Abd Elghany et al. published the first study using dextrose injection for PRP in 2019. This was a treatment comparison study. The citation is --> Abd Elghany SE, Al Ashkar DS, El-Barbary AM, El Khouly RM, Aboelhawa MA, Nada DW, Darwish NF, Hussein MS, Ragah ES, Abo-Zaid MH, Elseoky IF, Afifi S. Regenerative injection therapy and repetitive transcranial magnetic stimulation in primary fibromyalgia treatment: A comparative study. J Back Musculoskel Rehabil 2019;32:55-62.
The link for the abstract is below
The link for the abstract is below
Here is a summary
•Design: Participants were randomized to treatment of prolotherapy three times at 2 week intervals versus repetitive transcranial magnetic stimulation rTMS every other day for 1 month. DPT was with 12.5% dextrose/0.3% lidocaine in each trigger point as well as tender ligament and tendinous insertion points. Injection sites were cervical intertransverse ligaments, posterior superior trapezius, infraspinatus, common extensors, iliolumbar and SI ligament. The method was not described in enough detail to be repeatable and there were no illustrations offered to help. This is a major weakness.
•Candidates: Participants met American College of Rheumatology preliminary diagnostic criteria for fibromyalgia syndrome with exclusions for secondary fibromyalgia or systemic diseases.
•Study size: 120 female, age matched FM participants. This was a good-sized study.
•Bias: There was no mention of either allocation blinding or randomization method. This is an are of high potential bias.
•Measures: VAS pain (0-100), tender point score (classic 18), Beck Depression Inventory (BDI), Fibromyalgia Impact Questionnaire Revised (RFIQ), and measurement of cortical auditory evoked potentials (CADPs) elicited at 1000 Hz. Assessment was at 1 month post treatment. These were excellent and standard measures.
•ITT versus Per Protocol: Apparently ITT equivalent. 60 per group listed for final data analysis without dropouts mentioned. It is unusual to not have dropout from 120 initial participants. Without clear mention of dropouts or the presence of a consort flow diagram this is a concern and also has to be considered a potential source of bias.
•Other: Statistical analysis does not appear to be accurate. Specificlaly, an examination of the tables shows that the raw scores for belore, immediately after treatment, and at 1 month follow-up post treatment are listed and no change scores. Between group analysis based on raw score comparisons are not accurate althhough an examinatioof the raw scores suggests that the changes in FIQR, VAS score, and tender points would all have been significant based on the estimated chagne scores.
•Results: The DPT group had more severe pain at baseline. Clinically important improvements in VAS pain, and RFIQ, were oberved, favoring DPT. Mean tender point decrease was significantly more in the DPT group. However, the BDI and CAEPs improved significantly more in the rTMS group
•Limitations: Short duration of follow-up; only 1 month after last treatment (2 months after start of treatment.) There was substantial bias for this study, and it was a treatment comparison study rather than a controlled study. The improper statistics and limited description of treatment methods are both substantial issue although the difference between groups appears to be significant if properly done. Duye to shortcomimngs and treatment comparison deisgn, this cannot be considered more than B- evidence of benfit of potential benefit of dextrose in fibromyalgia and probably close to C level evidence.
•Design: Participants were randomized to treatment of prolotherapy three times at 2 week intervals versus repetitive transcranial magnetic stimulation rTMS every other day for 1 month. DPT was with 12.5% dextrose/0.3% lidocaine in each trigger point as well as tender ligament and tendinous insertion points. Injection sites were cervical intertransverse ligaments, posterior superior trapezius, infraspinatus, common extensors, iliolumbar and SI ligament. The method was not described in enough detail to be repeatable and there were no illustrations offered to help. This is a major weakness.
•Candidates: Participants met American College of Rheumatology preliminary diagnostic criteria for fibromyalgia syndrome with exclusions for secondary fibromyalgia or systemic diseases.
•Study size: 120 female, age matched FM participants. This was a good-sized study.
•Bias: There was no mention of either allocation blinding or randomization method. This is an are of high potential bias.
•Measures: VAS pain (0-100), tender point score (classic 18), Beck Depression Inventory (BDI), Fibromyalgia Impact Questionnaire Revised (RFIQ), and measurement of cortical auditory evoked potentials (CADPs) elicited at 1000 Hz. Assessment was at 1 month post treatment. These were excellent and standard measures.
•ITT versus Per Protocol: Apparently ITT equivalent. 60 per group listed for final data analysis without dropouts mentioned. It is unusual to not have dropout from 120 initial participants. Without clear mention of dropouts or the presence of a consort flow diagram this is a concern and also has to be considered a potential source of bias.
•Other: Statistical analysis does not appear to be accurate. Specificlaly, an examination of the tables shows that the raw scores for belore, immediately after treatment, and at 1 month follow-up post treatment are listed and no change scores. Between group analysis based on raw score comparisons are not accurate althhough an examinatioof the raw scores suggests that the changes in FIQR, VAS score, and tender points would all have been significant based on the estimated chagne scores.
•Results: The DPT group had more severe pain at baseline. Clinically important improvements in VAS pain, and RFIQ, were oberved, favoring DPT. Mean tender point decrease was significantly more in the DPT group. However, the BDI and CAEPs improved significantly more in the rTMS group
•Limitations: Short duration of follow-up; only 1 month after last treatment (2 months after start of treatment.) There was substantial bias for this study, and it was a treatment comparison study rather than a controlled study. The improper statistics and limited description of treatment methods are both substantial issue although the difference between groups appears to be significant if properly done. Duye to shortcomimngs and treatment comparison deisgn, this cannot be considered more than B- evidence of benfit of potential benefit of dextrose in fibromyalgia and probably close to C level evidence.