Skip to main content

Advertisement

Log in

Efficacy of phloroglucinol for treatment of abdominal pain: a systematic review of literature and meta-analysis of randomised controlled trials versus placebo

  • Review
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Aim

Phloroglucinol is a musculotropic anti-spasmodic drug. It is frequently prescribed in many European countries with a considerable cost for health services. The purpose of this study was to review the existing randomised controlled trials (RCT) comparing the efficacy of phloroglucinol treating abdominal pain versus placebo.

Methods

A literature search was carried out up to May 2017 to select RCT comparing the effect of phloroglucinol versus placebo with intensity of abdominal pain as an endpoint. Studies concerning obstetric or gynaecologic-related pain were not included.

Results

Three RCT were included and then analysed for risk of bias and meta-analysed. Only one RCT found that phloroglucinol was superior to placebo, although with a high risk of bias. The meta-analysis found a risk ratio of 1.10 (95% CI 0.95, 1.27) with no statistical significance.

Discussion

There is insufficient data to justify the wide-spread prescription of phloroglucinol for alleviating abdominal pain.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Annaházi A, Róka R, Rosztóczy A, Wittmann T (2014) Role of antispasmodics in the treatment of irritable bowel syndrome. World J Gastroenterol 20(20):6031–6043. https://doi.org/10.3748/wjg.v20.i20.6031

    Article  PubMed  PubMed Central  Google Scholar 

  2. Vademecum (2010) Equivalencias internacionales: phloroglucinol. http://www.vademecum.es/equivalencia-lista-spasmex+tablet+80+mg+80+mg-italia-a03ax12-it_1. Accessed 13 Jun 2017

  3. Cahen R (1962) Phloroglucinol: a pharmacological reevaluation. Smooth muscle relaxing properties. Arch Int Pharmacodyn Ther 138:311–319

    CAS  PubMed  Google Scholar 

  4. Base de données publiques des médicaments (2016) Résumé des caractéristiques du produit Phloroglucinol EG 80 mg. http://base-donnees-publique.medicaments.gouv.fr/affichageDoc.php?specid=60399956&typedoc=R. Accessed 13 Jun 2017

  5. Sasaki D, Kido A, Yoshida Y (1984) Effect of antispasmodic drugs on colonic motility. Part I: laboratory study of the dog. Int J Clin Pharmacol Ther Toxicol 22:333–337

    CAS  PubMed  Google Scholar 

  6. Subissi A, Brunori P, Bachi M (1983) Effects of spasmolytics on K+−induced contraction of rat intestine in vivo. Eur J Pharmacol 96(3-4):295–301. https://doi.org/10.1016/0014-2999(83)90320-5

    Article  CAS  PubMed  Google Scholar 

  7. Vidal (2017) Médicaments par substance active: phloroglucinol. https://www.vidal.fr/Substance/phloroglucinol-3760.htm. Accessed 5 Jun 2017

  8. HAS (Haute autorité de santé) (2014) Commission de la Transparence, Avis 17 septembre 2014 Spasfon. https://www.has-sante.fr//portail/upload/docs/evamed/CT-12373_SPASFON_RI_Avis2_CT12373.pdf. Accessed 5 Jun 2017

  9. Medic’AM (2016) Données mensuelles et annuelles sur les médicaments remboursés par l’Assurance Maladie. https://www.ameli.fr/l-assurance-maladie/statistiques-et-publications/donnees-statistiques/medicament/medic-am/medic-am-mensuel-2016.php. Accessed 31 May 2017

  10. Moher D, Liberati A, Tetzlaff J, Altman DG (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 339(jul21 1):b2535. https://doi.org/10.1136/bmj.b2535

    Article  PubMed  PubMed Central  Google Scholar 

  11. Parab S, Bhalerao S (2010) Study designs. Int J Ayurveda Res 1(2):128–131. https://doi.org/10.4103/0974-7788.64406

    Article  PubMed  PubMed Central  Google Scholar 

  12. Higgins J, Altman D, Gøtzsche PC et al (2011) The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 343(oct18 2):d5928. https://doi.org/10.1136/bmj.d5928

    Article  PubMed  PubMed Central  Google Scholar 

  13. Wu Z-S, Liu LB, Tang G-H, Deng Q-L (2012) Efficacy of phloroglucinol in the treatment of patients after surgery for mixed hemorrhoid. World Chinese J Dig 1259–1262

  14. Cha BK, Choi CH, Kim BJ et al (2011) The effect of phloroglucinol in diarrhea-dominant irritable bowel syndrome: randomized, double-blind, placebo-controlled trial. Gastroenterology 140:611. https://doi.org/10.1016/S0016-5085(11)62529-8

    Google Scholar 

  15. Boubaker H, Boukef R, Claessens YE, Bouida W, Grissa MH, Beltaief K, Trimech MN, Kerkeni W, Boudhib L, Nouira S (2010) Phloroglucinol as an adjuvant analgesic to treat renal colic. Am J Emerg Med 28(6):720–723. https://doi.org/10.1016/j.ajem.2009.04.030

    Article  PubMed  Google Scholar 

  16. Fu W, Yao J, Li Q, Wang Y, Wu X, Zhou Z, Li WB, Yan JA (2014) Efficacy and safety of Parecoxib/Phloroglucinol combination therapy versus Parecoxib monotherapy for acute renal colic: a randomized, double-blind clinical trial. Cell Biochem Biophys 69(1):157–161. https://doi.org/10.1007/s12013-013-9782-6

    Article  CAS  PubMed  Google Scholar 

  17. Chassany O, Bonaz B, Bruley DES Varannes S et al (2007) Acute exacerbation of pain in irritable bowel syndrome: efficacy of phloroglucinol/trimethylphloroglucinol. A randomized, double-blind, placebo-controlled study. Aliment Pharmacol Ther 25(9):1115–1123. https://doi.org/10.1111/j.1365-2036.2007.03296.x

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  18. Association Mieux Prescrire (2010) Phloroglucinol: réactions allergiques graves. La Rev Prescrire 30:114

    Google Scholar 

  19. Committee for the Proprietary Medicinal Products (CPMP) (2002) Note for guidance on clinical investigation of medicinal products for treatment of nociceptive pain. Eur. Agency Eval. Med. Prod

  20. Tashjian RZ, Deloach J, Porucznik CA, Powell AP (2009) Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elb Surg 18(6):927–932. https://doi.org/10.1016/j.jse.2009.03.021

    Article  Google Scholar 

  21. Gerlinger C, Schumacher U, Faustmann T et al (2010) Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials. https://doi.org/10.1186/1477-7525-8-138

  22. Todd K, Funk J (1996) The minimum clinically important difference in physician-assigned visual analog pain scores. Acad Emerg Med 3(2):142–146. https://doi.org/10.1111/j.1553-2712.1996.tb03402.x

    Article  CAS  PubMed  Google Scholar 

  23. Haroon M, Haroon R, Akram J (1999) Irritable bowel syndrome—a clinical comparison of mebeverine and phloroglucinol. Pak J Gastroenterol 13:0

    CAS  Google Scholar 

  24. Cargill G, Salin B, Lubin S et al (1992) Effect of phloroglucinol on rectosigmoid motility stimulated by a test meal. Study in patients with irritable bowel syndrome. Press Medicale 21:19–23

    CAS  Google Scholar 

  25. Louvel D, Delvaux M, Staumont G, Camman F, Fioramonti J, Bueno L, Frexinos J (1996) Intracolonic injection of glycerol: a model for abdominal pain in irritable bowel syndrome? Gastroenterology 110(2):351–361. https://doi.org/10.1053/gast.1996.v110.pm8566580

    Article  CAS  PubMed  Google Scholar 

  26. Chen N-J, Cheng B, Liao J-Z, Li RX, Hu JF, Yang YZ (2011) Clinical application of phloroglucinol in special endoscopic treatment for esophageal diseases. World Chinese J Dig 19(17):1834–1838. https://doi.org/10.11569/wcjd.v19.i17.1834

    Article  CAS  Google Scholar 

  27. García-Perdomo HA, Echeverría-García F, López H, Fernández N, Manzano-Nunez R (2017) Pharmacologic interventions to treat renal colic pain in acute stone episodes: systematic review and meta-analysis. Prog Urol 27(12):654–665. https://doi.org/10.1016/j.purol.2017.05.011

    Article  PubMed  Google Scholar 

  28. Pathan SA, Mitra B, Straney LD, Afzal MS, Anjum S, Shukla D, Morley K, Hilli SAA, Rumaihi KA, Thomas SH, Cameron PA (2016) Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial. Lancet 387(10032):1999–2007. https://doi.org/10.1016/S0140-6736(16)00652-8

    Article  CAS  PubMed  Google Scholar 

  29. Dellabella M, Milanese G, Muzzonigro G (2005) Randomized trial of the efficacy of tamsulosin, nifedipine and phloroglucinol in medical expulsive therapy for distal ureteral calculi. J Urol 174(1):167–172. https://doi.org/10.1097/01.ju.0000161600.54732.86

    Article  CAS  PubMed  Google Scholar 

  30. Hübner WA, Irby P, Stoller ML (1993) Natural history and current concepts for the treatment of small ureteral calculi. Eur Urol 24(2):172–176. https://doi.org/10.1159/000474289

    Article  PubMed  Google Scholar 

  31. Chen T-D, Wang Y-H, Yang L-Y et al (2010) Phloroglucinol: safe and effective for the prevention of bladder spasm after TURP. Zhonghua nan ke xue / Natl J Androl 16:1004–1006

    CAS  Google Scholar 

  32. Romics I, Molnár DL, Timberg G, Mrklic B, Jelakovic B, Köszegi G, Blaskó G (2003) The effect of drotaverine hydrochloride in acute colicky pain caused by renal and ureteric stones. BJU Int 92(1):92–96. https://doi.org/10.1046/j.1464-410X.2003.04262.x

    Article  CAS  PubMed  Google Scholar 

  33. Surdea-Blaga T, Baban A, Nedelcu L, Dumitrascu DL (2016) Psychological interventions for irritable bowel syndrome. J Gastrointest Liver Dis 25(3):359–366. https://doi.org/10.15403/jgld.2014.1121.253.ibs

    Google Scholar 

  34. Patel S, Stason W, Legedza A et al (2005) The placebo effect in irritable bowel syndrome trials: a meta-analysis. Neurogastroenterol Motil 17(3):332–340. https://doi.org/10.1111/j.1365-2982.2005.00650.x

    Article  CAS  PubMed  Google Scholar 

  35. Boussageon R, Huas C, Rat C, et al (2017) Reconstruire l’Evidence Based pour une décision médicale partagée. Evaluation de l’efficacité et de la sécurité des médicaments fondée sur une revue systématique des essais cliniques randomisés et des méta-analyses. Exercer 130:90–4

Download references

Author information

Authors and Affiliations

Authors

Contributions

Clara Blanchard: performed the research, analysed the data and wrote the paper.

Denis Pouchain: contributed to the writing of the paper and to the analysis of the data.

Paul Vanderkam: contributed to the writing of the paper.

Marie-Christine Perrault-Pochat: contributed to the analysis of the data.

Remy Boussageon: conceived the study and analysed the data.

Hélène Vaillant-Roussel: analysed the data and contributed to the writing of the paper.

Corresponding author

Correspondence to Clara Blanchard.

Electronic supplementary material

ESM 1

(DOCX 22 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Blanchard, C., Pouchain, D., Vanderkam, P. et al. Efficacy of phloroglucinol for treatment of abdominal pain: a systematic review of literature and meta-analysis of randomised controlled trials versus placebo. Eur J Clin Pharmacol 74, 541–548 (2018). https://doi.org/10.1007/s00228-018-2416-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00228-018-2416-6

Keywords

Navigation