated that anxiety due to insomnia impairs the therapeutic effect,[6] the constant excitement of the nervous system increases the oxygen consumption of the brain,[7] leading to encephaloedema, which affects rehabilitation[8] and relapse,[9] as well as the quality of life[10],[11] and mental health.[12],[13],[14] PSI also aggravates other complications of stroke, such as significant disabilities and poststroke depression (PSD), and is associated with increased mortality.[15],[16],[17],[18]

Western medicine for treating PSI mainly includes pharmacological and cognitive-behavioral therapy (CBT).[10],[19],[20] Drug therapy mainly includes benzodiazepines, nonbenzodiazepines, and melatonin receptor agonists, such as alprazolam, diazepam, zolpidem tartrate, ramelteon, dexzopiclone, zaleplon, agomelatine, and estazolam.[21] Although these drugs are useful, their side effects are also evident in long-term users: disturbed sleep architecture, drowsiness, dizziness, damage to cerebral nerves, memory and psychomotor impairment, cognitive impairment, drug dependence, withdrawal effects, dependency, and addiction.[13],[22],[23],[24] CBT is also useful in clinical practice, but its short-term efficacy is less than that of drugs,[25] and it is not effective in all patients.[26] At the same time, this treatment is limited because of qualified CBT therapists' exiguity and its exorbitant price.[27]

Moxibustion is a typical therapeutic tool in traditional Chinese medicine (TCM) and has been used to prevent and treat diseases for >2000 years.[28] By burning herbal materials, moxibustion produces chemical and thermal stimulants on body surface acupoints.[29],[30] It stimulates the activity of meridian qi to adjust the disorder of human function to achieve treatment. Currently, moxibustion is widely used for the treatment of PSI. It is easy to operate, less expensive, and does not cause dependence.[31] Therefore, moxibustion has apparent advantages in the treatment of PSI. To provide evidence for moxibustion in PSI treatment, we performed a systematic review and meta-analysis of the current literature.


  Methods Top


Protocol and registration

This study protocol was registered in the PROSPERO database before the start of the review process (CRD: 42020223581).

Literature search

Electronic searches

We searched four English language electronic databases: PubMed, Embase, the Cochrane Library, Clinical Trial, and three Chinese language electronic databases: China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and the Wanfang Database. Relevant information was collected until December 12, 2020, and the languages were English and Chinese. To avoid omission, the retrieval scheme contained subject words, free words, or keywords. We searched Chinese keywords such as “Zhenci” (the Chinese Pinyin for acupuncture), “Aijiu” (the Chinese Pinyin for Moxibustion), “Zhongfeng” (the Chinese Pinyin for stroke), and English words such as “acupuncture,” “moxibustion,” “insomnia,” and “stroke” [Table 1].
Table 1: Search strategy in PubMed

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Manual searches

Retrievals were conducted at the Tianjin University of Chinese Medicine library collection (2017–2020): Journal of Tianjin University of Traditional Chinese Medicine, Tianjin Journal of Traditional Chinese Medicine, Chinese Journal of Basic Medicine in Traditional Chinese Medicine, and some related clinical trials were listed as a supplement.

Inclusion and exclusion criteria

Types of studies

Randomized controlled trials (RCTs), regardless of the blinding methods used, reported in either English or Chinese were included; non-RCTs including animal experiments, experience summaries, systematic reviews, case reports, and self-controlled trials were excluded. The definitions of the outcome measures are described in detail in [Table 2] and [Table 3].
Table 2: Characteristic of trials about moxibustion therapy for poststroke insomnia

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Table 3: Characteristic of trials about acupoint for poststroke insomnia

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The inclusion criteria were as follows: (1) patients diagnosed with PSI based on the diagnostic criteria; (2) no contraindications; (3) age over 18 years; and (4) the patients or patients' guardians agreed to participate in the study and signed the consent form.

Types of interventions

Single moxibustion treatment and moxibustion combined with acupuncture as the central part of the therapy were included.

Types of control groups

The control interventions included no treatment or single acupuncture, mind-cure, and other medical treatments.

Types of outcome measures

The primary outcome measures were the total efficacy rate, the Pittsburgh Sleep Quality Index (PSQI), SPIEGEL Sleep Questionnaire Index, and stroke-specific quality of life (SS-QOL) Scale. Secondary outcomes were the sleep quality score (SQS), time to falling asleep score (FAS), sleep time score (STS), sleep efficiency score (SES), sleep disorder score (SDS), and daily function disturbance score (DFDS).

Data extraction

Two reviewers independently determined the following information in each study: author's name, publication year, sample size (treatment group, control group), the typical course of the disease, interventions (treatment group, control group), outcome, and adverse events. Discrepancies were resolved in a consensus meeting or resolved by referral to a third reviewer if an agreement could not be reached. The independent reviewers extracted and tabulated data using a standardized data extraction form, with disagreements finally interpreted by the corresponding author.

Quality assessment

To analyze the included RCTs, two researchers used the Cochrane bias risk tool to independently assess the quality of the included trials. Each term was divided into three grades: high risks, low risk, and unclear risk, based on seven aspects: (1) random sequence generation; (2) allocation concealment; (3) blinding of participants and personnel; (4) blinding of outcome assessment; (5) incomplete outcome data; (6) selective reporting; and (7) other biases. The risk-of-bias graphs were generated using Revman version 5.4 software (London, UK).

Statistical analysis

Meta-analysis and statistical analysis were conducted using Stata 15 (Texas, USA) and RevMan 5.4, provided by the Cochrane Collaboration. The data were expressed as follows: The risk ratio was utilized to assess dichotomous data; the mean difference (MD) and standard mean difference were used to assess continuous data; the 95% confidence interval (CI) was used for interval estimation. Heterogeneity was tested using I2 statistics. If the results were uniform (P > 0.1, I2 < 50%), the fixed-effect model was selected. If not, we used a random-effect model. Subgroup analyses were performed to avoid any heterogeneity. A funnel plot was used to estimate publication bias.


  Results Top


Literature search

We searched the database and identified 110 publications and related abstracts. After an initial review of the abstracts and titles, 60 records were excluded [Figure 1]. The remaining 13 trials were reviewed in full text, and 11 trials[32],[33],[34],[35],[36],[37],[38],[39],[40],[41],[42] were finally included in the analysis. The risk of bias is shown in [Figure 2] and [Figure 3].
Figure 1: Literature search

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Figure 2: Risk of bias graph

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Figure 3: Risk of bias summary

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Study characteristics

The basic characteristics of the 11 RCTs and the details of each research scheme are shown in [Table 2] and [Table 3]. All RCTs were conducted and released in China. A total of 996 patients with PSI were enrolled, with a sample size ranging from 30 to 120. Three trials were undergoing basic stroke sequelae treatment (low-salt and low-fat diet, control blood pressure, blood lipids, and blood sugar). All patients were adults over the age of 18 years.

Among all trials, nine trials[32],[34],[35],[36],[38],[39],[40],[41],[42] selected acupuncture combined with moxibustion in the treatment group, while another two trials[33],[37] only selected moxibustion. Compared to the treatment group, five trials[32],[35],[39],[41] in the control group admitted acupuncture treatment, three trials[34],[40],[42] admitted alprazolam, and the other three trials[33],[37],[38] admitted regular life work and rest education.

Random sequence generation

Among the 11 trials, five used computer-programmed random sequencing or random number tables, which were evaluated as having a low risk of bias;[32],[33],[35],[38],[41] two trials selected the wrong sequence generation method, selected as the number of appointments, was evaluated as having a high risk of bias.[37],[39] Hence, the remaining four trials, which were evaluated as having an unclear risk of bias, did not mention the random sequence method.[34],[36],[40],[42]

Allocation concealment

Among the 11 trials, four that used sealed-envelop or random assignment methods to determine the grouping were given a low risk of bias based on allocation concealment.[32],[33],[35],[41] Two trials did not select allocation concealment during the course of treatment.[37],[39] The other five trials, which were evaluated as having unclear risk of bias, did not mention the allocation concealment method.[34],[36],[38],[40],[42]

Blinding of participants and personnel

Due to the nature of the active controls, none of the trials performed blinding.

Blinding of outcome assessment

For outcome blinding, none of the trials adopted single-blind or double-blind methods to assess the intervention measure.

Incomplete outcome data

All 11 trials had no attrition for missing participants and were considered to have a low risk of bias.[32],[33],[34],[35],[36],[37],[38],[39],[40],[41],[42]

Selective outcome reporting

None of the trials registered the protocols, but all trials reported the expected outcomes. The outcome indicators were complete and were thus considered to have a low risk of bias.

Other sources of bias

All trials were at low risk of bias due to the lack of clear evidence to display other obvious biases.

Outcomes

Efficacy rate

The effectiveness rate was evaluated in the treatments and controls in nine trials.[32],[33],[34],[35],[36],[37],[40],[41] The results showed that moxibustion therapy had significant differences (odds ratio = 3.25, 95% CI [1.3, 7.65], P = 0.007, random model, I2 = 71%, nine trials) [Figure 4].
Figure 4: Effect of moxibustion on effectiveness rate

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Sleep quality scale (SQS)

Four trials[33],[37],[38],[42] showed the time of fever disappearance in 332 PSI patients. We chose a random-effect model due to homogeneity after the test (P < 0.00001, I2 = 92%). The results suggested that the treatment group (moxibustion) was significantly more effective than the control group in decreasing the SQS (MD = −0.50, 95% CI [−0.89, −0.11], Z = 2.51, P = 0.01) [Figure 5].
Figure 5: Effect of moxibustion therapy on SQS

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Time to falling asleep score

Four trials[33],[37],[38],[42] showed the FAS of 332 PSI patients. With the result of homogeneity after the test (P = 0.61, I2 = 0%), we chose a fixed-effect model. The results suggested that the treatment group (moxibustion therapy) was significantly more effective than the control group in decreasing the FAS (MD = −0.39, 95% CI (−0.49, −0.29), Z = 7.79, P < 0.00001) [Figure 6].
Figure 6: Effect of moxibustion therapy on falling asleep score

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Sleep time score

Four trials[33],[37],[38],[42] showed the STS of 332 patients with PSI. We chose a random-effect model due to homogeneity after the test (P = 0.01, I2 = 73%). The results suggested that the treatment group (moxibustion therapy) was significantly more effective than the control group in decreasing STS (MD = −0.34, 95% CI [−0.59, −0.09], Z = 2.64, P = 0.008) [Figure 7].
Figure 7: Effect of moxibustion therapy on sleep time score

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Sleep efficiency score

Four trials[33],[37],[38],[42] showed the SES results of 332 PSI patients. We chose a random-effect model with the result of homogeneity after the test (P = 0.03, I2 = 66%). The results suggested that the treatment group (moxibustion therapy) was significantly more effective than the control group in decreasing the SES (MD = −0.30, 95% CI [−0.52, −0.08], Z = 2.69, P = 0.007) [Figure 8].
Figure 8: Effect of moxibustion therapy on sleep efficiency score

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Sleep disorder score

Four trials[33],[37],[38],[42] showed the SDS results of 332 PSI patients. We chose a random-effect model with the result of homogeneity after the test (P = 0.03, I2 = 68%). The results suggested that the treatment group (moxibustion therapy) was significantly more effective than the control group in decreasing the SDS (MD = −0.29, 95% CI [−0.49, −0.09], Z = 2.85, P = 0.004) [Figure 9].
Figure 9: Effect of moxibustion therapy on sleep disorder score

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Daily function disturbance score

Three trials[33],[37],[38] showed the DFDS results of 264 patients with PSI. We chose a random-effect model with the result of homogeneity after the test (P = 0.02, I2 = 75%). The results suggested that the treatment group (moxibustion therapy) was significantly more effective than the control group in decreasing the DFDS (MD = −0.54, 95% CI [−0.82, −0.26], Z = 3.78, P = 0.0002) [Figure 10].
Figure 10: Effect of moxibustion therapy on daily function disturbance score

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Pittsburgh Sleep Quality Index aggregate score

Six trials[32],[33],[34],[36],[37],[38] showed a PSQI of 466 PSI patients. Based on the course of treatment, six trials were divided into two subgroup analyses. The results showed that the moxibustion group had significant differences (MD = −2.15, 95% CI [−2.57, −1.74], P < 0.00001, random model, I2 = 53%, 6 trials), subgroup meta-analysis showed that the course of treatment ≤ 2 weeks (MD = −1.85, 95% CI [−2.33, −1.38), P < 0.00001, random model, I2 = 0%, 4 trials), and the course of treatment >2 weeks both showed significant differences (MD = −3.17, 95% CI [−4.04, −2.29], P < 0.00001, random model, I2 = 65%, 2 trials) [Figure 11].
Figure 11: Effect of moxibustion therapy on Pittsburgh Sleep Quality Index in different course of treatment

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SPIEGEL aggregate score

Two trials[35],[41] showed the SPIEGEL aggregate score of 145 patients with PSI. With the result of homogeneity after the test (P = 0.035, I2 = 0%), we chose a fixed-effect model. The results suggested that the treatment group (moxibustion therapy) was significantly more effective than the control group in decreasing SPIEGEL (MD = −7.62, 95% CI [−8.12, −7.12], Z = 29.75, P < 0.00001) [Figure 12].
Figure 12: Effect of moxibustion therapy on SPIEGEL

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Stroke-specific quality of life aggregate score

Three trials[35],[37],[41] showed the SS-QOL aggregate scores of 205 patients with PSI. We chose a random-effect model with the result of homogeneity after the test (P = 0.07, I2 = 62%). The results suggested that the treatment group (moxibustion therapy) was significantly more effective than the control group in increasing the SS-QOL (MD = 12.68, 95% CI [0.92, 24.44], Z = 2.11, P = 0.03) [Figure 13].
Figure 13: Effect of moxibustion therapy on stroke-specific quality of life

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Publication bias

The asymmetric distribution of the trials is shown in a funnel plot [Figure 14]. Scatters in the funnel plot were not visually symmetrical, which implies that bias existed in these trials.
Figure 14: Funnel plot

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  Discussion Top


This is the first systematic review to independently evaluate the effectiveness of moxibustion therapy for PSI. We only incorporated the widely used techniques in China for practical reasons: moxibustion (11 trials). The current analysis results support that moxibustion therapy is significantly more effective than traditional therapy (acupuncture or alprazolam) of PSI, significantly reducing the PSQI score, SPIEGEL score, and SS-QOL score of PSI patients. Therefore, we speculated that moxibustion therapy could play an essential role in treating PSI because of its effectiveness and safety, which provides a potential effect for traditional therapy in PSI treatment.

According to the subgroup meta-analysis of PSQI aggregate score, we found that when the duration of treatment is ≤2 weeks, the score can only be reduced 1.85 on average, but when it is >2 weeks, the PSQI score will be reduced 3.17 on average. These results provide an effective evidence-based direction for doctors to choose a treatment cycle in the clinic.

The mechanisms of insomnia caused by stroke include anatomy, hemodynamics,[10] neuroendocrine, and immunity. Current studies have found that when the anatomical parts of the thalamus, frontal lobe, basal ganglia, and brain stem are damaged,[43],[44] patients may suffer from sleep disorders. The brain stem, thalamus, and basal ganglia of the human body are sleep centers. Hence, after stroke, the brain's corresponding anatomical parts are damaged, the thalamus and cerebral cortex cannot be inhibited or excited normally, the sleep–wake regulation system of the brain is dysregulated, and insomnia is caused at the end. In addition, after stroke, brain tissue damage can lead to a rapid decrease in serotonin concentration in the brain.[45] Serotonin, which is involved in fatigue and sleep regulation, is the primary neurotransmitter that produces nonrapid oculomotor sleep.[46] This reduction can reduce the sleep quality. Based on current studies, the immune regulatory system may be disordered after stroke, and the levels of inflammatory response factors such as interleukin-1 (IL-1), IL-β, IL-8, and tumor necrosis factor-α are positively correlated with sleep disorders.[47] The cerebral blood volume, blood flow velocity, and cerebral blood flow decreased during sleep, and the blood supply was insufficient during sleep,[48],[49] which prevented the normal operation of sleep and arousal function, which affected the maintenance of normal sleep–wake function, resulting in abnormal nocturnal daytime sleepiness.[50]

Researchers found that local thermal stimulation of moxibustion can speed up the blood flow,[51],[52],[53] promote the release of CO from vascular endothelial cells, relax the vascular smooth muscle, and increase the cerebral blood volume,[54],[55],[56] accelerate the blood flow in the brain, and repair the damaged brain tissue. Xiao et al.[57] found that moxibustion can improve superoxide dismutase activity and act on hippocampal neurons to increase serotonin secretion to ameliorate sleep quality.[58] Moxibustion can also modulate the activity of TR-PV1 through a variety of signaling pathways, plays an anti-inflammatory role, regulates inflammatory factors, protects neurons, and restores sleep–wake function. In addition, moxibustion can also improve the decline in motor function caused by stroke. Moxibustion can activate the TRPV channel, inhibit the activation of AMPK, increase the content of NAD + in muscle, and contribute to the recovery of motor function.[59]

Acupuncture is widely used in combination with moxibustion. Acupuncture has proven to be an effective treatment for stroke and stroke-related sequelae,[60],[61],[62] such as PSI and PSD. In terms of acupoint selection, DU20 (Chinese named Baihui) has been used most frequently by researchers and has been used eight times in 11 trials. DU20 is the intersection point of the Du meridian, liver meridian of foot-queyin, and kidney meridian of foot-shaoyin. From TCM theory, it can be understood that Yang Qi of the whole body converges in DU20.[63] Acupuncture or moxibustion has the effect of refreshing the brain, resuscitating, and tonifying the brain.[64] PC6 (Chinese named Neiguan) was used six times in 11 trials. PC6 is the collateral point of the pericardial meridian of the hand jueyin, one of the eight intersecting points of the Shaoyang Sanjiao meridian of the hand. PC6 is connected to the Yinwei meridian and promotes Qi, calming nerves,[65] and relieves pain. HT7 (Chinese named Shenmen) was used eight times in 11 trials. HT7 is the original point of the hand–heart meridian of hand-shaoyin. Acupuncture or moxibustion can be used to treat heart and mental system diseases.[66],[67]

In TCM, after a stroke, qi and blood cannot go up to the brain. The heart was not supported. Kidney deficiency leads to Yin deficiency, wind stirring, and liver-Yang syndrome. Therefore, Yin and Yang's imbalance consists of the pathogenesis of insomnia that Yang does not merge into Yin. Insomnia damages qi and blood, which aggravates the deficiency of qi and blood. Therefore, the delay was not cured. Moxibustion at DU20 (Chinese named Baihui) can nourish Yang Qi, making the meridian unobstructed. Moxibustion at PC6 (Chinese named Neiguan) can nourish the heart and mind. Moreover, moxibustion at K11(Chinese named Yongquan) could nourish the kidney essence to balance Yin and Yang. Therefore, a pleasing effect must be achieved.[68]

This literature did not mention the side effects of moxibustion therapy. By consulting more literature, we found that the safety of moxibustion, especially the safety and effect of moxibustion smoke, has been widely controversial. Some studies have identified the beneficial effects of moxibustion smoke in reducing inflammatory factors and promoting blood flow.[69] However, some studies have shown that long-term exposure to this smoke environment may affect the respiratory system, and its oxidation-promoting effect might be cytotoxic.[70] Therefore, it is necessary to standardize the duration of moxibustion,[71] such as the “traditional Chinese medicine treatment technology standard moxibustion T/CACM1075-2018”[72] to ensure its safety. This will be conducive for the promotion of moxibustion therapy worldwide.

Quality of evidence

Due to the high risk of bias in these included trials, the results should be interpreted cautiously. The risk of bias was due to allocation concealment, random sequence generation, blinding of participants, etc. First, random sequence generation is essential to prevent selection bias. Only four out of 11 trials selected allocation concealment. Second, blinding of patients, doctors, and outcome assessments is also important. Since moxibustion therapy is unique, it is difficult for experimenters to employ the blinding method of clinical trials. Third, according to our clinical experience, insomniacs can easily become anxious and drop out when the treatment is invalid, especially in the long term. Therefore, details about how to prevent dropouts or how to deal with dropout data are significant in warranting the reliability and validity of data. However, most of the included studies did not report these aspects.

Limitations

  1. The diagnostic criteria for insomnia were different among the included trials. This is the same as in other meta-analyses of TCM on insomnia
  2. Evaluation criteria for efficacy, length, and moxibustion location were not identical, leading to heterogeneity among the trials or subgroup differences. Furthermore, the number of outcomes was low, which would affect the analysis of the results
  3. The overall risk of bias in the 11 included trials was high
  4. Although we adopted an adequate search strategy to minimize publication bias, there are still some randomized studies because of language restrictions
  5. There was an obvious publication bias. Some Asian countries (such as China) publish an unusually high proportion of positive results
  6. No study paid attention to adverse effects.


Implications

Our data suggest that it is necessary to perform more high-quality trials to prove the benefits of moxibustion for insomnia. In future RCTs, we suggest designing the experiment according to CONSORT 2010.[73] Although blinding of doctors and patients is difficult, blinding of outcome assessors is feasible. We recommend using recognized PSOI and SRSS scoring methods for the diagnosis and therapeutic evaluation of insomnia. For the operation of moxibustion, we suggest referring to the document[71] of moxibustion standardization.


  Conclusion Top


Our meta-analysis is the first to summarize the application of moxibustion in PSI. We found that moxibustion has many advantages in the treatment of PSI. It can better address both symptoms and root causes with a higher success rate compared to Western medicine. This review provides evidence of the treatment of PSI with moxibustion. Furthermore, the study of moxibustion in PSI requires a large sample, multicenter design, high-quality, and normative clinical to ascertain its usage in a broader medical field.

Financial support and sponsorship

This study was supported by the Special Research Project of the Traditional Chinese Medicine Industry (201107006) and the School-level Scientific Research Project of Tianjin University of Traditional Chinese Medicine (XJ201801).

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10], [Figure 11], [Figure 12], [Figure 13], [Figure 14], [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10], [Figure 11], [Figure 12], [Figure 13], [Figure 14]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 1], [Table 2], [Table 3]



 

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