- Mikyung Kim(1Department of Internal Medicine, College of Korean Medicine, Sangji University), Chang-ho Han(Department of Internal Medicine, College of Korean Medicine, Dongguk University)
- J Korean Med. 2021;42(4):75-101
2. RoB of the included studies
Only two studies15,24) which provided enough information to confirm that both the random sequence generation and allocation concealment process were properly performed, met the first domain of the RoB 2 (randomization process). The remaining included studies did not provide enough information to judge relevant procedures and were judged to be at the level of raising some concerns in this domain.
In the second domain, deviations from the intended interventions, all studies were judged to be at low RoB. Although patient blinding and performer blinding were not performed, it was judged that this situation was due to the unique nature of the cupping therapy and would not have affected the intended intervention.
In the third domain, missing outcome data, most studies were judged to be at high RoB. This was because they did not mention anything about loss to follow-up or dropout and we could not rule out the possibility that any missingness led to
biased results. Only 3 studies15,18,24) reported dropout, and we could confirm that the missingness did not bias the results, these studies were judged to be at low RoB.
In the fourth domain, measurement of the outcome, all the included studies were judged to be at high RoB. This was because no studies mentioned anything about the achievement or impact of assessor blinding.
In the fifth domain, selection of the reported result, we judged that some concerns were raised in the RoB of all included studies. No studies involved previously published study protocol papers prior to initiation of trial. Therefore, we reviewed whether the results session was described in accordance with the plans mentioned in the Methods section of the paper. No significant biases were identified in the Methods and Result sections. However, no studies provided information that could confirm whether the reported outcome was selected from among multiple outcome measurements, and therefore, this issue raised some concerns for all included studies. The overall RoB of all included studies derived by synthesizing the evaluations in the above domains was judged to be high. The results of the RoB assessment for each domain of the included studies are schematically shown in Supplements 5 and 6.
3. Meta-analysis and evidence level
1) Effectiveness of cupping therapy compared to Western medication Two studies17,24) compared the effect of wet cupping therapy with Western medication (baclofen 10 mg tid pc [P.O.]) in patients with upper limb spasticity after stroke. The meta-analysis of these two studies showed that cupping therapy was significantly more advantageous in improving upper limb dysfunction assessed by the subdomain score of the FMA scale (MD 5.20, 95% CI 1.51 to 8.88, P=0.006) (Fig. 2).
The degree of spasticity assessed by the modified Ashworth scale (MAS) was also significantly improved in the cupping therapy group compared to the Western medication group (MD -0.69, 95% CI -0.82 to -0.56, P<0.00001) (Fig. 3(A)). The proportion of patients who responded positively regarding the clinical aspects of spasticity was also significantly higher in the cupping group (MD 3.81, 95% CI 1.50 to 9.65, P=0.005) (Fig. 3(B)). Changes in the biceps and triceps muscles detected by integrated electromyography were also more favorable with cupping therapy (MD -4.05, 95% CI -6.36 to -1.74, P=0.0006; MD=3.56, 95% CI 1.62 to 5.50, P=0.0003) (Fig. 3(C, D)). The certainty of the evidence assessed by the GRADE approach was low in all cases. This was because of the high RoB and small sample size of the included studies (Supplement 7). (To Be Continued.)
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