Effectiveness and safety of moxibustion for primary insomnia: a systematic review and meta-analysis

Sun et al. · BMC Complementary and Alternative Medicine · 2016

📊Systematic Review👥n=1,971 participants⚠️Limited evidence
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OBJECTIVE

To assess the efficacy and safety of moxibustion in the treatment of primary insomnia

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WHO

Patients aged 13 to 75 years with primary insomnia

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DURATION

Treatments ranging from 10 to 47 days

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POINTS

Mainly Bǎihuì (GV-20) and other specific points

🔬 Study Design

1971participants
randomization

Moxibustion vs. Western medications

n=477

5 studies comparing moxibustion with medications

Moxibustion vs. oral Chinese medicine

n=533

6 studies comparing with medicinal herbs

Moxibustion vs. other TCM therapies

n=961

11 studies comparing with acupuncture, massage

⏱️ Duration: Treatments ranging from 10 to 47 days

📊 Results in numbers

RR=1.17, 95% CI 1.12-1.23, P<0.00001

Overall efficacy of moxibustion

RR=1.16, 95% CI 1.09-1.24

Moxibustion vs. medications

RR=1.11, 95% CI 1.04-1.18

Moxibustion vs. Chinese medicine

RR=1.22, 95% CI 1.15-1.30

Moxibustion vs. other TCM therapies

📊 Outcome Comparison

Relative efficacy rate

Moxibustion vs. medications
1.16
Moxibustion vs. Chinese medicine
1.11
Moxibustion vs. other therapies
1.22
💬 What does this mean for you?

This study investigated whether moxibustion (the application of heat to acupuncture points) is effective in treating insomnia. The findings suggest that it may be more effective than conventional medications or other therapies, but the quality of the studies analyzed was low, so further research is needed to confirm these benefits.

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Article summary

Plain-language narrative summary

Insomnia is a sleep disorder that affects millions of people worldwide, characterized by difficulty falling asleep, maintaining sleep, or experiencing nonrestorative sleep. In industrialized countries, it is estimated that between 23% and 56% of the population suffers from this disorder, causing not only nighttime discomfort but also significant daytime consequences. Insomnia can lead to memory problems, depression, irritability, and increase the risk of cardiovascular disease, hypertension, and accidents. It also significantly compromises quality of life, affecting performance at work and in daily activities.

Despite its high prevalence, insomnia is still underdiagnosed and undertreated, with many people not seeking adequate medical care.

Conventional treatment for insomnia generally involves sedative medications and cognitive behavioral therapy. Although medications can be effective in the short term, their prolonged use is associated with a number of adverse effects, such as alterations in sleep architecture, rebound insomnia, dependence, and memory impairment. Cognitive behavioral therapy, in turn, is not always available because of the shortage of qualified therapists and the high costs. Given these limitations, many people seek alternative treatments, including traditional Chinese medicine.

Moxibustion, a technique that uses the burning of herbs over specific points on the body, has shown potential as a therapeutic alternative for insomnia in some Chinese studies, but its efficacy had not yet been systematically evaluated.

This study aimed to rigorously assess the efficacy and safety of moxibustion in the treatment of primary insomnia through a systematic review and meta-analysis. The researchers conducted a comprehensive search of several scientific databases, including PubMed, EMBASE, and Chinese databases, from inception through July 2015. Only randomized controlled trials comparing moxibustion with Western medications, oral Chinese medications, or other traditional Chinese medicine therapies in patients with primary insomnia were included. The primary outcome analyzed was the treatment efficacy rate, defined as the proportion of participants who showed improvement in sleep quality based on established criteria for evaluating insomnia treatment.

The secondary outcome was the occurrence of adverse events associated with moxibustion treatment.

A total of 22 randomized clinical trials were identified and analyzed, involving 1,971 patients. Of these, five studies compared moxibustion with Western medications, six compared it with oral Chinese medications, and eleven compared it with other traditional Chinese medicine therapies, such as acupuncture and massage. The overall analysis demonstrated that moxibustion was more effective for insomnia than all other treatment modalities tested, with a risk ratio of 1.17, indicating a 17% greater probability of improvement with moxibustion. When analyzed separately, the results showed that moxibustion was superior to Western medications, oral Chinese medications, and other traditional Chinese medicine therapies.

With regard to safety, only three studies reported adverse events, which were rare and mild, suggesting that moxibustion is a relatively safe therapy for insomnia.

Although the results suggest that moxibustion may be a promising therapeutic option for patients with insomnia, these findings should be interpreted with caution. The findings indicate that patients treated with moxibustion are more likely to experience improvement in sleep quality compared with those treated with conventional medications or other traditional therapies. This is particularly relevant given that moxibustion had a low incidence of adverse effects, unlike sedative medications, which often cause dependence, daytime drowsiness, and other unwanted effects. For health care professionals, these results suggest that moxibustion could be considered as an alternative or complement to conventional treatments, especially for patients who do not respond well to medications or who wish to avoid their adverse effects.

However, this study has important limitations that should be considered. The methodological quality of the included studies was deemed low, with a high risk of bias in several crucial aspects of the clinical research. Many studies did not adequately describe randomization methods, did not use appropriate techniques for blinding of participants and assessors, and did not provide sufficient information on how dropouts during treatment were handled. In addition, significant publication bias was detected, meaning that studies with negative results may not have been published, artificially inflating the observed benefits.

Only three studies reported safety data, limiting the ability to fully assess the adverse-event profile of moxibustion.

In conclusion, although this study suggests that moxibustion may be an effective and safe therapeutic option for primary insomnia, the available evidence is still insufficient to draw definitive conclusions about its efficacy and safety. The authors emphasize the need for more rigorous clinical studies, with better methodological quality, larger samples, and more detailed reporting of adverse events. For patients considering moxibustion as a treatment option, it is advisable to discuss with qualified health care professionals, weighing both the potential benefits and the limitations of the current evidence. Moxibustion should be viewed as a promising therapeutic option that warrants further investigation, but not as a treatment definitively shown to be superior to established conventional therapies.

Strengths

  • 1Large number of participants (1,971)
  • 2Comparison with different types of controls
  • 3Few adverse reactions reported
  • 4Sensitivity analysis performed
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Limitations

  • 1High risk of bias in the included studies
  • 2Inability to perform adequate blinding
  • 3Heterogeneous diagnostic criteria
  • 4Evident publication bias
Prof. Dr. Hong Jin Pai

Expert Commentary

Prof. Dr. Hong Jin Pai

PhD in Sciences, University of São Paulo

Clinical Relevance

Primary insomnia is one of the most frequent reasons for consultation in chronic pain and integrative medicine clinics, and the limitations of the conventional pharmacological arsenal — dependence, rebound, cognitive impairment with prolonged use — push physicians to seek alternatives with a more favorable safety profile. This meta-analysis, pooling 1,971 patients across 22 randomized trials, offers the first comprehensive quantitative synthesis on moxibustion for primary insomnia and points to consistent superiority over Western medications, Chinese herbal medicines, and other traditional Chinese medicine modalities. The relative risk of 1.17 for overall efficacy, stable across the three active comparisons, lends the result a degree of coherence that supports the inclusion of moxibustion in multimodal clinical protocols, especially for elderly patients, pregnant women, or those with contraindications to benzodiazepines and non-benzodiazepine hypnotics.

Notable Findings

The finding that most warrants attention is not only the overall superiority of moxibustion but also the consistency of the direction of effect across the three independent comparisons: an RR of 1.16 versus Western medications, 1.11 versus oral Chinese medicine, and 1.22 versus other TCM therapies such as acupuncture and massage. This pattern suggests that the effect is not an artifact of a single comparator group. The safety profile is also notable: of the 22 included studies, only three reported adverse events, all of which were mild, with no withdrawals due to toxicity. In a field where the risk of daytime sedation, falls, and cognitive impairment from hypnotic drugs is clinically significant — particularly in the elderly patient — a thermal intervention over specific points with this level of tolerability is a differentiator that the physician should not underestimate.

From My Experience

In my practice with the Acupuncture Group at the HC-FMUSP Pain Center, moxibustion for insomnia is part of the protocol when the patient shows signs of Yang deficiency — cold extremities, pale tongue, deep and slow pulse — in which dry heat over points such as Shenmen (HT-7), Zusanli (ST-36), and Baihui (GV-20) has a notably more consistent effect than needling alone. I usually observe the first signs of response between the third and fifth sessions, with improvement in sleep latency and the sense of restorative sleep; consolidation typically occurs between the eighth and twelfth sessions in the initial cycle. I routinely combine this with sleep-hygiene counseling and, when there is a relevant anxiety component, with brief cognitive behavioral therapy. The profile that responds best, in my experience, is the middle-aged or elderly patient, with predominant sleep-maintenance insomnia and somatic complaints of cold. For rebound insomnia after benzodiazepine discontinuation, moxibustion has been a valuable resource during the withdrawal transition.

Specialist physician in Medical Acupuncture. Adjunct Professor at the Institute of Orthopedics, HC-FMUSP. Coordinator of the Acupuncture Group at the HC-FMUSP Pain Center.

Full original article

Read the full scientific study

BMC Complementary and Alternative Medicine · 2016

DOI: 10.1186/s12906-016-1179-9

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Scientific Review

Marcus Yu Bin Pai, MD, PhD

Marcus Yu Bin Pai, MD, PhD

CRM-SP: 158074 | RQE: 65523 · 65524 · 655241

PhD in Health Sciences, University of São Paulo. Board-certified in Pain Medicine, Physical Medicine and Rehabilitation, and Medical Acupuncture. Scientific review and curation of every entry in this library.

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Medical disclaimer: This content is for educational purposes only and does not replace consultation, diagnosis, or treatment by a qualified professional. Some information may be assisted by artificial intelligence and is subject to inaccuracies. Always consult a physician.

Content reviewed by the medical team at CEIMEC — Integrated Centre for Chinese Medicine Studies, a reference in Medical Acupuncture for over 30 years.