Cupping Therapy Article

[Viola Mathenia]

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The fibromyalgia syndrome is a condition characterised by chronic widespread pain in combination with fatigue, cognitive disturbances, sleep disorders and pronounced somatic and/or psychological distress1,2. Between 2.9 and 3.8% of the general population in Europe suffer from fibromyalgia1,3, the majority of them being women2. Only a few complementary therapies have been recommended in the treatment guidelines4, however cupping therapy has not been included due to the lack of evidence5,6.

This study aimed to investigate the efficacy of cupping therapy compared to usual care and a sham procedure to improve symptoms and quality of life in patients diagnosed with the fibromyalgia syndrome.

The trial was conducted between October 2012 and February 2015 in the Department of Complementary and Integrative Medicine in Essen, Germany. The study was approved by the ethics committee of the University Hospital Essen (approval number: 12-5056-BO) and registered at ClinicalTrials.gov (registry number: NCT01635634, date of registration 03 July 2012), prior to patient recruitment. The study was conducted according to common standard guidelines for clinical trials (Declaration of Helsinki, and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and Good Clinical Practice (ICH-GCP) revised version, Somerset West, Republic of South Africa, 1996).

This was a randomised sham-controlled three-armed parallel group trial. The intervention group received five sessions of dry cupping, whereas the control groups received either five sessions of sham cupping, or usual care. Each group received the allocated intervention within 18 days; measurements were conducted at day 0, day 18 and after 6 months. After the measurements at day 18 usual care group patients received the cupping treatment.

The trial exclusion criteria included pain due to inflammatory rheumatic disorder, any major psychiatric disorder, severe depression or substance abuse, any severe comorbidity such as cancer or neurological disorders, recently initiated or modified drug treatment, prior injections or acupuncture (within the past 3 months or during the trial), treatment with opioids or steroidal pain medication. Medications with non-steroidal anti-inflammatory drugs or antidepressants were admitted if the dosage was kept constant during the trial. Finally pregnant or lactating women or patients taking part in other clinical trials were excluded.

Patients in this group were advised to continue their usual activities and therapies, but not to initiate any new therapeutic regimen for symptom management. After baseline measurement they were asked to return at day 18 for their final examination, after which they received the cupping therapy.

The fibromyalgia impact questionnaire (FIQ)27,28 was used to determine health status and functioning of fibromyalgia patients. The FIQ is composed of 20 items, and patients can score between 0 and 100 points with higher scores indicating higher impairments. Scores above 70 usually indicate severe affliction.

Health-related quality of life was assessed using the Short Form 36 Health Survey Questionnaire (SF-36)29. This widely used comprehensive 36-item questionnaire yields an 8-scale health profile as well as two component summaries of physical and mental health-related quality of life.

Sleep disturbance was assessed on the Pittsburgh Sleep Quality Inventory (PSQI)32. Results of the PSQI are presented as seven subscales (max. 3 points each) and one total score (max. 21 points), with higher values indicating more severe sleep disturbances32.

All analyses were based on the intention to treat population, i.e. each patient providing baseline data was included in the final analysis. Missing data were substituted using the arithmetical average of 50 complete data sets created by the Markov-Chain-Monte-Carlo multiple imputation procedure in SPSS. Pain and medication diary were analysed using the per-protocol population only.

The primary outcome was analysed using the univariate analysis of covariance (ANCOVA) which modelled the post-treatment outcome as a function of treatment group (classified factor), and the respective baseline value (linear covariate). A stepwise analysis was conducted; starting with the comparison cupping therapy vs. usual care; followed by cupping therapy vs. sham cupping, each with a p-value of 0.05 indicating significant differences. Within this model the treatment effect was estimated, accompanied with a 95% confidence interval. The p-value was based on a two-sided t-test within this statistical model. All other outcomes were defined as secondary outcomes and were analysed exploratively only using comparable models, without reporting p-values. This way, no alpha level adjustment was necessary to maintain the overall type I error rate of 5%38,39.

From 362 patients initially screened by telephone, 150 patients were seen by the study physician, of whom 141 were enrolled. The most common reasons for excluding patients were violations of the inclusion criteria, or lost interest in the study. Of the 141 patients finally enrolled, all were randomised and allocated to their intervention. During the intervention seven patients each were lost to follow-up in cupping therapy and sham cupping, due to adverse events, private or unknown reasons. In the usual care group five patients were lost for similar reasons. A high proportion of patients withdrew from the study during the long-term follow up (see Fig. 1 for CONSORT flowchart).

The following non-serious adverse events were recorded in the cupping group: two patients reported severely increased pain after cupping, one patient had an accident with bruised rips and one patient had the flu. All events resolved without intervention. A fifth patient suffered from acute torticollis which radiated into the arm but was resolved without treatment within days. In sham cupping two serious adverse events were reported: one patient with a torn meniscus and one patient with persistent pain after spinal operation. Both patients had consulted a specialist on their own. A third patient in that group had the flu. No patient in the usual care group reported adverse events.

This trial included 141 mainly female patients with the fibromyalgia syndrome, and found that five cupping treatments were more effective than usual care to improve pain and mental quality of life. Cupping however was not superior to sham cupping. Patients were able to distinguish the two types of cupping, and were mildly satisfied with either intervention. Adverse events related to cupping therapy mainly included increased pain, no serious adverse events related to the intervention were observed.

Only one trial could be located during literature search40. Cao and colleagues investigated 30 patients. Cupping was performed daily for 15 days with bamboo cups that had been boiled in herbal decoction before the application. The authors found a pain decrease by 48% on average; and the effect was sustained at two weeks follow-up. In our current study cupping was not nearly as effective, for a number of possible reasons. Patients may not have been comparable between the studies as indicated by different pain levels and medication use. Cupping in the previous trial was also performed more frequently, and there might have been effects due to the herbal decoction. Patients in the trial were also diagnosed with the 1990 criteria of the American College of Rheumatology2, while diagnosis in our current trial was confirmed on the basis 2010 ACR criteria without the presence of tender point counts.

The strengths of the study include the randomised study design; the use of two different comparators; and the blinding of patients in the active treatment groups as well as outcome assessors. Outcomes were further chosen according to the guiding symptoms of fibromyalgia according to current definitions4,52; however only pain was selected as the primary outcome because it was considered the most important outcome. The low number of drop-outs at the post-intervention measurement and the overall good compliance also indicated that the tested interventions were tolerable. Finally analgesic medication and concomitant treatments were evaluated and their influence on the outcomes ruled out.

Five cupping treatments were more effective than usual care to improve pain intensity and quality of life in patients diagnosed with the fibromyalgia syndrome. Given that effects were small, and cupping was not superior to sham cupping treatments currently no recommendation for cupping in the treatment of fibromyalgia can be made. Further research is warranted for conclusive judgement of the efficacy of cupping therapy for chronic pain.

The authors want to express their gratitude towards the Pneumed GmbH for providing cupping equipment and preparing the sham cupping devices for this trial. The provider had no other role in the study.

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